Sample records for safety regulatory compliance

  1. MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Phillips, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  2. Regulatory Compliance in Multi-Tier Supplier Networks

    NASA Technical Reports Server (NTRS)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

    Over the years, avionics systems have increased in complexity to the point where 1st tier suppliers to an aircraft OEM find it financially beneficial to outsource designs of subsystems to 2nd tier and at times to 3rd tier suppliers. Combined with challenging schedule and budgetary pressures, the environment in which safety-critical systems are being developed introduces new hurdles for regulatory agencies and industry. This new environment of both complex systems and tiered development has raised concerns in the ability of the designers to ensure safety considerations are fully addressed throughout the tier levels. This has also raised questions about the sufficiency of current regulatory guidance to ensure: proper flow down of safety awareness, avionics application understanding at the lower tiers, OEM and 1st tier oversight practices, and capabilities of lower tier suppliers. Therefore, NASA established a research project to address Regulatory Compliance in a Multi-tier Supplier Network. This research was divided into three major study efforts: 1. Describe Modern Multi-tier Avionics Development 2. Identify Current Issues in Achieving Safety and Regulatory Compliance 3. Short-term/Long-term Recommendations Toward Higher Assurance Confidence This report presents our findings of the risks, weaknesses, and our recommendations. It also includes a collection of industry-identified risks, an assessment of guideline weaknesses related to multi-tier development of complex avionics systems, and a postulation of potential modifications to guidelines to close the identified risks and weaknesses.

  3. 76 FR 3825 - Regulatory Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-21

    ... Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to... regulatory compliance and enforcement activities, such as information with respect to administrative... compliance information fosters fair and consistent enforcement of important regulatory obligations. Such...

  4. 3 CFR - Regulatory Compliance

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 3 The President 1 2012-01-01 2012-01-01 false Regulatory Compliance Presidential Documents Other Presidential Documents Memorandum of January 18, 2011 Regulatory Compliance Memorandum for the Heads of Executive Departments and Agencies My Administration is committed to enhancing effectiveness and efficiency in Government. Pursuant to the...

  5. Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

    PubMed

    Pires, Carla; Vigário, Marina; Cavaco, Afonso

    2015-01-01

    Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

  6. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kroger, L.

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatorymore » Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  7. Poster — Thur Eve — 50: Common Regulatory Non-Compliances and How to Avoid Them

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Heimann, M.

    The Accelerators and Class II Facilities Division (ACFD) of the Canadian Nuclear Safety Commission (CNSC), is responsible for the oversight of radiotherapy facilities containing Class II prescribed equipment in Canada. Over the past several years, ACFD has been performing compliance inspections of Class II nuclear facilities across the country (medical and otherwise), and in that time, has issued several hundred corrective actions to licensees due to non-compliance with regulatory requirements. Recently, a study was done to determine the most common regulatory non-compliances. The purpose of this poster presentation is to disseminate information to the licensee community about the nature ofmore » these non-compliances, and how they can be avoided by licensees in the future.« less

  8. Regulatory fit effects on perceived fiscal exchange and tax compliance

    PubMed Central

    Leder, Susanne; Mannetti, Lucia; Hölzl, Erik; Kirchler, Erich

    2010-01-01

    Paying taxes can be considered a contribution to the welfare of a society. But even though tax payments are redistributed to citizens in the form of public goods and services, taxpayers often do not perceive many benefits from paying taxes. Information campaigns about the use of taxes for financing public goods and services could increase taxpayers’ understanding of the importance of taxes, strengthen their perception of fiscal exchange and consequently also increase tax compliance. Two studies examined how fit between framing of information and taxpayers’ regulatory focus affects perceived fiscal exchange and tax compliance. Taxpayers should perceive the exchange between tax payments and provision of public goods and services as higher if information framing suits their regulatory focus. Study 1 supported this hypothesis for induced regulatory focus. Study 2 replicated the findings for chronic regulatory focus and further demonstrated that regulatory fit also affects tax compliance. The results provide further evidence for findings from previous studies concerning regulatory fit effects on tax attitudes and extend these findings to a context with low tax morale. PMID:20890461

  9. Health and Safety in Family Day Care Homes: Association Between Regulatory Non-compliance and Lower Median Income.

    PubMed

    Rosenthal, Marjorie S; Jeon, Sangchoon; Crowley, Angela A

    2016-05-01

    To determine frequency of non-compliance with child care regulations among family day care homes (FDCH) and identify the role of income in compliance. We analyzed non-compliance in 746 routine, unannounced inspection and re-inspection reports of FDCH collected by the Connecticut Department of Public Health licensing specialists in 2007-2008 and linked results to median income of zip code data. We grouped the 83 state regulations into 12 regulation categories, analyzed 11 categories, and used latent class analysis to classify each FDCH as high or low compliance for each category. We used logistic regression analysis to estimate the odds ratios of low compliance. Among the 746 FDCH inspections (594 first inspections and 152 re-inspections), we found high rates of non-compliance in inspection regulations in immunizations (32.9 %), water temperature (35.6 %) and hazards (30.0 %). Among the 11 regulation categories, 4 categories (indoor safety, emergency preparedness, child/family/staff documentation, and qualifications of provider) had regulations with high non-compliance. Median household income of FDCH zip code was lower for re-inspection sites than for inspection sites ($34,715 vs. $57,118, p < 0.0001) and FDCH in the lowest quartile of income had greater odds of low compliance in indoor safety (OR 1.86, 95 % CI 1.04, 3.35, p < 0.05). The majority of FDCH were in compliance with the majority of regulations, yet there are glaring non-compliance issues in inspections and re-inspections and there are income-based inequities that place children at higher risk who are already at high risk for suboptimal health outcomes.

  10. SU-F-P-10: A Web-Based Radiation Safety Relational Database Module for Regulatory Compliance

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Rosen, C; Ramsay, B; Konerth, S

    Purpose: Maintaining compliance with Radioactive Materials Licenses is inherently a time-consuming task requiring focus and attention to detail. Staff tasked with these responsibilities, such as the Radiation Safety Officer and associated personnel must retain disparate records for eventual placement into one or more annual reports. Entering results and records in a relational database using a web browser as the interface, and storing that data in a cloud-based storage site, removes procedural barriers. The data becomes more adaptable for mining and sharing. Methods: Web-based code was written utilizing the web framework Django, written in Python. Additionally, the application utilizes JavaScript formore » front-end interaction, SQL, HTML and CSS. Quality assurance code testing is performed in a sequential style, and new code is only added after the successful testing of the previous goals. Separate sections of the module include data entry and analysis for audits, surveys, quality management, and continuous quality improvement. Data elements can be adapted for quarterly and annual reporting, and for immediate notification of user determined alarm settings. Results: Current advances are focusing on user interface issues, and determining the simplest manner by which to teach the user to build query forms. One solution has been to prepare library documents that a user can select or edit in place of creation a new document. Forms are being developed based upon Nuclear Regulatory Commission federal code, and will be expanded to include State Regulations. Conclusion: Establishing a secure website to act as the portal for data entry, storage and manipulation can lead to added efficiencies for a Radiation Safety Program. Access to multiple databases can lead to mining for big data programs, and for determining safety issues before they occur. Overcoming web programming challenges, a category that includes mathematical handling, is providing challenges that are being

  11. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance

    PubMed Central

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2010-01-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus. PMID:20495689

  12. Framing of information on the use of public finances, regulatory fit of recipients and tax compliance.

    PubMed

    Holler, Marianne; Hoelzl, Erik; Kirchler, Erich; Leder, Susanne; Mannetti, Lucia

    2008-08-01

    Information campaigns to increase tax compliance could be framed in different ways. They can either highlight the potential gains when tax compliance is high, or the potential losses when compliance is low. According to regulatory focus theory, such framing should be most effective when it is congruent with the promotion or prevention focus of its recipients. Two studies confirmed the hypothesized interaction effects between recipients' regulatory focus and framing of information campaigns, with tax compliance being highest under conditions of regulatory fit. To address taxpayers effectively, information campaigns by tax authorities should consider the positive and negative framing of information, and the moderating effect of recipients' regulatory focus.

  13. 49 CFR 554.4 - Office of Vehicle Safety Compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 6 2013-10-01 2013-10-01 false Office of Vehicle Safety Compliance. 554.4 Section 554.4 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION STANDARDS ENFORCEMENT AND DEFECTS INVESTIGATION § 554.4 Office of Vehicle Safety Compliance....

  14. Security practices and regulatory compliance in the healthcare industry.

    PubMed

    Kwon, Juhee; Johnson, M Eric

    2013-01-01

    Securing protected health information is a critical responsibility of every healthcare organization. We explore information security practices and identify practice patterns that are associated with improved regulatory compliance. We employed Ward's cluster analysis using minimum variance based on the adoption of security practices. Variance between organizations was measured using dichotomous data indicating the presence or absence of each security practice. Using t tests, we identified the relationships between the clusters of security practices and their regulatory compliance. We utilized the results from the Kroll/Healthcare Information and Management Systems Society telephone-based survey of 250 US healthcare organizations including adoption status of security practices, breach incidents, and perceived compliance levels on Health Information Technology for Economic and Clinical Health, Health Insurance Portability and Accountability Act, Red Flags rules, Centers for Medicare and Medicaid Services, and state laws governing patient information security. Our analysis identified three clusters (which we call leaders, followers, and laggers) based on the variance of security practice patterns. The clusters have significant differences among non-technical practices rather than technical practices, and the highest level of compliance was associated with hospitals that employed a balanced approach between technical and non-technical practices (or between one-off and cultural practices). Hospitals in the highest level of compliance were significantly managing third parties' breaches and training. Audit practices were important to those who scored in the middle of the pack on compliance. Our results provide security practice benchmarks for healthcare administrators and can help policy makers in developing strategic and practical guidelines for practice adoption.

  15. Security practices and regulatory compliance in the healthcare industry

    PubMed Central

    Kwon, Juhee; Johnson, M Eric

    2013-01-01

    Objective Securing protected health information is a critical responsibility of every healthcare organization. We explore information security practices and identify practice patterns that are associated with improved regulatory compliance. Design We employed Ward's cluster analysis using minimum variance based on the adoption of security practices. Variance between organizations was measured using dichotomous data indicating the presence or absence of each security practice. Using t tests, we identified the relationships between the clusters of security practices and their regulatory compliance. Measurement We utilized the results from the Kroll/Healthcare Information and Management Systems Society telephone-based survey of 250 US healthcare organizations including adoption status of security practices, breach incidents, and perceived compliance levels on Health Information Technology for Economic and Clinical Health, Health Insurance Portability and Accountability Act, Red Flags rules, Centers for Medicare and Medicaid Services, and state laws governing patient information security. Results Our analysis identified three clusters (which we call leaders, followers, and laggers) based on the variance of security practice patterns. The clusters have significant differences among non-technical practices rather than technical practices, and the highest level of compliance was associated with hospitals that employed a balanced approach between technical and non-technical practices (or between one-off and cultural practices). Conclusions Hospitals in the highest level of compliance were significantly managing third parties’ breaches and training. Audit practices were important to those who scored in the middle of the pack on compliance. Our results provide security practice benchmarks for healthcare administrators and can help policy makers in developing strategic and practical guidelines for practice adoption. PMID:22955497

  16. Disentangling the roles of safety climate and safety culture: Multi-level effects on the relationship between supervisor enforcement and safety compliance.

    PubMed

    Petitta, Laura; Probst, Tahira M; Barbaranelli, Claudio; Ghezzi, Valerio

    2017-02-01

    Despite increasing attention to contextual effects on the relationship between supervisor enforcement and employee safety compliance, no study has yet explored the conjoint influence exerted simultaneously by organizational safety climate and safety culture. The present study seeks to address this literature shortcoming. We first begin by briefly discussing the theoretical distinctions between safety climate and culture and the rationale for examining these together. Next, using survey data collected from 1342 employees in 32 Italian organizations, we found that employee-level supervisor enforcement, organizational-level safety climate, and autocratic, bureaucratic, and technocratic safety culture dimensions all predicted individual-level safety compliance behaviors. However, the cross-level moderating effect of safety climate was bounded by certain safety culture dimensions, such that safety climate moderated the supervisor enforcement-compliance relationship only under the clan-patronage culture dimension. Additionally, the autocratic and bureaucratic culture dimensions attenuated the relationship between supervisor enforcement and compliance. Finally, when testing the effects of technocratic safety culture and cooperative safety culture, neither safety culture nor climate moderated the relationship between supervisor enforcement and safety compliance. The results suggest a complex relationship between organizational safety culture and safety climate, indicating that organizations with particular safety cultures may be more likely to develop more (or less) positive safety climates. Moreover, employee safety compliance is a function of supervisor safety leadership, as well as the safety climate and safety culture dimensions prevalent within the organization. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. 7 CFR 636.17 - Compliance with regulatory measures.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 6 2011-01-01 2011-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...

  18. 7 CFR 636.17 - Compliance with regulatory measures.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 6 2013-01-01 2013-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...

  19. 7 CFR 636.17 - Compliance with regulatory measures.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 6 2014-01-01 2014-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...

  20. 7 CFR 636.17 - Compliance with regulatory measures.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 6 2012-01-01 2012-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVE PROGRAM § 636...

  1. 7 CFR 636.17 - Compliance with regulatory measures.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 6 2010-01-01 2010-01-01 false Compliance with regulatory measures. 636.17 Section 636.17 Agriculture Regulations of the Department of Agriculture (Continued) NATURAL RESOURCES CONSERVATION SERVICE, DEPARTMENT OF AGRICULTURE LONG TERM CONTRACTING WILDLIFE HABITAT INCENTIVES PROGRAM § 636...

  2. Mobile Source Emissions Regulatory Compliance Data Inventory

    EPA Pesticide Factsheets

    The Mobile Source Emissions Regulatory Compliance Data Inventory data asset contains measured summary compliance information on light-duty, heavy-duty, and non-road engine manufacturers by model, as well as fee payment data required by Title II of the 1990 Amendments to the Clean Air Act, to certify engines for sale in the U.S. and collect compliance certification fees. Data submitted by manufacturers falls into 12 industries: Heavy Duty Compression Ignition, Marine Spark Ignition, Heavy Duty Spark Ignition, Marine Compression Ignition, Snowmobile, Motorcycle & ATV, Non-Road Compression Ignition, Non-Road Small Spark Ignition, Light-Duty, Evaporative Components, Non-Road Large Spark Ignition, and Locomotive. Title II also requires the collection of fees from manufacturers submitting for compliance certification. Manufacturers submit data on an annual basis, to document engine model changes for certification. Manufacturers also submit compliance information on already certified in-use vehicles randomly selected by the EPA (1) year into their life and (4) years into their life to ensure that emissions systems continue to function appropriately over time.The EPA performs targeted confirmatory tests on approximately 15% of vehicles submitted for certification. Confirmatory data on engines is associated with its corresponding submission data to verify the accuracy of manufacturer submission beyond standard business rules.Section 209 of the 1990 Amendments to the Clea

  3. 12 CFR 391.12 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Filing of safety and soundness compliance plan. 391.12 Section 391.12 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND... and Compliance Procedures § 391.12 Filing of safety and soundness compliance plan. (a) Schedule for...

  4. 12 CFR 391.12 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Filing of safety and soundness compliance plan. 391.12 Section 391.12 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND... and Compliance Procedures § 391.12 Filing of safety and soundness compliance plan. (a) Schedule for...

  5. 12 CFR 391.12 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Filing of safety and soundness compliance plan. 391.12 Section 391.12 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION REGULATIONS AND... and Compliance Procedures § 391.12 Filing of safety and soundness compliance plan. (a) Schedule for...

  6. 49 CFR 397.2 - Compliance with Federal motor carrier safety regulations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Compliance with Federal motor carrier safety...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS TRANSPORTATION OF HAZARDOUS MATERIALS; DRIVING AND PARKING RULES General § 397.2 Compliance with...

  7. Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.

    PubMed

    Kvalheim, Sverre A; Dahl, Øyvind

    2016-12-01

    Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.

  8. Stress, coping and safety compliance in a multinational gold mining company.

    PubMed

    Jacobs, Melissa; Pienaar, Jacobus

    2017-06-01

    The primary objective of this study was to investigate the relationship of work stress, consisting of role stressors and job insecurity, with safety compliance at work. A secondary objective was to test for the possible moderating effect of individual employees' coping behaviour between experienced work stress and job insecurity, and their safety compliance. A cross-sectional survey design was used (n = 771). An electronic survey, with a biographical questionnaire and scales on role conflict, role ambiguity, role overload, job insecurity, coping and safety compliance at work, was administered. The results indicated that specific aspects of work stress, notably role conflict, role ambiguity and quantitative job insecurity, and of coping, namely an avoidance style and changing the situation, were important in understanding safety compliance. A moderating effect of avoidance coping was also found.

  9. 12 CFR 30.4 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... steps the bank will take to correct the deficiency and the time within which those steps will be taken. (c) Review of safety and soundness compliance plans. Within 30 days after receiving a safety and... AND SOUNDNESS STANDARDS § 30.4 Filing of safety and soundness compliance plan. (a) Schedule for filing...

  10. Surgical Safety Checklist compliance: a job done poorly!

    PubMed

    Sparks, Eric A; Wehbe-Janek, Hania; Johnson, Rebecca L; Smythe, W Roy; Papaconstantinou, Harry T

    2013-11-01

    The Surgical Safety Checklist (SSC) has been introduced as an effective tool for reducing perioperative mortality and complications. Although reported completion rates are high, objective compliance is not well defined. The purpose of this retrospective analysis is to determine SSC compliance as measured by accuracy and completion, and factors that can affect compliance. In September 2010, our institution implemented an adaptation of the World Health Organization's SSC in an effort to improve patient safety and outcomes. A tool was developed for objective evaluation of overall compliance (maximum score 40) that was an aggregate score of completion and accuracy (20 each). Random samples of SSCs were analyzed at specific, predefined, time points throughout the first year after implementation. Procedure start time, operative time, and case complexity were assessed to determine association with compliance. A total of 671 SSCs were analyzed. The participation rate improved from 33% (95 of 285) at week 1 to 94% (249 of 265) at 1 year (p < 0.0001, chi-square test). Mean overall compliance score was 27.7 (± 5.4 SD) of 40 possible points (69.3% ± 13.5% of total possible score; n = 671) and did not change over time. Although completion scores were high (16.9 ± 2.7 out of 20 [84.5% ± 13.6%]), accuracy was poor (10.8 ± 3.4 out of 20 [54.1% ± 16.9%]). Overall compliance score was significantly associated with case start-time (p < 0.05), and operative time and case complexity showed no association. Our data indicate that although implementation of an SSC results in a high level of overall participation and completion, accuracy remained poor. Identification of barriers to effective use is needed, as improper checklist use can adversely affect patient safety. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  11. 7 CFR 1724.50 - Compliance with National Electrical Safety Code (NESC).

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 11 2013-01-01 2013-01-01 false Compliance with National Electrical Safety Code (NESC... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC ENGINEERING, ARCHITECTURAL SERVICES AND DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.50 Compliance with National Electrical Safety Code...

  12. 7 CFR 1724.50 - Compliance with National Electrical Safety Code (NESC).

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false Compliance with National Electrical Safety Code (NESC... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC ENGINEERING, ARCHITECTURAL SERVICES AND DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.50 Compliance with National Electrical Safety Code...

  13. 7 CFR 1724.50 - Compliance with National Electrical Safety Code (NESC).

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 11 2011-01-01 2011-01-01 false Compliance with National Electrical Safety Code (NESC... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC ENGINEERING, ARCHITECTURAL SERVICES AND DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.50 Compliance with National Electrical Safety Code...

  14. 7 CFR 1724.50 - Compliance with National Electrical Safety Code (NESC).

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 11 2012-01-01 2012-01-01 false Compliance with National Electrical Safety Code (NESC... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC ENGINEERING, ARCHITECTURAL SERVICES AND DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.50 Compliance with National Electrical Safety Code...

  15. 7 CFR 1724.50 - Compliance with National Electrical Safety Code (NESC).

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 11 2014-01-01 2014-01-01 false Compliance with National Electrical Safety Code (NESC... UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE ELECTRIC ENGINEERING, ARCHITECTURAL SERVICES AND DESIGN POLICIES AND PROCEDURES Electric System Design § 1724.50 Compliance with National Electrical Safety Code...

  16. 29 CFR 1910.35 - Compliance with NFPA 101-2000, Life Safety Code.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 5 2011-07-01 2011-07-01 false Compliance with NFPA 101-2000, Life Safety Code. 1910.35 Section 1910.35 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS Means of Egress § 1910.35 Compliance...

  17. A systematic literature review of the effectiveness of occupational health and safety regulatory enforcement.

    PubMed

    Tompa, Emile; Kalcevich, Christina; Foley, Michael; McLeod, Chris; Hogg-Johnson, Sheilah; Cullen, Kim; MacEachen, Ellen; Mahood, Quenby; Irvin, Emma

    2016-11-01

    We aimed to determine the strength of evidence on the effectiveness of legislative and regulatory policy levers in creating incentives for organizations to improve occupational health and safety processes and outcomes. A systematic review was undertaken to assess the strength of evidence on the effectiveness of specific policy levers using a "best-evidence" synthesis approach. A structured literature search identified 11,947 citations from 13 peer-reviewed literature databases. Forty-three studies were retained for synthesis. Strong evidence was identified for three out of nine clusters. There is strong evidence that several OHS policy levers are effective in terms of reducing injuries and/or increasing compliance with legislation. This study adds to the evidence on OHS regulatory effectiveness from an earlier review. In addition to new evidence supporting previous study findings, it included new categories of evidence-compliance as an outcome, nature of enforcement, awareness campaigns, and smoke-free workplace legislation. Am. J. Ind. Med. 59:919-933, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  18. 49 CFR 177.804 - Compliance with Federal Motor Carrier Safety Regulations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Compliance with Federal Motor Carrier Safety... CARRIAGE BY PUBLIC HIGHWAY General Information and Regulations § 177.804 Compliance with Federal Motor Carrier Safety Regulations. Motor carriers and other persons subject to this part must comply with 49 CFR...

  19. 16 CFR 1115.8 - Compliance with product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... applicable mandatory consumer product safety standards and to report to the Commission any products which do.... 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.8 Compliance with...

  20. NOAA Safety and Environmental Compliance Office (NESSO)

    Science.gov Websites

    Intranet NOAA Environmental, Safety, and Sustainability Office NOAA's Environmental, Safety, and Atmospheric Administration's (NOAA) policy and provides guidance, and oversight in the areas of Safety and with regulatory, internal, and other requirements and to drive toward continuous improvement in Safety

  1. Strengthening safety compliance in nuclear power operations: a role-based approach.

    PubMed

    Martínez-Córcoles, Mario; Gracia, Francisco J; Tomás, Inés; Peiró, José M

    2014-07-01

    Safety compliance is of paramount importance in guaranteeing the safe running of nuclear power plants. However, it depends mostly on procedures that do not always involve the safest outcomes. This article introduces an empirical model based on the organizational role theory to analyze the influence of legitimate sources of expectations (procedures formalization and leadership) on workers' compliance behaviors. The sample was composed of 495 employees from two Spanish nuclear power plants. Structural equation analysis showed that, in spite of some problematic effects of proceduralization (such as role conflict and role ambiguity), procedure formalization along with an empowering leadership style lead to safety compliance by clarifying a worker's role in safety. Implications of these findings for safety research are outlined, as well as their practical implications. © 2014 Society for Risk Analysis.

  2. Food safety knowledge, attitude, and practice toward compliance with abattoir laws among the abattoir workers in Malaysia.

    PubMed

    Abdullahi, Auwalu; Hassan, Azmi; Kadarman, Norizhar; Saleh, Ahmadu; Baraya, Yusha'u Shu'aibu; Lua, Pei Lin

    2016-01-01

    Foodborne diseases are common in the developing countries due to the predominant poor food handling and sanitation practices, particularly as a result of inadequate food safety laws, weak regulatory structures, and inadequate funding as well as a lack of appropriate education for food-handlers. The most frequently involved foods in disease outbreaks are of animal origin. However, in spite of the adequate legislation and laws governing the abattoir operation in Malaysia, compliance with food safety requirements during meat processing and waste disposal is inadequate. Therefore, the present study was designed to assess the food safety knowledge, attitude, and practice toward compliance with abattoir laws among the workers in Terengganu, Malaysia. A cross-sectional survey was conducted using simple random sampling technique in the six districts of Terengganu: two districts were used for the pilot study and the remaining four were used for the main study. One hundred sixty-five abattoir workers from the selected districts were interviewed using a structured questionnaire. The mean and standard deviation of knowledge, attitude, and practice scores of the workers were 6.02 and 1.954, 45.16 and 4.496, and 18.03 and 3.186, respectively. The majority of the workers (38.8%) had a low level of knowledge and 91.7% had a positive attitude, while 77.7% had a good practice of compliance. Sex had a significant association with the level of knowledge (P<0.001) and practice (P=0.044) among the workers. The females had a higher level of knowledge than the males, while the males had a better practice of compliance than females. Similarly, knowledge also had a significant (P=0.009) association with the level of practice toward compliance with abattoir laws among the workers. The abattoir workers had a positive attitude and good practice, but a low level of knowledge toward compliance with the abattoir laws. Therefore, public awareness, workshops, and seminars relevant to the abattoir

  3. Food safety knowledge, attitude, and practice toward compliance with abattoir laws among the abattoir workers in Malaysia

    PubMed Central

    Abdullahi, Auwalu; Hassan, Azmi; Kadarman, Norizhar; Saleh, Ahmadu; Baraya, Yusha’u Shu’aibu; Lua, Pei Lin

    2016-01-01

    Purpose Foodborne diseases are common in the developing countries due to the predominant poor food handling and sanitation practices, particularly as a result of inadequate food safety laws, weak regulatory structures, and inadequate funding as well as a lack of appropriate education for food-handlers. The most frequently involved foods in disease outbreaks are of animal origin. However, in spite of the adequate legislation and laws governing the abattoir operation in Malaysia, compliance with food safety requirements during meat processing and waste disposal is inadequate. Therefore, the present study was designed to assess the food safety knowledge, attitude, and practice toward compliance with abattoir laws among the workers in Terengganu, Malaysia. Materials and methods A cross-sectional survey was conducted using simple random sampling technique in the six districts of Terengganu: two districts were used for the pilot study and the remaining four were used for the main study. One hundred sixty-five abattoir workers from the selected districts were interviewed using a structured questionnaire. Results The mean and standard deviation of knowledge, attitude, and practice scores of the workers were 6.02 and 1.954, 45.16 and 4.496, and 18.03 and 3.186, respectively. The majority of the workers (38.8%) had a low level of knowledge and 91.7% had a positive attitude, while 77.7% had a good practice of compliance. Sex had a significant association with the level of knowledge (P<0.001) and practice (P=0.044) among the workers. The females had a higher level of knowledge than the males, while the males had a better practice of compliance than females. Similarly, knowledge also had a significant (P=0.009) association with the level of practice toward compliance with abattoir laws among the workers. Conclusion The abattoir workers had a positive attitude and good practice, but a low level of knowledge toward compliance with the abattoir laws. Therefore, public awareness

  4. Effect of safety education on knowledge of and compliance with road safety signs among commercial motorcyclists in Uyo, Southern Nigeria.

    PubMed

    Johnson, O E; Adebayo, A M

    2011-09-01

    Compliance with road safety signs is important in the reduction of motorcycle accidents. The aim of this study was to implement health education intervention and assess its impact on the knowledge of and compliance with road safety signs among commercial motorcyclists in Uyo, Southern Nigeria. This was an intervention study among motorcyclists in Uyo, Southern Nigeria, with a control group from a similar town. The instrument of data collection was a semi-structured interviewer administered questionnaire. Subjects were selected through multistage sampling method. Baseline data on compliance to road safety signs was collected from both groups. Motorcyclists in the intervention group were given education on the importance of compliance to road safety signs. Data was subsequently collected from both groups 3 months post intervention and analysed using the Statistical Package for the Social Sciences version 11. A total of 200 respondents participated in the study, 100 from each group. Following intervention, respondents with good knowledge score increased from 21% at baseline to 82% at 3 months post intervention in the intervention group (p<0.05) and from 19% to 21% in the control group. Compliance score in the intervention group increased from 15% to 70% (p<0.05) and from 12% to 18% in the control group. A significant increase in compliance to road safety signs was recorded among motorcyclists in the intervention group after safety education. All motorcyclists should therefore be given education on road safety signs as this will improve compliance and lead to safer road use among them.

  5. 12 CFR 570.3 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... compliance plan shall include a description of the steps the savings association will take to correct the deficiency and the time within which those steps will be taken. (c) Review of safety and soundness compliance... plan. (a) Schedule for filing compliance plan—(1) In general. A savings association shall file a...

  6. 17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...

  7. 17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...

  8. 17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...

  9. 17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...

  10. 17 CFR 240.15b7-1 - Compliance with qualification requirements of self-regulatory organizations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... requirements of self-regulatory organizations. 240.15b7-1 Section 240.15b7-1 Commodity and Securities Exchanges... § 240.15b7-1 Compliance with qualification requirements of self-regulatory organizations. No registered... rules of that organization). [58 FR 27658, May 11, 1993] ...

  11. Safety assurance and compliance program (SACP) : accomplishments for CY 2001

    DOT National Transportation Integrated Search

    2002-08-01

    This recent research report by the Federal Railroad Administration (FRA), posted online, provides ease of access to information on the Safety Assurance and Compliance Program. The FRA promotes and helps ensure the safety of the nation's railroad indu...

  12. Quality of drug stores: Storage practices & Regulatory compliance in Karachi, Pakistan

    PubMed Central

    Shah, Syed Shaukat Ali Muttaqi; Naqvi, Baqar Shyum; Fatima, Mashhad; Khaliq, Asif; Sheikh, Abdul Latif; Baqar, Muhammad

    2016-01-01

    Objective: To assess and evaluate the drug storage quality and regulatory compliance among privately operated drug stores of Karachi Pakistan. Methods: A cross-sectional survey of drug stores located in Karachi was conducted from May to December 2013. A total of 1003 drug stores that were involved in the sales, purchase and dispensing of pharmaceutical products were approached by non-probability purposive sampling technique, and the information was collected using a close ended, structured questionnaire. Results: Out of 1003 drug stores inspected only 4.1%(n=41) were found compliant to regulatory requirements. Most of the stores 74.9%(n=752) were selling general items along with the drugs. Only 12%(n=124) stores were having qualified person working on the store, out of which 33% were pharmacist. 47.4%(n=400) of the stores had drug sales license displayed in the premises and 33.4%(n=282) of the stores had expired drug sales license. 11.4%(n=94) stores were found selling vaccines without proper refrigerator and only 11.7% stores had the power backup for the refrigerator. Only 40.2%(n=403) of stores were protected from direct sunlight and 5.4%(n=54) having air conditioning in the premises. Conclusion: The regulatory compliance of majority of the drug stores operated privately in different areas of Karachi is below standard. Only a few drugs stores have adequate facilities to protect the drugs from extreme temperature, sunlight and provision of refrigeration. Very few of the drug stores carry out drug sales under the supervision of qualified pharmacist. There is a dire need to improve the storage practices in the drug stores by complying with the regulatory standards/laws as specified by the Drug Regulatory Authority of Pakistan. PMID:27881996

  13. Regulatory system reform of occupational health and safety in China.

    PubMed

    Wu, Fenghong; Chi, Yan

    2015-01-01

    With the explosive economic growth and social development, China's regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined.

  14. Regulatory system reform of occupational health and safety in China

    PubMed Central

    WU, Fenghong; CHI, Yan

    2015-01-01

    With the explosive economic growth and social development, China’s regulatory system of occupational health and safety now faces more and more challenges. This article reviews the history of regulatory system of occupational health and safety in China, as well as the current reform of this regulatory system in the country. Comprehensive, a range of laws, regulations and standards that promulgated by Chinese government, duties and responsibilities of the regulatory departments are described. Problems of current regulatory system, the ongoing adjustments and changes for modifying and improving regulatory system are discussed. The aim of reform and the incentives to drive forward more health and safety conditions in workplaces are also outlined. PMID:25843565

  15. Compliance With Recommended Food Safety Practices in Television Cooking Shows.

    PubMed

    Cohen, Nancy L; Olson, Rita Brennan

    Examine compliance with recommended food safety practices in television cooking shows. Using a tool based on the Massachusetts Food Establishment Inspection Report, raters examined 39 episodes from 10 television cooking shows. Chefs demonstrated conformance with good retail practices for proper use and storage of utensils in 78% of episodes; preventing contamination (62%), and fingernail care (82%). However, 50% to 88% of episodes were found to be out of compliance with other personal hygiene practices, proper use of gloves and barriers (85% to 100%), and maintaining proper time and temperature controls (93%). Over 90% failed to conform to recommendations regarding preventing contamination through wiping cloths and washing produce. In only 13% of episodes were food safety practices mentioned. There appears to be little attention to food safety during most cooking shows. Celebrity and competing chefs have the opportunity to model and teach good food safety practices for millions of viewers. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

  16. Student manual, Book 2: Orientation to occupational safety compliance in DOE

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Colley, D.L.

