Science.gov

Sample records for act regulations safety

  1. The Activity Centres (Young Persons' Safety) Act 1995, the Adventure Activities Licensing Regulations 1996.

    ERIC Educational Resources Information Center

    Journal of Adventure Education and Outdoor Leadership, 1996

    1996-01-01

    Explains licensing regulations applicable in the United Kingdom to commercial providers of adventure education programs that offer caving, climbing, trekking, and water sports; provides information on license applications, including licensing standards related to risk assessment and safety management procedures; and addresses issues related to the…

  2. Regulations for the administration and enforcement of the Radiation Control for Health and Safety Act of 1968

    SciTech Connect

    Not Available

    1988-04-01

    The purpose of the Act is to protect the public from unnecessary exposure to radiation from electronic products, including ionizing, nonionizing, electromagnetic, or particulate radiation, or any sonic, infrasonic, or ultrasonic wave. The regulations in the publication cover general provisions, statements of policy and interpretation, radiation protection recommendations, recordkeeping and reporting requirements for manufacturers, dealers, and distributors; notification requirements for defects or failure to comply; repurchase, repairs, or replacement of electronic products; importation of products; and performance standards for television receivers, cathode ray tubes, diagnostic x-ray equipment, radiographic equipment, fluoroscopic equipment, computer aided tomography equipment, microwave ovens, laser products, sunlamps, ultraviolet lamps, mercury lamps, and ultrasonic therapy products.

  3. Nuclear regulation and safety

    SciTech Connect

    Hendrie, J.M.

    1982-01-01

    Nuclear regulation and safety are discussed from the standpoint of a hypothetical country that is in the process of introducing a nuclear power industry and setting up a regulatory system. The national policy is assumed to be in favor of nuclear power. The regulators will have responsibility for economic, reliable electric production as well as for safety. Reactor safety is divided into three parts: shut it down, keep it covered, take out the afterheat. Emergency plans also have to be provided. Ways of keeping the core covered with water are discussed. (DLC)

  4. Nuclear safety: risks and regulation

    SciTech Connect

    Wood, W.C.

    1983-01-01

    Taking a fresh look at nuclear safety regulations, this study finds that the mandate and organization of the Nuclear Regulatory Commission (NRC) militate against its making sound decisions. The author criticizes failures to make hard decisions on societal risk, to clarify responsibility, and to implement cost-effective safety measures. Among his recommendations are reorganization of the NRC under a single authoritative administrator, separation of technical issues from social ones, and reform of the Price-Anderson Act. The author concludes that the worst eventuality would be to continue the current state of indecision. 161 references, 6 figures, 4 tables.

  5. 75 FR 22320 - Regulations Implementing the Freedom of Information Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-28

    ... HEALTH REVIEW COMMISSION 29 CFR Part 2201 Regulations Implementing the Freedom of Information Act AGENCY: Occupational Safety and Health Review Commission. ACTION: Notice of proposed rulemaking. SUMMARY: The Occupational Safety and Health Review Commission (OSHRC) is proposing to revise its regulations...

  6. The French Space Operations Act: Technical Regulations

    NASA Astrophysics Data System (ADS)

    Lazare, B.

    2013-12-01

    The French Space Operations Act (FSOA) [1] stipulates that one of the National Technical Regulations' prime objectives is to protect people, property, public health and the environment. Compliance with these Technical Regulations has been mandatory since 10 December, 2010 for space operations by French space operators and for space operations conducted on French territory. The space safety requirements and regulations governing procedures are based on national and international best practices and experience. A critical design review of the space system and procedures shall be carried out by applicant space operators, in order to verify compliance with the Technical Regulations. An independent technical assessment of the operation is delegated to CNES. The principles applied when drafting the Technical Regulations are as follows: requirements must, as far as possible, establish the rules according to the objective to be obtained, rather than how it is to be achieved; requirements must give preference to international standards recognised as being state of the art; requirements must take previous experience into account. The Technical Regulations are divided into three sections covering requirements common to the launch, control and return of a space object. A special section will cover specific rules to be applied at the Guiana Space Centre. The main topics addressed by the Technical Regulations are: operator safety management system; study of risks to people, property, public health and the Earth's environment; impact study on the outer space environment: space debris generated by the operation; planetary protection. The first version of the Technical Regulations [2], issued in March 2011, is dedicated to unmanned space systems.

  7. 75 FR 41370 - Regulations Implementing the Freedom of Information Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-16

    ... amended. 75 FR 22320, Apr. 28, 2010. Interested persons were afforded an opportunity to participate in the... HEALTH REVIEW COMMISSION 29 CFR Part 2201 Regulations Implementing the Freedom of Information Act AGENCY: Occupational Safety and Health Review Commission. ACTION: Final rule. SUMMARY: The Occupational Safety...

  8. 48 CFR 50.205-1 - SAFETY Act Considerations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Fostering Effective Technologies Act of 2002 50.205-1 SAFETY Act Considerations. (a) SAFETY Act applicability. Requiring activities should review requirements to identify potential technologies that prevent... acquisitions involving such technologies, the requiring activity should ascertain through discussions with...

  9. 75 FR 63703 - Privacy Act of 1974; Privacy Act Regulation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ...The Board of Governors of the Federal Reserve System (Board) is issuing a final rule to amend its regulation implementing the Privacy Act of 1974 (Privacy Act). The primary changes concern the waiver of copying fees charged to current and former Board employees, and applicants for Board employment, for access to their records under the Privacy Act; the amendment of special procedures for the......

  10. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains...

  11. 48 CFR 22.403-3 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Standards for Contracts Involving Construction 22.403-3 Contract Work Hours and Safety Standards Act. The Contract Work Hours and Safety Standards Act (40 U.S.C. 3701 et seq.) requires that certain contracts (see... 48 Federal Acquisition Regulations System 1 2010-10-01 2010-10-01 false Contract Work Hours...

  12. 75 FR 37287 - Privacy Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-29

    ... April 19, 2010 (75 FR 20298) for a public comment period to end on June 18, 2010. This rule amends the... criminal law enforcement duties. (2) From subsection (c)(4) and (d) because notification would alert a... regulations implementing the Privacy Act of 1974 (Privacy Act), Public Law 93-579, 5 U.S.C. 552a. This...

  13. Occupational Safety and Health Act: A Responsibility for Science Teachers

    ERIC Educational Resources Information Center

    Science Teacher, 1974

    1974-01-01

    Presents implications of the Occupational Safety and Health Act for science teachers both as workers and as they encourage, in students, the development of positive safety attitudes for future occupations. (PEB)

  14. NRC - regulator of nuclear safety

    SciTech Connect

    1997-05-01

    The U.S. Nuclear Regulatory Commission (NRC) was formed in 1975 to regulate the various commercial and institutional uses of nuclear energy, including nuclear power plants. The agency succeeded the Atomic Energy Commission, which previously had responsibility for both developing and regulating nuclear activities. Federal research and development work for all energy sources, as well as nuclear weapons production, is now conducted by the U.S. Department of Energy. Under its responsibility to protect public health and safety, the NRC has three principal regulatory functions: (1) establish standards and regulations, (2) issue licenses for nuclear facilities and users of nuclear materials, and (3) inspect facilities and users of nuclear materials to ensure compliance with the requirements. These regulatory functions relate to both nuclear power plants and to other uses of nuclear materials - like nuclear medicine programs at hospitals, academic activities at educational institutions, research work, and such industrial applications as gauges and testing equipment. The NRC places a high priority on keeping the public informed of its work. The agency recognizes the interest of citizens in what it does through such activities as maintaining public document rooms across the country and holding public hearings, public meetings in local areas, and discussions with individuals and organizations.

  15. Regulations to implement 46 USC 3705(C) and 3706(D), formerly sections 5(7) (E) and (H) of the Port and Tanker Safety Act of 1978

    SciTech Connect

    Not Available

    1985-03-01

    Amendment of certain pollution prevention regulations of the Code of Federal Regulations is proposed to alter Coast Guard requirements concerning ballast tanks in crude oil and product carriers. The amended regulations would be applicable to all US vessels and all foreign vessels that enter navigable waters of the United States or transfer cargo at a port or place subject to US jurisdiction. The new regulations would require that existing crude oil carriers of 20,000 to 40,000 dead-weight tons (DWT) have segregated ballast tanks or a crude oil washing system before January 2, 1986 or when they reach 15 years of age, whichever occurred later, and existing product carriers of 20,000 to 40,000 DWT have segregated ballast tanks or dedicated clean ballast tanks before January 2, 1986, or when they reach 15 years of age, whichever occurred later. An existing vessel is any self-propelled vessel for which the building contract was placed on or before June 1, 1979; for which the keel was laid on or before January 1, 1980; for which delivery was made on or before June 1, 1982; for which major conversion work was performed on or before June 1, 1979; or on which construction work was begun on or before January 1, 1980 or completed on or before June 1, 1982.

  16. Recent Cases: Administrative Law--Occupational Safety and Health Act

    ERIC Educational Resources Information Center

    Harvard Law Review, 1976

    1976-01-01

    Implications of the Occupational Safety and Health Act of 1970 are described in two cases: Brennan v. Occupational Safety and Health Review Commission (Underhill Construction Corp.), and Anning-Johnson Co. v. United States Occupational Safety and Health Review Commission. (LBH)

  17. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  18. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  19. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  20. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  1. 32 CFR 770.5 - Safety regulations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 5 2012-07-01 2012-07-01 false Safety regulations. 770.5 Section 770.5 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY MISCELLANEOUS RULES RULES LIMITING PUBLIC... Safety regulations. (a) Hunting is not permitted within 200 yards of the following: Ammunition...

  2. 32 CFR 770.5 - Safety regulations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 5 2013-07-01 2013-07-01 false Safety regulations. 770.5 Section 770.5 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY MISCELLANEOUS RULES RULES LIMITING PUBLIC... Safety regulations. (a) Hunting is not permitted within 200 yards of the following: Ammunition...

  3. 32 CFR 770.5 - Safety regulations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 5 2014-07-01 2014-07-01 false Safety regulations. 770.5 Section 770.5 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY MISCELLANEOUS RULES RULES LIMITING PUBLIC... Safety regulations. (a) Hunting is not permitted within 200 yards of the following: Ammunition...

  4. Analysis of US child care safety regulations.

    PubMed Central

    Runyan, C W; Gray, D E; Kotch, J B; Kreuter, M W

    1991-01-01

    BACKGROUND: With 1.9 million US children cared for in organized group child care, the safety of these children is a public health concern. In the absence of federal policy, each state has developed its own day care safety regulations. METHODS: After creating a set of 36 criteria from three sets of national guidelines, we assessed the safety regulations of 45 states. With a mailed survey of state day care regulatory personnel, we examined the processes of formulating and implementing safety policy in 47 states. RESULTS: For 24 of the 36 items, more than half the states' regulations were below the criteria or failed to mention the topic. Most notable is the inattention to playground safety, choking hazards, and firearms. CONCLUSION: The uneven quality of regulations may be a reflection of a regulatory process that is fragmented, with many different groups sharing authority and with limited involvement of injury prevention specialists. PMID:1854015

  5. China's food safety regulation and mass spectrometry.

    PubMed

    Chu, Xiaogang; Zhang, Feng; Nie, Xuemei; Wang, Wenzhi; Feng, Feng

    2011-01-01

    Food safety is essential to people's health and people's livelihood. To ensure that food safety is an important current strategy of the governments, both regulation and standardization are important support for implementing this strategic initiative effectively. The status and prospects of China's food laws, regulations, and standards system are introduced. China now has established a complete law regime providing a sound foundation and good environment for keeping the health of people, maintaining the order of social economy and promoting the international trade of food. At the same time, it is undoubtedly important to strengthen standardization and improve the food safety standards system. In the administration of food safety, mass spectrometry is becoming more and more important and many analytical methods developed in China are based on its application. PMID:21643903

  6. 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.

  7. The Food Safety Modernization Act: a barrier to trade? Only if the science says so.

    PubMed

    McNeill, Naomi

    2012-01-01

    The Food Safety Modernization Act improves oversight of America's food safety system. Title III, which regulates imported food, may create extra burdens for importers and therefore act as a barrier to trade. What will be on trial before the World Trade Organization (WTO), however, is not the law's content, but the science supporting it. Under the WTO regime, food safety laws that could restrict the free movement of food commodities must be sufficiently justified by scientific evidence. Member states must engage in risk assessments and regulate food imports in a manner that is "no more restrictive than necessary" to protect against the health risks identified by scientific evidence. This article examines the requirements of the WTO to evaluate the FSMA's legality under WTO rules. It analyzes the case law of the WTO Panel and Appellate Body and compares the FMSA to the EU's General Food Law. PMID:24620418

  8. 48 CFR 1480.102 - Buy Indian Act acquisition regulations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Buy Indian Act acquisition... INDIAN AFFAIRS SUPPLEMENT ACQUISITIONS UNDER THE BUY INDIAN ACT General 1480.102 Buy Indian Act... the Buy Indian Act. (b) This part is under the direct oversight and control of the Chief...

  9. NASA Principal Center for Review of Clean Air Act Regulations

    NASA Technical Reports Server (NTRS)

    Clark-Ingram, Marceia; Munafo, Paul M. (Technical Monitor)

    2002-01-01

    The Clean Air Act (CAA) regulations have greatly impacted materials and processes utilized in the manufacture of aerospace hardware. Code JE/ NASA's Environmental Management Division at NASA Headquarters recognized the need for a formal, Agency-wide review process of CAA regulations. Marshall Space Flight Center (MSFC) was selected as the 'Principal Center for Review of Clean Air Act Regulations'. This presentation describes the centralized support provided by MSFC for the management and leadership of NASA's CAA regulation review process.

  10. 75 FR 35686 - Community Reinvestment Act Regulation Hearings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-23

    ... TREASURY Office of Thrift Supervision 12 CFR Part 563e Community Reinvestment Act Regulation Hearings... financial institution's performance under the Community Reinvestment Act (CRA). The purpose of the hearings... better serve the goals of the Community Reinvestment Act. The hearings will be held in:...

  11. 48 CFR 1480.102 - Buy Indian Act acquisition regulations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Buy Indian Act acquisition... INDIAN AFFAIRS SUPPLEMENT ACQUISITIONS UNDER THE BUY INDIAN ACT Subpart 1480.1 General 1480.102 Buy... in implementing the Buy Indian Act. (b) This part is under the direct oversight and control of...

  12. 13 CFR 108.30 - Amendments to Act and regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Amendments to Act and regulations. 108.30 Section 108.30 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION NEW MARKETS VENTURE CAPITAL (âNMVCâ) PROGRAM Introduction to Part 108 § 108.30 Amendments to Act and regulations. A...

  13. 13 CFR 107.30 - Amendments to Act and regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Amendments to Act and regulations. 107.30 Section 107.30 Business Credit and Assistance SMALL BUSINESS ADMINISTRATION SMALL BUSINESS INVESTMENT COMPANIES Introduction to Part 107 § 107.30 Amendments to Act and regulations. A Licensee shall...

  14. 75 FR 20298 - Privacy Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-19

    ...,'' pursuant to the Privacy Act, as amended (74 FR 60302, Nov. 20, 2009). The Board received no comments on... amendment procedures for this record system. Ivan J. Flores, Paralegal Specialist, Recovery...

  15. An analysis of the FDA Food Safety Modernization Act: protection for consumers and boon for business.

    PubMed

    Strauss, Debra M

    2011-01-01

    This article analyzes components of the FDA Food Safety Modernization Act, which was prompted by incidents of food contamination, exploring the history of its passage and explaining its significance, as well as its limitations. As the first time in 70 years that food law has been changed substantially, this new law represents only an initial but significant step in the direction of improving food safety. With bipartisan support from both Congress and the President, this legislation embodies a mandate that food safety is at this moment becoming a priority. As a result, the time is ripe for a reassessment of other areas of food laws--particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny--which are allowed under current U.S. law with no labeling, preapprovals, or post-market monitoring. These areas warrant special regulation consistent with the new proactive policy towards securing the safety of the food supply. PMID:24505853

  16. 76 FR 62605 - Virginia Graeme Baker Pool and Spa Safety Act; Interpretation of Unblockable Drain

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ...The Consumer Product Safety Commission (``Commission,'' ``CPSC'' or ``we'') is revoking its interpretation of the term ``unblockable drain'' as used in the Virginia Graeme Baker Pool and Spa Safety Act (``VGB Act'').\\1\\...

  17. 77 FR 75521 - Community Reinvestment Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-21

    ... 1, 2005. 70 FR 44256 (Aug. 2, 2005). As explained in the SUPPLEMENTARY INFORMATION section of these... Home Mortgage Disclosure Act (HMDA). 70 FR 12148 (Mar. 11, 2005). See 12 U.S.C. 2808; 12 CFR 203.2(e)(1... the other federal banking agencies in its CRA rule set forth at 12 CFR part 563e. 72 FR 13429 (Mar....

  18. 75 FR 78932 - Federal Seed Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-17

    ...--Zea mays L. subsp. mays'', ``Crambe--Crambe abyssinica R.E. Fr.'', ``Crotalaria, slenderleaf... Federalism implications. Background The FSA, Title II (7 U.S.C. 1571-1575) regulates agricultural...

  19. 78 FR 32595 - Revision of Freedom of Information Act Regulation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-31

    ...This proposed rule would amend HUD's regulations implementing the Freedom of Information Act (FOIA). HUD is proposing these amendments to update and streamline HUD's current FOIA regulation. This proposed rule would update HUD's regulations to reflect statutory changes to FOIA, current HUD organizational structure, and current HUD policies and practices with respect to FOIA. Finally, the rule......

  20. 78 FR 79283 - Community Reinvestment Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ... CRA purposes by the OCC, Board, and FDIC on August 2, 2005, effective September 1, 2005. 70 FR 44256... Act (HMDA). 70 FR 12148 (Mar. 11, 2005). See 12 U.S.C. 2808; 12 CFR 203.2(e)(1). On March 22, 2007... other federal banking agencies in its CRA rule previously set forth at 12 CFR 563e. 72 FR 13429 (Mar....

  1. 76 FR 79529 - Community Reinvestment Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-22

    ... adopted for CRA purposes by the OCC, Board, and FDIC on August 2, 2005, effective September 1, 2005. 70 FR... Disclosure Act (HMDA). 70 FR 12148 (Mar. 22, 2007). See 12 U.S.C. 2808; 12 CFR 203.2(e)(1). On March 22, 2007... federal banking agencies in its CRA rule set forth at 12 CFR 563e. 72 FR 13429. Pursuant to the...

  2. 75 FR 56533 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-16

    ... COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications... presenting their proposed recommendations on issues such as public safety consolidation, E911 reliability and... Chief for Cybersecurity and Communications Reliability Public Safety and Homeland Security...

  3. 76 FR 23810 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Emergency Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-28

    ... COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Emergency Response Interoperability Center Public Safety Advisory Committee Meeting AGENCY: Federal Communications Commission. ACTION... advises interested persons that the FCC Emergency Response Interoperability Center Public Safety...

  4. 76 FR 10898 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Emergency Response...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-28

    ... COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Emergency Response Interoperability Center Public Safety Advisory Committee Meeting AGENCY: Federal Communications Commission. ACTION... advises interested persons that the FCC Emergency Response Interoperability Center Public Safety...

  5. 78 FR 46555 - Privacy Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-01

    ... File ] System--Interior, FWS-20 (48 FR 54719, December 6, 1983); Bureau of Land Management Criminal... proposing to amend its regulations to exempt certain records in the Incident Management, Analysis and... Management, Analysis and Reporting System (IMARS) system of records. IMARS is an incident management...

  6. 75 FR 36270 - Appraisal Subcommittee; Appraiser Regulation; Privacy Act Implementation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ... From the Federal Register Online via the Government Publishing Office FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL 12 CFR Part 1102 Appraisal Subcommittee; Appraiser Regulation; Privacy Act Implementation AGENCY: Appraisal Subcommittee of the Federal Financial Institutions Examination...

  7. 77 FR 56592 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-13

    ... Office of the Secretary 43 CFR Part 2 RIN 1093-AA15 Freedom of Information Act Regulations AGENCY: Office... Department follows in processing records under the Freedom of Information Act (``FOIA''). The revisions clarify and update procedures for requesting information from the Department and procedures that...

  8. ARIES-ACT1 Safety Design and Analysis

    SciTech Connect

    Humrickhouse, Paul W.; Merrill, Brad J.

    2014-01-01

    ARIES-ACT1 (Advanced and Conservative Tokamak) is a 1000-MW(electric) tokamak design featuring advanced plasma physics and divertor and blanket engineering. Some relevant features include an advanced SiC blanket with PbLi as coolant and breeder; a helium-cooled steel structural ring and tungsten divertors; a thin-walled, helium-cooled vacuum vessel; and a room-temperature, water-cooled shield outside the vacuum vessel. We consider here some safety aspects of the ARIES-ACT1 design and model a series of design-basis and beyond-design-basis accidents with the MELCOR code modified for fusion. The presence of multiple coolants (PbLi, helium, and water) makes possible a variety of such accidents. We consider here a loss-of-flow accident caused by a long-term station blackout (LTSBO), an ex-vessel helium break into the cryostat, and a beyond-design-basis accident in which a LTSBO is aggravated by a loss-of-coolant accident in ARIES-ACT1's ultimate decay heat removal system, the water-cooled shield. In the design-basis accidents, we find that the secondary confinement boundaries are not challenged, and the structural integrity of in-vessel components is not threatened by high temperatures or pressures; decay heat can be passively removed.

  9. 78 FR 6216 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... corrections to the final rule published on December 31, 2012 (77 FR 76898). The regulation revises the... publication on December 31, 2012, of the final rule that was the subject of FR Doc. 2012-31117, is corrected... Office of the Secretary 43 CFR Part 2 RIN 1093-AA15 Freedom of Information Act Regulations AGENCY:...

  10. 77 FR 75362 - Government in the Sunshine Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-20

    ... From the Federal Register Online via the Government Publishing Office EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1612 Government in the Sunshine Act Regulations CFR Correction 0 In Title 29 of the Code of Federal Regulations, Parts 900 to 1899, revised as of July 1, 2012, on page 266, in Sec....

  11. 7 CFR 4290.30 - Amendments to Act and regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 4290.30 Agriculture Regulations of the Department of Agriculture (Continued) RURAL BUSINESS-COOPERATIVE SERVICE AND RURAL UTILITIES SERVICE, DEPARTMENT OF AGRICULTURE RURAL BUSINESS INVESTMENT COMPANY (âRBICâ) PROGRAM Introduction to Part 4290 § 4290.30 Amendments to Act and regulations. A RBIC is subject to...

  12. 76 FR 15236 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-21

    ... Information Fee Schedule and Guidelines published by the Office of Management and Budget at 52 FR 10012 (Mar... Information Act (FOIA). The regulations are being revised to update and streamline the language of several... revisions to the Department's regulations under the FOIA to update and streamline the language of...

  13. The Federal Mine Safety and Health Act of 1977: Preserving a law that works

    SciTech Connect

    McAteer, J.D.

    1996-10-01

    The wisdom of the past has been that dead miners make the best lobbyists for mine safety laws. Today, this view suggests a troubling question: What happens to mine safety laws when the terrible disasters that produced legislation are rare? We should be grateful that the question is timely. It means that decades of progressively stronger laws have finally made a difference for miners, their families, and their communities. But this hard-won success has had one ironic result: Some people are tempted to believe that a strong statute is no longer necessary. In fact, the Federal Mine Safety and Health Act of 1977 (Mine Act) should be preserved. Mining remains a high-risk industry, and tomarrow`s miners, just like today`s, need the protection of this well-crafted and effective law. Recent legislation (H.R. 1834) seemed to view the Mine Act as a relic of the past. It would have repealed the statute, a prospect that should trouble anyone familiar with the statute`s success. As introduced, the bill would have regulated mining under a scaled-back version of the Occupational Safety and Health Act (OSH Act), and eliminated the Mine Safety and Health Administration (MSHA) as well. A host of important enforcement tools would have vanished in the process, including MSHA`s right of entry into mines, certain mandatory inspections, most civil fines, and the use of withdrawal orders except in cases of imminent danger. The bill would have made it far more difficult to issue effective safety and health standards and to preserve existing standards. Miners and their unions, as well as some industry representatives, rightly raised concerns about the bill. Now is a good time, then, to review what federal mine safety laws have achieved and how they did it. Working conditions in America`s mines are, indeed, better. They are better because of the current law and the legislation that preceded it, as representatives of the mining industry acknowledge.

  14. 20 CFR 726.203 - Federal Coal Mine Health and Safety Act endorsement.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Federal Coal Mine Health and Safety Act... LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL MINE OPERATOR'S INSURANCE Insurance Contracts § 726.203 Federal Coal Mine Health and Safety...

  15. 48 CFR 52.250-2 - SAFETY Act Coverage Not Applicable.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... entitled to a pre-determination that the products or services are qualified anti-terrorism technologies as that term is defined by the Support Anti-terrorism by Fostering Effective Technologies Act of 2002... contingent upon SAFETY Act designation as a qualified anti-terrorism technology or SAFETY Act...

  16. Combination pressure regulator and safety valve: A Concept

    NASA Technical Reports Server (NTRS)

    Acres, R. L.

    1972-01-01

    Device for regulating high pressure liquefied gas to high pressure vapor generator using liquid oxygen is described. System includes pressure regulation and safety valve features. Construction of the equipment and method of operation are presented.

  17. New safety rules challenge U. K. operators, regulators

    SciTech Connect

    Hudson, J. )

    1994-08-15

    Offshore safety regulations based on lessons learned from the Piper Alpha blast of 1988 have been in operation in the U.K. for a year. The Offshore Installations (Safety Case) Regulations 1992 make operators of fixed and mobile installations (the duty holders'') responsible for producing a formal safety assessment, or safety case, for each installation. After the end of November 1995 it will be an offense to operate an installation without a safety case which has been approved by the government's Health and Safety Executive (HSE). Producing safety cases for installations is a major task for duty holder, while assessing them is a huge under taking for HSE's Offshore Safety Division (OSD). This paper reviews how HSE has established management arrangements to handle safety cases, considers progress in assessment, highlights some of the important lessons learned, and look to the future.

  18. 77 FR 5472 - Pipeline Safety: Miscellaneous Changes to Pipeline Safety Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-03

    ... amendments to the pipeline safety regulations (76 FR 73570). On January 12, 2012, the Interstate Natural Gas... Committee on Pipe and Tube Imports Ad Hoc Large Diameter Line Pipe Producers Group Transportation... to the regulations covering pipeline safety regulations. The Committee on Pipe and Tube Imports...

  19. 75 FR 9899 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-04

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications... Division, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445 12th...

  20. 76 FR 54234 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-31

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications... Goldthorp, Associate Bureau Chief, Public Safety and Homeland Security Bureau, Federal...

  1. 77 FR 12054 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-28

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications... Safety and Homeland Security Bureau, Federal Communications Commission, 445 12th Street SW., Room 7-...

  2. 75 FR 75692 - Manufactured Home Construction and Safety Standards Act Reporting Requirements; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... URBAN DEVELOPMENT Manufactured Home Construction and Safety Standards Act Reporting Requirements; Notice.... This Notice also lists the following information: Title of Proposal: Manufactured Home Construction and Safety Standards Reporting Requirements. OMB Control Number, if applicable: 2502-0253. Description of...

  3. 47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches § 80.305 Watch requirements of the Communications Act and the...

  4. 47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 47 Telecommunication 5 2011-10-01 2011-10-01 false Watch requirements of the Communications Act and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches...

  5. 47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Watch requirements of the Communications Act and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches...

  6. 47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 47 Telecommunication 5 2014-10-01 2014-10-01 false Watch requirements of the Communications Act and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches...

  7. 47 CFR 80.305 - Watch requirements of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 47 Telecommunication 5 2012-10-01 2012-10-01 false Watch requirements of the Communications Act and the Safety Convention. 80.305 Section 80.305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Ship Station Safety Watches...

  8. 78 FR 11092 - Safety and Health Regulations for Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... From the Federal Register Online via the Government Publishing Office LABOR DEPARTMENT Occupational Safety and Health Administration 29 CFR Part 1926 Safety and Health Regulations for Construction CFR Correction In Title 29 of the Code of Federal Regulations, Part 1926, revised as of July 1,...

  9. The Food Safety Modernization Act: Implications for U.S. Small Scale Farms.

    PubMed

    Boys, Kathryn A; Ollinger, Michael; Geyer, Leon L

    2015-01-01

    The Food Safety Modernization Act (FSMA) reforms law governing the safety of human and animal foods produced for consumption in the United States. Recognizing the challenges that the proposed regulations would impose on small farms, Congress included an amendment to exempt small farms from the full scope of FSMA requirements. This special treatment and other issues left unaddressed by FSMA, however, present challenges for buyers of small farm products and is inducing a private sector response to these regulatory gaps. This Article reviews the current treatment of small farms under FSMA and explores some key impacts and implications of FSMA on these organizations. Particular consideration is given to the unintended consequences of the Tester-Hagan Amendment and the unaddressed issue of liability for foodborne illness. PMID:26591825

  10. 76 FR 59071 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-23

    ... follows: Authority: 50 U.S.C. 401-442; 50 U.S.C. 403a-403v; 5 U.S.C. 552; Executive Order 13392, 70 FR... From the Federal Register Online via the Government Publishing Office CENTRAL INTELLIGENCE AGENCY 32 CFR Part 1900 Freedom of Information Act Regulations AGENCY: Central Intelligence Agency....

  11. 78 FR 50351 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ... compliance with, among others, the Comprehensive Plan, principals of good planning and urban design, and...; ] NATIONAL CAPITAL PLANNING COMMISSION 1 CFR Part 456 Freedom of Information Act Regulations AGENCY: National Capital Planning Commission. ACTION: Notice of Proposed Rulemaking. SUMMARY: The National Capital...

  12. 76 FR 45403 - Bank Secrecy Act Regulations-Definitions and Other Regulations Relating to Prepaid Access

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... regulations. See 75 FR 65806 (October 26, 2010) (Transfer and Reorganization of Bank Secrecy Act Regulations... Relating to Money Services Businesses, 74 FR 22129 (May 12, 2009), was issued before the Chapter X Final...), (c). \\16\\ 75 FR 36589. B. Prior Regulation of Stored Value In 1999, when FinCEN issued its final...

  13. NASA's Principal Center for Review of Clean Air Act Regulations

    NASA Technical Reports Server (NTRS)

    Clark-Ingram, Marceia

    2003-01-01

    Marshall Space Flight Center (MSFC) was selected as the Principal Center for review of Clean Air Act (CAA) regulations. The CAA Principal Center is tasked to: 1) Provide centralized support to NASA/HDQ Code JE for the management and leadership of NASA's CAA regulation review process; 2) Identify potential impact from proposed CAA regulations to NASA program hardware and supporting facilities. The Shuttle Environmental Assurance Initiative, one of the responsibilities of the NASA CAA Working Group (WG), is described in part of this viewgraph presentation.

  14. 76 FR 40367 - Federal Acquisition Regulation; Information Collection; Buy American Act-Construction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-08

    ... Regulation; Information Collection; Buy American Act--Construction AGENCY: Department of Defense (DOD... previously approved information collection requirement concerning the Buy American Act--Construction..., American Act--Construction (Grimberg Decision), by any of the following methods: ] Regulations.gov :...

  15. 20 CFR 726.203 - Federal Coal Mine Health and Safety Act endorsement.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Federal Coal Mine Health and Safety Act... OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG BENEFITS; REQUIREMENTS FOR COAL MINE OPERATOR'S INSURANCE Insurance Contracts § 726.203 Federal Coal Mine Health...

  16. 20 CFR 726.203 - Federal Coal Mine Health and Safety Act endorsement.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 20 Employees' Benefits 4 2014-04-01 2014-04-01 false Federal Coal Mine Health and Safety Act endorsement. 726.203 Section 726.203 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG...

  17. 20 CFR 726.203 - Federal Coal Mine Health and Safety Act endorsement.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 4 2012-04-01 2012-04-01 false Federal Coal Mine Health and Safety Act endorsement. 726.203 Section 726.203 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG...

  18. 20 CFR 726.203 - Federal Coal Mine Health and Safety Act endorsement.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 20 Employees' Benefits 4 2013-04-01 2013-04-01 false Federal Coal Mine Health and Safety Act endorsement. 726.203 Section 726.203 Employees' Benefits OFFICE OF WORKERS' COMPENSATION PROGRAMS, DEPARTMENT OF LABOR FEDERAL COAL MINE HEALTH AND SAFETY ACT OF 1969, AS AMENDED BLACK LUNG...

  19. Medical loss ratio regulation under the Affordable Care Act.

    PubMed

    Harrington, Scott E

    2013-01-01

    The minimum medical loss ratio (MLR) regulations in the Affordable Care Act guarantee that a specific percentage of health insurance premiums is spent on medical care and specified activities to improve health care quality. This paper analyzes the regulations' potential unintended consequences and incentive effects, including: higher medical costs and premiums for some insurers; less innovation to align consumer, provider, and health plan incentives, less consumer choice and increased market concentration; and the risk that insurers will pay rebates if claim costs are lower than projected when premiums are established, despite the regulations' permitted "credibility adjustments." The paper discusses modifications and alternatives to the MLR regulations to help achieve their stated goals with less potential for adverse effects. PMID:23720876

  20. 75 FR 76465 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-08

    ... COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications... complete its work. As a significant amount of the Council's work focuses on public safety issues, it is... solutions and best practices for public safety communications and cybersecurity. Recognizing the...

  1. 48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002 50.205-3 Authorization of offers contingent upon SAFETY Act designation or certification before... contingent upon SAFETY Act designation or certification before contract award. 50.205-3 Section...

  2. 48 CFR 50.205-4 - Authorization of awards made presuming SAFETY Act designation or certification after contract award.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... CONTRACTUAL ACTIONS AND THE SAFETY ACT Support Anti-terrorism by Fostering Effective Technologies Act of 2002 50.205-4 Authorization of awards made presuming SAFETY Act designation or certification after... made presuming SAFETY Act designation or certification after contract award. 50.205-4 Section...

  3. Balancing act creating the right regulation for coal combustion waste

    SciTech Connect

    Manuel, J.

    2009-11-15

    The December 2008 collapse of a coal ash pond in Tennessee threw safe management of coal combustion waste (CCW) into the spotlight. Millions of tons of CCW are produced in the United States each year, and a large percentage of that is recycled. The US Environmental Protection Agency is pursuing a host of initiatives that could directly or indirectly affect the disposition of CCW. States, too, are taking a look at how they regulate CCW. Among the options is the possibility of regulating CCW under the Resource Conservation and Recovery Act, a move that could have far-reaching implications for both the recycling and the disposal of this waste.

  4. International Safety Regulation and Standards for Space Travel and Commerce

    NASA Astrophysics Data System (ADS)

    Pelton, J. N.; Jakhu, R.

    The evolution of air travel has led to the adoption of the 1944 Chicago Convention that created the International Civil Aviation Organization (ICAO), headquartered in Montreal, Canada, and the propagation of aviation safety standards. Today, ICAO standardizes and harmonizes commercial air safety worldwide. Space travel and space safety are still at an early stage of development, and the adoption of international space safety standards and regulation still remains largely at the national level. This paper explores the international treaties and conventions that govern space travel, applications and exploration today and analyzes current efforts to create space safety standards and regulations at the national, regional and global level. Recent efforts to create a commercial space travel industry and to license commercial space ports are foreseen as means to hasten a space safety regulatory process.

  5. 77 FR 74347 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-14

    ... Information Act (FOIA) (U.S.C. 552) in the Federal Register. See 77 FR 42673, July 20, 2012. CIGIE provided..., Regulatory Planning and Review, 58 FR 51735. This regulation has not been reviewed by the Office of.... Authority: Pub. L. 110-409, 122 Stat. 4302; 5 U.S.C. App; E.O. 12600, 52 FR 23781, 3 CFR, 1987 Comp., p....

  6. Youth Camp Safety & Health. Suggested State Statute & Regulations.

    ERIC Educational Resources Information Center

    Center for Disease Control (DHEW/PHS), Atlanta, GA.

    To assist state regulatory agencies in development of comprehensive youth camp safety programs, this publication contains a brief suggested statute that could be used for initiation or modification of any state's youth camp safety programs and it outlines minimal regulations. Various categories of camps are covered--day, primitive, residential,…

  7. 76 FR 43585 - Bank Secrecy Act Regulations; Definitions and Other Regulations Relating to Money Services...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ...The Financial Crimes Enforcement Network (``FinCEN''), a bureau of the Department of the Treasury (``Treasury''), is revising the regulations implementing the Bank Secrecy Act (``BSA'') regarding money services businesses (``MSBs'') to clarify which entities are covered by the definitions. The changes more clearly delineate the scope of entities regulated as MSBs, so that determining which......

  8. The safety and regulation of natural products used as foods and food ingredients.

    PubMed

    Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

    2011-10-01

    The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements. PMID:21821733

  9. A comparison of some Mexican/U.S. safety regulations

    SciTech Connect

    Bunner, W.R.

    1994-12-31

    In the US, safety and hygiene began to be enforced broadly with the formation of the US Department of Labor`s, Occupational Safety and Health Administration (OSHA) in 1970. In Mexico, the 1917 Constitution required companies to protect their workers against safety and hygiene hazards in the workplace. Additional requirements were added with the Federal Labor Law of 1931. General safety and hygiene regulations were added in 1934. Modern-day federal labor law in Mexico requires the creation of mixed safety and hygiene commissions in all industries. However, only about 114,000 workplaces have registered mixed commissions. In a similar vein, the most favored OSHA reform bill in the US proposes to require safety and health committees in all work places. At this time such committees are common in larger companies but not in smaller ones.

  10. 77 FR 70777 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-27

    ... From the Federal Register Online via the Government Publishing Office FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal Communications Commission....

