21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Animal food labeling warning statements. 501.17... food labeling warning statements. (a) Self-pressurized containers. (1) The label of a food packaged in... the following warning: Warning Avoid spraying in eyes. Contents under pressure. Do not puncture or...

40 CFR 156.70 - Precautionary statements for human hazards.

Code of Federal Regulations, 2013 CFR

2013-07-01

... mitigate the effect. The precautionary paragraph must be immediately preceded by the appropriate signal... clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed...

40 CFR 156.70 - Precautionary statements for human hazards.

Code of Federal Regulations, 2014 CFR

2014-07-01

... mitigate the effect. The precautionary paragraph must be immediately preceded by the appropriate signal... clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed...

40 CFR 156.70 - Precautionary statements for human hazards.

Code of Federal Regulations, 2012 CFR

2012-07-01

... mitigate the effect. The precautionary paragraph must be immediately preceded by the appropriate signal... clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed...

PRN 93-3: Labeling Statement Prohibiting Application to Water

EPA Pesticide Factsheets

This notice explaining the policy on label statement prohibiting pesticide application to water pertains only to the labeling statement on pesticide products. It does not address the term wetlands as defined with respect to the Clean Water Act.

40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...

40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Form of label bearing warning... Substances § 82.110 Form of label bearing warning statement. (a) Conspicuousness and contrast. The warning... matter on the label. The warning statement shall appear in sharp contrast to any background upon which it...

PRN 2000-5: Guidance for Mandatory and Advisory Labeling Statements

EPA Pesticide Factsheets

This notice provides guidance for improving the clarity of labeling statements in order to avoid confusing directions and precautions and to prevent the misuse of pesticides. It includes definitions and examples for mandatory and advisory label statements.

Challenges and Path Forward on Mandatory Allergen Labeling and Voluntary Precautionary Allergen Labeling for a Global Company.

PubMed

Yeung, Jupiter; Robert, Marie-Claude

2018-01-01

For food manufacturers, the label on a food package is a tool meant to alert consumers to the presence of specific allergens, allowing consumers to make informed decisions and not unnecessarily limit their food choices. Mandatory allergen labeling is used when the allergen is an intentionally added ingredient, whereas voluntary allergen labeling is used when the presence of the allergen is unintentional and may be in the finished product as a result of cross-contact. In a globalized economy, ensuring food safety is a growing challenge for manufacturers. When ingredients and technologies are sourced worldwide from multiple business partners, complexity rises, which can increase the chance for errors, leading to potential harm. Threshold science, Voluntary Incidental Trace Allergen Labelling (VITAL) reference doses, fit-for-purpose analytical technology, and common sense enable us to optimize allergen management for the benefit of allergic consumers. This is a good strategy because all stakeholders share the common goal of making foods safe and wholesome for all. Herein, we recommend that (1) senior management make science-based thresholds a priority for both regulatory authorities and the food industry; (2) VITAL 2.0 be adopted as a risk assessment and risk management tool for precautionary allergen labeling (PAL); (3) a standardized message for PAL, i.e., "may contain x," be used to make it easily understandable to allergic consumers so they can make informed food choices; and (4) validated fit-for-purpose allergen methods be used to meet analytical needs. This is an opportunity for us to speak with one voice and demonstrate that food safety is not a competitive issue, but a shared responsibility. This approach could significantly improve allergic consumers' lives.

21 CFR 801.15 - Medical devices; prominence of required label statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements. (a...

40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...

40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Removal of label bearing warning... Substances § 82.112 Removal of label bearing warning statement. (a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or...

Precautionary discourse. Thinking through the distinction between the precautionary principle and the precautionary approach in theory and practice.

PubMed

Dinneen, Nathan

2013-01-01

This paper addresses the distinction, arising from the different ways the European Union and United States have come to adopt precaution regarding various environmental and health-related risks, between the precautionary principle and the precautionary approach in both theory and practice. First, this paper addresses how the precautionary principle has been variously defined, along with an exploration of some of the concepts with which it has been associated. Next, it addresses how the distinction between the precautionary principle and precautionary approach manifested itself within the political realm. Last, it considers the theoretical foundation of the precautionary principle in the philosophy of Hans Jonas, considering whether the principled-pragmatic distinction regarding precaution does or doesn't hold up in Jonas' thought.

PRN 93-10: Effluent Discharge Labeling Statements

EPA Pesticide Factsheets

This notice describes revised effluent discharge labeling statements required on all manufacturing use products and end use products that may be discharged to waters of the United States ormunicipal sewer systems.

PRN 83-3: Label Improvement Program - Storage and Disposal Label Statements

EPA Pesticide Factsheets

This Notice is to inform all registrants that the label of all pesticide products must include updated storage and disposal statements. No application for amended registration is required if you use the exact wording contained in this Notice.

27 CFR 19.517 - Statements required on labels under an exemption from label approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... chapter; (d) State of distillation. In the case of whisky, the state of distillation statement on the... conform to the requirements of § 19.518; (g) Age of whisky containing no neutral spirits. In the case of whisky containing no neutral spirits, statements of age and percentage by volume on the label must...

PRN 95-1: Effluent Discharge Labeling Statements

EPA Pesticide Factsheets

This notice exempts certain pesticide products from bearing effluent discharge labeling statements specified by P.R. Notice 93-10 for manufacturing use products and end use products that may be discharged to waters of the U.S. or municipal sewer systems.

21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Animal food labeling warning statements. 501.17 Section 501.17 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal...

21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

21 CFR 501.17 - Animal food labeling warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Animal food labeling warning statements. 501.17... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.17 Animal... with each valve actuation. (iv) Products of a net quantity of contents of less than 1/2 oz. (c) Animal...

40 CFR 82.110 - Form of label bearing warning statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Form of label bearing warning statement. 82.110 Section 82.110 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...

40 CFR 82.112 - Removal of label bearing warning statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Removal of label bearing warning statement. 82.112 Section 82.112 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) PROTECTION OF STRATOSPHERIC OZONE The Labeling of Products Using Ozone-Depleting...

76 FR 30093 - Effectiveness Indications Statements in Veterinary Biologics Labeling; Notice of Public Meeting...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

...] Effectiveness Indications Statements in Veterinary Biologics Labeling; Notice of Public Meeting and Request for... this notice to inform producers and users of veterinary biological products, as well as other...) concerning effectiveness indications statements in veterinary biologics labeling. We are also making the...

The precautionary principle.

PubMed

Hayes, A Wallace

2005-06-01

The Precautionary Principle in its simplest form states: "When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically". This Principle is the basis for European environmental law, and plays an increasing role in developing environmental health policies as well. It also is used in environmental decision-making in Canada and in several European countries, especially in Denmark, Sweden, and Germany. The Precautionary Principle has been used in the environmental decision-making process and in regulating drugs and other consumer products in the United States. The Precautionary Principle enhances the collection of risk information for, among other items, high production volume chemicals and risk-based analyses in general. It does not eliminate the need for good science or for science-based risk assessments. Public participation is encouraged in both the review process and the decision-making process. The Precautionary Principle encourages, and in some cases may require, transparency of the risk assessment process on health risk of chemicals both for public health and the environment. A debate continues on whether the Principle should embrace the "polluter pays" directive and place the responsibility for providing risk assessment on industry. The best elements of a precautionary approach demand good science and challenge the scientific community to improve methods used for risk assessment.