    1993-10-01

    This is a student hand-book an Occupational Safety Compliance in DOE. Topics include the following: Electrical; materials handling & storage; inspection responsibilities & procedures; general environmental controls; confined space entry; lockout/tagout; office safety, ergonomics & human factors; medical & first aid, access to records; construction safety; injury/illness reporting system; and accident investigation procedures.

  17. Training Course for Compliance Safety and Health Officers. Final Report.

    ERIC Educational Resources Information Center

    McKnight, A. James; And Others

    The report describes revision of the Compliance Safety and Health Officers (CSHO) course for the Department of Labor, Occupational Safety and Health Administration (OSHA). The CSHO's job was analyzed in depth, in accord with OSHA standards, policies, and procedures. A listing of over 1,700 violations of OSHA standards was prepared, and specialists…

  18. Improving compliance with Occupational Safety and Health Administration standards.

    PubMed

    Cuming, Richard; Rocco, Tonette S; McEachern, Adriana G

    2008-02-01

    Health care facilities can be dangerous places. The mission of the Occupational Safety and Health Administration (OSHA) is to improve the safety of the American workplace by developing and implementing standards that prevent occupational injury, illness, and death. Perioperative services are performed in environments where exposure to bloodborne pathogens is a daily occurrence, making implementation and compliance with OSHA standards very important. Employees and employers must remain current with workplace safety requirements, including use of personal protective equipment. This article presents implications of the OSHA standards for employers, educators, and employees.

  19. The effects of perceived organizational support, perceived supervisor support and perceived co-worker support on safety and health compliance.

    PubMed

    Puah, Lee Na; Ong, Lin Dar; Chong, Wei Ying

    2016-09-01

    Although knowledge is cumulating, very little is known about the effects of various sources of support on safety and health compliance. This study goes beyond previous research by investigating the relationships among perceived support from organizations, supervisors and co-workers, and employees' safety and health compliance behaviour at chemical and petroleum process plants. The results of this study show that the support from organizations, supervisors and co-workers was significantly related to employees' safety and health compliance. Also, the findings reveal that perceived supervisor support has the strongest influence in ensuring employees' safety and health compliance behaviour.

  20. Does compliance to patient safety tasks improve and sustain when radiotherapy treatment processes are standardized?

    PubMed

    Simons, Pascale A M; Houben, Ruud; Benders, Jos; Pijls-Johannesma, Madelon; Vandijck, Dominique; Marneffe, Wim; Backes, Huub; Groothuis, Siebren

    2014-10-01

    To realize safe radiotherapy treatment, processes must be stabilized. Standard operating procedures (SOP's) were expected to stabilize the treatment process and perceived task importance would increase sustainability in compliance. This paper presents the effects on compliance to safety related tasks of a process redesign based on lean principles. Compliance to patient safety tasks was measured by video recording of actual radiation treatment, before (T0), directly after (T1) and 1.5 years after (T2) a process redesign. Additionally, technologists were surveyed on perceived task importance and reported incidents were collected for three half-year periods between 2007 and 2009. Compliance to four out of eleven tasks increased at T1, of which improvements on three sustained (T2). Perceived importance of tasks strongly correlated (0.82) to compliance rates at T2. The two tasks, perceived as least important, presented low base-line compliance, improved (T1), but relapsed at T2. The reported near misses (patient-level not reached) on accelerators increased (P < 0.001) from 144 (2007) to 535 (2009), while the reported misses (patient-level reached) remained constant. Compliance to specific tasks increased after introducing SOP's and improvements sustained after 1.5 years, indicating increased stability. Perceived importance of tasks correlated positively to compliance and sustainability. Raising the perception of task importance is thus crucial to increase compliance. The redesign resulted in increased willingness to report incidents, creating opportunities for patient safety improvement in radiotherapy treatment. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Intervention Effects on Safety Compliance and Citizenship Behaviors: Evidence from the Work, Family, and Health Study

    PubMed Central

    Hammer, Leslie B.; Johnson, Ryan C.; Crain, Tori L.; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly; Kelly, Erin L.; Buxton, Orfeu M.; Karuntzos, Georgia; Chosewood, L. Casey; Berkman, Lisa

    2015-01-01

    We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 healthcare facilities using a group-randomized trial. Based on Conservation of Resources theory and the Work-Home Resources Model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family and employee control over work time would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline, 6-month and 12-month post-intervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month and organizational citizenship behaviors at the 12-month follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors, compared to employees in the control facilities. The hypothesized mediators of perceptions of family supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. PMID:26348479

  2. Increasing compliance with the World Health Organization Surgical Safety Checklist-A regional health system's experience.

    PubMed

    Gitelis, Matthew E; Kaczynski, Adelaide; Shear, Torin; Deshur, Mark; Beig, Mohammad; Sefa, Meredith; Silverstein, Jonathan; Ujiki, Michael

    2017-07-01

    In 2009, NorthShore University HealthSystem adapted the World Health Organization Surgical Safety Checklist (SSC) at each of its 4 hospitals. Despite evidence that SSC reduces intraoperative mistakes and increase patient safety, compliance was found to be low with the paper form. In November 2013, NorthShore integrated the SSC into the electronic health record (EHR). The aim was to increase communication between operating room (OR) personnel and to encourage best practices during the natural workflow of surgeons, anesthesiologists, and nurses. The purpose of this study was to examine the impact of an electronic SSC on compliance and patient safety. An anonymous OR observer selected cases at random and evaluated the compliance rate before the rollout of the electronic SSC. In June 2014, an electronic audit was performed to assess the compliance rate. Random OR observations were also performed throughout the summer in 2014. Perioperative risk events, such as consent issues, incorrect counts, wrong site, and wrong procedure were compared before and after the electronic SSC rollout. A perception survey was also administered to NorthShore OR personnel. Compliance increased from 48% (n = 167) to 92% (n = 1,037; P < .001) after the SSC was integrated into the electronic health record. Surgeons (91% vs 97%; P < .001), anesthesiologists (89% vs 100%; P < .001), and nurses (55% vs 93%; P < .001) demonstrated an increase in compliance. A comparison between risk events in the pre- and post-rollout period showed a 32% decrease (P < .01). Hospital-wide indicators including length of stay and 30-day readmissions were lower. In a survey to assess the OR personnel's perceptions of the new checklist, 76% of surgeons, 86% of anesthesiologists, and 88% of nurses believed the electronic SSC will have a positive impact on patient safety. The World Health Organization SSC is a validated tool to increase patient safety and reduce intraoperative complications. The electronic SSC has

  3. Organizational safety culture/climate and worker compliance with hazardous drug guidelines: lessons from the blood-borne pathogen experience.

    PubMed

    McDiarmid, Melissa A; Condon, Marian

    2005-07-01

    The health risks posed to health care workers (HCW) handling antineoplastic and other hazardous drugs (HDs) are well established. However, despite nearly 20 years of professional practice standards, compliance with safe handling procedures is poor. We present documentation of undercompliance with recommended safety procedures for HDs. Then, we examine a similar problem, HCW compliance with blood-borne pathogen universal precautions (UP) and its partial solution tied to the strength of a facility's safety culture. Lessons learned here may be applicable to the HD issue. It is proposed that analyzing a facility's safety culture may enlarge our understanding of the barriers contributing to HD under-compliance and suggest strategies to improve it. The Safety Culture paradigm offers many targets for intervention to enhance and promote worker compliance with safe HD handling practices thus mitigating internal exposure.

  4. Work Smarter Not Harder: Utilizing an Environmental Management Information System to Meet Regulatory Compliance and Reporting Requirements for a Major Source Title V Facility

    DTIC Science & Technology

    2011-05-10

    Environmental Management Information System to Meet Regulatory Compliance and Reporting Requirements for a Major Source Title V Facility. Tannis Danley...AND SUBTITLE Work Smarter Not Harder: Utilizing an Environmental Management Information System to Meet Regulatory Compliance and Reporting...Carson) – EMS (Hawaii Garrison, West Virginia National Guard) Environmental Management Information System (EMIS) National Defense Center for Energy and

  5. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in FY 2008

    DOT National Transportation Integrated Search

    2012-09-30

    In FY 2008, Federal and State enforcement personnel conducted 14,906 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR, carriers...

  6. Intervention effects on safety compliance and citizenship behaviors: Evidence from the Work, Family, and Health Study.

    PubMed

    Hammer, Leslie B; Johnson, Ryan C; Crain, Tori L; Bodner, Todd; Kossek, Ellen Ernst; Davis, Kelly D; Kelly, Erin L; Buxton, Orfeu M; Karuntzos, Georgia; Chosewood, L Casey; Berkman, Lisa

    2016-02-01

    We tested the effects of a work-family intervention on employee reports of safety compliance and organizational citizenship behaviors in 30 health care facilities using a group-randomized trial. Based on conservation of resources theory and the work-home resources model, we hypothesized that implementing a work-family intervention aimed at increasing contextual resources via supervisor support for work and family, and employee control over work time, would lead to improved personal resources and increased employee performance on the job in the form of self-reported safety compliance and organizational citizenship behaviors. Multilevel analyses used survey data from 1,524 employees at baseline and at 6-month and 12-month postintervention follow-ups. Significant intervention effects were observed for safety compliance at the 6-month, and organizational citizenship behaviors at the 12-month, follow-ups. More specifically, results demonstrate that the intervention protected against declines in employee self-reported safety compliance and organizational citizenship behaviors compared with employees in the control facilities. The hypothesized mediators of perceptions of family-supportive supervisor behaviors, control over work time, and work-family conflict (work-to-family conflict, family-to-work conflict) were not significantly improved by the intervention. However, baseline perceptions of family-supportive supervisor behaviors, control over work time, and work-family climate were significant moderators of the intervention effect on the self-reported safety compliance and organizational citizenship behavior outcomes. (c) 2016 APA, all rights reserved).

  7. The roles of safety and compliance in determining effectiveness of topical therapy for psoriasis.

    PubMed

    Stein Gold, Linda; Corvari, Linda

    2007-01-01

    Topical therapies are the mainstays of treatment for most patients with psoriasis because they relieve symptoms and reduce the size and severity of lesions. The effectiveness of a therapeutic intervention is a function of drug efficacy (determined by randomized clinical trial results) and patient safety and compliance. Alterations in any parameter can have a substantial influence on clinical outcomes. However, topical agents can be associated with unwanted and potentially toxic side effects that make physicians reluctant to prescribe them, and patients intentionally discontinue treatment with these topical agents. To maximize effectiveness and improve patient safety, physicians may prescribe medications in combination, sequential, or rotational therapeutic regimens. This treatment strategy has the potential to improve the overall efficacy and safety of topical therapy; however, the effectiveness of this method may be compromised because the complexity of the therapeutic regimen may decrease patient compliance. Newer topical therapies that have a convenient once-daily dosing schedule are needed and will have important implications for patient compliance.

  8. Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

    PubMed

    Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

    2017-03-15

    Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Type A behavior pattern, accident optimism and fatalism: an investigation into non-compliance with safety work behaviors among hospital nurses.

    PubMed

    Ugwu, Fabian O; Onyishi, Ike E; Ugwu, Chidi; Onyishi, Charity N

    2015-01-01

    Safety work behavior has continued to attract the interest of organizational researchers and practitioners especially in the health sector. The goal of the study was to investigate whether personality type A, accident optimism and fatalism could predict non-compliance with safety work behaviors among hospital nurses. One hundred and fifty-nine nursing staff sampled from three government-owned hospitals in a state in southeast Nigeria, participated in the study. Data were collected through Type A Behavior Scale (TABS), Accident Optimism, Fatalism and Compliance with Safety Behavior (CSB) Scales. Our results showed that personality type A, accident optimism and fatalism were all related to non-compliance with safety work behaviors. Personality type A individuals tend to comply less with safety work behaviors than personality type B individuals. In addition, optimistic and fatalistic views about accidents and existing safety rules also have implications for compliance with safety work behaviors.

  10. Investigating Accidents in the Workplace. A Manual for Compliance Safety and Health Officers.

    ERIC Educational Resources Information Center

    Occupational Safety and Health Administration, Washington, DC.

    This manual was developed for Compliance Safety and Health Officers (CSHO) of the Occupational Safety and Health Administration (OSHA) to help them carry out their responsibilities when investigating workplace accidents. The content is presented in four sections. The first overviews the investigative roles of CSHO officers, including…

  11. Mobile Source Emissions Regulatory Compliance Data

    EPA Pesticide Factsheets

    The Engine and Vehicle Compliance Certification and Fuel Economy Inventory contains measured emissions and fuel economy compliance information for all types of vehicles (mobile sources of air pollution) excluding snowmobile, marine (diesel), and heavy duty engines whichsummary data is updated on an annual basis. Data is collected by EPA to certify compliance with the applicable fuel economy provisions of the Clean Air Act, Energy Policy and Conservation Act (EPCA) and the Energy Independent Security Act (EISA) of 2007.

  12. FMCSA safety program effectiveness measurement : compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009.

    DOT National Transportation Integrated Search

    2014-04-01

    In FY 2009, Federal and State enforcement personnel conducted more than 15,000 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR...

  13. An audit of implant practice websites: content and regulatory compliance.

    PubMed

    Raimundo, H; Robinson, P K

    2014-12-01

    To audit the content of dental practice websites offering dental implant services against a framework based on the GDC 2012 Guidelines for Ethical Advertising and other relevant advertising standards. An audit framework was constructed and applied to the top fifty websites resulting from a Google UK search using the search term 'dental implant specialist'. Compliance with many elements of the GDC Guidance remains poor. Sixty-eight percent of websites claimed that the practitioner providing the service was a GDC registered specialist, though examples were found where this claim was unfounded. Fourteen percent of practice websites claimed that the service was being carried out by an 'implant specialist' and 16% claimed the practitioner was an 'implantologist'; the majority of sites using these terms (10%) involved practitioners that had no specialist status. The display of potentially misleading memberships and fellowships of a range of dental associations, academies, societies and foundations remains common (52%), as does the adoption of the title 'Dr' (60%). Comparison with earlier studies indicates that compliance with recent GDC standards is generally improving, though whether the pace of improvement is seen as acceptable or not is something that policymakers and regulatory authorities may need to consider further.

  14. Chemical quality and regulatory compliance of drinking water in Iceland.

    PubMed

    Gunnarsdottir, Maria J; Gardarsson, Sigurdur M; Jonsson, Gunnar St; Bartram, Jamie

    2016-11-01

    Assuring sufficient quality of drinking water is of great importance for public wellbeing and prosperity. Nations have developed regulatory system with the aim of providing drinking water of sufficient quality and to minimize the risk of contamination of the water supply in the first place. In this study the chemical quality of Icelandic drinking water was evaluated by systematically analyzing results from audit monitoring where 53 parameters were assessed for 345 samples from 79 aquifers, serving 74 water supply systems. Compliance to the Icelandic Drinking Water Regulation (IDWR) was evaluated with regard to parametric values, minimum requirement of sampling, and limit of detection. Water quality compliance was divided according to health-related chemicals and indicators, and analyzed according to size. Samples from few individual locations were benchmarked against natural background levels (NBLs) in order to identify potential pollution sources. The results show that drinking compliance was 99.97% in health-related chemicals and 99.44% in indicator parameters indicating that Icelandic groundwater abstracted for drinking water supply is generally of high quality with no expected health risks. In 10 water supply systems, of the 74 tested, there was an indication of anthropogenic chemical pollution, either at the source or in the network, and in another 6 water supplies there was a need to improve the water intake to prevent surface water intrusion. Benchmarking against the NBLs proved to be useful in tracing potential pollution sources, providing a useful tool for identifying pollution at an early stage. Copyright © 2016 Elsevier GmbH. All rights reserved.

  15. Safe use of vaccines and vaccine compliance with food safety requirements.

    PubMed

    Grein, K; Papadopoulos, O; Tollis, M

    2007-08-01

    Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

  16. GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

    PubMed Central

    Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

    2002-01-01

    This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

  17. Job demands, job resources and safety outcomes: The roles of emotional exhaustion and safety compliance.

    PubMed

    Li, Feng; Jiang, Li; Yao, Xiang; Li, YongJuan

    2013-03-01

    The aim of this study was to assess the effectiveness of the job demands-resources (JD-R) model in explaining the relationship of job demands and resources with safety outcomes (i.e., workplace injuries and near-misses). We collected self-reported data from 670 crude oil production workers from three sub-companies of a major oilfield company in China. The results of a structural equation analysis indicated that job demands (psychological and physical demands) and job resources (decision latitude, supervisor support and coworker support) could affect emotional exhaustion and safety compliance, and thus influence the occurrence of injuries and near-misses. The implications of the present findings regarding both the JD-R model and occupational safety research were discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  18. Laser safety: regulations, standards, and recommendations

    NASA Astrophysics Data System (ADS)

    Smalley, Penny J.

    1993-07-01

    All healthcare professionals involved in the delivery of laser technology to patients, must develop and monitor clinical laser safety programs that ensure compliance with national, state, and local regulations, professional standards of practice, and national consensus standards. Laser safe treatment environments for patients and for personnel can be established and maintained through understanding the impact of both regulatory and advisory guidelines, comprehensive program planning, appropriate continuing education, and routine safety audits.

  19. Validation of the digital opacity compliance system under regulatory enforcement conditions.

    PubMed

    McFarland, Michael J; Rasmussen, Steve L; Stone, Daniel A; Palmer, Glenn R; Wander, Joseph D

    2006-09-01

    U.S. Environmental Protection Agency (EPA) Emission Measurement Center in conjunction with EPA Regions VI and VIII, the state of Utah, and the U.S. Department of Defense have conducted a series of long-term pilot and field tests to determine the accuracy and reliability of a visible opacity monitoring system consisting of a conventional digital camera and a separate computer software application for plume opacity determination. This technology, known as the Digital Opacity Compliance System (DOCS), has been successfully demonstrated at EPA-sponsored Method-9 "smoke schools", as well as at a number of government and commercially operated industrial facilities. Results from the current DOCS regulatory pilot study demonstrated that, under regulatory enforcement conditions, the average difference in opacity measurement between the DOCS technology and EPA Reference Method 9 (Method 9) was 1.12%. This opacity difference, which was computed from the evaluation of 241 regulated air sources, was found to be statistically significant at the 99% confidence level. In evaluating only those sources for which a nonzero visible opacity level was recorded, the

  20. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  1. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  2. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  3. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  4. 30 CFR 773.11 - Review of compliance history.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Review of compliance history. 773.11 Section... REGULATORY PROGRAMS REQUIREMENTS FOR PERMITS AND PERMIT PROCESSING § 773.11 Review of compliance history. (a... histories of compliance with the Act or the applicable State regulatory program, and any other applicable...

  5. Outsource Power, Import Safety? Challenges and Opportunities of the U.S.-China Food Safety Regulatory Cooperation.

    PubMed

    Lin, Ching-Fu

    The United States has a high stake in China’s serious food safety problem, as food products of Chinese origin have dominated the U.S. food market in numerous areas and continue to grow. The conclusion of the U.S.-China Food Safety Agreement (“the Agreement”) has allowed FDA to strengthen regulatory cooperation with its Chinese counterpart in various aspects. The Agreement also paves the way for the implementation of the new regulatory tools incorporated in FSMA, especially in the cross-border context. However, both the Agreement and FSMA have certain crucial limitations that may create future hurdles to effective implementation in the U.S.-China cooperation. This paper therefore endeavors to first examine China’s governance challenges over food safety, with a focus on the 2009 Food Safety Law, the 2015 Amendment, and the fundamental problem of “thin” rule of law. This paper moves to analyze the U.S.-China Food Safety Agreement, reviewing the agreement’s strengths and weaknesses. It further assesses FSMA’s innovative institutional design to regulate imported food products and its limitations. However, both the U.S.-China Food Safety Agreement and FSMA arguably create a regulatory dilemma for FDA when addressing imported food safety, due to structural mismatch between the broad scope of power granted to FDA and the long chain of power outsourcing to governments or private companies as primary “regulators.” Neither the Agreement nor FSMA give FDA adequate capacity to closely oversee such “agents” along the chain of power outsourcing. Framing the U.S.-China food safety cooperation as a multilayer structure that “outsources power” to “import safety,” this paper concludes by stressing the need for a robust accountability and effective mechanism for U.S.-China food safety cooperation.

  6. 77 FR 50723 - Verification, Validation, Reviews, and Audits for Digital Computer Software Used in Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... Digital Computer Software Used in Safety Systems of Nuclear Power Plants AGENCY: Nuclear Regulatory..., ``Verification, Validation, Reviews, and Audits for Digital Computer Software used in Safety Systems of Nuclear... NRC regulations promoting the development of, and compliance with, software verification and...

  7. 12 CFR 308.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... response, subject to the deadline provided in paragraph (a)(1) of this section. (b) Contents of plan. The... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Filing of safety and soundness compliance plan. 308.303 Section 308.303 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF...

  8. 12 CFR 263.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... that plan, order, agreement, or response, subject to the deadline provided in paragraph (a)(1) of this... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Filing of safety and soundness compliance plan. 263.303 Section 263.303 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE...

  9. 12 CFR 308.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... response, subject to the deadline provided in paragraph (a)(1) of this section. (b) Contents of plan. The... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Filing of safety and soundness compliance plan. 308.303 Section 308.303 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF...

  10. 12 CFR 308.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... response, subject to the deadline provided in paragraph (a)(1) of this section. (b) Contents of plan. The... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Filing of safety and soundness compliance plan. 308.303 Section 308.303 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF...

  11. 12 CFR 263.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... that plan, order, agreement, or response, subject to the deadline provided in paragraph (a)(1) of this... 12 Banks and Banking 3 2011-01-01 2011-01-01 false Filing of safety and soundness compliance plan. 263.303 Section 263.303 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE...

  12. 12 CFR 263.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... this section as part of that plan, order, agreement, or response, subject to the deadline provided in... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Filing of safety and soundness compliance plan. 263.303 Section 263.303 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE...

  13. 12 CFR 263.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... this section as part of that plan, order, agreement, or response, subject to the deadline provided in... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Filing of safety and soundness compliance plan. 263.303 Section 263.303 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE...

  14. 12 CFR 263.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... this section as part of that plan, order, agreement, or response, subject to the deadline provided in... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Filing of safety and soundness compliance plan. 263.303 Section 263.303 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE...

  15. 12 CFR 308.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... response, subject to the deadline provided in paragraph (a)(1) of this section. (b) Contents of plan. The... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Filing of safety and soundness compliance plan. 308.303 Section 308.303 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF...

  16. 12 CFR 308.303 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... response, subject to the deadline provided in paragraph (a)(1) of this section. (b) Contents of plan. The... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Filing of safety and soundness compliance plan. 308.303 Section 308.303 Banks and Banking FEDERAL DEPOSIT INSURANCE CORPORATION PROCEDURE AND RULES OF...

  17. Relationship between Risk Assessment and Compliance to Health and Safety in Ugandan Secondary Schools

    ERIC Educational Resources Information Center

    Sekiwu, Denis; Kabanda, Milly; Naluwemba, Esther Frances; Kaggwa, Victoria Tamale

    2015-01-01

    Health hazards are part and parcel of human life necessitating the provision of safety in every organizational environment (WHO regional Office for Africa, 2004). Likewise, the area of safety and accident prevention is of great concern to school improvement. The study sought to investigate the relationship between Risk Assessment and Compliancy to…

  18. Analysis of new entrant motor carrier safety performance and compliance using SafeStat

    DOT National Transportation Integrated Search

    2000-03-01

    This report documents the findings of a special study undertaken to update, confirm and expand upon previous studies on the comparative (to experienced carriers) safety performance and compliance of large commercial motor vehicle operators (motor car...

  19. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hughes, P. J.; Westwood, R.N; Mark, R. T.

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety casesmore » for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)« less

  20. Quick Tips for Buying Medicines Over the Internet: A Consumer Safety Guide

    MedlinePlus

    ... Laser Products Other Resources State Pharmacy Boards Federal Trade Commission U.S. Customs and Border Protection Spotlight A ... Products Advisory Committees Regulatory Information Safety Emergency Preparedness International Programs News & Events Training & Continuing Education Inspections & Compliance ...

  1. [Compliance with the surgical safety checklist and surgical events detected by the Global Trigger Tool].

    PubMed

    Menéndez Fraga, M D; Cueva Álvarez, M A; Franco Castellanos, M R; Fernández Moral, V; Castro Del Río, M P; Arias Pérez, J I; Fernández León, A; Vázquez Valdés, F

    2016-06-01

    The implementing of the WHO Surgical Safety Checklist (SSC) has helped to improve patient safety. The aim of this study was to assess the level of compliance of the SSC, and incorporating the non-compliances as «triggers» in the Global Trigger Tool (GTT). Acute Geriatric Hospital (200 beds). Retrospective study, study period: 2011-2014. The SSC formulary and the methodology of the GTT were used for the analysis of electronic medical records and the compliance with the SSC. The NCCP MERP categories were used to assess the severity of the harm. Out of all the electronic medical records (EMR), a total of 227 (23.6%) discharged patients (1.7% of interventions in the four year study period) were analysed. All (100%) of the EMR included the SSC, with 94.4% of the items being completed, and 28.2% of SSC had all items completed in the 3 phases of the process. Surgical adverse events decreased from 16.3% in 2011 to 9.4% in 2014 (P=.2838, not significant), and compliance with all items of SSC was increased from 18.6% to 39.1% (P=.0246, significant). The GTT systematises and evaluates, at low cost, the triggers and incidents/ AEs found in the EMR in order to assess the compliance with the SSC and consider non-compliance of SSC as «triggers» for further analysis. This strategy has never been referred to in the GTT or in the SCC formulary. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

  2. 10 CFR 851.13 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Compliance. 851.13 Section 851.13 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.13 Compliance. (a) Contractors must achieve compliance with all the requirements of Subpart C of this part, and their approved worker safety...

  3. 14 CFR 417.203 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Compliance. 417.203 Section 417.203... TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.203 Compliance. (a) General. A launch... need for further demonstration of compliance to the FAA, if: (1) A launch operator has contracted with...

  4. 10 CFR 851.13 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 4 2011-01-01 2011-01-01 false Compliance. 851.13 Section 851.13 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM Program Requirements § 851.13 Compliance. (a) Contractors must achieve compliance with all the requirements of Subpart C of this part, and their approved worker safety...

  5. 14 CFR 417.203 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Compliance. 417.203 Section 417.203... TRANSPORTATION LICENSING LAUNCH SAFETY Flight Safety Analysis § 417.203 Compliance. (a) General. A launch... need for further demonstration of compliance to the FAA, if: (1) A launch operator has contracted with...

  6. Stability Testing of Herbal Drugs: Challenges, Regulatory Compliance and Perspectives.

    PubMed

    Bansal, Gulshan; Suthar, Nancy; Kaur, Jasmeen; Jain, Astha

    2016-07-01

    Stability testing is an important component of herbal drugs and products (HDPs) development process. Drugs regulatory agencies across the globe have recommended guidelines for the conduct of stability studies on HDPs, which require that stability data should be included in the product registration dossier. From the scientific viewpoint, numerous chemical constituents in an herbal drug are liable to varied chemical reactions under the influence of different conditions during its shelf life. These reactions can lead to altered chemical composition of HDP and consequently altered therapeutic profile. Many reports on stability testing of HDPs have appeared in literature since the last 10 years. A review of these reports reveals that there is wide variability in temperature (-80 to 100 °C), humidity (0-100%) and duration (a few hours-36 months) for stability assessment of HDPs. Of these, only 1% studies are conducted in compliance with the regulatory guidelines for stability testing. The present review is aimed at compiling all stability testing reports, understanding key challenges in stability testing of HDPs and suggesting possible solutions for these. The key challenges are classified as chemical complexity and biochemical composition variability in raw material, selection of marker(s) and influences of enzymes. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  7. Impact of regulatory science on global public health.

    PubMed

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

  8. 14 CFR 417.402 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Compliance. 417.402 Section 417.402... TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.402 Compliance. (a) General. A launch operator's... of compliance to the FAA if: (1) A launch operator has contracted with a Federal launch range for the...

  9. 14 CFR 417.402 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Compliance. 417.402 Section 417.402... TRANSPORTATION LICENSING LAUNCH SAFETY Ground Safety § 417.402 Compliance. (a) General. A launch operator's... of compliance to the FAA if: (1) A launch operator has contracted with a Federal launch range for the...

  10. 42 CFR 137.368 - Is the Secretary responsible for oversight and compliance of health and safety codes during...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... compliance of health and safety codes during construction projects being performed by a Self-Governance Tribe... SERVICES TRIBAL SELF-GOVERNANCE Construction Roles of the Secretary in Establishing and Implementing Construction Project Agreements § 137.368 Is the Secretary responsible for oversight and compliance of health...

  11. Organizational performance and regulatory compliance as measured by clinical pertinence indicators before and after implementation of Anesthesia Information Management System (AIMS).

    PubMed

    Choi, Clark K; Saberito, Darlene; Tyagaraj, Changa; Tyagaraj, Kalpana

    2014-01-01

    Previous studies have suggested that electronic medical records (EMR) can lead to a greater reduction of medical errors and better adherence to regulatory compliance than paper medical records (PMR). In order to assess the organizational performance and regulatory compliance, we tracked different clinical pertinence indicators (CPI) in our anesthesia information management system (AIMS) for 5 years. These indicators comprised of the protocols from the Surgical Care Improvement Project (SCIP), elements of performance (EP) from The Joint Commission (TJC), and guidelines from the Centers for Medicare and Medicaid Services (CMS). A comprehensive AIMS was initiated and the CPI were collected from October 5, 2009 to December 31, 2010 (EMR period) and from January 1, 2006 to October 4, 2009 (PMR period). Fourteen CPI were found to be common between the EMR and PMR periods. Based on the statistical analysis of the 14 common CPI, there was a significant increase (p < 0.001) in overall compliance after the introduction of EMR compared to the PMR period. The increase in overall compliance was significantly progressive (p = 0.013) from year to year over 2006 and 2010. Of the 14 CPI, Documentation of a) medication doses, and b) monitoring of postoperative physiological status, mental status, and pain scores showed significant improvement (p < 0.001) during the EMR period compared to the PMR period.

  12. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MULKEY, C.H.

    1999-07-06

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through themore » DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.« less

  13. Predicting Regulatory Compliance in Beer Advertising on Facebook.

    PubMed

    Noel, Jonathan K; Babor, Thomas F

    2017-11-01

    The prevalence of alcohol advertising has been growing on social media platforms. The purpose of this study was to evaluate alcohol advertising on Facebook for regulatory compliance and thematic content. A total of 50 Budweiser and Bud Light ads posted on Facebook within 1 month of the 2015 NFL Super Bowl were evaluated for compliance with a self-regulated alcohol advertising code and for thematic content. An exploratory sensitivity/specificity analysis was conducted to determine if thematic content could predict code violations. The code violation rate was 82%, with violations prevalent in guidelines prohibiting the association of alcohol with success (Guideline 5) and health benefits (Guideline 3). Overall, 21 thematic content areas were identified. Displaying the product (62%) and adventure/sensation seeking (52%) were the most prevalent. There was perfect specificity (100%) for 10 content areas for detecting any code violation (animals, negative emotions, positive emotions, games/contests/promotions, female characters, minorities, party, sexuality, night-time, sunrise) and high specificity (>80%) for 10 content areas for detecting violations of guidelines intended to protect minors (animals, negative emotions, famous people, friendship, games/contests/promotions, minorities, responsibility messages, sexuality, sunrise, video games). The high prevalence of code violations indicates a failure of self-regulation to prevent potentially harmful content from appearing in alcohol advertising, including explicit code violations (e.g. sexuality). Routine violations indicate an unwillingness to restrict advertising content for public health purposes, and statutory restrictions may be necessary to sufficiently deter alcohol producers from repeatedly violating marketing codes. Violations of a self-regulated alcohol advertising code are prevalent in a sample of beer ads published on Facebook near the US National Football League's Super Bowl. Overall, 16 thematic content

  14. The effects of compliance cost and specific consequence information on the use of safety equipment.

    PubMed

    Hathaway, J A; Dingus, T A

    1992-12-01

    The effects of compliance cost and warning content on the use of protective eyewear by racquetball players were evaluated. Four-hundred-twenty subjects were observed for use of eye protection in a field setting. Results indicate that proximal placement of eyewear and the inclusion of specific consequence warning information increased safety equipment use. Implications of this research for augmenting warning effectiveness and safety are discussed.

  15. Watershed monitoring and modelling and USA regulatory compliance.

    PubMed

    Turner, B G; Boner, M C

    2004-01-01

    The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.

  16. Regulatory Anatomy: How "Safety Logics" Structure European Transplant Medicine.

    PubMed

    Hoeyer, Klaus

    2015-07-01

    This article proposes the term "safety logics" to understand attempts within the European Union (EU) to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of "safety" produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape.