  11. 75 FR 74050 - Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-30

    ... COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal Communications Commission. ACTION... advises interested persons that the Federal Communications Commission's (FCC) Communications...

  12. Aerospace Safety Advisory Panel report to the NASA acting administrator

    NASA Technical Reports Server (NTRS)

    1986-01-01

    The level of activity of the Aerospace Safety Advisory Panel was increased smewhat during 1985 in concert with the increased mission rate of the National Space Transportation System, the evolutionary changes in management and operation of that program, and the preparation of the Vandenberg Launch Site; the implementation of the Program Definition Phase of the Space Station Program; and the actual flight testing of the X-29 research aircraft. Impending payload STS missions and NASA's overall aircraft operations are reviewed. The safety aspects of the LEASAT salvage mission were assessed. The findings and recommendation of the committee are summerized.

  13. 48 CFR 52.250-3 - SAFETY Act Block Designation/Certification.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9, that a QATT for which a SAFETY Act... determination by DHS pursuant to 6 U.S.C. 441(b) and 6 U.S.C. 443(a), as further delineated in 6 CFR 25.4, that... review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY Act designation...

  14. 48 CFR 52.250-3 - SAFETY Act Block Designation/Certification.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9, that a QATT for which a SAFETY Act... determination by DHS pursuant to 6 U.S.C. 441(b) and 6 U.S.C. 443(a), as further delineated in 6 CFR 25.4, that... review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY Act designation...

  15. 48 CFR 52.250-3 - SAFETY Act Block Designation/Certification.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9, that a QATT for which a SAFETY Act... determination by DHS pursuant to 6 U.S.C. 441(b) and 6 U.S.C. 443(a), as further delineated in 6 CFR 25.4, that... review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY Act designation...

  16. 48 CFR 52.250-3 - SAFETY Act Block Designation/Certification.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9, that a QATT for which a SAFETY Act... determination by DHS pursuant to 6 U.S.C. 441(b) and 6 U.S.C. 443(a), as further delineated in 6 CFR 25.4, that... review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY Act designation...

  17. 48 CFR 52.250-3 - SAFETY Act Block Designation/Certification.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9, that a QATT for which a SAFETY Act... determination by DHS pursuant to 6 U.S.C. 441(b) and 6 U.S.C. 443(a), as further delineated in 6 CFR 25.4, that... review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY Act designation...

  18. Juggling Act: Balancing Safety, Security, and Yield in School Investments.

    ERIC Educational Resources Information Center

    Sallack, David J.

    2001-01-01

    Although state laws governing school district investing are quite conservative, there have been some notable investment failures leading to the loss of public funds. School districts must beware three kinds of investment risks involving credit, market, and interest rates and consider safety, legality, liquidity, and cash-flow requirements. (MLH)

  19. 77 FR 61513 - Information Disclosure Under Section 6(b) of the Consumer Product Safety Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1101 Information Disclosure Under Section 6(b) of the Consumer Product Safety Act CFR..., on page 147, in Sec. 1101.25 (a) and (b), the words ``5 working'' are corrected to read...

  20. 76 FR 42683 - Establishment of a Team Under the National Construction Safety Team Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ...The Director of the National Institute of Standards and Technology (NIST), United States Department of Commerce, announces the establishment of a National Construction Safety Team pursuant to the National Construction Safety Team Act. The Team was established to study the effects of the tornado that touched down in Joplin, MO, on May 22,...

  1. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Findings Under the Consumer Product Safety Act Appendix to Part 1213 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER...

  2. 77 FR 55271 - Truth in Lending Act (Regulation Z); Loan Originator Compensation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-07

    ...The Bureau of Consumer Financial Protection is publishing for public comment a proposed rule amending Regulation Z (Truth in Lending) to implement amendments to the Truth in Lending Act (TILA) made by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). The proposal would implement statutory changes made by the Dodd- Frank Act to Regulation Z's current loan......

  3. The Clery Act, Campus Safety and the Views of Assault Victim Advocates

    ERIC Educational Resources Information Center

    Janosik, Steven M.; Plummer, Ellen

    2005-01-01

    One hundred forty-seven directors of women's centers and advocates for assault victims responded to a questionnaire about the effectiveness of the Clery Act and their views of campus safety. The purpose of this study was to assess victim advocates' knowledge of the Act and their views of campus crime prevention strategies. The following questions…

  4. 7 CFR 800.7 - Information about the Service, Act, and regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 7 2011-01-01 2011-01-01 false Information about the Service, Act, and regulations... AGRICULTURE GENERAL REGULATIONS Administration § 800.7 Information about the Service, Act, and regulations. Information about the Grain Inspection, Packers and Stockyards Administration, Service, Act,...

  5. Regulations Under the Americans With Disabilities Act; Genetic Information Nondiscrimination Act. Final rule.

    PubMed

    2016-05-17

    The Equal Employment Opportunity Commission (EEOC or Commission) is issuing its final rule to amend the regulations and interpretive guidance implementing Title I of the Americans with Disabilities Act (ADA) to provide guidance on the extent to which employers may use incentives to encourage employees to participate in wellness programs that ask them to respond to disability-related inquiries and/or undergo medical examinations. This rule applies to all wellness programs that include disability-related inquiries and/or medical examinations whether they are offered only to employees enrolled in an employer-sponsored group health plan, offered to all employees regardless of whether they are enrolled in such a plan, or offered as a benefit of employment by employers that do not sponsor a group health plan or group health insurance. Published elsewhere in this issue of the Federal Register, the EEOC also issued a final rule to amend the regulations implementing Title II of the Genetic Information Nondiscrimination Act (GINA) that addresses the extent to which employers may offer incentives for an employee's spouse to participate in a wellness program. PMID:27192736

  6. Adaptive Equilibrium Regulation: A Balancing Act in Two Timescales

    PubMed Central

    Boker, Steven M.

    2015-01-01

    An equilibrium involves a balancing of forces. Just as one maintains upright posture in standing or walking, many self-regulatory and interpersonal behaviors can be framed as a balancing act between an ever changing environment and within-person processes. The emerging balance between person and environment, the equilibria, are dynamic and adaptive in response to development and learning. A distinction is made between equilibrium achieved solely due to a short timescale balancing of forces and a longer timescale preferred equilibrium which we define as a state towards which the system slowly adapts. Together, these are developed into a framework that this article calls Adaptive Equilibrium Regulation (ÆR), which separates a regulatory process into two timescales: a faster regulation that automatically balances forces and a slower timescale adaptation process that reconfigures the fast regulation so as to move the system towards its preferred equilibrium when an environmental force persists over the longer timescale. This way of thinking leads to novel models for the interplay between multiple timescales of behavior, learning, and development. PMID:27066197

  7. Polypurine/polypyrimidine sequences as cis-acting transcriptional regulators.

    PubMed

    Brahmachari, S K; Sarkar, P S; Raghavan, S; Narayan, M; Maiti, A K

    1997-04-29

    Genome sequence information has generated increasing evidence for the claim that repetitive DNA sequences present within and around genes could play a important role in the regulation of gene expression. Polypurine/polypyrimidine sequences [poly(Pu/Py)] have been observed in the vicinity of promoters and within the transcribed regions of many genes. To understand whether such sequences influence the level of gene expression, we constructed several prokaryotic and eukaryotic expression vectors incorporating poly(Pu/Py) repeats both within and upstream of a reporter gene, lacZ (encoding beta-galactosidase), and studied its expression in vivo. We find that, in contrast to the situation in Escherichia coli, the presence of poly(Pu/Py) sequences within the gene does not significantly inhibit gene expression in mammalian cells. On the other hand, the presence of such sequences upstream of lacZ leads to a several-fold reduction of gene expression in mammalian cells. Similar down-regulation was observed when a structural cassette containing poly(Pu/Py) sequences upstream of lacZ was integrated into yeast chromosome V. Sequence analysis of the nine totally sequenced yeast chromosomes shows that a large number of such sequences occur upstream of ORFs. On the basis of our experimental results and DNA sequence analysis, we propose that these sequences can function as cis-acting transcriptional regulators. PMID:9185844

  8. 77 FR 43081 - Federal Acquisition Regulation; Information Collection; Buy American Act-Free Trade Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-23

    ... Regulation; Information Collection; Buy American Act--Free Trade Agreements--Israeli Trade Act Certificate... previously approved information collection requirement concerning the Buy American Act--Free Trade Agreements..., Buy American Act--Free Trade Agreements--Israeli Trade Act Certificate, by any of the...

  9. STENOFOLIA acts as a repressor in regulating leaf blade outgrowth

    PubMed Central

    Lin, Hao; Niu, Lifang; Tadege, Million

    2013-01-01

    We recently reported that the Medicago WOX gene, STENOFOLIA (STF), acts as a transcriptional repressor in regulating leaf blade outgrowth. By using the Nicotiana sylvestris bladeless lam1 mutant as a genetic tool, we showed that the WUS-box, which is conserved among WUS clade WOX genes, is partly responsible for the repressive activity of STF. All members of the modern/WUS clade genes (WUS, WOX1-WOX7) in Arabidopsis that contain intact WUS-box can substitute for STF/LAM1 function while the intermediate and ancient clade members including WOX9,WOX11 and WOX13 cannot, due to lack of the intact WUS-box. Taken together, our results reveal a conserved repression mechanism playing a central role in cell proliferation conferred to the evolutionarily dynamic WOX gene family with acquisition of a repressor domain. PMID:23603965

  10. The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

    PubMed

    Lemaire, François; Marchenay, Brigitte; Chassany, Olivier; Barthélémy, Philippe; Bouzzagou, Mohamed; Comet, Denis; Delval, Cécile; Dubray, Claude; Fouret, Cécile; Frija-Orvoen, Elisabeth; Gambotti, Laetitia; Lamarque, Véronique; d'Orsay, Geneviève; Plattner, Valérie; Sibenaler, Claire; Roux, Jacques; Thoby, Frédérique

    2015-01-01

    In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency. PMID:25679191

  11. Food Safety and Regulation: Evaluation of an Online Multimedia Course

    ERIC Educational Resources Information Center

    Pintauro, Stephen J.; Krahl, Augusta G.; Buzzell, Paul R.; Chamberlain, Valerie M.

    2005-01-01

    The effectiveness of, and student attitudes toward, an online Food Safety and Regulation course (WEB) were compared with lecture (LECTURE) and combined lecture/online (COMBINED) courses. All students took identical pre-tests, post-tests, and attitude assessments. No significant differences were detected in pre-test scores. Post-test results for…

  12. 49 CFR 176.4 - Port security and safety regulations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the applicable provisions of 33 CFR parts 6, 109, 110, 125, 126, and 160. (b) Division 1.1 and 1.2... hazard as defined in 33 CFR 126.05(b); (2) An explosives anchorage listed in 33 CFR part 110; or (3) A... 49 Transportation 2 2010-10-01 2010-10-01 false Port security and safety regulations....

  13. Rig safety depends on equipment, regulations, and personnel

    SciTech Connect

    Bates, T.R. Jr.; Tait, S. ); Mumford, G. )

    1990-03-05

    The authors discuss how improvements that can increase rig safety can be made in equipment, regulations, and stabilized personnel levels. With regard to equipment, exposure to material handling must be reduced through automation, and well-control technology must be improved by enhanced use of computers and better systems to handle gas. According to this analysis, regulations are needed that are global in scope and have had their costs-to-benefits fully and fairly assessed. Self regulation must be used effectively throughout the industry. Job security and wages should be made adequate to maintain an experienced, motivated, and safe work force.

  14. 49 CFR 179.103-4 - Safety relief devices and pressure regulators.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Safety relief devices and pressure regulators. 179...) § 179.103-4 Safety relief devices and pressure regulators. (a) Safety relief devices and pressure... design must be provided to protect safety relief devices and pressure regulators from damage....

  15. Efficacy and Safety of Long-Acting Reversible Contraception

    PubMed Central

    Stoddard, Amy; McNicholas, Colleen; Peipert, Jeffrey F.

    2013-01-01

    Long-acting reversible contraception (LARC) includes intrauterine devices (IUDs) and the subdermal implant. These methods are the most effective reversible methods of contraception, and have the additional advantages of being long-lasting, convenient, well liked by users and cost effective. Compared with other user-dependent methods that increase the risk of noncompliance-related method failure, LARC methods can bring ‘typical use’ failure rates more in line with ‘perfect use’ failure rates. LARC methods are ‘forgettable’; they are not dependent on compliance with a pill-taking regimen, remembering to change a patch or ring, or coming back to the clinician for an injection. LARC method failure rates rival that of tubal sterilization at <1% for IUDs and the subdermal implant. For these reasons, we believe that IUDs and implants should be offered as first-line contraception for most women. This article provides a review of the LARC methods that are currently available in the US, including their effectiveness, advantages, disadvantages and contraindications. Additionally, we dispel myths and misconceptions regarding IUDs, and address the barriers to LARC use. PMID:21668037

  16. Administrative and private searches for smoking articles conducted pursuant to the federal mine safety and health act: Constitutional considerations

    SciTech Connect

    Hardy, D.J.; McCambley, M.E.

    1995-11-01

    Searches conducted to detect the presence of smoking articles are required to fulfill the legitimate, administrative objectives that underlie the Federal Mine Safety and Health Act of 1977. Consequently, such searches may be conducted by government mine safety enforcement officials without benefit of either a warrant based upon probable cause or an administrative warrant. The authority to conduct warrantless administrative searches on mine property is limited by FMSHA, however, and MSHA must either comply with the administrative substitutes for a warrant set forth in that Act or obtain an administrative warrant before entering onto a mine-operator`s property for purposes of conducting a search for smoking articles. Once mine safety enforcement officials properly gain entry onto mine property, no further warrants are required to conduct searches of individual miners. Miners who choose to work in underground mines are put on notice, by the FMSHA, MSHA regulations, and the training they receive, that they will be subject to searches for smoking articles. Thus, miners have no reasonable expectation that they will be free from the type of pat-down and personal effects searches used to detect the presence of smoking articles. The Fourth amendment is simply not implicated by such searches. This is true even though the legislative scheme designed to enhance mine safety imposes criminal as well as civil penalties on miners found with smoking articles.

  17. 77 FR 57199 - 2012 Real Estate Settlement Procedures Act (Regulation X) Mortgage Servicing Proposal

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ...The Bureau of Consumer Financial Protection (the Bureau) is proposing to amend Regulation X, which implements the Real Estate Settlement Procedures Act of 1974 (RESPA) and the official interpretation of the regulation. The proposed amendments implement the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) provisions regarding mortgage loan servicing. Specifically, this......

  18. 45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and... contracts and in excess of $2500 for other contracts that involve the employment of mechanics or...

  19. 45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and... contracts and in excess of $2500 for other contracts that involve the employment of mechanics or...

  20. 45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and... contracts and in excess of $2500 for other contracts that involve the employment of mechanics or...

  1. 45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and... contracts and in excess of $2500 for other contracts that involve the employment of mechanics or...

  2. 45 CFR 2543.84 - Contract Work Hours and Safety Standards Act.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Standards Act (40 U.S.C. 327-333), as supplemented by Department of Labor regulations (29 CFR part 5). Under Section 102 of the Act, each contractor shall be required to compute the wages of every mechanic and... contracts and in excess of $2500 for other contracts that involve the employment of mechanics or...

  3. 78 FR 11279 - Loan Originator Compensation Requirements Under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ...The Bureau of Consumer Financial Protection (Bureau) is amending Regulation Z to implement amendments to the Truth in Lending Act (TILA) made by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). The final rule implements requirements and restrictions imposed by the Dodd-Frank Act concerning loan originator compensation; qualifications of, and registration or......

  4. 7 CFR 868.10 - Information about the Service, Act, and regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 7 2011-01-01 2011-01-01 false Information about the Service, Act, and regulations. 868.10 Section 868.10 Agriculture Regulations of the Department of Agriculture (Continued) GRAIN... § 868.10 Information about the Service, Act, and regulations. Information about the Service,...

  5. 76 FR 24027 - Federal Acquisition Regulation; Information Collection; Buy American Act Certificate

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... Regulation; Information Collection; Buy American Act Certificate AGENCY: Department of Defense (DOD), General... previously approved information collection requirement concerning the Buy American Act certificate. Public... Comment'' screen. Please include your name, company name (if any), and ``Information Collection...

  6. Safety and efficacy of an ultrashort-acting β1-blocker on left ventricular dysfunction.

    PubMed

    Ito, Nobuhisa; Tashiro, Tadashi; Morishige, Noritsugu; Nishimi, Masaru; Hayashida, Yoshio; Minematsu, Noritoshi; Kuwahara, Go; Sukehiro, Yuta; Teratani, Hiromitsu

    2012-08-01

    Landiolol hydrochloride, an ultrashort-acting β1-selective blocker, is a highly regulated drug. This study evaluated the safety and efficacy of this drug for cases of coronary artery bypass grafting (CABG) with left ventricular dysfunction. Between September 2006 and August 2009, 32 patients with a left ventricular ejection fraction of <40% underwent CABG. Two groups of patients, a group administered landiolol hydrochloride and a control group not administered this drug, were compared. The administration of landiolol hydrochloride was initiated at 1 μg/kg per minute (γ) after cardiopulmonary bypass in on-pump cases and after completion of all the distal anastomoses in off-pump cases. We observed no significant differences between the groups with respect to preoperative patient background or incidences of complications, except for postoperative atrial fibrillation. The heart rate decreased significantly 30 minutes after landiolol hydrochloride administration, but no change was observed in arterial pressure. No change was observed in other parameters; the hemodynamics were stable. The occurrence of atrial fibrillation during the intensive care unit stay (during landiolol hydrochloride administration) was significantly lower in the administration group. The difference remained significant after multiple logistic regression analysis; landiolol hydrochloride was the sole inhibitory factor. PMID:22917822

  7. Food safety regulations in Australia and New Zealand Food Standards.

    PubMed

    Ghosh, Dilip

    2014-08-01

    Citizens of Australia and New Zealand recognise that food security is a major global issue. Food security also affects Australia and New Zealand's status as premier food exporting nations and the health and wellbeing of the Australasian population. Australia is uniquely positioned to help build a resilient food value chain and support programs aimed at addressing existing and emerging food security challenges. The Australian food governance system is fragmented and less transparent, being largely in the hands of government and semi-governmental regulatory authorities. The high level of consumer trust in Australian food governance suggests that this may be habitual and taken for granted, arising from a lack of negative experiences of food safety. In New Zealand the Ministry of Primary Industries regulates food safety issues. To improve trade and food safety, New Zealand and Australia work together through Food Standards Australia New Zealand (FSANZ) and other co-operative agreements. Although the potential risks to the food supply are dynamic and constantly changing, the demand, requirement and supply for providing safe food remains firm. The Australasian food industry will need to continually develop its system that supports the food safety program with the help of scientific investigations that underpin the assurance of what is and is not safe. The incorporation of a comprehensive and validated food safety program is one of the total quality management systems that will ensure that all areas of potential problems are being addressed by industry. PMID:24638225

  8. 76 FR 30374 - Cruise Vessel Safety and Security Act of 2010, Available Technology

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ... published on April 11, 2000 (65 FR 19477), or you may visit http://dms.dot.gov . Basis and Purpose On July... SECURITY Coast Guard Cruise Vessel Safety and Security Act of 2010, Available Technology AGENCY: Coast... public comment on the availability of technology to meet certain provisions of the Cruise Vessel...

  9. 78 FR 14309 - Implementation of the FDA Food Safety Modernization Act Provision Requiring FDA To Establish...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-05

    ...In September 2011, the Food and Drug Administration (FDA or the Agency) asked the Institute of Food Technologists (IFT) to execute product tracing pilot projects as described in the FDA Food Safety Modernization Act (FSMA). FDA recently released a report from IFT on these pilot projects, entitled ``Pilot Projects for Improving Product Tracing along the Food Supply System.'' FDA is announcing......

  10. 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

    ... reportable food that is the subject of a summary posting and that are part of a chain of establishments with... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food Safety Modernization Act: Focus on Inspections and Compliance AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  11. The Clery Act, Campus Safety, and the Perceptions of Senior Student Affairs Officers

    ERIC Educational Resources Information Center

    Janosik, Steven M.; Gregory, Dennis E.

    2009-01-01

    Three hundred and twenty-seven senior student affairs officers (SSAOs) responded to a questionnaire about the effectiveness of the Clery Act and their views of campus safety. As a group, SSAO responses were very homogenous, resulting in few significant differences when institutional type (public v. private) and status (2-year v. 4-year) were…

  12. 78 FR 46966 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ... small businesses (76 FR 45818, August 1, 2011). The comment period for this request ended November 30... Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Thus, as the starting... FR 45639). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated...

  13. 76 FR 7107 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... Bridge.... Safety Zones (Part 165)...... 11/9/2009 USCG-2008-0700 Portland, OR Safety Zones (Part 165... SECURITY Coast Guard 33 CFR Parts 100, 117, 147, and 165 Quarterly Listings; Safety Zones, Security Zones... temporary safety zones, security zones, special local regulations, drawbridge operation regulations...

  14. 76 FR 78977 - Real Estate Settlement Procedures Act (Regulation X)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... this rule. See 76 FR 43569 (July 21, 2011). \\11\\ Section 1066 of the Dodd-Frank Act grants the...-Frank Act In developing the interim final rule, the Bureau has conducted an analysis of potential... the described analyses and consultations. Although not required by the interim final rule,...

  15. 47 CFR 80.159 - Operator requirements of Title III of the Communications Act and the Safety Convention.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Operator requirements of Title III of the Communications Act and the Safety Convention. 80.159 Section 80.159 Telecommunication FEDERAL COMMUNICATIONS... Communications Act and the Safety Convention. (a) Each telegraphy passenger ship equipped with a...

  16. 77 FR 63245 - Rules of Practice in Air Safety Proceedings; Rules Implementing the Equal Access to Justice Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-16

    ... Equal Access to Justice Act of 1980 AGENCY: National Transportation Safety Board (NTSB or Board). ACTION... procedure, Airmen, Aviation safety. 49 CFR Part 826 Claims, Equal access to justice, Lawyers. For the... to Justice Act of 1980 (EAJA). The NTSB previously issued an advance notice of proposed...

  17. Safety Sufficiency for NextGen: Assessment of Selected Existing Safety Methods, Tools, Processes, and Regulations

    NASA Technical Reports Server (NTRS)

    Xu, Xidong; Ulrey, Mike L.; Brown, John A.; Mast, James; Lapis, Mary B.

    2013-01-01

    NextGen is a complex socio-technical system and, in many ways, it is expected to be more complex than the current system. It is vital to assess the safety impact of the NextGen elements (technologies, systems, and procedures) in a rigorous and systematic way and to ensure that they do not compromise safety. In this study, the NextGen elements in the form of Operational Improvements (OIs), Enablers, Research Activities, Development Activities, and Policy Issues were identified. The overall hazard situation in NextGen was outlined; a high-level hazard analysis was conducted with respect to multiple elements in a representative NextGen OI known as OI-0349 (Automation Support for Separation Management); and the hazards resulting from the highly dynamic complexity involved in an OI-0349 scenario were illustrated. A selected but representative set of the existing safety methods, tools, processes, and regulations was then reviewed and analyzed regarding whether they are sufficient to assess safety in the elements of that OI and ensure that safety will not be compromised and whether they might incur intolerably high costs.

  18. 60 FR 8812 - Real Estate Settlement Procedures Act (Regulation X); Escrow Accounting Procedures

    Federal Register 2010, 2011, 2012, 2013, 2014

    1995-02-15

    ... 24 CFR Part 3500 Real Estate Settlement Procedures Act (Regulation X); Escrow Accounting Procedures...-Federal Housing Commissioner 24 CFR Part 3500 RIN 2502-AF77 Real Estate Settlement Procedures Act... of the Real Estate Settlement Procedures Act. Subsequent to the publication of that rule,...

  19. 76 FR 68690 - Rules and Regulations Under the Textile Fiber Products Identification Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-07

    ... Wool Products Labeling Act, and the Fur Products Labeling Act: Final Rule, 63 FR 7508 (Feb. 13, 1998). \\2\\ Federal Trade Commission: Miscellaneous Rules: Final Rule, 63 FR 71582 (Dec. 29, 1998). \\3... and Regulations Under the Wool Products Labeling Act of 1939, Final Rule, 65 FR 75154 (Dec. 1,...

  20. 22 CFR 91.1 - Answering inquiries regarding tariff acts and customs regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 22 Foreign Relations 1 2010-04-01 2010-04-01 false Answering inquiries regarding tariff acts and... IMPORT CONTROLS § 91.1 Answering inquiries regarding tariff acts and customs regulations. In replying to inquiries received from exporters, travelers, or other interested parties, concerning tariff acts or...

  1. 20 CFR 626.3 - Purpose, scope, and applicability of the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Purpose, scope, and applicability of the Job... ADMINISTRATION, DEPARTMENT OF LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.3 Purpose, scope, and applicability of the Job Training Partnership Act regulations. (a) Parts...

  2. 20 CFR 626.3 - Purpose, scope, and applicability of the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 20 Employees' Benefits 3 2011-04-01 2011-04-01 false Purpose, scope, and applicability of the Job Training Partnership Act regulations. 626.3 Section 626.3 Employees' Benefits EMPLOYMENT AND TRAINING ADMINISTRATION, DEPARTMENT OF LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.3 Purpose, scope, and...

  3. 20 CFR 626.3 - Purpose, scope, and applicability of the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Purpose, scope, and applicability of the Job... ADMINISTRATION, DEPARTMENT OF LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.3 Purpose, scope, and applicability of the Job Training Partnership Act regulations. (a) Parts...

  4. 14 CFR 374.3 - Compliance with the Consumer Credit Protection Act and regulations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Compliance with the Consumer Credit Protection Act and regulations. 374.3 Section 374.3 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) SPECIAL REGULATIONS IMPLEMENTATION OF THE CONSUMER CREDIT PROTECTION ACT WITH RESPECT TO AIR CARRIERS...

  5. 29 CFR 1903.2 - Posting of notice; availability of the Act, regulations and applicable standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 29 Labor 5 2010-07-01 2010-07-01 false Posting of notice; availability of the Act, regulations and... § 1903.2 Posting of notice; availability of the Act, regulations and applicable standards. (a)(1) Each... large type, generally not less than 36 pt. (b) Establishment means a single physical location...

  6. 78 FR 29263 - Rules andRegulations Under the Textile Fiber Products Identification Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-20

    ... Under the Textile Fiber Products Identification Act, 76 FR 68690 (Nov. 7, 2011). This Notice of Proposed...--Rules and Regulations Under the Textile Fiber Products Identification Act, 24 FR 4480, 4485 (June 2... Rulemaking, 50 FR 15100 at 15101 (Apr. 15, 1985). This Notice compared the Customs regulations in 19 CFR...

  7. 75 FR 50718 - Regulations Implementing the Longshore and Harbor Workers' Compensation Act: Recreational Vessels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ...This document contains proposed regulations implementing amendments to the Longshore and Harbor Workers' Compensation Act (LHWCA) by the American Recovery and Reinvestment Act of 2009 (ARRA), relating to the exclusion of certain recreational-vessel workers from the LHWCA's definition of ``employee.'' These regulations would clarify both the definition of ``recreational vessel'' and those......

  8. 77 FR 29982 - Federal Acquisition Regulation; Submission for OMB Review; Davis Bacon Act-Price Adjustment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... (actual method). A notice was published in the Federal Register at 77 FR 13328, on March 6, 2012. No... Regulation; Submission for OMB Review; Davis Bacon Act-Price Adjustment (Actual Method) AGENCY: Department of... Bacon Act-Price Adjustment (Actual Method), by any of the following methods: Regulations.gov :...

  9. 78 FR 4725 - Escrow Requirements Under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-22

    ...The Bureau of Consumer Financial Protection (Bureau) is publishing a final rule that amends Regulation Z (Truth in Lending) to implement certain amendments to the Truth in Lending Act made by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Regulation Z currently requires creditors to establish escrow accounts for higher-priced mortgage loans secured by a first......

  10. The calcium stored in the sarcoplasmic reticulum acts as a safety mechanism in rainbow trout heart

    PubMed Central

    Cros, Caroline; Sallé, Laurent; Warren, Daniel E.; Shiels, Holly A.

    2014-01-01

    Cardiomyocyte contraction depends on rapid changes in intracellular Ca2+. In mammals, Ca2+ influx as L-type Ca2+ current (ICa) triggers the release of Ca2+ from sarcoplasmic reticulum (SR) and Ca2+-induced Ca2+ release (CICR) is critical for excitation-contraction coupling. In fish, the relative contribution of external and internal Ca2+ is unclear. Here, we characterized the role of ICa to trigger SR Ca2+ release in rainbow trout ventricular myocytes using ICa regulation by Ca2+ as an index of CICR. ICa was recorded with a slow (EGTA) or fast (BAPTA) Ca2+ chelator in control and isoproterenol conditions. In the absence of β-adrenergic stimulation, the rate of ICa inactivation was not significantly different in EGTA and BAPTA (27.1 ± 1.8 vs. 30.3 ± 2.4 ms), whereas with isoproterenol (1 μM), inactivation was significantly faster with EGTA (11.6 ± 1.7 vs. 27.3 ± 1.6 ms). When barium was the charge carrier, inactivation was significantly slower in both conditions (61.9 ± 6.1 vs. 68.0 ± 8.7 ms, control, isoproterenol). Quantification revealed that without isoproterenol, only 39% of ICa inactivation was due to Ca2+, while with isoproterenol, inactivation was Ca2+-dependent (∼65%) and highly reliant on SR Ca2+ (∼46%). Thus, SR Ca2+ is not released in basal conditions, and ICa is the main trigger of contraction, whereas during a stress response, SR Ca2+ is an important source of cytosolic Ca2+. This was not attributed to differences in SR Ca2+ load because caffeine-induced transients were not different in both conditions. Therefore, Ca2+ stored in SR of trout cardiomyocytes may act as a safety mechanism, allowing greater contraction when higher contractility is required, such as stress or exercise. PMID:25377479

  11. Improved nuclear power plant operations and safety through performance-based safety regulation.

    PubMed

    Golay, M W

    2000-01-01

    This paper illustrates some of the promise and needed future work for risk-informed, performance-based regulation (RIPBR). RIPBR is an evolving alternative to the current prescriptive method of nuclear safety regulation. Prescriptive regulation effectively constitutes a long, fragmented checklist of requirements that safety-related systems in a plant must satisfy. RIPBR, instead, concentrates upon satisfying negotiated performance goals and incentives for judging and rewarding licensee behavior to improve safety and reduce costs. In a project reported here, a case study was conducted concerning a pressurized water reactor (PWR) emergency diesel generator (EDG). Overall, this work has shown that the methods of RIPBR are feasible to use, and capable of justifying simultaneous safety and economic nuclear power improvements. However, it also reveals several areas where the framework of RIPBR should be strengthened. First, researchers need better data and understanding regarding individual component-failure modes that may cause components to fail. Not only are more data needed on failure rates, but more data and understanding are needed to enable analysts to evaluate whether these failures become more likely as the interval between tests is increased. This is because the current state of failure data is not sufficiently finely detailed to define the failure rates of individual component failure modes; such knowledge is needed when changing component-specific regulatory requirements. Second, the role of component testing, given that a component has failed, needs to be strengthened within the context of RIPBR. This includes formulating requirements for updating the prior probability distribution of a component failure rate and conducting additional or more frequent testing. Finally, as a means of compensating for unavoidable uncertainty as an obstacle to regulatory decision-making, limits to knowledge must be treated explicitly and formally. This treatment includes the

  12. 33 CFR 165.1319 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... point of origin. (c) Regulations. In accordance with the general regulations in 33 CFR Part 165, Subpart... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false Safety Zone Regulations, Seafair... Thirteenth Coast Guard District § 165.1319 Safety Zone Regulations, Seafair Blue Angels Air Show...

  13. 33 CFR 165.1319 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... point of origin. (c) Regulations. In accordance with the general regulations in 33 CFR Part 165, Subpart... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false Safety Zone Regulations, Seafair... Thirteenth Coast Guard District § 165.1319 Safety Zone Regulations, Seafair Blue Angels Air Show...

  14. 78 FR 10107 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... human consumption (the produce safety proposed rule) and for current good manufacturing practice and... 1960s, FDA established HACCP-based regulations for seafood (21 CFR part 123) in 1995 (60 FR...

  15. Legal issues of the environmental safety regulation in the sphere of nanotechnology in Russian Federation

    NASA Astrophysics Data System (ADS)

    Belokrylova, Ekaterina A.

    2013-04-01

    Nowadays one of the principal innovative spheres in Russia is considered to be a rapid development of nanotechnology and nanomaterials and implementation its products into almost all fields of social and industrial life. Nevertheless, despite the pointed advantages an appearance of nano products has set not only a positive example of the scientific progress development and dynamics, but also a potential threat of possible risks for the environment and people's health in the case of its massive use when there is a lack of research about its impacts. In Russian Federation the problem of nanosafety regulation is extremely actual. A number of international documents have noted a lack of legal regulation in the sphere of nanotechnologies in Russian Federation. Thus, according to the strategic EU program, it's mentioned that in 2009 on an annual meeting of OECD Tour de Table Meeting in Paris (November, 2007) Russia took responsibility to develop a long term program of nanoindustry development by 2015 (Nanotechnology Action Plan for Russia-2015). The key role should be dedicated to the nanosafety aspects and potential risk assessment of nanomaterials for environment and humans' health. Unfortunately, until now Russia did not provide this document for discussion at the international level by the partners of nanoconsortcium. Indeed, from 2007 until nowadays in Russian Federation there are no a single federal act of legislation (federal'nyi zakon), establishing the state foundations of regulation of nanosafety. The only one Federeal Legal Act in the described sphere is the Federalniy Zakon from 19 July 2007 "About the Russian corporation of nanotechnologies", which has established the principles of organization, activites, functions and termination of Rosnanotech. However, there are no articles dedicated to the environmental safety provision in regards of nano products applications. Also there is no complex federal act consolidating legal status of action in the field of

  16. 77 FR 57043 - Regulations Under the Fur Products Labeling Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-17

    ... Labeling Act (``TFLA''), and, on its own initiative, deleting unnecessary requirements. \\1\\ 76 FR 13550..., most recently in 1967.\\17\\ \\16\\ 15 U.S.C. 69e(b). \\17\\ 32 FR 6023 (Apr. 15, 1967). C. TFLA In 2010....ftc.gov/opa/2011/07/regreview.shtm . \\24\\ 76 FR 13550. \\25\\ The comments, along with a transcript...

  17. 77 FR 66539 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-06

    ... electronic records and automated searches along with paper records and manual searches. In addition, FMCS's... twenty cents per page, while document search and review charges will increase to $4.00 per each quarter... revisions read as follows: Sec. 1401.36 Freedom of Information Act fee schedules. (a) * * * (2) Search...

  18. The Equal Access Act: Policy and Regulations for Implementation.

    ERIC Educational Resources Information Center

    Jones, H. Lawrence; Martin, James

    The Equal Access Act of 1984 was drafted to implement access for religious clubs to public secondary schools, but with constitutionally protected safeguards to preclude entanglement of church and state. A number of challenges were made on the constitutional grounds of excessive entanglement of church and state, as well as what the definition of…

  19. 77 FR 50390 - Equal Credit Opportunity Act (Regulation B)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... from the Bureau's rulemaking authority by section 1029 of the Dodd-Frank Act). 76 FR 79442 (Dec. 21... burdens on industry. Thus, many of the rulemakings listed above involve issues that extend across two or... Bureau planned to conduct qualitative testing with industry participants as well as consumers. Each...

  20. 25 CFR 101.10 - Federal Reserve Regulation Z and Fair Credit Reporting Act.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... subject to the provisions of Federal Reserve Regulation Z (Truth In Lending, 12 CFR part 226; Pub. L. 91... 25 Indians 1 2012-04-01 2011-04-01 true Federal Reserve Regulation Z and Fair Credit Reporting Act... ACTIVITIES LOANS TO INDIANS FROM THE REVOLVING LOAN FUND § 101.10 Federal Reserve Regulation Z and...

  1. The Final Regulations to the Carl D. Perkins Vocational and Applied Technology Education Act of 1990.

    ERIC Educational Resources Information Center

    American Vocational Association, Alexandria, VA.

    This publication presents the final regulations to the Carl D. Perkins Vocational and Applied Technology Education Act of 1990. The first section is an analysis of the regulations. This analysis compares the proposed regulations to the final version and explains the differences between the two and the potential impact on program administration.…

  2. 49 CFR 397.2 - Compliance with Federal motor carrier safety regulations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 5 2013-10-01 2013-10-01 false Compliance with Federal motor carrier safety...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... Federal motor carrier safety regulations. A motor carrier or other person to whom this part is...

  3. 49 CFR 397.2 - Compliance with Federal motor carrier safety regulations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 5 2011-10-01 2011-10-01 false Compliance with Federal motor carrier safety...) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY... Federal motor carrier safety regulations. A motor carrier or other person to whom this part is...

  4. 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... Federal motor carrier safety regulations. A motor carrier or other person to whom this part is...

  5. Twenty Years of the Dietary Supplement Health and Education Act--How Should Dietary Supplements Be Regulated?

    PubMed

    Wallace, Taylor C

    2015-08-01

    The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines the FDA's statutory authority to regulate dietary supplement products in the United States. The dietary supplement industry has rapidly expanded since 1994, presenting an obvious need for "DSHEA 2.0." Current regulations surrounding dietary supplements have been increasingly and reasonably scrutinized, given their widespread use by over one-half of the US population as well as highly publicized safety concerns over the past 20 y. As the market continues to expand and evolve, so too must the laws that protect consumers from potential harm and misleading communication. This article is meant to begin a scientific dialogue on how regulations may be improved to provide both ease of access and safer products to the consumer by focusing on 4 topics: premarket approval, label claims, current Good Manufacturing Practices, and adverse event reporting. PMID:26063064

  6. 77 FR 76898 - Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-31

    ... Federal Register (77 FR 56592) and requested comments over a 60-day period ending on November 13, 2012... regulations must be based on the best available science and that the rulemaking process must allow for public.... Finally, the revisions include current cost figures to be used in calculating and charging fees...