PRN 2001-X Draft: Spray and Dust Drift Label Statements for Pesticide Products

EPA Pesticide Factsheets

This Notice sets forth the U.S. Environmental Protection Agency's (EPA or Agency) draft guidance for labeling statements for controlling spray drift and dust drift from application sites and for implementing these statements for risk mitigation.

[Precautionary maternity leave in Tirol].

PubMed

Ludescher, K; Baumgartner, E; Roner, A; Brezinka, C

1998-01-01

Under Austrian law, precautionary maternity leave is a decree issued by the district public health physician. It forbids a pregnant woman to work and mandates immediate maternity leave. Regular maternity leave for all women employed in all jobs begins at 32 weeks of gestation. Women who work in workplaces deemed dangerous and women with a history of obstetric problems such as premature or growth-retarded babies from previous pregnancies are regularly 'sent' into precautionary maternity leave. The public health physicians of Tirol's nine administrative districts were interviewed and supplied data on precautionary maternity leave from their districts. In 100 women who attended the clinic for pregnancies at risk of the Obstetrics/Gynecology Department of Innsbruck University Hospital and who had already obtained precautionary maternity leave, the medical/administrative procedure was studied in each case and correlated with pregnancy outcome. The town district of Innsbruck and the district that comprises the suburbs of the provincial capital had the highest rates of precautionary maternity leave. The town district of Innsbruck had a rate of 24.3% of all pregnant women (employed and not employed) in precautionary maternity leave in 1997, whereas the whole province of Tirol had 13.4%. More than 80% of decrees for precautionary maternity leave are issued by district public health physicians on the basis of written recommendations from gynecologists. One third of women who are sent into precautionary maternity leave are issued the decree prior to 12 weeks of gestation - mostly cases of multiple pregnancies and women with previous miscarriages. The present system of precautionary maternity leave appears to work in the sense that most working pregnant women with risk factors are correctly identified - with most errors on the side of caution. As the system also helps employers - the employee's pay is paid from the federal family support fund and state insurance once she is in

The precautionary principle is incoherent.

PubMed

Peterson, Martin

2006-06-01

This article argues that no version of the precautionary principle can be reasonably applied to decisions that may lead to fatal outcomes. In support of this strong claim, a number of desiderata are proposed, which reasonable rules for rational decision making ought to satisfy. Thereafter, two impossibility theorems are proved, showing that no version of the precautionary principle can satisfy the proposed desiderata. These theorems are directly applicable to recent discussions of the precautionary principle in medicine, biotechnology, environmental management, and related fields. The impossibility theorems do not imply, however, that the precautionary principle is of no relevance at all in policy discussions. Even if it is not a reasonable rule for rational decision making, it is possible to interpret the precautionary principle in other ways, e.g., as an argumentative tool or as an epistemic principle favoring a reversed burden of proof.

A Critique of the New Statement on Labeling

ERIC Educational Resources Information Center

Hitchcock, Leonard A.

2006-01-01

In this paper, the 2005 revision of ALA's position document on labeling and rating systems is closely examined and assessed, not only in comparison with the previous version of the document, but also in terms of its adequacy as a statement of library principles and as a practical guide for library practice. It is found to be ambiguous in meaning,…

Food allergen law and the Food Allergen Labeling and Consumer Protection Act of 2004: falling short of true protection for food allergy sufferers.

PubMed

Roses, Jonathan B

2011-01-01

In 2004, Congress mandated labeling of food allergens on packaged foods for the first time by passing the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA requires that manufacturers of foods containing one of the eight major allergens responsible for 90 percent of food allergies either state on the food's packaging that the food contains the allergen, or refers to the allergen by a name easily understandable by consumers in the ingredients listing. Despite this important first step in protecting consumers with food allergies, FALCPA left unregulated the use of conditional precautionary statements (e.g., "may contain [allergen]"), which many manufacturers have used as a low-cost shield to liability. Further, FALCPA applies only to packaged foods, and does not mandate listing of food allergen ingredients in restaurants. This article discusses the history of food allergen litigation in the United States, highlighting the problems plaintiffs have faced in seeking recovery for allergic reactions to a defendants' food product, and some of the practical difficulties still extant due to the lack of regulation of precautionary statements. Also presented is a review of the Massachusetts Food Allergy Awareness Act, the first state legislation requiring restaurants to take an active role in educating employees and consumers about the presence and dangers of food allergens.

PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

EPA Pesticide Factsheets

This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2011 CFR

2011-01-01

... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2012 CFR

2012-01-01

... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2013 CFR

2013-01-01

... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2010 CFR

2010-01-01

... INSPECTION REGULATIONS Nutrition Labeling § 381.480 Label statements relating to usefulness in reducing or... special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition labeling in...) and (e)(3) of this section, a product may be labeled with terms such as “diet,” “dietetic...

The precautionary principle: is it safe.

PubMed

Gignon, Maxime; Ganry, Olivier; Jardé, Olivier; Manaouil, Cécile

2013-06-01

The precautionary principle is generally acknowledged to be a powerful tool for protecting health but it was originally invoked by policy makers for dealing with environmental issues. In the 1990s, the principle was incorporated into many legislative and regulatory texts in international law. One can consider that the precautionary principle has turned into "precautionism" necessary to prove to the people, taking account of risk in decisions. There is now a risk that these abuses will deprive the principle of its meaning and value. When pushed to its limits, the precautionary principle can even be dangerous when applied to the healthcare field. This is why a critical analysis of the principle is necessary. Through the literature, it sometimes seems to deviate somehow from the essence of the precautionary principle as it is commonly used in relation to health. We believe that educational work is necessary to familiarize professionals, policy makers and public opinion of the precautionary principle and avoid confusion. We propose a critical analysis of the use and misuse of the precautionary principle.

Is the Precautionary Principle Really Incoherent?

PubMed

Boyer-Kassem, Thomas

2017-11-01

The Precautionary Principle has been an increasingly important principle in international treaties since the 1980s. Through varying formulations, it states that when an activity can lead to a catastrophe for human health or the environment, measures should be taken to prevent it even if the cause-and-effect relationship is not fully established scientifically. The Precautionary Principle has been critically discussed from many sides. This article concentrates on a theoretical argument by Peterson (2006) according to which the Precautionary Principle is incoherent with other desiderata of rational decision making, and thus cannot be used as a decision rule that selects an action among several ones. I claim here that Peterson's argument fails to establish the incoherence of the Precautionary Principle, by attacking three of its premises. I argue (i) that Peterson's treatment of uncertainties lacks generality, (ii) that his Archimedian condition is problematic for incommensurability reasons, and (iii) that his explication of the Precautionary Principle is not adequate. This leads me to conjecture that the Precautionary Principle can be envisaged as a coherent decision rule, again. © 2017 Society for Risk Analysis.

PRN 93-8: Labeling Statement Prohibiting Application to Water; Amendment to PR Notice 93-3

EPA Pesticide Factsheets

This notice adds one paragraph to P.R. Notice 93-3, which requested registrants to amend product labeling to include a new labeling statement prohibiting application of a pesticide to water for certain products.

16 CFR 1615.5 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS STANDARD FOR THE.... (a) Care labels. All items of children's sleepwear shall be labeled with precautionary instructions... accordance with rules and regulations established by the Consumer Product Safety Commission. (b) [Reserved...

Extrapolation, uncertainty factors, and the precautionary principle.