  17. Safety and compliance-related hazards in the medical practice: Part one.

    PubMed

    Calway, R C

    2001-01-01

    Safety and risk management hazards are a fact of life for the medical practice, and the costs of these incidents can place the group at significant risk of liability. Good compliance and risk management programs help minimize these incidents, improve staff morale, increase a practice's visibility in the community, and positively affect the practice's financial and operational bottom line performance. Medical practices that implement effective safety and risk management programs can realize savings in staffing costs, operational efficiency, morale, insurance premiums, and improved third-party relationships while at the same time avoiding embarrassing risks, fines, and liability. This article outlines some of the most common safety and risk management-related deficiencies seen in medical practices today. The author explains how to remedy these deficiencies and provides a self-test tool to enable the reader to assess areas within his or her own practice in need of attention.

  18. Outsourcing your medical practice call center: how to choose a vendor to ensure regulatory compliance.

    PubMed

    Johnson, Bill

    2014-01-01

    Medical practices receive hundreds if not thousands of calls every week from patients, payers, pharmacies, and others. Outsourcing call centers can be a smart move to improve efficiency, lower costs, improve customer care, ensure proper payer management, and ensure regulatory compliance. This article discusses how to know when it's time to move to an outsourced call center, the benefits of making the move, how to choose the right call center, and how to make the transition. It also provides tips on how to manage the call center to ensure the objectives are being met.

  19. A comparison of the results of regulatory compliance inspections in 1999 by the states of Texas, Maine, and Washington.

    PubMed

    Brown, B J; Emery, R J; Stock, T H; Lee, E S

    2004-03-01

    Inspection outcome data provided by the state of Washington Department of Health, Division of Radiation Protection, for licensees of radioactive materials was encoded according to a system established by the Texas Department of Health, Bureau of Radiation Control. The data, representing calendar year 1999 inspection activities, were then analyzed and the results compared to previously published studies for the same year in the states of Texas and Maine. Despite significant differences in regulatory program size, age, and geographic proximity, the most frequently cited violation for radioactive materials licensees were shown to be similar for all three states. Of particular note were the violations that were identified to be consistently issued in all three states. These included physical inventories and utilization logs not performed, not available, or incomplete; leak testing not performed or not performed on schedule; inadequate or unapproved operating and safety procedures; radiation survey and disposal records not available or incomplete; detection or measurement instrument calibration not performed or records not available; and radiation surveys or sampling not performed or performed with a noncalibrated instrument. Comparisons were made in an attempt to generate a summary of the most commonly issued violations that could be generalized to users of radioactive materials across the United States. A generalized list of common violations would be an invaluable tool for radiation protection programs, serving to aid in the reduction of the overall instance of program non-compliance. Any reduction in instances of non-compliance would result in the conservation of finite public health resources that might then be directed to other pressing public health matters.

  20. Electromagnetic compatibility and safety design of a patient compliance-free, inductive implant charger.

    PubMed

    Theodoridis, Michael P; Mollov, Stefan V

    2014-10-01

    This article presents the design of a domestic, radiofrequency induction charger for implants toward compliance with the Federal Communications Commission safety and electromagnetic compatibility regulations. The suggested arrangement does not impose any patient compliance requirements other than the use of a designated bed for night sleep, and therefore can find a domestic use. The method can be applied to a number of applications; a rechargeable pacemaker is considered as a case study. The presented work has proven that it is possible to realize a fully compliant inductive charging system with minimal patient interaction, and has generated important information for consideration by the designers of inductive charging systems. Experimental results have verified the validity of the theoretical findings.

  1. 16 CFR 1209.39 - Certification of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certification of compliance. 1209.39 Section 1209.39 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INTERIM SAFETY STANDARD FOR CELLULOSE INSULATION Certification § 1209.39 Certification of compliance. (a...

  2. Validation of gamma irradiator controls for quality and regulatory compliance

    NASA Astrophysics Data System (ADS)

    Harding, Rorry B.; Pinteric, Francis J. A.

    1995-09-01

    Since 1978 the U.S. Food and Drug Administration (FDA) has had both the legal authority and the Current Good Manufacturing Practice (CGMP) regulations in place to require irradiator owners who process medical devices to produce evidence of Irradiation Process Validation. One of the key components of Irradiation Process Validation is the validation of the irradiator controls. However, it is only recently that FDA audits have focused on this component of the process validation. What is Irradiator Control System Validation? What constitutes evidence of control? How do owners obtain evidence? What is the irradiator supplier's role in validation? How does the ISO 9000 Quality Standard relate to the FDA's CGMP requirement for evidence of Control System Validation? This paper presents answers to these questions based on the recent experiences of Nordion's engineering and product management staff who have worked with several US-based irradiator owners. This topic — Validation of Irradiator Controls — is a significant regulatory compliance and operations issue within the irradiator suppliers' and users' community.

  3. Developing a Model on Improving Maritime English Training for Maritime Transportation Safety

    ERIC Educational Resources Information Center

    Yercan, Funda; Fricke, Donna; Stone, Laurie

    2005-01-01

    Maritime services form an integral part of what regulatory agencies requires for the safe navigation and operation of vessels. Therefore, the maritime industry's compliance with governmental regulations and international protocols has been essential for maritime safety management. As a basis to this aspect, the preparation of maritime students as…

  4. Biosafety, biosecurity and internationally mandated regulatory regimes: compliance mechanisms for education and global health security

    PubMed Central

    Sture, Judi; Whitby, Simon; Perkins, Dana

    2015-01-01

    This paper highlights the biosafety and biosecurity training obligations that three international regulatory regimes place upon states parties. The duty to report upon the existence of such provisions as evidence of compliance is discussed in relation to each regime. We argue that such mechanisms can be regarded as building blocks for the development and delivery of complementary biosafety and biosecurity teaching and training materials. We show that such building blocks represent foundations upon which life and associated scientists – through greater awareness of biosecurity concerns – can better fulfil their responsibilities to guard their work from misuse in the future. PMID:24494580

  5. Regulatory forum opinion piece*: supporting the need for international harmonization of safety assessments for food flavoring substances.

    PubMed

    Konishi, Yoichi; Hayashi, Shim-Mo; Fukushima, Shoji

    2014-08-01

    The advancement of technology and the growth of international commerce underscore the need for global harmonization of regulatory safety requirements and their assessment pertaining to consumer products such as drugs, medical devices, and food. This need is particularly relevant when safety requirements involve time-intensive and costly animal safety studies. Here we present the current regulatory requirements in Europe, the United States, and Japan for flavoring substances (FSs) used in foods and point out significant differences relevant to the international standardization for safety assessments that in our opinion need to be addressed and overcome. The safety assessments that are carried out for FSs in various countries are influenced by divergent definitions of FS, by the information required and available for regulatory submission, and by different regulatory procedures, including the use of decision tree approaches. The European Food Safety Authority (EFSA), the Expert Panel of the U.S. Flavor and Extract Manufacturers Association (FEMA), and the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) are making efforts to improve and harmonize the safety assessment of FSs. The application of in silico methods such as quantitative structure-activity relationships and read-across strategies relying on expert input are useful as a first-step screening of the assessment. Application of the Threshold of Toxicological Concern (TTC) approach permits conclusions that are compatible with the risk assessment approaches currently used by international advisory committees. The Japanese Regulatory Authority, on the other hand, does not yet consider in silico methods but still requires in vivo and in vitro genotoxicity test data as well as repeat-dose 90-day toxicity data in at least one species, to be submitted as the first step in the safety assessment of FSs. With this article, we echo requests that have

  6. 17 CFR 37.1501 - Chief compliance officer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... facility's self-regulatory program that is requested by the board of directors or the regulatory oversight... compliance office review, look-back, internal or external audit finding, self-reported error, or validated...) Supervising the swap execution facility's self-regulatory program with respect to trade practice surveillance...

  7. 18 CFR 284.11 - Environmental compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Environmental compliance. 284.11 Section 284.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... RELATED AUTHORITIES General Provisions and Conditions § 284.11 Environmental compliance. (a) Any activity...

  8. 18 CFR 284.11 - Environmental compliance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Environmental compliance. 284.11 Section 284.11 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... RELATED AUTHORITIES General Provisions and Conditions § 284.11 Environmental compliance. (a) Any activity...

  9. Regulatory considerations for pluripotent stem cell therapies.

    PubMed

    Carpenter, Melissa K

    2017-01-01

    The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products. © 2017 Elsevier B.V. All rights reserved.

  10. 78 FR 1276 - FY 2012 Annual Compliance Report

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... POSTAL REGULATORY COMMISSION [Docket No. ACR2012; Order No. 1609] FY 2012 Annual Compliance Report... Compliance Report on the costs, revenues, rates, and quality of service associated with its products in... Compliance Report. DATES: Comments are due: February 1, 2013. Reply Comments are due: February 15, 2013...

  11. 76 FR 38454 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ...] Petition for Waiver of Compliance In accordance with part 211 of Title 49 of the Code of Federal... of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR... a waiver of compliance from the Railroad Freight Car Safety Standards, 49 CFR 215.303, which...

  12. Managing quality and compliance.

    PubMed

    McNeil, Alice; Koppel, Carl

    2015-01-01

    Critical care nurses assume vital roles in maintaining patient care quality. There are distinct facets to the process including standard setting, regulatory compliance, and completion of reports associated with these endeavors. Typically, multiple niche software applications are required and user interfaces are varied and complex. Although there are distinct quality indicators that must be tracked as well as a list of serious or sentinel events that must be documented and reported, nurses may not know the precise steps to ensure that information is properly documented and actually reaches the proper authorities for further investigation and follow-up actions. Technology advances have permitted the evolution of a singular software platform, capable of monitoring quality indicators and managing all facets of reporting associated with regulatory compliance.

  13. 76 FR 38453 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Parts 215... waiver of compliance from certain provisions of the Railroad Freight Car Safety Standards, 49 CFR 215.303...

  14. 76 FR 39977 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR 215.303... waiver of compliance from certain provisions of the Railroad Freight Car Safety Standards, 49 CFR 215.303...

  15. 75 FR 69432 - Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Compliance Filing November 5, 2010. Ameren Services Company, Northern Indiana Public Service Company Docket No. EL07-86-014. v.... submitted an errata reflecting changes to its October 29, 2010 compliance filing containing proposed...

  16. Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

    PubMed

    Hess, Ralf D; Weber, Friedemann; Watson, Keith; Schmitt, Siegfried

    2012-04-05

    In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human

  17. Resolving the problem of compliance with the ever increasing and changing regulations

    NASA Astrophysics Data System (ADS)

    Leigh, Harley

    1992-01-01

    The most common problem identified at several U.S. Department of Energy (DOE) sites is regulatory compliance. Simply, the project viability depends on identifying regulatory requirements at the beginning of a specific project to avoid possible delays and cost overruns. The Radioisotope Power Systems Facility (RPSF) is using the Regulatory Compliance System (RCS) to deal with the problem that well over 1000 regulatory documents had to be reviewed for possible compliance requirements applicable to the facility. This overwhelming number of possible documents is not atypical of all DOE facilities thus far reviewed using the RCS system. The RCS was developed to provide control and tracking of all the regulatory and institutional requirements on a given project. WASTREN, Inc., developed the RCS through various DOE contracts and continues to enhance and update the system for existing and new contracts. The RCS provides the information to allow the technical expert to assimilate and manage accurate resource information, compile the necessary checklists, and document that the project or facility fulfills all of the appropriate regulatory requirements. The RCS provides on-line information, including status throughout the project life, thereby allowing more intelligent and proactive decision making. Also, consistency and traceability are provided for regulatory compliance documentation.

  18. Resolving the problem of compliance with the ever increasing and changing regulations

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Leigh, H.

    1991-06-01

    The most common problem identified at several US Department of Energy (DOE) sites is regulatory compliance. Simply, the project viability depends on identifying regulatory requirements at the beginning of a specific project to avoid possible delays and cost overruns. The Radioisotope Power Systems Facility (RFSP) is using the Regulatory Compliance System (RCS) to deal with the problem that well over 1000 regulatory documents had to be reviewed for possible compliance requirements applicable to the facility. This overwhelming number of possible documents is not atypical of all DOE facilities thus far reviewed using the RCS system. The RCS was developed tomore » provide a control and tracking of all the regulatory and institutional requirements on a given project. WASTREN, Inc., developed the RCS through various DOE contracts and continues to enhance and update the system for existing and new contracts. The RCS provides the information to allow the technical expert to assimilate and manage accurate resource information, compile the checklists, and document that the project or facility fulfills all of the appropriate regulatory requirements. The RCS provides on-line information, including status throughput the project life, thereby allowing more intelligent and proactive decision making. Also, consistency and traceability are provided for regulatory compliance documentation. 1 ref., 1 fig.« less

  19. 29 CFR 1952.213 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 36 safety and 18 health compliance officers. After opportunity for public...

  20. 29 CFR 1952.233 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 23 safety and 14 health compliance officers. After opportunity for public...

  1. 29 CFR 1952.323 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 47 safety and 23 health compliance officers. After opportunity for public...

  2. 29 CFR 1952.93 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., in conjunction with OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 17 safety and 12 health compliance officers. After...

  3. 29 CFR 1952.223 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 22 safety and 14 health compliance officers. After opportunity for public...

  4. 29 CFR 1952.223 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 22 safety and 14 health compliance officers. After opportunity for public...

  5. 29 CFR 1952.343 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 6 safety and 2 health compliance officers. After opportunity for pulbic...

  6. 29 CFR 1952.353 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 9 safety and 6 health compliance officers. After opportunity for public...

  7. 29 CFR 1952.373 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 38 safety and 21 health compliance officers. After opportunity for public...

  8. 29 CFR 1952.203 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 31 safety and 12 health compliance officers. After opportunity for public...

  9. 29 CFR 1952.203 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 31 safety and 12 health compliance officers. After opportunity for public...

  10. 29 CFR 1952.343 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 6 safety and 2 health compliance officers. After opportunity for pulbic...

  11. 29 CFR 1952.373 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 38 safety and 21 health compliance officers. After opportunity for public...

  12. 29 CFR 1952.93 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., in conjunction with OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 17 safety and 12 health compliance officers. After...

  13. 29 CFR 1952.233 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 23 safety and 14 health compliance officers. After opportunity for public...

  14. 29 CFR 1952.323 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 47 safety and 23 health compliance officers. After opportunity for public...

  15. 29 CFR 1952.353 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 9 safety and 6 health compliance officers. After opportunity for public...

  16. 29 CFR 1952.213 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... OSHA, completed a reassessment of the levels initially established in 1980 and proposed revised compliance staffing benchmarks of 36 safety and 18 health compliance officers. After opportunity for public...

  17. Implementation of Good Laboratory Practices (GLP) in basic scientific research: Translating the concept beyond regulatory compliance.

    PubMed

    Jena, G B; Chavan, Sapana

    2017-10-01

    The principles of Good Laboratory Practices (GLPs) are mainly intended for the laboratories performing studies for regulatory compliances. However, today GLP can be applied to broad disciplines of science to cater to the needs of the experimental objectives, generation of quality data and assay reproducibility. Considering its significance, it can now be applied in academics; industries as well as government set ups throughout the world. GLP is the best way to promote the reliability, reproducibility of the test data and hence facilitates the international acceptability. Now it is high time to translate and implement the concept of GLP beyond regulatory studies. Thus, it can pave the way for better understanding of scientific problems and help to maintain a good human and environmental health. Through this review, we have made an attempt to explore the uses of GLP principles in different fields of science and its acceptability as well as looking for its future perspectives. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. 78 FR 28284 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ...] Petition for Waiver of Compliance In accordance with part 211 of Title 49 Code of Federal Regulations (CFR... extension of a waiver of compliance from certain provisions of the Federal railroad safety regulations... compliance from the safety glazing provisions of 49 CFR 223.9(a) and from the requirements of 49 CFR 231.30(c...

  19. 76 FR 30727 - Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0366] Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. SUMMARY: The...

  20. [Regulatory science: modern trends in science and education for pharmaceutical products].

    PubMed

    Beregovykh, V V; Piatigorskaia, N V; Aladysheva, Zh I

    2012-01-01

    This article reviews modern trends in development of new instruments, standards and approaches to drugs safety, efficacy and quality assessment in USA and EU that can be called by unique term--"regulatory science" which is a new concept for Russian Federation. New education programs (curricula) developed by USA and EU universities within last 3 years are reviewed. These programs were designed in order to build workforce capable to utilize science approach for drug regulation. The principal mechanisms for financing research in regulatory science used by Food and Drug Administration are analyzed. There are no such science and relevant researches in Russian Federation despite the high demand as well as needs for the system for higher education and life-long learning education of specialists for regulatory affairs (or compliance).

  1. The role of quantitative safety evaluation in regulatory decision making of drugs.

    PubMed

    Chakravarty, Aloka G; Izem, Rima; Keeton, Stephine; Kim, Clara Y; Levenson, Mark S; Soukup, Mat

    2016-01-01

    Evaluation of safety is a critical component of drug review at the US Food and Drug Administration (FDA). Statisticians are playing an increasingly visible role in quantitative safety evaluation and regulatory decision-making. This article reviews the history and the recent events relating to quantitative drug safety evaluation at the FDA. The article then focuses on five active areas of quantitative drug safety evaluation and the role Division of Biometrics VII (DBVII) plays in these areas, namely meta-analysis for safety evaluation, large safety outcome trials, post-marketing requirements (PMRs), the Sentinel Initiative, and the evaluation of risk from extended/long-acting opioids. This article will focus chiefly on developments related to quantitative drug safety evaluation and not on the many additional developments in drug safety in general.

  2. TU-AB-204-02: Device Adverse Events and Compliance

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Gonzales, S.

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

  3. 76 FR 62128 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-06

    ...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule Change to Amend Certain Trade Reporting and Compliance Rules September 30, 2011. Pursuant to Section 19(b... hereby given that on September 22, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA...

  4. The influence of individual and contextual work factors on workers' compliance with health and safety routines.

    PubMed

    Torp, Steffen; Grøgaard, Jens B

    2009-03-01

    This study investigated the relationships between workers' compliance with health and safety (H&S) routines and instructions adopted in the company (dependent variable) and psychological demands, decision authority, social support, management support, unionization and H&S management system (independent variables). A cross-sectional questionnaire study was performed among 1051 workers and the managers of 102 small- and medium-sized motor vehicle repair garages. Multilevel modeling was performed to account for the hierarchical structure of the data. At the worker level, high compliance with H&S routines correlated significantly with both social support and H&S-related management support. At the garage level, mean management support and a well-developed H&S management system correlated significantly with high workers' compliance. Changing both the individual and contextual factors in the work environment may thus increase workers' participation in H&S activities.

  5. Regulatory facility guide for Ohio

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Anderson, S.S.; Bock, R.E.; Francis, M.W.

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  6. 10 CFR 590.406 - Compliance with orders.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Compliance with orders. 590.406 Section 590.406 Energy DEPARTMENT OF ENERGY (CONTINUED) NATURAL GAS (ECONOMIC REGULATORY ADMINISTRATION) ADMINISTRATIVE PROCEDURES WITH RESPECT TO THE IMPORT AND EXPORT OF NATURAL GAS Opinions and Orders § 590.406 Compliance with...

  7. Enforcement of continuous compliance with air quality regulations

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Harrington, C.W.

    1985-01-01

    The compliance of stationary air-pollution sources with air quality regulations is examined. Contrary to the predictions of economic models of enforcement, sources are generally in continuous compliance with the regulations. An alternative voluntary compliance model of enforcement is proposed, in which regulated sources are penalized not for violations, but for failing to return to compliance when a violation is discovered. It is argued that continuous compliance is a bargain struck between the source and the regulatory agency, in which the agency agrees to avoid use of penalties in return for the source's good faith attempts to maintain compliance.

  8. Water quality, compliance, and health outcomes among utilities implementing Water Safety Plans in France and Spain.

    PubMed

    Setty, Karen E; Kayser, Georgia L; Bowling, Michael; Enault, Jerome; Loret, Jean-Francois; Serra, Claudia Puigdomenech; Alonso, Jordi Martin; Mateu, Arnau Pla; Bartram, Jamie

    2017-05-01

    Water Safety Plans (WSPs), recommended by the World Health Organization since 2004, seek to proactively identify potential risks to drinking water supplies and implement preventive barriers that improve safety. To evaluate the outcomes of WSP application in large drinking water systems in France and Spain, we undertook analysis of water quality and compliance indicators between 2003 and 2015, in conjunction with an observational retrospective cohort study of acute gastroenteritis incidence, before and after WSPs were implemented at five locations. Measured water quality indicators included bacteria (E. coli, fecal streptococci, total coliform, heterotrophic plate count), disinfectants (residual free and total chlorine), disinfection by-products (trihalomethanes, bromate), aluminum, pH, turbidity, and total organic carbon, comprising about 240K manual samples and 1.2M automated sensor readings. We used multiple, Poisson, or Tobit regression models to evaluate water quality before and after the WSP intervention. The compliance assessment analyzed exceedances of regulated, recommended, or operational water quality thresholds using chi-squared or Fisher's exact tests. Poisson regression was used to examine acute gastroenteritis incidence rates in WSP-affected drinking water service areas relative to a comparison area. Implementation of a WSP generally resulted in unchanged or improved water quality, while compliance improved at most locations. Evidence for reduced acute gastroenteritis incidence following WSP implementation was found at only one of the three locations examined. Outcomes of WSPs should be expected to vary across large water utilities in developed nations, as the intervention itself is adapted to the needs of each location. The approach may translate to diverse water quality, compliance, and health outcomes. Copyright © 2017 Elsevier GmbH. All rights reserved.

  9. 49 CFR 807.170 - Compliance procedures.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false Compliance procedures. 807.170 Section 807.170... TRANSPORTATION SAFETY BOARD § 807.170 Compliance procedures. (a) Except as provided in paragraph (b) of this... the Architectural and Transportation Barriers Compliance Board upon receipt of any complaint alleging...

  10. 24 CFR 232.620 - Determination of compliance by HHS.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... of Fire Safety Equipment Special Requirements § 232.620 Determination of compliance by HHS. An... the fire safety equipment has been installed, will be in compliance with the HHS requirements for fire... Security Act upon the installation of the fire safety equipment. The architectural exhibits, as approved...

  11. Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

    PubMed

    Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

    2007-05-01

    Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

  12. 30 CFR 772.13 - Coal exploration compliance duties.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 3 2014-07-01 2014-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

  13. 30 CFR 772.13 - Coal exploration compliance duties.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 3 2010-07-01 2010-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

  14. 30 CFR 772.13 - Coal exploration compliance duties.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 3 2012-07-01 2012-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

  15. 30 CFR 772.13 - Coal exploration compliance duties.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 3 2013-07-01 2013-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

  16. 30 CFR 772.13 - Coal exploration compliance duties.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 3 2011-07-01 2011-07-01 false Coal exploration compliance duties. 772.13... INTERIOR SURFACE COAL MINING AND RECLAMATION OPERATIONS PERMITS AND COAL EXPLORATION SYSTEMS UNDER REGULATORY PROGRAMS REQUIREMENTS FOR COAL EXPLORATION § 772.13 Coal exploration compliance duties. (a) All...

  17. Compliance Groundwater Monitoring of Nonpoint Sources - Emerging Approaches

    NASA Astrophysics Data System (ADS)

    Harter, T.

    2008-12-01

    Groundwater monitoring networks are typically designed for regulatory compliance of discharges from industrial sites. There, the quality of first encountered (shallow-most) groundwater is of key importance. Network design criteria have been developed for purposes of determining whether an actual or potential, permitted or incidental waste discharge has had or will have a degrading effect on groundwater quality. The fundamental underlying paradigm is that such discharge (if it occurs) will form a distinct contamination plume. Networks that guide (post-contamination) mitigation efforts are designed to capture the shape and dynamics of existing, finite-scale plumes. In general, these networks extend over areas less than one to ten hectare. In recent years, regulatory programs such as the EU Nitrate Directive and the U.S. Clean Water Act have forced regulatory agencies to also control groundwater contamination from non-incidental, recharging, non-point sources, particularly agricultural sources (fertilizer, pesticides, animal waste application, biosolids application). Sources and contamination from these sources can stretch over several tens, hundreds, or even thousands of square kilometers with no distinct plumes. A key question in implementing monitoring programs at the local, regional, and national level is, whether groundwater monitoring can be effectively used as a landowner compliance tool, as is currently done at point-source sites. We compare the efficiency of such traditional site-specific compliance networks in nonpoint source regulation with various designs of regional nonpoint source monitoring networks that could be used for compliance monitoring. We discuss advantages and disadvantages of the site vs. regional monitoring approaches with respect to effectively protecting groundwater resources impacted by nonpoint sources: Site-networks provide a tool to enforce compliance by an individual landowner. But the nonpoint source character of the contamination

  18. 42 CFR 3.308 - Compliance reviews.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Compliance reviews. 3.308 Section 3.308 Public... ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program § 3.308 Compliance reviews. The Secretary may conduct compliance reviews to determine whether a respondent is complying with the applicable...

  19. Analysis of pharmaceutical safety-related regulatory actions in Japan: do tradeoffs exist between safer drugs and launch delay?

    PubMed

    Yamada, Toru; Kusama, Makiko; Hirai, Yuka; Arnold, Frank; Sugiyama, Yuichi; Ono, Shunsuke

    2010-12-01

    Prediction and management of drug safety is a global regulatory issue. Safety-related regulatory actions (SRRAs) are taken mostly when unexpected adverse drug reactions occur. Currently, Japan is reconciled to delayed access to new drugs (ie, launch delay compared to Western countries), but may have been benefiting by free-riding on safety data accumulated in other countries prior to Japanese launch. To identify factors that are significantly associated with SRRAs, and to discuss the challenges that Japan might have to face with increasing access to new drugs. The SRRAs of 135 new drugs approved from January 2000 to December 2005 were analyzed to investigate association with launch lag, company and drug characteristics, market size, submission data, and regulatory status. SRRAs were measured in terms of the number of emergency safety information notifications and official safety instructions issued by the Japanese regulatory agency within 3 years after approval. A negative binomial distribution model was used for regression analysis. Longer launch lags and presence of drugs with similar modes of action were associated with fewer SRRAs. Bridging strategy showed increased SRRAs. No significant association was observed between SRRAs and the subject number in clinical data packages. Occurrence of SRRAs was varied among development strategy, preceding products, and regional regulations. The occurrence of SRRAs was associated with the accumulation of both foreign and domestic postmarketing evidence rather than with clinical trial data upon launch. Considering the paradigm shift to simultaneous global drug development and filing for regulatory approval, this study indicates the importance of intensive data collection in the early postmarketing phase and use of safety information in early markets. However, even if we would be sufficiently cautious about safety risks of new drugs, a population that enjoys first-in-class drugs probably has to bear the risks.

  20. 76 FR 38597 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-01

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383 and 390 [Docket No. FMCSA-2011-0146] Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators of Certain Farm Vehicles and Off-Road Agricultural Equipment AGENCY: Federal Motor...

  1. 76 FR 50433 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383 and 390 [Docket No. FMCSA-2011-0146] Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators of Certain Farm Vehicles and Off-Road Agricultural Equipment AGENCY: Federal Motor...

  2. Impact of federal compliance reviews of trucking companies in reducing highway truck crashes.

    PubMed

    Chen, Guang Xiang

    2008-01-01

    The compliance review (CR) is a federal program monitoring motor carrier safety performance and regulatory compliance. This study sought to assess the impact of CRs on reviewed trucking companies in reducing truck crashes. Data was from the Motor Carrier Management Information System. Study subjects were trucking companies established during 1990-1995, had at least one truck, and remained active until April 2004. Truck crash data of these companies was examined from 1996 to 2003. The crash rates in 2003 and annual percentage changes in number of crashes were computed. Analyses were stratified by company size, organization, operation classification, and safety rating. Companies that received CRs had a higher crash rate than never-reviewed companies. Reviewed companies experienced a 39-15% reduction in number of crashes in the year the CR was performed. The reduction in crashes was observed in all reviewed companies regardless of company size, operation classification, type of organization, or safety rating. The reduction in crashes was sustained for at least 7 years after CRs. The study results were controlled for the year in which CRs were performed, crash trend, and CR selection bias. However, further studies, especially a randomized prospective longitudinal study, are needed to overcome the limitations that are associated with an observation study.

  3. 40 CFR 716.1 - Scope and compliance.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.1 Scope and compliance. (a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical... 40 Protection of Environment 32 2012-07-01 2012-07-01 false Scope and compliance. 716.1 Section...

  4. 40 CFR 716.1 - Scope and compliance.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.1 Scope and compliance. (a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical... 40 Protection of Environment 31 2014-07-01 2014-07-01 false Scope and compliance. 716.1 Section...

  5. 40 CFR 716.1 - Scope and compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.1 Scope and compliance. (a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical... 40 Protection of Environment 30 2010-07-01 2010-07-01 false Scope and compliance. 716.1 Section...

  6. 40 CFR 716.1 - Scope and compliance.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.1 Scope and compliance. (a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical... 40 Protection of Environment 31 2011-07-01 2011-07-01 false Scope and compliance. 716.1 Section...

  7. 40 CFR 716.1 - Scope and compliance.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... ACT HEALTH AND SAFETY DATA REPORTING General Provisions § 716.1 Scope and compliance. (a) This subpart sets forth requirements for the submission of lists and copies of health and safety studies on chemical... 40 Protection of Environment 32 2013-07-01 2013-07-01 false Scope and compliance. 716.1 Section...

  8. Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

    PubMed

    Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

    2016-04-07

    Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

  9. Regulatory Issues Associated with Preharvest Food Safety: United States Perspective.

    PubMed

    Micallef, Shirley A; Buchanan, Robert L

    2017-07-01

    The preharvest and preslaughter steps of food production constitute a first stage at which food can become contaminated with foodborne and toxigenic pathogens. Contamination at this early stage of food production can lead to amplification as food travels through the production and supply chain, accentuating the crucial need to address hazards and establish science-based metrics that are feasible to implement. This article discusses the preharvest food safety regulatory landscape in the United States, with a specific emphasis on fresh produce crops. Best practices, certification, audit schemes and challenges due to market channels, economies of scales, and grower behavior are considered in relation to the Food Safety Modernization Act. An outlook on the needs to facilitate implementation of the new law, develop educational programs for growers and stakeholders, and continue to better align food safety with environmental goals are presented.

  10. 77 FR 68883 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ... compliance from the Railroad Freight Car Safety Standards contained in 49 CFR 215.303-Stenciling of restricted cars, which requires stenciling on restricted freight cars with a clearly legible letter ``R... waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49...

  11. 77 FR 17470 - Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-26

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [EL11-22-000, QF11-115-001, QF11-116-001, et al.] Notice of Compliance Filing Docket Nos. OREG 1, Inc EL11-22-000 OREG 2, Inc QF11-115-001 OREG...., OREG 3, Inc., and OREG 4, Inc filed compliance refund reports, pursuant to the Federal Energy...

  12. 77 FR 48137 - Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [EL11-22-000, QF11-115-001, QF11-116-001, et al.] Notice of Compliance Filing OREG 1, Inc.; OREG 2, Inc.; OREG 3, Inc.; Docket Nos. EL11-22-000..., OREG 1, Inc., OREG 2, Inc., OREG 3, Inc., and OREG 4, Inc. submitted a supplement to the compliance...

  13. 10 CFR 851.4 - Compliance order.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Compliance order. 851.4 Section 851.4 Energy DEPARTMENT OF ENERGY WORKER SAFETY AND HEALTH PROGRAM General Provisions § 851.4 Compliance order. (a) The Secretary... effectiveness of a Compliance Order unless the Secretary issues an order to that effect. (d) A copy of the...

  14. 75 FR 80315 - Compliance Directive for Fall Protection in Residential Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1926 Compliance Directive for Fall Protection in Residential Construction AGENCY: Occupational Safety and Health... Protection Compliance Directive for Residential Construction. SUMMARY: The Occupational Safety and Health...

  15. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

  16. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

  17. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

  18. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

  19. 21 CFR 500.88 - Regulatory method.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b) The...

  20. 42 CFR 3.110 - Assessment of PSO compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Assessment of PSO compliance. 3.110 Section 3.110... SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT PSO Requirements and Agency Procedures § 3.110 Assessment of PSO compliance. The Secretary may request information or conduct announced or unannounced...

  1. 18 CFR 154.600 - Compliance with other subparts.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Compliance with other subparts. 154.600 Section 154.600 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.600 Compliance with other subparts. Any proposal to implement a tariff change other than in...

  2. 18 CFR 154.600 - Compliance with other subparts.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Compliance with other subparts. 154.600 Section 154.600 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.600 Compliance with other subparts. Any proposal to implement a tariff change other than in...

  3. 18 CFR 154.600 - Compliance with other subparts.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Compliance with other subparts. 154.600 Section 154.600 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.600 Compliance with other subparts. Any proposal to implement a tariff change other than in...

  4. 18 CFR 154.600 - Compliance with other subparts.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Compliance with other subparts. 154.600 Section 154.600 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.600 Compliance with other subparts. Any proposal to implement a tariff change other than in...

  5. 18 CFR 154.600 - Compliance with other subparts.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Compliance with other subparts. 154.600 Section 154.600 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY... Changes § 154.600 Compliance with other subparts. Any proposal to implement a tariff change other than in...