  7. Auxin acts independently of DELLA proteins in regulating gibberellin levels.

    PubMed

    Reid, James B; Davidson, Sandra E; Ross, John J

    2011-03-01

    Shoot elongation is a vital process for plant development and productivity, in both ecological and economic contexts. Auxin and bioactive gibberellins (GAs), such as GA1, play critical roles in the control of elongation, along with environmental and endogenous factors, including other hormones such as the brassinosteroids. The effect of auxins, such as indole-3-acetic acid (IAA), is at least in part mediated by its effect on GA metabolism, since auxin up-regulates biosynthesis genes such as GA 3-oxidase and GA 20-oxidase and down regulates GA catabolism genes such as GA 2-oxidases, leading to elevated levels of bioactive GA 1. In our recent paper, we have provided evidence that this action of IAA is largely independent of DELLA proteins, the negative regulators of GA action, since the auxin effects are still present in the DELLA-deficient la cry-s genotype of pea. This was a crucial issue to resolve, since like auxin, the DELLAs also promote GA 1 synthesis and inhibit its deactivation. DELLAs are deactivated by GA, and thereby mediate a feedback system by which bioactive GA regulates its own level. However, our recent results, in themselves, do not show the generality of the auxin-GA relationship across species and phylogenetic groups or across different tissue types and responses. Further, they do not touch on the ecological benefits of the auxin-GA interaction. These issues are discussed below as well as the need for the development of suitable experimental systems to allow this process to be examined. PMID:21358281

  8. TRF2 acts as a transcriptional regulator in tumor angiogenesis

    PubMed Central

    Maï, Mounir El; Wagner, Kay-Dietrich; Michiels, Jean-François; Gilson, Eric; Wagner, Nicole

    2015-01-01

    We recently showed that telomeric repeat-binding factor 2 (TRF2) regulates gene expression to promote angiogenesis. We found that TRF2 is highly expressed in tumor vessels and transcriptionally activates platelet-derived growth factor receptor β to promote endothelial cell angiogenic properties independently of its function in telomere protection. This work identifies TRF2 as a promising dual target for cancer therapy. PMID:27308469

  9. Brightening up: the effect of the Physician Payment Sunshine Act on existing regulation of pharmaceutical marketing.

    PubMed

    Gorlach, Igor; Pham-Kanter, Genevieve

    2013-01-01

    With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. PMID:23581674

  10. 20 CFR 626.2 - Format of the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., including complaint processing and compliance reviews, will be governed by the provisions of 29 CFR part 34... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Format of the Job Training Partnership Act... LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.2 Format of the...

  11. 20 CFR 626.4 - Table of contents for the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... the Job Training Partnership Act, 20 CFR parts 626-638 and 1005, 1 is as follows: 1 Part 1005 was... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Table of contents for the Job Training..., DEPARTMENT OF LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.4 Table...

  12. 20 CFR 626.2 - Format of the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., including complaint processing and compliance reviews, will be governed by the provisions of 29 CFR part 34... 20 Employees' Benefits 3 2012-04-01 2012-04-01 false Format of the Job Training Partnership Act... LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.2 Format of the...

  13. 20 CFR 626.4 - Table of contents for the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... the Job Training Partnership Act, 20 CFR parts 626-638 and 1005, 1 is as follows: 1 Part 1005 was... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false Table of contents for the Job Training..., DEPARTMENT OF LABOR INTRODUCTION TO THE REGULATIONS UNDER THE JOB TRAINING PARTNERSHIP ACT § 626.4 Table...

  14. The Fair Labor Standards Act and the Child Care Industry--What Regulations Apply.

    ERIC Educational Resources Information Center

    Lee, Elisa

    1996-01-01

    Discusses how the federal Fair Labor Standard Act (FLSA) affects the wages and work hours of child care employees and how FLSA interacts with analogous state laws. Examines how child care centers can determine whether FLSA regulations apply to them, existing exemptions to the current act, minimum wage and overtime, whether training time is working…

  15. 77 FR 13328 - Federal Acquisition Regulation; Information Collection; Davis Bacon Act-Price Adjustment (Actual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ... Regulation; Information Collection; Davis Bacon Act--Price Adjustment (Actual Method) AGENCY: Department of... (actual method). Public comments are particularly invited on: Whether this collection of information is... comments identified by Information Collection 9000- 0154, Davis Bacon Act--Price Adjustment (Actual...

  16. International laser-safety regulations: a status update

    NASA Astrophysics Data System (ADS)

    Weiner, Robert M.

    1990-07-01

    There is an increase in international laser safety requirements as part of the emphasis on world-wide standardization of products and regulations. In particular the documents which will evolve from the 1992 consolidation efforts of the European Community (EC) will impact both laser manufacturers and users. This paper provides a discussion of the current status of the various laser radiation standards. NORTH AMERICAN REQUIREMENTS United States Requirements on manufacturers from the Food and Drug Administration (FDA) have been in effect since 1975. The Center for Devices and Radiological Health (CDRH) within that agency ensures that these mandatory requirements [1] are satisfied. The CDRH regulations include the division of products into classes depending on their potential for hazard criteria for power measurement and requirements for product features labels and manuals and records and reports. Manufacturers must test products and certify that they comply with the CDRH requirements. User requirements are found in a standard published by the American National Standards Institute (ANSI) and in requirements from several individual states. Specific ANSI standards have also been published for fiber communications systems [34] and for lasers in medical applications [35]. Please note that the Appendix includes additional information on the standards discussed in this paper including sources for obtaining the documents. Canada In the past Canada has had requirements for two specified product categories (bar code scanners and educational lasers) [26 These will be replaced

  17. Improving the regulation of safety at DOE nuclear facilities. Final report: Appendices

    SciTech Connect

    1995-12-01

    The report strongly recommends that, with the end of the Cold War, safety and health at DOE facilities should be regulated by outside agencies rather than by any regulatory scheme, DOE must maintain a strong internal safety management system; essentially all aspects of safety at DOE`s nuclear facilities should be externally regulated; and existing agencies rather than a new one should be responsible for external regulation.

  18. Improving the regulation of safety at DOE nuclear facilities. Final report

    SciTech Connect

    1995-12-01

    The report strongly recommends that, with the end of the Cold War, safety and health at DOE facilities should be regulated by outside agencies rather than by DOE itself. The three major recommendations are: under any regulatory scheme, DOE must maintain a strong internal safety management system; essentially all aspects of safety at DOE`s nuclear facilities should be externally regulated; and existing agencies rather than a new one should be responsible for external regulation.

  19. Organized labor and the origins of the Occupational Safety and Health Act.

    PubMed

    Asher, Robert

    2014-11-01

    New Solutions is republishing this 1991 article by Robert Asher, which reviews the history of organized labor's efforts in the United States to secure health and safety protections for workers. The 1877 passage of the Massachusetts factory inspection law and the implementation of primitive industrial safety inspection systems in many states paralleled labor action for improved measures to protect workers' health and safety. In the early 1900s labor was focusing on workers' compensation laws. The New Deal expanded the federal government's role in worker protection, supported at least by the Congress of Industrial Organizations (CIO), but challenged by industry and many members of the U.S. Congress. The American Federation of Labor (AFL) and the CIO backed opposing legal and inspection strategies in the late 1940s and through the 1950s. Still, by the late 1960s, several unions were able to help craft the Occupational Safety and Health Act of 1970 and secure new federal protections for U.S. workers. PMID:25261023

  20. Accidents and Apathy: The Construction of the ‘Robens Philosophy’ of Occupational Safety and Health Regulation in Britain, 1961–1974

    PubMed Central

    Sirrs, Christopher

    2016-01-01

    The 1972 Robens Report is widely regarded to have provided the underlying rationale for the ‘modern’ system of occupational health and safety regulation in Britain, embodied in the Health and Safety at Work Act (HSW Act) 1974. The HSW Act advanced a new, more flexible system of regulation, premised on the ideal of self-regulation by industry. This article advances a more nuanced historical understanding of the Report and its ethos—the ‘Robens philosophy’—than hitherto developed, situating its assumptions about accidents, regulation and the role of the state in the social, economic and political context of Britain in the 1960s and early 1970s. Highlighting the interaction between these trends and long-established regulatory practices, the article argues that the turn to ‘self-regulation’ heralded by the Robens Report was highly convincing from a political and regulatory perspective at the time it was promulgated. PMID:26858514

  1. Harmonization of legislation and regulations to achieve food safety: US and Canada perspective.

    PubMed

    Keener, Larry; Nicholson-Keener, Sophia M; Koutchma, Tatiana

    2014-08-01

    Trade in food and food ingredients among the nations of the world is rapidly expanding and, with this expansion, new supply chain partners, from globally disparate geographic regions, are being enrolled. Food and food ingredients are progressively sourced more from lesser developed nations. Food safety incidents in the USA and Canada show a high unfavorable correlation between illness outbreaks and imported foods. In the USA, for example, foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks, associated with imported food, implicated foods imported from areas which previously had not been associated with outbreaks. Projecting supply chains into new geographical regions raises serious questions about the capacity of the new supply chain partners to provide the requisite regulatory framework and sufficiently robust public health measures for ensuring the safety of the foods and foodstuffs offered for international trade. The laws, regulation and legislation among the many nations participating in the global food trade are, at best, inconsistent. These inconsistencies frequently give rise to trade disputes and cause large quantities of food to be at risk of destruction on the often dubious pretext that they are not safe. Food safety is often viewed through a political or normative lens. Often as not, this lens has been wrought absent scientific precision. Harmonization of food safety legislation around sound scientific principles, as advocated by the US Food Safety Modernization Act (FSMA), would ultimately promote trade and likely provide for incremental improvement in public health. Among the priority roles of most national governments are the advancement of commerce and trade, preservation of public health and ensuring domestic tranquility. Achieving these priorities is fundamental to creating and preserving the wealth of nations. Countries such as the Netherlands, Canada, Germany, Japan and the USA

  2. [Safety and health in work from the perspective of the Prevention of Occupational Hazards Act].

    PubMed

    Gómez-Hortigüela Amillo, J

    1996-01-01

    The passing of the Prevention of Occupational Hazards Act, (Ley 31/1995), constituted a change in direction in the development of occupational safety and health in Spain. This article describes the most salient points of this new legislation, from the criteria and principles that have to govern preventive activities, to the obligations and rights of both employers and workers, together with the co-operation and co-ordination of the activities of the various Administrations which have jurisdiction and the participation of employers' and workers' organisations, as the backbone of policy in matters concerning the prevention of occupational hazards. PMID:8998687

  3. 78 FR 39901 - Amendments to the 2013 Mortgage Rules Under the Equal Credit Opportunity Act (Regulation B), Real...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-02

    ... Bureau issued Escrow Requirements Under the Truth in Lending Act (Regulation Z), 78 FR 4726 (Jan. 30... Settlement Procedures Act (Regulation X), 78 FR 6856 (Jan. 31, 2013) (2013 HOEPA Final Rule), and Ability to Repay and Qualified Mortgage Standards Under the Truth in Lending Act (Regulation Z), 78 FR 6407...

  4. 48 CFR 852.222-70 - Contract Work Hours and Safety Standards Act-nursing home care contract supplement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Safety Standards Act-nursing home care contract supplement. 852.222-70 Section 852.222-70 Federal...—nursing home care contract supplement. As prescribed in 822.305, for nursing home care requirements, insert the following clause: Contract Work Hours and Safety Standards Act—Nursing Home Care...

  5. 48 CFR 852.222-70 - Contract Work Hours and Safety Standards Act-nursing home care contract supplement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Safety Standards Act-nursing home care contract supplement. 852.222-70 Section 852.222-70 Federal...—nursing home care contract supplement. As prescribed in 822.305, for nursing home care requirements, insert the following clause: Contract Work Hours and Safety Standards Act—Nursing Home Care...

  6. 48 CFR 852.222-70 - Contract Work Hours and Safety Standards Act-nursing home care contract supplement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... Safety Standards Act-nursing home care contract supplement. 852.222-70 Section 852.222-70 Federal...—nursing home care contract supplement. As prescribed in 822.305, for nursing home care requirements, insert the following clause: Contract Work Hours and Safety Standards Act—Nursing Home Care...

  7. 48 CFR 852.222-70 - Contract Work Hours and Safety Standards Act-nursing home care contract supplement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Safety Standards Act-nursing home care contract supplement. 852.222-70 Section 852.222-70 Federal...—nursing home care contract supplement. As prescribed in 822.305, for nursing home care requirements, insert the following clause: Contract Work Hours and Safety Standards Act—Nursing Home Care...

  8. 48 CFR 852.222-70 - Contract Work Hours and Safety Standards Act-nursing home care contract supplement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... Safety Standards Act-nursing home care contract supplement. 852.222-70 Section 852.222-70 Federal...—nursing home care contract supplement. As prescribed in 822.305, for nursing home care requirements, insert the following clause: Contract Work Hours and Safety Standards Act—Nursing Home Care...

  9. Radiation safety in the nuclear medicine department: impact of the UK Ionising Radiations Regulations.

    PubMed

    Harding, L K

    1987-09-01

    The practice of nuclear medicine requires integration of radiation safety with patient care and radiopharmaceutical standards. Nationally there was useful discussion in the UK before the Ionising Radiations Regulations and Approved Code of Practice were published, although such consultation had been lacking when the Medicines Act was implemented. Most of the new considerations relating to nuclear medicine stem from Schedule 6 of the Regulations. Generally, the presence of a single patient does not require a controlled area. However, when several patients are present, or radiopharmaceuticals are being prepared prior to injection, a controlled area is required. Classification of workers is not likely to be required in a typical nuclear medicine department in the UK, although most parts of the nuclear medicine department will need to be controlled areas. These include the radiopharmacy, radionuclide dispensary, injection room, and imaging rooms if patients are injected in them. The importance of finger dose measurements is emphasised. Patient wards, however, need not be controlled areas. A particular concern in nuclear medicine was that patients should not need to be admitted to hospital merely to comply with legislation. This is possibly the case and clarification will probably be available when the Notes for Guidance are published. Most procedures in nuclear medicine departments will remain unchanged. Further information is required, however, on patient waiting rooms, handling flood sources, pregnancy, and breast feeding. Within the hospital, detailed and multidisciplinary discussion will need to take place within the forum of the radiation safety committee. PMID:3664186

  10. 14 CFR 374.3 - Compliance with the Consumer Credit Protection Act and regulations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... credit card practices. (2) The Fair Credit Reporting Act, 15 U.S.C. 1681-1681 setting forth requirements... air carrier and foreign air carrier shall comply with the requirements of Regulation B, 12 CFR part 202, and Regulation Z, 12 CFR part 226, of the Board of Governors of the Federal Reserve Board....

  11. 14 CFR 374.3 - Compliance with the Consumer Credit Protection Act and regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... credit card practices. (2) The Fair Credit Reporting Act, 15 U.S.C. 1681-1681 setting forth requirements... air carrier and foreign air carrier shall comply with the requirements of Regulation B, 12 CFR part 202, and Regulation Z, 12 CFR part 226, of the Board of Governors of the Federal Reserve Board....

  12. 14 CFR 374.3 - Compliance with the Consumer Credit Protection Act and regulations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... credit card practices. (2) The Fair Credit Reporting Act, 15 U.S.C. 1681-1681 setting forth requirements... air carrier and foreign air carrier shall comply with the requirements of Regulation B, 12 CFR part 202, and Regulation Z, 12 CFR part 226, of the Board of Governors of the Federal Reserve Board....

  13. 40 CFR 261.8 - PCB wastes regulated under Toxic Substance Control Act.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 27 2012-07-01 2012-07-01 false PCB wastes regulated under Toxic... (CONTINUED) SOLID WASTES (CONTINUED) IDENTIFICATION AND LISTING OF HAZARDOUS WASTE General § 261.8 PCB wastes regulated under Toxic Substance Control Act. The disposal of PCB-containing dielectric fluid and...

  14. 40 CFR 261.8 - PCB wastes regulated under Toxic Substance Control Act.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 27 2013-07-01 2013-07-01 false PCB wastes regulated under Toxic... (CONTINUED) SOLID WASTES (CONTINUED) IDENTIFICATION AND LISTING OF HAZARDOUS WASTE General § 261.8 PCB wastes regulated under Toxic Substance Control Act. The disposal of PCB-containing dielectric fluid and...

  15. 40 CFR 261.8 - PCB wastes regulated under Toxic Substance Control Act.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 26 2014-07-01 2014-07-01 false PCB wastes regulated under Toxic... (CONTINUED) SOLID WASTES (CONTINUED) IDENTIFICATION AND LISTING OF HAZARDOUS WASTE General § 261.8 PCB wastes regulated under Toxic Substance Control Act. The disposal of PCB-containing dielectric fluid and...

  16. 40 CFR 261.8 - PCB wastes regulated under Toxic Substance Control Act.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 26 2011-07-01 2011-07-01 false PCB wastes regulated under Toxic... (CONTINUED) SOLID WASTES (CONTINUED) IDENTIFICATION AND LISTING OF HAZARDOUS WASTE General § 261.8 PCB wastes regulated under Toxic Substance Control Act. The disposal of PCB-containing dielectric fluid and...

  17. 75 FR 59609 - Rescission of Regulations Under the Comprehensive Smokeless Tobacco Health Education Act of 1986

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-28

    ... its smokeless tobacco regulations, 16 CFR Part 307, on November 4, 1986.\\1\\ 51 FR 40015. \\1\\ The... on utilitarian items. 56 FR 11654 (Mar. 20, 1991). II. Basis for Removal of Regulations On June 22... the enactment of the Family Smoking Prevention Act. 75 FR 3665 (Jan. 22, ] 2010). The...

  18. 78 FR 8963 - Update of Existing Privacy Act-NASA Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-07

    ... document contains corrections to the final regulations (NASA-2012-0005), which were published in the Federal Register of Thursday, October 4, 2012 (77 FR 60620). The regulations relate to requests to access... SPACE ADMINISTRATION 14 CFR Part 1212 RIN 2700-AD86 Update of Existing Privacy Act--NASA...

  19. GUAM - FACILITIES REGULATED UNDER THE RESOURCE CONVERVATION AND RECOVERY ACT (RCRA)

    EPA Science Inventory

    Points represent facilities that are regulated by the EPA under the Resource Conservation and Recovery Act (RCRA). Facilities regulated under RCRA generate, dispose of, treate or transport hazardous waste. RCRA is a law enacted by Congress in 1976 and amended in 1984 to include ...

  20. NEVADA FACILITIES REGULATED UNDER THE RESOURCE CONVERVATION AND RECOVERY ACT (RCRA)

    EPA Science Inventory

    Points represent facilities that are regulated by the EPA under the Resource Conservation and Recovery Act (RCRA). Facilities regulated under RCRA generate, dispose of, treate or transport hazardous waste. RCRA is a law enacted by Congress in 1976 and amended in 1984 to include ...

  1. 78 FR 32990 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-03

    ... Alcatraz Island. (77 FR 41902) The special local regulation and safety zone regulate the on-water... Alcatraz Island. DATES: Effective June 3, 2013. ADDRESSES: Documents indicated in this preamble as...

  2. 75 FR 80452 - Rules of Practice in Air Safety Proceedings and Implementing the Equal Access to Justice Act of 1980

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-22

    ... Equal Access to Justice Act of 1980 AGENCY: National Transportation Safety Board (NTSB or Board). ACTION... concerning applications for fees and expenses under the Equal Access to Justice Act (EAJA). The NTSB is... with a request for comments. 65 FR 42637. This Interim Rule amended 49 CFR part 821 by providing...

  3. Occupational health and safety regulation in the coal mining industry: public health at the workplace.

    PubMed

    Weeks, J L

    1991-01-01

    The strategy for preventing occupational disease and injury in the coal mining industry employs several elements. Standards are set and enforced; technical assistance, research, and development are provided; and surveillance is conducted. Compensation for black lung is a vivid reminder of the consequences of failure to prevent disease. And, workers are represented by a union that encourages active participation in all aspects of this strategy. There are significant problems in each of these elements. Regulatory reform threatens to weaken many standards, there is a decline in government research budgets, surveillance is not well monitored, and compensation for black lung is significantly more difficult to obtain now than in the past. Moreover, the conservative governments of the past decade are not friendly towards unions. Nevertheless, the fundamental structure of disease and injury prevention remains intact and, more importantly, it has a historical record of success. The Mine Safety and Health Act provided for a wide array of basic public health measures to prevent occupational disease and injury in the mining industry. These measures have been effective in reducing both risk of fatal injury and exposure to respirable coal mine dust. They are also associated with temporary declines in productivity. In recent years, however, productivity has increased, while risk of fatal injury and exposure to respirable dust have declined. At individual mines, productivity with longwall mining methods appear to be associated with increases in exposure to respirable dust. These trends are not inconsistent with similar trends following implementation of regulations by OSHA. When OSHA promulgated regulations to control exposure to vinyl chloride monomer, enforcement of the standard promoted significant efficiencies in vinyl chloride production (5). Similarly, when OSHA promulgated its standard regulating exposure to cotton dust, this effort provoked modernization in the cotton

  4. The Implementation of the Food Safety Modernization Act and the Strength of the Sustainable Agriculture Movement.

    PubMed

    Wiseman, Samuel R

    2015-01-01

    In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug Administration (FDA) rules to implement the Act threatened to weaken this victory for small farm groups, however, prompting a loud response from small farmers and local food proponents. The FDA's second set of proposed rules, issued in September 2014 in response to these and other complaints, were, perhaps surprisingly, responsive to small farmers' concerns. Using comments submitted to the FDA, this article explores the responses of the agriculture industry and public health organizations, as well as small farm groups, consumers of local food, and sustainable agriculture interests (which, for simplicity, I alternately describe as comprising the "sustainable agriculture" or "small farm" movement), to three aspects of the FDA's proposed rules--involving manure application, on-farm packing activities, and exemptions for very small farms--to assess the strength of the sustainable agriculture movement. The rules involving manure application and on-farm packing, it turns out, reveal little about the independent political strength of the local food movement, as large industry groups also objected to these provisions. But for the third issue discussed here--exemptions for very small farms--the interests of sustainable agriculture groups were directly opposed to both industry and public health organizations

  5. Safety of long-acting beta agonists and inhaled corticosteroids in children and adolescents with asthma

    PubMed Central

    Xia, Ying; Kelton, Christina M. L.; Xue, Liang; Bian, Boyang; Wigle, Patricia R.

    2013-01-01

    The introduction of long-acting beta agonists (LABAs) was considered a major advance in bronchodilator therapy for adult, as well as pediatric, patients with asthma. However, the use of LABAs has raised safety concerns, especially the potential for severe asthma exacerbations (SAEs) resulting in hospitalizations or even death. Meanwhile, the use of inhaled corticosteroids (ICSs), a cornerstone in the treatment of mild-to-severe persistent asthma, has been associated with growth suppression in children. The purpose of this review was to identify and discuss the major published safety studies surrounding LABA, ICS, and combined LABA/ICS usage in children. By way of a critical search for influential published clinical trials, meta-analyses, and observational studies, six studies relevant to the safety of LABA monotherapy, seven studies relevant to ICS monotherapy, and four studies on the subject of LABA/ICS combination usage were identified and reviewed. Based on the reviewed literature, the controversy surrounding these anti-asthma medications was clearly exposed. On the one hand, there is some evidence that LABA monotherapy may be associated with SAEs and asthma-related death, while ICS monotherapy may be associated with a higher risk of growth suppression. On the other hand, the concurrent use of a LABA with an ICS has been associated with positive outcomes including symptom reduction and reduced rate and severity of exacerbations. Further clinical research is warranted and has been called for by the US Food and Drug Administration. PMID:25114786

  6. 76 FR 34867 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... SECURITY Coast Guard 33 CFR Part 165 Safety Zone Regulations, Seafair Blue Angels Air Show Performance... Guard will enforce the annual Seafair Blue Angels Air Show safety zone on Lake Washington, Seattle, WA...: The Coast Guard will enforce the Seafair Blue Angels Air Show Performance safety zone in 33 CFR...

  7. 33 CFR 165.1319 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... accordance with the general regulations in 33 CFR Part 165, Subpart C, no person or vessel may enter or... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone Regulations, Seafair... Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY...

  8. 33 CFR 165.1319 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... accordance with the general regulations in 33 CFR Part 165, Subpart C, no person or vessel may enter or... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false Safety Zone Regulations, Seafair... Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY...

  9. 33 CFR 165.1319 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... accordance with the general regulations in 33 CFR Part 165, Subpart C, no person or vessel may enter or... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety Zone Regulations, Seafair... Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY...

  10. Motor Vehicle Safety Authorization Act of 1986. House of Representatives, Ninety-Ninth Congress, Second Session, September 17, 1986

    SciTech Connect

    Not Available

    1986-01-01

    The House Committee on Energy and Commerce suggests several amendments to H.R. 2248, which authorizes National Highway Traffic Safety Administration appropriations for 1987-1988. The legislation addresses such safety issues as the requirement that dealers inform potential buyers of true odometer readings, tire registration, bumper strength, and defects. The report covers automobile recalls of the past decade, the need for safety standard equality certification for imports, and state safety inspection programs. Oversight hearings and findings of the committee also addressed mandatory seat belt use. The bill affects the National Traffic and Motor Vehicle Safety Act of 1966 and the Motor Vehicle Information and Cost Savings Act. The report notes several areas of compromise.

  11. Safety of long acting muscarinic antagonists: are all these drugs always and equally safe?

    PubMed

    Melani, Andrea S; Sestini, Piersante

    2016-05-01

    Inhaled bronchodilators - such as long-acting muscarinic receptor antagonists (LAMAs) - are central to the pharmacological management of symptomatic chronic obstructive pulmonary disease. LAMAs are considered to be safe drugs at recommended dosages. In the present issue of the Journal safety of umeclidinium, a recently marketed LAMA, at twice the recommended dosage, has been evaluated with good results in a Japanese, COPD population. However, because muscarinic receptors are expressed not only in the lungs but also at the level of heart, digestive and urinary apparatus, the potential exists for LAMAs to cause adverse events related to stimulation of receptors in these organs. Head-to-head and post-marketing vigilance studies are required to determine the profile risk of these drugs, ultimately, and whether differences exist between currently available LAMAs. PMID:26789695

  12. 78 FR 18344 - Federal Acquisition Regulation; Submission for OMB Review; Buy American Act-Free Trade Agreements...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... Regulation; Submission for OMB Review; Buy American Act--Free Trade Agreements--Israeli Trade Act Certificate... previously approved information collection requirement concerning the Buy American Act--Free Trade Agreements... comments identified by Information Collection 9000- 0130, Buy American Act--Free Trade......

  13. 77 FR 6007 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...This document provides required notice of substantive rules issued by the Coast Guard and that were made temporarily effective between May 2011 and November 2011, and that expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of......

  14. 76 FR 44803 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, Drawbridge Operation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-27

    ...This document provides required notice of substantive rules issued by the Coast Guard and temporarily effective between December 2008 and July 2010, that expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and......

  15. 21 CFR 16.24 - Regulatory hearing required by the act or a regulation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory hearing required by the act or a regulation. 16.24 Section 16.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION Initiation of Proceedings §...

  16. 60 FR 11194 - Real Estate Settlement Procedures Act (Regulation X); Escrow Accounting Procedures

    Federal Register 2010, 2011, 2012, 2013, 2014

    1995-03-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Office of the Assistant Secretary for Housing-Federal Housing Commissioner 24 CFR Part 3500 RIN 2502-AF77 Real Estate Settlement Procedures Act (Regulation X); Escrow Accounting...

  17. 75 FR 40754 - Government in the Sunshine Act Regulations of the National Science Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... From the Federal Register Online via the Government Publishing Office NATIONAL SCIENCE FOUNDATION 45 CFR Part 614 RIN 3145-AA53 Government in the Sunshine Act Regulations of the National Science Board AGENCY: National Science Board (NSB), National Science Foundation (NSF). ACTION: Direct final...

  18. The National Labor Relations Act and the Regulation of Public Employee Collective Bargaining

    ERIC Educational Resources Information Center

    McCann, Walter; Smiley, Stafford

    1976-01-01

    The arguments for and against federal assumption of the responsibility for regulating the relationship between public employers and public employees are analyzed. It is suggested that the National Labor Relations Act should be extended to include them, thereby imposing upon them a duty to bargain collectively. Available from: the Harvard…

  19. 77 FR 20295 - Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-04

    ... From the Federal Register Online via the Government Publishing Office ] EQUAL EMPLOYMENT OPPORTUNITY COMMISSION 29 CFR Part 1630 Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act, as Amended CFR Correction In Title 29 of the Code of Federal...

  20. 78 FR 70515 - Petition To Promulgate Standards for Bears Under the Animal Welfare Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-26

    ...; ] DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 9 CFR Part 3 Petition To Promulgate Standards for Bears Under the Animal Welfare Act Regulations AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Notice of petition. SUMMARY: We are notifying the public that the Animal and...

  1. 75 FR 24862 - Removing Regulations Implementing the Fish and Wildlife Conservation Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-06

    ...'' (59 FR 22951), E.O. 13175, and 512 DM 2. We have determined that there are no potential effects. This... Fish and Wildlife Service 50 CFR Part 83 RIN 1018-AX00 Removing Regulations Implementing the Fish and Wildlife Conservation Act AGENCY: Fish and Wildlife Service, Interior. ACTION: Proposed rule. SUMMARY:...

  2. 75 FR 19241 - Financial Crimes Enforcement Network; Amendment to the Bank Secrecy Act Regulations; Defining...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... for Mutual Funds, 67 FR 21117 (April 29, 2002); Customer Identification Programs for Mutual Funds, 68 FR 25131 (May 9, 2003); Amendment to the Bank Secrecy Act Regulations--Requirement That Mutual Funds Report Suspicious Activity, 71 FR 26213 (May 4, 2006); Anti-Money Laundering Programs; Special...

  3. 76 FR 57940 - Revision of Department of Justice Freedom of Information Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... NRPM published on March 21, 2011 (76 FR 15236), closed on April 20, 2011. This document reopens the... the Freedom of Information Act. The comment period for that rule closed on April 20, 2011. The... revising its existing regulations under the FOIA. (See 76 FR 15236.) The rule proposed to amend...

  4. 76 FR 35963 - Disclosure of Information; Privacy Act Regulations; Notice and Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-21

    ... CORPORATION 12 CFR Parts 309 and 310 RIN 3064-AD83 Disclosure of Information; Privacy Act Regulations; Notice... disclosure of information and the PA, as amended. In taking this action the FDIC's goal is to avoid potential... to correct addresses and other matters that have changed since the FDIC's rules involving...

  5. Impact of Clean Air Act Regulations on Nitrogen Fate and Transport in Neuse River Basin

    EPA Science Inventory

    This study investigated impacts of Clean Air Act Amendment (CAAA) NOx emissions regulations on the fate and transport of nitrogen for two watersheds in the Neuse River Basin, North Carolina, USA from 1990 to 2020. The Soil and Water Assessment Tool (SWAT) and the Community Multi-...

  6. 75 FR 14547 - Tribal Consultation on Draft Buy Indian Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 48 CFR Chapter 14 RIN 1076-AE95 Tribal Consultation on Draft Buy Indian Act Regulations AGENCY: Bureau of Indian Affairs, Interior. ACTION: Notice of tribal consultation...

  7. 14 CFR 374.3 - Compliance with the Consumer Credit Protection Act and regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Compliance with the Consumer Credit... OF TRANSPORTATION (AVIATION PROCEEDINGS) SPECIAL REGULATIONS IMPLEMENTATION OF THE CONSUMER CREDIT PROTECTION ACT WITH RESPECT TO AIR CARRIERS AND FOREIGN AIR CARRIERS § 374.3 Compliance with the...

  8. 76 FR 20569 - Horse Protection Act; Petition for Amendments to Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Animal and Plant Health Inspection Service 9 CFR Part 11 Horse Protection Act; Petition for Amendments to... changes to our horse protection regulations and our current enforcement practices and related policies... are noting, however, that certain requests in the petition lack authority in the Horse Protection...

  9. Regulations on Meat Hygiene and Safety in the European Union

    NASA Astrophysics Data System (ADS)

    Dwinger, Ron H.; Golden, Thomas E.; Hatakka, Maija; Chalus, Thierry

    Meat safety concerns physical, chemical and biological aspects. With regard to these aspects it is important that the slaughterhouse and processing industry implement a HACCP programme. By implementing such a programme all hazards, which could affect human safety, will have to be identified, monitored when considered as critical and eliminated, reduced or prevented. With regard to preventing physical hazards, a metal detector should be a regular piece of equipment in the meat processing industry.

  10. 75 FR 12167 - Virginia Graeme Baker Pool and Spa Safety Act; Public Accommodation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Consumer Product Safety Commission. ACTION: Proposed interpretive rule. SUMMARY: The Consumer Product... of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda,...

  11. Rationing health protection: a proposal to exempt nuisance dust from US Clean Air Act regulations.

    PubMed

    Centner, Terence J; Colson, Gregory

    2013-03-15

    The US House of Representative has passed a bill called the "Farm Dust Regulation Prevention Act" (Dust Act) that would exempt most types of particulate matter (PM) in rural areas from the air quality controls of the US Clean Air Act. The Dust Act would markedly change the country's air quality standards. An examination of the proposed provisions shows that they would exempt non-combustion PM pollutants from mining, smelting, petroleum production, and power generation from existing air quality standards. Persons downwind from pollutants generated in rural areas could be exposed to concentrations of carcinogenic heavy metals, asbestos, and benzene known to adversely affect their health and ecological resources. Existing federal air quality standards based on science would be replaced by a flexible standard that rations health protection. PMID:23376304

  12. Establishing a list of qualifying pathogens under the Food and Drug Administration Safety and Innovation Act. Final rule.

    PubMed

    2014-06-01

    The Food and Drug Administration (FDA or Agency) is issuing a regulation to establish a list of "qualifying pathogens'' that have the potential to pose a serious threat to public health. This final rule implements a provision of the Generating Antibiotic Incentives Now (GAIN) title of the Food and Drug Administration Safety and Innovation Act (FDASIA). GAIN is intended to encourage development of new antibacterial and antifungal drugs for the treatment of serious or life-threatening infections, and provides incentives such as eligibility for designation as a fast-track product and an additional 5 years of exclusivity to be added to certain exclusivity periods. Based on analyses conducted both in the proposed rule and in response to comments to the proposed rule, FDA has determined that the following pathogens comprise the list of ``qualifying pathogens:'' Acinetobacter species, Aspergillus species, Burkholderia cepacia complex, Campylobacter species, Candida species, Clostridium difficile, Coccidioides species, Cryptococcus species, Enterobacteriaceae (e.g., Klebsiella pneumoniae), Enterococcus species, Helicobacter pylori, Mycobacterium tuberculosis complex, Neisseria gonorrhoeae, N. meningitidis, Non-tuberculous mycobacteria species, Pseudomonas species, Staphylococcus aureus, Streptococcus agalactiae, S. pneumoniae, S. pyogenes, and Vibrio cholerae. The preamble to the proposed rule described the factors the Agency considered and the methodology used to develop the list of qualifying pathogens. As described in the preamble of this final rule, FDA applied those factors and that methodology to additional pathogens suggested via comments on the proposed rule. PMID:24908687

  13. Regulating the regulator: Numb acts upstream of p53 to control mammary stem and progenitor cell

    PubMed Central

    Faraldo, Marisa M.

    2015-01-01

    In this issue, Tosoni et al. (2015. J. Cell Biol. http://dx.doi.org/10.1083/jcb.201505037) report that cell fate determinant and tumor suppressor Numb imposes asymmetric cell divisions in mammary stem cells by regulating p53. Numb thereby restricts mammary stem cell expansion and controls the proliferation and lineage-specific characteristics of their progeny. PMID:26598611

  14. 75 FR 23589 - Safety Zone Regulations, Seafair Blue Angels Air Show Performance, Seattle, WA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... June 24, 2004, the Coast Guard published a Final Rule in the Federal Register (69 FR 35250) to... SECURITY Coast Guard 33 CFR Part 165 Safety Zone Regulations, Seafair Blue Angels Air Show Performance... Guard will enforce a safety zone on Lake Washington, WA for the annual Seafair Blue Angels Air Show...

  15. 49 CFR 179.103-4 - Safety relief devices and pressure regulators.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 3 2011-10-01 2011-10-01 false Safety relief devices and pressure regulators. 179...) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) SPECIFICATIONS FOR TANK CARS Specifications for Pressure Tank Car Tanks (Classes DOT-105, 109, 112, 114 and...

  16. 77 FR 70166 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is establishing a public docket for information pertaining to FDA's implementation of the provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) related to medical gases. This action is intended to ensure that information submitted to FDA on the implementation of the medical gas provisions of FDASIA is available to all......

  17. 78 FR 17611 - Provisions of the Food and Drug Administration Safety and Innovation Act Related to Medical Gases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-22

    ... these new sections. On November 23, 2012 (77 FR 70166), FDA issued a Federal Register notice... FR 74852), FDA issued a notice of availability announcing publication of a draft guidance for... Administration Safety and Innovation Act Related to Medical Gases; Request for Comments Regarding...

  18. 76 FR 13643 - FDA Food Safety Modernization Act: Title III-A New Paradigm for Importers; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... accountability for domestic and foreign food and animal feed firms in the supply chain from farm to U.S. table... HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-N-0134, FDA-2011-N-0143, FDA-2011-N-0144, FDA- 2011-N-0145, and FDA-2011-N-0146] FDA Food Safety Modernization Act: Title III--A...