PubMed

Steel, Daniel

2011-09-01

This essay examines the relationship between the precautionary principle and uncertainty factors used by toxicologists to estimate acceptable exposure levels for toxic chemicals from animal experiments. It shows that the adoption of uncertainty factors in the United States in the 1950s can be understood by reference to the precautionary principle, but not by cost-benefit analysis because of a lack of relevant quantitative data at that time. In addition, it argues that uncertainty factors continue to be relevant to efforts to implement the precautionary principle and that the precautionary principle should not be restricted to cases involving unquantifiable hazards. Copyright © 2011 Elsevier Ltd. All rights reserved.

40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...

40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...

40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...

40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...

40 CFR 156.66 - Child hazard warning.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Child hazard warning. 156.66 Section... LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.66 Child... Out of Reach of Children.” That statement, or any alternative statement approved by EPA, must appear...

Consumer preferences for food allergen labeling.

PubMed

Marra, Carlo A; Harvard, Stephanie; Grubisic, Maja; Galo, Jessica; Clarke, Ann; Elliott, Susan; Lynd, Larry D

2017-01-01

Food allergen labeling is an important tool to reduce risk of exposure and prevent anaphylaxis for individuals with food allergies. Health Canada released a Canadian food allergen labeling regulation (2008) and subsequent update (2012) suggesting that research is needed to guide further iterations of the regulation to improve food allergen labeling and reduce risk of exposure. The primary objective of this study was to examine consumer preferences in food labeling for allergy avoidance and anaphylaxis prevention. A secondary objective was to identify whether different subgroups within the consumer population emerged. A discrete choice experiment using a fractional factorial design divided into ten different versions with 18 choice-sets per version was developed to examine consumer preferences for different attributes of food labeling. Three distinct subgroups of Canadian consumers with different allergen considerations and food allergen labeling needs were identified. Overall, preferences for standardized precautionary and safety symbols at little or no increased cost emerged. While three distinct groups with different preferences were identified, in general the results revealed that the current Canadian food allergen labeling regulation can be improved by enforcing the use of standardized precautionary and safety symbols and educating the public on the use of these symbols.

9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2013 CFR

2013-01-01

... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...

9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2012 CFR

2012-01-01

... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...

9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2011 CFR

2011-01-01

... DEVICES, AND CONTAINERS Nutrition Labeling § 317.380 Label statements relating to usefulness in reducing... represented for special dietary use because of usefulness in reducing body weight shall bear: (1) Nutrition... as “diet,” “dietetic,” “artificially sweetened,” or “sweetened with nonnutritive sweetener” only if...

33 CFR 167.1701 - In Prince William Sound: Precautionary areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

...: Precautionary areas. 167.1701 Section 167.1701 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF... Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1701 In Prince William Sound: Precautionary areas. (a) Cape Hinchinbrook. A precautionary area is established and is bounded by a line...

33 CFR 167.1701 - In Prince William Sound: Precautionary areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

...: Precautionary areas. 167.1701 Section 167.1701 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF... Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1701 In Prince William Sound: Precautionary areas. (a) Cape Hinchinbrook. A precautionary area is established and is bounded by a line...

33 CFR 167.1701 - In Prince William Sound: Precautionary areas.

Code of Federal Regulations, 2014 CFR

2014-07-01

...: Precautionary areas. 167.1701 Section 167.1701 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF... Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1701 In Prince William Sound: Precautionary areas. (a) Cape Hinchinbrook. A precautionary area is established and is bounded by a line...

33 CFR 167.1701 - In Prince William Sound: Precautionary areas.

Code of Federal Regulations, 2012 CFR

2012-07-01

...: Precautionary areas. 167.1701 Section 167.1701 Navigation and Navigable Waters COAST GUARD, DEPARTMENT OF... Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1701 In Prince William Sound: Precautionary areas. (a) Cape Hinchinbrook. A precautionary area is established and is bounded by a line...

The precautionary principle and pharmaceutical risk management.

PubMed

Callréus, Torbjörn

2005-01-01

Although it is often vigorously contested and has several different formulations, the precautionary principle has in recent decades guided environmental policy making in the face of scientific uncertainty. Originating from a criticism of traditional risk assessment, the key element of the precautionary principle is the justification for acting in the face of uncertain knowledge about risks. In the light of its growing invocation in various areas that are related to public health and recently in relation to drug safety issues, this article presents an introductory review of the main elements of the precautionary principle and some arguments conveyed by its advocates and opponents. A comparison of the characteristics of pharmaceutical risk management and environmental policy making (i.e. the setting within which the precautionary principle evolved), indicates that several important differences exist. If believed to be of relevance, in order to avoid arbitrary and unpredictable decision making, both the interpretation and possible application of the precautionary principle need to be adapted to the conditions of pharmaceutical risk management.

[The precautionary principle: advantages and risks].

PubMed

Tubiana, M

2001-04-01

The extension of the precautionary principle to the field of healthcare is the social response to two demands of the population: improved health safety and the inclusion of an informed public in the decision-making process. The necessary balance between cost (treatment-induced risk) and benefit (therapeutic effect) underlies all healthcare decisions. An underestimation or an overestimation of cost, i.e. risk, is equally harmful in public healthcare. A vaccination should be prescribed when its beneficial effect outweighs its inevitable risk. Mandatory vaccination, such as in the case of the Hepatitis B virus, is a health policy requiring some courage because those who benefit will never be aware of its positive effect while those who are victims of the risk could resort to litigation. Defense against such accusations requires an accurate assessment of risk and benefit, which underlines the importance of expertise. Even within the framework of the precautionary principle, it is impossible to act without knowledge, or at least a plausible estimation, of expected effects. Recent affairs (blood contamination, transmissible spongiform encephalitis by growth hormone, and new variant of Creutzfeldt-Jacob disease) illustrate that in such cases the precautionary principle would have had limited impact and it is only when enough knowledge was available that effective action could be taken. Likewise, in current debates concerning the possible risks of electromagnetic fields, cellular phones and radon, research efforts must be given priority. The general public understands intuitively the concept of cost and benefit. For example, the possible health risks of oral contraceptives and hormone replacement therapy were not ignored, but the public has judged that their advantages justify the risk. Estimating risk and benefit and finding a balance between risk and preventive measures could help avoid the main drawbacks of the precautionary principle, i.e. inaction and refusal of

33 CFR 167.151 - Off New York: Precautionary areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.151 Off New York: Precautionary areas. (a) A.... (b) A precautionary area is established between the traffic separation scheme “Eastern Approach, off...

33 CFR 167.151 - Off New York: Precautionary areas.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.151 Off New York: Precautionary areas. (a) A.... (b) A precautionary area is established between the traffic separation scheme “Eastern Approach, off...

33 CFR 167.151 - Off New York: Precautionary areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.151 Off New York: Precautionary areas. (a) A.... (b) A precautionary area is established between the traffic separation scheme “Eastern Approach, off...

33 CFR 167.151 - Off New York: Precautionary areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.151 Off New York: Precautionary areas. (a) A.... (b) A precautionary area is established between the traffic separation scheme “Eastern Approach, off...

33 CFR 167.151 - Off New York: Precautionary areas.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.151 Off New York: Precautionary areas. (a) A.... (b) A precautionary area is established between the traffic separation scheme “Eastern Approach, off...

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule, Treasury decision.

PubMed

2003-03-03

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.

40 CFR 156.70 - Precautionary statements for human hazards.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., dermal, inhalation toxicity) Irritation effects (skin and eye) Sensitizer (There are no categories of... or spray mist]. Do not get in eyes, on skin, or on clothing. [Front panel first aid statement required.] Corrosive, causes eye and skin damage [or skin irritation]. Do not get in eyes on skin, or on...