  6. Steps towards the international regulatory acceptance of non-animal methodology in safety assessment.

    PubMed

    Sewell, Fiona; Doe, John; Gellatly, Nichola; Ragan, Ian; Burden, Natalie

    2017-10-01

    The current animal-based paradigm for safety assessment must change. In September 2016, the UK National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs) brought together scientists from regulatory authorities, academia and industry to review progress in bringing new methodology into regulatory use, and to identify ways to expedite progress. Progress has been slow. Science is advancing to make this possible but changes are necessary. The new paradigm should allow new methodology to be adopted once it is developed rather than being based on a fixed set of studies. Regulatory authorities can help by developing Performance-Based Standards. The most pressing need is in repeat dose toxicology, although setting standards will be more complex than in areas such as sensitization. Performance standards should be aimed directly at human safety, not at reproducing the results of animal studies. Regulatory authorities can also aid progress towards the acceptance of non-animal based methodology by promoting "safe-haven" trials where traditional and new methodology data can be submitted in parallel to build up experience in the new methods. Industry can play its part in the acceptance of new methodology, by contributing to the setting of performance standards and by actively contributing to "safe-haven" trials. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  7. Regulatory Agencies and Food Safety

    PubMed Central

    Chapman, R. A.; Morrison, A. B.

    1966-01-01

    Prior to Confederation, food control legislation in Canada consisted of only a few simple laws governing the quality, grading, packing and inspection of certain staple foods. The Inland Revenue Act of 1875 provided the first real control in Canada over adulteration of liquor, foods and drugs. Since then, food legislation has evolved in scope and complexity as the industries involved have developed, as consumers have become better informed, and as scientific advances have provided a sound basis for regulations. Present regulations under the Food and Drugs Act are intended to give consumers broad protection against health hazards and fraud in the production, manufacture, labelling, packaging, advertising, and sale of foods. This principle is well illustrated by present requirements for the control of pesticide residues, chemical additives, and the addition of vitamins to foods. In today's era of rapid technological change, application of current scientific knowledge to the food industry obviously involves the possibility of hazards to health. Regulatory agencies with responsibility for food safety must, therefore, fully utilize scientific knowledge in order to reduce the risks involved to a minimum. PMID:5905951

  8. 12 CFR 1770.5 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 7 2011-01-01 2011-01-01 false Compliance. 1770.5 Section 1770.5 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS EXECUTIVE COMPENSATION § 1770.5 Compliance. (a) An employment agreement or contract...

  9. 12 CFR 1770.5 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Compliance. 1770.5 Section 1770.5 Banks and Banking OFFICE OF FEDERAL HOUSING ENTERPRISE OVERSIGHT, DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS EXECUTIVE COMPENSATION § 1770.5 Compliance. (a) An employment agreement or contract...

  10. Managing business compliance using model-driven security management

    NASA Astrophysics Data System (ADS)

    Lang, Ulrich; Schreiner, Rudolf

    Compliance with regulatory and governance standards is rapidly becoming one of the hot topics of information security today. This is because, especially with regulatory compliance, both business and government have to expect large financial and reputational losses if compliance cannot be ensured and demonstrated. One major difficulty of implementing such regulations is caused the fact that they are captured at a high level of abstraction that is business-centric and not IT centric. This means that the abstract intent needs to be translated in a trustworthy, traceable way into compliance and security policies that the IT security infrastructure can enforce. Carrying out this mapping process manually is time consuming, maintenance-intensive, costly, and error-prone. Compliance monitoring is also critical in order to be able to demonstrate compliance at any given point in time. The problem is further complicated because of the need for business-driven IT agility, where IT policies and enforcement can change frequently, e.g. Business Process Modelling (BPM) driven Service Oriented Architecture (SOA). Model Driven Security (MDS) is an innovative technology approach that can solve these problems as an extension of identity and access management (IAM) and authorization management (also called entitlement management). In this paper we will illustrate the theory behind Model Driven Security for compliance, provide an improved and extended architecture, as well as a case study in the healthcare industry using our OpenPMF 2.0 technology.

  11. 49 CFR 214.305 - Compliance dates.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Compliance dates. 214.305 Section 214.305 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection § 214.305 Compliance dates...

  12. 24 CFR 232.620 - Determination of compliance by HHS.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... AUTHORITIES MORTGAGE INSURANCE FOR NURSING HOMES, INTERMEDIATE CARE FACILITIES, BOARD AND CARE HOMES, AND... of Fire Safety Equipment Special Requirements § 232.620 Determination of compliance by HHS. An... the fire safety equipment has been installed, will be in compliance with the HHS requirements for fire...

  13. Expanding the scope of practice for radiology managers: radiation safety duties.

    PubMed

    Orders, Amy B; Wright, Donna

    2003-01-01

    In addition to financial responsibilities and patient care duties, many medical facilities also expect radiology department managers to wear "safety" hats and complete fundamental quality control/quality assurance, conduct routine safety surveillance in the department, and to meet regulatory demands in the workplace. All managers influence continuous quality improvement initiatives, from effective utilization of resource and staffing allocations, to efficacy of patient scheduling tactics. It is critically important to understand continuous quality improvement (CQI) and its relationship with the radiology manager, specifically quality assurance/quality control in routine work, as these are the fundamentals of institutional safety, including radiation safety. When an institution applies for a registration for radiation-producing devices or a license for the use of radioactive materials, the permit granting body has specific requirements, policies and procedures that must be satisfied in order to be granted a permit and to maintain it continuously. In the 32 U.S. Agreement states, which are states that have radiation safety programs equivalent to the Nuclear Regulatory Commission programs, individual facilities apply for permits through the local governing body of radiation protection. Other states are directly licensed by the Nuclear Regulatory Commission and associated regulatory entities. These regulatory agencies grant permits, set conditions for use in accordance with state and federal laws, monitor and enforce radiation safety activities, and audit facilities for compliance with their regulations. Every radiology department and associated areas of radiation use are subject to inspection and enforcement policies in order to ensure safety of equipment and personnel. In today's business practice, department managers or chief technologists may actively participate in the duties associated with institutional radiation safety, especially in smaller institutions, while

  14. 75 FR 20035 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... safety requirements. Jasper petitioned FRA for a waiver of compliance from certain provisions of the...

  15. Regulatory Information By Sector

    EPA Pesticide Factsheets

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  16. 24 CFR 232.620 - Determination of compliance by HHS.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... of Fire Safety Equipment Special Requirements § 232.620 Determination of compliance by HHS. An... the fire safety equipment has been installed, will be in compliance with the HHS requirements for fire... services along with a plan prepared by the applicant for correcting those deficiencies. In such event, HHS...

  17. 24 CFR 232.620 - Determination of compliance by HHS.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... of Fire Safety Equipment Special Requirements § 232.620 Determination of compliance by HHS. An... the fire safety equipment has been installed, will be in compliance with the HHS requirements for fire... services along with a plan prepared by the applicant for correcting those deficiencies. In such event, HHS...

  18. Safety system augmentation at Russian nuclear power plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Scerbo, J.A.; Satpute, S.N.; Donkin, J.Y.

    1996-12-31

    This paper describes the design and procurement of a Class IE DC power supply system to upgrade plant safety at the Kola Nuclear Power Plant (NPP). Kola NPP is located above the Arctic circle at Polyarnie Zorie, Murmansk, Russia. Kola NPP consists of four units. Units 1 and 2 have VVER-440/230 type reactors: Units 3 and 4 have VVER-440/213 type reactors. The VVER-440 reactor design is similar to the pressurized water reactor design used in the US. This project provided redundant, Class 1E DC station batteries and DC switchboards for Kola NPP, Units 1 and 2. The new DC powermore » supply system was designed and procured in compliance with current nuclear design practices and requirements. Technical issues that needed to be addressed included reconciling the requirements in both US and Russian codes and satisfying the requirements of the Russian nuclear regulatory authority. Close interface with ATOMENERGOPROEKT (AEP), the Russian design organization, KOLA NPP plant personnel, and GOSATOMNADZOR (GAN), the Russian version of US Nuclear Regulatory Commission, was necessary to develop a design that would assure compliance with current Russian design requirements. Hence, this project was expected to serve as an example for plant upgrades at other similar VVER-440 nuclear plants. In addition to technical issues, the project needed to address language barriers and the logistics of shipping equipment to a remote section of the Former Soviet Union (FSU). This project was executed by Burns and Roe under the sponsorship of the US DOE as part of the International Safety Program (INSP). The INSP is a comprehensive effort, in cooperation with partners in other countries, to improve nuclear safety worldwide. A major element within the INSP is the improvement of the safety of Soviet-designed nuclear reactors.« less

  19. 75 FR 20036 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-16

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) received a request for a waiver of compliance with certain... waiver of compliance with the Locomotive Safety Standards, 49 CFR 229.129(b)(2), which requires that the...

  20. 75 FR 39617 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... waiver of compliance with the Locomotive Safety Standards, 49 CFR 229.129(b)(2), which requires that the...

  1. 75 FR 39616 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain... Pan Am Railways (Pan Am) seeks a waiver of compliance with the Locomotive Safety Standards, 49 CFR 229...

  2. Probabilistic modeling approach for evaluating the compliance of ready-to-eat foods with new European Union safety criteria for Listeria monocytogenes.

    PubMed

    Koutsoumanis, Konstantinos; Angelidis, Apostolos S

    2007-08-01

    Among the new microbiological criteria that have been incorporated in EU Regulation 2073/2005, of particular interest are those concerning Listeria monocytogenes in ready-to eat (RTE) foods, because for certain food categories, they no longer require zero tolerance but rather specify a maximum allowable concentration of 100 CFU/g or ml. This study presents a probabilistic modeling approach for evaluating the compliance of RTE sliced meat products with the new safety criteria for L. monocytogenes. The approach was based on the combined use of (i) growth/no growth boundary models, (ii) kinetic growth models, (iii) product characteristics data (pH, a(w), shelf life) collected from 160 meat products from the Hellenic retail market, and (iv) storage temperature data recorded from 50 retail stores in Greece. This study shows that probabilistic analysis of the above components using Monte Carlo simulation, which takes into account the variability of factors affecting microbial growth, can lead to a realistic estimation of the behavior of L. monocytogenes throughout the food supply chain, and the quantitative output generated can be further used by food managers as a decision-making tool regarding the design or modification of a product's formulation or its "use-by" date in order to ensure its compliance with the new safety criteria. The study also argues that compliance of RTE foods with the new safety criteria should not be considered a parameter with a discrete and binary outcome because it depends on factors such as product characteristics, storage temperature, and initial contamination level, which display considerable variability even among different packages of the same RTE product. Rather, compliance should be expressed and therefore regulated in a more probabilistic fashion.

  3. 77 FR 15096 - Bonneville Power Administration; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-14

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL11-44-002] Bonneville Power Administration; Notice of Compliance Filing Take notice that on March 6, 2012, the Bonneville Power Administration (Bonneville) submitted a compliance filing with Pro Forma sheets in response to the...

  4. 23 CFR 630.1016 - Compliance date.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 23 Highways 1 2011-04-01 2011-04-01 false Compliance date. 630.1016 Section 630.1016 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1016 Compliance date. States shall comply with all...

  5. 23 CFR 630.1016 - Compliance date.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 23 Highways 1 2012-04-01 2012-04-01 false Compliance date. 630.1016 Section 630.1016 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1016 Compliance date. States shall comply with all...

  6. 23 CFR 630.1016 - Compliance date.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 23 Highways 1 2013-04-01 2013-04-01 false Compliance date. 630.1016 Section 630.1016 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1016 Compliance date. States shall comply with all...

  7. 23 CFR 630.1016 - Compliance date.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 23 Highways 1 2014-04-01 2014-04-01 false Compliance date. 630.1016 Section 630.1016 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1016 Compliance date. States shall comply with all...

  8. 23 CFR 630.1016 - Compliance date.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 23 Highways 1 2010-04-01 2010-04-01 false Compliance date. 630.1016 Section 630.1016 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1016 Compliance date. States shall comply with all...

  9. 49 CFR 178.33-1 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Compliance. 178.33-1 Section 178.33-1 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Containers, and Linings § 178.33-1 Compliance. (a) Required in all details. (b) [Reserved] ...

  10. 75 FR 65397 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-22

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration Petition for Waiver of Compliance In... Federal Railroad Administration (FRA) received a request for a waiver of compliance with certain... of compliance with the Locomotive Safety Standards, 49 CFR 229.21, 229.23(d), 229.27(a)(3), and 229...

  11. 49 CFR 178.33-1 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Compliance. 178.33-1 Section 178.33-1 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... Specifications for Inside Containers, and Linings § 178.33-1 Compliance. (a) Required in all details. (b...

  12. 49 CFR 244.21 - Compliance and Enforcement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.21 Compliance and Enforcement. (a...

  13. 78 FR 46681 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR... compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 214... all work for compliance with the requirements of the protection procedures and would ensure that all...

  14. 76 FR 38456 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety...- 0048. TriMet has petitioned FRA for a waiver of compliance from certain provisions of the Federal...

  15. Clean Air Markets - Compliance Query Wizard

    EPA Pesticide Factsheets

    The Compliance Query Wizard is part of a suite of Clean Air Markets-related tools that are accessible at http://ampd.epa.gov/ampd/. The Compliance module provides final compliance results. Using the Compliance Query Wizard, the user can find compliance information associated with specific programs, facilities, states or time frames. Quick Reports and Prepackaged Datasets are also available for data that are commonly requested. Final compliance results are available for all years since 1995 for the Acid Rain Program and for the various NOx trading programs EPA has operated since 1999.EPA's Clean Air Markets Division (CAMD) includes several market-based regulatory programs designed to improve air quality and ecosystems. The most well-known of these programs are EPA's Acid Rain Program and the NOx Programs, which reduce emissions of sulfur dioxide (SO2) and nitrogen oxides (NOx)-compounds that adversely affect air quality, the environment, and public health. CAMD also plays an integral role in the development and implementation of the Clean Air Interstate Rule (CAIR).

  16. 78 FR 46680 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR... Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety.... Specifically, AAR seeks a waiver of compliance from Part 232, Appendix B, Part 232 Prior to May 31, 2001 as...

  17. 77 FR 6171 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... request for a waiver of compliance from certain requirements of its safety standards. In a letter dated... permanent waiver of compliance for one switching locomotive (HVRM 11) from the requirements of 49 CFR part...

  18. 29 CFR 1910.9 - Compliance duties owed to each employee.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 29 Labor 5 2012-07-01 2012-07-01 false Compliance duties owed to each employee. 1910.9 Section 1910.9 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH STANDARDS General § 1910.9 Compliance duties owed to each...

  19. Waste Sampling & Characterization Facility (WSCF) Complex Safety Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    MELOY, R.T.

    2002-04-01

    This document was prepared to analyze the Waste Sampling and Characterization Facility for safety consequences by: Determining radionuclide and highly hazardous chemical inventories; Comparing these inventories to the appropriate regulatory limits; Documenting the compliance status with respect to these limits; and Identifying the administrative controls necessary to maintain this status. The primary purpose of the Waste Sampling and Characterization Facility (WSCF) is to perform low-level radiological and chemical analyses on various types of samples taken from the Hanford Site. These analyses will support the fulfillment of federal, Washington State, and Department of Energy requirements.

  20. 23 CFR 1200.26 - Non-compliance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Implementation and Management of the Highway Safety Program § 1200.26 Non-compliance. Where a State is found to... special conditions for high-risk grantees and the enforcement procedures of 49 CFR part 18, or the...

  1. 10 CFR 76.64 - Denial of certificate or compliance plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Denial of certificate or compliance plan. 76.64 Section 76.64 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.64 Denial of certificate or compliance plan. (a) The Director may deny an application for a...

  2. 10 CFR 76.64 - Denial of certificate or compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Denial of certificate or compliance plan. 76.64 Section 76.64 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.64 Denial of certificate or compliance plan. (a) The Director may deny an application for a...

  3. 10 CFR 76.64 - Denial of certificate or compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Denial of certificate or compliance plan. 76.64 Section 76.64 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.64 Denial of certificate or compliance plan. (a) The Director may deny an application for a...

  4. 10 CFR 76.64 - Denial of certificate or compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Denial of certificate or compliance plan. 76.64 Section 76.64 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.64 Denial of certificate or compliance plan. (a) The Director may deny an application for a...

  5. 10 CFR 76.64 - Denial of certificate or compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Denial of certificate or compliance plan. 76.64 Section 76.64 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.64 Denial of certificate or compliance plan. (a) The Director may deny an application for a...

  6. 10 CFR 20.2007 - Compliance with environmental and health protection regulations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Compliance with environmental and health protection regulations. 20.2007 Section 20.2007 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2007 Compliance with environmental and health protection regulations. Nothing...

  7. 10 CFR 20.2007 - Compliance with environmental and health protection regulations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Compliance with environmental and health protection regulations. 20.2007 Section 20.2007 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2007 Compliance with environmental and health protection regulations. Nothing...

  8. 10 CFR 20.2007 - Compliance with environmental and health protection regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Compliance with environmental and health protection regulations. 20.2007 Section 20.2007 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2007 Compliance with environmental and health protection regulations. Nothing...

  9. 10 CFR 20.2007 - Compliance with environmental and health protection regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Compliance with environmental and health protection regulations. 20.2007 Section 20.2007 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2007 Compliance with environmental and health protection regulations. Nothing...

  10. 10 CFR 20.2007 - Compliance with environmental and health protection regulations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Compliance with environmental and health protection regulations. 20.2007 Section 20.2007 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Waste Disposal § 20.2007 Compliance with environmental and health protection regulations. Nothing...

  11. 16 CFR 1204.13 - Certificate of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Certificate of compliance. 1204.13 Section 1204.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR OMNIDIRECTIONAL CITIZENS BAND BASE STATION ANTENNAS Certification § 1204.13...

  12. 29 CFR 1952.153 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... further revision of its benchmarks to 64 safety inspectors and 50 industrial hygienists. After opportunity... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... benchmarks of 50 safety and 27 health compliance officers. After opportunity for public comment and service...

  13. 29 CFR 1952.153 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... further revision of its benchmarks to 64 safety inspectors and 50 industrial hygienists. After opportunity... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... benchmarks of 50 safety and 27 health compliance officers. After opportunity for public comment and service...

  14. 29 CFR 1952.153 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... further revision of its benchmarks to 64 safety inspectors and 50 industrial hygienists. After opportunity... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... benchmarks of 50 safety and 27 health compliance officers. After opportunity for public comment and service...

  15. 29 CFR 1952.153 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... further revision of its benchmarks to 64 safety inspectors and 50 industrial hygienists. After opportunity... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... benchmarks of 50 safety and 27 health compliance officers. After opportunity for public comment and service...

  16. 29 CFR 1952.153 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... further revision of its benchmarks to 64 safety inspectors and 50 industrial hygienists. After opportunity... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... benchmarks of 50 safety and 27 health compliance officers. After opportunity for public comment and service...

  17. 16 CFR 1210.12 - Certificate of compliance.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.12 Certificate of compliance. (a... Product Safety Standard for Cigarette Lighters (16 CFR 1210),” (2) The name and address of the...

  18. 18 CFR 1b.15 - Non-compliance with compulsory processes.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Non-compliance with compulsory processes. 1b.15 Section 1b.15 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.15 Non-compliance with...

  19. 18 CFR 1b.15 - Non-compliance with compulsory processes.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Non-compliance with compulsory processes. 1b.15 Section 1b.15 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.15 Non-compliance with...

  20. 18 CFR 1b.15 - Non-compliance with compulsory processes.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Non-compliance with compulsory processes. 1b.15 Section 1b.15 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.15 Non-compliance with...

  1. 18 CFR 1b.15 - Non-compliance with compulsory processes.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Non-compliance with compulsory processes. 1b.15 Section 1b.15 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY GENERAL RULES RULES RELATING TO INVESTIGATIONS § 1b.15 Non-compliance with...

  2. Regulations: Can They Control Staff Compliance in Human Services Systems?

    ERIC Educational Resources Information Center

    Jacobson, John W.

    1990-01-01

    This article discusses results of regulations for Intermediate Care Facilities for the Mentally Retarded, arguing that, by establishing minimum standards for funding, these policies promote mediocrity. Strategies for promoting compliance behaviors are offered, as are observations on regulatory reform and the process of regulatory impact. (PB)

  3. 75 FR 27772 - Corning Natural Gas Corporation; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-30-002] Corning Natural Gas Corporation; Notice of Compliance Filing May 11, 2010. Take notice that on May 3, 2010, Corning Natural Gas Corporation, (Corning) filed its Statement of section 311 Operating Conditions in compliance...

  4. Compliance of camps in the United States with guidelines for health and safety practices.

    PubMed

    Olympia, Robert P; Hollern, Kaylee; Armstrong, Caitlin; Adedayo, Pelumi; Dunnick, Jennifer; Hartley, Jessica; Doshi, Bhavin

    2015-03-01

    To determine the compliance of US camps with guidelines for health and safety practices as set forth by the American Academy of Pediatrics and the US Department of Homeland Security. An electronic questionnaire was distributed to US camps during the summer of 2012 as identified by 3 online summer camp directories. Analysis was performed on 433 completed questionnaires. Fourteen percent of camps were considered medically related. Ninety-three percent of camps have established relationships with community emergency medical services, 34% with local orthodontists, and 37% with local mental health professionals. Camps reported the immediate availability of the following: automated external defibrillators (75%), respiratory rescue inhalers (44%), epinephrine autoinjectors (64%), cervical spine collars (62%), and backboard with restraints (76%). Camps reported the presence of the following written health policies: dehydration (91%), asthma and anaphylaxis (88%), head injuries (90%), seizures (78%), cardiac arrest (76%), and drowning (73%). Although 93% of camps have a disaster response plan, 15% never practice the plan. Sixty-eight percent of camps are familiar with community evacuation plans, and 67% have access to vehicles for transport. Camps reported the presence of the following written disaster policies: fire (96%), tornadoes (68%), arrival of suspicious individuals (84%), hostage situations (18%). Areas for improvement in the compliance of US camps with specific recommendations for health and safety practices were identified, such as medically preparing campers before their attendance, developing relationships with community health providers, increasing the immediate availability of several emergency medications and equipment, and developing policies and protocols for medical and disaster emergencies.

  5. Compliance with vessel speed restrictions to protect North Atlantic right whales.

    PubMed

    Silber, Gregory K; Adams, Jeffrey D; Fonnesbeck, Christopher J

    2014-01-01

    Environmental regulations can only be effective if they are adhered to, but the motivations for regulatory compliance are not always clear. We assessed vessel operator compliance with a December 2008 regulation aimed at reducing collisions with the endangered North Atlantic right whale that requires vessels 65 feet or greater in length to travel at speeds of 10 knots or less at prescribed times and locations along the U.S. eastern seaboard. Extensive outreach efforts were undertaken to notify affected entities both before and after the regulation went into effect. Vessel speeds of 201,862 trips made between November 2008 and August 2013 by 8,009 individual vessels were quantified remotely, constituting a nearly complete census of transits made by the regulated population. Of these, 437 vessels (or their parent companies), some of whom had been observed exceeding the speed limit, were contacted through one of four non-punitive information programs. A fraction (n = 26 vessels/companies) received citations and fines. Despite the efforts to inform mariners, initial compliance was low (<5% of the trips were completely <10 knots) but improved in the latter part of the study. Each notification/enforcement program improved compliance to some degree and some may have influenced compliance across the entire regulated community. Citations/fines appeared to have the greatest influence on improving compliance in notified vessels/companies, followed in order of effectiveness by enforcement-office information letters, monthly summaries of vessel operations, and direct at-sea radio contact. Trips by cargo vessels exhibited the greatest change in behavior followed by tanker and passenger vessels. These results have application to other regulatory systems, especially where remote monitoring is feasible, and any setting where regulatory compliance is sought.

  6. Compliance with vessel speed restrictions to protect North Atlantic right whales

    PubMed Central

    Adams, Jeffrey D.; Fonnesbeck, Christopher J.

    2014-01-01

    Environmental regulations can only be effective if they are adhered to, but the motivations for regulatory compliance are not always clear. We assessed vessel operator compliance with a December 2008 regulation aimed at reducing collisions with the endangered North Atlantic right whale that requires vessels 65 feet or greater in length to travel at speeds of 10 knots or less at prescribed times and locations along the U.S. eastern seaboard. Extensive outreach efforts were undertaken to notify affected entities both before and after the regulation went into effect. Vessel speeds of 201,862 trips made between November 2008 and August 2013 by 8,009 individual vessels were quantified remotely, constituting a nearly complete census of transits made by the regulated population. Of these, 437 vessels (or their parent companies), some of whom had been observed exceeding the speed limit, were contacted through one of four non-punitive information programs. A fraction (n = 26 vessels/companies) received citations and fines. Despite the efforts to inform mariners, initial compliance was low (<5% of the trips were completely <10 knots) but improved in the latter part of the study. Each notification/enforcement program improved compliance to some degree and some may have influenced compliance across the entire regulated community. Citations/fines appeared to have the greatest influence on improving compliance in notified vessels/companies, followed in order of effectiveness by enforcement-office information letters, monthly summaries of vessel operations, and direct at-sea radio contact. Trips by cargo vessels exhibited the greatest change in behavior followed by tanker and passenger vessels. These results have application to other regulatory systems, especially where remote monitoring is feasible, and any setting where regulatory compliance is sought. PMID:24949229

  7. Industrial responses to constrained OSHA regulation. Occupational Safety and Health Administration.

    PubMed

    Pedersen, D H

    2000-01-01

    As part of the effort to reduce the size and economic impact of the federal establishment, congressional conservatives are proposing legislation to restrict the regulatory activity of the Occupational Safety and Health Administration (OSHA). These proposals push OSHA toward a purely consultative role, at a corresponding cost in direct regulatory capability. The Clinton administration's reinvention of government initiative is also moving OSHA toward a consultative role based on a strategy of cooperative compliance or industry self-regulation with a strong coercive foundation. Since both camps appear to agree that self-regulation can assure a safe and healthy workplace, the remaining debate concerns the extent to which coercive regulation is still needed. National survey data on the industrial provision of occupational safety and health services in the manufacturing sector were used to measure changes in industrial safety and health activity between 1972-74 and 1981-83. In conjunction with data on OSHA command-and-control regulatory activity from 1972 to 1979, these data permitted an examination of the relationship between command-and-control regulatory activities and changes in industrial behavior that could be regarded as a form of self-regulation. This analysis showed that coercive regulation by OSHA in the 1970s was significantly related to industry self-regulation efforts, although the relationship varied by industrial facility employment size and type of regulatory coercion. These results indicate that coercive regulation should be retained as an industrial incentive in any self-regulation policy paradigm. The results also provide evidence that OSHA regulatory policy should be based on anticipated differences in industrial response to various coercive measures.

  8. Engineering nucleases for gene targeting: safety and regulatory considerations.

    PubMed

    Pauwels, Katia; Podevin, Nancy; Breyer, Didier; Carroll, Dana; Herman, Philippe

    2014-01-25

    Nuclease-based gene targeting (NBGT) represents a significant breakthrough in targeted genome editing since it is applicable from single-celled protozoa to human, including several species of economic importance. Along with the fast progress in NBGT and the increasing availability of customized nucleases, more data are available about off-target effects associated with the use of this approach. We discuss how NBGT may offer a new perspective for genetic modification, we address some aspects crucial for a safety improvement of the corresponding techniques and we also briefly relate the use of NBGT applications and products to the regulatory oversight. Copyright © 2013 Elsevier B.V. All rights reserved.

  9. 75 FR 67960 - North American Electric Reliability Corporation; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-04

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. RM06-16-011] North American Electric Reliability Corporation; Notice of Compliance Filing October 28, 2010. Take notice that on October 25, 2010, the North American Electric Reliability Corporation (NERC), submitted a compliance filing...

  10. 77 FR 12277 - City of Banning, CA; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-29

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. NJ12-3-001] City of Banning, CA; Notice of Compliance Filing Take notice that on February 16, 2012, the City of Banning, CA (Banning) submitted a compliance filing with a revised version of Appendix I to Banning's Transmission...

  11. 14 CFR 26.49 - Compliance plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 1 2011-01-01 2011-01-01 false Compliance plan. 26.49 Section 26.49 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CONTINUED AIRWORTHINESS AND SAFETY IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance...

  12. 14 CFR 26.49 - Compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 1 2012-01-01 2012-01-01 false Compliance plan. 26.49 Section 26.49 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CONTINUED AIRWORTHINESS AND SAFETY IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance...

  13. 14 CFR 26.49 - Compliance plan.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Compliance plan. 26.49 Section 26.49 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CONTINUED AIRWORTHINESS AND SAFETY IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance...

  14. 14 CFR 26.49 - Compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 1 2013-01-01 2013-01-01 false Compliance plan. 26.49 Section 26.49 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CONTINUED AIRWORTHINESS AND SAFETY IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance...

  15. 14 CFR 26.49 - Compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 1 2014-01-01 2014-01-01 false Compliance plan. 26.49 Section 26.49 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION AIRCRAFT CONTINUED AIRWORTHINESS AND SAFETY IMPROVEMENTS FOR TRANSPORT CATEGORY AIRPLANES Aging Airplane Safety-Damage Tolerance...

  16. 39 CFR 3010.20 - Test for compliance with the annual limitation.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 39 Postal Service 1 2010-07-01 2010-07-01 false Test for compliance with the annual limitation. 3010.20 Section 3010.20 Postal Service POSTAL REGULATORY COMMISSION PERSONNEL REGULATION OF RATES FOR MARKET DOMINANT PRODUCTS Rules for Applying the Price Cap § 3010.20 Test for compliance with the annual...

  17. 49 CFR 178.33a-1 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Compliance. 178.33a-1 Section 178.33a-1 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... Specifications for Inside Containers, and Linings § 178.33a-1 Compliance. (a) Required in all details. (b...

  18. 49 CFR 178.33b-1 - Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Compliance. 178.33b-1 Section 178.33b-1 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY... Specifications for Inside Containers, and Linings § 178.33b-1 Compliance. (a) Required in all details. (b...

  19. 16 CFR 1210.12 - Certificate of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 1210.12 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR CIGARETTE LIGHTERS Certification Requirements § 1210.12 Certificate of compliance. (a..., based on a reasonable testing program or a test of each product, as required by §§ 1210.13-1210.14 and...

  20. The interaction between intellectual property and drug regulatory systems: global perspectives.

    PubMed

    Madden, Edward A

    2007-02-01

    Regulatory compliance in the development, production and sale of new drugs accounts for the largest single expense in bringing a drug product to market. To justify developmental and regulatory compliance costs, drug innovators turn to the intellectual property (IP) system to provide a means for securing returns on investment. Because the drug regulatory system in most countries operates in isolation of the IP system, one of the greatest challenges facing the pharmaceutical industry is the extent to which IP rights can be managed against an independent drug regulatory system. Many regulatory bodies in developed countries have sought to ensure a compromise between the rights of generic companies and IP owners by including safeguards in the regulatory framework, such as patent linking and data protection; however, these efforts are yet to be applied in some of the biggest potential drug markets in emerging economies.

  1. 18 CFR 154.203 - Compliance filings.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 18 Conservation of Power and Water Resources 1 2012-04-01 2012-04-01 false Compliance filings. 154.203 Section 154.203 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER NATURAL GAS ACT RATE SCHEDULES AND TARIFFS Procedures for Changing...

  2. 18 CFR 154.203 - Compliance filings.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 18 Conservation of Power and Water Resources 1 2011-04-01 2011-04-01 false Compliance filings. 154.203 Section 154.203 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER NATURAL GAS ACT RATE SCHEDULES AND TARIFFS Procedures for Changing...

  3. 18 CFR 154.203 - Compliance filings.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Compliance filings. 154.203 Section 154.203 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER NATURAL GAS ACT RATE SCHEDULES AND TARIFFS Procedures for Changing...

  4. 18 CFR 154.203 - Compliance filings.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 18 Conservation of Power and Water Resources 1 2013-04-01 2013-04-01 false Compliance filings. 154.203 Section 154.203 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER NATURAL GAS ACT RATE SCHEDULES AND TARIFFS Procedures for Changing...

  5. 18 CFR 154.203 - Compliance filings.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 18 Conservation of Power and Water Resources 1 2014-04-01 2014-04-01 false Compliance filings. 154.203 Section 154.203 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION, DEPARTMENT OF ENERGY REGULATIONS UNDER NATURAL GAS ACT RATE SCHEDULES AND TARIFFS Procedures for Changing...

  6. Regulatory Supervision of Radiological Protection in the Russian Federation as Applied to Facility Decommissioning and Site Remediation

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Sneve, M.K.; Shandala, N.K.

    2007-07-01

    The Russian Federation is carrying out major work to manage the legacy of exploitation of nuclear power and use of radioactive materials. This paper describes work on-going to provide enhanced regulatory supervision of these activities as regards radiological protection. The scope includes worker and public protection in routine operation; emergency preparedness and response; radioactive waste management, including treatment, interim storage and transport as well as final disposal; and long term site restoration. Examples examined include waste from facilities in NW Russia, including remediation of previous shore technical bases (STBs) for submarines, spent fuel and radioactive waste management from ice-breakers, andmore » decommissioning of Radio-Thermal-Generators (RTGs) used in navigational devices. Consideration is given to the identification of regulatory responsibilities among different regulators; development of necessary regulatory instruments; and development of regulatory procedures for safety case reviews and compliance monitoring and international cooperation between different regulators. (authors)« less

  7. 75 FR 62534 - Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Notice of Technical Conference October 1, 2010. The Federal...-referenced proceeding to explore issues associated with reliability monitoring, enforcement and compliance...