  19. 78 FR 36711 - Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Food and Drug Administration Safety and Innovation Act Title VII--Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of...: Food and Drug Administration, HHS. ACTION: Notification of public meeting; request for...

  20. 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Are my HCT/P's regulated solely under section 361..., AND CELLULAR AND TISSUE-BASED PRODUCTS General Provisions § 1271.10 Are my HCT/P's regulated solely.../P is regulated solely under section 361 of the PHS Act and the regulations in this part if it...

  1. Chapter 2: The Need for Physical Protection, Safety, and Regulation

    ERIC Educational Resources Information Center

    Brazelton, T. Berry; Greenspan, Stanley I.

    2007-01-01

    This article discusses the need for physical protection and care of infants and young children and families. One of the most important preventable challenges to children's physical safety and protection is toxic substances in their environment. Many toxic substances that affect the central nervous system are in drinking water, soil, air, and areas…

  2. Laser sources in dentistry and radiation safety regulations

    NASA Astrophysics Data System (ADS)

    De Luca, D.; Gaeta, G. M.; Lepore, M.

    2007-02-01

    Nowadays laser sources are largely adopted in dentistry due to their unique properties making them good candidates to substitute traditional scalpel and conventional diamond bur in the surgery of the soft and hard oral tissue, respectively. The large use of laser sources outside the research laboratories without the need of highly specialized personnel can ask for a widespread knowledge of safety issues related to this kind of equipment. The main hazard of accidental exposures regards eyes injury but increasing the power of the laser beam also skin can be involved. Safety legislations in Europe and U.S.A. take into account non ionizing radiations and laser radiation for the hazards for the health deriving from physical agents. Laser safety standards introduce 3 useful parameters for hazard characterization: "Accessible Emission Limit" (AEL), "Maximum Permissible Exposure" (MPE) and "Nominal Ocular Hazard Distance" (NOHD). We measured the MPE and NOHD for Er:YAG and other laser sources currently adopted in dentistry and we compared our results with data elaborated from standards in order to single out safe and comfortable working conditions. In fact an experimental assessment of the hazard parameters and the comparison with those of reference from safety standards turns out to be useful in order to estimate the residual hazard that can be still present after applying all the engineering protection and administrative rules.

  3. Industry invites regulation: the passage of the Pure Food and Drug Act of 1906.

    PubMed Central

    Barkan, I D

    1985-01-01

    Ending its 27-year stranglehold on proposals for federal pure food and drug legislation, Congress passed the Pure Food and Drug Act and its companion bill, the Meat Inspection Act, on June 30, 1906. An unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action; most industries even planned for it, hoping regulation would restore the competitiveness of their products on weak foreign and domestic markets. The ways in which these interests converged, and the reasons therefore, suggest a change in their relationships to each other and with the federal government as America headed into the twentieth century. Images p21-a p21-b PMID:3881052

  4. Safety monitoring of drugs granted exclusivity under the Best Pharmaceuticals for Children Act: what the FDA has learned.

    PubMed

    Mathis, L L; Iyasu, S

    2007-08-01

    The Best Pharmaceuticals for Children Act (BPCA) was signed into law on 4 January 2002, shortly after the pediatric exclusivity provision of the Food and Drug Administration (FDA) Modernization Act expired on 1 January 2002. This Act provides six months of marketing exclusivity for a drug when a pharmaceutical company studies that drug for use in the pediatric population as requested by the FDA. Section 17 of the BPCA specifically requires that the FDA review all adverse events reported for drugs that receive pediatric exclusivity. In most of the cases, no unexpected adverse events were reported in the pediatric population; however, in some cases, this focused safety review provided information important to the safety of medication use in children. PMID:17632537

  5. The Maharashtra Felling of Trees (Regulation) (Amendment) Act, 1988 (No. 26 of 1989), 5 August 1989.

    PubMed

    1989-01-01

    Among other things, this Act amends the Maharashtra (India) Felling of Trees (Regulation) Act, 1964, to authorize the Tree Officer to order the planting of trees in any land (other than government-designated drought land) that he thinks does not contain an adequate number of trees. Owners and occupiers of the land must comply with the order, after being given a reasonable opportunity to be heard. If they do not comply, they can be charged for expenses incurred in having the trees planted. In 1989 the government of West Bengal enacted The Indian Forest (West Bengal Amendment) Act, 1989 (No. 22 of 1988) (Calcutta Gazette, Extraordinary, Part III, 3 February 1989). This Act increases the punishment for various infractions of the Indian Forest Act, 1927, as applied to West Bengal and inserts new language relating to the power of officers to stop and search vehicles; the ability of the state government to seize contraband and related tools, vehicles, boats, and cattle; and punishment for abetting offenses delineated by the Act. PMID:12344326

  6. Long-term safety and tolerability of long-acting injectable risperidone in patients with schizophrenia or schizoaffective disorder.

    PubMed

    Lindenmayer, Jean-Pierre; Khan, Akbar; Eerdekens, Mariëlle; Van Hove, Ilse; Kushner, Stuart

    2007-01-15

    Subjects were patients with schizophrenia or schizoaffective disorder enrolled in extension studies (Study A and Study B) after participating in 12-week studies of long-acting injectable risperidone [Kane, J.M., Eerdekens, M., Lindenmayer, J.-P., Keith, S.J., Lesem, M., Karcher, K., 2003. Long-acting injectable risperidone: efficacy and safety of the first long-acting atypical antipsychotic. Am. J. Psychiatry 160, 1125-1132; Lindenmayer, J.-P., Eerdekens, L., Berry, S., Eerdekens, M., 2004. Safety and efficacy of long-acting risperidone in schizophrenia: a 12-week, multicenter, open-label study in stable patients switched from typical and atypical oral antipsychotics. J. Clin. Psychiatry 65, 1084-1089]. Twelve months of treatment were completed by 55% of Study A patients and 52% of Study B patients. The median modal dose of long-acting injectable risperidone was 50 mg/14 days in both studies. Most frequent adverse events were psychosis, headache, insomnia, agitation, and rhinitis. EPS-related adverse events were reported in 33% of patients in Study A and 22% in Study B. Patients with Clinical Global Impressions ratings of "not ill" and "mild" increased from 14% at baseline to 54% at endpoint in Study A and from 42% to 65% in Study B. It is concluded that treatment with long-acting injectable risperidone for 1 year or longer appeared to be safe and well tolerated in patients with schizophrenia or schizoaffective disorder. PMID:17049818

  7. 78 FR 45842 - Amendments to the 2013 Mortgage Rules Under the Real Estate Settlement Procedure Act (Regulation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-30

    ... From the Federal Register Online via the Government Publishing Office BUREAU OF CONSUMER FINANCIAL PROTECTION 12 CFR Parts 1024 and 1026 RIN 3170-AA37 Amendments to the 2013 Mortgage Rules Under the Real Estate Settlement Procedure Act (Regulation X) and the Truth in Lending Act (Regulation Z) Correction...

  8. 26 CFR 1.706-2T - Temporary regulations; question and answer under the Tax Reform Act of 1984.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 26 Internal Revenue 8 2011-04-01 2011-04-01 false Temporary regulations; question and answer under the Tax Reform Act of 1984. 1.706-2T Section 1.706-2T Internal Revenue INTERNAL REVENUE SERVICE... Partnerships § 1.706-2T Temporary regulations; question and answer under the Tax Reform Act of 1984. Question...

  9. 26 CFR 1.706-2T - Temporary regulations; question and answer under the Tax Reform Act of 1984.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 8 2010-04-01 2010-04-01 false Temporary regulations; question and answer under the Tax Reform Act of 1984. 1.706-2T Section 1.706-2T Internal Revenue INTERNAL REVENUE SERVICE...-2T Temporary regulations; question and answer under the Tax Reform Act of 1984. Question 1:...

  10. 26 CFR 18.0 - Effective date of temporary regulations under the Subchapter S Revision Act of 1982.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 26 Internal Revenue 14 2014-04-01 2013-04-01 true Effective date of temporary regulations under the Subchapter S Revision Act of 1982. 18.0 Section 18.0 Internal Revenue INTERNAL REVENUE SERVICE... SUBCHAPTER S REVISION ACT OF 1982 § 18.0 Effective date of temporary regulations under the Subchapter...

  11. 26 CFR 18.0 - Effective date of temporary regulations under the Subchapter S Revision Act of 1982.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 14 2012-04-01 2012-04-01 false Effective date of temporary regulations under the Subchapter S Revision Act of 1982. 18.0 Section 18.0 Internal Revenue INTERNAL REVENUE SERVICE... SUBCHAPTER S REVISION ACT OF 1982 § 18.0 Effective date of temporary regulations under the Subchapter...

  12. GP supervisors' experience in supporting self-regulated learning: a balancing act.

    PubMed

    Sagasser, Margaretha H; Kramer, Anneke W M; van Weel, Chris; van der Vleuten, Cees P M

    2015-08-01

    Self-regulated learning is essential for professional development and lifelong learning. As self-regulated learning has many inaccuracies, the need to support self-regulated learning has been recommended. Supervisors can provide such support. In a prior study trainees reported on the variation in received supervisor support. This study aims at exploring supervisors' perspectives. The aim is to explore how supervisors experience self-regulated learning of postgraduate general practitioners (GP) trainees and their role in this, and what helps and hinders them in supervising. In a qualitative study using a phenomenological approach, we interviewed 20 supervisors of first- and third-year postgraduate GP trainees. Supervisors recognised trainee activity in self-regulated learning and adapted their coaching style to trainee needs, occasionally causing conflicting emotions. Supervisors' beliefs regarding their role, trainees' role and the usefulness of educational interventions influenced their support. Supervisors experienced a relation between patient safety, self-regulated learning and trainee capability to learn. Supervisor training was helpful to exchange experience and obtain advice. Supervisors found colleagues helpful in sharing supervision tasks or in calibrating judgments of trainees. Busy practice occasionally hindered the supervisory process. In conclusion, supervisors adapt their coaching to trainees' self-regulated learning, sometimes causing conflicting emotions. Patient safety and entrustment are key aspects of the supervisory process. Supervisors' beliefs about their role and trainees' role influence their support. Supervisor training is important to increase awareness of these beliefs and the influence on their behaviour, and to improve the use of educational instruments. The results align with findings from other (medical) education, thereby illustrating its relevance. PMID:25314934

  13. 75 FR 50700 - Quarterly Listings; Safety Zones, Security Zones, Special Local Regulations, and Drawbridge...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-17

    ...This document provides required notice of substantive rules issued by the Coast Guard and temporarily effective between February 2006 and August 2009, that expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, and drawbridge operation regulations, all of limited duration and for which timely......

  14. Draft Regulations for the Comprehensive Public School Building Safety Program. Amendment to Regulations of the Commissioner of Education.

    ERIC Educational Resources Information Center

    New York State Education Dept., Albany. Office of Facilities Planning.

    The New York State Department of Education provides the amendments to regulations of the Commissioner of Education concerning the Comprehensive Public School Building Safety Program effective May 7, 1999. Amended items include those involving the school district 5-year capital assets preservation facilities plan, building inspections, construction…

  15. HIPAA Mental Health Parity Act--IRS. Notice of proposed rulemaking by cross-reference to temporary regulations.

    PubMed

    1997-12-22

    Elsewhere in this issue of the Federal Register, the IRS is issuing temporary regulations relating to mental health parity requirements imposed on group health plans. These requirements were added to the Internal Revenue Code by section 1532 of the Taxpayer Relief Act of 1997. The IRS is issuing the temporary regulations at the same time that the Pension and Welfare Benefits Administration of the U.S. Department of Labor and the Health Care Financing Administration of the U.S. Department of Health and Human Services are issuing substantially similar interim final regulations relating to mental health parity requirements added by the Mental Health Parity Act of 1996 to the Employee Retirement Income Security Act of 1974 and the Public Health Service Act. The temporary regulations provide guidance to employers and group health plans relating to the new mental health parity requirements. The text of those temporary regulations also serves as the text of these proposed regulations. PMID:10179306

  16. 78 FR 44685 - Amendments to the 2013 Mortgage Rules Under the Real Estate Settlement Procedures Act (Regulation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... Final Rule), 78 FR 6407 (Jan. 30, 2013). \\2\\ Mortgage Servicing Rules Under the Real Estate Settlement... Final Rules), 78 FR 10695 (Feb. 14, 2013) (Regulation X), 78 FR 10901 (Feb. 14, 2013) (Regulation Z). \\3\\ Amendments to the 2013 Escrows Final Rule under the Truth in Lending Act (Regulation Z), 78 FR 30739 (May...

  17. 78 FR 13298 - Notice of Retrospective Review of the Americans With Disabilities Act Regulations for Over-the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... Statement in the Federal Register published on April 11, 2000 (65 FR 19477). FOR FURTHER INFORMATION CONTACT... Act Regulations for Over-the-Road Bus Operators; Request for Comments AGENCY: Office of the Secretary...) implementing regulations for over-the-road bus (OTRB) operators. The DOT will review regulations specified...

  18. Revision of Department of Justice Freedom of Information Act and Privacy Act Regulations and Implementation of Electronic Freedom of Information Act Amendments of 1996--DoJ. Proposed Rule.

    PubMed

    1997-08-26

    This document sets forth proposed revision of the Department's regulations under both the Freedom of Information Act (FOIA) and the Privacy Act of 1974. The FOIA and Privacy Act regulations have been streamlined and condensed, in accordance with the principles of the National Performance Reviews. With more "user-friendly" language wherever possible. These revisions also reflect the principles established by President Clinton and Attorney General Reno in their FOIA Policy Memoranda of October 4, 1993. The new statement of discretionary disclosure policy will supercede the existing regulation regarding discretionary access to records of historical interest. Additionally, the regulations have been updated to reflect developments in the case law and to include updated cost figures to be used in calculating and charging fees. These proposed revisions also contain new provisions implementing the Electronic Freedom of Information Act Amendments of 1996. PMID:10169840

  19. Transportin acts to regulate mitotic assembly events by target binding rather than Ran sequestration

    PubMed Central

    Bernis, Cyril; Swift-Taylor, Beth; Nord, Matthew; Carmona, Sarah; Chook, Yuh Min; Forbes, Douglass J.

    2014-01-01

    The nuclear import receptors importin β and transportin play a different role in mitosis: both act phenotypically as spatial regulators to ensure that mitotic spindle, nuclear membrane, and nuclear pore assembly occur exclusively around chromatin. Importin β is known to act by repressing assembly factors in regions distant from chromatin, whereas RanGTP produced on chromatin frees factors from importin β for localized assembly. The mechanism of transportin regulation was unknown. Diametrically opposed models for transportin action are as follows: 1) indirect action by RanGTP sequestration, thus down-regulating release of assembly factors from importin β, and 2) direct action by transportin binding and inhibiting assembly factors. Experiments in Xenopus assembly extracts with M9M, a superaffinity nuclear localization sequence that displaces cargoes bound by transportin, or TLB, a mutant transportin that can bind cargo and RanGTP simultaneously, support direct inhibition. Consistently, simple addition of M9M to mitotic cytosol induces microtubule aster assembly. ELYS and the nucleoporin 107–160 complex, components of mitotic kinetochores and nuclear pores, are blocked from binding to kinetochores in vitro by transportin, a block reversible by M9M. In vivo, 30% of M9M-transfected cells have spindle/cytokinesis defects. We conclude that the cell contains importin β and transportin “global positioning system”or “GPS” pathways that are mechanistically parallel. PMID:24478460

  20. The Arabidopsis LYST INTERACTING PROTEIN 5 Acts in Regulating Abscisic Acid Signaling and Drought Response.

    PubMed

    Xia, Zongliang; Huo, Yongjin; Wei, Yangyang; Chen, Qiansi; Xu, Ziwei; Zhang, Wei

    2016-01-01

    Multivesicular bodies (MVBs) are unique endosomes containing vesicles in the lumens and play essential roles in many eukaryotic cellular processes. The Arabidopsis LYST INTERACTING PROTEIN 5 (LIP5), a positive regulator of MVB biogenesis, has critical roles in biotic and abiotic stress responses. However, whether the abscisic acid (ABA) signaling is involved in LIP5-mediated stress response is largely unknown. Here, we report that LIP5 functions in regulating ABA signaling and drought response in Arabidopsis. Analyses of a LIP5 promoter-β-glucuronidase (GUS) construct revealed substantial GUS activity in whole seedlings. The expression of LIP5 was induced by ABA and drought, and overexpression of LIP5 led to ABA hypersensitivity, enhanced stomatal closure, reduced water loss, and, therefore, increased drought tolerance. On the contrary, LIP5 knockdown mutants showed ABA-insensitive phenotypes and reduced drought tolerance; suggesting that LIP5 acts in regulating ABA response. Further analysis using a fluorescent dye revealed that ABA and water stress induced cell endocytosis or vesicle trafficking in a largely LIP5-dependent manner. Furthermore, expression of several drought- or ABA-inducible marker genes was significantly down-regulated in the lip5 mutant seedlings. Collectively, our data suggest that LIP5 positively regulates drought tolerance through ABA-mediated cell signaling. PMID:27313589

  1. The Arabidopsis LYST INTERACTING PROTEIN 5 Acts in Regulating Abscisic Acid Signaling and Drought Response

    PubMed Central

    Xia, Zongliang; Huo, Yongjin; Wei, Yangyang; Chen, Qiansi; Xu, Ziwei; Zhang, Wei

    2016-01-01

    Multivesicular bodies (MVBs) are unique endosomes containing vesicles in the lumens and play essential roles in many eukaryotic cellular processes. The Arabidopsis LYST INTERACTING PROTEIN 5 (LIP5), a positive regulator of MVB biogenesis, has critical roles in biotic and abiotic stress responses. However, whether the abscisic acid (ABA) signaling is involved in LIP5-mediated stress response is largely unknown. Here, we report that LIP5 functions in regulating ABA signaling and drought response in Arabidopsis. Analyses of a LIP5 promoter-β-glucuronidase (GUS) construct revealed substantial GUS activity in whole seedlings. The expression of LIP5 was induced by ABA and drought, and overexpression of LIP5 led to ABA hypersensitivity, enhanced stomatal closure, reduced water loss, and, therefore, increased drought tolerance. On the contrary, LIP5 knockdown mutants showed ABA-insensitive phenotypes and reduced drought tolerance; suggesting that LIP5 acts in regulating ABA response. Further analysis using a fluorescent dye revealed that ABA and water stress induced cell endocytosis or vesicle trafficking in a largely LIP5-dependent manner. Furthermore, expression of several drought- or ABA-inducible marker genes was significantly down-regulated in the lip5 mutant seedlings. Collectively, our data suggest that LIP5 positively regulates drought tolerance through ABA-mediated cell signaling. PMID:27313589

  2. 75 FR 43164 - Federal Advisory Committee Act; Emergency Response Interoperability Center Public Safety Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-23

    ... technical framework and requirements for interoperability in order to ensure that the public safety wireless broadband network is interoperable on a nationwide basis. In particular, the Committee will provide... broadband networks, and other matters related to the functioning of the nationwide public safety...

  3. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  4. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  5. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  6. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  7. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the Commission... number of features from the cigarette lighter standard, 16 CFR part 1210, in order to minimize...

  8. Identification of trans-acting factors regulating SamDC expression in Oryza sativa

    SciTech Connect

    Basu, Supratim; Roychoudhury, Aryadeep; Sengupta, Dibyendu N.

    2014-03-07

    Highlights: • Identification of cis elements responsible for SamDC expression by in silico analysis. • qPCR analysis of SamDC expression to abiotic and biotic stress treatments. • Detection of SamDC regulators using identified cis-elements as probe by EMSA. • Southwestern Blot analysis to predict the size of the trans-acting factors. - Abstract: Abiotic stress affects the growth and productivity of crop plants; to cope with the adverse environmental conditions, plants have developed efficient defense machinery comprising of antioxidants like phenolics and flavonoids, and osmolytes like polyamines. SamDC is a key enzyme in the polyamine biosynthesis pathway in plants. In our present communication we have done in silico analysis of the promoter region of SamDC to look for the presence of different cis-regulatory elements contributing to its expression. Based on the presence of different cis-regulatory elements we completed comparative analysis of SamDC gene expression in rice lamina of IR-29 and Nonabokra by qPCR in response to the abiotic stress treatments of salinity, drought, cold and the biotic stress treatments of ABA and light. Additionally, to explore the role of the cis-regulatory elements in regulating the expression of SamDC gene in plants we comparatively analyzed the binding of rice nuclear proteins prepared from IR-29 and Nonabokra undergoing various stress treatments. The intensity of the complex formed was low and inducible in IR-29 in contrast to Nonabokra. Southwestern blot analysis helped in predicting the size of the trans-acting factors binding to these cis-elements. To our knowledge this is the first report on the comprehensive analysis of SamDC gene expression in rice and identification of the trans-acting factors regulating its expression.

  9. Safety, effectiveness, and cost effectiveness of long acting versus intermediate acting insulin for patients with type 1 diabetes: systematic review and network meta-analysis

    PubMed Central

    Tricco, Andrea C; Ashoor, Huda M; Antony, Jesmin; Beyene, Joseph; Veroniki, Areti Angeliki; Isaranuwatchai, Wanrudee; Harrington, Alana; Wilson, Charlotte; Tsouros, Sophia; Soobiah, Charlene; Yu, Catherine H; Hutton, Brian; Hoch, Jeffrey S; Hemmelgarn, Brenda R; Moher, David; Majumdar, Sumit R

    2014-01-01

    Objective To examine the safety, effectiveness, and cost effectiveness of long acting insulin for type 1 diabetes. Design Systematic review and network meta-analysis. Data sources Medline, Cochrane Central Register of Controlled Trials, Embase, and grey literature were searched through January 2013. Study selection Randomized controlled trials or non-randomized studies of long acting (glargine, detemir) and intermediate acting (neutral protamine Hagedorn (NPH), lente) insulin for adults with type 1 diabetes were included. Results 39 studies (27 randomized controlled trials including 7496 patients) were included after screening of 6501 titles/abstracts and 190 full text articles. Glargine once daily, detemir once daily, and detemir once/twice daily significantly reduced hemoglobin A1c compared with NPH once daily in network meta-analysis (26 randomized controlled trials, mean difference −0.39%, 95% confidence interval −0.59% to −0.19%; −0.26%, −0.48% to −0.03%; and −0.36%, −0.65% to −0.08%; respectively). Differences in network meta-analysis were observed between long acting and intermediate acting insulin for severe hypoglycemia (16 randomized controlled trials; detemir once/twice daily versus NPH once/twice daily: odds ratio 0.62, 95% confidence interval 0.42 to 0.91) and weight gain (13 randomized controlled trials; detemir once daily versus NPH once/twice daily: mean difference 4.04 kg, 3.06 to 5.02 kg; detemir once/twice daily versus NPH once daily: −5.51 kg, −6.56 to −4.46 kg; glargine once daily versus NPH once daily: −5.14 kg, −6.07 to −4.21). Compared with NPH, detemir was less costly and more effective in 3/14 cost effectiveness analyses and glargine was less costly and more effective in 2/8 cost effectiveness analyses. The remaining cost effectiveness analyses found that detemir and glargine were more costly but more effective than NPH. Glargine was not cost effective compared with detemir in 2/2 cost effectiveness analyses

  10. Disruption of a long-range cis-acting regulator for Shh causes preaxial polydactyly.

    PubMed

    Lettice, Laura A; Horikoshi, Taizo; Heaney, Simon J H; van Baren, Marijke J; van der Linde, Herma C; Breedveld, Guido J; Joosse, Marijke; Akarsu, Nurten; Oostra, Ben A; Endo, Naoto; Shibata, Minoru; Suzuki, Mikio; Takahashi, Eiichi; Shinka, Toshikatsu; Nakahori, Yutaka; Ayusawa, Dai; Nakabayashi, Kazuhiko; Scherer, Stephen W; Heutink, Peter; Hill, Robert E; Noji, Sumihare

    2002-05-28

    Preaxial polydactyly (PPD) is a common limb malformation in human. A number of polydactylous mouse mutants indicate that misexpression of Shh is a common requirement for generating extra digits. Here we identify a translocation breakpoint in a PPD patient and a transgenic insertion site in the polydactylous mouse mutant sasquatch (Ssq). The genetic lesions in both lie within the same respective intron of the LMBR1/Lmbr1 gene, which resides approximately 1 Mb away from Shh. Genetic analysis of Ssq reveals that the Lmbr1 gene is incidental to the phenotype and that the mutation directly interrupts a cis-acting regulator of Shh. This regulator is most likely the target for generating PPD mutations in human. PMID:12032320

  11. Disruption of a long-range cis-acting regulator for Shh causes preaxial polydactyly

    PubMed Central

    Lettice, Laura A.; Horikoshi, Taizo; Heaney, Simon J. H.; van Baren, Marijke J.; van der Linde, Herma C.; Breedveld, Guido J.; Joosse, Marijke; Akarsu, Nurten; Oostra, Ben A.; Endo, Naoto; Shibata, Minoru; Suzuki, Mikio; Takahashi, Eiichi; Shinka, Toshikatsu; Nakahori, Yutaka; Ayusawa, Dai; Nakabayashi, Kazuhiko; Scherer, Stephen W.; Heutink, Peter; Hill, Robert E.; Noji, Sumihare

    2002-01-01

    Preaxial polydactyly (PPD) is a common limb malformation in human. A number of polydactylous mouse mutants indicate that misexpression of Shh is a common requirement for generating extra digits. Here we identify a translocation breakpoint in a PPD patient and a transgenic insertion site in the polydactylous mouse mutant sasquatch (Ssq). The genetic lesions in both lie within the same respective intron of the LMBR1/Lmbr1 gene, which resides ≈1 Mb away from Shh. Genetic analysis of Ssq reveals that the Lmbr1 gene is incidental to the phenotype and that the mutation directly interrupts a cis-acting regulator of Shh. This regulator is most likely the target for generating PPD mutations in human. PMID:12032320

  12. [Topical issues of biological safety under current conditions. Part 3. Scientific provision for the national regulation of the biological safety framework in its broad interpretation].

    PubMed

    Onishchenko, G G; Smolensky, V Yu; Ezhlova, E B; Demina, Yu V; Toporkov, V P; Toporkov, A V; Lyapin, M N; Kutyrev, V V

    2014-01-01

    Consequent of investigation concerned with biological safety (BS) framework development in its broad interpretation, reflected in the Russian Federation State Acts, identified have been conceptual entity parameters of the up-to-date broad interpretation of BS, which have formed a part of the developed by the authors system for surveillance (prophylaxis, localization, indication, identification, and diagnostics) and control (prophylaxis, localization, and response/elimination) over the emergency situations of biological (sanitary-epidemiological) character. The System functionality is activated through supplying the content with information data which are concerned with monitoring and control of specific internal and external threats in the sphere of BS provision fixed in the Supplement 2 of the International Health Regulations (IHR, 2005), and with the previously characterized nomenclature of hazardous biological factors. The system is designed as a network-based research-and-practice tool for evaluation of the situation in the sphere of BS provision, as well as assessment of efficacy of management decision making as regards BS control and proper State policy implementation. Most of the system elements either directly or indirectly relate to the scope of activities conducted by Federal Service for Surveillance in the Sphere of Consumers Rights Protection and Human Welfare, being substantial argument for allocating coordination functions in the sphere of BS provision to this government agency and consistent with its function as the State Coordinator on IHR (2005). The data collected serve as materials to Draft Federal Law "Concerning biological safety provision of the population". PMID:25971137

  13. Inconsistencies among European Union Pharmaceutical Regulator Safety Communications: A Cross-Country Comparison

    PubMed Central

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

    2014-01-01

    Background The European Medicines Agency (EMA) and national regulators share the responsibility to communicate to healthcare providers postmarketing safety events but little is known about the consistency of this process. We aimed to compare public availability of safety-related communications and drug withdrawals from the EMA and European Union member countries for novel medicines. Methods and Findings We performed a cross-sectional analysis using public Dear Healthcare Professional Communications (DHPCs) for all novel medicines authorized between 2001 and 2010 by the EMA and available for use in France, Netherlands, Spain, and the United Kingdom. Between 2001 and 2010, the EMA approved 185 novel medicines. DHPCs could not be ascertained for the EMA. Among the 4 national regulators, as of April 30, 2013, at least one safety DHPC or withdrawal occurred for 53 (28.6%) medicines, totaling 90 DHPCs and 5 withdrawals. Among these 53 medicines, all 4 national agencies issued at least one communication for 17 (32.1%), three of the four for 25 (47.2%), two of the four for 6 (11.3%), and one of the four for 5 (9.4%). Five drugs were reported to be withdrawn, three by all four countries, one by three and one by two. Among the 95 DHPCs and withdrawals, 20 (21.1%) were issued by all 4 national regulators, 37 (38.9%) by 3 of the 4, 22 (23.2%) by 2 of the 4, and 16 (16.8%) by one. Consistency of making publicly available all identified safety DHPC or withdrawal across regulator pairs varied from 33% to 73% agreement. Conclusions Safety communications were not made publicly available by the EMA. Among the 4 European member countries with national regulators that make DHPCs publicly available since at least 2001, there were substantial inconsistencies in safety communications for novel medicines. The impact of those inconsistencies in terms of public health remains to be determined. PMID:25333986

  14. Knowledge of the animal welfare act and animal welfare regulations influences attitudes toward animal research.

    PubMed

    Metzger, Mitchell M

    2015-01-01

    Recent public-opinion polls indicate that Americans have shown a decline in support for animal experimentation, and several reports suggest a relationship between people's knowledge of animal welfare regulations and their attitudes toward animal research. Therefore, this study was designed to assess respondent's knowledge of several provisions in the Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR), and determine whether exposure to elements of this legislation would influence an individual's attitudes toward the use of animals in research. A survey was used to assess knowledge of animal research regulations and attitudes toward animal research from a sample of individuals recruited through Amazon's Mechanical Turk crowdsourcing marketplace. Results from study 1 confirmed the hypothesis that respondents had little knowledge of various federal regulations that govern animal research activities. Data from study 2 revealed that exposure to elements of the AWA and AWR influenced participants' attitudes toward the use of animals in research. These results suggest that providing information to the general public about the AWA and AWR that protect laboratory animals from abuse and neglect may help alleviate concerns about using animals in research settings. PMID:25651094

  15. Knowledge of the Animal Welfare Act and Animal Welfare Regulations Influences Attitudes toward Animal Research

    PubMed Central

    2015-01-01

    Recent public-opinion polls indicate that Americans have shown a decline in support for animal experimentation, and several reports suggest a relationship between people's knowledge of animal welfare regulations and their attitudes toward animal research. Therefore, this study was designed to assess respondent's knowledge of several provisions in the Animal Welfare Act (AWA) and Animal Welfare Regulations (AWR), and determine whether exposure to elements of this legislation would influence an individual's attitudes toward the use of animals in research. A survey was used to assess knowledge of animal research regulations and attitudes toward animal research from a sample of individuals recruited through Amazon's Mechanical Turk crowdsourcing marketplace. Results from study 1 confirmed the hypothesis that respondents had little knowledge of various federal regulations that govern animal research activities. Data from study 2 revealed that exposure to elements of the AWA and AWR influenced participants’ attitudes toward the use of animals in research. These results suggest that providing information to the general public about the AWA and AWR that protect laboratory animals from abuse and neglect may help alleviate concerns about using animals in research settings. PMID:25651094

  16. APP intracellular domain acts as a transcriptional regulator of miR-663 suppressing neuronal differentiation

    PubMed Central

    Shu, R; Wong, W; Ma, Q H; Yang, Z Z; Zhu, H; Liu, F J; Wang, P; Ma, J; Yan, S; Polo, J M; Bernard, C C A; Stanton, L W; Dawe, G S; Xiao, Z C

    2015-01-01

    Amyloid precursor protein (APP) is best known for its involvement in the pathogenesis of Alzheimer's disease. We have previously demonstrated that APP intracellular domain (AICD) regulates neurogenesis; however, the mechanisms underlying AICD-mediated regulation of neuronal differentiation are not yet fully characterized. Using genome-wide chromatin immunoprecipitation approaches, we found that AICD is specifically recruited to the regulatory regions of several microRNA genes, and acts as a transcriptional regulator for miR-663, miR-3648 and miR-3687 in human neural stem cells. Functional assays show that AICD negatively modulates neuronal differentiation through miR-663, a primate-specific microRNA. Microarray data further demonstrate that miR-663 suppresses the expression of multiple genes implicated in neurogenesis, including FBXL18 and CDK6. Our results indicate that AICD has a novel role in suppression of neuronal differentiation via transcriptional regulation of miR-663 in human neural stem cells. PMID:25695604

  17. Administration of the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, (1987 annual report). Report for January-December 1987

    SciTech Connect

    Not Available

    1988-04-01

    This document is an annual report submitted to the President for transmittal to the Congress. The Food and Drug Administration, through its Center for Devices and Radiological Health, is responsible for the day-to-day administration of the Radiation Control for Health and Safety Act of 1968. The report provides a summary of the operations of the Center in carrying out that responsibility for calendar year 1987. In reviewing the operations of the CDRH as reported in the document, it should be kept in mind that the day-to-day administration of the Act is only part of the Center's function. Other responsibilities include the administration and enforcement of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (not covered in the report). Manufacturers of electronic products are required by 21 CFR 1002.20 to report accidental radiation occurrences to the CDRH. The Center no longer maintains a Radiation Incidents Registry, since accidental radiation occurrences are reported through the Device Experience Network (DEN) and through the requirements of the Medical Device Reporting (MDR) regulations.

  18. Identification of trans-acting factors regulating SamDC expression in Oryza sativa.

    PubMed

    Basu, Supratim; Roychoudhury, Aryadeep; Sengupta, Dibyendu N

    2014-03-01

    Abiotic stress affects the growth and productivity of crop plants; to cope with the adverse environmental conditions, plants have developed efficient defense machinery comprising of antioxidants like phenolics and flavonoids, and osmolytes like polyamines. SamDC is a key enzyme in the polyamine biosynthesis pathway in plants. In our present communication we have done in silico analysis of the promoter region of SamDC to look for the presence of different cis-regulatory elements contributing to its expression. Based on the presence of different cis-regulatory elements we completed comparative analysis of SamDC gene expression in rice lamina of IR-29 and Nonabokra by qPCR in response to the abiotic stress treatments of salinity, drought, cold and the biotic stress treatments of ABA and light. Additionally, to explore the role of the cis-regulatory elements in regulating the expression of SamDC gene in plants we comparatively analyzed the binding of rice nuclear proteins prepared from IR-29 and Nonabokra undergoing various stress treatments. The intensity of the complex formed was low and inducible in IR-29 in contrast to Nonabokra. Southwestern blot analysis helped in predicting the size of the trans-acting factors binding to these cis-elements. To our knowledge this is the first report on the comprehensive analysis of SamDC gene expression in rice and identification of the trans-acting factors regulating its expression. PMID:24530223

  19. 75 FR 35338 - Implementation of Regulations Required Under Title XI of the Food, Conservation and Energy Act of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ...-AB07 Implementation of Regulations Required Under Title XI of the Food, Conservation and Energy Act of... participants regarding compliance. In enacting Title XI of the Food, Conservation and Energy Act of 2008 (Farm..., and its coverage was to encompass the complete chain of commerce and give the Secretary of...

  20. 76 FR 39007 - Native American Graves Protection and Repatriation Act Regulations- Definition of “Indian Tribe”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-05

    ... Office of the Secretary of the Interior 43 CFR Part 10 RIN 1024-AD98 Native American Graves Protection... regulations implementing the Native American Graves Protection and Repatriation Act (NAGPRA) removes the... implementation of the Native American Graves Protection and Repatriation Act, including the issuance...

  1. 78 FR 13576 - Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-28

    ... amended in the March 23, 2012, issue of the Federal Register (77 FR 16932). The Coast Guard revised the... SECURITY Coast Guard 33 CFR Parts 100 and 165 RIN 1625-AA00, AA08 Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within the Fifth Coast Guard District...

  2. Coast Guard Regulations Applied to Offshore Drilling. Module SH-45. Safety and Health.

    ERIC Educational Resources Information Center

    Center for Occupational Research and Development, Inc., Waco, TX.

    This student module on Coast Guard regulations applied to offshore drilling is one of 50 modules concerned with job safety and health. This module presents requirements that apply to the design, construction, equipment, inspection, and operation of offshore drilling units. Following the introduction, 10 objectives (each keyed to a page in the…

  3. 78 FR 29629 - Special Local Regulations and Safety Zones; Recurring Marine Events and Fireworks Displays Within...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-21

    ..., 2012, issue of the Federal Register (77 FR 16932). The Coast Guard revised the list of permanent safety... and Fireworks Displays within the Fifth Coast Guard District'' in the Federal Register (78 FR 13576... SECURITY Coast Guard 33 CFR Parts 100 and 165 RIN 1625-AA00, AA08 Special Local Regulations and...

  4. 49 CFR 177.804 - Compliance with Federal Motor Carrier Safety Regulations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Carrier Safety Regulations. Motor carriers and other persons subject to this part must comply with 49 CFR part 383 and 49 CFR parts 390 through 397 (excluding §§ 397.3 and 397.9) to the extent those... 49 Transportation 2 2010-10-01 2010-10-01 false Compliance with Federal Motor Carrier...