40 CFR 156.70 - Precautionary statements for human hazards.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., dermal, inhalation toxicity) Irritation effects (skin and eye) Sensitizer (There are no categories of... or spray mist]. Do not get in eyes, on skin, or on clothing. [Front panel first aid statement required.] Corrosive, causes eye and skin damage [or skin irritation]. Do not get in eyes on skin, or on...

Survey of peanut levels in selected Irish food products bearing peanut allergen advisory labels.

PubMed

Robertson, Orla N; Hourihane, Jonathan O'B; Remington, Benjamin C; Baumert, Joseph L; Taylor, Steve L

2013-01-01

Peanut allergy affects up to 2% of consumers and is responsible for the majority of fatalities caused by food-induced anaphylaxis. Peanut-containing products must be clearly labelled. Manufacturers are not legally required to label peanut if its inclusion resulted from unintentional cross contact with foods manufactured in the same facility. However, the use of allergen advisory statements alerting consumers of the potential presence of peanut allergen has increased in recent years. In previous studies, the vast majority of foods with precautionary allergen statements did not contain detectable levels of peanut, but no data are available on Irish food products. Thirty-eight food products bearing peanut/nut allergen-related statements were purchased from multiple locations in the Republic of Ireland and analysed for the presence of peanut. Peanut was detected in at least one lot in 5.3% (2 of 38) of the products tested. The doses of peanut detected ranged from 0.14 mg to 0.52 mg per suggested serving size (0.035-0.13 mg peanut protein). No detectable levels of peanut were found in the products that indicated peanut/nuts as a minor ingredient. Quantitative risk assessment, based on the known distribution of individual threshold doses for peanut, indicates that only a very small percentage of the peanut-allergic population would be likely to experience an allergic reaction to those products while the majority of products with advisory labels appear safe for the peanut-allergic population. Food manufacturers should be encouraged to analyse products manufactured in shared facilities and even on shared equipment with peanuts for peanut residues to determine whether sufficient risk exists to warrant the use of advisory labelling. Although it appears that the majority of food products bearing advisory nut statements are in fact free of peanut contamination, advice to peanut allergy sufferers to avoid said foods should continue in Ireland and therefore in the wider European

33 CFR 167.401 - Off San Francisco: Precautionary area.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.401 Off San Francisco: Precautionary area...

33 CFR 167.174 - Off Delaware Bay: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.174 Off Delaware Bay: Precautionary area...

33 CFR 167.174 - Off Delaware Bay: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.174 Off Delaware Bay: Precautionary area...

33 CFR 167.174 - Off Delaware Bay: Precautionary area.

Code of Federal Regulations, 2010 CFR

2010-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.174 Off Delaware Bay: Precautionary area...

33 CFR 167.401 - Off San Francisco: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.401 Off San Francisco: Precautionary area...

33 CFR 167.174 - Off Delaware Bay: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.174 Off Delaware Bay: Precautionary area...

33 CFR 167.401 - Off San Francisco: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.401 Off San Francisco: Precautionary area...

33 CFR 167.174 - Off Delaware Bay: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.174 Off Delaware Bay: Precautionary area...

33 CFR 167.401 - Off San Francisco: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.401 Off San Francisco: Precautionary area...

33 CFR 167.401 - Off San Francisco: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.401 Off San Francisco: Precautionary area...

Yes, The Precautionary Principle Is Incoherent.

PubMed

Peterson, Martin

2017-11-01

This article is a reply to Thomas Boyer-Kassem's discussion of my criticism of the precautionary principle published in this journal about a decade ago. Boyer-Kassem does not question the logical validity of the theorem proved in my original article, but he brings up important questions about its scope. He also challenges the plausibility of some of the assumptions on which it is based. In this comment, I argue that each objection can be adequately dealt with. As a decision rule, the precautionary principle is (still) incoherent. © 2017 Society for Risk Analysis.

Food labeling issues in patients with severe food allergies: solving a hamlet-like doubt.

PubMed

Fierro, Vincenzo; Di Girolamo, Francesco; Marzano, Valeria; Dahdah, Lamia; Mennini, Maurizio

2017-06-01

We review the laws on labeling in the international community, the difficulties they pose to the food manufacturers to prepare the food labels and the methodologies to determine the concentration of potential allergens in foods. European Food Safety Authority and International Life Sciences Institute Europe are evaluating strategies to identify the threshold level of allergen that can trigger a reaction in individuals. The most used techniques to detect the presence of protein in food are Enzyme-linked immunosorbent assay, polymerase chain reaction and real time polymerase chain reaction. Researchers are now trying to apply proteomics to estimate the amount of protein within the food.In order to protect the health of consumers, the Codex Alimentarius Commission updates constantly the list of allergens. In response to these regulations, some industries have also added some precautionary allergen labeling (PAL). It was generally agreed that PAL statements needed to be visible, simple, and safe. It was suggested that PAL be standardized, an action that would occur if the 'Voluntary Incidental Trace Allergen Labelling' process was made mandatory. So far, no laboratory technique is able to reassure the consumers about the composition of foods found on the packaging. International authorities produced increasingly stringent laws, but more is still to do.

The precautionary principle in environmental science.

PubMed Central

Kriebel, D; Tickner, J; Epstein, P; Lemons, J; Levins, R; Loechler, E L; Quinn, M; Rudel, R; Schettler, T; Stoto, M

2001-01-01

Environmental scientists play a key role in society's responses to environmental problems, and many of the studies they perform are intended ultimately to affect policy. The precautionary principle, proposed as a new guideline in environmental decision making, has four central components: taking preventive action in the face of uncertainty; shifting the burden of proof to the proponents of an activity; exploring a wide range of alternatives to possibly harmful actions; and increasing public participation in decision making. In this paper we examine the implications of the precautionary principle for environmental scientists, whose work often involves studying highly complex, poorly understood systems, while at the same time facing conflicting pressures from those who seek to balance economic growth and environmental protection. In this complicated and contested terrain, it is useful to examine the methodologies of science and to consider ways that, without compromising integrity and objectivity, research can be more or less helpful to those who would act with precaution. We argue that a shift to more precautionary policies creates opportunities and challenges for scientists to think differently about the ways they conduct studies and communicate results. There is a complicated feedback relation between the discoveries of science and the setting of policy. While maintaining their objectivity and focus on understanding the world, environmental scientists should be aware of the policy uses of their work and of their social responsibility to do science that protects human health and the environment. The precautionary principle highlights this tight, challenging linkage between science and policy. PMID:11673114

10 CFR 20.1904 - Labeling containers.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary Procedures § 20... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

10 CFR 20.1904 - Labeling containers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary Procedures § 20... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

10 CFR 20.1904 - Labeling containers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary Procedures § 20... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

10 CFR 20.1904 - Labeling containers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary Procedures § 20... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

10 CFR 20.1904 - Labeling containers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Labeling containers. 20.1904 Section 20.1904 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary Procedures § 20... handling or using the containers, or working in the vicinity of the containers, to take precautions to...

27 CFR 31.212 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

27 CFR 31.212 - Labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

27 CFR 31.212 - Labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

27 CFR 31.212 - Labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

27 CFR 31.212 - Labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

Label Review Training: Module 1: Label Basics, Page 26

EPA Pesticide Factsheets

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. Learn about mandatory and advisory label statements.