  8. 49 CFR 659.43 - Certification of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Certification of compliance. 659.43 Section 659.43..., DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the State Oversight Agency § 659.43 Certification of compliance. (a) Annually, the oversight agency must certify to the FTA...

  9. Applying the Analytic Hierarchy Process to Oil Sands Environmental Compliance Risk Management

    NASA Astrophysics Data System (ADS)

    Roux, Izak Johannes, III

    Oil companies in Alberta, Canada, invested $32 billion on new oil sands projects in 2013. Despite the size of this investment, there is a demonstrable deficiency in the uniformity and understanding of environmental legislation requirements that manifest into increased project compliance risks. This descriptive study developed 2 prioritized lists of environmental regulatory compliance risks and mitigation strategies and used multi-criteria decision theory for its theoretical framework. Information from compiled lists of environmental compliance risks and mitigation strategies was used to generate a specialized pairwise survey, which was piloted by 5 subject matter experts (SMEs). The survey was validated by a sample of 16 SMEs, after which the Analytic Hierarchy Process (AHP) was used to rank a total of 33 compliance risks and 12 mitigation strategy criteria. A key finding was that the AHP is a suitable tool for ranking of compliance risks and mitigation strategies. Several working hypotheses were also tested regarding how SMEs prioritized 1 compliance risk or mitigation strategy compared to another. The AHP showed that regulatory compliance, company reputation, environmental compliance, and economics ranked the highest and that a multi criteria mitigation strategy for environmental compliance ranked the highest. The study results will inform Alberta oil sands industry leaders about the ranking and utility of specific compliance risks and mitigations strategies, enabling them to focus on actions that will generate legislative and public trust. Oil sands leaders implementing a risk management program using the risks and mitigation strategies identified in this study will contribute to environmental conservation, economic growth, and positive social change.

  10. 78 FR 28283 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-14

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0031] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR... for a waiver of compliance from certain provisions of the Federal railroad safety regulations...

  11. Regulatory pathways to enable the licencing of alternatives to antibiotics.

    PubMed

    Ioannou, Faye; Burnsteel, Cindy; Mackay, David K J; Gay, Cyril G

    2018-05-01

    Effective alternatives to antibiotics (ATA) such as vaccines, antibodies, phage therapies, prebiotics, probiotics and herbal medicines can be used in place of traditional antibiotics in a way that does not compromise animal health as means of tackling the growing threat to both animal and human health from antimicrobial resistance (AMR). This paper reflects the key points on the approaches that were discussed during the 2nd International Symposium on ATA between regulatory agencies, veterinary product companies representing largely the pharmaceutical and feed-additive sectors, academia and other stakeholders on regulatory pathways to enable the licensing of alternatives to antibiotics for food producing animals. The need to demonstrate compliance with generally accepted standards for quality, safety and efficacy is considered a pre-requisite for all veterinary medicinal products receiving an authorisation including ATA, irrespective of the region in which they are approved. ATA are often based on novel technologies, with complex mechanisms of action; therefore, early and close communication with regulators is encouraged. In addition, strategic use by ATA applicants of all regulatory tools available to support innovation is highly recommended. The veterinary product manufacturers consider that the regulation of veterinary medicines should evolve to accommodate innovative ATA technologies and incentives from regulatory agencies provided to stimulate further ATA development. Copyright © 2018.

  12. Development of Greenhouse Gas Emissions Model (GEM) for Heavy- & Medium-Duty Vehicle Compliance

    EPA Science Inventory

    A regulatory vehicle simulation program was designed for determining greenhouse gas (GHG) emissions and fuel consumption by estimating the performance of technologies, verifying compliance with the regulatory standards and estimating the overall benefits of the program.

  13. A comparative analysis of drug safety withdrawals in the UK and the US (1971-1992): implications for current regulatory thinking and policy.

    PubMed

    Abraham, John; Davis, Courtney

    2005-09-01

    By going beyond individual case studies and solely quantitative surveys, this paper systematically examines why there were over twice as many new prescription drugs withdrawn from the market on grounds of safety in the UK as there were in the US between 1971 and 1992. Drawing on interviews with regulators, industry scientists and others involved, and on regulatory data never before accessed outside governments and companies, five key hypotheses which might explain this difference in drug safety withdrawals are analysed. These are: (1) simply because the UK approved more new drugs than the US; (2) because of an industrial corporate strategy to seek approval of 'less safe' drugs in the UK earlier; (3) because British regulators were more vigilant at spotting post-marketing safety problems than their US counterparts; (4) because the slowness of the US in approving new drugs enabled regulators there to learn from, and avoid, safety problems that had already emerged in the UK or European market; and (5) because more stringent regulation in the US meant that they approved fewer unsafe drugs on to the market in the first place. It is concluded that the main explanation for fewer drug safety withdrawals in the US is that the regulatory agency there applied more stringent pre-market review and/or standards, which took longer than UK regulatory checks, but prevented unsafe drugs marketed in the UK from entering the US market. Contrary to the claims frequently made by the pharmaceutical industry and regulatory agencies on both sides of the Atlantic, these results imply that it is likely that acceleration of regulatory review times in the US and the UK since the early 1990s is compromising drug safety.

  14. 49 CFR 178.33a-1 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Compliance. 178.33a-1 Section 178.33a-1 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Containers, and Linings § 178.33a-1 Compliance. (a) Required in all details. (b) [Reserved] [Order 71, 31 FR...

  15. 49 CFR 178.33b-1 - Compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Compliance. 178.33b-1 Section 178.33b-1 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY... Containers, and Linings § 178.33b-1 Compliance. (a) Required in all details. (b) [Reserved] [74 FR 2268, Jan...

  16. Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

    PubMed Central

    Rowe, Laura A; Vossenaar, Marieke; Garrett, Greg S

    2015-01-01

    While fortification of staple foods and condiments has gained enormous global traction, poor performance persists throughout many aspects of implementation, most notably around the critical element of regulatory monitoring, which is essential for ensuring foods meet national fortification standards. Where coverage of fortified foods is high, limited nutritional impact of fortification programs largely exists due to regulatory monitoring that insufficiently identifies and holds producers accountable for underfortified products. Based on quality assurance data from 20 national fortification programs in 12 countries, we estimate that less than half of the samples are adequately fortified against relevant national standards. In this paper, we outline key findings from a literature review, key informant interviews with 11 fortification experts, and semi-quantitative surveys with 39 individuals from regulatory agencies and the food fortification industry in 17 countries on the perceived effectiveness of regulatory monitoring systems and barriers to compliance against national fortification standards. Findings highlight that regulatory agencies and industry disagree on the value that enforcement mechanisms have in ensuring compliance against standards. Perceived political risk of enforcement and poorly resourced inspectorate capacity appear to adversely reinforce each other within an environment of unclear legislation to create a major hurdle for improving overall compliance of fortification programs against national standards. Budget constraints affect the ability of regulatory agencies to create a well-trained inspector cadre and improve the detection and enforcement of non-compliant and underfortified products. Recommendations to improve fortification compliance include improving technical capacity; ensuring sustained leadership, accountability, and funding in both the private and the public sectors; and removing political barriers to ensure consistent detection of

  17. 75 FR 18200 - Monroe Gas Storage Company, LLC; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. RP09-447-004] Monroe Gas Storage Company, LLC; Notice of Compliance Filing April 1, 2010. Take notice that on March 23, 2010, Monroe Gas Storage Company, LLC (Monroe), submitted a compliance filing to comply with the February 18...

  18. 78 FR 46679 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2013-0057] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR...

  19. 76 FR 38455 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2006-24216] Petition for Waiver of Compliance In accordance with Part 211 of Title 49 of the Code of Federal... waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49...

  20. Meta-analysis of surgical safety checklist effects on teamwork, communication, morbidity, mortality, and safety.

    PubMed

    Lyons, Vanessa E; Popejoy, Lori L

    2014-02-01

    The purpose of this study is to examine the effectiveness of surgical safety checklists on teamwork, communication, morbidity, mortality, and compliance with safety measures through meta-analysis. Four meta-analyses were conducted on 19 studies that met the inclusion criteria. The effect size of checklists on teamwork and communication was 1.180 (p = .003), on morbidity and mortality was 0.123 (p = .003) and 0.088 (p = .001), respectively, and on compliance with safety measures was 0.268 (p < .001). The results indicate that surgical safety checklists improve teamwork and communication, reduce morbidity and mortality, and improve compliance with safety measures. This meta-analysis is limited in its generalizability based on the limited number of studies and the inclusion of only published research. Future research is needed to examine possible moderating variables for the effects of surgical safety checklists.

  1. TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) andmore » the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission

  2. Compliance to two city convenience store ordinance requirements

    PubMed Central

    Menéndez, Cammie K Chaumont; Amandus, Harlan E; Wu, Nan; Hendricks, Scott A

    2015-01-01

    Background Robbery-related homicides and assaults are the leading cause of death in retail businesses. Robbery reduction approaches focus on compliance to Crime Prevention Through Environmental Design (CPTED) guidelines. Purpose We evaluated the level of compliance to CPTED guidelines specified by convenience store safety ordinances effective in 2010 in Dallas and Houston, Texas, USA. Methods Convenience stores were defined as businesses less than 10 000 square feet that sell grocery items. Store managers were interviewed for store ordinance requirements from August to November 2011, in a random sample of 594 (289 in Dallas, 305 in Houston) convenience stores that were open before and after the effective dates of their city’s ordinance. Data were collected in 2011 and analysed in 2012–2014. Results Overall, 9% of stores were in full compliance, although 79% reported being registered with the police departments as compliant. Compliance was consistently significantly higher in Dallas than in Houston for many requirements and by store type. Compliance was lower among single owner-operator stores compared with corporate/franchise stores. Compliance to individual requirements was lowest for signage and visibility. Conclusions Full compliance to the required safety measures is consistent with industry ‘best practices’ and evidence-based workplace violence prevention research findings. In Houston and Dallas compliance was higher for some CPTED requirements but not the less costly approaches that are also the more straightforward to adopt. PMID:26337569

  3. 76 FR 38455 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-30

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Numbers FRA-2003-14565 and FRA-2006-24216] Petition for Waiver of Compliance In accordance with part 211 of Title 49 of the Code... Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety...

  4. The effect of challenge and hindrance stressors on safety behavior and safety outcomes: a meta-analysis.

    PubMed

    Clarke, Sharon

    2012-10-01

    The significance of occupational stressors as a risk factor in accidents has long been recognized; however, the behavioral mechanisms underlying this relationship are currently not well-understood. Meta-analysis was utilized to test the relationships between occupational stressors (challenge and hindrance), safety behaviors (compliance and participation), and safety outcomes (occupational injuries and near-misses). It was hypothesized that hindrance stressors would have negative effects on both safety compliance and safety participation, and subsequently, safety outcomes, whereas challenge stressors would have positive effects. The hypotheses relating to hindrance stressors were supported, suggesting that hindrance stressors lead to a significant reduction in both compliance with safety rules and participation in safety-related activities. Hindrance stressors were also associated with higher levels of occupational injuries and near-misses. The relationship between hindrance stressors and occupational injuries was fully mediated by safety behaviors. However, the hypotheses related to challenge stressors were not supported. Challenge stressors had a nonsignificant, near-zero association with compliance and occupational injuries, a small negative association with participation, and a small positive association with near-misses. The theoretical and practical implications of the meta-analytic findings are discussed, as well as avenues for further research.

  5. 77 FR 64502 - Notice of Compliance Filings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Compliance Filings Docket Nos. Northwestern Corporation (South Dakota). ER13-62-000 PacificCorp ER13-64-000 Deseret Generation & Transmission ER13-65-000 Cooperative, Inc.. Northwestern Corporation (Montana)...... ER13-67-000 Portland General...

  6. 75 FR 68780 - Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD11-1-000] Reliability Monitoring, Enforcement and Compliance Issues; Agenda for the Technical Conference November 2, 2010. The... associated with reliability monitoring, enforcement and compliance. The Commission announced the conference...

  7. 29 CFR 1952.103 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a...

  8. 29 CFR 1952.163 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 16 safety and 13 health compliance officers. After opportunity for public comment... established for each State operating an approved State plan. In September 1984, Iowa, in conjunction with OSHA...

  9. 29 CFR 1952.103 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a...

  10. 29 CFR 1952.113 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 10 safety and 9 health compliance officers. After opportunity for public comments... established for each State operating an approved State plan. In September 1984, Utah, in conjunction with OSHA...

  11. 29 CFR 1952.113 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 10 safety and 9 health compliance officers. After opportunity for public comments... established for each State operating an approved State plan. In September 1984, Utah, in conjunction with OSHA...

  12. 29 CFR 1952.163 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 16 safety and 13 health compliance officers. After opportunity for public comment... established for each State operating an approved State plan. In September 1984, Iowa, in conjunction with OSHA...

  13. 75 FR 52059 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-24

    ... compliance with certain requirements of 49 CFR part 232 --Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-of Train Devices and CFR Part 215--Railroad Freight Car Safety... requirements of its safety standards. The individual petition is described below, including the party seeking...

  14. Patient compliance in hypertension: role of illness perceptions and treatment beliefs.

    PubMed

    Ross, S; Walker, A; MacLeod, M J

    2004-09-01

    Despite many years of study, questions remain about why patients do or do not take medicines and what can be done to change their behaviour. Hypertension is poorly controlled in the UK and poor compliance is one possible reason for this. Recent questionnaires based on the self-regulatory model have been successfully used to assess illness perceptions and beliefs about medicines. This study was designed to describe hypertensive patients' beliefs about their illness and medication using the self-regulatory model and investigate whether these beliefs influence compliance with antihypertensive medication. We recruited 514 patients from our secondary care population. These patients were asked to complete a questionnaire that included the Beliefs about Medicines and Illness Perception Questionnaires. A case note review was also undertaken. Analysis shows that patients who believe in the necessity of medication are more likely to be compliant (odds ratio (OR)) 3.06 (95% CI 1.74-5.38), P<0.001). Other important predictive factors in this population are age (OR 4.82 (2.85-8.15), P<0.001), emotional response to illness (OR 0.65 (0.47-0.90), P=0.01) and belief in personal ability to control illness (OR 0.59 (0.40-0.89), P=0.01). Beliefs about illness and about medicines are interconnected; aspects that are not directly related to compliance influence it indirectly. The self-regulatory model is useful in assessing patients health beliefs. Beliefs about specific medications and about hypertension are predictive of compliance. Information about health beliefs is important in achieving concordance and may be a target for intervention to improve compliance.

  15. Food safety security: a new concept for enhancing food safety measures.

    PubMed

    Iyengar, Venkatesh; Elmadfa, Ibrahim

    2012-06-01

    The food safety security (FSS) concept is perceived as an early warning system for minimizing food safety (FS) breaches, and it functions in conjunction with existing FS measures. Essentially, the function of FS and FSS measures can be visualized in two parts: (i) the FS preventive measures as actions taken at the stem level, and (ii) the FSS interventions as actions taken at the root level, to enhance the impact of the implemented safety steps. In practice, along with FS, FSS also draws its support from (i) legislative directives and regulatory measures for enforcing verifiable, timely, and effective compliance; (ii) measurement systems in place for sustained quality assurance; and (iii) shared responsibility to ensure cohesion among all the stakeholders namely, policy makers, regulators, food producers, processors and distributors, and consumers. However, the functional framework of FSS differs from that of FS by way of: (i) retooling the vulnerable segments of the preventive features of existing FS measures; (ii) fine-tuning response systems to efficiently preempt the FS breaches; (iii) building a long-term nutrient and toxicant surveillance network based on validated measurement systems functioning in real time; (iv) focusing on crisp, clear, and correct communication that resonates among all the stakeholders; and (v) developing inter-disciplinary human resources to meet ever-increasing FS challenges. Important determinants of FSS include: (i) strengthening international dialogue for refining regulatory reforms and addressing emerging risks; (ii) developing innovative and strategic action points for intervention {in addition to Hazard Analysis and Critical Control Points (HACCP) procedures]; and (iii) introducing additional science-based tools such as metrology-based measurement systems.

  16. 15 CFR 291.4 - National industry-specific pollution prevention and environmental compliance resource centers.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 15 Commerce and Foreign Trade 1 2011-01-01 2011-01-01 false National industry-specific pollution... § 291.4 National industry-specific pollution prevention and environmental compliance resource centers... information on pollution prevention opportunities, regulatory compliance and technologies and techniques for...

  17. Transforming a hospital safety and ergonomics program: a four year journey of change.

    PubMed

    Missar, Vicki J; Metcalfe, Don; Gilmore, Gail

    2012-01-01

    The conception of "Patient Safety" being the number one priority at Hospitals can reduce the emphasis on overall employee safety and health. This review examines a hospital's need to improve 24/7 active (i.e., not reactive) coverage, regulatory compliance, as well as the frequency and severity of employee injury losses. It also discusses a journey to integrate and improve safety and ergonomics to achieve these goals. Three approaches used by the ergonomist to create the transformation included: 1) adoption of the safety and ergonomic hazard identification; 2) safe patient handling; and 3) implementation of a 5S program. The results of the four (4) year effort at the not for profit, 637 bed, full service, acute-care hospital has shown a steady decline in frequency, reduced waste, and improved housekeeping. Ergonomists can have a key role in transforming Hospital Safety and Ergonomic Programs.

  18. 29 CFR 1952.293 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 11 safety and 5 health compliance officers. After opportunity for public comment and... established for each State operating an approved State plan. In July 1986 Nevada, in conjunction with OSHA...

  19. 29 CFR 1952.293 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... staffing benchmarks of 11 safety and 5 health compliance officers. After opportunity for public comment and... established for each State operating an approved State plan. In July 1986 Nevada, in conjunction with OSHA...

  20. A Unified Approach to Information Security Compliance

    ERIC Educational Resources Information Center

    Adler, M. Peter

    2006-01-01

    The increased number of government-mandated and private contractual information security requirements in recent years has caused higher education security professionals to view information security as another aspect of regulatory or contractual compliance. The existence of fines, penalties, or loss (including bad publicity) has also increased the…

  1. "Smart pharmacy" master blends integrated supply chains with patient care to uphold regulatory compliances.

    PubMed

    Bhinder, Prabhjot; Oberoi, Mandeep Singh

    2009-01-01

    Hospitals require better information connectivity because timing and content of the information to be traded is critical. The imperative success in the past has generated renewed thrust on the expectations and credibility of the current enterprise resource planning (ERP) applications in health care. The desire to bring improved connectivity and to match it with critical timing remains the penultimate dream. Currently, majority of ERP system integrators are not able to match these requirements of the healthcare industry. It is perceived that the concept of ERP has made the process of segregating bills and patient records much easier. Hence the industry is able to save more lives, but at the cost of an individual's privacy as it enables to access the database of patients and medical histories through the common database shared by hospitals though at a quicker rate. Businesses such as health care providers, pharmaceutical manufacturers, and distributors have already implemented rapid ERPs. The new concept "Smart Pharmacies" will link the process all the way from drug delivery, patient care, demand management, drug repository, and pharmaceutical manufacturers while maintaining Regulatory Compliances and make the vital connections where these Businesses will talk to each other electronically.

  2. 10 CFR 76.62 - Issuance of certificate and/or approval of compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 2 2012-01-01 2012-01-01 false Issuance of certificate and/or approval of compliance plan. 76.62 Section 76.62 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.62 Issuance of certificate and/or approval of compliance plan. (a) Upon...

  3. 10 CFR 76.62 - Issuance of certificate and/or approval of compliance plan.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 2 2011-01-01 2011-01-01 false Issuance of certificate and/or approval of compliance plan. 76.62 Section 76.62 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.62 Issuance of certificate and/or approval of compliance plan. (a) Upon...

  4. 10 CFR 76.62 - Issuance of certificate and/or approval of compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 2 2013-01-01 2013-01-01 false Issuance of certificate and/or approval of compliance plan. 76.62 Section 76.62 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.62 Issuance of certificate and/or approval of compliance plan. (a) Upon...

  5. 10 CFR 76.62 - Issuance of certificate and/or approval of compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 2 2014-01-01 2014-01-01 false Issuance of certificate and/or approval of compliance plan. 76.62 Section 76.62 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) CERTIFICATION OF GASEOUS DIFFUSION PLANTS Certification § 76.62 Issuance of certificate and/or approval of compliance plan. (a) Upon...

  6. Manufacturing of biodrugs: need for harmonization in regulatory standards.

    PubMed

    Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

    2009-01-01

    Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

  7. Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

    PubMed

    Shimazawa, Rumiko; Ikeda, Masayuki

    2016-03-01

    Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

  8. GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations.

    PubMed

    Van Eenennaam, Alison L

    2013-09-25

    In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away

  9. GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations

    PubMed Central

    2013-01-01

    In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away

  10. Compliance to two city convenience store ordinance requirements.

    PubMed

    Chaumont Menéndez, Cammie K; Amandus, Harlan E; Wu, Nan; Hendricks, Scott A

    2016-04-01

    Robbery-related homicides and assaults are the leading cause of death in retail businesses. Robbery reduction approaches focus on compliance to Crime Prevention Through Environmental Design (CPTED) guidelines. We evaluated the level of compliance to CPTED guidelines specified by convenience store safety ordinances effective in 2010 in Dallas and Houston, Texas, USA. Convenience stores were defined as businesses less than 10 000 square feet that sell grocery items. Store managers were interviewed for store ordinance requirements from August to November 2011, in a random sample of 594 (289 in Dallas, 305 in Houston) convenience stores that were open before and after the effective dates of their city's ordinance. Data were collected in 2011 and analysed in 2012-2014. Overall, 9% of stores were in full compliance, although 79% reported being registered with the police departments as compliant. Compliance was consistently significantly higher in Dallas than in Houston for many requirements and by store type. Compliance was lower among single owner-operator stores compared with corporate/franchise stores. Compliance to individual requirements was lowest for signage and visibility. Full compliance to the required safety measures is consistent with industry 'best practices' and evidence-based workplace violence prevention research findings. In Houston and Dallas compliance was higher for some CPTED requirements but not the less costly approaches that are also the more straightforward to adopt. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. EPA Enforcement and Compliance History Online

    EPA Pesticide Factsheets

    The Environmental Protection Agency's Enforcement and Compliance History Online (ECHO) website provides customizable and downloadable information about environmental inspections, violations, and enforcement actions for EPA-regulated facilities related to the Clean Air Act, Clean Water Act, Resource Conservation and Recovery Act, and Safe Drinking Water Act. These data are updated weekly as part of the ECHO data refresh, and ECHO offers many user-friendly options to explore data, including:? Facility Search: ECHO information is searchable by varied criteria, including location, facility type, and compliance status. Search results are customizable and downloadable.? Comparative Maps and State Dashboards: These tools offer aggregated information about facility compliance status, regulatory agency compliance monitoring, and enforcement activity at the national and state level.? Bulk Data Downloads: One of ECHO??s most popular features is the ability to work offline by downloading large data sets. Users can take advantage of the ECHO Exporter, which provides summary information about each facility in comma-separated values (csv) file format, or download data sets by program as zip files.

  12. Fraud and abuse. Building an effective corporate compliance program.

    PubMed

    Matusicky, C F

    1998-04-01

    In 1997, General Health System (GHS), a not-for-profit integrated delivery system headquartered in Baton Rouge, Louisiana, developed a formal corporate compliance program. A newly appointed corporate compliance officer worked with key GHS managers and employees to assess the organization's current fraud and abuse prevention practices and recommend changes to meet new regulatory and organizational requirements. Then a structure for implementing these changes was developed, with staff training at its core. The program required a significant initial outlay of financial and human resources. The benefits to the organization, however, including a greater ability to respond quickly and effectively to possible compliance problems and better organizational communications, were worth the investment.

  13. Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

    PubMed

    Furlan, Giovanni

    2012-08-01

    Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

  14. Applying your corporate compliance skills to the HIPAA security standard.

    PubMed

    Carter, P I

    2000-01-01

    Compliance programs are an increasingly hot topic among healthcare providers. These programs establish policies and procedures covering billing, referrals, gifts, confidentiality of patient records, and many other areas. The purpose is to help providers prevent and detect violations of the law. These programs are voluntary, but are also simply good business practice. Any compliance program should now incorporate the Health Insurance Portability and Accountability Act (HIPAA) security standard. Several sets of guidelines for development of compliance programs have been issued by the federal government, and each is directed toward a different type of healthcare provider. These guidelines share certain key features with the HIPAA security standard. This article examines the common areas between compliance programs and the HIPAA security standard to help you to do two very important things: (1) Leverage your resources by combining compliance with the security standard with other legal and regulatory compliance efforts, and (2) apply the lessons learned in developing your corporate compliance program to developing strategies for compliance with the HIPAA security standard.

  15. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 10 Energy 1 2011-01-01 2011-01-01 false Compliance with requirements for summation of external and internal doses. 20.1202 Section 20.1202 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1202 Compliance with requirements for summation of...

  16. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 10 Energy 1 2014-01-01 2014-01-01 false Compliance with requirements for summation of external and internal doses. 20.1202 Section 20.1202 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1202 Compliance with requirements for summation of...

  17. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 10 Energy 1 2013-01-01 2013-01-01 false Compliance with requirements for summation of external and internal doses. 20.1202 Section 20.1202 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1202 Compliance with requirements for summation of...

  18. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 10 Energy 1 2012-01-01 2012-01-01 false Compliance with requirements for summation of external and internal doses. 20.1202 Section 20.1202 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1202 Compliance with requirements for summation of...

  19. 10 CFR 20.1202 - Compliance with requirements for summation of external and internal doses.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Compliance with requirements for summation of external and internal doses. 20.1202 Section 20.1202 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Occupational Dose Limits § 20.1202 Compliance with requirements for summation of...

  20. State Regulatory Authority (SRA) Coordination of Safety, Security, and Safeguards of Nuclear Facilities: A Framework for Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Mladineo, Stephen V.; Frazar, Sarah L.; Kurzrok, Andrew J.

    This paper will explore the development of a framework for conducting an assessment of safety-security-safeguards integration within a State. The goal is to examine State regulatory structures to identify conflicts and gaps that hinder management of the three disciplines at nuclear facilities. Such an analysis could be performed by a State Regulatory Authority (SRA) to provide a self-assessment or as part of technical cooperation with either a newcomer State, or to a State with a fully developed SRA.

  1. An observational analysis of surgical team compliance with perioperative safety practices after crew resource management training.

    PubMed

    France, Daniel J; Leming-Lee, Susie; Jackson, Tom; Feistritzer, Nancye R; Higgins, Michael S

    2008-04-01

    Acknowledging the need to improve team communication and coordination among health care providers, health care administrators and improvement officers have been quick to endorse and invest in aviation crew resource management (CRM). Despite the increased interest in CRM there exists limited data on the effectiveness of CRM to change team behavior and performance in clinical settings. Direct observational analyses were performed on 30 surgical teams (15 neurosurgery cases and 15 cardiac cases) to evaluate surgical team compliance with integrated safety and CRM practices after extensive CRM training. Observed surgical teams were compliant with only 60% of the CRM and perioperative safety practices emphasized in the training program. The results highlight many of the challenges the health care industry faces in its efforts to adapt CRM from aviation to medicine. Additional research is needed to develop and test new team training methods and performance feedback mechanisms for clinical teams.

  2. Improved compliance with the World Health Organization Surgical Safety Checklist is associated with reduced surgical specimen labelling errors.

    PubMed

    Martis, Walston R; Hannam, Jacqueline A; Lee, Tracey; Merry, Alan F; Mitchell, Simon J

    2016-09-09

    A new approach to administering the surgical safety checklist (SSC) at our institution using wall-mounted charts for each SSC domain coupled with migrated leadership among operating room (OR) sub-teams, led to improved compliance with the Sign Out domain. Since surgical specimens are reviewed at Sign Out, we aimed to quantify any related change in surgical specimen labelling errors. Prospectively maintained error logs for surgical specimens sent to pathology were examined for the six months before and after introduction of the new SSC administration paradigm. We recorded errors made in the labelling or completion of the specimen pot and on the specimen laboratory request form. Total error rates were calculated from the number of errors divided by total number of specimens. Rates from the two periods were compared using a chi square test. There were 19 errors in 4,760 specimens (rate 3.99/1,000) and eight errors in 5,065 specimens (rate 1.58/1,000) before and after the change in SSC administration paradigm (P=0.0225). Improved compliance with administering the Sign Out domain of the SSC can reduce surgical specimen errors. This finding provides further evidence that OR teams should optimise compliance with the SSC.

  3. 12 CFR 170.3 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... plan. (a) Schedule for filing compliance plan— (1) In general. A Federal savings association shall file... of plan. The compliance plan shall include a description of the steps the Federal savings association... plan under this subpart, the OCC shall provide written notice to the Federal savings association of...

  4. 12 CFR 170.3 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... plan. (a) Schedule for filing compliance plan— (1) In general. A Federal savings association shall file... of plan. The compliance plan shall include a description of the steps the Federal savings association... plan under this subpart, the OCC shall provide written notice to the Federal savings association of...

  5. 12 CFR 170.3 - Filing of safety and soundness compliance plan.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... plan. (a) Schedule for filing compliance plan— (1) In general. A Federal savings association shall file... of plan. The compliance plan shall include a description of the steps the Federal savings association... plan under this subpart, the OCC shall provide written notice to the Federal savings association of...

  6. A single-laboratory validated method for the generation of DNA barcodes for the identification of fish for regulatory compliance.

    PubMed

    Handy, Sara M; Deeds, Jonathan R; Ivanova, Natalia V; Hebert, Paul D N; Hanner, Robert H; Ormos, Andrea; Weigt, Lee A; Moore, Michelle M; Yancy, Haile F

    2011-01-01

    The U.S. Food and Drug Administration is responsible for ensuring that the nation's food supply is safe and accurately labeled. This task is particularly challenging in the case of seafood where a large variety of species are marketed, most of this commodity is imported, and processed product is difficult to identify using traditional morphological methods. Reliable species identification is critical for both foodborne illness investigations and for prevention of deceptive practices, such as those where species are intentionally mislabeled to circumvent import restrictions or for resale as species of higher value. New methods that allow accurate and rapid species identifications are needed, but any new methods to be used for regulatory compliance must be both standardized and adequately validated. "DNA barcoding" is a process by which species discriminations are achieved through the use of short, standardized gene fragments. For animals, a fragment (655 base pairs starting near the 5' end) of the cytochrome c oxidase subunit 1 mitochondrial gene has been shown to provide reliable species level discrimination in most cases. We provide here a protocol with single-laboratory validation for the generation of DNA barcodes suitable for the identification of seafood products, specifically fish, in a manner that is suitable for FDA regulatory use.

  7. 78 FR 39367 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ... effective upon receipt of this filing by the Commission. The Commission is publishing this notice to solicit... FINRA Firm Gateway.\\5\\ As announced in Regulatory Notice 12-40, the Form, an abbreviated version of...\\ FINRA Firm Gateway is an online compliance tool that provides consolidated access to FINRA applications...

  8. 75 FR 34204 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... compliance from certain provisions of 49 CFR part 215, Railroad Freight Car Safety Standards, specifically 49 CFR 215.303 (Stenciling of restricted cars), which requires that restricted railroad freight cars... requirements of its safety standards. The individual petition is described below, including the party seeking...

  9. Process measures to improve perioperative prophylactic antibiotic compliance: quality and financial implications.

    PubMed

    Sutherland, Tori; Beloff, Jennifer; Lightowler, Marie; Liu, Xiaoxia; Nascimben, Luigino; Urman, Richard D

    2014-01-01

    The Surgical Care Improvement Project (SCIP) was launched in 2005. The core prophylactic perioperative antibiotic guidelines were created because of recognition of the impact of proper perioperative prophylaxis on an estimated annual 1 million inpatient days and $1.6 billion in excess health care costs that are secondary to preventable surgical site infections. There is a need to create low-cost, standardized processes on an institutional level to improve compliance with prophylactic antibiotic administration. The impact of interventions on provider compliance with SCIP inpatient antibiotic guidelines and net financial gain or loss to a large tertiary center were assessed. A single hospital was able to significantly improve their SCIP compliance and emphasis on patient safety within a year of intervention implementation. The hospital earned an additional $290,612 in 2011 and $209,096 in 2012 for reinvestment in patient safety initiatives. Low-cost interventions aimed at educating providers that utilize existing infrastructure result in improved SCIP compliance and patient safety. As a secondary gain, there were hundreds of thousands of dollars in annual cost savings. The impact of compliance on infection rates is inferred but requires further study.