  5. The challenges for global harmonisation of food safety norms and regulations: issues for India.

    PubMed

    Prakash, Jamuna

    2014-08-01

    Safe and adequate food is a human right, safety being a prime quality attribute without which food is unfit for consumption. Food safety regulations are framed to exercise control over all types of food produced, processed and sold so that the customer is assured that the food consumed will not cause any harm. From the Indian perspective, global harmonisation of food regulations is needed to improve food and nutrition security, the food trade and delivery of safe ready-to-eat (RTE) foods at all places and at all times. The Millennium Development Goals (MDGs) put forward to transform developing societies incorporate many food safety issues. The success of the MDGs, including that of poverty reduction, will in part depend on an effective reduction of food-borne diseases, particularly among the vulnerable group, which includes women and children. Food- and water-borne illnesses can be a serious health hazard, being responsible for high incidences of morbidity and mortality across all age groups of people. Global harmonisation of food regulations would assist in facilitating food trade within and outside India through better compliance, ensuring the safety of RTE catered foods, as well as addressing issues related to the environment. At the same time, regulations need to be optimum, as overregulation may have undue negative effects on the food trade. PMID:23553336

  6. 76 FR 31279 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-31

    ...FMCSA requests public comment on: (1) Previously published regulatory guidance on the distinction between interstate and intrastate commerce in deciding whether operations of commercial motor vehicles within the boundaries of a single State are subject to the Federal Motor Carrier Safety Regulations (FMCSRs); (2) the factors the States are using in deciding whether farm vehicle drivers......

  7. 48 CFR 1252.217-80 - Department of Labor Safety and Health Regulations for Ship Repairing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Repairing. As prescribed at (TAR) 48 CFR 1217.7001(b) and (c), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (APR 2005) Nothing contained in this contract shall... Shipyard Employment (29 CFR part 1915); or (c) Any other applicable Federal, State, and local laws,...

  8. 48 CFR 1252.217-80 - Department of Labor Safety and Health Regulations for Ship Repairing.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... Repairing. As prescribed at (TAR) 48 CFR 1217.7001(b) and (c), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (APR 2005) Nothing contained in this contract shall... Shipyard Employment (29 CFR part 1915); or (c) Any other applicable Federal, State, and local laws,...

  9. 76 FR 52138 - Defense Federal Acquisition Regulation Supplement; Identification of Critical Safety Items (DFARS...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-19

    ... a proposed rule at 76 FR 14641 on March 17, 2011, to add a contract clause that clearly identifies... published at 76 FR 14642 on March 17, 2011. Briefly, the combination of the actions of the design control... Regulation Supplement; Identification of Critical Safety Items (DFARS Case 2010-D022) AGENCY:...

  10. 75 FR 16370 - Regulated Navigation Areas, Safety Zones, Security Zones; Deepwater Ports in Boston Captain of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ..., 2008 issue of the Federal Register (73 FR 3316). Public Meeting We do not now plan to hold a public....O. 12777, sec. 2; E.O. 13286, sec. 34, 68 FR 10619; Department of Homeland Security Delegation No... regulated navigation areas (RNAs) and safety and security zones for deepwater liquefied natural gas...

  11. 77 FR 27621 - Special Local Regulations and Safety Zone; War of 1812 Bicentennial Commemorations, Chesapeake...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-11

    ... Bicentennial Commemorations, Chesapeake Bay and Port of Baltimore, MD'' in the Federal Register (77 FR 15323... Zone; War of 1812 Bicentennial Commemorations, Chesapeake Bay and Port of Baltimore, MD AGENCY: Coast... local regulations and a safety zone in the Chesapeake Bay and Port of Baltimore, Maryland for War...

  12. 77 FR 15323 - Special Local Regulations and Safety Zone; War of 1812 Bicentennial Commemorations, Chesapeake...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-15

    ... Federal Register (73 FR 3316). Public Meeting We do not now plan to hold a public meeting. But you may...; War of 1812 Bicentennial Commemorations, Chesapeake Bay and Port of Baltimore, MD AGENCY: Coast Guard... special local regulations and safety zone in the Chesapeake Bay and Port of Baltimore, Maryland for War...

  13. 48 CFR 1252.217-80 - Department of Labor Safety and Health Regulations for Ship Repairing.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... Repairing. As prescribed at (TAR) 48 CFR 1217.7001(b) and (c), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (APR 2005) Nothing contained in this contract shall... Shipyard Employment (29 CFR part 1915); or (c) Any other applicable Federal, State, and local laws,...

  14. 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

    ... vehicles (76 FR 31279). Recognizing that changes in regulatory guidance (if implemented by a State) could... the Federal Motor Carrier Safety Regulations to Operators of Certain Farm Vehicles and Off-Road...) to operators of farm vehicles: first, the interpretation of interstate commerce as it applies...

  15. 77 FR 46285 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-03

    ... designated race area, and create a temporary safety zone around racing vessels (77 FR 41902, July 17, 2012... Golden Gate Bridge and Alcatraz Island. DATES: This notice of availability is effective on August 3, 2012... the vicinity of the Golden Gate Bridge and Alcatraz Island. The special local regulation and...

  16. 77 FR 22706 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-17

    ... notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316... public input, we proposed a special local regulation and safety zone on January 30, 2012 (77 FR 4501). In... adjacent to the City of San Francisco waterfront in the vicinity of the Golden Gate Bridge and...

  17. 77 FR 4501 - Special Local Regulation and Safety Zone; America's Cup Sailing Events, San Francisco, CA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ...The Coast Guard proposes to adopt a temporary special local regulation and temporary safety zone for those portions of the ``America's Cup World Series,'' the ``Louis Vuitton Cup'' challenger selection series, and the ``America's Cup Finals Match'' sailing regattas that may be conducted in the waters of San Francisco Bay adjacent to the City of San Francisco waterfront in the vicinity of the......

  18. 76 FR 30255 - Special Local Regulations and Safety Zones; Recurring Events in Northern New England

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-25

    ...The Coast Guard is announcing specific dates and times for Special Local Regulations and Safety Zones occurring in the Northern New England Captain of the Port Zone. This action is necessary to protect marine traffic and spectators from the hazards associated with powerboat races, regattas, boat parades, rowing and paddling boat races, swim events, and fireworks displays. During the......

  19. 75 FR 4305 - Regulatory Guidance Concerning the Applicability of the Federal Motor Carrier Safety Regulations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-27

    ... Applicability of the Federal Motor Carrier Safety Regulations to Texting by Commercial Motor Vehicle Drivers.... SUMMARY: The FMCSA announces regulatory guidance concerning texting while driving a commercial motor... operators engaged in ``texting'' on an electronic device while driving a CMV in interstate...

  20. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  1. 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Are my HCT/P's regulated solely under section 361... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS,...

  2. 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Are my HCT/P's regulated solely under section 361... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS,...

  3. MecA Protein Acts as a Negative Regulator of Genetic Competence in Streptococcus mutans

    PubMed Central

    Tian, Xiao-Lin; Dong, Gaofeng; Liu, Tianlei; Gomez, Zubelda A.; Wahl, Astrid; Hols, Pascal

    2013-01-01

    Streptococcus mutans develops competence for genetic transformation through a complex network that receives inputs from at least two signaling peptides, competence-stimulating peptide (CSP) and sigX-inducing peptide (XIP). The key step of competence induction is the transcriptional activation of comX, which encodes an alternative sigma factor, SigX (σX), controlling the expression of late competence genes essential for DNA uptake and recombination. In this study, we provide evidence that MecA acts as a negative regulator in the posttranslational regulation of SigX in S. mutans. Using luxAB transcriptional reporter strains, we demonstrate that MecA represses the expression of late competence genes in S. mutans grown in a complex medium that is subpermissive for competence induction by CSP. The negative regulation of competence by MecA requires the presence of a functional SigX. Accordingly, inactivation of MecA results in a prolonged competence state of S. mutans under this condition. We have also found that the AAA+ protease ClpC displays a similar repressing effect on late competence genes, suggesting that both MecA and ClpC function coordinately to regulate competence in the same regulatory circuit in S. mutans. This suggestion is strongly supported by the results of bacterial two-hybrid assays, which demonstrate that MecA interacts with both SigX and ClpC, forming a ternary SigX-MecA-ClpC complex. Western blot analysis also confirms that inactivation of MecA or ClpC results in the intracellular accumulation of the SigX in S. mutans. Together, our data support the notion that MecA mediates the formation of a ternary SigX-MecA-ClpC complex that sequesters SigX and thereby negatively regulates genetic competence in S. mutans. PMID:24039267

  4. 14-3-3 family members act coordinately to regulate mitotic progression.

    PubMed

    Dalal, Sorab N; Yaffe, Michael B; DeCaprio, James A

    2004-05-01

    The mitosis promoting phosphatase, cdc25C, is a target of both the DNA replication and DNA damage checkpoint pathways. These pathways regulate cdc25C function, in part, by promoting the association of cdc25C with 14-3-3 proteins, which results in the retention of cdc25C in the cytoplasm. To determine which 14-3-3 proteins were required to regulate cdc25C function, we tested the ability of various 14-3-3 family members to form a complex with and negatively regulate cdc25C in human cells. Two 14-3-3 family members, 14-3-3epsilon and 14-3-3gamma specifically formed a complex with cdc25C but not with the 14-3-3 binding defective cdc25C mutant, S216A. In addition, 14-3-3epsilon and 14-3-3gamma inhibited the ability of cdc25C, but not the S216A mutant, to induce premature chromatin condensation (PCC) in U-2OS cells. These results suggested that the reduction in PCC by 14-3-3epsilon and 14-3-3gamma was due to inhibition of cdc25C function. In contrast, 14-3-3sigma was unable to form a complex with cdc25C, but was able to inhibit the ability of both wild type cdc25C and S216A to induce PCC. This suggests that 14-3-3sigma regulates entry into mitosis independently of cdc25C and 14-3-3epsilon and 14-3-3gamma. Thus, specific members of the 14-3-3 family of proteins may act coordinately to maintain the DNA replication checkpoint by regulating the activity of different cell cycle proteins. PMID:15107609

  5. Eya 1 acts as a critical regulator for specifying the metanephric mesenchyme.

    PubMed

    Sajithlal, Gangadharan; Zou, Dan; Silvius, Derek; Xu, Pin-Xian

    2005-08-15

    Although it is well established that the Gdnf-Ret signal transduction pathway initiates metanephric induction, no single regulator has yet been identified to specify the metanephric mesenchyme or blastema within the intermediate mesoderm, the earliest step of metanephric kidney development and the molecular mechanisms controlling Gdnf expression are essentially unknown. Previous studies have shown that a loss of Eya 1 function leads to renal agenesis that is a likely result of failure of metanephric induction. The studies presented here demonstrate that Eya 1 specifies the metanephric blastema within the intermediate mesoderm at the caudal end of the nephrogenic cord. In contrast to its specific roles in metanephric development, Eya 1 appears dispensable for the formation of nephric duct and mesonephric tubules. Using a combination of null and hypomorphic Eya 1 mutants, we now demonstrated that approximately 20% of normal Eya 1 protein level is sufficient for establishing the metanephric blastema and inducing the ureteric bud formation but not for its normal branching. Using Eya 1, Gdnf, Six 1 and Pax 2 mutant mice, we show that Eya 1 probably functions at the top of the genetic hierarchy controlling kidney organogenesis and it acts in combination with Six 1 and Pax 2 to regulate Gdnf expression during UB outgrowth and branching. These findings uncover an essential function for Eya 1 as a critical determination factor in acquiring metanephric fate within the intermediate mesoderm and as a key regulator of Gdnf expression during ureteric induction and branching morphogenesis. PMID:16018995

  6. Polycomb Group Protein Pcgf6 Acts as a Master Regulator to Maintain Embryonic Stem Cell Identity

    PubMed Central

    Yang, Chao-Shun; Chang, Kung-Yen; Dang, Jason; Rana, Tariq M.

    2016-01-01

    The polycomb repressive complex 1 (PRC1) is a multi-subunit complex that plays critical roles in the epigenetic modulation of gene expression. Here, we show that the PRC1 component polycomb group ring finger 6 (Pcgf6) is required to maintain embryonic stem cell (ESC) identity. In contrast to canonical PRC1, Pcgf6 acts as a positive regulator of transcription and binds predominantly to promoters bearing active chromatin marks. Pcgf6 is expressed at high levels in ESCs, and knockdown reduces the expression of the core ESC regulators Oct4, Sox2, and Nanog. Conversely, Pcgf6 overexpression prevents downregulation of these factors and impairs differentiation. In addition, Pcgf6 enhanced reprogramming in both mouse and human somatic cells. The genomic binding profile of Pcgf6 is highly similar to that of trithorax group proteins, but not of PRC1 or PRC2 complexes, suggesting that Pcgf6 functions atypically in ESCs. Our data reveal novel roles for Pcgf6 in directly regulating Oct4, Nanog, Sox2, and Lin28 expression to maintain ESC identity. PMID:27247273

  7. Epithelial IL-1R2 acts as a homeostatic regulator during remission of ulcerative colitis

    PubMed Central

    Mora-Buch, R; Dotti, I; Planell, N; Calderón-Gómez, E; Jung, P; Masamunt, M C; Llach, J; Ricart, E; Batlle, E; Panés, J; Salas, A

    2016-01-01

    Ulcerative colitis (UC) is a chronic intestinal inflammatory disease that may undergo periods of activity followed by remission. We aimed to identify the endogenous regulatory mechanisms that may promote disease remission. Transcriptional and protein analysis of the intestinal mucosa revealed that the IL-1 decoy receptor, interleukin-1 receptor type 2 (IL1R2), was upregulated in remission compared with active UC and controls. We identified epithelial cells as being responsible for increased IL-1R2 production during remission. Expression of IL1R2 was negatively regulated by Wnt/beta-catenin signals in colonic crypts or epithelial stem cell cultures; accordingly, epithelial stem cells upregulated IL-1R2 upon differentiation. Blocking IL-1R2 in isolated colonic crypt cultures of UC patients in remission and T-cell cultures stimulated with biopsy supernatant from UC patients in remission boosted IL-1β-dependent production of inflammation-related cytokines. Finally, IL1R2 transcription was significantly lower in patients that relapsed during a 1-year follow-up period compared with those in endoscopic remission. Collectively, our results reveal that the IL-1/IL-1R2 axis is differentially regulated in the remitting intestinal mucosa of UC patients. We hypothesize that IL-1R2 in the presence of low concentrations of IL-1β may act locally as a regulator of intestinal homeostasis. PMID:26530134

  8. The NEPA mandate and federal regulation of the natural gas industry. [NEPA (National Environmental Policy Act)

    SciTech Connect

    Hoecker, J.J.

    1992-01-01

    Utility regulators increasingly take responsibility for the [open quotes]extemalities[close quotes] associated with their decisions, meaning the economic and social costs related to rate decisions or other kinds of authorizations. Yet, when Congress adopted the National Environmental Policy Act of 1969 (NEPA), it intervened to ensure protection of the natural environment, not from abuses by the citizenry but from the activities of the federal government itself. Comprised of action forcing procedures, NEPA was designed to infuse the decisional processes of federal agencies with a broad awareness of the environmental consequences of their actions. NEPA encourages decisionmakers to counterbalance the organic statutory and political missions of their departments or agencies with a sensitivity to the ecological consequences of their directives and authorizations. This paper examines how the requirements of NEPA have fared in the environment of classical public utility regulation at the Federal Energy Regulatory Commission. Commission proceedings did not evidence any widely held opinion that economic regulation of the gas industry is hostile to the NEPA process.

  9. 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

    ... Management System Number FMCSA-2011-0146 by any of the following methods Web site: http://www.regulations.gov...-2251. Mail: Docket Management Facility; U.S. Department of Transportation, Room W12-140, 1200 New... Privacy Act System of Records Notice for the DOT Federal Docket Management System published in the...

  10. 78 FR 30296 - Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual Change in the Producer Price Index for Finished Goods The Commission's regulations include a methodology for oil...

  11. 77 FR 29997 - Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-21

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual Change in the Producer Price Index for Finished Goods The Commission's regulations include a methodology for oil...

  12. 76 FR 28966 - Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual Change in the Producer Price Index for Finished Goods The Commission's regulations include a methodology for oil...

  13. S. 1583: This Act may be cited as the Pipeline Safety Improvement Act of 1991, introduced in the United States Senate, One Hundred Second Congress, First Session, September 16, 1991

    SciTech Connect

    Not Available

    1991-01-01

    This bill would amend the Natural Gas Pipeline Act of 1968 and the Hazardous Liquid Pipeline Safety Act of 1979 to authorize appropriations and to improve pipeline safety. The bill describes the following: authorization of appropriations; definitions; environmental protection; identification of certain pipelines; rapid shutdown of pipeline facilities; excess flow valves; replacement of cast iron pipelines; safety of pipe not owned by pipeline operators; one-call notification systems; underwater abandoned pipeline facilities; study of underwater abandoned pipeline facilities; and exemption from hours of service requirements.

  14. Pesticide regulations and farm worker safety: the need to improve pesticide regulations in Viet Nam

    PubMed Central

    Connell, Des; Miller, Greg; Rutherford, Shannon; Chu, Cordia

    2012-01-01

    Abstract Agricultural pesticide use in Viet Nam has more than tripled since 1990. However, pesticide legislation and regulations have not been developed in response to this large increase in usage, as a result of which pesticides pose a serious threat to human health and the environment. This paper identifies the need to improve pesticide regulations in Viet Nam through a comparative analysis of pesticide regulations in Viet Nam and the United States of America, where the rate of acute poisoning among agricultural workers is much lower than in Viet Nam and where information pertaining to pesticide regulations is made accessible to the public. The analysis identified several measures that would help to improve Viet Nam’s pesticide regulations. These include enhancing pesticide legislation, clarifying the specific roles and active involvement of both the environmental and health sectors; performing a comprehensive risk–benefit evaluation of pesticide registration and management practices; improving regulations on pesticide suspension and cancellation, transport, storage and disposal; developing import and export policies and enhancing pesticide-related occupational safety programmes. PMID:22690037

  15. 48 CFR 52.222-4 - Contract Work Hours and Safety Standards Act-Overtime Compensation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... duplicate those required for construction work by Department of Labor regulations at 29 CFR 5.5(a)(3... employing laborers or mechanics (see Federal Acquisition Regulation 22.300) shall require or permit them to... all laborers and mechanics working on the contract during the contract and shall make them...

  16. 48 CFR 52.222-4 - Contract Work Hours and Safety Standards Act-Overtime Compensation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... duplicate those required for construction work by Department of Labor regulations at 29 CFR 5.5(a)(3... employing laborers or mechanics (see Federal Acquisition Regulation 22.300) shall require or permit them to... all laborers and mechanics working on the contract during the contract and shall make them...

  17. 48 CFR 52.222-4 - Contract Work Hours and Safety Standards Act-Overtime Compensation.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... duplicate those required for construction work by Department of Labor regulations at 29 CFR 5.5(a)(3... employing laborers or mechanics (see Federal Acquisition Regulation 22.300) shall require or permit them to... all laborers and mechanics working on the contract during the contract and shall make them...

  18. 76 FR 69613 - Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port New York Zone

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-09

    ...The Coast Guard is removing, adding, and consolidating special local regulations and establishing permanent safety zones in the Coast Guard Captain of the Port (COTP) New York Zone for annual recurring swim events, fireworks displays, and marine events (annual recurring events). When these special local regulations or safety zones are activated and subject to enforcement, this will restrict......

  19. 48 CFR 3052.217-99 - Department of Labor safety and health regulations for ship repairing (USCG).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... at (HSAR) 48 CFR 3017.9000(a) and (b), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (DEC 2003) Nothing contained in this contract shall relieve the... (29 U.S.C. 651, et seq.); (b) The Safety and Health Regulations for Ship Repairing (29 CFR part...

  20. 33 CFR 165.T09-1080 - Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL. 165.T09-1080 Section 165.T09-1080 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY REGULATED NAVIGATION AREAS AND...

  1. 48 CFR 3052.217-99 - Department of Labor safety and health regulations for ship repairing (USCG).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... at (HSAR) 48 CFR 3017.9000(a) and (b), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (DEC 2003) Nothing contained in this contract shall relieve the... (29 U.S.C. 651, et seq.); (b) The Safety and Health Regulations for Ship Repairing (29 CFR part...

  2. 48 CFR 3052.217-99 - Department of Labor safety and health regulations for ship repairing (USCG).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... at (HSAR) 48 CFR 3017.9000(a) and (b), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (DEC 2003) Nothing contained in this contract shall relieve the... (29 U.S.C. 651, et seq.); (b) The Safety and Health Regulations for Ship Repairing (29 CFR part...

  3. 48 CFR 3052.217-99 - Department of Labor safety and health regulations for ship repairing (USCG).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... at (HSAR) 48 CFR 3017.9000(a) and (b), insert the following clause: Department of Labor Safety and Health Regulations for Ship Repair (DEC 2003) Nothing contained in this contract shall relieve the... (29 U.S.C. 651, et seq.); (b) The Safety and Health Regulations for Ship Repairing (29 CFR part...

  4. 48 CFR 3052.217-99 - Department of Labor safety and health regulations for ship repairing (USCG).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... (29 U.S.C. 651, et seq.); (b) The Safety and Health Regulations for Ship Repairing (29 CFR part 1915... at (HSAR) 48 CFR 3017.9000(a) and (b), insert the following clause: Department of Labor Safety and... and health regulations for ship repairing (USCG). 3052.217-99 Section 3052.217-99 Federal...

  5. Assessing coal-mine safety regulation: A pooled time-series analysis

    SciTech Connect

    Chun Youngpyoung.

    1991-01-01

    This study attempts to assess the independent, relative, and conjoint effects of four types of variables on coal-mine safety: administrative (mine inspections, mine investigations, and mine safety grants); political (state party competition, gubernatorial party affiliation, and deregulation); economic (state per-capita income and unemployment rates); task-related (mine size, technology, and type of mining), and state dummy variables. Trend, Pearson correlation, and pooled time-series analyses are performed on fatal and nonfatal injury rates reported in 25 coal-producing states during the 1975-1985 time period. These are then interpreted in light of three competing theories of regulation: capture, nonmarket failure, and threshold. Analysis reveals: (1) distinctions in the total explanatory power of the model across different types of injuries, as well as across presidential administrations; (2) a consistently more powerful impact on safety of informational implementation tools (safety education grants) over command-and-control approaches (inspections and investigations) or political variables; and (3) limited, albeit conjectural, support for a threshold theory of regulation in the coal mine safety arena.

  6. 78 FR 57320 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ...The Food and Drug Administration (FDA or we) is announcing two public meetings to discuss two proposed rules aimed at strengthening assurances that imported food meets the same safety standards as food produced domestically. The Foreign Supplier Verification Programs (FSVP) proposal establishes requirements for importers to verify that their foreign suppliers are implementing the modern,......

  7. 76 FR 45820 - Food Safety Modernization Act Domestic and Foreign Facility Reinspections, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ... activities on behalf of FDA's product centers, including the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), which have FSMA implementation responsibilities... inspection trips related to FDA's food and veterinary medicine programs, which averaged a total of...

  8. 78 FR 6762 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules To Establish Standards...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-31

    ... Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food... produce safety proposed rule) and for current good manufacturing practice and hazard analysis and risk... (60 FR 65096, December 18, 1995) and for juice (21 CFR part 120) in 2001 (66 FR 6138, January 19,...

  9. 76 FR 20588 - FDA Food Safety Modernization Act: Focus on Preventive Controls for Facilities; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... examine and update current good manufacturing practice requirements and to develop an animal feed safety... methods in manufacturing, processing, packing, and holding food and feed. FDA is interested in making... three of the following five break-out sessions: Preventive Controls Guidance, On- Farm Manufacturing...

  10. Alcohol-related road traffic accidents before and after the passing of the Road Traffic Safety Act in Croatia.

    PubMed

    Missoni, Eduard; Bozić, Boris; Missoni, Ivan

    2012-12-01

    The aim of this study was to gather enough data in order to formulate theory- and research-based recommendations to policy makers with the intention of decreasing the number of alcohol-related accidents and victims on Croatian roads. The data on the injured traffic participants and the share of participants under the influence of alcohol were collected from the police reports of the Traffic Police Department, Ministry of the Interior, written at the scene of the respective accidents. This documentation was then processed by descriptive epidemiology and analysed through a four-year period, before and after the passing of the New Road Traffic Safety Act in the Republic of Croatia, on 20 August 2004. In the first six months of 2005, after the passing of the Act, there were 3,275 accidents caused by the motorists under the influence of alcohol (12.5% of all the accidents), with 64 persons killed. Only 5 fatalities (8%) were caused by the drivers with measured blood alcohol concentration of up to 0.5 per thousand. As much as 27 fatalities (42%) were caused by the drivers with measured more than 1.5 per thousand, while half of the fatalities, 32 (50%), were caused by drivers with 0.5-1.5 per thousand. In this period, more than 451,000 violations were recorded, whereas in the same period of the previous year, the number of violations was about 519,000. A reduction of the total number of accidents is the result of the new regulation provision, according to which the incidents without human victims do not have to be reported to the police. The number of traffic accidents caused by drivers under the influence of alcohol had increased by some dozen per cents, namely: 2005 - 6,219 persons, 2006- 6,590 persons, noting that in 2006 one less person was killed (123) compared to 2005. In 2005, drivers with alcohol concentration of 0-0.5 per thousand caused 1,096 accidents, with 14 fatalities, whereas in 2006 there were 1,164 accidents with 9 fatalities. A total of 2,314 accidents

  11. atonal regulates neurite arborization but does not act as a proneural gene in the Drosophila brain

    NASA Technical Reports Server (NTRS)

    Hassan, B. A.; Bermingham, N. A.; He, Y.; Sun, Y.; Jan, Y. N.; Zoghbi, H. Y.; Bellen, H. J.

    2000-01-01

    Drosophila atonal (ato) is the proneural gene of the chordotonal organs (CHOs) in the peripheral nervous system (PNS) and the larval and adult photoreceptor organs. Here, we show that ato is expressed at multiple stages during the development of a lineage of central brain neurons that innervate the optic lobes and are required for eclosion. A novel fate mapping approach shows that ato is expressed in the embryonic precursors of these neurons and that its expression is reactivated in third instar larvae (L3). In contrast to its function in the PNS, ato does not act as a proneural gene in the embryonic brain. Instead, ato performs a novel function, regulating arborization during larval and pupal development by interacting with Notch.

  12. 78 FR 41300 - Special Local Regulations and Safety Zones; Marine Events in Captain of the Port Long Island...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-10

    ...The Coast Guard is establishing one special local regulation for a regatta and four safety zones for two fireworks displays and two swim events within the Captain of the Port (COTP) Long Island Sound (LIS) Zone. This action is necessary to provide for the safety of life on navigable waters during these events. The special local regulation and safety zones will facilitate public notification of......

  13. Enhancer of zeste acts as a major developmental regulator of Ciona intestinalis embryogenesis

    PubMed Central

    Le Goff, Emilie; Martinand-Mari, Camille; Martin, Marianne; Feuillard, Jérôme; Boublik, Yvan; Godefroy, Nelly; Mangeat, Paul; Baghdiguian, Stephen; Cavalli, Giacomo

    2015-01-01

    ABSTRACT The paradigm of developmental regulation by Polycomb group (PcG) proteins posits that they maintain silencing outside the spatial expression domains of their target genes, particularly of Hox genes, starting from mid embryogenesis. The Enhancer of zeste [E(z)] PcG protein is the catalytic subunit of the PRC2 complex, which silences its targets via deposition of the H3K27me3 mark. Here, we studied the ascidian Ciona intestinalis counterpart of E(z). Ci-E(z) is detected by immunohistochemistry as soon as the 2- and 4-cell stages as a cytoplasmic form and becomes exclusively nuclear thereafter, whereas the H3K27me3 mark is detected starting from the gastrula stage and later. Morpholino invalidation of Ci-E(z) leads to the total disappearance of both Ci-E(z) protein and its H3K27me3 mark. Ci-E(z) morphants display a severe phenotype. Strikingly, the earliest defects occur at the 4-cell stage with the dysregulation of cell positioning and mitotic impairment. At later stages, Ci-E(z)-deficient embryos are affected by terminal differentiation defects of neural, epidermal and muscle tissues, by the failure to form a notochord and by the absence of caudal nerve. These major phenotypic defects are specifically rescued by injection of a morpholino-resistant Ci-E(z) mRNA, which restores expression of Ci-E(z) protein and re-deposition of the H3K27me3 mark. As observed by qPCR analyses, Ci-E(z) invalidation leads to the early derepression of tissue-specific developmental genes, whereas late-acting developmental genes are generally down-regulated. Altogether, our results suggest that Ci-E(z) plays a major role during embryonic development in Ciona intestinalis by silencing early-acting developmental genes in a Hox-independent manner. PMID:26276097

  14. Aurora-A acts as a tumor suppressor and regulates self-renewal of Drosophila neuroblasts

    PubMed Central

    Wang, Hongyan; Somers, Gregory W.; Bashirullah, Arash; Heberlein, Ulrike; Yu, Fengwei; Chia, William

    2006-01-01

    The choice of self-renewal versus differentiation is a fundamental issue in stem cell and cancer biology. Neural progenitors of the Drosophila post-embryonic brain, larval neuroblasts (NBs), divide asymmetrically in a stem cell-like fashion to generate a self-renewing NB and a Ganglion Mother Cell (GMC), which divides terminally to produce two differentiating neuronal/glial daughters. Here we show that Aurora-A (AurA) acts as a tumor suppressor by suppressing NB self-renewal and promoting neuronal differentiation. In aurA loss-of-function mutants, supernumerary NBs are produced at the expense of neurons. AurA suppresses tumor formation by asymmetrically localizing atypical protein kinase C (aPKC), an NB proliferation factor. Numb, which also acts as a tumor suppressor in larval brains, is a major downstream target of AurA and aPKC. Notch activity is up-regulated in aurA and numb larval brains, and Notch signaling is necessary and sufficient to promote NB self-renewal and suppress differentiation in larval brains. Our data suggest that AurA, aPKC, Numb, and Notch function in a pathway that involved a series of negative genetic interactions. We have identified a novel mechanism for controlling the balance between self-renewal and neuronal differentiation during the asymmetric division of Drosophila larval NBs. PMID:17182870

  15. 77 FR 45636 - Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-01

    ... the fees authorized by section 743 of the FD&C Act on small businesses (76 FR 45818, Aug. 1, 2011.... These indirect ] and supporting FTEs function in budget, facility, human resource, information... Federal Register of August 1, 2011 (see 76 FR 45831). Utilizing the method set forth in section...

  16. Design-based regulation and patient safety: a regulatory studies perspective.

    PubMed

    Yeung, Karen; Dixon-Woods, Mary

    2010-08-01

    The optimal choice of regulatory approach for securing patient safety is an important problem. In this review article, we show how insights from the field of regulatory studies can provide a conceptual apparatus for analysis of important problems in the regulation of medicine and healthcare. Design-based regulation operates through technical constraints that are self-executing. Technology, by concretising rules about proper behaviour and conduct, not only functions as a regulatory instrument, but may also encode particular values and versions of rationality. As debates in the broader area of "code" or "design"-based regulation, including the crime prevention context have highlighted, design-based approaches may have significant social, political and ethical implications. Though design-based regulation can be an attractive solution where there is widespread agreement about what constitutes good medical practice, it is considerably more problematic where there is contestation about what constitutes an error and who owns the definition of an error. Design-based regulation involves challenges to professional agency and authority, and engages with wider debates about the regulation of the medical profession. It is vital that the introduction of patient safety technology is sensitive to the values and motives that get encoded in design. PMID:20538395

  17. 48 CFR 52.250-4 - SAFETY Act Pre-qualification Designation Notice.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... certification means a determination by DHS pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9....S.C. 443(a), as further delineated in 6 CFR 25.4, that a particular Anti-Terrorism Technology... submitted for DHS review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY...

  18. 48 CFR 52.250-4 - SAFETY Act Pre-qualification Designation Notice.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... certification means a determination by DHS pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9....S.C. 443(a), as further delineated in 6 CFR 25.4, that a particular Anti-Terrorism Technology... submitted for DHS review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY...

  19. 48 CFR 52.250-4 - SAFETY Act Pre-qualification Designation Notice.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... certification means a determination by DHS pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9....S.C. 443(a), as further delineated in 6 CFR 25.4, that a particular Anti-Terrorism Technology... submitted for DHS review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY...

  20. 48 CFR 52.250-4 - SAFETY Act Pre-qualification Designation Notice.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... certification means a determination by DHS pursuant to 6 U.S.C. 442(d), as further delineated in 6 CFR 25.9....S.C. 443(a), as further delineated in 6 CFR 25.4, that a particular Anti-Terrorism Technology... submitted for DHS review are based on the factors identified in 6 CFR 25.4(b). (e) Neither SAFETY...

  1. Clinical safety of tbo-filgrastim, a short-acting human granulocyte colony-stimulating factor.

    PubMed

    Pettengell, Ruth; Bias, Peter; Mueller, Udo; Lang, Nicole

    2016-06-01

    The recombinant human granulocyte colony-stimulating factor (G-CSF) known as filgrastim (Tevagrastim(®), Ratiograstim(®), Biograstim(®)) in Europe (approved in 2008) and tbo-filgrastim (Granix(®)) in the USA (approved in 2012; Teva Pharmaceutical Industries Ltd., Petach Tikva, Israel) is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. This article presents pooled clinical data for tbo-filgrastim compared with Neupogen(®) (Amgen, Thousand Oaks, CA, USA) as well as tbo-filgrastim post-marketing safety data. The safety and efficacy of tbo-filgrastim were evaluated in three phase III studies in 677 patients receiving myelosuppressive chemotherapy and study drug (348 patients with breast cancer, 237 with lung cancer, 92 with non-Hodgkin lymphoma). In each study, the efficacy of tbo-filgrastim was similar to that of Neupogen. Overall, 633 (93.5 %) patients receiving the study drug experienced 6093 treatment-emergent adverse events (AEs), most of which were related to chemotherapy. Adverse events related to the study drug (tbo-filgrastim or Neupogen) were experienced by 185 (27.3 %) patients; 19 (2.8 %) had severe drug-related AEs, 5 (0.7 %) had drug-related serious AEs, and 6 (0.9 %) discontinued the study due to drug-related AEs. Overall, the most common drug-related AEs were bone pain (7.1 %), myalgia (4.0 %), and asthenia (4.4 %). The post-marketing safety profile of tbo-filgrastim was consistent with that observed during the clinical studies. The availability of tbo-filgrastim, a G-CSF with safety and efficacy comparable to those of Neupogen, provides physicians with an alternative treatment option for supportive care of patients with non-myeloid malignancies receiving myelosuppressive chemotherapy. PMID:26780505

  2. ABORTED MICROSPORES Acts as a Master Regulator of Pollen Wall Formation in Arabidopsis.

    PubMed

    Xu, Jie; Ding, Zhiwen; Vizcay-Barrena, Gema; Shi, Jianxin; Liang, Wanqi; Yuan, Zheng; Werck-Reichhart, Danièle; Schreiber, Lukas; Wilson, Zoe A; Zhang, Dabing

    2014-04-29

    Mature pollen is covered by durable cell walls, principally composed of sporopollenin, an evolutionary conserved, highly resilient, but not fully characterized, biopolymer of aliphatic and aromatic components. Here, we report that ABORTED MICROSPORES (AMS) acts as a master regulator coordinating pollen wall development and sporopollenin biosynthesis in Arabidopsis thaliana. Genome-wide coexpression analysis revealed 98 candidate genes with specific expression in the anther and 70 that showed reduced expression in ams. Among these 70 members, we showed that AMS can directly regulate 23 genes implicated in callose dissociation, fatty acids elongation, formation of phenolic compounds, and lipidic transport putatively involved in sporopollenin precursor synthesis. Consistently, ams mutants showed defective microspore release, a lack of sporopollenin deposition, and a dramatic reduction in total phenolic compounds and cutin monomers. The functional importance of the AMS pathway was further demonstrated by the observation of impaired pollen wall architecture in plant lines with reduced expression of several AMS targets: the abundant pollen coat protein extracellular lipases (EXL5 and EXL6), and CYP98A8 and CYP98A9, which are enzymes required for the production of phenolic precursors. These findings demonstrate the central role of AMS in coordinating sporopollenin biosynthesis and the secretion of materials for pollen wall patterning. PMID:24781116

  3. PKR is activated by cellular dsRNAs during mitosis and acts as a mitotic regulator

    PubMed Central

    Kim, Yoosik; Lee, Jung Hyun; Park, Jong-Eun; Cho, Jun; Yi, Hyerim; Kim, V. Narry

    2014-01-01

    dsRNA-dependent protein kinase R (PKR) is a ubiquitously expressed enzyme well known for its roles in immune response. Upon binding to viral dsRNA, PKR undergoes autophosphorylation, and the phosphorylated PKR (pPKR) regulates translation and multiple signaling pathways in infected cells. Here, we found that PKR is activated in uninfected cells, specifically during mitosis, by binding to dsRNAs formed by inverted Alu repeats (IRAlus). While PKR and IRAlu-containing RNAs are segregated in the cytosol and nucleus of interphase cells, respectively, they interact during mitosis when nuclear structure is disrupted. Once phosphorylated, PKR suppresses global translation by phosphorylating the α subunit of eukaryotic initiation factor 2 (eIF2α). In addition, pPKR acts as an upstream kinase for c-Jun N-terminal kinase and regulates the levels of multiple mitotic factors such as CYCLINS A and B and POLO-LIKE KINASE 1 and phosphorylation of HISTONE H3. Disruption of PKR activation via RNAi or expression of a transdominant-negative mutant leads to misregulation of the mitotic factors, delay in mitotic progression, and defects in cytokinesis. Our study unveils a novel function of PKR and endogenous dsRNAs as signaling molecules during the mitosis of uninfected cells. PMID:24939934

  4. Gamma-aminobutyric acid acts as a specific virulence regulator in Pseudomonas aeruginosa.

    PubMed

    Dagorn, Audrey; Hillion, Mélanie; Chapalain, Annelise; Lesouhaitier, Olivier; Duclairoir Poc, Cécile; Vieillard, Julien; Chevalier, Sylvie; Taupin, Laure; Le Derf, Franck; Feuilloley, Marc G J

    2013-02-01

    Gamma-aminobutyric acid (GABA) is widespread in the environment and can be used by animal and plants as a communication molecule. Pseudomonas species, in particular fluorescent ones, synthesize GABA and express GABA-binding proteins. In this study, we investigated the effects of GABA on the virulence of Pseudomonas aeruginosa. While exposure to GABA (10 µM) did not modify either the growth kinetics or the motility of the bacterium, its cytotoxicity and virulence were strongly increased. The Caenorhabditis elegans 'fast killing test' model revealed that GABA acts essentially through an increase in diffusible toxin(s). GABA also modulates the biofilm formation activity and adhesion properties of PAO1. GABA has no effect on cell surface polarity, biosurfactant secretion or on the lipopolysaccharide structure. The production of several exo-enzymes, pyoverdin and exotoxin A is not modified by GABA but we observed an increase in cyanogenesis which, by itself, could explain the effect of GABA on P. aeruginosa virulence. This mechanism appears to be regulated by quorum sensing. A proteomic analysis revealed that the effect of GABA on cyanogenesis is correlated with a reduction of oxygen accessibility and an over-expression of oxygen-scavenging proteins. GABA also promotes specific changes in the expression of thermostable and unstable elongation factors Tuf/Ts involved in the interaction of the bacterium with the host proteins. Taken together, these results suggest that GABA is a physiological regulator of P. aeruginosa virulence. PMID:23154974

  5. Hypothalamic Neuropeptide 26RFa Acts as an Incretin to Regulate Glucose Homeostasis.

    PubMed

    Prévost, Gaëtan; Jeandel, Lydie; Arabo, Arnaud; Coëffier, Moïse; El Ouahli, Mariama; Picot, Marie; Alexandre, David; Gobet, Françoise; Leprince, Jérôme; Berrahmoune, Hind; Déchelotte, Pierre; Malagon, Maria; Bonner, Caroline; Kerr-Conte, Julie; Chigr, Fatiha; Lefebvre, Hervé; Anouar, Youssef; Chartrel, Nicolas

    2015-08-01

    26RFa is a hypothalamic neuropeptide that promotes food intake. 26RFa is upregulated in obese animal models, and its orexigenic activity is accentuated in rodents fed a high-fat diet, suggesting that this neuropeptide might play a role in the development and maintenance of the obese status. As obesity is frequently associated with type 2 diabetes, we investigated whether 26RFa may be involved in the regulation of glucose homeostasis. In the current study, we show a moderate positive correlation between plasma 26RFa levels and plasma insulin in patients with diabetes. Plasma 26RFa concentration also increases in response to an oral glucose tolerance test. In addition, we found that 26RFa and its receptor GPR103 are present in human pancreatic β-cells as well as in the gut. In mice, 26RFa attenuates the hyperglycemia induced by a glucose load, potentiates insulin sensitivity, and increases plasma insulin concentrations. Consistent with these data, 26RFa stimulates insulin production by MIN6 insulinoma cells. Finally, we show, using in vivo and in vitro approaches, that a glucose load induces a massive secretion of 26RFa by the small intestine. Altogether, the present data indicate that 26RFa acts as an incretin to regulate glucose homeostasis. PMID:25858563

  6. Neuropeptide Y acts in the paraventricular nucleus to suppress sympathetic nerve activity and its baroreflex regulation.