21 CFR 801.61 - Statement of identity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...

21 CFR 801.61 - Statement of identity.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...

21 CFR 801.61 - Statement of identity.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...

21 CFR 801.61 - Statement of identity.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...

21 CFR 801.61 - Statement of identity.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Statement of identity. 801.61 Section 801.61 Food... DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.61 Statement of identity. (a... principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in...

Label Review Training: Module 1: Label Basics, Page 27

EPA Pesticide Factsheets

This module of the pesticide label review training provides basic information about pesticides, their labeling and regulation, and the core principles of pesticide label review. See examples of mandatory and advisory label statements.

21 CFR 201.61 - Statement of identity.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...

21 CFR 201.61 - Statement of identity.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...

21 CFR 201.61 - Statement of identity.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...

21 CFR 201.61 - Statement of identity.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...

21 CFR 201.61 - Statement of identity.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Statement of identity. 201.61 Section 201.61 Food...: GENERAL LABELING Labeling Requirements for Over-the-Counter Drugs § 201.61 Statement of identity. (a) The... features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of...

[Conclusions. The precautionary principle: its advantages and risks].

PubMed

Tubiana, M

2000-01-01

The proposed extension to health of the precautionary principle is the reaction to two social demands: the desire for greater health safety and for more transparency in the decision making process by associating the public. In medical care, all decisions are based on the balance between cost (dangers induced by the treatment) and benefit (the therapeutic effect). It is as dangerous to overestimate the cost, in other words the risks, as it is to underestimate them. The same problem is encountered in public health. If a vaccination is to be prescribed, the beneficial effects must outweigh the risks; however, these risks are inevitable and have been known to exist since the 18th century, but they have been accepted for the public good. It takes courage to make a vaccination mandatory because those who benefit from it will never know, while those who suffer from its ill effects could take legal action. In order to counter accusations, an evaluation must be made beforehand of the risks and benefits, which underlines the important role of expert opinion. Within the framework of the precautionary principle, actions cannot be taken in ignorance and, at the very least, plausible estimations must be made. The analysis of several recent events (contaminated blood, BSE, growth hormone and Creutzfeldt-Jacob disease) shows that the precautionary principle would have had a very limited impact and that only once there was sufficient knowledge was action made possible. The same is true concerning current debates (the possible risks associated with electromagnetic fields, mobile phones and radon); in these three cases, no country in the world has invoked the precautionary principle, but rather the priority has been given to research. The public understands quite readily the cost/benefit relationship. In the case of oral contraceptives, or hormone replacement therapy the public was aware of their possible health risks but judged that the advantages outweighed the risks. The

16 CFR § 1615.5 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling requirements. § 1615.5 Section § 1615.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FLAMMABLE FABRICS ACT REGULATIONS... precautionary instructions to protect the items from agents or treatments which are known to cause deterioration...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 10 Energy 1 2013-01-01 2013-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 1 2014-01-01 2014-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 1 2012-01-01 2012-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

10 CFR 20.1905 - Exemptions to labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 1 2011-01-01 2011-01-01 false Exemptions to labeling requirements. 20.1905 Section 20.1905 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Precautionary... have sufficient instruction to minimize radiation exposure while handling or working in the vicinity of...

The Precautionary Principle: implications for risk management strategies.

PubMed

Saltelli, Andrea; Funtowicz, Silvio

2004-01-01

The European Commission has published a Communication on the Precautionary Principle and a White Book on Governance. These provide us (as research civil servants of the Commission) an institutional framework for handling scientific information that is often incomplete, uncertain, and contested. But, although the Precautionary Principle is intuitively straightforward to understand, there is no agreed way of applying it to real decision-making. To meet this perceived need, researchers have proposed a vast number of taxonomies. These include ignorance auditing, type one-two-three errors, a combination of uncertainty and decision stakes through post-normal science and the plotting of ignorance of probabilities against ignorance of consequences. Any of these could be used to define a precautionary principle region inside a multidimensional space and to position an issue within that region. The role of anticipatory research is clearly critical but scientific input is only part of the picture. It is difficult to imagine an issue where the application of the Precautionary Principle would be non-contentious. From genetically-modified food to electro-smog, from climate change to hormone growth in meat, it is clear that: 1) risk and cost-benefit are only part of the picture; 2) there are ethical issues involved; 3) there is a plurality of interests and perspectives that are often in conflict; 4) there will be losers and winners whatever decision is made. Operationalization of the Precautionary Principle must preserve transparency. Only in this way will the incommensurable costs and benefits associated with different stakeholders be registered. A typical decision will include the following sorts of considerations: 1) the commercial interests of companies and the communities that depend on them; 2) the worldviews of those who might want a greener, less consumerist society and/or who believe in the sanctity of human or animal life; 3) potential benefits such as enabling the

[Precautionary principle. State of the situation in Argentina].

PubMed

Kemelmajer de Carlucci, Aída

2017-10-13

The new Argentine Civil and Commercial Code includes the prevention principle. The precautionary Principle is regulated by the Environmental Protection Act.A significant number of cases have reached the Supreme Court of the Nation. This Court, in general, estimates that the decisions concerning the precautionary principle have definitive nature, i.e., are not merely provisional. Usually, the situation is caused by the State itself, which fails to control. The different decisions show a Judiciary worried about protecting the environment.

A Canadian framework for applying the precautionary principle to public health issues.

PubMed

Weir, Erica; Schabas, Richard; Wilson, Kumanan; Mackie, Chris

2010-01-01

The precautionary principle has influenced environmental and public health policy. It essentially states that complete evidence of a potential risk is not required before action is taken to mitigate the effects of the potential risk. The application of precaution to public health issues is not straightforward and could paradoxically cause harm to the public's health when applied inappropriately. To avoid this, we propose a framework for applying the precautionary principle to potential public health risks. The framework consists of ten guiding questions to help establish whether a proposed application of the precautionary principle on a public health matter is based on adequacy of the evidence of causation, severity of harm and acceptability of the precautionary measures.

Group presence, category labels, and generic statements influence children to treat descriptive group regularities as prescriptive.

PubMed

Roberts, Steven O; Ho, Arnold K; Gelman, Susan A

2017-06-01

Children use descriptive regularities of social groups (what is) to generate prescriptive judgments (what should be). We examined whether this tendency held when the regularities were introduced through group presence, category labels, or generic statements. Children (ages 4-9years, N=203) were randomly assigned to one of four conditions that manipulated how descriptive group regularities were presented: group presence (e.g., "These ones [a group of three individuals] eat this kind of berry"), category labels (e.g., "This [individual] Hibble eats this kind of berry"), generic statements (e.g., [showing an individual] "Hibbles eat this kind of berry"), or control (e.g., "This one [individual] eats this kind of berry"). Then, children saw conforming and non-conforming individuals and were asked to evaluate their behavior. As predicted, children evaluated non-conformity negatively in all conditions except the control condition. Together, these results suggest that minimal perceptual and linguistic cues provoke children to treat social groups as having normative force. Copyright © 2016 Elsevier Inc. All rights reserved.

33 CFR 167.51 - In the approaches to Portland, ME: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.51 In the approaches to Portland, ME: Precautionary area. A...

33 CFR 167.51 - In the approaches to Portland, ME: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.51 In the approaches to Portland, ME: Precautionary area. A...

33 CFR 167.51 - In the approaches to Portland, ME: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.51 In the approaches to Portland, ME: Precautionary area. A...