  10. Unlocking Potentials of Microwaves for Food Safety and Quality

    PubMed Central

    Tang, Juming

    2015-01-01

    Microwave is an effective means to deliver energy to food through polymeric package materials, offering potential for developing short-time in-package sterilization and pasteurization processes. The complex physics related to microwave propagation and microwave heating require special attention to the design of process systems and development of thermal processes in compliance with regulatory requirements for food safety. This article describes the basic microwave properties relevant to heating uniformity and system design, and provides a historical overview on the development of microwave-assisted thermal sterilization (MATS) and pasteurization systems in research laboratories and used in food plants. It presents recent activities on the development of 915 MHz single-mode MATS technology, the procedures leading to regulatory acceptance, and sensory results of the processed products. The article discusses needs for further efforts to bridge remaining knowledge gaps and facilitate transfer of academic research to industrial implementation. PMID:26242920

  11. 78 FR 1646 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-08

    ... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council in compliance with Executive Order 12866 ``Regulatory... issuance of changes published in the Federal Register and produced electronically as Federal Acquisition...

  12. Compliance with universal precautions in correctional health care facilities.

    PubMed

    Gershon, R R; Karkashian, C D; Vlahov, D; Kummer, L; Kasting, C; Green-McKenzie, J; Escamilla-Cejudo, J A; Kendig, N; Swetz, A; Martin, L

    1999-03-01

    There were three main objectives of this cross-sectional study of Maryland State correctional health care workers. The first was to evaluate compliance with work practices designed to minimize exposure to blood and body fluids; the second, to identify correlates of compliance with universal precautions (UPs); and the third was to determine the relationship, if any, between compliance and exposures. Of 216 responding health care workers, 34% reported overall compliance across all 15 items on a compliance scale. Rates for specific items were particularly low for use of certain types of personal protective equipment, such as protective eyewear (53.5%), face mask (47.2%) and protective clothing (33.9%). Compliance rates were highest for glove use (93.2%) waste disposal (89.8%), and sharps disposal (80.8%). Compliance rates were generally not associated with demographic factors, except for age; younger workers were more likely to be compliant with safe work practices than were older workers (P < 0.05). Compliance was positively associated with several work-related variables, including perceived safety climate (i.e., management's commitment to infection control and the overall safety program) and job satisfaction, and was found to be inversely associated with security-related work constraints, job/task factors, adverse working conditions, workplace discrimination, and perceived work stress. Bloodborne exposures were not uncommon; 13.8% of all respondents had at least one bloodborne exposure within the previous 6 months, and compliance was inversely related to blood and body fluid exposures. This study identified several potentially modifiable correlates of compliance, including factors unique to the correctional setting. Infection-control interventional strategies specifically tailored to these health care workers may therefore be most effective in reducing the risk of bloodborne exposures.

  13. 77 FR 66829 - Notice of Compliance Filings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [ Docket Nos. ER13-187-000; ER13-187-001, et al.] Notice of Compliance Filings Docket Nos. Midwest Independent Transmission System ER13-187-000 Docket No. ER13- Operator, Inc. 187-001. ISO New England Inc ER13-193-000. PJM Transmission Owners ER13...

  14. 78 FR 54951 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 215-Railroad Freight Car Safety Standards. FRA assigned the petition Docket Number FRA-2013- 0065. TEVR seeks relief from 49 CFR 215.303-Stenciling of restricted cars, which requires that...

  15. Safety Learning, Organizational Contradictions and the Dynamics of Safety Practice

    ERIC Educational Resources Information Center

    Ripamonti, Silvio Carlo; Scaratti, Giuseppe

    2015-01-01

    Purpose: The purpose of this paper is to explore the enactment of safety routines in a transshipment port. Research on work safety and reliability has largely neglected the role of the workers' knowledge in practice in the enactment of organisational safety. The workers' lack of compliance with safety regulations represents an enduring problem…

  16. The use of in-situ simulation to improve safety in the plastic surgery office: a feasibility study.

    PubMed

    Shapiro, Fred E; Pawlowski, John B; Rosenberg, Noah M; Liu, Xiaoxia; Feinstein, David M; Urman, Richard D

    2014-01-01

    Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors.

  17. The Use of In-Situ Simulation to Improve Safety in the Plastic Surgery Office: A Feasibility Study

    PubMed Central

    Shapiro, Fred E.; Pawlowski, John B.; Rosenberg, Noah M.; Liu, Xiaoxia; Feinstein, David M.; Urman, Richard D.

    2014-01-01

    Objective: Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. Methods: A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. Results: The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Conclusions: Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors. PMID:24501616

  18. 49 CFR 214.5 - Responsibility for compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY General § 214.5 Responsibility for compliance. Any... railroad; a manager, supervisor, official, or other employee or agent of a railroad; any owner...

  19. 75 FR 71344 - Uniform Compliance Date for Food Labeling Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-23

    ... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 317 and 381 [Docket No. FSIS-2010-0031] RIN 0583-AD Uniform Compliance Date for Food Labeling Regulations AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service...

  20. A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance.

    PubMed

    Han, Yonghong

    2015-01-01

    After describing the historical development of China's food safety system from the perspectives of legislation and administration, this article discusses progress in its food law (The Draft Amendments to Food Safety Law). As a further legislative reform for China's food safety system, the Draft Amendments to the Food Safety Law contain innovative institutional designs and manifest a regulatory paradigm shift from government-centered governance to collaborative governance. However, the Draft Amendments face challenges in their implementation. This article argues that developing collaborative governance for food safety in China can be a solution to these challenges. Based on theoretical and empirical studies of collaborative governance, this article proposes that the institutional design of collaborative governance should focus on providing obligations for administrative agencies in the process of food safety rule-making and standard-setting, increasing the independence of nongovernmental organizations, and building two-way electronic platforms for public participation.

  1. 77 FR 31429 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-25

    ... request for a waiver of compliance from certain requirements of its safety standards. The South Carolina... from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 213. FRA... day interval between inspections if the track carries passenger trains or more than 10 million gross...

  2. 78 FR 47823 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-06

    ... Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 232, Brake System Safety Standards for Freight and Other Non-Passenger Trains and Equipment; End-of-Train Devices. FRA assigned the petition Docket Number FRA-2013-0069...

  3. 78 FR 44341 - Semiannual Regulatory Agenda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... provides summary descriptions of regulations being developed by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council in compliance with Executive Order 12866 ``Regulatory... Acquisition Circulars (FACs). The electronic version of the FAR, including changes, can be accessed on the FAR...

  4. Work-related road safety in Australia, the United Kingdom and the United States of America: an overview of regulatory approaches and recommendations to enhance strategy and practice

    PubMed Central

    Stuckey, R; Pratt, SG; Murray, W

    2015-01-01

    Work-related travel and transport by road is fundamental for industry, government and organisations. Traditionally, road safety interventions at societal level have focussed on improving road and vehicle engineering and changing road-user behaviour through transport laws and safety campaigns. Crash data indicate that significant numbers of road-user fatalities occur while driving to or for work. Therefore, workplace initiatives can improve both road and worker safety. This paper reviews regulatory approaches to work-related road safety (WRRS) in Australia, the United Kingdom and United States, identifying significant and consistent gaps in policy, management and research. In all three countries, responsibility for managing and regulating WRRS is spread across government agencies, without a single coordinating body. This paper makes the case that integrating management of WRRS into regulatory and non-regulatory occupational health and safety (OHS) initiatives would foster and support collaboration between research and practice communities, ensuring a comprehensive evidence base for future programs. PMID:26279686

  5. Analysis of roadside inspection data and its relationship to accident and safety/compliance review data and reviews of previous and ongoing research in these areas

    DOT National Transportation Integrated Search

    1993-01-01

    The main objective of the present study is to analyze roadside inspection data and its relationship to safety/compliance review and accident data. Data used for this analysis is provided by the Office of Motor Carriers and includes a sample of larger...

  6. 49 CFR 389.5 - Regulatory docket.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Regulatory docket. 389.5 Section 389.5...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS General § 389.5 Regulatory docket. (a) Information and data... § 389.25; and final rules are maintained at headquarters, Federal Motor Carrier Safety Administration...

  7. 49 CFR 389.5 - Regulatory docket.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory docket. 389.5 Section 389.5...-FEDERAL MOTOR CARRIER SAFETY REGULATIONS General § 389.5 Regulatory docket. (a) Information and data... § 389.25; and final rules are maintained at headquarters, Federal Motor Carrier Safety Administration...

  8. Organ procurement organization compliance with 21 CFR 1271: a challenge for allogeneic pancreatic islet cell transplantation programs.

    PubMed

    Winters, J L; Tran, S A; Gastineau, D A; Padley, D J; Dean, P G; Kudva, Y C

    2009-06-01

    In order to protect tissue recipients, the Food and Drug Administration drafted Title 21, Section 1271 of the Code of Federal Regulations 1271 (21 CFR 1271) to address infectious disease risk. These regulations apply to tissues but not vascularized organs. Pancreatic islet cells are regulated under 21 CFR 1271. These regulations require qualification of suppliers of critical materials and services with regard to 21 CFR 1271 compliance. As part of supplier qualification, all organ procurement organizations (OPOs) in the United States were sent a questionnaire covering the key components of these regulations. Of the 57 OPOs, 29 (51%) were in compliance based upon survey results. Twelve (21%) were not compliant in one or more areas. All indicated plans to become compliant. The remaining 15 (27%) either failed or refused to complete the survey, some indicating 21 CFR 1271 did not apply to OPOs. Using 2006 data, OPOs compliant with 21 CFR 1271 recovered 50% of the organs procured in the United States. These findings represent a challenge for allogeneic islet cell transplant programs whose raw material must comply with 21 CFR 1271. OPOs should work toward understanding and complying with 21 CFR 1271. Regulatory agencies should work toward enhancing safety of the pancreas supply by facilitating compliance through harmonization of requirements.

  9. 78 FR 76191 - Operational Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other Speed Restrictions... safety advisory; Operational tests and inspections for compliance with maximum authorized train speeds and other speed restrictions. SUMMARY: FRA is issuing Safety Advisory 2013-08 to stress to railroads...

  10. SAFEGUARD: An Assured Safety Net Technology for UAS

    NASA Technical Reports Server (NTRS)

    Dill, Evan T.; Young, Steven D.; Hayhurst, Kelly J.

    2016-01-01

    As demands increase to use unmanned aircraft systems (UAS) for a broad spectrum of commercial applications, regulatory authorities are examining how to safely integrate them without loss of safety or major disruption to existing airspace operations. This work addresses the development of the Safeguard system as an assured safety net technology for UAS. The Safeguard system monitors and enforces conformance to a set of rules defined prior to flight (e.g., geospatial stay-out or stay-in regions, speed limits, altitude limits). Safeguard operates independently of the UAS autopilot and is strategically designed in a way that can be realized by a small set of verifiable functions to simplify compliance with regulatory standards for commercial aircraft. A framework is described that decouples the system from any other devices on the UAS as well as introduces complementary positioning source(s) for applications that require integrity and availability beyond what the Global Positioning System (GPS) can provide. Additionally, the high level logic embedded within the software is presented, as well as the steps being taken toward verification and validation (V&V) of proper functionality. Next, an initial prototype implementation of the described system is disclosed. Lastly, future work including development, testing, and system V&V is summarized.

  11. Review of Regulatory Emphasis on Transportation Safety in the United States, 2002-2009: Public versus Private Modes.

    PubMed

    Waycaster, Garrett C; Matsumura, Taiki; Bilotkach, Volodymyr; Haftka, Raphael T; Kim, Nam H

    2018-05-01

    The U.S. Department of Transportation is responsible for implementing new safety improvements and regulations with the goal of ensuring limited funds are distributed to where they can have the greatest impact on safety. In this work, we conduct a study of new regulations and other reactions (such as recalls) to fatal accidents in several different modes of transportation implemented from 2002 to 2009. We find that in the safest modes of commercial aviation and bus transport, the amount of spending on new regulations is high in relation to the number of fatalities compared to the regulatory attention received by less safe modes of general aviation and private automobiles. Additionally, we study two major fatal accident investigations from commercial aviation and two major automotive recalls associated with fatal accidents. We find differences in the cost per expected fatality prevented for these reactions, with the airline accident investigations being more cost effective. Overall, we observe trends in both the automotive and aviation sectors that suggest that public transportation receives more regulatory attention than private transport. We also observe that the types of safety remedies utilized, regulation versus investigation, have varying levels of effectiveness in different transport modes. We suggest that these differences are indicative of increased public demand for safety in modes where a third party may be held responsible, even for those not participating in the transportation. These findings have important implications for the transportation industry, policymakers, and for estimating the public demand for safety in new transport modes. © 2017 Society for Risk Analysis.

  12. Regulatory guidance concerning the applicability of the Federal Motor Carrier Safety regulations to texting by commercial motor vehicle drivers

    DOT National Transportation Integrated Search

    2010-01-10

    The FMCSA announces regulatory guidance concerning texting while driving a commercial motor vehicle (CMV). The guidance is applicable to all interstate drivers of CMVs subject to the Federal Motor Carrier Safety Regulations (FMCSRs).

  13. Nuclear Regulatory Commission activities to prepare for reviewing license applications and issuing licenses

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Uleck, R.B.; DeFino, C.V.

    1991-12-31

    The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) assigned States the responsibility to provide for disposal of commercial low-level radioactive waste (LLRW) by 1993. The LLRWPAA also required the US Nuclear Regulatory Commission (NRC) to establish procedures and develop the technical review capability to process license applications for new LLRW disposal facilities. Under the LLRWPAA, NRC is required, to the extent practicable, to complete its review of an LLRW disposal facility license application within 15 months of its submittal by a State. This provision of the LLRWPAA helps ensure that NRC, in addition to protecting public health andmore » safety and the environment, facilitates States` achievement of LLRWPAA milestones for new facility development. A timely NRC review is needed for States to accomplish their objective of having new disposal facilities in operation on the dates prescribed in the LLRWPAA. To help assure NRC and States` compliance with the provisions of the LLRWPAA, NRC has developed a licensing review strategy that includes: (1) the further development of regulatory guidance, (2) enhancement of licensing review capability, and (3) prelicensing regulatory consultation with potential applicants.« less

  14. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents).

    PubMed

    Calixto, J B

    2000-02-01

    This review highlights the current advances in knowledge about the safety, efficacy, quality control, marketing and regulatory aspects of botanical medicines. Phytotherapeutic agents are standardized herbal preparations consisting of complex mixtures of one or more plants which contain as active ingredients plant parts or plant material in the crude or processed state. A marked growth in the worldwide phytotherapeutic market has occurred over the last 15 years. For the European and USA markets alone, this will reach about $7 billion and $5 billion per annum, respectively, in 1999, and has thus attracted the interest of most large pharmaceutical companies. Insufficient data exist for most plants to guarantee their quality, efficacy and safety. The idea that herbal drugs are safe and free from side effects is false. Plants contain hundreds of constituents and some of them are very toxic, such as the most cytotoxic anti-cancer plant-derived drugs, digitalis and the pyrrolizidine alkaloids, etc. However, the adverse effects of phytotherapeutic agents are less frequent compared with synthetic drugs, but well-controlled clinical trials have now confirmed that such effects really exist. Several regulatory models for herbal medicines are currently available including prescription drugs, over-the-counter substances, traditional medicines and dietary supplements. Harmonization and improvement in the processes of regulation is needed, and the general tendency is to perpetuate the German Commission E experience, which combines scientific studies and traditional knowledge (monographs). Finally, the trend in the domestication, production and biotechnological studies and genetic improvement of medicinal plants, instead of the use of plants harvested in the wild, will offer great advantages, since it will be possible to obtain uniform and high quality raw materials which are fundamental to the efficacy and safety of herbal drugs.

  15. 78 FR 54952 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-06

    ... Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 232, Brake System Safety Standards for Freight and Other Non- Passenger Trains and Equipment; End-of-Train Devices. FRA assigned the petition Docket Number FRA-2013-0080. In its...

  16. 77 FR 64374 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... internal safety audits to evaluate compliance with SSPP and measure its effectiveness. An annual report identifying the audits performed and any corrective action must be submitted to the New Jersey Department of... audit. In addition, NJDOT conducts a safety review a minimum of once every 3 years to evaluate the...

  17. Sterile compounding: clinical, legal, and regulatory implications for patient safety.

    PubMed

    Qureshi, Nabeel; Wesolowicz, Laurie; Stievater, Trish; Lin, Alexandra Tungol

    2014-12-01

    Poor compounding practices by the New England Compounding Center resulted in the 2012-2013 fungal infections outbreak. Contaminated injectable methylprednisolone led to the diagnosis of fungal infections in 751 patients and 64 deaths. In the United States, pharmacy compounding has traditionally been regulated by state boards of pharmacy rather than the FDA. To minimize safety risks related to pharmacy compounding, the Drug Quality and Security Act (DQSA) was signed into law November 27, 2013, to improve regulation of compounding pharmacies. To (a) review the literature regarding clinical, legal, and regulatory implications of pharmacy compounding for patient safety during the 2012-2013 fungal infections outbreak and (b) discuss strategies that managed care organizations (MCOs) can use to promote safe compounding practices.  A literature search was conducted via PubMed for original articles on fungal infections related to drug compounding published October 2012 to March 2014. Specific search terms included "drug compounding and fungal infection" and "fungal meningitis outbreak." The FDA website was also utilized for material related to the Food, Drug, and Cosmetic Act and the DQSA.  Four articles met inclusion criteria. The 2012-2013 fungal infections outbreak was attributed to 3 lots of preservative-free methylprednisolone acetate, which comprised 17,675 vials distributed to 76 facilities across 23 states. Median incubation period (from time of last injection to initial diagnosis) was 47 days, ranging from 0 to 249 days. According to the FDA, a total of 30 recalls regarding compounded products were issued by pharmacies during March through December 2013. Pharmacy compounding has the potential for significant safety risks. The purpose of the DQSA is to improve regulation of compounding pharmacies. Since registration as an outsourcing facility is voluntary, uncertainty still remains regarding advancement in safe compounding practices. MCOs can employ multiple

  18. Job Demands-Control-Support model and employee safety performance.

    PubMed

    Turner, Nick; Stride, Chris B; Carter, Angela J; McCaughey, Deirdre; Carroll, Anthony E

    2012-03-01

    The aim of this study was to explore whether work characteristics (job demands, job control, social support) comprising Karasek and Theorell's (1990) Job Demands-Control-Support framework predict employee safety performance (safety compliance and safety participation; Neal and Griffin, 2006). We used cross-sectional data of self-reported work characteristics and employee safety performance from 280 healthcare staff (doctors, nurses, and administrative staff) from Emergency Departments of seven hospitals in the United Kingdom. We analyzed these data using a structural equation model that simultaneously regressed safety compliance and safety participation on the main effects of each of the aforementioned work characteristics, their two-way interactions, and the three-way interaction among them, while controlling for demographic, occupational, and organizational characteristics. Social support was positively related to safety compliance, and both job control and the two-way interaction between job control and social support were positively related to safety participation. How work design is related to employee safety performance remains an important area for research and provides insight into how organizations can improve workplace safety. The current findings emphasize the importance of the co-worker in promoting both safety compliance and safety participation. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

  19. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

    PubMed Central

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-01-01

    Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

  20. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

    PubMed

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-10-01

    Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

  1. Assessment of public perception and environmental compliance at a pulp and paper facility: a Canadian case study.

    PubMed

    Hoffman, Emma; Bernier, Meagan; Blotnicky, Brenden; Golden, Peter G; Janes, Jeffrey; Kader, Allison; Kovacs-Da Costa, Rachel; Pettipas, Shauna; Vermeulen, Sarah; Walker, Tony R

    2015-12-01

    Communities across Canada rely heavily on natural resources for their livelihoods. One such community in Pictou County, Nova Scotia, has both benefited and suffered, because of its proximity to a pulp and paper mill (currently owned by Northern Pulp). Since production began in 1967, there have been increasing impacts to the local environment and human health. Environmental reports funded by the mill were reviewed and compared against provincial and federal regulatory compliance standards. Reports contrasted starkly to societal perceptions of local impacts and independent studies. Most environmental monitoring reports funded by the mill indicate some levels of compliance in atmospheric and effluent emissions, but when compliance targets were not met, there was a lack of regulatory enforcement. After decades of local pollution impacts and lack of environmental compliance, corporate social responsibility initiatives need implementing for the mill to maintain its social licence to operate.

  2. Compliance With Protective Lens Wear in Anophthalmic Patients.

    PubMed

    Neimkin, Michael G; Custer, Philip L

    To evaluate the frequency of protective lens wear by anophthalmic patients and identify factors that influence compliance. An IRB approved descriptive retrospective chart review of patients undergoing surgery with the senior author (PLC) with an anophthalmic orbit and one remaining sighted eye. Results were tabulated and analyzed using age, indication for procedure, duration of visual symptoms, safety glasses wear, number of postoperative visits, and evidence of new trauma to the remaining eye. All patients underwent counseling on the importance of protective lens wear preoperatively and each subsequent visit. Etiologies for loss of the eye in the 132 study patients included trauma (33.3%), blind painful eye (33.3%), congenital disorders (14.4%), adult-onset malignancy (14.4%), and retinoblastoma (4.5%). At the final visit, protective lenses were worn in the following patterns: full-time (55.3%), frequently (11.4%), occasional (6%), and never (28.8%). The regular use of protective eyewear at last visit was more common in patients wearing glasses at presentation (79.7%), than in those who did not (32.9%; p ≤ 0.001). Increased number of office encounters correlated with more frequent use of protective eyewear (p ≤ 0.01). Patient age (p = 0.95), indication for surgery (p = 0.97), and duration of visual loss (p = 0.85) were not predictive of safety glasses wear. Three patients had evidence of subsequent ocular trauma to the remaining eye, with 2 having resultant decrease in acuity; none of these 3 patients wore safety glasses full-time. A significant number of anopthalmic patients were not wearing protective lenses at presentation. Overall compliance was poor; but repeated education on the importance of safety glasses appears to improve compliance. Educating referring providers and primary care physicians about the importance of early and repeated counseling is vital to increasing compliance.

  3. Compliance with Protective Lens Wear in Anophthalmic Patients

    PubMed Central

    Neimkin, Michael G.; Custer, Philip L.

    2016-01-01

    Purpose To evaluate the frequency of protective lens wear by anophthalmic patients and identify factors that influence compliance. Methods An IRB approved descriptive retrospective chart review of patients undergoing surgery with the senior author (PLC) with an anophthalmic orbit and one remaining sighted eye. Results were tabulated and analyzed using age, indication for procedure, duration of visual symptoms, safety glasses wear, number of post-operative visits, and evidence of new trauma to the remaining eye. All pateints underwent counseling on the importance of protective lens wear preoperatively and each subsequent visit. Results Etiologies for loss of the eye in the 132 study patients included trauma (33.3%), blind painful eye (33.3%), congenital disorders (14.4%), adult-onset malignancy (14.4%), and retinoblastoma (4.5%). At the final visit, protective lenses were worn in the following patterns: full-time (55.3%), frequently (11.4%), occasional (6%), and never (28.8%). The regular use of protective eyewear at last visit was more common in patients wearing glasses at presentation (79.7%), than in those who did not (32.9%) (p=<0.001). Increased number of office encounters correlated with more frequent use of protective eyewear (p=<0.01. Patient age (p=0.95), indication for surgery (p=0.97), and duration of visual loss (p=0.85) were not predictive of safety glasses wear. 3 patients had evidence of subsequent ocular trauma to the remaining eye, with 2 having resultant decrease in acuity; none of these 3 patients wore safety glasses full-time. Conclusions A significant number of anopthalmic patients were not wearing protective lenses at presentation. Overall compliance was poor; but repeated education on the importance of safety glasses appears to improve compliance. Educating referring providers and primary care physicians about the importance of early and repeated counseling is vital to increasing compliance. PMID:26866334

  4. Wetland mitigation compliance in the western upper peninsula of Michigan.

    PubMed

    Hornyak, Melissa M; Halvorsen, Kathleen E

    2003-11-01

    The Army Corps of Engineers (ACE) is generally responsible for the implementation of federal Clean Water Act wetland regulations. It therefore plays an important role in the protection of wetlands within the United States. Unfortunately, past evaluators of ACE's implementation of these regulations found low rates of regulatory compliance. However, the fact that two states have taken responsibility for the implementation of these regulations within their boundaries provided the opportunity to assess whether one of these states might be doing a better job of enforcement. This paper reports on compliance with some of these regulations within one Michigan region. We evaluated permittee compliance with paperwork filing requirements related to wetland mitigation projects. Sixty-seven percent of county road commission permittees were out of compliance with at least one filing requirement. Forty percent of private and non-county government permittees were out of compliance. Our results therefore suggest that serious problems exist with Michigan's implementation of wetland regulations. They do not suggest that compliance in this state is significantly better than in states under ACE administration. We believe that increased agency monitoring and enforcement would improve compliance.

  5. Comparison between continuous or intermittent schedules of sublingual immunotherapy for house dust mites: effects on compliance, patients satisfaction, quality of life and safety.

    PubMed

    Cadario, G; Ciprandi, G; Di Cara, G; Fadel, R; Incorvaia, C; Marcucci, F; Marengo, F; Puccinelli, P; Sensi, L; Strazzeri, L; Frati, F

    2008-01-01

    Sublingual immunotherapy (SLIT) is indicated in the treatment of allergic rhinitis and asthma. However, an issue scantly investigated is the patients satisfaction and the consequent compliance. This study is aimed at evaluating the possible differences of SLIT administered continuously or intermittently on several parameters: clinical efficacy, Quality of Life (QoL), satisfaction, compliance and safety. Forty allergic patients were treated for 12 months. The treatment was carried out by sublingual administration of an allergen extract of a 50% mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae at 10 and 300 IR/ml concentrations. Patients were randomly treated continuously or intermittently (i.e. 2 month treatment alternate to 2 month suspension). Both schedules were significantly effective in reducing allergic symptoms and improving QoL. Compliance and satisfaction were good in both groups. Local and systemic reactions were few, self-resolving, and mild in both schedules. Intergroup analysis did not reveal any difference between the two groups regarding these parameters. In conclusion, this preliminary study provides the evidence that also intermittent SLIT is as effective and safe as traditional continuous treatment. In addition, compliance and satisfaction are super-imposable in the two groups.

  6. 9 CFR 318.19 - Compliance procedure for cured pork products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Compliance procedure for cured pork products. 318.19 Section 318.19 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT... PREPARATION OF PRODUCTS General § 318.19 Compliance procedure for cured pork products. (a) Definitions. For...

  7. 49 CFR 659.27 - Internal safety and security reviews.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAIL FIXED GUIDEWAY SYSTEMS; STATE SAFETY OVERSIGHT Role of the..., indicating that the rail transit agency is in compliance with its system safety program plan and system... security reviews indicate that the rail transit agency is not in compliance with its system safety program...

  8. Quality beyond compliance.

    PubMed

    Centanni, N; Monroe, M; White, L; Larson, R

    1999-01-01

    The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.

  9. 77 FR 4396 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-27

    ... from the Railroad Freight Car Safety Standards, 49 CFR 215.303, which requires stenciling on restricted freight cars, for 13 freight cars. The list of these 13 cars is contained in the Exhibit A of the petition... compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 215...

  10. Unlocking Potentials of Microwaves for Food Safety and Quality.

    PubMed

    Tang, Juming

    2015-08-01

    Microwave is an effective means to deliver energy to food through polymeric package materials, offering potential for developing short-time in-package sterilization and pasteurization processes. The complex physics related to microwave propagation and microwave heating require special attention to the design of process systems and development of thermal processes in compliance with regulatory requirements for food safety. This article describes the basic microwave properties relevant to heating uniformity and system design, and provides a historical overview on the development of microwave-assisted thermal sterilization (MATS) and pasteurization systems in research laboratories and used in food plants. It presents recent activities on the development of 915 MHz single-mode MATS technology, the procedures leading to regulatory acceptance, and sensory results of the processed products. The article discusses needs for further efforts to bridge remaining knowledge gaps and facilitate transfer of academic research to industrial implementation. © 2015 Institute of Food Technologists®

  11. Assessing the status of airline safety culture and its relationship to key employee attitudes

    NASA Astrophysics Data System (ADS)

    Owen, Edward L.

    The need to identify the factors that influence the overall safety environment and compliance with safety procedures within airline operations is substantial. This study examines the relationships between job satisfaction, the overall perception of the safety culture, and compliance with safety rules and regulations of airline employees working in flight operations. A survey questionnaire administered via the internet gathered responses which were converted to numerical values for quantitative analysis. The results were grouped to provide indications of overall average levels in each of the three categories, satisfaction, perceptions, and compliance. Correlations between data in the three sets were tested for statistical significance using two-sample t-tests assuming equal variances. Strong statistical significance was found between job satisfaction and compliance with safety rules and between perceptions of the safety environment and safety compliance. The relationship between job satisfaction and safety perceptions did not show strong statistical significance.

  12. A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

    PubMed

    Mol, Peter G M; Straus, Sabine M J M; Piening, Sigrid; de Vries, Jonie T N; de Graeff, Pieter A; Haaijer-Ruskamp, Flora M

    2010-06-01

    As pre-approval trials are inherently limited in assessing the complete benefit-risk profile of a new drug, serious safety issues may emerge once a drug gains widespread use after approval. Regulators face the dilemma of balancing timely market access with the need for complete data on risks. This challenge has led to a life-cycle approach but, so far, few data are available on post-approval safety issues requiring regulatory action. The aim of this study is to determine the frequency, timing and nature of safety issues that necessitated safety-related regulatory action in the form of a Direct Healthcare Professional Communication (DHPC) issued by pharmaceutical companies in collaboration with the Dutch Medicines Evaluation Board during the past decade. All DHPCs issued in the Netherlands from 1 January 1999 to 1 January 2009 were retrospectively collected from the national regulatory authorities. Elapsed time between the approval date and the issue of the DHPC was determined. Characteristics of the action including the nature of the safety issue (according to Medical Dictionary for Regulatory Activities [MedDRA] terminology), type of drug and procedural aspects of the regulatory action taken were reviewed. DHPC characteristics were tabulated and explorative non-parametric tests were performed to study the effect of safety issue, drug class, drug type, orphan drug and first-in-class status on elapsed time from approval to the DHPC. 157 DHPCs were issued concerning 112 different active substances, approximately 9% (112/1200) of active substances available in the Netherlands in 2007. The number of DHPCs issued increased by 2.1 (95% CI 1.2, 3.1; p < 0.001) DHPCs per year over the past decade, reaching a total of 25 in 2008. The median time between approval and DHPC was 5.3 years (range 0.13-48 years). No significant trend in elapsed time to DHPC was observed in relation to the studied years (p = 0.06). One-third of all DHPCs were issued in the first 3 years after

  13. 14 CFR 417.23 - Compliance monitoring.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Compliance monitoring. 417.23 Section 417.23 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY General and License Terms and Conditions § 417.23...

  14. 48 CFR 2823.107 - Compliance responsibilities.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SOCIOECONOMIC PROGRAMS ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Pollution Control and Clean Air and Water 2823.107 Compliance responsibilities. If a contracting officer becomes aware of noncompliance with clean air, water or other affected media standards in facilities used in...

  15. 48 CFR 2823.107 - Compliance responsibilities.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Programs ENVIRONMENT, CONSERVATION, OCCUPATIONAL SAFETY, AND DRUG-FREE WORKPLACE Pollution Control and Clean Air and Water 2823.107 Compliance responsibilities. If a contracting officer becomes aware of noncompliance with clean air, water or other affected media standards in facilities used in performing nonexempt...

  16. Self-Regulated Compliance in Preschoolers with Autism Spectrum Disorder: The Role of Temperament and Parental Disciplinary Style

    ERIC Educational Resources Information Center

    Ostfeld-Etzion, Sharon; Feldman, Ruth; Hirschler-Guttenberg, Yael; Laor, Nathaniel; Golan, Ofer

    2016-01-01

    Regulatory difficulties are common in children with autism spectrum disorder. This study focused on an important aspect of self-regulation--the ability to willingly comply with frustrating demands of socialization agents, termed "self-regulated compliance." We studied compliance to parental demands in 40 preschoolers with autism spectrum…

  17. FMCSA safety program effectiveness measurement compliance review effectiveness model results for carriers with compliance reviews in fiscal year 2009 : [analysis brief].

    DOT National Transportation Integrated Search

    2014-04-01

    This Analysis Brief documents the methodology and results from the Compliance Review Effectiveness Model (CREM) for carriers receiving CRs in fiscal year (FY) 2009. The model measures the effectiveness of the compliance review (CR) program, one of th...

  18. [Evaluation of regulatory policies: the prevention of traffic accidents in Spain].

    PubMed

    Villalbí, Joan R; Pérez, Catherine

    2006-03-01

    Traffic accident injuries may be reduced with public policies. We review regulatory policies extending beyond the health sector by studying the case of traffic accident injuries. They have been the object of other analyses in Spain by both health professionals and professionals from other sectors, but we have not found a previous thorough review including regulatory aspects. We analyze the evolution of fatal victims of traffic accidents as collected by the Dirección General de Tráfico, stratifying for pedestrians, two-wheel vehicle occupants and occupants of other vehicles, and breaking down accidents between those occurring in roads and in urban settings. Despite the increase in exposure factors between 1970 and 2003, we observe a strong impact of regulatory policies in accident mortality. A favorable impact is seen for regulations and enforcement actions on motorcycle helmets, speed limits and the control of alcohol use, and a lower impact for safety belts, perhaps because its actual effective implementation was not equally sharp. The adoption of comprehensive plans or complex legislation packages seems to have had a positive impact, perhaps attributable to its triggering of more effective enforcement of already existing regulations. Although the existence of legal norms is not enough in itself, as its impact is low without active enforcement, compliance improves over time. In any case, the existence of specific initiatives to influence this field is important to obtain the best results of regulatory policies in public health.