    PubMed

    Cassaglia, Priscila A; Shi, Zhigang; Li, Baoxin; Reis, Wagner L; Clute-Reinig, Nicholas M; Stern, Javier E; Brooks, Virginia L

    2014-04-01

    Neuropeptide Y (NPY), a brain neuromodulator that has been strongly implicated in the regulation of energy balance, also acts centrally to inhibit sympathetic nerve activity (SNA); however, the site and mechanism of action are unknown. In chloralose-anaesthetized female rats, nanoinjection of NPY into the paraventricular nucleus of the hypothalamus (PVN) dose-dependently suppressed lumbar SNA (LSNA) and its baroreflex regulation, and these effects were blocked by prior inhibition of NPY Y1 or Y5 receptors. Moreover, PVN injection of Y1 and Y5 receptor antagonists in otherwise untreated rats increased basal and baroreflex control of LSNA, indicating that endogenous NPY tonically inhibits PVN presympathetic neurons. The sympathoexcitation following blockade of PVN NPY inhibition was eliminated by prior PVN nanoinjection of the melanocortin 3/4 receptor inhibitor SHU9119. Moreover, presympathetic neurons, identified immunohistochemically using cholera toxin b neuronal tract tracing from the rostral ventrolateral medulla (RVLM), express NPY Y1 receptor immunoreactivity, and patch-clamp recordings revealed that both NPY and α-melanocyte-stimulating hormone (α-MSH) inhibit and stimulate, respectively, PVN-RVLM neurons. Collectively, these data suggest that PVN NPY inputs converge with α-MSH to influence presympathetic neurons. Together these results identify endogenous NPY as a novel and potent inhibitory neuromodulator within the PVN that may contribute to changes in SNA that occur in states associated with altered energy balance, such as obesity and pregnancy. PMID:24535439

  7. Cis-acting elements in its 3' UTR mediate post-transcriptional regulation of KRAS.

    PubMed

    Kim, Minlee; Kogan, Nicole; Slack, Frank J

    2016-03-15

    Multiple RNA-binding proteins and non-coding RNAs, such as microRNAs (miRNAs), are involved in post-transcriptional gene regulation through recognition motifs in the 3' untranslated region (UTR) of their target genes. The KRAS gene encodes a key signaling protein, and its messenger RNA (mRNA) contains an exceptionally long 3' UTR; this suggests that it may be subject to a highly complex set of regulatory processes. However, 3' UTR-dependent regulation of KRAS expression has not been explored in detail. Using extensive deletion and mutational analyses combined with luciferase reporter assays, we have identified inhibitory and stabilizing cis-acting regions within the KRAS 3' UTR that may interact with miRNAs and RNA-binding proteins, such as HuR. Particularly, we have identified an AU-rich 49-nt fragment in the KRAS 3' UTR that is required for KRAS 3' UTR reporter repression. This element contains a miR-185 complementary element, and we show that overexpression of miR-185 represses endogenous KRAS mRNA and protein in vitro. In addition, we have identified another 49-nt fragment that is required to promote KRAS 3' UTR reporter expression. These findings indicate that multiple cis-regulatory motifs in the 3' UTR of KRAS finely modulate its expression, and sequence alterations within a binding motif may disrupt the precise functions of trans-regulatory factors, potentially leading to aberrant KRAS expression. PMID:26930719

  8. Flavonoids act as negative regulators of auxin transport in vivo in arabidopsis

    NASA Technical Reports Server (NTRS)

    Brown, D. E.; Rashotte, A. M.; Murphy, A. S.; Normanly, J.; Tague, B. W.; Peer, W. A.; Taiz, L.; Muday, G. K.

    2001-01-01

    Polar transport of the plant hormone auxin controls many aspects of plant growth and development. A number of synthetic compounds have been shown to block the process of auxin transport by inhibition of the auxin efflux carrier complex. These synthetic auxin transport inhibitors may act by mimicking endogenous molecules. Flavonoids, a class of secondary plant metabolic compounds, have been suggested to be auxin transport inhibitors based on their in vitro activity. The hypothesis that flavonoids regulate auxin transport in vivo was tested in Arabidopsis by comparing wild-type (WT) and transparent testa (tt4) plants with a mutation in the gene encoding the first enzyme in flavonoid biosynthesis, chalcone synthase. In a comparison between tt4 and WT plants, phenotypic differences were observed, including three times as many secondary inflorescence stems, reduced plant height, decreased stem diameter, and increased secondary root development. Growth of WT Arabidopsis plants on naringenin, a biosynthetic precursor to those flavonoids with auxin transport inhibitor activity in vitro, leads to a reduction in root growth and gravitropism, similar to the effects of synthetic auxin transport inhibitors. Analyses of auxin transport in the inflorescence and hypocotyl of independent tt4 alleles indicate that auxin transport is elevated in plants with a tt4 mutation. In hypocotyls of tt4, this elevated transport is reversed when flavonoids are synthesized by growth of plants on the flavonoid precursor, naringenin. These results are consistent with a role for flavonoids as endogenous regulators of auxin transport.

  9. Neuropeptide Y acts in the paraventricular nucleus to suppress sympathetic nerve activity and its baroreflex regulation

    PubMed Central

    Cassaglia, Priscila A; Shi, Zhigang; Li, Baoxin; Reis, Wagner L; Clute-Reinig, Nicholas M; Stern, Javier E; Brooks, Virginia L

    2014-01-01

    Neuropeptide Y (NPY), a brain neuromodulator that has been strongly implicated in the regulation of energy balance, also acts centrally to inhibit sympathetic nerve activity (SNA); however, the site and mechanism of action are unknown. In chloralose-anaesthetized female rats, nanoinjection of NPY into the paraventricular nucleus of the hypothalamus (PVN) dose-dependently suppressed lumbar SNA (LSNA) and its baroreflex regulation, and these effects were blocked by prior inhibition of NPY Y1 or Y5 receptors. Moreover, PVN injection of Y1 and Y5 receptor antagonists in otherwise untreated rats increased basal and baroreflex control of LSNA, indicating that endogenous NPY tonically inhibits PVN presympathetic neurons. The sympathoexcitation following blockade of PVN NPY inhibition was eliminated by prior PVN nanoinjection of the melanocortin 3/4 receptor inhibitor SHU9119. Moreover, presympathetic neurons, identified immunohistochemically using cholera toxin b neuronal tract tracing from the rostral ventrolateral medulla (RVLM), express NPY Y1 receptor immunoreactivity, and patch-clamp recordings revealed that both NPY and α–melanocyte-stimulating hormone (α-MSH) inhibit and stimulate, respectively, PVN–RVLM neurons. Collectively, these data suggest that PVN NPY inputs converge with α-MSH to influence presympathetic neurons. Together these results identify endogenous NPY as a novel and potent inhibitory neuromodulator within the PVN that may contribute to changes in SNA that occur in states associated with altered energy balance, such as obesity and pregnancy. PMID:24535439

  10. Flavonoids act as negative regulators of auxin transport in vivo in arabidopsis.

    PubMed

    Brown, D E; Rashotte, A M; Murphy, A S; Normanly, J; Tague, B W; Peer, W A; Taiz, L; Muday, G K

    2001-06-01

    Polar transport of the plant hormone auxin controls many aspects of plant growth and development. A number of synthetic compounds have been shown to block the process of auxin transport by inhibition of the auxin efflux carrier complex. These synthetic auxin transport inhibitors may act by mimicking endogenous molecules. Flavonoids, a class of secondary plant metabolic compounds, have been suggested to be auxin transport inhibitors based on their in vitro activity. The hypothesis that flavonoids regulate auxin transport in vivo was tested in Arabidopsis by comparing wild-type (WT) and transparent testa (tt4) plants with a mutation in the gene encoding the first enzyme in flavonoid biosynthesis, chalcone synthase. In a comparison between tt4 and WT plants, phenotypic differences were observed, including three times as many secondary inflorescence stems, reduced plant height, decreased stem diameter, and increased secondary root development. Growth of WT Arabidopsis plants on naringenin, a biosynthetic precursor to those flavonoids with auxin transport inhibitor activity in vitro, leads to a reduction in root growth and gravitropism, similar to the effects of synthetic auxin transport inhibitors. Analyses of auxin transport in the inflorescence and hypocotyl of independent tt4 alleles indicate that auxin transport is elevated in plants with a tt4 mutation. In hypocotyls of tt4, this elevated transport is reversed when flavonoids are synthesized by growth of plants on the flavonoid precursor, naringenin. These results are consistent with a role for flavonoids as endogenous regulators of auxin transport. PMID:11402184

  11. [Responsibility for prescribing and monitoring an act transfusion and safety blood transfusion].

    PubMed

    Piercecchi-Marti, M D; Tuchtan-Torrents, L; Lassale, B; Leonetti, G; Bartoli, C

    2014-11-01

    The act to transfuse is a prescription following basic rules similar to drug prescriptions. If harm happens, potentially linked with this prescription, the harm's responsibility is borne by the physician, the paramedics, the care organization but by the supplier laboratory too. The setting of good practice rules consistent with science data at the time when the act is performed, the respect of the patient's rights and the quality of supplied products will be assessed during the expertise. Under restorative responsibility, it is necessary to previously establish a direct and certain causation between the litigious act and the harm to enforce the vicarious liability. Nowadays, legal precedents grant a larger protection to more and more numerous victims, enhancing the field of the fault with the appeal to assumption of fault. At the same time, the lawmaker himself promulgated objective conditions of compensation for many categories of victims of medical risk from which transfused people are part. The law of March the 4th of 2002 went one step closer devoting a new foundation of compensation: national solidarity. PMID:25282487

  12. Decree No. 0784 of 18 April 1989 regulating, in part, Act 21 of 1982 and Act 71 of 1988.

    PubMed

    1989-01-01

    This Colombian Decree regulates certain aspects of the system of family allowances. Among other things, it provides that allowances can be granted in terms of food, clothing, school scholarships, textbooks, drugs, and other substitutes for money. Further provisions of the Decree deal with the definition of persons affiliated to the regime, booklets certifying affiliation, family service subsidies, and financing. PMID:12344547

  13. Allowance trading under the Clean Air Act: Who should regulate, and when?

    SciTech Connect

    Lock, R.

    1993-07-01

    The goal of this paper is to explore how compliance with the Clean Air Act Amendments of 1990 (CAAA), especially Title IV and emission trading under it, will affect the current relationship between state and federal regulation. It is difficult, with the limited experience we have had under Title IV, to be definitive about or to be a very strong advocate of too many policy positions. What may be most helpful at this point is to identify where the difficult issues in state/federal relations might arise; and then to explore ways in which tensions might be either avoided or resolved. One anticipated conclusion is that a traditional regulatory mindset could be very destructive if applied to this new area of oversight without due sensitivity to what Congress is trying to achieve in Title IV. That concern pervaded the early legislative debates; and it persists today. Title IV presents some unique challenges to state regulators and will require some creative solutions and fresh thinking if the goals of Congress are to be realized and the full benefits that allowance trading can offer are to be reaped by electricity consumers. In the ultimate analysis, Title IV amounts to a massive internalization of the external costs imposed on society by acid rain deposition. (This places in serious question the notion of additional externality {open_quotes}adders{close_quotes} for sulfur dioxide (SO{sub 2}) and nitrous oxide (NO{sub x}) at the state level for utility supply planning purposes.) The whole point of Title IV is to give those directly charged with compliance, namely power producers, the maximum flexibility to pursue least-cost compliance solutions. Perhaps the biggest single factor in how well they do this will be how state regulators respond to their compliance and allowance trading initiatives.

  14. IMMUTANS Does Not Act as a Stress-Induced Safety Valve in the Protection of the Photosynthetic Apparatus of Arabidopsis during Steady-State Photosynthesis1

    PubMed Central

    Rosso, Dominic; Ivanov, Alexander G.; Fu, Aigen; Geisler-Lee, Jane; Hendrickson, Luke; Geisler, Matt; Stewart, Gregory; Krol, Marianna; Hurry, Vaughan; Rodermel, Steven R.; Maxwell, Denis P.; Hüner, Norman P.A.

    2006-01-01

    stresses, which is consistent with our functional data. However, IM exhibited significant modulation in response to development in concert with changes in AOX1a expression. Thus, neither our functional analyses of the IM knockout and overexpression lines nor meta-analyses of gene expression support the model that IM acts as a safety valve to regulate the redox state of the PQ pool during stress and acclimation. Rather, IM appears to be strongly regulated by developmental stage of Arabidopsis. PMID:16891546

  15. IMMUTANS does not act as a stress-induced safety valve in the protection of the photosynthetic apparatus of Arabidopsis during steady-state photosynthesis.

    PubMed

    Rosso, Dominic; Ivanov, Alexander G; Fu, Aigen; Geisler-Lee, Jane; Hendrickson, Luke; Geisler, Matt; Stewart, Gregory; Krol, Marianna; Hurry, Vaughan; Rodermel, Steven R; Maxwell, Denis P; Hüner, Norman P A

    2006-10-01

    minimal modulation in response to myriad abiotic stresses, which is consistent with our functional data. However, IM exhibited significant modulation in response to development in concert with changes in AOX1a expression. Thus, neither our functional analyses of the IM knockout and overexpression lines nor meta-analyses of gene expression support the model that IM acts as a safety valve to regulate the redox state of the PQ pool during stress and acclimation. Rather, IM appears to be strongly regulated by developmental stage of Arabidopsis. PMID:16891546

  16. 77 FR 4498 - Rules and Regulations Under the Wool Products Labeling Act of 1939

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-30

    ... Identification Act, the Wool Products Labeling Act, and the Fur Products Labeling Act: Final Rule, 63 FR 7508...: Miscellaneous Rules: Final Rule, 63 FR 71582 (Dec. 29, 1998). \\7\\ Federal Trade Commission: Rules and... Labeling Act of 1939, Final Rule, 65 FR 75154 (Dec. 1, 2000). \\8\\ The Wool Rules provide that...

  17. The impact of regulations, safety considerations and physical limitations on research progress at maximum biocontainment.

    PubMed

    Shurtleff, Amy C; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S; Bavari, Sina

    2012-12-01

    We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review. PMID:23342380

  18. The Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment

    PubMed Central

    Shurtleff, Amy C.; Garza, Nicole; Lackemeyer, Matthew; Carrion, Ricardo; Griffiths, Anthony; Patterson, Jean; Edwin, Samuel S.; Bavari, Sina

    2012-01-01

    We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review. PMID:23342380

  19. 78 FR 49988 - Food and Drug Administration Food Safety Modernization Act: Proposed Rules on Foreign Supplier...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-16

    ... efforts on prevention over the past several years. In the Federal Register of January 16, 2013 (78 FR 3503 and 78 FR 3646), FDA announced the establishment of two dockets so that the public can review the.../GuidanceRegulation/FSMA/default.htm . In the Federal Register of July 29, 2013 (78 FR 45729 and 78 FR...

  20. Users guide to working in and around water: Regulation under British Columbia`s Water Act. Revised edition

    SciTech Connect

    1998-12-01

    This booklet has been published to help understand and comply with the Regulation under the British Columbia Water Act for works and changes in and about a stream. Works carried out under the Regulation are those that do not involve water diversion, may be completed within a short period of time, and have little environmental impact. Examples include installation or removal of culverts or docks, repair of dikes, beaver dam removal, and installation of drain tile outlets. Information is included on definitions of terms, scope of the Regulation, general conditions for projects, specific project requirements, notification requirements, and enforcement. A copy of the Regulation is included.

  1. The differential regulation of human ACT1 isoforms by Hsp90 in IL-17 signaling1

    PubMed Central

    Wu, Ling; Wang, Chenhui; Boisson, Bertrand; Misra, Saurav; Rayman, Patricia; Finke, James H.; Puel, Anne; Casanova, Jean-Laurent; Li, Xiaoxia

    2014-01-01

    IL-17 is a pro-inflammatory cytokine implicated in the pathogenesis of autoimmune diseases including psoriasis. ACT1 is an essential adaptor molecule in the IL-17 signaling pathway. A missense single nucleotide polymorphism (rs33980500; SNP-D10N) that resulted in the substitution of an asparagine for an aspartic acid at position 10 of ACT1 (ACT1-D10N) is associated with psoriasis susceptibility. Due to alternative splicing in humans, SNP-D10N encodes two mutated ACT1 proteins, ACT1-D10N and ACT1-D19N. Though both ACT1 isoforms are Hsp90 ‘client’ proteins, the nine additional amino acids in ACT1-D19N provide an additional Hsp90 binding site that is absent in ACT1-D10N. Therefore, while ACT1-D10N is a dead protein that is unable to transduce IL-17 signals for gene expression, ACT1-D19N is fully responsive to IL-17. Intriguingly, the two ACT1 isoforms are differentially expressed in ACT1D10N/D10N fibroblasts and T cells. Fibroblasts express both isoforms equally, enabling ACT1-D19N to compensate for the loss of ACT1-D10N function. ACT1D10N/D10N T cells, however, express predominantly ACT1-D10N. Lacking this compensatory mechanism, ACT1D10N/D10N T cells behave like ACT1-deficient T cells, exhibiting a dysregulated and hyperactive Th17 phenotype with overproduction of IL-22 and IL-17. The hyperactive Th17 response combined with fully responsive fibroblasts likely synergized to contribute to psoriasis susceptibility in SNP-D10N patients. PMID:25024377

  2. The differential regulation of human ACT1 isoforms by Hsp90 in IL-17 signaling.

    PubMed

    Wu, Ling; Wang, Chenhui; Boisson, Bertrand; Misra, Saurav; Rayman, Patricia; Finke, James H; Puel, Anne; Casanova, Jean-Laurent; Li, Xiaoxia

    2014-08-15

    IL-17 is a proinflammatory cytokine implicated in the pathogenesis of autoimmune diseases including psoriasis. ACT1 is an essential adaptor molecule in the IL-17 signaling pathway. A missense single nucleotide polymorphism (rs33980500; SNP-D10N) that resulted in the substitution of an asparagine for an aspartic acid at position 10 of ACT1 (ACT1-D10N) is associated with psoriasis susceptibility. Due to alternative splicing in humans, SNP-D10N encodes two mutated ACT1 proteins, ACT1-D10N and ACT1-D19N. Although both ACT1 isoforms are Hsp90 client proteins, the nine additional amino acids in ACT1-D19N provide an additional Hsp90 binding site that is absent in ACT1-D10N. Therefore, whereas ACT1-D10N is a dead protein that is unable to transduce IL-17 signals for gene expression, ACT1-D19N is fully responsive to IL-17. Intriguingly, the two ACT1 isoforms are differentially expressed in ACT1(D10N/D10N) fibroblasts and T cells. Fibroblasts express both isoforms equally, enabling ACT1-D19N to compensate for the loss of ACT1-D10N function. ACT1(D10N/D10N) T cells, however, express predominantly ACT1-D10N. Lacking this compensatory mechanism, ACT1(D10N/D10N) T cells behave like ACT1-deficient T cells, exhibiting a dysregulated and hyperactive Th17 phenotype with overproduction of IL-22 and IL-17. The hyperactive Th17 response combined with fully responsive fibroblasts likely synergized to contribute to psoriasis susceptibility in SNP-D10N patients. PMID:25024377

  3. Some impacts of the 1990 Clean Air Act and state clean-air regulations on the fertilizer industry

    SciTech Connect

    Breed, C.E.; Kerns, O.S.

    1992-12-01

    The Clean Air Act amendments of 1990 will intensify national efforts to reduce air pollution. They will have major impacts an governmental agencies and on industrial and commercial facilities throughout the country. As with other industries, it is essential for fertilizer dealers and producers to understand how these changes to the Clean Air Act can significantly change the way they do business. This paper is proffered as an overview of ways in which the 1990 amendments to the Clean Air Act may impact the fertilizer industry. The nonattainment, toxics, and permit provisions of the amended act will be three areas of particular concern to the fertilizer industry. Implementation of the new regulatory requirements of this legislation promises to be a long and onerous process for all concerned. However, it appears that state and local regulations may have a much more profound impact on the fertilizer industry than the new Clean Air Act.

  4. Some impacts of the 1990 Clean Air Act and state clean-air regulations on the fertilizer industry

    SciTech Connect

    Breed, C.E.; Kerns, O.S.

    1992-12-31

    The Clean Air Act amendments of 1990 will intensify national efforts to reduce air pollution. They will have major impacts on governmental agencies and on industrial and commercial facilities throughout the country. As with other industries, it is essential for fertilizer dealers and producers to understand how these changes to the Clean Air Act can significantly change the way they do business. This paper is proffered as an overview of ways in which the 1990 amendments to the Clean Air Act may impact the fertilizer industry. The nonattainment, toxics, and permit provisions of the amended act will be three areas of particular concern to the fertilizer industry. Implementation of the new regulatory requirements of this legislation promises to be a long and onerous process for all concerned. However, it appears that state and local regulations may have a much more profound impact on the fertilizer industry than the new Clean Air Act.

  5. Risperidone long-acting injection: a review of its long term safety and efficacy

    PubMed Central

    Rainer, Michael K

    2008-01-01

    A long-acting form of the second-generation antipsychotic drug risperidone is now broadly available for the treatment of schizophrenia and closely related psychiatric conditions. It combines the advantage of previously available depot formulations for first-generation drugs with the favorable characteristics of the modern “atypical” antipsychotics, namely higher efficacy in the treatment of the negative symptoms of schizophrenia and reduced motor disturbances. Published clinical studies show an objective clinical efficacy (as per psychiatric symptom scores and relapse data) that exceeds that of oral atypical antipsychotics when patients are switched to the long-acting injectable form, a low incidence of treatment-emergent extrapyramidal side effects, and very good acceptance by patients. Available data for maintenance treatment of bipolar disorder show equivalence with the oral form instead of superiority, but are still limited. As it seems likely that efficacy benefits are mostly due to the fact that the injectable form reduces the demand for patient compliance to one physician visit every 2 weeks instead of self-administration on a daily or twice-daily basis, additional potential could exist in other psychiatric disorders where atypical antipsychotic drugs are of benefit but where patient adherence to treatment schedules is typically low. PMID:19183782

  6. Cis-acting elements in its 3′ UTR mediate post-transcriptional regulation of KRAS

    PubMed Central

    Kim, Minlee; Kogan, Nicole; Slack, Frank J.

    2016-01-01

    Multiple RNA-binding proteins and non-coding RNAs, such as microRNAs (miRNAs), are involved in post-transcriptional gene regulation through recognition motifs in the 3′ untranslated region (UTR) of their target genes. The KRAS gene encodes a key signaling protein, and its messenger RNA (mRNA) contains an exceptionally long 3′ UTR; this suggests that it may be subject to a highly complex set of regulatory processes. However, 3′ UTR-dependent regulation of KRAS expression has not been explored in detail. Using extensive deletion and mutational analyses combined with luciferase reporter assays, we have identified inhibitory and stabilizing cis-acting regions within the KRAS 3′ UTR that may interact with miRNAs and RNA-binding proteins, such as HuR. Particularly, we have identified an AU-rich 49-nt fragment in the KRAS 3′ UTR that is required for KRAS 3′ UTR reporter repression. This element contains a miR-185 complementary element, and we show that overexpression of miR-185 represses endogenous KRAS mRNA and protein in vitro. In addition, we have identified another 49-nt fragment that is required to promote KRAS 3′ UTR reporter expression. These findings indicate that multiple cis-regulatory motifs in the 3′ UTR of KRAS finely modulate its expression, and sequence alterations within a binding motif may disrupt the precise functions of trans-regulatory factors, potentially leading to aberrant KRAS expression. PMID:26930719

  7. Alternative 3'UTRs act as scaffolds to regulate membrane protein localization

    PubMed Central

    Berkovits, Binyamin D.; Mayr, Christine

    2015-01-01

    About half of human genes use alternative cleavage and polyadenylation (ApA) to generate mRNA transcripts that differ in the length of their 3' untranslated regions (3'UTRs) while producing the same protein 1–3. Here we show in human cell lines that alternative 3' UTRs differentially regulate the localization of membrane proteins. The long 3'UTR of CD47 enables efficient cell surface expression of CD47 protein, whereas the short 3'UTR primarily localizes CD47 protein to the endoplasmic reticulum. CD47 protein localization occurs post-translationally and independently of RNA localization. In our model of 3' UTR-dependent protein localization, the long 3' UTR of CD47 acts as a scaffold to recruit a protein complex containing the RNA-binding protein HuR (also known as ELAVL1) and SET4 to the site of translation. This facilitates interaction of SET with the newly translated cytoplasmic domains of CD47 and results in subsequent translocation of CD47 to the plasma membrane via activated RAC1 5. We also show that CD47 protein has different functions depending on whether it was generated by the short or long 3'UTR isoforms. Thus, ApA contributes to the functional diversity of the proteome without changing the amino acid sequence. 3' UTR-dependent protein localization has the potential to be a widespread trafficking mechanism for membrane proteins because HuR binds to thousands of mRNAs6–9, and we show that the long 3' UTRs of CD44, ITGA1 and TNFRSF13C, which are bound by HuR, increase surface protein expression compared to their corresponding short 3' UTRs. We propose that during translation the scaffold function of 3' UTRs facilitates binding of proteins to nascent proteins to direct their transport or function—and that this role of 3' UTRs can be regulated by ApA. PMID:25896326

  8. Have government regulations improved workplace safety? A test of the asynchronous regulatory effects in China's coal industry, 1995-2006

    SciTech Connect

    Shi, X.P.

    2009-07-01

    Empirical studies on the effectiveness of workplace safety regulations are inconclusive. This study hypothesizes that the asynchronous effects of safety regulations occur because regulations need time to become effective. Safety regulations will work initially by reducing the most serious accidents, and later by improving overall safety performance. The hypothesis is tested by studying a provincial level aggregate panel dataset for China's coal industry using two different models with different sets of dependent variables: a fixed-effects model on mortality rate, which is defined as fatalities per 1,000 employees; and a negative binominal model on the annual number (frequency) of disastrous accidents. Safety regulations can reduce the frequency of disastrous accidents, but have not reduced mortality rate, which represents overall safety performance. Policy recommendations are made, including shifting production from small to large mines through industrial consolidation, improving the safety performance of large mines, addressing consequences of decentralization, and facilitating the implementation of regulations through carrying on institutional actions and supporting legislation.

  9. Impact of Clean Air Act Regulations on Nitrogen Fate and Transport in the Neuse River Basin

    NASA Astrophysics Data System (ADS)

    Gabriel, M. C.; Knightes, C. D.; Dennis, R. L.; Cooter, E. J.

    2012-12-01

    This study investigated impacts of Clean Air Act Amendment (CAAA) NOx emissions regulations on the fate and transport of nitrogen for two watersheds in the Neuse River Basin, North Carolina, USA from 1990 to 2020. The Soil and Water Assessment Tool (SWAT) and the Community Multi-scale Air Quality (CMAQ) modeling system were used. CMAQ simulated atmospheric chemical transport and nitrogen deposition. This data was entered into SWAT which simulated watershed hydrology and water quality. Two cases were investigated: one that incorporates CAAA regulatory emissions controls in CMAQ simulation (with) and a second case that does not (without). SWAT model results forecasted a 70% decrease in inorganic nitrogen discharge from the Little River watershed and a 50% decrease for the Nahunta watershed by 2020 under the emission control (with) scenario. Denitrification and plant nitrogen uptake played important roles in nitrogen discharge from each watershed. The nitrogen discharge response time following a change in atmospheric nitrogen deposition was 4 years for the Nahunta watershed and 2 years for the Little River watershed. The longer response time for Nahunta is primarily due to a higher percentage of soybean land cover (22.5% [Nahunta]; 1.6% [Little River]). Agricultural land covers had varied nitrogen response times to changes in atmospheric deposition, particularly for soybean, hay and corn. The studied watersheds retained >80% of all nitrogen delivered by agriculture fertilization, biological fixation and atmospheric deposition.

  10. 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES... objective intent; (3) The manufacture of the HCT/P does not involve the combination of the cells or tissues... not have a systemic effect and is not dependent upon the metabolic activity of living cells for...

  11. 21 CFR 1271.10 - Are my HCT/P's regulated solely under section 361 of the PHS Act and the regulations in this part...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION HUMAN CELLS, TISSUES... objective intent; (3) The manufacture of the HCT/P does not involve the combination of the cells or tissues... not have a systemic effect and is not dependent upon the metabolic activity of living cells for...

  12. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    PubMed

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. PMID:23794245

  13. Tanker navigation safety standards: Tanker navigation safety research baseline: A study required by section 4111(b)(9) of the Oil Pollution Act of 1990. Final report

    SciTech Connect

    1996-12-31

    The Oil Pollution Act of 1990 directed the Secretary of Transportation to review and incorporate the results of past studies, including studies by the Coast Guard and Office of Technology Assessment (OTA). This literature search and review focuses on materials pertinent to determining or evaluating current and/or `best` practices, and not on the adequacy of current statutes or regulations. In addition, it is not the intention of the report to assess best practices (e.g., suggest the appropriate crew sizes or what navigation equipment should be required on tankers), but to establish the baseline for future study of best practices. The report does not provide answers to new analytical quations, but presents the status of research so that questions addressed previoulsy will not be duplicated by future studies.

  14. 29 CFR 102.117 - Freedom of Information Act Regulations: Board materials and formal documents available for public...

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 29 Labor 2 2011-07-01 2011-07-01 false Freedom of Information Act Regulations: Board materials and formal documents available for public inspection and copying; requests for described records; time limit for response; appeal from denial of request; fees for document search and duplication; files and records not subject to inspection....

  15. 75 FR 8844 - Financial Crimes Enforcement Network; Amendment to the Bank Secrecy Act Regulations-Reports of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE TREASURY 31 CFR Part 103 RIN 1506-AB08 Financial Crimes Enforcement Network; Amendment to the Bank Secrecy Act Regulations--Reports of Foreign Financial Accounts AGENCY: Financial Crimes Enforcement Network...

  16. 78 FR 6407 - Ability-to-Repay and Qualified Mortgage Standards Under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... underwriting standards. See 73 FR 44524 (July 30, 2008). The following discussion provides background... rulemaking authority by section 1029 of the Dodd- Frank Act). 76 FR 79768 (Dec. 22, 2011). This rule did not... Regulation Z. See 60 FR 15463 (Mar. 24, 1995). In particular, Sec. 226.32(e)(1) \\42\\ implemented TILA...

  17. 78 FR 23171 - Amendments to the 2013 Escrows Final Rule Under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-18

    ... loans made in ``rural'' or ``underserved'' areas. \\1\\ 78 FR 4726 (Jan. 22, 2013). \\2\\ The other rules...) (2013 ATR Final Rule), 78 FR 6407; High-Cost Mortgages and Homeownership Counseling Amendments to the... Settlement Procedures Act (Regulation X) (2013 HOEPA Final Rule), 78 FR 6855; Disclosure and...

  18. 75 FR 29526 - Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission 61,161; Docket No. RM93-11-000] Revisions to Oil Pipeline Regulations Pursuant to the Energy Policy Act of 1992; Notice of Annual Change in the Producer Price Index for Finished Goods May 19, 2010. The...

  19. 78 FR 60381 - Amendments to the 2013 Mortgage Rules Under the Equal Credit Opportunity Act (Regulation B), Real...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... February 15, 2013, at 78 FR 11280. FOR FURTHER INFORMATION CONTACT: Whitney Patross, Attorney; Richard... Under the Truth in Lending Act (Regulation Z), 78 FR 4726 (Jan. 22, 2013) (2013 Escrows Final Rule...), 78 FR 6856 (Jan. 31, 2013) (2013 HOEPA Final Rule), and Ability-to-Repay and Qualified...

  20. 9 CFR 331.3 - States designated under paragraph 301(c) of the Act; application of regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false States designated under paragraph 301(c) of the Act; application of regulations. 331.3 Section 331.3 Animals and Animal Products FOOD... DESIGNATED STATES AND TERRITORIES; AND FOR DESIGNATION OF ESTABLISHMENTS WHICH ENDANGER PUBLIC HEALTH AND...

  1. 9 CFR 381.222 - States designated under paragraph 5(c) of the Act; application of regulations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false States designated under paragraph 5(c) of the Act; application of regulations. 381.222 Section 381.222 Animals and Animal Products FOOD... Designating Establishments With Operations Which Would Clearly Endanger the Public Health; Disposition...

  2. 78 FR 63408 - Petition To Amend Animal Welfare Act Regulations To Prohibit Public Contact With Big Cats, Bears...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... 5, 2013 (78 FR 47215) is reopened. We will consider all comments that we receive on or before.... SUPPLEMENTARY INFORMATION: On August 5, 2013, we published in the Federal Register (78 FR 47215-47217, Docket No... Animal Welfare Act Regulations To Prohibit Public Contact With Big Cats, Bears, and Nonhuman...

  3. 78 FR 30739 - Amendments to the 2013 Escrows Final Rule under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    .... \\1\\ 78 FR 4726 (Jan. 22, 2013). \\2\\ The other rules include: Ability-to-Repay and Qualified Mortgage Standards under the Truth in Lending Act (Regulation Z) (2013 ATR Final Rule), 78 FR 6407 (Jan. 30, 2013...) (2013 HOEPA Final Rule), 78 FR 6855 (Jan. 31, 2013); Disclosure and Delivery Requirements for Copies...

  4. 75 FR 34271 - Federal Acquisition Regulation; FAR Case 2009-010, American Recovery and Reinvestment Act of 2009...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... Federal Register at 74 FR 14636 on March 31, 2009, with a request for comments by June 1, 2009. The... the Federal Register at 74 FR 14636 on March 31, 2009, is adopted as a final rule with the following... Acquisition Regulation; FAR Case 2009-010, American Recovery and Reinvestment Act of 2009 (the Recovery...

  5. [Efficacy and safety in the new regulation of pharmaceutical products in Peru].

    PubMed

    Vásquez, Hans; Salas, Sofía; Figueroa, Linder; Gutiérrez, Sonia

    2012-01-01

    Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category. PMID:23338643

  6. 33 CFR 165.117 - Regulated Navigation Areas, Safety and Security Zones: Deepwater Ports, First Coast Guard District.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., Safety and Security Zones: Deepwater Ports, First Coast Guard District. 165.117 Section 165.117 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS... Limited Access Areas First Coast Guard District § 165.117 Regulated Navigation Areas, Safety and...

  7. 33 CFR 165.117 - Regulated Navigation Areas, Safety and Security Zones: Deepwater Ports, First Coast Guard District.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Safety and Security Zones: Deepwater Ports, First Coast Guard District. 165.117 Section 165.117 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS... Limited Access Areas First Coast Guard District § 165.117 Regulated Navigation Areas, Safety and...

  8. 33 CFR 165.117 - Regulated Navigation Areas, Safety and Security Zones: Deepwater Ports, First Coast Guard District.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., Safety and Security Zones: Deepwater Ports, First Coast Guard District. 165.117 Section 165.117 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS... Limited Access Areas First Coast Guard District § 165.117 Regulated Navigation Areas, Safety and...