33 CFR 167.51 - In the approaches to Portland, ME: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.51 In the approaches to Portland, ME: Precautionary area. A...

What are the core ideas behind the Precautionary Principle?

PubMed

Persson, Erik

2016-07-01

The Precautionary Principle is both celebrated and criticized. It has become an important principle for decision making, but it is also subject to criticism. One problem that is often pointed out with the principle is that is not clear what it actually says and how to use it. I have taken on this problem by performing an analysis of some of the most influential formulations of the principle in an attempt to identify the core ideas behind it, with the purpose of producing a formulation of the principle that is clear and practically applicable. It was found that what is called the Precautionary Principle is not a principle that tells us what do to achieve extra precaution or how to handle situations when extra precaution is called for. Instead, it was found to be a list of circumstances that each justify extra precaution. An analysis of some of the most common and influential formulations of the Precautionary Principle identified four such circumstances: (1) When we deal with important values that tend to be systematically downplayed by traditional decision methods - such as human health and the environment. (2) When we suspect that the decision might lead to irreversible and severe consequences and the values at stake are also irreplaceable, (3) When timing is at least as important as being right. (4) When it is more important to avoid false negatives than false positives. This interpretation of the Precautionary Principle does not say anything about what kind of actions to take when extra precaution is called for, but it does provide a clear and practically useful list of circumstances that call for extra precaution and that is not subject to the most common objections to the Precautionary Principle. Copyright © 2016 Elsevier B.V. All rights reserved.

Innovative surgery and the precautionary principle.

PubMed

Meyerson, Denise

2013-12-01

Surgical innovation involves practices, such as new devices, technologies, procedures, or applications, which are novel and untested. Although innovative practices are believed to offer an improvement on the standard surgical approach, they may prove to be inefficacious or even dangerous. This article considers how surgeons considering innovation should reason in the conditions of uncertainty that characterize innovative surgery. What attitude to the unknown risks of innovative surgery should they take? The answer to this question involves value judgments about the acceptability of risk taking when satisfactory scientific information is not available. This question has been confronted in legal contexts, where risk aversion in the form of the precautionary principle has become increasingly influential as a regulatory response to innovative technologies that pose uncertain future hazards. This article considers whether it is appropriate to apply a precautionary approach when making decisions about innovative surgery.

Precautionary Principles: General Definitions and Specific Applications to Genetically Modified Organisms

ERIC Educational Resources Information Center

Lofstedt, Ragnar E.; Fischhoff, Baruch; Fischhoff, Ilya R.

2002-01-01

Precautionary principles have been proposed as a fundamental element of sound risk management. Their advocates see them as guiding action in the face of uncertainty, encouraging the adoption of measures that reduce serious risks to health, safety, and the environment. Their opponents may reject the very idea of precautionary principles, find…

Non-precautionary aspects of toxicology

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

Grandjean, Philippe

2005-09-01

Empirical studies in toxicology aim at deciphering complex causal relationships, especially in regard to human disease etiologies. Several scientific traditions limit the usefulness of documentation from current toxicological research, in regard to decision-making based on the precautionary principle. Among non-precautionary aspects of toxicology are the focus on simplified model systems and the effects of single hazards, one by one. Thus, less attention is paid to sources of variability and uncertainty, including individual susceptibility, impacts of mixed and variable exposures, susceptible life-stages, and vulnerable communities. In emphasizing the need for confirmatory evidence, toxicology tends to penalize false positives more than falsemore » negatives. An important source of uncertainty is measurement error that results in misclassification, especially in regard to exposure assessment. Standard statistical analysis assumes that the exposure is measured without error, and imprecisions will usually result in an underestimation of the dose-effect relationship. In testing whether an effect could be considered a possible result of natural variability, a 5% limit for 'statistical significance' is usually applied, even though it may rule out many findings of causal associations, simply because the study was too small (and thus lacked statistical power) or because some imprecision or limited sensitivity of the parameters precluded a more definitive observation. These limitations may be aggravated when toxicology is influenced by vested interests. Because current toxicology overlooks the important goal of achieving a better characterization of uncertainties and their implications, research approaches should be revised and strengthened to counteract the innate ideological biases, thereby supporting our confidence in using toxicology as a main source of documentation and in using the precautionary principle as a decision procedure in the public policy arena.« less

Comprehension of hazard communication: effects of pictograms on safety data sheets and labels.

PubMed

Boelhouwer, Eric; Davis, Jerry; Franco-Watkins, Ana; Dorris, Nathan; Lungu, Claudiu

2013-09-01

The United Nations has proposed the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals to make hazard communication more uniform and to improve comprehension. Two experiments were conducted to test whether the addition of hazard and precautionary pictograms to safety data sheets and product labels would improve the transfer of information to users compared to safety data sheets and product labels containing text only. Additionally, naïve users, workers, and experts were tested to determine any potential differences among users. The effect of adding pictograms to safety data sheets and labels was statistically significant for some conditions, but was not significant across all conditions. One benefit of the addition of pictograms was that the time to respond to the survey questions decreased when the pictograms were present for both the SDS and the labels. GHS format SDS and labels do provide benefits to users, but the system will need further enhancements and modifications to continue to improve the effectiveness of hazard communication. The final rule to modify the HCS to include the Globally Harmonized System (GHS) for the Classification and Labelling of Chemicals announced by OSHA (2012b) will change the information content of every chemical SDS and label used in commerce. This study suggests that the inclusion of GHS hazard pictograms and precautionary pictograms to SDS and labels may benefit the user. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

21 CFR 201.6 - Drugs; misleading statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...

21 CFR 201.6 - Drugs; misleading statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...

21 CFR 201.6 - Drugs; misleading statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...

21 CFR 201.6 - Drugs; misleading statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.6 Drugs; misleading statements. (a) Among...

33 CFR 167.76 - In the approach to Boston, MA: Precautionary areas.

Code of Federal Regulations, 2012 CFR

2012-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.76 In the approach to Boston, MA: Precautionary areas. (a) A... the traffic separation schemes in the approach to Boston, MA, and Eastern approach, off Nantucket...

33 CFR 167.76 - In the approach to Boston, MA: Precautionary areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.76 In the approach to Boston, MA: Precautionary areas. (a) A... the traffic separation schemes in the approach to Boston, MA, and Eastern approach, off Nantucket...

33 CFR 167.76 - In the approach to Boston, MA: Precautionary areas.

Code of Federal Regulations, 2014 CFR

2014-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.76 In the approach to Boston, MA: Precautionary areas. (a) A... the traffic separation schemes in the approach to Boston, MA, and Eastern approach, off Nantucket...

33 CFR 167.76 - In the approach to Boston, MA: Precautionary areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas § 167.76 In the approach to Boston, MA: Precautionary areas. (a) A... the traffic separation schemes in the approach to Boston, MA, and Eastern approach, off Nantucket...

21 CFR 201.55 - Statement of dosage.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...

21 CFR 201.55 - Statement of dosage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...

21 CFR 201.55 - Statement of dosage.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...

21 CFR 201.55 - Statement of dosage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...

21 CFR 201.55 - Statement of dosage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Statement of dosage. 201.55 Section 201.55 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.55 Statement of dosage...

The precautionary principle in the context of mobile phone and base station radiofrequency exposures.