  19. Compliance of middle school-aged babysitters in central Pennsylvania with national recommendations for emergency preparedness and safety practices.

    PubMed

    Hackman, Nicole M; Cass, Katie; Olympia, Robert P

    2012-06-01

    To determine the compliance of middle school-aged babysitters with national recommendations for emergency preparedness and safety practices. A prospective, self-administered questionnaire-based study was conducted at 3 middle schools in central Pennsylvania. A total of 1364 questionnaires were available for analysis. Responding babysitters (n = 890) reported previous training that included babysitter (21%), first aid (64%), and cardiopulmonary resuscitation (59%) training. Reported unsafe babysitter practices were leaving a child unattended (36%) and opening the door to a stranger (24%). The most common emergency experience encountered by responding babysitters included cut or scrape (83%), burns (28%), and choking (14%). Ten percent of responding babysitters have activated the 911 system. Middle school-aged babysitters will likely encounter common household emergencies and therefore benefit from first aid training; however, very little difference in safety knowledge was found between trained and untrained babysitters, suggesting modifications in babysitter training programs may be required.

  20. 78 FR 70356 - Compliance With Order EA-13-109, Order Modifying Licenses With Regard to Reliable Hardened...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... industry guidance contained in Nuclear Energy Institute (NEI) 13-02, ``Industry Guidance for Compliance.... ML13295A225), and Nuclear Energy Institute by letter dated October 18, 2013 (ADAMS Accession No. ML13295A494... NUCLEAR REGULATORY COMMISSION [NRC-2013-0215] Compliance With Order EA-13-109, Order Modifying...

  1. Analysis of workplace compliance measurements of asbestos by the U.S. Occupational Safety and Health Administration (1984-2011).

    PubMed

    Cowan, Dallas M; Cheng, Thales J; Ground, Matthew; Sahmel, Jennifer; Varughese, Allysha; Madl, Amy K

    2015-08-01

    The United States Occupational Safety and Health Administration (OSHA) maintains the Chemical Exposure Health Data (CEHD) and the Integrated Management Information System (IMIS) databases, which contain quantitative and qualitative data resulting from compliance inspections conducted from 1984 to 2011. This analysis aimed to evaluate trends in workplace asbestos concentrations over time and across industries by combining the samples from these two databases. From 1984 to 2011, personal air samples ranged from 0.001 to 175 f/cc. Asbestos compliance sampling data associated with the construction, automotive repair, manufacturing, and chemical/petroleum/rubber industries included measurements in excess of 10 f/cc, and were above the permissible exposure limit from 2001 to 2011. The utility of combining the databases was limited by the completeness and accuracy of the data recorded. In this analysis, 40% of the data overlapped between the two databases. Other limitations included sampling bias associated with compliance sampling and errors occurring from user-entered data. A clear decreasing trend in both airborne fiber concentrations and the numbers of asbestos samples collected parallels historically decreasing trends in the consumption of asbestos, and declining mesothelioma incidence rates. Although air sampling data indicated that airborne fiber exposure potential was high (>10 f/cc for short and long-term samples) in some industries (e.g., construction, manufacturing), airborne concentrations have significantly declined over the past 30 years. Recommendations for improving the existing exposure OSHA databases are provided. Copyright © 2015. Published by Elsevier Inc.

  2. Complying with Executive Order 13148 using the Enterprise Environmental Safety And Occupational Health Management Information System.

    PubMed

    McFarland, Michael J; Nelson, Tim M; Rasmussen, Steve L; Palmer, Glenn R; Olivas, Arthur C

    2005-03-01

    All U.S. Department of Defense (DoD) facilities are required under Executive Order (EO) 13148, "Greening the Government through Leadership in Environmental Management," to establish quality-based environmental management systems (EMSs) that support environmental decision-making and verification of continuous environmental improvement by December 31, 2005. Compliance with EO 13148 as well as other federal, state, and local environmental regulations places a significant information management burden on DoD facilities. Cost-effective management of environmental data compels DoD facilities to establish robust database systems that not only address the complex and multifaceted environmental monitoring, record-keeping, and reporting requirements demanded by these rules but enable environmental management decision-makers to gauge improvements in environmental performance. The Enterprise Environmental Safety and Occupational Health Management Information System (EESOH-MIS) is a new electronic database developed by the U.S. Air Force to manage both the data needs associated with regulatory compliance programs across its facilities as well as the non-regulatory environmental information that supports installation business practices. The U.S. Air Force, which has adopted the Plan-Do-Check-Act methodology as the EMS standard that it will employ to address EO 13148 requirements.

  3. Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports.

    PubMed

    Jullian, Sandra; Jaskiewicz, Lukasz; Pfannkuche, Hans-Jürgen; Parker, Jeremy; Lalande-Luesink, Isabelle; Lewis, David J; Close, Philippe

    2015-09-01

    Marketing authorization holders (MAHs) are expected to provide high-quality periodic safety update reports (PSURs) on their pharmaceutical products to health authorities (HAs). We present a novel instrument aiming at improving quality of PSURs based on standardized analysis of PSUR assessment reports (ARs) received from the European Union HAs across products and therapeutic areas. All HA comments were classified into one of three categories: "Request for regulatory actions," "Request for medical and scientific information," or "Data deficiencies." The comments were graded according to their impact on patients' safety, the drug's benefit-risk profile, and the MAH's pharmacovigilance system. A total of 476 comments were identified through the analysis of 63 PSUR HA ARs received in 2013 and 2014; 47 (10%) were classified as "Requests for regulatory actions," 309 (65%) as "Requests for medical and scientific information," and 118 (25%) comments were related to "Data deficiencies." The most frequent comments were requests for labeling changes (35 HA comments in 19 ARs). The aggregate analysis revealed commonly raised issues and prompted changes of the MAH's procedures related to the preparation of PSURs. The authors believe that this novel instrument based on the evaluation of PSUR HA ARs serves as a valuable mechanism to enhance the quality of PSURs and decisions about optimization of the use of the products and, therefore, contributes to improve further the MAH's pharmacovigilance system and patient safety. Copyright © 2015 John Wiley & Sons, Ltd.

  4. 29 CFR 1915.9 - Compliance duties owed to each employee.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 29 Labor 7 2013-07-01 2013-07-01 false Compliance duties owed to each employee. 1915.9 Section 1915.9 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) OCCUPATIONAL SAFETY AND HEALTH STANDARDS FOR SHIPYARD EMPLOYMENT General...

  5. 42 CFR 488.26 - Determining compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the need for improvement in relation to the prescribed conditions. (c) The State survey agency must... survey process is the means to assess compliance with Federal health, safety and quality standards; (2... facilities. Specifically surveyors will directly observe the actual provision of care and services to...

  6. Research on Current Water Systems and Regulatory Support

    EPA Science Inventory

    This project will supply research results to support federal regulations and guidance. It will also provide strategies to regions, states, and communities for improved regulatory compliance and rapid and effective emergency response where appropriate (e.g. harmful algal bloom out...

  7. The affect heuristic in occupational safety.

    PubMed

    Savadori, Lucia; Caovilla, Jessica; Zaniboni, Sara; Fraccaroli, Franco

    2015-07-08

    The affect heuristic is a rule of thumb according to which, in the process of making a judgment or decision, people use affect as a cue. If a stimulus elicits positive affect then risks associated to that stimulus are viewed as low and benefits as high; conversely, if the stimulus elicits negative affect, then risks are perceived as high and benefits as low. The basic tenet of this study is that affect heuristic guides worker's judgment and decision making in a risk situation. The more the worker likes her/his organization the less she/he will perceive the risks as high. A sample of 115 employers and 65 employees working in small family agricultural businesses completed a questionnaire measuring perceived safety costs, psychological safety climate, affective commitment and safety compliance. A multi-sample structural analysis supported the thesis that safety compliance can be explained through an affect-based heuristic reasoning, but only for employers. Positive affective commitment towards their family business reduced employers' compliance with safety procedures by increasing the perceived cost of implementing them.

  8. Marketing of breast-milk substitutes in Zambia: evaluation of compliance to the international regulatory code.

    PubMed

    Funduluka, P; Bosomprah, S; Chilengi, R; Mugode, R H; Bwembya, P A; Mudenda, B

    2018-03-01

    We sought to assess the level of non-compliance with the International Code of Marketing breast-milk substitutes (BMS) and/or Statutory Instrument (SI) Number 48 of 2006 of the Laws of Zambia in two suburbs, Kalingalinga and Chelstone, in Zambia. This was a cross sectional survey. Shop owners (80), health workers (8) and mothers (214) were interviewed. BMS labels and advertisements (62) were observed. The primary outcome was mean non-compliance defined as the number of article violations divided by the total 'obtainable' violations. The score ranges from 0 to 1 with 0 representing no violations in all the articles and one representing violations in all the articles. A total of 62 BMS were assessed. The mean non-compliance score by manufacturers in terms of violations in labelling of BMS was 0.33 (SD = 0.28; 95% CI: 0.26, 0.40). These violations were mainly due to labels containing pictures or graphics representing an infant. 80 shops were also assessed with mean non-compliance score in respect of violations in tie-in-sales, special display, and contact with mothers at the shop estimated as 0.14 (SD = 0.14; 95% CI: 0.11, 0.18). Non-compliance with the Code and/or the local SI is high after 10 years of domesticating the Code.

  9. Safety climate and mindful safety practices in the oil and gas industry.

    PubMed

    Dahl, Øyvind; Kongsvik, Trond

    2018-02-01

    The existence of a positive association between safety climate and the safety behavior of sharp-end workers in high-risk organizations is supported by a considerable body of research. Previous research has primarily analyzed two components of safety behavior, namely safety compliance and safety participation. The present study extends previous research by looking into the relationship between safety climate and another component of safety behavior, namely mindful safety practices. Mindful safety practices are defined as the ability to be aware of critical factors in the environment and to act appropriately when dangers arise. Regression analysis was used to examine whether mindful safety practices are, like compliance and participation, promoted by a positive safety climate, in a questionnaire-based study of 5712 sharp-end workers in the oil and gas industry. The analysis revealed that a positive safety climate promotes mindful safety practices. The regression model accounted for roughly 31% of the variance in mindful safety practices. The most important safety climate factor was safety leadership. The findings clearly demonstrate that mindful safety practices are highly context-dependent, hence, manageable and susceptible to change. In order to improve safety climate in a direction which is favorable for mindful safety practices, the results demonstrate that it is important to give the fundamental features of safety climate high priority and in particular that of safety leadership. Copyright © 2017 National Safety Council and Elsevier Ltd. All rights reserved.

  10. 76 FR 66713 - Atlanta Gas Light Company; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-27

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR11-108-003] Atlanta Gas Light Company; Notice of Compliance Filing Take notice that on October 19, 2011, Atlanta Gas Light Company filed a revised Statement of Operating Conditions to incorporate three modifications to comply...

  11. Implementing a Comprehensive Research Compliance Program: A Handbook for Research Officers

    ERIC Educational Resources Information Center

    Dade, Aurali, Ed.; Olafson, Lori, Ed.; DiBella, Suzan M., Ed.

    2015-01-01

    The senior research compliance administrator has emerged as a critically important position as universities and other research organizations face an increasingly intricate regulatory environment. These administrators are tasked with a special challenge: ensuring that their institutions conduct safe, ethical, and compliant research while also…

  12. Good manufacturing practice (GMP) compliance in the biologics sector: plasma fractionation.

    PubMed

    Ways, J P; Preston, M S; Baker, D; Huxsoll, J; Bablak, J

    1999-12-01

    The U.S. blood supply is the safest it has ever been. Due to blood safety and the introduction of viral inactivation/clearance technologies, protein therapies derived from human blood have also in recent years had a history of product safety. Nevertheless, since 1995, the plasma-fractionation industry has experienced increased compliance-related actions by the Food and Drug Administration (FDA), as shown by a substantive increase in the number of FDA 483 inspectional observations, FDA warning letters and other FDA regulatory action. An evaluation of these trends shows that they reflect the implementation by the FDA of increased inspectional interest in the plasma-fractionation industry and an evolution of inspectional practices and standards of current good manufacturing practice (cGMP). Plasma fractionators have responded to FDA actions by carefully evaluating and addressing each inspectional observation, assessing impact to product and taking appropriate actions, including corrective actions to prevent future occurrence. They have made major investments in facilities, quality systems, personnel and training to meet the evolving standards of cGMP and in an effort to implement these standards systemically. Through industry associations, manufacturers have further enhanced product safety by adopting additional voluntary standards for plasma to prevent the entry of potentially unsuitable plasma into the production process. The industry remains committed to application of cGMP and to working with the FDA in further evolution of these standards while striving to assure a continued supply of safe, pure and effective plasma-derived therapies.

  13. Radiological safety status and quality assurance audit of medical X-ray diagnostic installations in India.

    PubMed

    Sonawane, A U; Singh, Meghraj; Sunil Kumar, J V K; Kulkarni, Arti; Shirva, V K; Pradhan, A S

    2010-10-01

    We conducted a radiological safety and quality assurance (QA) audit of 118 medical X-ray diagnostic machines installed in 45 major hospitals in India. The main objective of the audit was to verify compliance with the regulatory requirements stipulated by the national regulatory body. The audit mainly covered accuracy check of accelerating potential (kVp), linearity of tube current (mA station) and timer, congruence of radiation and optical field, and total filtration; in addition, we also reviewed medical X-ray diagnostic installations with reference to room layout of X-ray machines and conduct of radiological protection survey. A QA kit consisting of a kVp Test-O-Meter (ToM) (Model RAD/FLU-9001), dose Test-O-Meter (ToM) (Model 6001), ionization chamber-based radiation survey meter model Gun Monitor and other standard accessories were used for the required measurements. The important areas where there was noncompliance with the national safety code were: inaccuracy of kVp calibration (23%), lack of congruence of radiation and optical field (23%), nonlinearity of mA station (16%) and timer (9%), improper collimator/diaphragm (19.6%), faulty adjustor knob for alignment of field size (4%), nonavailability of warning light (red light) at the entrance of the X-ray room (29%), and use of mobile protective barriers without lead glass viewing window (14%). The present study on the radiological safety status of diagnostic X-ray installations may be a reasonably good representation of the situation in the country as a whole. The study contributes significantly to the improvement of radiological safety by the way of the steps already taken and by providing a vital feed back to the national regulatory body.

  14. The effect of nurses' empowerment perceptions on job safety behaviours: a research study in Turkey.

    PubMed

    Yıldız, Ahmet; Kaya, Sıdıka; Teleş, Mesut; Korku, Cahit

    2018-05-03

    This study aimed to investigate the effect of nurses' empowerment perceptions on job safety behaviours. A survey of 377 nurses working in five hospitals in Turkey was conducted using the conditions of work effectiveness questionnaire, psychological empowerment instrument, universal precautions compliance scale and occupational health and safety obligations compliance scale. Relations between variables were tested using Pearson's correlation and path analysis. There was a moderate and statistically significant relationship between psychological and structural empowerment and complying with universal safety measures and meeting occupational health and safety obligations. Also, an increase of 1 unit on the level of psychological empowerment was found to correspond to an increase of 0.37 units on the level of universal precautions compliance and to an increase of 0.46 units on the level of occupational health and safety obligations compliance. As such, an increase of 1 unit in structural empowerment corresponds to an increase of 0.53 units on the level of universal precautions compliance and to an increase of 0.36 units (total effect) on the level of occupational health and safety obligations compliance. The findings reveal that empowerment is a valuable tool for nurses' positive job safety behaviours.

  15. Development, implementation, and compliance of treatment pathways in radiation medicine.

    PubMed

    Potters, Louis; Raince, Jadeep; Chou, Henry; Kapur, Ajay; Bulanowski, Daniel; Stanzione, Regina; Lee, Lucille

    2013-01-01

    While much emphasis on safety in the radiation oncology clinic is placed on process, there remains considerable opportunity to increase safety, enhance outcomes, and avoid ad hoc care by instituting detailed treatment pathways. The purpose of this study was to review the process of developing evidence and consensus-based, outcomes-oriented treatment pathways that standardize treatment and patient management in a large multi-center radiation oncology practice. Further, we reviewed our compliance in incorporating these directives into our day-to-day clinical practice. Using the Institute of Medicine guideline for developing treatment pathways, 87 disease specific pathways were developed and incorporated into the electronic medical system in our multi-facility radiation oncology department. Compliance in incorporating treatment pathways was assessed by mining our electronic medical records (EMR) data from January 1, 2010 through February 2012 for patients with breast and prostate cancer. This retrospective analysis of data from EMR found overall compliance to breast and prostate cancer treatment pathways to be 97 and 99%, respectively. The reason for non-compliance proved to be either a failure to complete the prescribed care based on grade II or III toxicity (n = 1 breast, 3 prostate) or patient elected discontinuance of care (n = 1 prostate) or the physician chose a higher dose for positive/close margins (n = 3 breast). This study demonstrates that consensus and evidence-based treatment pathways can be developed and implemented in a multi-center department of radiation oncology. And that for prostate and breast cancer there was a high degree of compliance using these directives. The development and implementation of these pathways serve as a key component of our safety program, most notably in our effort to facilitate consistent decision-making and reducing variation between physicians.

  16. PAA, WSH, and CIS Overview Self-Study #47656

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Schroeder, Rachel Anne

    This course presents an overview of the Department of Energy’s (DOE’s) regulatory requirements relevant to the Price-Anderson Amendments Act (PAAA, also referred to as nuclear safety), worker safety and health (WSH), and classified information security (CIS) that are enforceable under the DOE enforcement program; describes the DOE enforcement process; and provides an overview of Los Alamos National Laboratory’s (LANL’s) internal compliance program relative to these DOE regulatory requirements. The LANL PAAA Program is responsible for maintaining LANL’s internal compliance program, which ensures the prompt identification, screening, and reporting of noncompliances to DOE regulatory requirements pertaining to nuclear safety, WSH, andmore » CIS to build the strongest mitigation position for the Laboratory with respect to civil or other penalties.« less

  17. Water Systems Project 1: Current Systems and Regulatory Support

    EPA Science Inventory

    Water Systems Project 1 objectives: 1) Supply research results to support federal regulations and guidance; 2) provide strategies to regions, states, and communities for improved regulatory compliance, and 3) provide rapid and effective emergency response where appropriate (e.g. ...

  18. Motivational Postures and Compliance with Environmental Law in Australian Agriculture

    ERIC Educational Resources Information Center

    Bartel, Robyn; Barclay, Elaine

    2011-01-01

    Motivational posture theory is applied and extended to the context of Australian agriculture and environmental regulation. Regulatory failure in this area has been observed but little was known of the compliance attitudes and behaviours of farmers prior to this study. Agriculture covers over 60% of Australia's land surface so this information is…

  19. Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation.

    PubMed

    Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, C T; Jacobs, Danny O

    2006-07-27

    Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open-source application will promote improved

  20. Duke Surgery Research Central: an open-source Web application for the improvement of compliance with research regulation

    PubMed Central

    Pietrobon, Ricardo; Shah, Anand; Kuo, Paul; Harker, Matthew; McCready, Mariana; Butler, Christeen; Martins, Henrique; Moorman, CT; Jacobs, Danny O

    2006-01-01

    Background Although regulatory compliance in academic research is enforced by law to ensure high quality and safety to participants, its implementation is frequently hindered by cost and logistical barriers. In order to decrease these barriers, we have developed a Web-based application, Duke Surgery Research Central (DSRC), to monitor and streamline the regulatory research process. Results The main objective of DSRC is to streamline regulatory research processes. The application was built using a combination of paper prototyping for system requirements and Java as the primary language for the application, in conjunction with the Model-View-Controller design model. The researcher interface was designed for simplicity so that it could be used by individuals with different computer literacy levels. Analogously, the administrator interface was designed with functionality as its primary goal. DSRC facilitates the exchange of regulatory documents between researchers and research administrators, allowing for tasks to be tracked and documents to be stored in a Web environment accessible from an Intranet. Usability was evaluated using formal usability tests and field observations. Formal usability results demonstrated that DSRC presented good speed, was easy to learn and use, had a functionality that was easily understandable, and a navigation that was intuitive. Additional features implemented upon request by initial users included: extensive variable categorization (in contrast with data capture using free text), searching capabilities to improve how research administrators could search an extensive number of researcher names, warning messages before critical tasks were performed (such as deleting a task), and confirmatory e-mails for critical tasks (such as completing a regulatory task). Conclusion The current version of DSRC was shown to have excellent overall usability properties in handling research regulatory issues. It is hoped that its release as an open

  1. Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

    PubMed

    Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information.

  2. 10 CFR 72.238 - Issuance of an NRC Certificate of Compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Issuance of an NRC Certificate of Compliance. 72.238 Section 72.238 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C...

  3. 75 FR 28602 - Corning Natural Gas Corporation; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-30-003] Corning Natural Gas Corporation; Notice of Compliance Filing May 17, 2010. Take notice that on May 10, 2010, Corning Natural Gas Corporation, (Corning) filed a corrected rate sheet to replace the rate sheet filed with its...

  4. 29 CFR 1952.103 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Oregon § 1952.103... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in...

  5. 29 CFR 1952.103 - Compliance staffing benchmarks.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., DEPARTMENT OF LABOR (CONTINUED) APPROVED STATE PLANS FOR ENFORCEMENT OF STATE STANDARDS Oregon § 1952.103... State operating an approved State plan. In October 1992, Oregon completed, in conjunction with OSHA, a... of 28 health compliance officers. Oregon elected to retain the safety benchmark level established in...

  6. 33 CFR 96.350 - Interim Document of Compliance certificate: what is it and when can it be used?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Document of Compliance certificate may be issued to help set up a company's safety management system when— (1) A company is newly set up or in transition from an existing company into a new company; or (2) A new type of vessel is added to an existing safety management system and Document of Compliance...

  7. Comparison of food safety cognitions and self-reported food-handling behaviors with observed food safety behaviors of young adults.

    PubMed

    Abbot, J M; Byrd-Bredbenner, C; Schaffner, D; Bruhn, C M; Blalock, L

    2009-04-01

    Developing tailored and effective food safety education for young adults is critical given their future roles as caregivers likely to be preparing food for populations who may be at greater risk for foodborne disease (FBD). The objective of this study was to examine the relationship between food safety self-reported food-handling behaviors and cognitions of young adults to observed food-handling behaviors. Participants were 153 young adults (mean age 20.74+/-1.30 s.d.) attending a major American university. Each prepared a meal under observation in a controlled laboratory setting, permitted researchers to observe their home kitchen and completed an online survey assessing food safety knowledge, behavior and psychosocial measures. Descriptive statistics were generated for participants' self-reported food-handling behaviors, psychosocial characteristics, knowledge, food preparation observations and home kitchen observations. Determinants of compliance with safe food-handling procedures while preparing a meal and home food storage/rotation practices were identified using backward regression models. Participants engaged in less than half of the recommended safe food-handling practices evaluated and correctly answered only two-thirds of the food safety knowledge items. They reported positive food safety beliefs and high food safety self-efficacy. Self-reported compliance with cross-contamination prevention, disinfection procedures and knowledge of groups at greatest risk for FBD were the best measures for predicting compliance with established safe food-handling practices. Food safety education directed toward young adults should focus on increasing awareness of FBD and knowledge of proper cross-contamination prevention procedures to help promote better compliance with actual safe food handling.

  8. Notification: Audit of the CSB's compliance with the FISMA

    EPA Pesticide Factsheets

    May 19, 2014. The EPA OIG plans to begin fieldwork for an audit of the U.S. Chemical Safety and Hazard Investigation Board's (CSB's) compliance with the Federal Information Security Management Act (FISMA).

  9. Poster — Thur Eve — 54: Radiotherapy and Non-Radiotherapy Safety Practices Beyond Licensing Expectations

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Kosierb, Rick

    The Canadian Nuclear Safety Commission (CNSC) regulates the use of nuclear energy and materials to protect the health, safety and security of Canadians and the environment, and to implement Canada's international obligations on the peaceful use of nuclear energy. In order to perform this regulatory activity, the CNSC issue licences and has its staff perform inspections to verify conformity to the aspects of those licences. Within the CNSC, the Accelerators and Class II Facilities Division (ACFD) is responsible for the regulatory oversight of Class II Prescribed Equipment used in medical, academic, and industrial sectors in Canada. In performing inspections, ACFDmore » has encountered licensees with practices that are either below, meet or exceed regulatory expectations in specific areas. Unfortunately, none of these practices are ever communicated to the broader Class II community to help other licensees avoid the same problem or achieve high standards. In this poster, ACFD will highlight safety practices that go beyond expectations. These practices are taken from observations during site inspections between 2007 and 2013 and will be presented in six areas: Procedures, Participation, Awareness, Equipment, Servicing and Software. Each area briefly discusses a number of practices that the CNSC feels went beyond the expectations dictated by the licence. Where possible, names are added of the contact people at the centres who can be reached for full details of their implementations. It is hoped that this communication will assist other licensees to achieve these same high levels of compliance and possibly go beyond.« less

  10. The natural lifespan of a safety policy: violations and system migration in anaesthesia.

    PubMed

    de Saint Maurice, Guillaume; Auroy, Yves; Vincent, Charles; Amalberti, René

    2010-08-01

    Safety rules continue growing rapidly, as if constraining human behaviour was the unique avenue for reaching ultimate safety. Safety rules are essential for a safe system, but their multiplication can have counterproductive effects. To monitor, in an anaesthesia ward, compliance with a process-oriented safety rule, and understand barriers and facilitators which help and hinder physicians from following guidelines. The rule stipulated that the day before surgery anaesthetists had to record in the patient's file the drugs to be used for the anaesthesia (induction, maintenance, airway control). Compliance was assessed before introduction of the rule, immediately after, at 6 months and at 12 months. All medical staff were blinded to the protocol. 717 patient records were included. The results showed an initial compliance with policy, reaching 86% for some items (never 100%). Reduction began within 6 months and returned almost to initial levels within a year. One individual showed poor compliance throughout the study but even initially compliant doctors experienced a reduction. Compliance was higher for complex surgery but lower for unscheduled surgery and when job pressure was greater. Compliance eroded over time. A major trigger of erosion seemed to be lack of continued compliance by a senior member of staff. Rules and procedures constitute fragile safety barriers, and it may be better to forego introducing a new safety rule if it is not considered as a priority by staff and is therefore vulnerable to sacrifice in case of conflict with competitive demands.

  11. Value-Based Argumentation for Justifying Compliance

    NASA Astrophysics Data System (ADS)

    Burgemeestre, Brigitte; Hulstijn, Joris; Tan, Yao-Hua

    Compliance is often achieved 'by design' through a coherent system of controls consisting of information systems and procedures . This system-based control requires a new approach to auditing in which companies must demonstrate to the regulator that they are 'in control'. They must determine the relevance of a regulation for their business, justify which set of control measures they have taken to comply with it, and demonstrate that the control measures are operationally effective. In this paper we show how value-based argumentation theory can be applied to the compliance domain. Corporate values motivate the selection of control measures (actions) which aim to fulfill control objectives, i.e. adopted norms (goals). In particular, we show how to formalize the dialogue in which companies justify their compliance decisions to regulators using value-based argumentation. The approach is illustrated by a case study of the safety and security measures adopted in the context of EU customs regulation.

  12. ENA study cites barriers to NPSG compliance.

    PubMed

    2009-04-01

    There are many barriers to compliance with the National Patient Safety Goals, as a recent study shows. However, emergency medicine experts say there are several strategies you can adopt to help overcome those barriers. Send the right message to your staff by establishing a culture of shared responsibility for safety. Establish scripts for talking with patients. Standardization will help ensure they are getting the correct information. Put standardized abbreviations on posters in your department, and list them on your medication reconciliation form.

  13. Consideration of future safety consequences: a new predictor of employee safety.

    PubMed

    Probst, Tahira M; Graso, Maja; Estrada, Armando X; Greer, Sarah

    2013-06-01

    Compliance with safety behaviors is often associated with longer term benefits, but may require some short-term sacrifices. This study examines the extent to which consideration of future safety consequences (CFSC) predicts employee safety outcomes. Two field studies were conducted to evaluate the reliability and validity of the newly developed Consideration of Future Safety Consequences (CFSC) scale. Surveys containing the CFSC scale and other measures of safety attitudes, behaviors, and outcomes were administered during working hours to a sample of 128 pulp and paper mill employees; after revising the CFSC scale based on these initial results, follow-up survey data were collected in a second sample of 212 copper miners. In Study I, CFSC was predictive of employee safety knowledge and motivation, compliance, safety citizenship behaviors, accident reporting attitudes and behaviors, and workplace injuries - even after accounting for conscientiousness and demographic variables. Moreover, the effects of CFSC on the variables generally appear to be direct, as opposed to mediated by safety knowledge or motivation. These findings were largely replicated in Study II. CFSC appears to be an important personality construct that may predict those individuals who are more likely to comply with safety rules and have more positive safety outcomes. Future research should examine the longitudinal stability of CFSC to determine the extent to which this construct is a stable trait, rather than a safety attitude amenable to change over time or following an intervention. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. 29 CFR 1921.7 - Stipulations of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR... WORKERS' COMPENSATION ACT Prehearing Procedures § 1921.7 Stipulations of compliance. At any time prior to... admits the material facts and agrees to discontinue the acts or practices which are intended to be set up...

  15. 49 CFR 238.201 - Scope/alternative compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... equivalent safety and compliance with this subpart, other than § 238.203, based upon a submission of data and analysis sufficient to support that determination. The petition shall include: (i) The information required..., sufficient to describe the actual construction of the equipment of special design; (iii) Engineering analysis...

  16. 77 FR 69923 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... DEPARTMENT OF TRANSPORTATION Federal Railroad Administration [Docket Number FRA-2012-0069... Rail d.b.a. Toledo Lake Erie and Western Railway (TLEW) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety...

  17. 49 CFR 385.335 - If the FMCSA conducts a compliance review on a new entrant, will the new entrant also be subject...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... entrant, will the new entrant also be subject to a safety audit? 385.335 Section 385.335 Transportation... Safety Assurance Program § 385.335 If the FMCSA conducts a compliance review on a new entrant, will the new entrant also be subject to a safety audit? If the FMCSA conducts a compliance review on a new...

  18. 10 CFR 72.246 - Issuance of amendment to a certificate of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Issuance of amendment to a certificate of compliance. 72.246 Section 72.246 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN...

  19. 10 CFR 72.244 - Application for amendment of a certificate of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 2 2010-01-01 2010-01-01 false Application for amendment of a certificate of compliance. 72.244 Section 72.244 Energy NUCLEAR REGULATORY COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN...

  20. RRA-12-010 Compliance Review Effectiveness Model: FY 2008

    DOT National Transportation Integrated Search

    2012-09-01

    In FY 2008, Federal and State enforcement personnel conducted 14,906 compliance reviews (CRs) on individual motor carriers. It is intended that through education, heightened safety regulation awareness, and the enforcement effects of the CR, carriers...

  1. REFLECTIONS ON THE ROLE OF THE PHARMACY REGULATORY AUTHORITY IN ENHANCING QUALITY RELATED EVENT REPORTING IN COMMUNITY PHARMACIESi

    PubMed Central

    Boyle, Todd A.; Bishop, Andrea C.; Mahaffey, Thomas; MacKinnon, Neil J.; Ashcroft, Darren; Zwicker, Bev; Reid, Carolyn

    2016-01-01

    Background Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice Objective This study aims to better understand the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies and identifying regulatory best practices to execute such roles. Methods A purposive case sampling approach was used to identify PRA staff members from two groups (deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Results Two focus groups were conducted, one with seven deputy registrars/practice managers and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Conclusions Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may

  2. Reflections on the role of the pharmacy regulatory authority in enhancing quality related event reporting in community pharmacies.

    PubMed

    Boyle, Todd A; Bishop, Andrea C; Mahaffey, Thomas; Mackinnon, Neil J; Ashcroft, Darren M; Zwicker, Bev; Reid, Carolyn

    2014-01-01

    Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice. This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles. A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict

  3. 75 FR 9201 - DCP Raptor Pipeline, LLC; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR09-32-002] DCP Raptor... Raptor Pipeline, LLC (Raptor) filed its Statement of Operating Conditions in compliance with the January 27, 2010 Letter Order (January 27th Letter Order) in Docket Nos. PR09-32-000 and PR09-32-001. Raptor...