  9. 33 CFR 165.117 - Regulated Navigation Areas, Safety and Security Zones: Deepwater Ports, First Coast Guard District.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ..., Safety and Security Zones: Deepwater Ports, First Coast Guard District. 165.117 Section 165.117 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS... Limited Access Areas First Coast Guard District § 165.117 Regulated Navigation Areas, Safety and...

  10. 76 FR 39292 - Special Local Regulations & Safety Zones; Marine Events in Captain of the Port Long Island Sound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ...The Coast Guard is establishing fourteen temporary special local regulations and safety zones for marine events and fireworks displays within the Captain of the Port (COTP) Long Island Sound Zone. This action is necessary to provide for the safety of life on navigable waters during the events. Entry into, transit through, mooring or anchoring within these zones is prohibited unless authorized......

  11. 76 FR 53337 - Special Local Regulation and Safety Zones; Marine Events in Captain of the Port Long Island Sound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-26

    ...The Coast Guard is establishing temporary special local regulations and safety zones for marine events within the Captain of the Port (COTP) Long Island Sound Zone for regattas, fireworks displays and swim events. This action is necessary to provide for the safety of life on navigable waters during the events. Entry into, transit through, mooring or anchoring within this zone is prohibited......

  12. 76 FR 69622 - Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port Boston Zone

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-09

    ...The Coast Guard is amending special local regulations (SLR) and establishing permanent safety zones in the Coast Guard Sector Boston Captain of the Port (COTP) Zone for annually recurring marine events. The revised SLRs and safety zones are implemented to reduce administrative overhead, expedite public notification of events, and to ensure the protection of the maritime public and event......

  13. 75 FR 36288 - Amended Safety Zone and Regulated Navigation Area, Chicago Sanitary and Ship Canal, Romeoville, IL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-25

    ...The Coast Guard is revising its safety zone and Regulated Navigation Area (RNA) on the Chicago Sanitary and Ship Canal (CSSC) near Romeoville, IL. This revised temporary interim rule reduces the areas covered by the safety zone and RNA, and places additional restrictions on vessels that may transit the...

  14. Molten metal burns: further evidence of industrial foundries' failure to comply with Occupational Safety and Health Administration regulations.

    PubMed

    Faulkner, B C; Drake, D B; Gear, A J; Watkins, F H; Edlich, R F

    1997-01-01

    The purpose of this report is to describe another case of a molten metal burn to the foot of a foundry worker. The foundry in which he worked failed to comply with Occupational Safety and Health Administration regulations with regard to protective apparel. This injury could have been prevented with annual, unscheduled inspections by the Occupational Safety and Health Administration and with enforcement of additional regulations regarding protective apparel. PMID:9348058

  15. Review of the regulation and safety assessment of food substances in various countries and jurisdictions

    PubMed Central

    Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan

    2013-01-01

    This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843

  16. Regulation and safety implementation of nanotechnology for chemical enterprises in the Central Europe Space

    NASA Astrophysics Data System (ADS)

    Falk, A.; Hartl, S.; Sinner, F.

    2013-04-01

    As result of the gradually increasing nanotechnology sector there is the necessity of a contemporary analysis of the present regulations used for nanomaterials, to outline the current situation of the nanotechnology sector, to promote international cooperation and research's coordination to overcome disciplinary boundaries, to fill the gap between more and less experienced regions and to turn investments in R&D in industrial innovations. The general objective of the Central Europe project NANOFORCE, which is developed by national and regional chemistry associations and R&D Centres of the Central Europe area, is to foster the innovative nanotechnology-sector networks across Central Europe regions by bringing together public and private organizations to carry out collaborative and interdisciplinary researches on nanomaterials (in the frame of REACH Regulation) and to turn the most promising laboratory results into innovative industrial applications. To build up a legal advisory board for chemical enterprises starting in nanotechnology, a state of the art report on existing safety procedures and nanotech related regulations was produced to give an overview on currently available regulations used by chemical industries and manufacturing companies within the European region to secure their products. The main emphasis was placed on REACH regulation to search for relevant sections concentrating on nanomaterials which are applicable for nanotechnology. In addition, all relevant directives and amendments of REACH were screened with regard to identify gaps where action is still needed and give possible recommendations for the European Commission. Beyond literature research a questionnaire for producers, users, researchers and financiers was developed with the goal to collect information about the nanotechnology sector in the CE region concerning development, financial status, and international cooperation within joint ventures, safety and nanotoxicology.

  17. CANDU reactors, their regulation in Canada, and the identification of relevant NRC safety issues

    SciTech Connect

    Charak, I.; Kier, P.H.

    1995-04-01

    Atomic Energy of Canada, Limited (AECL) and its subsidiary in the US, are considering submitting the CANDU 3 design for standard design certification under 10 CFR Part 52. CANDU reactors are pressurized heavy water power reactors. They have some substantially different safety responses and safety systems than the LWRs that the commercial power reactor licensing regulations of the US Nuclear Regulatory Commission (NRC) have been developed to deal with. In this report, the authors discuss the basic design characteristics of CANDU reactors, specifically of the CANDU 3 where possible, and some safety-related consequences of these characteristics. The authors also discuss the Canadian regulatory provisions, and the CANDU safety systems that have evolved to satisfy the Canadian regulatory requirements as of December 1992. Finally, the authors identify NRC regulations, mainly in 10 CFR Parts 50 and 100, with issues for CANDU 3 reactor designs. In all, eleven such regulatory issues are identified. They are: (1) the ATWS rule ({section}50.62); (2) station blackout ({section}50.63); (3) conformance with Standard Review Plan (SRP); (4) appropriateness of the source term ({section}50.34(f) and {section}100.11); (5) applicability of reactor coolant pressure boundary (RCPB) requirements ({section}50.55a, etc); (6) ECCS acceptance criteria ({section}50.46)(b); (7) combustible gas control ({section}50.44, etc); (8) power coefficient of reactivity (GDC 11); (9) seismic design (Part 100); (10) environmental impacts of the fuel cycle ({section}51.51); and (11) (standards {section}50.55a).

  18. 16 CFR 1117.9 - Prohibited acts and sanctions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Prohibited acts and sanctions. 1117.9 Section 1117.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER...

  19. 16 CFR 1117.9 - Prohibited acts and sanctions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Prohibited acts and sanctions. 1117.9 Section 1117.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER...

  20. 16 CFR 1117.9 - Prohibited acts and sanctions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Prohibited acts and sanctions. 1117.9 Section 1117.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER...

  1. 16 CFR 1117.9 - Prohibited acts and sanctions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Prohibited acts and sanctions. 1117.9 Section 1117.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER...

  2. 16 CFR 1117.9 - Prohibited acts and sanctions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Prohibited acts and sanctions. 1117.9 Section 1117.9 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS REPORTING OF CHOKING INCIDENTS INVOLVING MARBLES, SMALL BALLS, LATEX BALLOONS AND OTHER...

  3. 29 CFR 1987.102 - Obligations and prohibited acts.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... FOOD SAFETY MODERNIZATION ACT Complaints, Investigations, Findings and Preliminary Orders § 1987.102... 29 Labor 9 2014-07-01 2014-07-01 false Obligations and prohibited acts. 1987.102 Section 1987.102 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

  4. Safety regulations of food and water implemented in the first year following the Fukushima nuclear accident.

    PubMed

    Hamada, Nobuyuki; Ogino, Haruyuki; Fujimichi, Yuki

    2012-09-01

    An earthquake and tsunami of historic proportions caused massive damage across the northeastern coast of Japan on the afternoon of 11 March 2011, and the release of radionuclides from the stricken reactors of the Fukushima nuclear power plant 1 was detected early on the next morning. High levels of radioiodines and radiocesiums were detected in the topsoil and plants on 15 March 2011, so sampling of food and water for monitoring surveys began on 16 March 2011. On 17 March 2011, provisional regulation values for radioiodine, radiocesiums, uranium, plutonium and other transuranic α emitters were set to regulate the safety of radioactively contaminated food and water. On 21 March 2011, the first restrictions on distribution and consumption of contaminated items were ordered. So far, tap water, raw milk, vegetables, mushrooms, fruit, nut, seaweeds, marine invertebrates, coastal fish, freshwater fish, beef, wild animal meat, brown rice, wheat, tea leaves and other foodstuffs had been contaminated above the provisional regulation values. The provisional regulation values for radioiodine were exceeded in samples taken from 16 March 2011 to 21 May 2011, and those for radiocesiums from 18 March 2011 to date. All restrictions were imposed within 318 days after the provisional regulation values were first exceeded for each item. This paper summarizes the policy for the execution of monitoring surveys and restrictions, and the outlines of the monitoring results of 220 411 samples and the enforced restrictions predicated on the information available as of 31 March 2012. PMID:22843368

  5. Safety regulations of food and water implemented in the first year following the Fukushima nuclear accident

    PubMed Central

    Hamada, Nobuyuki; Ogino, Haruyuki; Fujimichi, Yuki

    2012-01-01

    An earthquake and tsunami of historic proportions caused massive damage across the northeastern coast of Japan on the afternoon of 11 March 2011, and the release of radionuclides from the stricken reactors of the Fukushima nuclear power plant 1 was detected early on the next morning. High levels of radioiodines and radiocesiums were detected in the topsoil and plants on 15 March 2011, so sampling of food and water for monitoring surveys began on 16 March 2011. On 17 March 2011, provisional regulation values for radioiodine, radiocesiums, uranium, plutonium and other transuranic α emitters were set to regulate the safety of radioactively contaminated food and water. On 21 March 2011, the first restrictions on distribution and consumption of contaminated items were ordered. So far, tap water, raw milk, vegetables, mushrooms, fruit, nut, seaweeds, marine invertebrates, coastal fish, freshwater fish, beef, wild animal meat, brown rice, wheat, tea leaves and other foodstuffs had been contaminated above the provisional regulation values. The provisional regulation values for radioiodine were exceeded in samples taken from 16 March 2011 to 21 May 2011, and those for radiocesiums from 18 March 2011 to date. All restrictions were imposed within 318 days after the provisional regulation values were first exceeded for each item. This paper summarizes the policy for the execution of monitoring surveys and restrictions, and the outlines of the monitoring results of 220 411 samples and the enforced restrictions predicated on the information available as of 31 March 2012. PMID:22843368

  6. European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

    PubMed

    Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

    2006-04-01

    This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including

  7. 76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-25

    ... regulations implementing the National Organic Program (NOP) were published December 21, 2000 (65 FR 80548... FR 14827), its schedule to review certain regulations, including the NOP regulations, under criteria... Organic Program Regulations AGENCY: Agricultural Marketing Service, USDA. ACTION: Review and request...

  8. Regulation of toxin production by Bacillus cereus and its food safety implications.

    PubMed

    Ceuppens, Siele; Rajkovic, Andreja; Heyndrickx, Marc; Tsilia, Varvara; Van De Wiele, Tom; Boon, Nico; Uyttendaele, Mieke

    2011-08-01

    Toxin expression is of utmost importance for the food-borne pathogen B. cereus, both in food poisoning and non-gastrointestinal host infections as well as in interbacterial competition. Therefore it is no surprise that the toxin gene expression is tightly regulated by various internal and environmental signals. An overview of the current knowledge regarding emetic and diarrheal toxin transcription and expression is presented in this review. The food safety aspects and management tools such as temperature control, food preservatives and modified atmosphere packaging are discussed specifically for B. cereus emetic and diarrheal toxin production. PMID:21417966

  9. 76 FR 47436 - Virginia Graeme Baker Pool and Spa Safety Act; Incorporation by Reference of Successor Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY... Successor Standard AGENCY: U.S. Consumer Product Safety Commission. ACTION: Final rule. SUMMARY: The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') finds the successor drain...

  10. 76 FR 78130 - Mortgage Acts and Practices-Advertising (Regulation N); Mortgage Assistance Relief Services...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-16

    ... Advance Notice of Proposed Rulemaking: Mortgage Acts and Practices, 74 FR 26118 (June 1, 2009), that.... See 76 FR 43569 (July 21, 2011). The Omnibus Appropriations Act, as amended, authorizes the Bureau to... response to a notice published at 76 FR 75825 (Dec. 5, 2011) concerning its efforts to identify...

  11. 75 FR 12377 - Native American Graves Protection and Repatriation Act Regulations-Disposition of Culturally...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... first rules to implement the Act on December 4, 1995 (43 CFR part 10, 60 FR 62158). --We published rules for assessing civil penalties under the Act on April 3, 2003 (43 CFR 10.12, 68 FR 16354). --We....13, 72 FR 13189). --We are publishing this rule today. --We are developing additional rules to...

  12. 78 FR 41835 - Inflation Adjustments to the Price-Anderson Act Financial Protection Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-12

    ... consistent with the Plain Writing Act as well as the Presidential Memorandum, ``Plain Language in Government... made the initial changes to the Price-Anderson Act amounts on October 27, 2005 (70 FR 61885), and the first periodic inflation adjustments on September 29, 2008 (73 FR 56451). This final rule makes...

  13. A double-regulated oncolytic adenovirus with improved safety for adenocarcinoma therapy

    SciTech Connect

    Wei, Na; Fan, Jun Kai; Gu, Jin Fa; He, Ling Feng; Tang, Wen Hao; Cao, Xin; Liu, Xin Yuan

    2009-10-16

    Safety and efficiency are equally important to be considered in developing oncolytic adenovirus. Previously, we have reported that ZD55, an oncolytic adenovirus with the deletion of E1B-55K gene, exhibited potent antitumor activity. In this study, to improve the safety of ZD55, we utilized MUC1 promoter to replace the native promoter of E1A on the basis of ZD55, and generated a double-regulated adenovirus, named MUD55. Our data demonstrated that the expression of early and late genes of MUD55 was both reduced in MUC1-negative cells, resulting in its stricter glandular-tumor selective progeny production. The cytopathic effect of MUD55 was about 10-fold lower than mono-regulated adenovirus ZD55 or Ad.MUC1 in normal cells and not obviously attenuated in glandular tumor cells. Moreover, MUD55 showed the least liver toxicity when administrated by intravenous injection in nude mice. These results indicate that MUD55 could be a promising candidate for the treatment of adenocarcinoma.

  14. 77 FR 52604 - Special Local Regulations; Safety Zones; Recurring Events in Captain of the Port Long Island Sound

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ... of the Port Long Island Sound AGENCY: Coast Guard, DHS. ACTION: Notice of enforcement of regulation. SUMMARY: The Coast Guard will enforce two fireworks display safety zones in the Sector Long Island Sound... Port (COTP) Sector Long Island Sound or designated representative. DATES: The regulations in 33 CFR...

  15. 15 CFR 971.804 - Amendment to regulations for conservation, protection of the environment, and safety of life and...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... sea. The Administrator may amend the regulations in this part and 15 CFR part 970 at any time as the... issued or maintained pursuant to this part or 15 CFR part 970, except that amended regulations which... conservation, protection of the environment, and safety of life and property at sea. 971.804 Section...

  16. 78 FR 31402 - Safety Zones and Special Local Regulations; Recurring Marine Events in Captain of the Port Long...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-24

    ...The Coast Guard is adding, deleting, and modifying safety zones and special local regulations and adding language to clarify time frames and notification requirements for annual marine events in the Sector Long Island Sound Captain of the Port (COTP) Zone. When these regulated areas are activated and subject to enforcement, this rule will restrict vessels from portions of water areas during......

  17. 15 CFR 971.804 - Amendment to regulations for conservation, protection of the environment, and safety of life and...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... sea. The Administrator may amend the regulations in this part and 15 CFR part 970 at any time as the... issued or maintained pursuant to this part or 15 CFR part 970, except that amended regulations which... conservation, protection of the environment, and safety of life and property at sea. 971.804 Section...

  18. 15 CFR 971.804 - Amendment to regulations for conservation, protection of the environment, and safety of life and...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... sea. The Administrator may amend the regulations in this part and 15 CFR part 970 at any time as the... issued or maintained pursuant to this part or 15 CFR part 970, except that amended regulations which... conservation, protection of the environment, and safety of life and property at sea. 971.804 Section...

  19. 15 CFR 971.804 - Amendment to regulations for conservation, protection of the environment, and safety of life and...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... sea. The Administrator may amend the regulations in this part and 15 CFR part 970 at any time as the... issued or maintained pursuant to this part or 15 CFR part 970, except that amended regulations which... conservation, protection of the environment, and safety of life and property at sea. 971.804 Section...

  20. Annual report on the administration of the Radiation Control for health and Safety Act of 1968, Public Law 90-602, April 1, 1991. Rept. for Jan-Dec 90

    SciTech Connect

    Not Available

    1991-04-01

    The Secretary of Health and Human Services is required by Subpart 3, Part F of Title III of the Public Health Service Act; 42 USC 263b et seq. (Public Law 90-602) to submit an annual report to the President for transmittal to the Congress on or before April 1 on the administration of the Radiation Control for Health and Safety Act. The detailed information required in the report is outlined in Section 360D of the Public Health Service Act. The Food and Drug Administration, through its Center for Devices and Radiological Health, is responsible for the day-to-day administration of the Radiation Control for Health and Safety Act of 1968. The report provides a summary of the operations of the Center in carrying out that responsibility for calendar year 1990. In reviewing the operations of the Center for Devices and Radiological Health as reported in the document, it should be kept in mind that the day-to-day administration of the Act is only part of the Center's function. Other responsibilities include the administration and enforcement of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (not covered in the report). Manufacturers of electronic products are required by 21 CFR 1002.20 to report accidental radiation occurrences to the Center for Devices and Radiological Health. The Center no longer maintains a Radiation Incidents Registry, since accidental radiation occurrences are reported through the Device Experience Network (DEN) and through the requirements of the Medical Device Reporting (MDR) Regulations.

  1. 49 CFR 215.7 - Prohibited acts.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 4 2011-10-01 2011-10-01 false Prohibited acts. 215.7 Section 215.7 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS General § 215.7 Prohibited acts....

  2. 49 CFR 215.7 - Prohibited acts.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Prohibited acts. 215.7 Section 215.7 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS General § 215.7 Prohibited acts....

  3. 49 CFR 215.7 - Prohibited acts.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Prohibited acts. 215.7 Section 215.7 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS General § 215.7 Prohibited acts....

  4. 49 CFR 215.7 - Prohibited acts.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Prohibited acts. 215.7 Section 215.7 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS General § 215.7 Prohibited acts....

  5. 49 CFR 215.7 - Prohibited acts.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Prohibited acts. 215.7 Section 215.7 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD FREIGHT CAR SAFETY STANDARDS General § 215.7 Prohibited acts....

  6. 25 CFR 101.10 - Federal Reserve Regulation Z and Fair Credit Reporting Act.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... subject to the provisions of Federal Reserve Regulation Z (Truth In Lending, 12 CFR part 226; Pub. L. 91... 25 Indians 1 2013-04-01 2013-04-01 false Federal Reserve Regulation Z and Fair Credit Reporting... ACTIVITIES LOANS TO INDIANS FROM THE REVOLVING LOAN FUND § 101.10 Federal Reserve Regulation Z and...

  7. 25 CFR 101.10 - Federal Reserve Regulation Z and Fair Credit Reporting Act.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... subject to the provisions of Federal Reserve Regulation Z (Truth In Lending, 12 CFR part 226; Pub. L. 91... 25 Indians 1 2010-04-01 2010-04-01 false Federal Reserve Regulation Z and Fair Credit Reporting... ACTIVITIES LOANS TO INDIANS FROM THE REVOLVING LOAN FUND § 101.10 Federal Reserve Regulation Z and...

  8. 25 CFR 101.10 - Federal Reserve Regulation Z and Fair Credit Reporting Act.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... subject to the provisions of Federal Reserve Regulation Z (Truth In Lending, 12 CFR part 226; Pub. L. 91... 25 Indians 1 2014-04-01 2014-04-01 false Federal Reserve Regulation Z and Fair Credit Reporting... ACTIVITIES LOANS TO INDIANS FROM THE REVOLVING LOAN FUND § 101.10 Federal Reserve Regulation Z and...

  9. 25 CFR 101.10 - Federal Reserve Regulation Z and Fair Credit Reporting Act.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... subject to the provisions of Federal Reserve Regulation Z (Truth In Lending, 12 CFR part 226; Pub. L. 91... 25 Indians 1 2011-04-01 2011-04-01 false Federal Reserve Regulation Z and Fair Credit Reporting... ACTIVITIES LOANS TO INDIANS FROM THE REVOLVING LOAN FUND § 101.10 Federal Reserve Regulation Z and...

  10. GP Supervisors' Experience in Supporting Self-Regulated Learning: A Balancing Act

    ERIC Educational Resources Information Center

    Sagasser, Margaretha H.; Kramer, Anneke W. M.; van Weel, Chris; van der Vleuten, Cees P. M.

    2015-01-01

    Self-regulated learning is essential for professional development and lifelong learning. As self-regulated learning has many inaccuracies, the need to support self-regulated learning has been recommended. Supervisors can provide such support. In a prior study trainees reported on the variation in received supervisor support. This study aims at…

  11. Florida Postsecondary Education Security Information Act. Annual Report of Campus Crime Statistics 1990-92 and Annual Assessment of Physical Plant Safety 1993.

    ERIC Educational Resources Information Center

    Florida State Dept. of Education, Tallahassee. Office of Postsecondary Education Coordination.

    This report contains campus crime statistics for 1990-92 of crimes reported to have occurred on the community colleges, state universities, and independent colleges and universities of Florida, as required by the Florida Postsecondary Education Security Information (FPESI) Act. It also includes an assessment of physical plant safety for 1993…

  12. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  13. The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act

    PubMed Central

    Brannigan, Vincent

    1986-01-01

    Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the statutory scheme, examine constitutional arguments relating to computer software, and discuss regulatory principles that should be taken into account when deciding appropriate regulation. This paper is limited to computer program output used by humans in deciding appropriate medical therapy for a patient.

  14. 78 FR 20291 - Fisheries of the United States; Billfish Conservation Act of 2012 Implementing Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ...NMFS issues this advance notice of proposed rulemaking (ANPR) to provide background information and request public comment on potential issues related to the implementation of the Billfish Conservation Act of...

  15. Development of the preliminary procedure for a national nuclear safety authority staff acting during the PWR NPP accident

    SciTech Connect

    Kostadinov, V.

    1997-12-01

    We present the development of the new preliminary procedure for a National Nuclear Safety Authority staff preparedness for action in the case of a Pressurized Water Reactor Nuclear Power Plant accident. The procedures are generic and equally applicable for advanced nuclear plants. The basic goal of the procedure is systematic determination of the responsibilities of the staff expert group(s) members for accident analysis and consequences prediction. Moreover, the procedure describes anticipated practices of an expert group acting during a plant accident. Different sources will define the state(s) of the plant as: the plant form for initial notification of an accident, the particular form for specific plant information, etc. By this procedure we propose three expert groups successively to work up to eight hours each, in the circumstances of an accident. We suppose the expert group to have mostly five members each. The members should have different tasks for resolution, defined by the procedure. The head of the group will coordinate group members work during an accident. Group members have to be qualified and acquainted with all adequate references. In the paper we present a newly devised agenda with presumed duties of each member of the group. Furthermore, we also composed a special form for information exchange between the utility and regulatory staff member during an accident. 8 refs., 1 fig.

  16. [On improvement of the mechanism for establishing and changing indicators of quality and food safety in the regulatory and legal acts of the Eurasian Economical Union].

    PubMed

    Arnautov, O V

    2016-01-01

    In accordance with the Treaty on the Eurasian Economic Union (EAEU) to ensure the sanitary and epidemiological welfare of the population within the Union, a coordinated policy in agreed policy in the sphere of application of sanitary measures is carried out. Sanitary measures are the obligatory requirements and procedures, including requirements for the final product, processing methods, production, transportation, storage and disposal, sampling procedures, methods of research (tests), risk assessment, the state registration, requirements for packaging directly aimed at ensuring the safety of products (goods) in order to protect human welfare, and they should be applied on the basis having a scientific explanation, and only to the extent that is necessary to protect human welfare. Sanitary measures applied within the Union should be based on international and regional standards, guidelines and (or) the recommendations, except when they based on appropriate scientific studies and explanations. In this case sanitary measures which could provide a higher level of sanitary protection are introduced. At present, the mechanism of the development, justification and approval of common sanitary and epidemiological requirements (ESR) and procedures of the Eurasian Economic Commission (the Commission) is not installed. The absence of a clear mechanism for the development, approval and implementation of the ESR to the products (goods) on the basis having a scientific explanation on the one hand could lead to the creation of unjustified barriers to foreign and mutual trade, on the other--to weaken the level of safety for human life and health of products (goods) placed on markets of the Union. In order to bring the regulatory legal acts of the Customs Union in accordance with the Treaty on the Eurasian Economic Union the Commission in cooperation with the competent authorities of the Member States in the field of sanitary and epidemiological welfare developed the project of

  17. 49 CFR 826.2 - When the Act applies.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 7 2011-10-01 2011-10-01 false When the Act applies. 826.2 Section 826.2 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD... applies. The Act applies to any adversary adjudication identified in § 826.3 as covered under the Act....

  18. Chemical Safety Improvement Act

    THOMAS, 113th Congress

    Sen. Lautenberg, Frank R. [D-NJ

    2013-05-22

    02/04/2014 Committee on Environment and Public Works Subcommittee on Water and Wildlife. Hearings held. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. School Bus Safety Act

    THOMAS, 113th Congress

    Rep. Braley, Bruce L. [D-IA-1

    2014-05-07

    06/13/2014 Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. Online Pharmacy Safety Act

    THOMAS, 112th Congress

    Sen. Feinstein, Dianne [D-CA

    2011-12-15

    12/15/2011 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S8685-8687) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  1. Child Handgun Safety Act

    THOMAS, 113th Congress

    Rep. Speier, Jackie [D-CA-14

    2013-06-27

    07/15/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  2. Buyback Our Safety Act

    THOMAS, 113th Congress

    Rep. Deutch, Theodore E. [D-FL-21

    2013-01-14

    01/25/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, And Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  3. Personalized Handgun Safety Act

    THOMAS, 113th Congress

    Rep. Tierney, John F. [D-MA-6

    2013-05-15

    06/14/2013 Referred to the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  4. Genetically Engineered Safety Act

    THOMAS, 112th Congress

    Rep. Kucinich, Dennis J. [D-OH-10

    2011-12-02

    12/19/2011 Referred to the Subcommittee on Rural Development, Research, Biotechnology, and Foreign Agriculture. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  5. Regulation of caulimovirus gene expression and the involvement of cis-acting elements on both viral transcripts.

    PubMed

    Scholthof, H B; Wu, F C; Gowda, S; Shepherd, R J

    1992-09-01

    In a further analysis of gene regulation of figwort mosaic virus (FMV), a caulimovirus, we studied transient gene expression with modified viral genomes in Nicotiana edwardsonii cell suspension protoplasts. The results demonstrated that the presence of the promoter for the full-length RNA interferes with expression from the separate downstream promoter for gene VI. In addition, expression of gene VI was inhibited by cis-acting sequences within gene VI itself. Both inhibitory effects could be partially relieved by coelectroporation with a plasmid that produces gene VI protein, demonstrating that expression of gene VI is transactivated by its own product. Subsequent expression studies with partially redundant FMV plasmids containing a reporter gene in frame with gene IV showed that efficient transactivation of CAT expression relies on a cis-acting element inside the downstream gene VI. Insertions of a transcriptional terminator upstream of the cis-acting element for premature termination of transcription showed that the cis-acting region is not a DNA element but is active only as a feature of the RNA transcript. We conclude that the cis-acting element, together with the transacting gene VI product, enhances expression of all major genes, including gene VI, from the polycistronic mRNA and the separate mRNA for gene VI. PMID:1529539

  6. Annual report on the administration of the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, (1988), April 1, 1989. Annual report

    SciTech Connect

    Not Available

    1989-04-01

    The Secretary of Health and Human Services is required by Subpart 3, Part F of Title III of the Public Health Service Act; 42 USC 263b et seq. (Public Law 90-602) to submit an annual report to the President for transmittal to the Congress on or before April 1 on the administration of the Radiation Control for Health and Safety Act. The detailed information required in the report is outlined in Section 360D of the Public Health Service Act. The Food and Drug Administration, through its Center for Devices and Radiological Health, is responsible for the day-to-day administration of the Radiation Control for Health and Safety Act of 1968. The report provides a summary of the operations of the Center in carrying out that responsibility for calendar year 1988. In reviewing the operations of the Center for Devices and Radiological Health as reported in the document, it should be kept in mind that the day-to-day administration of the Act is only part of the Center's function. Other responsibilities include the administration and enforcement of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (not covered in the report).

  7. 76 FR 10234 - Amendment to the Bank Secrecy Act Regulations-Reports of Foreign Financial Accounts

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-24

    ... Regulations (CFR) for BSA regulations. (See 75 FR 65806 (October 26, 2010) (Transfer and Reorganization of... draft of which appeared in the Federal Register as an attachment to the NPRM. \\3\\ See 75 FR 8844... foreign financial institution.\\5\\ \\4\\ 75 FR 8851 (February 26, 2010) (Emphasis added). \\5\\ A revised...

  8. 75 FR 51420 - Removing Regulations Implementing the Fish and Wildlife Conservation Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-20

    ... implementing regulations (50 CFR 83) in the May 6, 2010, Federal Register (75 FR 24862) and invited public... with Native American Tribal Governments'' (59 FR 22951), E.O. 13175, and 512 DM 2. We have determined... Fish and Wildlife Service 50 CFR Part 83 RIN 1018-AX00 Removing Regulations Implementing the Fish...

  9. 76 FR 64049 - Bank Secrecy Act Regulations: Definition of “Monetary Instrument”

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Code of Federal Regulations for the BSA regulations. See 75 FR 65806 (October 26, 2010) (Transfer and... rule could be proposed by creating a regulatory framework and definition of prepaid access. \\10\\ 75 FR... regarding reporting of the international transport of prepaid access, see 75 FR 36593. \\11\\ 76 FR 45403....

  10. An overview of safety assessment, regulation, and control of hazardous material use at NREL

    SciTech Connect

    Nelson, B.P.; Crandall, R.S. ); Moskowitz, P.D.; Fthenakis, V.M. )

    1992-01-01

    This paper summarizes the methodology we use to ensure the safe use of hazardous materials at the National Renewable Energy Laboratory (NREL). First, we analyze the processes and the materials used in those processes to identify the hazards presented. Then we study federal, state, and local regulations and apply the relevant requirements to our operations. When necessary, we generate internal safety documents to consolidate this information. We design research operations and support systems to conform to these requirements. Before we construct the systems, we perform a semiquantitative risk analysis on likely accident scenarios. All scenarios presenting in unacceptable risk require system or procedural modifications to reduce the risk. Following these modifications, we repeat the risk analysis to ensure that the respective accident scenarios present acceptable risk. Once all risks are acceptable, we conduct an operational readiness review (ORR). A management appointed panel performs the ORR ensuring compliance with all relevant requirements. After successful completion of the ORR, operations can begin.

  11. An overview of safety assessment, regulation, and control of hazardous material use at NREL

    SciTech Connect

    Nelson, B.P.; Crandall, R.S.; Moskowitz, P.D.; Fthenakis, V.M.

    1992-07-01

    This paper summarizes the methodology we use to ensure the safe use of hazardous materials at the National Renewable Energy Laboratory (NREL). First, we analyze the processes and the materials used in those processes to identify the hazards presented. Then we study federal, state, and local regulations and apply the relevant requirements to our operations. When necessary, we generate internal safety documents to consolidate this information. We design research operations and support systems to conform to these requirements. Before we construct the systems, we perform a semiquantitative risk analysis on likely accident scenarios. All scenarios presenting in unacceptable risk require system or procedural modifications to reduce the risk. Following these modifications, we repeat the risk analysis to ensure that the respective accident scenarios present acceptable risk. Once all risks are acceptable, we conduct an operational readiness review (ORR). A management appointed panel performs the ORR ensuring compliance with all relevant requirements. After successful completion of the ORR, operations can begin.

  12. Changes in technical regulations and drivers' safety in top‐class motor sports

    PubMed Central

    Lippi, G; Salvagno, G L; Franchini, M; Guidi, G C

    2007-01-01

    Motor racing is a dangerous sport and an inherently risky activity. The organisers of top‐class motor sports championships, Formula One and MotoGP, have agreed on a set of regulations to reduce speed and improve safety over the last 10 years. These changes include limitations in weight, fuel and engine capacity. Nevertheless, there is evidence that most of the restrictions that have been introduced over the past 10 years have failed slow down vehicles, since the lap times have decreased almost linearly from 1995 to 2006 and drivers continue to die or to sustain serious injuries that keep them away from competition. Therefore, new and efficient measures should be adopted, such as lowering the cornering speed, having heavier and safer vehicles, having barriers surrounding the track to protect both spectators and competitors better, and having innovative clothing and protective devices to defend key anatomical structures while minimising the hindrance to the rider. PMID:17925386

  13. 16 CFR 1610.36 - Application of Act to particular types of products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Application of Act to particular types of products. 1610.36 Section 1610.36 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES Rules and Regulations § 1610.36 Application of Act to particular types...

  14. Overview of Development and Deployment of Codes, Standards and Regulations Affecting Energy Storage System Safety in the United States

    SciTech Connect

    Conover, David R.

    2014-08-22

    This report acquaints stakeholders and interested parties involved in the development and/or deployment of energy storage systems (ESS) with the subject of safety-related codes, standards and regulations (CSRs). It is hoped that users of this document gain a more in depth and uniform understanding of safety-related CSR development and deployment that can foster improved communications among all ESS stakeholders and the collaboration needed to realize more timely acceptance and approval of safe ESS technology through appropriate CSR.

  15. Active and Passive Fatigue in Simulated Driving: Discriminating Styles of Workload Regulation and Their Safety Impacts

    PubMed Central

    Saxby, Dyani J.; Matthews, Gerald; Warm, Joel S.; Hitchcock, Edward M.; Neubauer, Catherine

    2015-01-01

    Despite the known dangers of driver fatigue, it is a difficult construct to study empirically. Different forms of task-induced fatigue may differ in their effects on driver performance and safety. Desmond and Hancock (2001) defined active and passive fatigue states that reflect different styles of workload regulation. In 2 driving simulator studies we investigated the multidimensional subjective states and safety outcomes associated with active and passive fatigue. Wind gusts were used to induce active fatigue, and full vehicle automation to induce passive fatigue. Drive duration was independently manipulated to track the development of fatigue states over time. Participants were undergraduate students. Study 1 (N = 108) focused on subjective response and associated cognitive stress processes, while Study 2 (N = 168) tested fatigue effects on vehicle control and alertness. In both studies the 2 fatigue manipulations produced different patterns of subjective response reflecting different styles of workload regulation, appraisal, and coping. Active fatigue was associated with distress, overload, and heightened coping efforts, whereas passive fatigue corresponded to large-magnitude declines in task engagement, cognitive underload, and reduced challenge appraisal. Study 2 showed that only passive fatigue reduced alertness, operationalized as speed of braking and steering responses to an emergency event. Passive fatigue also increased crash probability, but did not affect a measure of vehicle control. Findings support theories that see fatigue as an outcome of strategies for managing workload. The distinction between active and passive fatigue is important for assessment of fatigue and for evaluating automated driving systems which may induce dangerous levels of passive fatigue. PMID:24041288

  16. Fnr (EtrA) acts as a fine-tuning regulator of anaerobic metabolism in Shewanella oneidensis MR-1

    SciTech Connect

    Cruz-Garza, Claribel; Murray, Alison E.; Rodrigues, Jorge L.M.; Gralnick, Jeffrey A.; McCue, Lee Ann; Romine, Margaret F.; Loffler, F. E.; Tiedje, James M.

    2011-03-30

    EtrA in Shewanella oneidensis MR-1, a model organism for study of adaptation to varied redox niches, shares 73.6% and 50.8% amino acid sequence identity with the oxygen-sensing regulators Fnr in E. coli and Anr in Pseudomonas aeruginosa, respectively; however, its regulatory role of anaerobic metabolism in Shewanella spp. is not well understood. The expression of the nap genes, nrfA, cymA and hcp was significantly reduced in etrA deletion mutant EtrA7-1; however, limited anaerobic growth and nitrate reduction occurred, suggesting that multiple regulators control nitrate reduction in this strain. Dimethyl sulfoxide (DMSO) and fumarate reductase gene expression was down regulated at least 2-fold and the EtrA7-1 mutant grew poorly with fumarate and dimethyl sulfoxide (DMSO), suggesting both respiratory pathways are under EtrA control. Transcript analysis further suggested a role of EtrA in prophage activation and down regulation of genes implicated in aerobic metabolism. In contrast to previous studies that attributed a minor regulatory role to EtrA in Shewanella spp., this study demonstrates that EtrA acts as a global transcriptional regulator and confers physiological advantages to strain MR-1 under certain growth conditions. In conjunction with other regulators, EtrA fine-tunes the expression of genes involved in anaerobic metabolism in S. oneidensis strain MR-1.

  17. 75 FR 63425 - Regulations Implementing the Longshore and Harbor Workers' Compensation Act: Recreational Vessels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... the responsible employer, and that he or she is disabled as a result of the illness. (3) Hearing loss. If the individual claims compensation for hearing loss, the date of injury is the date the individual... and Harbor Workers' Compensation Act: Recreational Vessels, published on August 17, 2010 (75 FR...

  18. 75 FR 46859 - Lacey Act Implementation Plan; Definitions for Exempt and Regulated Articles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-04

    ... is being phased in, as described in two notices we published in the Federal Register (74 FR 5911-5913 and 74 FR 45415- 45418, Docket No. APHIS-2008-0119). Under the Act, ``Plant'' means: ``Any wild member... an appendix to the Convention on International Trade in Endangered Species of Wild Fauna and...