PubMed

Dolan, Mike; Rowley, Jack

2009-09-01

No health hazard has been established from exposure to radiofrequency fields up to the levels recommended by the International Commission on Non-Ionizing Radiation Protection. However, in response to public concern and the perceived level of scientific uncertainty, there are continuing calls for the application of the precautionary principle to radiofrequency exposures from mobile phones and base stations. We examined the international evolution of calls for precautionary measures in relation to mobile phones and base stations, with particular focus on Australia and the United Kingdom. The precautionary principle is difficult to define, and there is no widespread agreement as to how it should be implemented. However, there is a strong argument that precautionary measures should not be implemented in the absence of reliable scientific data and logical reasoning pointing to a possible health hazard. There is also experimental evidence that precautionary advice may increase public concern. We argue that conservative exposure standards, technical features that minimize unnecessary exposures, ongoing research, regular review of standards, and availability of consumer information make mobile communications inherently precautionary. Commonsense measures can be adopted by individuals, governments, and industry to address public concern while ensuring that mobile networks are developed for the benefit of society.

The Precautionary Principle in the Context of Mobile Phone and Base Station Radiofrequency Exposures

PubMed Central

Dolan, Mike; Rowley, Jack

2009-01-01

Background No health hazard has been established from exposure to radiofrequency fields up to the levels recommended by the International Commission on Non-Ionizing Radiation Protection. However, in response to public concern and the perceived level of scientific uncertainty, there are continuing calls for the application of the precautionary principle to radiofrequency exposures from mobile phones and base stations. Objective We examined the international evolution of calls for precautionary measures in relation to mobile phones and base stations, with particular focus on Australia and the United Kingdom. Results The precautionary principle is difficult to define, and there is no widespread agreement as to how it should be implemented. However, there is a strong argument that precautionary measures should not be implemented in the absence of reliable scientific data and logical reasoning pointing to a possible health hazard. There is also experimental evidence that precautionary advice may increase public concern. Conclusion We argue that conservative exposure standards, technical features that minimize unnecessary exposures, ongoing research, regular review of standards, and availability of consumer information make mobile communications inherently precautionary. Commonsense measures can be adopted by individuals, governments, and industry to address public concern while ensuring that mobile networks are developed for the benefit of society. PMID:19750093

The Precautionary Principle and the Tolerability of Blood Transfusion Risks.

PubMed

Kramer, Koen; Zaaijer, Hans L; Verweij, Marcel F

2017-03-01

Tolerance for blood transfusion risks is very low, as evidenced by the implementation of expensive blood tests and the rejection of gay men as blood donors. Is this low risk tolerance supported by the precautionary principle, as defenders of such policies claim? We discuss three constraints on applying (any version of) the precautionary principle and show that respecting these implies tolerating certain risks. Consistency means that the precautionary principle cannot prescribe precautions that it must simultaneously forbid taking, considering the harms they might cause. Avoiding counterproductivity requires rejecting precautions that cause more harm than they prevent. Proportionality forbids taking precautions that are more harmful than adequate alternatives. When applying these constraints, we argue, attention should not be restricted to harms that are human caused or that affect human health or the environment. Tolerating transfusion risks can be justified if available precautions have serious side effects, such as high social or economic costs.

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.10 - Drugs; statement of ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drugs; statement of ingredients. 201.10 Section 201.10 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL LABELING General Labeling Provisions § 201.10 Drugs; statement of ingredients. (a) The...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2013 CFR

2013-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2014 CFR

2014-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2012 CFR

2012-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2010 CFR

2010-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

21 CFR 201.50 - Statement of identity.

Code of Federal Regulations, 2011 CFR

2011-04-01

...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

40 CFR 156.68 - First aid statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false First aid statement. 156.68 Section... aid statement. (a) Product as sold and distributed. Each product must bear a first aid statement if... with water prior to use, the label may also include a statement describing how the first aid measures...

33 CFR 167.101 - In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. 167.101 Section 167.101 Navigation and Navigable... the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. (a) A precautionary...

33 CFR 167.101 - In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. 167.101 Section 167.101 Navigation and Navigable... the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. (a) A precautionary...

33 CFR 167.101 - In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. 167.101 Section 167.101 Navigation and Navigable... the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. (a) A precautionary...

33 CFR 167.101 - In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false In the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. 167.101 Section 167.101 Navigation and Navigable... the approaches to Narragansett Bay, RI, and Buzzards Bay, MA: Precautionary areas. (a) A precautionary...

21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...

21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...

21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...

21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...

21 CFR 740.2 - Conspicuousness of warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Conspicuousness of warning statements. 740.2... (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.2 Conspicuousness of warning statements. (a) A warning statement shall appear on the label prominently and conspicuously as compared to...

Analyzing precautionary regulation: do precaution, science, and innovation go together?

PubMed

Todt, Oliver; Luján, José Luis

2014-12-01

In this article we argue that the precautionary principle, as applied to the regulation of science and technology, cannot be considered in any general manner inconsistent with the norms and methods of scientific knowledge generation and justification. Moreover, it does not necessarily curtail scientific-technological innovation. Our argument flows from a differentiated view of what precaution in regulation means. We first characterize several of the most relevant interpretations given to the precautionary principle in academic debate and regulatory practice. We then use examples of actual precaution-based regulation to show that, even though science can have varying functions in different circumstances and frames, all of those interpretations recur to scientific method and knowledge, and tend to imply innovation in methods, products, and processes. In fact, the interplay of regulation and innovation in precautionary policy, at least in the case of the interpretations of precaution that our analysis takes into account, could be understood as a way of reconciling the two fundamental science and technology policy functions of promotion and control. © 2014 Society for Risk Analysis.

ECOLOGICAL RISK ASSESSMENT AND THE PRECAUTIONARY PRINCIPLE

EPA Science Inventory

The Precautionary Principle, generated during the late 1980s as a unifying principle for regulating discharge of hazardous material into the North Sea, has been broadened to include a shifting of the burden of proof to the proponent of a proposed activity, adoption of a more holi...

Risk management in transfusion after the HIV blood contamination crisis in France: the impact of the precautionary principle.

PubMed

Hergon, Eric; Moutel, Grégoire; Duchange, Nathalie; Bellier, Lucile; Rouger, Philippe; Hervé, Christian

2005-10-01

The importance of the precautionary principle in public health was highlighted in France after the HIV contamination of blood products used for transfusion. However, the definition of this principle, its objectives, the way in which it should be applied, and its consequences had not been considered previously. The question as to whether the application of the precautionary principle is appropriate remains unanswered. The aim of this study was to analyze the interpretations of the application of the precautionary principle to determine its consequences in terms of risk management and patient rights. This was accomplished by interviewing persons involved in transfusion medicine. We conducted 33 interviews and describe the issues enunciated for and against the application of the precautionary principle. The precautionary principle concept was confusing to the respondents. A major issue emerging from the interviews was that the precautionary principle was perceived more as a means of protecting the decision maker than as a means of protecting the patient. Taken to its extreme, the use of the precautionary principle could prejudice sound medical decision making. However, it was felt that it also can lead to the introduction of measures that update and gradually reduce risks associated with transfusion.

21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...

21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...

21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...

21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...

21 CFR 740.1 - Establishment of warning statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Establishment of warning statements. 740.1 Section...) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS General § 740.1 Establishment of warning statements. (a) The label of a cosmetic product shall bear a warning statement whenever necessary or appropriate to prevent...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

40 CFR 168.65 - Pesticide export label and labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... toxic pesticides. If the pesticide, device or active ingredient is highly toxic to humans, the skull and... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Pesticide export label and labeling...) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for...