  4. The role of trust in nurturing compliance: a study of accused tax avoiders.

    PubMed

    Murphy, Kristina

    2004-04-01

    Why an institution's rules and regulations are obeyed or disobeyed is an important question for regulatory agencies. This paper discusses the findings of an empirical study that shows that the use of threat and legal coercion as a regulatory tool--in addition to being more expensive to implement--can sometimes be ineffective in gaining compliance. Using survey data collected from 2,292 taxpayers accused of tax avoidance, it will be demonstrated that variables such as trust need to be considered when managing noncompliance. If regulators are seen to be acting fairly, people will trust the motives of that authority, and will defer to their decisions voluntarily. This paper therefore argues that to shape desired behavior, regulators will need to move beyond motivation linked purely to deterrence. Strategies directed at reducing levels of distrust between the two sides may prove particularly effective in gaining voluntary compliance with an organization's rules and regulations.

  5. Launch Services Safety Overview

    NASA Technical Reports Server (NTRS)

    Loftin, Charles E.

    2008-01-01

    NASA/KSC Launch Services Division Safety (SA-D) services include: (1) Assessing the safety of the launch vehicle (2) Assessing the safety of NASA ELV spacecraft (S/C) / launch vehicle (LV) interfaces (3) Assessing the safety of spacecraft processing to ensure resource protection of: - KSC facilities - KSC VAFB facilities - KSC controlled property - Other NASA assets (4) NASA personnel safety (5) Interfacing with payload organizations to review spacecraft for adequate safety implementation and compliance for integrated activities (6) Assisting in the integration of safety activities between the payload, launch vehicle, and processing facilities

  6. Foodservice employees benefit from interventions targeting barriers to food safety.

    PubMed

    York, Valerie K; Brannon, Laura A; Shanklin, Carol W; Roberts, Kevin R; Howells, Amber D; Barrett, Elizabeth B

    2009-09-01

    The number of foodborne illnesses traced to improper food handling in restaurants indicates a need for research to improve food safety in these establishments. Therefore, this 2-year longitudinal study investigated the effectiveness of traditional ServSafe (National Restaurant Association Educational Foundation, Chicago, IL) food-safety training and a Theory of Planned Behavior intervention program targeting employees' perceived barriers and attitudes toward important food-safety behaviors. The effectiveness of the training and intervention was measured by knowledge scores and observed behavioral compliance rates related to food-safety practices. Employees were observed for handwashing, thermometer usage, and proper handling of work surfaces at baseline, after receiving ServSafe training, and again after exposure to the intervention targeting barriers and negative attitudes about food-safety practices. Repeated-measures analyses of variance indicated training improved handwashing knowledge, but the intervention was necessary to improve overall behavioral compliance and handwashing compliance. Results suggest that registered dietitians; dietetic technicians, registered; and foodservice managers should implement a combination of training and intervention to improve knowledge and compliance with food-safety behaviors, rather than relying on training alone. Challenges encountered while conducting this research are discussed, and recommendations are provided for researchers interested in conducting this type of research in the future.

  7. Understanding patient compliance and persistence with osteoporosis therapy.

    PubMed

    Gold, Deborah T

    2011-04-01

    Chronic non-terminal diseases, including postmenopausal osteoporosis, are associated with poor treatment compliance and persistence. The longer a patient with osteoporosis complies and persists with treatment, the lower the risk of fracture. Retrospective studies with emphasis on real-world data have led to a greater understanding of the factors affecting medication compliance and persistence, and their association with improved treatment outcomes. However, these data do not contain information about patient choices of medication or patient commitment to particular medication regimens. Patient preferences can affect compliance and persistence behaviours. While recent evidence questions the importance of dosing regimen in patient preferences, other recent data show that medication efficacy and safety remain the most important determinants of patient preference. Informed patient decision making about treatment options, adverse effects and outcomes can have a beneficial impact on medication-taking behaviour. Healthcare professionals play a crucial role in the management of factors associated with poor compliance and persistence with osteoporosis therapies. Education about disease consequences and differences among treatment options, as well as treatment monitoring and positive reinforcement, are crucial to improving medication compliance and persistence in osteoporotic patients.

  8. 77 FR 19412 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ... of compliance from certain requirements of its safety standards. The individual petition is described... Hazardous Materials Regulations (49 CFR part 172) to operate in a single-unit train consist. Farmrail... delivery to the different logistics customers. Additionally, Farmrail states that a rail shipper in Sayre...

  9. 78 FR 36013 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49..., and Repair of Signal and Train Control Systems, Devices, and Appliances. FRA assigned the petition... each train operating in train stop, train control or cab signal territory; equipped. Specifically...

  10. 49 CFR 1542.109 - Alternate means of compliance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRPORT SECURITY Airport Security Program § 1542.109 Alternate means of compliance. If in TSA's judgment, the overall safety and security of the airport, and aircraft operator or foreign air carrier operations are not diminished, TSA...

  11. 49 CFR 1542.109 - Alternate means of compliance.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRPORT SECURITY Airport Security Program § 1542.109 Alternate means of compliance. If in TSA's judgment, the overall safety and security of the airport, and aircraft operator or foreign air carrier operations are not diminished, TSA...

  12. 49 CFR 1542.109 - Alternate means of compliance.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRPORT SECURITY Airport Security Program § 1542.109 Alternate means of compliance. If in TSA's judgment, the overall safety and security of the airport, and aircraft operator or foreign air carrier operations are not diminished, TSA...

  13. 49 CFR 1542.109 - Alternate means of compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRPORT SECURITY Airport Security Program § 1542.109 Alternate means of compliance. If in TSA's judgment, the overall safety and security of the airport, and aircraft operator or foreign air carrier operations are not diminished, TSA...

  14. 49 CFR 1542.109 - Alternate means of compliance.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... SECURITY ADMINISTRATION, DEPARTMENT OF HOMELAND SECURITY CIVIL AVIATION SECURITY AIRPORT SECURITY Airport Security Program § 1542.109 Alternate means of compliance. If in TSA's judgment, the overall safety and security of the airport, and aircraft operator or foreign air carrier operations are not diminished, TSA...

  15. Notification: Audit of CSB's Compliance With Improper Payment Legislation

    EPA Pesticide Factsheets

    November 17, 2015. The Environmental Protection Agency’s Office of Inspector General (OIG) for the U.S. Chemical Safety and Hazard Investigation Board (CSB) plans to begin its audit of CSB’s compliance with the improper payments legislation.

  16. 49 CFR 238.9 - Responsibility for compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... appliance and power brake provisions of this part, if the railroad has actual knowledge of the facts giving..., (i) That has one or more conditions not in compliance with a safety appliance or power brake... power brake provision of this part; or (2) Use, haul, offer in interchange, or accept in interchange any...

  17. Glycoconjugate Vaccines: The Regulatory Framework.

    PubMed

    Jones, Christopher

    2015-01-01

    Most vaccines, including the currently available glycoconjugate vaccines, are administered to healthy infants, to prevent future disease. The safety of a prospective vaccine is a key prerequisite for approval. Undesired side effects would not only have the potential to damage the individual infant but also lead to a loss of confidence in the respective vaccine-or vaccines in general-on a population level. Thus, regulatory requirements, particularly with regard to safety, are extremely rigorous. This chapter highlights regulatory aspects on carbohydrate-based vaccines with an emphasis on analytical approaches to ensure the consistent quality of successive manufacturing lots.

  18. Estimates and implications of the costs of compliance with biosafety regulations in developing countries.

    PubMed

    Falck-Zepeda, Jose; Yorobe, Jose; Husin, Bahagiawati Amir; Manalo, Abraham; Lokollo, Erna; Ramon, Godfrey; Zambrano, Patricia; Sutrisno

    2012-01-01

    Estimating the cost of compliance with biosafety regulations is important as it helps developers focus their investments in producer development. We provide estimates for the cost of compliance for a set of technologies in Indonesia, the Philippines and other countries. These costs vary from US $100,000 to 1.7 million. These are estimates of regulatory costs and do not include product development or deployment costs. Cost estimates need to be compared with potential gains when the technology is introduced in these countries and the gains in knowledge accumulate during the biosafety assessment process. Although the cost of compliance is important, time delays and uncertainty are even more important and may have an adverse impact on innovations reaching farmers.

  19. Database management systems for process safety.

    PubMed

    Early, William F

    2006-03-17

    Several elements of the process safety management regulation (PSM) require tracking and documentation of actions; process hazard analyses, management of change, process safety information, operating procedures, training, contractor safety programs, pre-startup safety reviews, incident investigations, emergency planning, and compliance audits. These elements can result in hundreds of actions annually that require actions. This tracking and documentation commonly is a failing identified in compliance audits, and is difficult to manage through action lists, spreadsheets, or other tools that are comfortably manipulated by plant personnel. This paper discusses the recent implementation of a database management system at a chemical plant and chronicles the improvements accomplished through the introduction of a customized system. The system as implemented modeled the normal plant workflows, and provided simple, recognizable user interfaces for ease of use.

  20. Individual safety performance in the construction industry: development and validation of two short scales.

    PubMed

    DeArmond, Sarah; Smith, April E; Wilson, Christina L; Chen, Peter Y; Cigularov, Konstantin P

    2011-05-01

    In the current research a short measure of safety performance is developed for use in the construction industry and the relationships between different components of safety performance and safety outcomes (e.g., occupational injuries and work-related pain) are explored within the construction context. This research consists of two field studies. In the first, comprehensive measures of safety compliance and safety participation were shortened and modified to be appropriate for use in construction. Evidence of reliability and validity is provided. Both safety compliance and safety participation were negatively related to occupational injuries, yet these two correlations were not statistically different. In the second study, we investigated the relationships between these two components of safety performance and work-related pain frequency, in addition to replicating Study 1. Safety compliance had a stronger negative relationship with pain than safety participation. Implications for research are discussed. Copyright © 2010 Elsevier Ltd. All rights reserved.

  1. 76 FR 2726 - Withdrawal of Regulatory Guide 1.154

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-14

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0010] Withdrawal of Regulatory Guide 1.154 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.154, ``Format and Content of Plant-Specific Pressurized Thermal Shock Safety Analysis Reports for Pressurized Water Reactors.'' FOR FURTHER INFORMATION CONTACT: Mekonen M. Bayssie,...

  2. 75 FR 66077 - Bay Gas Storage Company Ltd.; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-27

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR10-15-002] Bay Gas Storage Company Ltd.; Notice of Compliance Filing October 20, 2010. Take notice that on October 13, 2010, Bay Gas Storage Company Ltd. (Bay Gas) filed its Refund Report pursuant to its August 30, 2010 Settlement...

  3. 75 FR 73946 - Worker Safety and Health Program: Safety Conscious Work Environment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... DEPARTMENT OF ENERGY 10 CFR Part 851 Worker Safety and Health Program: Safety Conscious Work... Nuclear Regulatory Commission's ``Safety-Conscious Work Environment'' guidelines as a model. DOE published.... Second, not only would instituting a ``Safety-Conscious Work Environment'' by regulation be redundant...

  4. The Interface of Safety and Security in Transport: A Regional Perspective

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Welch, Tim; Duhamel, David A; Nandakumar, A. N.

    Security of nuclear and other radioactive material in transport continues to be a challenge for States that are working on strengthening their nuclear security regime. One reason for this is that State regulatory agencies and other organizations lack the resources and trained personnel to dedicate to this field. For over 50 years safety has been a major focus in the use, storage and transport of radioactive material. Only recently, since the late 1990s, has dedicated focus been given to the field of security. One way to assist States to advance nuclear security is to reach out to safety workers (regulators,more » inspectors, and safety compliance personnel) and showcase the need to better integrate safety and security practices. A recent IAEA regional workshop in Bangkok, Thailand (June 2015) yielded profound results when subject matter experts lectured on both the safety and the security of radioactive material in transport. These experts presented and discussed experiences and best practices for: 1) developing and implementing safety requirements and security recommendations for radioactive material in transport; 2) national and international cooperation; and 3) preventing shipment delays/denials of radioactive material. The workshop participants, who were predominantly from safety organizations, shared that they received the following from this event: 1. A clear understanding of the objectives of the IAEA safety requirements and security recommendations for radioactive material in transport. 2. A general understanding of and appreciation for the similarities and differences between safety requirements and security recommendations for radioactive material in transport. 3. A greater appreciation of the interface between transport safety and security and potential impacts of this interface on the efforts to strengthen the compliance assurance regime for the safe transport of radioactive material. 4. A general understanding of assessing the transport security

  5. 47 CFR 101.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 101.1309 Section 101.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Multiple Address Systems General Provisions § 101.1309 Regulatory status. (a) The Commission will...

  6. 47 CFR 101.533 - Regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Regulatory status. 101.533 Section 101.533 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES 24 GHz Service and Digital Electronic Message Service § 101.533 Regulatory status. (a) Initial...

  7. The impact of regulatory compliance behavior on hazardous waste generation in European private healthcare facilities.

    PubMed

    Botelho, Anabela

    2013-10-01

    This study empirically evaluates whether the increasingly large numbers of private outpatient healthcare facilities (HCFs) within the European Union (EU) countries comply with the existing European waste legislation, and whether compliance with such legislation affects the fraction of healthcare waste (HCW) classified as hazardous. To that end, this study uses data collected by a large survey of more than 700 small private HCFs distributed throughout Portugal, a full member of the EU since 1986, where 50% of outpatient care is currently dominated by private operators. The collected data are then used to estimate a hurdle model, i.e. a statistical specification in which there are two processes: one is the process by which some HCFs generate zero or some positive fraction of hazardous HCW, and another is the process by which HCFs generate a specific positive fraction of hazardous HCW conditional on producing any. Taken together, the results show that although compliance with the law is far from ideal, it is the strongest factor influencing hazardous waste generation. In particular, it is found that higher compliance has a small and insignificant effect on the probability of generating (or reporting) positive amounts of hazardous waste, but it does have a large and significant effect on the fraction of hazardous waste produced, conditional on producing any, with a unit increase in the compliance rate leading to an estimated decrease in the fraction of hazardous HCW by 16.3 percentage points.

  8. Implementation of a Surgical Safety Checklist: Interventions to Optimize the Process and Hints to Increase Compliance

    PubMed Central

    Sendlhofer, Gerald; Mosbacher, Nina; Karina, Leitgeb; Kober, Brigitte; Jantscher, Lydia; Berghold, Andrea; Pregartner, Gudrun; Brunner, Gernot; Kamolz, Lars Peter

    2015-01-01

    Background A surgical safety checklist (SSC) was implemented and routinely evaluated within our hospital. The purpose of this study was to analyze compliance, knowledge of and satisfaction with the SSC to determine further improvements. Methods The implementation of the SSC was observed in a pilot unit. After roll-out into each operating theater, compliance with the SSC was routinely measured. To assess subjective and objective knowledge, as well as satisfaction with the SSC implementation, an online survey (N = 891) was performed. Results During two test runs in a piloting unit, 305 operations were observed, 175 in test run 1 and 130 in test run 2. The SSC was used in 77.1% of all operations in test run 1 and in 99.2% in test run 2. Within used SSCs, completion rates were 36.3% in test run 1 and 1.6% in test run 2. After roll-out, three unannounced audits took place and showed that the SSC was used in 95.3%, 91.9% and 89.9%. Within used SSCs, completion rates decreased from 81.7% to 60.6% and 53.2%. In 2014, 164 (18.4%) operating team members responded to the online survey, 160 of which were included in the analysis. 146 (91.3%) consultants and nursing staff reported to use the SSC regularly in daily routine. Conclusion These data show that the implementation of new tools such as the adapted WHO SSC needs constant supervision and instruction until it becomes self-evident and accepted. Further efforts, consisting mainly of hands-on leadership and training are necessary. PMID:25658317

  9. School Bus Fleet Safety: Planning and Development.

    ERIC Educational Resources Information Center

    Bieber, Robert M.

    1984-01-01

    To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

  10. 49 CFR 193.2009 - Rules of regulatory construction.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 193.2009 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS General § 193.2009 Rules of regulatory...

  11. MODEL 9977 B(M)F-96 SAFETY ANALYSIS REPORT FOR PACKAGING

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Abramczyk, G; Paul Blanton, P; Kurt Eberl, K

    2006-05-18

    This Safety Analysis Report for Packaging (SARP) documents the analysis and testing performed on and for the 9977 Shipping Package, referred to as the General Purpose Fissile Package (GPFP). The performance evaluation presented in this SARP documents the compliance of the 9977 package with the regulatory safety requirements for Type B packages. Per 10 CFR 71.59, for the 9977 packages evaluated in this SARP, the value of ''N'' is 50, and the Transport Index based on nuclear criticality control is 1.0. The 9977 package is designed with a high degree of single containment. The 9977 complies with 10 CFR 71more » (2002), Department of Energy (DOE) Order 460.1B, DOE Order 460.2, and 10 CFR 20 (2003) for As Low As Reasonably Achievable (ALARA) principles. The 9977 also satisfies the requirements of the Regulations for the Safe Transport of Radioactive Material--1996 Edition (Revised)--Requirements. IAEA Safety Standards, Safety Series No. TS-R-1 (ST-1, Rev.), International Atomic Energy Agency, Vienna, Austria (2000). The 9977 package is designed, analyzed and fabricated in accordance with Section III of the American Society of Mechanical Engineers (ASME) Boiler and Pressure Vessel (B&PV) Code, 1992 edition.« less

  12. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory status...

  13. 47 CFR 90.1309 - Regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Regulatory status. 90.1309 Section 90.1309 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Wireless Broadband Services in the 3650-3700 MHz Band § 90.1309 Regulatory status...

  14. Job Burnout Reduces Hand Hygiene Compliance Among Nursing Staff.

    PubMed

    Manomenidis, Georgios; Panagopoulou, Efharis; Montgomery, Anthony

    2017-10-13

    Health professional burnout has been associated with suboptimal care and reduced patient safety. However, the extent to which burnout influences hand hygiene compliance among health professionals has yet to be explored. The aim of the study was to examine whether job burnout reduces hand washing compliance among nursing staff. A diary study was conducted. Forty registered nurses working in a general city hospital in Thessaloniki, Greece, completed a questionnaire, while they were monitored for hand hygiene compliance following the World Health Organization protocol for hand hygiene assessment. Burnout was measured using validated items from the Maslach Burnout Inventory. Data were collected from September to October 2015. Multiple regression analysis showed that controlling for years in practice, burnout was negatively associated with hand hygiene compliance (R = 0.322, F(3,36) = 5.704, P < 0.01). Nurses reporting higher levels of burnout were less likely to comply with hand hygiene opportunities (b = - 3.72, 95% confidence interval = -5.94 to -1.51). This study showed that burnout contributes to suboptimal care by reducing compliance to hand hygiene among nurses. Given the crucial role of hand hygiene compliance for the prevention of in-hospital infections, this study highlights the need for interventions targeting the prevention of burnout among nursing staff.

  15. Use of portable ladders - field observations and self-reported safety performance in the cable TV industry.

    PubMed

    Chang, Wen-Ruey; Huang, Yueng-Hsiang; Brunette, Christopher; Lee, Jin

    2017-11-01

    Portable ladders incidents remain a major cause of falls from heights. This study reported field observations of environments, work conditions and safety behaviour involving portable ladders and their correlations with self-reported safety performance. Seventy-five professional installers of a company in the cable and other pay TV industry were observed for 320 ladder usages at their worksites. The participants also filled out a questionnaire to measure self-reported safety performance. Proper setup on slippery surfaces, correct method for ladder inclination setup and ladder secured at the bottom had the lowest compliance with best practices and training guidelines. The observation compliance score was found to have significant correlation with straight ladder inclined angle (Pearson's r = 0.23, p < 0.0002) and employees' self-reported safety participation (r = 0.29, p < 0.01). The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours. Practitioner Summary: A checklist was used while observing professional installers of a cable company for portable ladder usage at their worksites. Items that had the lowest compliance with best practices and training guidelines were identified. The results provide a broad perspective on employees' safety compliance and identify areas for improving safety behaviours.

  16. Improving admission medication reconciliation compliance using the electronic tool in admitted medical patients.

    PubMed

    Taha, Haytham; Abdulhay, Dana; Luqman, Neama; Ellahham, Samer

    2016-01-01

    Sheikh Khalifa Medical City (SKMC) in Abu Dhabi is the main tertiary care referral hospital in the United Arab Emirates (UAE) with 560 bed capacity that is fully occupied most of the time. SKMC senior management has made a commitment to make quality and patient safety a top priority. Our governing body Abu Dhabi Health Services Company has identified medication reconciliation as a critical patient safety measure and key performance indicator (KPI). The medication reconciliation electronic form a computerized decision support tool was introduced to improve medication reconciliation compliance on transition of care at admission, transfer and discharge of patients both in the inpatient and outpatient settings. In order to improve medication reconciliation compliance a multidisciplinary task force team was formed and led this quality improvement project. The purpose of this publication is to indicate the quality improvement interventions implemented to enhance compliance with admission medication reconciliation and the outcomes of those interventions. We chose to conduct the pilot study in general medicine as it is the busiest department in the hospital, with an average of 390 patients admitted per month during the study period. The study period was from April 2014 till October 2015 and a total of 8576 patients were evaluated. The lessons learned were disseminated throughout the hospital. Our aim was to improve admission medication reconciliation compliance using the electronic form in order to ensure patient safety and reduce preventable harm in terms of medication errors. Admission medication reconciliation compliance improved in general medicine from 40% to above 85%, and this improvement was sustained for the last four months of the study period.

  17. Site-Specific Analyses for Demonstrating Compliance with 10 CFR 61 Performance Objectives - 12179

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Grossman, C.J.; Esh, D.W.; Yadav, P.

    2012-07-01

    The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations at 10 CFR Part 61 to require low-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance with the performance objectives in Subpart C. The amendments would require licensees to conduct site-specific analyses for protection of the public and inadvertent intruders as well as analyses for long-lived waste. The amendments would ensure protection of public health and safety, while providing flexibility to demonstrate compliance with the performance objectives, for current and potential future waste streams. NRC staff intends to submit proposed rule language and associated regulatorymore » basis to the Commission for its approval in early 2012. The NRC staff also intends to develop associated guidance to accompany any proposed amendments. The guidance is intended to supplement existing low-level radioactive waste guidance on issues pertinent to conducting site-specific analyses to demonstrate compliance with the performance objectives. The guidance will facilitate implementation of the proposed amendments by licensees and assist competent regulatory authorities in reviewing the site-specific analyses. Specifically, the guidance provides staff recommendations on general considerations for the site-specific analyses, modeling issues for assessments to demonstrate compliance with the performance objectives including the performance assessment, intruder assessment, stability assessment, and analyses for long-lived waste. This paper describes the technical basis for changes to the rule language and the proposed guidance associated with implementation of the rule language. The NRC staff, per Commission direction, intends to propose amendments to 10 CFR Part 61 to require licensees to conduct site-specific analyses to demonstrate compliance with performance objectives for the protection of public health and the environment. The amendments would

  18. 76 FR 24831 - Site-Specific Analyses for Demonstrating Compliance With Subpart C Performance Objectives

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-03

    ... available under ADAMS accession number ML111040419, and the ``Technical Analysis Supporting Definition of... NUCLEAR REGULATORY COMMISSION 10 CFR Part 61 RIN 3150-AI92 [NRC-2011-0012] Site-Specific Analyses...-level radioactive waste disposal facilities to conduct site-specific analyses to demonstrate compliance...

  19. 10 CFR 20.1302 - Compliance with dose limits for individual members of the public.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... public. 20.1302 Section 20.1302 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Dose Limits for Individual Members of the Public § 20.1302 Compliance with dose limits..., surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents...

  20. 10 CFR 20.1302 - Compliance with dose limits for individual members of the public.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... public. 20.1302 Section 20.1302 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Dose Limits for Individual Members of the Public § 20.1302 Compliance with dose limits..., surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents...

  1. 10 CFR 20.1302 - Compliance with dose limits for individual members of the public.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... public. 20.1302 Section 20.1302 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Dose Limits for Individual Members of the Public § 20.1302 Compliance with dose limits..., surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents...

  2. 10 CFR 20.1302 - Compliance with dose limits for individual members of the public.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... public. 20.1302 Section 20.1302 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Dose Limits for Individual Members of the Public § 20.1302 Compliance with dose limits..., surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents...

  3. 10 CFR 20.1302 - Compliance with dose limits for individual members of the public.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... public. 20.1302 Section 20.1302 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Radiation Dose Limits for Individual Members of the Public § 20.1302 Compliance with dose limits..., surveys of radiation levels in unrestricted and controlled areas and radioactive materials in effluents...

  4. 78 FR 59755 - Petition for Waiver of Compliance

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... waiver of compliance from certain provisions of the Federal railroad safety regulations contained at... Boundary, MN (Milepost 44.9), a distance of 43.8 miles. Approximately 15 trains per day are operated over this segment. Each train that traverses this territory is operated by the same crew. The entire Sprague...

  5. 76 FR 14896 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-18

    ...] Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public... specific regulatory guidance related to the Federal Select Agent Program established under the Public.... Sarah Kwiatkowski, Veterinary Program Assistant, APHIS Select Agent Program, APHIS, 4700 River Road Unit...

  6. 76 FR 17617 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ...] Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public... specific regulatory guidance related to the Federal Select Agent Program established under the Public.... Sarah Kwiatkowski, Veterinary Program Assistant, APHIS Select Agent Program, APHIS, 4700 River Road Unit...

  7. Waste Isolation Pilot Plant Biennial Environmental Compliance Report

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Westinghouse TRU Solutions

    This Biennial Environmental Compliance Report (BECR) documents environmental regulatory compliance at the Waste Isolation Pilot Plant (WIPP), a facility designed for the safe disposal of transuranic (TRU) radioactive waste, for the reporting period of April 1, 1998, to March 31, 2000. As required by the WIPP Land Withdrawal Act (LWA)(Public Law [Pub. L.] 102-579, and amended by Pub. L. 104-201), the BECR documents U.S. Department of Energy (DOE) Carlsbad Area Office's (hereinafter the ''CAO'') compliance with applicable environmental protection laws and regulations implemented by agencies of the federal government and the state of New Mexico. An issue was identified inmore » the 1998 BECR relating to a potential cross-connection between the fire-water systems and the site domestic water system. While the CAO and its managing and operating contractor (hereinafter the ''MOC'') believe the site was always in compliance with cross-connection control requirements, hardware and procedural upgrades w ere implemented in March 1999 to strengthen its compliance posture. Further discussion of this issue is presented in section 30.2.2 herein. During this reporting period WIPP received two letters and a compliance order alleging violation of certain requirements outlined in section 9(a)(1) of the LWA. With the exception of one item, pending a final decision by the New Mexico Environment Department (NMED), all alleged violations have been resolved without the assessment of fines or penalties. Non-mixed TRU waste shipments began on March 26, 1999. Shipments continued through November 26, 1999, the effective date of the Waste Isolation Pilot Plant Hazardous Waste Facility Permit (NM4890139088-TSDF). No shipments regulated under the Hazardous Waste Facility Permit were received at WIPP during this BECR reporting period.« less

  8. Low-income minority fathers' control strategies and children's regulatory skills

    PubMed Central

    Malin, Jenessa L.; Cabrera, Natasha J.; Karberg, Elizabeth; Aldoney, Daniela; Rowe, Meredith

    2015-01-01

    The current study explored the bidirectional association of children's individual characteristics, fathers' control strategies at 24-months and children's regulatory skills at pre-kindergarten (pre-K). Using a sample of low-income minority families with 2-year-olds from the Early Head Start Evaluation Research Program (n = 71) we assessed the association between child gender and vocabulary skills, fathers' control strategies at 24-months (e.g., regulatory behavior and regulatory language), and children's sustained attention and emotion regulation at pre-kindergarten. There were three main findings. First, fathers' overwhelmingly use commands (e.g., do that) to promote compliance in their 24-month old children. Second, children's vocabulary skills predict fathers' regulatory behaviors during a father-child interaction, whereas children's gender predicts fathers' regulatory language during an interaction. Third, controlling for maternal supportiveness, fathers' regulatory behaviors at 24-months predict children's sustained attention at pre-kindergarten whereas fathers' regulatory language at 24-months predicts children's emotion regulation at pre-kindergarten. Our findings highlight the importance of examining paternal contributions to children's regulatory skills. PMID:25798496

  9. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  10. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  11. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  12. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  13. 47 CFR 101.1017 - Requesting regulatory status.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 47 Telecommunication 5 2013-10-01 2013-10-01 false Requesting regulatory status. 101.1017 Section 101.1017 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Local Multipoint Distribution Service § 101.1017 Requesting regulatory...

  14. 49 CFR 173.461 - Demonstration of compliance with tests.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Demonstration of compliance with tests. 173.461 Section 173.461 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SHIPPERS-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS...

  15. 49 CFR 173.461 - Demonstration of compliance with tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Demonstration of compliance with tests. 173.461 Section 173.461 Transportation Other Regulations Relating to Transportation PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SHIPPERS-GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS...

  16. Environmental Regulatory Update Table, January/February 1995

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.

    1995-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  17. 75 FR 31429 - Bay Gas Storage Company, Ltd.; Notice of Compliance Filing

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-03

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. PR08-17-002] Bay Gas Storage Company, Ltd.; Notice of Compliance Filing May 27, 2010. Take notice that on May 21, 2010, Bay Gas Storage Company, Ltd (Bay Gas) filed to comply with the April 15, 2010, Commission Order which directed Bay Gas to...

  18. Regulatory cross-cutting topics for fuel cycle facilities.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Denman, Matthew R.; Brown, Jason; Goldmann, Andrew Scott

    This report overviews crosscutting regulatory topics for nuclear fuel cycle facilities for use in the Fuel Cycle Research & Development Nuclear Fuel Cycle Evaluation and Screening study. In particular, the regulatory infrastructure and analysis capability is assessed for the following topical areas: Fire Regulations (i.e., how applicable are current Nuclear Regulatory Commission (NRC) and/or International Atomic Energy Agency (IAEA) fire regulations to advance fuel cycle facilities) Consequence Assessment (i.e., how applicable are current radionuclide transportation tools to support risk-informed regulations and Level 2 and/or 3 PRA) While not addressed in detail, the following regulatory topic is also discussed: Integrated Security,more » Safeguard and Safety Requirement (i.e., how applicable are current Nuclear Regulatory Commission (NRC) regulations to future fuel cycle facilities which will likely be required to balance the sometimes conflicting Material Accountability, Security, and Safety requirements.)« less

  19. Safety and compliance of prescription spectacles ordered by the public via the Internet.

    PubMed

    Citek, Karl; Torgersen, Daniel L; Endres, Jeffrey D; Rosenberg, Robert R

    2011-09-01

    This study investigated prescription spectacles ordered from online vendors and delivered directly to the public for compliance with the optical tolerance and impact resistance requirements for eyewear dispensed in the United States. Ten individuals ordered 2 pairs of spectacles from each of 10 of the most visited Internet vendors, totaling 200 eyewear orders. Spectacles ordered consisted of ranges of lens and frame materials, lens styles, and refractive corrections reflecting current distributions in the United States. Evaluations included measurement of sphere power, cylinder power and axis, add power (if indicated), horizontal prism imbalance, and impact testing. We received and evaluated 154 pairs of spectacles, comprising 308 lenses. Several spectacles were provided incorrectly, such as single vision instead of multifocal and lens treatments added or omitted. In 28.6% of spectacles, at least 1 lens failed tolerance standards for at least 1 optical parameter, and in 22.7% of spectacles, at least 1 lens failed impact testing. Overall, 44.8% of spectacles failed at least 1 parameter of optical or impact testing. Nearly half of prescription spectacles delivered directly by online vendors did not meet either the optical requirements of the patient's visual needs or the physical requirements for the patient's safety. Copyright © 2011 American Optometric Association. Published by Elsevier Inc. All rights reserved.

  20. Exposure to fall hazards and safety climate in the aircraft maintenance industry.

    PubMed

    Neitzel, Richard L; Seixas, Noah S; Harris, Michael J; Camp, Janice

    2008-01-01

    Falls represent a significant occupational hazard, particularly in industries with dynamic work environments. This paper describes rates of noncompliance with fall hazard prevention requirements, perceived safety climate and worker knowledge and beliefs, and the association between fall exposure and safety climate measures in commercial aircraft maintenance activities. Walkthrough observations were conducted on aircraft mechanics at two participating facilities (Sites A and B) to ascertain the degree of noncompliance. Mechanics at each site completed questionnaires concerning fall hazard knowledge, personal safety beliefs, and safety climate. Questionnaire results were summarized into safety climate and belief scores by workgroup and site. Noncompliance rates observed during walkthroughs were compared to the climate-belief scores, and were expected to be inversely associated. Important differences were seen in fall safety performance between the sites. The study provided a characterization of aircraft maintenance fall hazards, and also demonstrated the effectiveness of an objective hazard assessment methodology. Noncompliance varied by height, equipment used, location of work on the aircraft, shift, and by safety system. Although the expected relationship between safety climate and noncompliance was seen for site-average climate scores, workgroups with higher safety climate scores had greater observed noncompliance within Site A. Overall, use of engineered safety systems had a significant impact on working safely, while safety beliefs and climate also contributed, though inconsistently. The results of this study indicate that safety systems are very important in reducing noncompliance with fall protection requirements in aircraft maintenance facilities. Site-level fall safety compliance was found to be related to safety climate, although an unexpected relationship between compliance and safety climate was seen at the workgroup level within site. Finally, observed

Some links on this page may take you to non-federal websites. Their policies may differ from this site.