  19. 76 FR 78483 - S.A.F.E. Mortgage Licensing Act (Regulations G & H)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-19

    ... part of the public record and subject to public disclosure. Sensitive personal information, such as... for licensing loan originators that meets the requirements of the S.A.F.E. Act. \\1\\ 75 FR 44656 (July... this rule. See 76 FR 43569 (July 21, 2011). \\6\\ Public Law 111-203, section 1002(14)...

  20. Trans-acting factors regulate the expression of CD44 splice variants.

    PubMed Central

    Konig, H; Moll, J; Ponta, H; Herrlich, P

    1996-01-01

    Variant isoforms of the cell surface glycoprotein CD44 (CD44v) are expressed during development, in selected adult tissues and in certain metastatic tumor cells. CD44v differ from the standard isoform (CD44s) by up to ten additional exon sequences included by alternative splicing. By cell fusion experiments, we have obtained evidence for the existence of cell-type specific trans-acting factors recruiting CD44 variant exon sequences. Stable cell hybrids of CD44s and CD44v expressing cells indicated a dominant mechanism for variant-exon inclusion. In transient interspecies heterokaryons of human keratinocytes and rat fibroblasts, the ability of the keratinocytes to include all variant exon sequences in CD44 was conferred completely on the rat fibroblast nucleus. Fusions of cells with complex CD44 splice patterns do not permit interpretation of splice control by the relative abundance of a single trans-acting factor, but rather by (a) positively acting factor(s) recruiting variant exon sequences in the 3' to 5' direction and additional factors selecting individual exons. Since the pancreatic carcinoma cell line BSp73ASML (in contrast to the cervix carcinoma cell lines SiHa and ME180) could not transfer its specific splice pattern in cell fusions, we conclude that in some tumors, splicing is also controlled by mutation of cis-acting recognition sites. Images PMID:8670907

  1. 78 FR 36693 - Rules and Regulations Under the Fur Products Labeling Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-19

    ... guaranties annually. \\10\\ 78 FR 29263 (May 20, 2013). In light of the proposed amendments to the Textile... Act, 77 FR 57043 (Sept. 17, 2012). \\8\\ National Retail Federation Comment 00025 at 1-5, available at... Activities; Submission for OMB Review; Comment Request, 7 FR 10744 (Feb. 23, 2012). D. Projected...

  2. 76 FR 63817 - Disclosure of Information; Privacy Act Regulations; Notice and Amendments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... supervisory agency, for purposes of Sec. 309.6, to which exempt records could be disclosed.\\1\\ \\1\\ 76 FR 35963.... D. Plain Language Section 722 of the Gramm-Leach-Bliley Act (Pub. L. 106-102, 113 Stat. 1338, 1471), requires the Federal banking agencies to use plain language in all proposed and final rules published...

  3. 75 FR 58389 - Federal Acquisition Regulation; Information Collection; American Recovery and Reinvestment Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... Reporting Requirements for Prime Contractors AGENCY: Department of Defense (DOD), General Services... American Recovery and Reinvestment Act-Reporting Requirements--One Time Reporting Requirements for Prime... for which the burden is imposed on the prime contractor under the FAR requirements include...

  4. 75 FR 58388 - Federal Acquisition Regulation; Information Collection; American Recovery and Reinvestment Act...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-24

    ... Reporting for Prime Contractors AGENCY: Department of Defense (DOD), General Services Administration (GSA... Recovery and Reinvestment Act--Quarterly Reporting for Prime Contractors. Public comments are particularly...- mail to ernest.woodson@gsa.gov . ] SUPPLEMENTARY INFORMATION: A. Purpose Quarterly Reporting for...

  5. 20 CFR 626.4 - Table of contents for the Job Training Partnership Act regulations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the Job Training Partnership Act, 20 CFR parts 626-638 and 1005, 1 is as follows: 1 Part 1005 was...—Center Operations 638.500Orientation program. 694.501Student handbook. 638.502Job Corps basic...

  6. Market effects of environmental regulation: coal, railroads, and the 1990 Clean Air Act

    SciTech Connect

    Busse, M.R.; Keohane, N.O.

    2007-01-01

    Many environmental regulations encourage the use of 'clean' inputs. When the suppliers of such an input have market power, environmental regulation will affect not only the quantity of the input used but also its price. We investigate the effect of the Title IV emissions trading program for sulfur dioxide on the market for low-sulfur coal. We find that the two railroads transporting coal were able to price discriminate on the basis of environmental regulation and geographic location. Delivered prices rose for plants in the trading program relative to other plants, and by more at plants near a low-sulfur coal source.

  7. Ethylene acts as a negative regulator of glucose induced lateral root emergence in Arabidopsis.

    PubMed

    Singh, Manjul; Gupta, Aditi; Laxmi, Ashverya

    2015-01-01

    Plants, being sessile organisms, are more exposed to the hazards of constantly changing environmental conditions globally. During the lifetime of a plant, the root system encounters various challenges such as obstacles, pathogens, high salinity, water logging, nutrient scarcity etc. The developmental plasticity of the root system provides brilliant adaptability to plants to counter the changes exerted by both external as well as internal cues and achieve an optimized growth status. Phytohormones are one of the major intrinsic factors regulating all aspects of plant growth and development both independently as well as through complex signal integrations at multiple levels. We have previously shown that glucose (Glc) and brassinosteroid (BR) signalings interact extensively to regulate lateral root (LR) development in Arabidopsis. (1) Auxin efflux as well as influx and downstream signaling components are also involved in Glc-BR regulation of LR emergence. Here, we provide evidence for involvement of ethylene signaling machinery downstream to Glc and BR in regulation of LR emergence. PMID:26236960

  8. 75 FR 3665 - Regulations under the Comprehensive Smokeless Tobacco Health Education Act; Termination of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-22

    ... cars, banners, flags, and other event-related objects. On November 4, 1993 (58 FR 58810), the FTC... Tobacco to Protect Children and Adolescents, 61 FR 44615-618 (Aug. 28, 1996). Those regulations...

  9. Ethylene acts as a negative regulator of glucose induced lateral root emergence in Arabidopsis

    PubMed Central

    Singh, Manjul; Gupta, Aditi; Laxmi, Ashverya

    2015-01-01

    Plants, being sessile organisms, are more exposed to the hazards of constantly changing environmental conditions globally. During the lifetime of a plant, the root system encounters various challenges such as obstacles, pathogens, high salinity, water logging, nutrient scarcity etc. The developmental plasticity of the root system provides brilliant adaptability to plants to counter the changes exerted by both external as well as internal cues and achieve an optimized growth status. Phytohormones are one of the major intrinsic factors regulating all aspects of plant growth and development both independently as well as through complex signal integrations at multiple levels. We have previously shown that glucose (Glc) and brassinosteroid (BR) signalings interact extensively to regulate lateral root (LR) development in Arabidopsis.1 Auxin efflux as well as influx and downstream signaling components are also involved in Glc-BR regulation of LR emergence. Here, we provide evidence for involvement of ethylene signaling machinery downstream to Glc and BR in regulation of LR emergence. PMID:26236960

  10. 75 FR 66699 - Lacey Act Implementation Plan; Definitions for Exempt and Regulated Articles

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-29

    ... published in the Federal Register (75 FR 46859-46861, Docket No. APHIS-2009-0018) a proposal to establish... Implementation Plan; Definitions for Exempt and Regulated Articles AGENCY: Animal and Plant Health...

  11. Encouraging Maternal Sacrifice: How Regulations Governing the Consumption of Pharmaceuticals During Pregnancy Prioritize Fetal Safety over Maternal Health and Autonomy.

    PubMed

    Donley, Greer

    Pregnant women are routinely faced with the stressful decision of whether to consume needed medications during their pregnancies. Because the risks associated with pharmaceutical drug consumption during pregnancy are largely unknown, pregnant women both inadvertently consume dangerous medications and avoid needed drugs. Both outcomes are harmful to pregnant women and their fetuses. This unparalleled lack of drug safety information is a result of ill-conceived, paternalistic regulations in two areas of the law: regulations governing ethical research in human subjects and regulations that dictate the required labels on drugs. The former categorizes pregnant women as "vulnerable" and thus precludes them from most medical research. The result is that ninety-one percent of drugs lack any reliable safety information for pregnant consumers. The latter currently requires all drug labels to encourage drug avoidance during pregnancy, despite ample evidence that avoiding needed medications can harm pregnant women. On June 30, 2015, new pregnancy labeling regulations took effect. Though these regulations make important improvements, they continue to treat pregnant women unlike any population, including other unique subpopulations, such as children. As a result, the new regulations do not fix the problem of over-warning pregnant women about the risks of drug consumption. This article questions the legitimacy of both regulations and suggests three reforms for how to improve access to vital safety information: (1) amend the regulations governing ethical research in human subjects to reclassify pregnant women as non-vulnerable adults; (2) create incentives to generate safety data in pregnant women by granting a period of market exclusivity for drug companies that invest in this research; and (3) make the FDA pregnancy labeling regulations consistent with the routine FDA practice of requiring the display of balanced, human data on risk. PMID:26793823

  12. Nano-food packaging: an overview of market, migration research, and safety regulations.

    PubMed

    Bumbudsanpharoke, Nattinee; Ko, Seonghyuk

    2015-05-01

    Recently, food packages produced with nanoparticles, "nano-food packaging," have become more available in the current market. However, although the use of nanomaterials is increasing in food packaging applications, concern over toxicity affects consumer perceptions and acceptance. Quite a number of commercialized forms of nano-food packaging are coated or composited product with inorganic materials, for example, nanosilver and nanoclay as representative examples. Several studies have shown the possibility of nanomaterial migration from packaging or containers to foodstuff. The debate is still ongoing among researchers about the extent of migration and whether it is negligible and safe. Government agencies and stakeholders must hurry to determine use limitations and release conclusive legislation and regulations as soon as possible since nano-food packaging may have great impacts on human health. This paper aims to review the availability of nano-food packaging in the current market, report case studies on nanomaterial migration, and present the current status of safety regulations and management of nano-food packaging in leading countries across regions. This review should enable governments and researchers to develop further nanomaterial risk assessment studies. PMID:25881665

  13. To Set Up Norms for Drug Safety and Inspection: To Guarantee Administrative Sufficiency and Avoid Regulators from Being Wrongly Punished.

    PubMed

    Xuan, Qingsheng; Dong, Zuojun; Shao, Mingli

    2015-09-01

    Currently, as there is no systematic norm or standard for drug safety and inspection, it cannot be judged whether the regulatory authority or regulators have fulfilled their administrative responsibilities entirely or not, when a drug safety-related incident occurs. And there is a probability that some may even be wrongly punished. In this study, we have analyzed the risk of not having appropriate norms in place and also put forward recommendations for the government or the regulatory authorities to set up norms to be fulfilled for drug safety and inspection issues. This, on one hand, could provide a basic guideline for the regulatory authorities and regulators to improve their professional levels and administrative acumen and on the other hand, it could also provide a baseline for society to judge whether the regulatory authorities and regulators have fulfilled their responsibilities correctly and thereby also help prevent regulators from being mistakenly punished. This study proposes that a systematic and functional norm for drug safety and inspection could be set up relating to the determination of the responsibilities of regulatory authorities and scope of various inspections, number and frequency of inspections, number and qualifications of regulators, handling of inspection results, inspection records, and disciplinary codes for inspectors. This study also puts forward suggestions on who should be responsible for drafting the norms and what are the factors that need to be considered while formulating the norms. PMID:27352264

  14. CoREST acts as a positive regulator of Notch signaling in the follicle cells of Drosophila melanogaster

    PubMed Central

    Domanitskaya, Elena; Schüpbach, Trudi

    2012-01-01

    The Notch signaling pathway plays important roles in a variety of developmental events. The context-dependent activities of positive and negative modulators dramatically increase the diversity of cellular responses to Notch signaling. In a screen for mutations affecting the Drosophila melanogaster follicular epithelium, we isolated a mutation in CoREST that disrupts the Notch-dependent mitotic-to-endocycle switch of follicle cells at stage 6 of oogenesis. We show that Drosophila CoREST positively regulates Notch signaling, acting downstream of the proteolytic cleavage of Notch but upstream of Hindsight activity; the Hindsight gene is a Notch target that coordinates responses in the follicle cells. We show that CoREST genetically interacts with components of the Notch repressor complex, Hairless, C-terminal Binding Protein and Groucho. In addition, we demonstrate that levels of H3K27me3 and H4K16 acetylation are dramatically increased in CoREST mutant follicle cells. Our data indicate that CoREST acts as a positive modulator of the Notch pathway in the follicular epithelium as well as in wing tissue, and suggests a previously unidentified role for CoREST in the regulation of Notch signaling. Given its high degree of conservation among species, CoREST probably also functions as a regulator of Notch-dependent cellular events in other organisms. PMID:22331351

  15. Regulation by consensus: The expanded use of regulatory negotiation under the Clean Air Act

    SciTech Connect

    Claiborne, M.L.

    1996-12-31

    This article discusses the consensus building approach, which stems from the more formal regulatory negotiation process under the Negotiated Rulemaking Act of 1990, for improving air quality. The article uses as examples the joint plan to improve air quality and visibility in the Grand Canyon and 15 other national parks and wilderness areas in the SW USA, and the Southern Appalachian Mountain initiative tackling more complex issues including visibility, ground ozone, acid deposition, etc.

  16. Nanotechnology research and regulation: A plan to ensure human and environmental safety

    NASA Astrophysics Data System (ADS)

    Reddy, Anitha

    The influence of nanotechnology spans numerous fields and is increasing rapidly due to the financial and research contributions to the field. The impact of nanotechnologybased products on human health and the environment is far from being understood. Research output related to environmental, health, and safety issues is too slow and far behind developments to address the vast number of types of nanoparticles and new uses being discovered. This thesis summarizes nanotechnology related regulations, applications, and current research related to environmental and human toxicity in order to put into perspective the gaping holes existing in the safe production, use, and disposal of nanotechnology. There were a number of conclusions that were determined following the literature survey of this thesis. There is currently a lack of international cooperation between regulatory agencies and research institutions who are involved with nanotechnology. The only entities that have made regulatory progress include the United States, European Union, and Australia. The toxicological impacts of nanotechnology are not fully understood due to the dearth of research, as well as the absence of testing and measuring infrastructure. Chapter 6 of this thesis proposes an effective and specific research strategy to expedite the creation of enforceable regulations in order to protect the environment, workers, and general public based on the conclusions described in the paragraph above. The strategy outlines the need for the development of an interagency committee, precationary limits, nanomaterial tracer system, nanomaterial data gathering, priority list, funds for toxicity research, and open database to information and materials. The aspects of the outline strategy will ensure the successful and efficient regulation of nanotechnology.

  17. Insulin/IGF-1 and Hypoxia Signaling Act in Concert to Regulate Iron Homeostasis in Caenorhabditis elegans

    PubMed Central

    Ackerman, Daniel; Gems, David

    2012-01-01

    Iron plays an essential role in many biological processes, but also catalyzes the formation of reactive oxygen species (ROS), which can cause molecular damage. Iron homeostasis is therefore a critical determinant of fitness. In Caenorhabditis elegans, insulin/IGF-1 signaling (IIS) promotes growth and reproduction but limits stress resistance and lifespan through inactivation of the DAF-16/FoxO transcription factor (TF). We report that long-lived daf-2 insulin/IGF-1 receptor mutants show a daf-16–dependent increase in expression of ftn-1, which encodes the iron storage protein H-ferritin. To better understand the regulation of iron homeostasis, we performed a TF–limited genetic screen for factors influencing ftn-1 gene expression. The screen identified the heat-shock TF hsf-1, the MAD bHLH TF mdl-1, and the putative histone acetyl transferase ada-2 as activators of ftn-1 expression. It also revealed that the HIFα homolog hif-1 and its binding partner aha-1 (HIFβ) are potent repressors of ftn-1 expression. ftn-1 expression is induced by exposure to iron, and we found that hif-1 was required for this induction. In addition, we found that the prolyl hydroxylase EGL-9, which represses HIF-1 via the von Hippel-Lindau tumor suppressor VHL-1, can also act antagonistically to VHL-1 in regulating ftn-1. This suggests a novel mechanism for HIF target gene regulation by these evolutionarily conserved and clinically important hydroxylases. Our findings imply that the IIS and HIF pathways act together to regulate iron homeostasis in C. elegans. We suggest that IIS/DAF-16 regulation of ftn-1 modulates a trade-off between growth and stress resistance, as elevated iron availability supports growth but also increases ROS production. PMID:22396654

  18. Nitric Oxide Acts as a Positive Regulator to Induce Metamorphosis of the Ascidian Herdmania momus

    PubMed Central

    Ueda, Nobuo; Degnan, Sandie M.

    2013-01-01

    Marine invertebrates commonly have a biphasic life cycle in which the metamorphic transition from a pelagic larva to a benthic post-larva is mediated by the nitric oxide signalling pathway. Nitric oxide (NO) is synthesised by nitric oxide synthase (NOS), which is a client protein of the molecular chaperon heat shock protein 90 (HSP90). It is notable, then, that both NO and HSP90 have been implicated in regulating metamorphosis in marine invertebrates as diverse as urochordates, echinoderms, molluscs, annelids, and crustaceans. Specifically, the suppression of NOS activity by the application of either NOS- or HSP90-inhibiting pharmacological agents has been shown consistently to induce the initiation of metamorphosis, leading to the hypothesis that a negative regulatory role of NO is widely conserved in biphasic life cycles. Further, the induction of metamorphosis by heat-shock has been demonstrated for multiple species. Here, we investigate the regulatory role of NO in induction of metamorphosis of the solitary tropical ascidian, Herdmania momus. By coupling pharmacological treatments with analysis of HmNOS and HmHSP90 gene expression, we present compelling evidence of a positive regulatory role for NO in metamorphosis of this species, in contrast to all existing ascidian data that supports the hypothesis of NO as a conserved negative regulator of metamorphosis. The exposure of competent H. momus larvae to a NOS inhibitor or an NO donor results in an up-regulation of NOS and HSP90 genes. Heat shock of competent larvae induces metamorphosis in a temperature dependent manner, up to a thermal tolerance that approaches 35°C. Both larval/post-larval survival and the appearance of abnormal morphologies in H. momus post-larvae reflect the magnitude of up-regulation of the HSP90 gene in response to heat-shock. The demonstrated role of NO as a positive metamorphic regulator in H. momus suggests the existence of inter-specific adaptations of NO regulation in ascidian

  19. Encouraging research and development of pediatric medical devices through legislative and regulatory action: the Pediatric Medical Device Safety and Improvement Act of 2007 in context.

    PubMed

    Bleicher, Ester W B

    2009-01-01

    In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title III within the context of the regulatory scheme previously in place, particularly in relation to the one in place to address the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading up to Title III. PMID:19999642

  20. Disemployment effects caused by regulation of drilling fluids and produced waters as hazardous under the Resource Conservation and Recovery Act

    SciTech Connect

    Flaim, S.J.

    1988-03-01

    This report reviews and compares several studies of the effects on employment of regulating wastes from oil and natural gas exploration and extraction under the Resource Conservation and Recovery Act (RCRA). The waste management scenarios on which most of the studies were based were developed by the U.S. Environmental Protection Agency. The analyses show that as many as 500,000-700,000 jobs may be lost in the first year if RCRA Subtitle C rules are applied to drilling fluids and produced waters. As a results, unemployment in major oil-producing states could rise by as much as six percentage points. 13 refs., 4 tabs.

  1. 78 FR 59101 - Regulations Implementing the Byrd Amendments to the Black Lung Benefits Act: Determining Coal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... public comment. 77 FR 19456-19478 (Mar. 30, 2012). These amendments reinstated two BLBA entitlement... Department recounted the history of these provisions in the NPRM. 77 FR at 19456-58. The Department also... streamlining the regulations where possible. See generally Executive Order 13563, 76 FR 3821 (January 18,...

  2. 78 FR 6621 - Ability To Repay Standards Under the Truth in Lending Act (Regulation Z)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-30

    ... lending model, and ties to their communities enable them to make more accurate assessments of consumers... deterioration in underwriting standards. See 73 FR 44524 (Jul. 30, 2008). The following is presented as..., which substantially parallels the Board's Regulation Z, 12 CFR part 226. See 76 FR 79767 (Dec. 22,...

  3. 75 FR 68911 - Regulations Under the Genetic Information Nondiscrimination Act of 2008

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-09

    ... document. See 74 FR 9056 (March 2, 2009). Several days earlier, on February 25, 2009, the Commission held a... FR 51664. The HHS Office for Civil Rights is responsible for issuing the regulations applicable to GINA section 105 and issued a proposed rule on October 7, 2009 at 74 FR 51698. Among the various...

  4. 77 FR 19455 - Regulations Implementing the Byrd Amendments to the Black Lung Benefits Act: Determining Coal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-30

    ..., 20 CFR 718.2 (2011); 45 FR 13677, 13679 (Feb. 29, 1980). The proposed rule does, however, retain... 65 FR 79920, 80029 (Dec. 20, 2000); 20 CFR 725.4(d) (2011). Consequently, there is no reason to... Federal Regulations in 2000. See 65 FR 79920, 80029 (Dec. 20, 2000); 20 CFR 725.4(d) (2011)....

  5. 77 FR 23196 - Native American Graves Protection and Repatriation Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-18

    ... amendments to the regulation concerning: Civil penalties (68 FR 16354, April 3, 2003); Future applicability (72 FR 13189, March 21, 2007); and Disposition of culturally unidentifiable human remains (75 FR 12378... Department of the Interior (Department) published the initial rules to implement NAGPRA (60 FR...

  6. 78 FR 27078 - Native American Graves Protection and Repatriation Act Regulations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-09

    ... Government Relations with Native American Tribal Governments'' (59 FR 22951, April 29, 1994); Executive Order... Office of the Secretary of the Interior 43 CFR Part 10 RIN 1024-AD99 Native American Graves Protection.... SUMMARY: This final rule revises regulations implementing the Native American Graves Protection...

  7. 77 FR 234 - Rules and Regulations Under the Textile Fiber Products Identification Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-04

    .... SUPPLEMENTARY INFORMATION: On November 7, 2011, the Commission published its ANPR (76 FR 68690) seeking comment...; ] FEDERAL TRADE COMMISSION 16 CFR Part 303 Rules and Regulations Under the Textile Fiber Products... section below. Write ``Textile Rules, 16 CFR Part 303, Project No. P948404'' on your comment, and...

  8. 78 FR 60686 - Regulations Implementing the Byrd Amendments to the Black Lung Benefits Act: Determining Coal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-02

    ... of Workers' Compensation Programs 20 CFR Parts 718 and 725 RIN 1240-AA04 Regulations Implementing the... Benefits; Correction AGENCY: Office of Workers' Compensation Programs, Labor. ACTION: Final rule; correction. SUMMARY: The Office of Workers' Compensation Programs is correcting the preamble to a final...

  9. 76 FR 25576 - Pipeline Safety: Applying Safety Regulations to All Rural Onshore Hazardous Liquid Low-Stress Lines

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-05

    ...: Apply all Part 195 requirements to small diameter rural low-stress pipelines located in or within one... that has transpired since the passage of the PIPES Act and the relatively small number of miles that... covered large diameter pipe (greater than or equal to 8\\5/8\\ inches in diameter) located in or within...

  10. 77 FR 50373 - Special Local Regulation and Safety Zone; America's Cup World Series Regattas, San Francisco Bay...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-21

    ... Cup Race Management DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed...'' regatta scheduled to occur August 21-26, 2012 (77 FR 41902). That rule created a special local regulation... temporary safety zone to govern these events from noon to 5 p.m. (77 FR 41902); however, the events...

  11. Food safety regulations: what we learned from the Fukushima nuclear accident.

    PubMed

    Hamada, Nobuyuki; Ogino, Haruyuki

    2012-09-01

    On 11 March 2011, the magnitude-9.0 earthquake and a substantial tsunami struck off the northeast coast of Japan. The Fukushima nuclear power plants were inundated and stricken, followed by radionuclide releases outside the crippled reactors. Provisional regulation values for radioactivity in food and drink were set on 17 March and were adopted from the preset index values, except that for radioiodines in water and milk ingested by infants. For radiocesiums, uranium, plutonium and transuranic α emitters, index values were defined in all food and drink not to exceed a committed effective dose of 5 mSv/year. Index values for radioiodines were defined not to exceed a committed equivalent dose to the thyroid of 50 mSv/year, and set in water, milk and some vegetables, but not in other foodstuffs. Index values were calculated as radioactive concentrations of indicator radionuclides ((131)I for radioiodines, (134)Cs and (137)Cs for radiocesiums) by postulating the relative radioactive concentration of coexisting radionuclides (e.g., (132)I, (133)I, (134)I, (135)I and (132)Te for (131)I). Surveys were thence conducted to monitor levels of (131)I, (134)Cs and (137)Cs. Provisional regulation values were exceeded in tap water, raw milk and some vegetables, and restrictions on distribution and consumption began on 21 March. Fish contaminated with radioiodines at levels of concern were then detected, so that the provisional regulation value for radioiodines in seafood adopted from that in vegetables were additionally set on 5 April. Overall, restrictions started within 25 days after the first excess in each food or drink item, and maximum levels were detected in leafy vegetables (54,100 Bq/kg for (131)I, and a total of 82,000 Bq/kg for (134)Cs and (137)Cs). This paper focuses on the logic behind such food safety regulations, and discusses its underlying issues. The outlines of the food monitoring results for 24,685 samples and the enforced restrictions will also be described

  12. Strigolactone acts downstream of auxin to regulate bud outgrowth in pea and Arabidopsis.

    PubMed

    Brewer, Philip B; Dun, Elizabeth A; Ferguson, Brett J; Rameau, Catherine; Beveridge, Christine A

    2009-05-01

    During the last century, two key hypotheses have been proposed to explain apical dominance in plants: auxin promotes the production of a second messenger that moves up into buds to repress their outgrowth, and auxin saturation in the stem inhibits auxin transport from buds, thereby inhibiting bud outgrowth. The recent discovery of strigolactone as the novel shoot-branching inhibitor allowed us to test its mode of action in relation to these hypotheses. We found that exogenously applied strigolactone inhibited bud outgrowth in pea (Pisum sativum) even when auxin was depleted after decapitation. We also found that strigolactone application reduced branching in Arabidopsis (Arabidopsis thaliana) auxin response mutants, suggesting that auxin may act through strigolactones to facilitate apical dominance. Moreover, strigolactone application to tiny buds of mutant or decapitated pea plants rapidly stopped outgrowth, in contrast to applying N-1-naphthylphthalamic acid (NPA), an auxin transport inhibitor, which significantly slowed growth only after several days. Whereas strigolactone or NPA applied to growing buds reduced bud length, only NPA blocked auxin transport in the bud. Wild-type and strigolactone biosynthesis mutant pea and Arabidopsis shoots were capable of instantly transporting additional amounts of auxin in excess of endogenous levels, contrary to predictions of auxin transport models. These data suggest that strigolactone does not act primarily by affecting auxin transport from buds. Rather, the primary repressor of bud outgrowth appears to be the auxin-dependent production of strigolactones. PMID:19321710

  13. Thyroid Hormone May Regulate mRNA Abundance in Liver by Acting on MicroRNAs

    PubMed Central

    Dong, Hongyan; Paquette, Martin; Williams, Andrew; Zoeller, R. Thomas; Wade, Mike; Yauk, Carole

    2010-01-01

    MicroRNAs (miRNAs) are extensively involved in diverse biological processes. However, very little is known about the role of miRNAs in mediating the action of thyroid hormones (TH). Appropriate TH levels are known to be critically important for development, differentiation and maintenance of metabolic balance in mammals. We induced transient hypothyroidism in juvenile mice by short-term exposure to methimazole and perchlorate from post natal day (PND) 12 to 15. The expression of miRNAs in the liver was analyzed using Taqman Low Density Arrays (containing up to 600 rodent miRNAs). We found the expression of 40 miRNAs was significantly altered in the livers of hypothyroid mice compared to euthyroid controls. Among the miRNAs, miRs-1, 206, 133a and 133b exhibited a massive increase in expression (50- to 500-fold). The regulation of TH on the expression of miRs-1, 206, 133a and 133b was confirmed in various mouse models including: chronic hypothyroid, short-term hyperthyroid and short-term hypothyroid followed by TH supplementation. TH regulation of these miRNAs was also confirmed in mouse hepatocyte AML 12 cells. The expression of precursors of miRs-1, 206, 133a and 133b were examined in AML 12 cells and shown to decrease after TH treatment, only pre-mir-206 and pre-mir-133b reached statistical significance. To identify the targets of these miRNAs, DNA microarrays were used to examine hepatic mRNA levels in the short-term hypothyroid mouse model relative to controls. We found transcripts from 92 known genes were significantly altered in these hypothyroid mice. Web-based target predication software (TargetScan and Microcosm) identified 14 of these transcripts as targets of miRs-1, 206, 133a and 133b. The vast majority of these mRNA targets were significantly down-regulated in hypothyroid mice, corresponding with the up-regulation of miRs-1, 206, 133a and 133b in hypothyroid mouse liver. To further investigate target genes, miR-206 was over-expressed in AML 12 cells. TH

  14. Potential Impact of Clean Air Act Regulations on Nitrogen Fate and Transport in the Neuse River Basin: a Modeling Investigation Using CMAQ and SWAT

    EPA Science Inventory

    There has been extensive analysis of Clean Air Act Amendment (CAAA) regulation impacts to changes in atmospheric nitrogen deposition; however, few studies have focused on watershed nitrogen transfer particularly regarding long-term predictions. In this study, we investigated impa...

  15. Superoxide dismutase 1 acts as a nuclear transcription factor to regulate oxidative stress resistance

    PubMed Central

    Tsang, Chi Kwan; Liu, Yuan; Thomas, Janice; Zhang, Yanjie; Zheng, X. F. Steven

    2015-01-01

    Summary Superoxide dismutase 1 (Sod1) has been known for nearly half a century for catalysis of superoxide to hydrogen peroxide. Here we report a new Sod1 function in oxidative signaling: in response to elevated endogenous and exogenous reactive oxygen species (ROS), Sod1 rapidly relocates into the nucleus, which is important for maintaining genomic stability. Interestingly, H2O2 is sufficient to promote Sod1 nuclear localization, indicating that it is responding to general ROS rather than Sod1 substrate superoxide. ROS signaling is mediated by Mec1/ATM and its effector Dun1/Cds1 kinase, through Dun1 interaction with Sod1 and regulation of Sod1 by phosphorylation at S60, 99. In the nucleus, Sod1 binds to the promoters and regulates the expression of oxidative resistance and repair genes. Altogether, our study unravels an unorthodox function of Sod1 as a transcription factor and elucidates the regulatory mechanism for its localization. PMID:24647101

  16. Anaplastic Lymphoma Kinase Acts in the Drosophila Mushroom Body to Negatively Regulate Sleep

    PubMed Central

    Bai, Lei; Sehgal, Amita

    2015-01-01

    Though evidence is mounting that a major function of sleep is to maintain brain plasticity and consolidate memory, little is known about the molecular pathways by which learning and sleep processes intercept. Anaplastic lymphoma kinase (Alk), the gene encoding a tyrosine receptor kinase whose inadvertent activation is the cause of many cancers, is implicated in synapse formation and cognitive functions. In particular, Alk genetically interacts with Neurofibromatosis 1 (Nf1) to regulate growth and associative learning in flies. We show that Alk mutants have increased sleep. Using a targeted RNAi screen we localized the negative effects of Alk on sleep to the mushroom body, a structure important for both sleep and memory. We also report that mutations in Nf1 produce a sexually dimorphic short sleep phenotype, and suppress the long sleep phenotype of Alk. Thus Alk and Nf1 interact in both learning and sleep regulation, highlighting a common pathway in these two processes. PMID:26536237

  17. Lysophosphatidic acid acts as a nutrient-derived developmental cue to regulate early hematopoiesis

    PubMed Central

    Li, Haisen; Yue, Rui; Wei, Bin; Gao, Ge; Du, Jiulin; Pei, Gang

    2014-01-01

    Primitive hematopoiesis occurs in the yolk sac blood islands during vertebrate embryogenesis, where abundant phosphatidylcholines (PC) are available as important nutrients for the developing embryo. However, whether these phospholipids also generate developmental cues to promote hematopoiesis is largely unknown. Here, we show that lysophosphatidic acid (LPA), a signaling molecule derived from PC, regulated hemangioblast formation and primitive hematopoiesis. Pharmacological and genetic blockage of LPA receptor 1 (LPAR1) or autotoxin (ATX), a secretory lysophospholipase that catalyzes LPA production, inhibited hematopoietic differentiation of mouse embryonic stem cells and impaired the formation of hemangioblasts. Mechanistic experiments revealed that the regulatory effect of ATX-LPA signaling was mediated by PI3K/Akt-Smad pathway. Furthermore, during in vivo embryogenesis in zebrafish, LPA functioned as a developmental cue for hemangioblast formation and primitive hematopoiesis. Taken together, we identified LPA as an important nutrient-derived developmental cue for primitive hematopoiesis as well as a novel mechanism of hemangioblast regulation. PMID:24829209

  18. Two Group A Streptococcal Peptide Pheromones Act through Opposing Rgg Regulators to Control Biofilm Development

    PubMed Central

    Chang, Jennifer C.; LaSarre, Breah; Jimenez, Juan C.; Aggarwal, Chaitanya; Federle, Michael J.

    2011-01-01

    Streptococcus pyogenes (Group A Streptococcus, GAS) is an important human commensal that occasionally causes localized infections and less frequently causes severe invasive disease with high mortality rates. How GAS regulates expression of factors used to colonize the host and avoid immune responses remains poorly understood. Intercellular communication is an important means by which bacteria coordinate gene expression to defend against host assaults and competing bacteria, yet no conserved cell-to-cell signaling system has been elucidated in GAS. Encoded within the GAS genome are four rgg-like genes, two of which (rgg2 and rgg3) have no previously described function. We tested the hypothesis that rgg2 or rgg3 rely on extracellular peptides to control target-gene regulation. We found that Rgg2 and Rgg3 together tightly regulate two linked genes encoding new peptide pheromones. Rgg2 activates transcription of and is required for full induction of the pheromone genes, while Rgg3 plays an antagonistic role and represses pheromone expression. The active pheromone signals, termed SHP2 and SHP3, are short and hydrophobic (DI[I/L]IIVGG), and, though highly similar in sequence, their ability to disrupt Rgg3-DNA complexes were observed to be different, indicating that specificity and differential activation of promoters are characteristics of the Rgg2/3 regulatory circuit. SHP-pheromone signaling requires an intact oligopeptide permease (opp) and a metalloprotease (eep), supporting the model that pro-peptides are secreted, processed to the mature form, and subsequently imported to the cytoplasm to interact directly with the Rgg receptors. At least one consequence of pheromone stimulation of the Rgg2/3 pathway is increased biogenesis of biofilms, which counteracts negative regulation of biofilms by RopB (Rgg1). These data provide the first demonstration that Rgg-dependent quorum sensing functions in GAS and substantiate the role that Rggs play as peptide receptors across the

  19. Phosphorylation acts positively and negatively to regulate MRTF-A subcellular localisation and activity.

    PubMed

    Panayiotou, Richard; Miralles, Francesc; Pawlowski, Rafal; Diring, Jessica; Flynn, Helen R; Skehel, Mark; Treisman, Richard

    2016-01-01

    The myocardin-related transcription factors (MRTF-A and MRTF-B) regulate cytoskeletal genes through their partner transcription factor SRF. The MRTFs bind G-actin, and signal-regulated changes in cellular G-actin concentration control their nuclear accumulation. The MRTFs also undergo Rho- and ERK-dependent phosphorylation, but the function of MRTF phosphorylation, and the elements and signals involved in MRTF-A nuclear export are largely unexplored. We show that Rho-dependent MRTF-A phosphorylation reflects relief from an inhibitory function of nuclear actin. We map multiple sites of serum-induced phosphorylation, most of which are S/T-P motifs and show that S/T-P phosphorylation is required for transcriptional activation. ERK-mediated S98 phosphorylation inhibits assembly of G-actin complexes on the MRTF-A regulatory RPEL domain, promoting nuclear import. In contrast, S33 phosphorylation potentiates the activity of an autonomous Crm1-dependent N-terminal NES, which cooperates with five other NES elements to exclude MRTF-A from the nucleus. Phosphorylation thus plays positive and negative roles in the regulation of MRTF-A. PMID:27304076

  20. Phosphorylation acts positively and negatively to regulate MRTF-A subcellular localisation and activity

    PubMed Central

    Panayiotou, Richard; Miralles, Francesc; Pawlowski, Rafal; Diring, Jessica; Flynn, Helen R; Skehel, Mark; Treisman, Richard

    2016-01-01

    The myocardin-related transcription factors (MRTF-A and MRTF-B) regulate cytoskeletal genes through their partner transcription factor SRF. The MRTFs bind G-actin, and signal-regulated changes in cellular G-actin concentration control their nuclear accumulation. The MRTFs also undergo Rho- and ERK-dependent phosphorylation, but the function of MRTF phosphorylation, and the elements and signals involved in MRTF-A nuclear export are largely unexplored. We show that Rho-dependent MRTF-A phosphorylation reflects relief from an inhibitory function of nuclear actin. We map multiple sites of serum-induced phosphorylation, most of which are S/T-P motifs and show that S/T-P phosphorylation is required for transcriptional activation. ERK-mediated S98 phosphorylation inhibits assembly of G-actin complexes on the MRTF-A regulatory RPEL domain, promoting nuclear import. In contrast, S33 phosphorylation potentiates the activity of an autonomous Crm1-dependent N-terminal NES, which cooperates with five other NES elements to exclude MRTF-A from the nucleus. Phosphorylation thus plays positive and negative roles in the regulation of MRTF-A. DOI: http://dx.doi.org/10.7554/eLife.15460.001 PMID:27304076