The Precautionary Principle Has Not Been Shown to Be Incoherent: A Reply to Peterson.

PubMed

Boyer-Kassem, Thomas

2017-11-01

In this journal, I have objected to Peterson's 2006 claim that the precautionary principle is an incoherent decision rule. I defend my objections to Peterson's recent replies, and I still claim that the precautionary principle has not been shown to be incoherent. © 2017 Society for Risk Analysis.

On different types of uncertainties in the context of the precautionary principle.

PubMed

Aven, Terje

2011-10-01

Few policies for risk management have created more controversy than the precautionary principle. A main problem is the extreme number of different definitions and interpretations. Almost all definitions of the precautionary principle identify "scientific uncertainties" as the trigger or criterion for its invocation; however, the meaning of this concept is not clear. For applying the precautionary principle it is not sufficient that the threats or hazards are uncertain. A stronger requirement is needed. This article provides an in-depth analysis of this issue. We question how the scientific uncertainties are linked to the interpretation of the probability concept, expected values, the results from probabilistic risk assessments, the common distinction between aleatory uncertainties and epistemic uncertainties, and the problem of establishing an accurate prediction model (cause-effect relationship). A new classification structure is suggested to define what scientific uncertainties mean. © 2011 Society for Risk Analysis.

27 CFR 4.62 - Mandatory statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., type, and distinctive designation. The advertisement shall contain a conspicuous statement of the class, type, or distinctive designation to which the product belongs, corresponding with the statement of class, type, or distinctive designation which is required to appear on the label of the product. (c...

Flood precautionary behaviour of private households in Can Tho city in the Mekong Delta

NASA Astrophysics Data System (ADS)

Kreibich, Heidi; Gani Adnan, Sarfaraz; Thi Chinh, Do; Bubeck, Philip

2015-04-01

Flood risk is high and it is projected to increase in many places due to the effects of climate change and the on-going intensification of human activities in risk-prone areas. These projections and the considerable uncertainties associated with these developments increasingly require integrated approaches in flood risk management. In addition to flood protection, private precautionary measures aim at reducing the potential negative consequences of floods. Thus, insights into flood precautionary behaviour are important. This study is grounded on the Protection Motivation Theory (PMT), which refers to the cognitive process that people undergo when evaluating their own ability to avoid a certain risk. Results of a survey among 858 flood-prone households in Can Tho city in the Mekong Delta, Vietnam are presented. It is shown that flood-coping appraisal is an important variable in terms of precautionary behaviour. Thus, risk communication should focus more on the potential of precautionary measures to effectively reduce flood damage, as well as on information about how to implement such measures in practice.

Scientific basis for the Precautionary Principle.

PubMed

Vineis, Paolo

2005-09-01

The Precautionary Principle is based on two general criteria: (a) appropriate public action should be taken in response to limited, but plausible and credible, evidence of likely and substantial harm; (b) the burden of proof is shifted from demonstrating the presence of risk to demonstrating the absence of risk. Not much has been written about the scientific basis of the precautionary principle, apart from the uncertainty that characterizes epidemiologic research on chronic disease, and the use of surrogate evidence when human evidence cannot be provided. It is proposed in this paper that a new scientific paradigm, based on the theory of evolution, is emerging; this might offer stronger support to the need for precaution in the regulation of environmental risks. Environmental hazards do not consist only in direct attacks to the integrity of DNA or other macromolecules. They can consist in changes that take place already in utero, and that condition disease risks many years later. Also, environmental exposures can act as "stressors", inducing hypermutability (the mutator phenotype) as an adaptive response. Finally, environmental changes should be evaluated against a background of a not-so-easily modifiable genetic make-up, inherited from a period in which humans were mainly hunters-gatherers and had dietary habits very different from the current ones.

The precautionary principle and/or risk assessment in World Trade Organization decisions: a possible role for risk perception.

PubMed

Goldstein, Bernard; Carruth, Russellyn S

2004-04-01

Risk analysis has been recognized and validated in World Trade Organization (WTO) decision processes. In recent years the precautionary principle has been proposed as an additional or alternative approach to standard risk assessment. The precautionary principle has also been advocated by some who see it as part of postmodern democracy in which more power is given to the public on health and safety matters relative to the judgments of technocrats. A more cynical view is that the precautionary principle is particularly championed by the European Community as a means to erect trade barriers. The WTO ruling against the European Community's trade barrier against beef from hormone-treated cattle seemed to support the use of risk assessment and appeared to reject the argument that the precautionary principle was a legitimate basis for trade barriers. However, a more recent WTO decision on asbestos contains language suggesting that the precautionary principle, in the form of taking into account public perception, may be acceptable as a basis for a trade barrier. This decision, if followed in future WTO trade disputes, such as for genetically modified foods, raises many issues central to the field of risk analysis. It is too early to tell whether the precautionary principle will become accepted in WTO decisions, either as a supplement or a substitute for standard risk assessment. But it would undermine the value of the precautionary principle if this principle were misused to justify unwarranted trade barriers.

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

40 CFR 156.10 - Labeling requirements.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) Prominence and legibility. (i) All words, statements, graphic representations, designs or other information..., statements, designs, or graphic matter on the labeling) and expressed in such terms as to render it likely to... phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of...

33 CFR 167.1303 - In the approaches to the Strait of Juan de Fuca: Precautionary area “JF.”

Code of Federal Regulations, 2011 CFR

2011-07-01

... of Juan de Fuca: Precautionary area âJF.â 167.1303 Section 167.1303 Navigation and Navigable Waters....1303 In the approaches to the Strait of Juan de Fuca: Precautionary area “JF.” In the approaches to the Strait of Juan de Fuca, precautionary area “JF” is established and is bounded by a line connecting the...

33 CFR 167.350 - In the approaches to Galveston Bay Traffic Separation Scheme and precautionary areas.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Bay Traffic Separation Scheme and precautionary areas. 167.350 Section 167.350 Navigation and... OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic Gulf Coast § 167.350 In the approaches to Galveston Bay Traffic Separation Scheme and...

33 CFR 167.350 - In the approaches to Galveston Bay Traffic Separation Scheme and precautionary areas.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Bay Traffic Separation Scheme and precautionary areas. 167.350 Section 167.350 Navigation and... OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic Gulf Coast § 167.350 In the approaches to Galveston Bay Traffic Separation Scheme and...

33 CFR 167.350 - In the approaches to Galveston Bay Traffic Separation Scheme and precautionary areas.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Bay Traffic Separation Scheme and precautionary areas. 167.350 Section 167.350 Navigation and... OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic Gulf Coast § 167.350 In the approaches to Galveston Bay Traffic Separation Scheme and...

33 CFR 167.350 - In the approaches to Galveston Bay Traffic Separation Scheme and precautionary areas.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Bay Traffic Separation Scheme and precautionary areas. 167.350 Section 167.350 Navigation and... OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic Gulf Coast § 167.350 In the approaches to Galveston Bay Traffic Separation Scheme and...

33 CFR 167.350 - In the approaches to Galveston Bay Traffic Separation Scheme and precautionary areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Bay Traffic Separation Scheme and precautionary areas. 167.350 Section 167.350 Navigation and... OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic Gulf Coast § 167.350 In the approaches to Galveston Bay Traffic Separation Scheme and...

33 CFR 167.1701 - In Prince William Sound: Precautionary areas.

Code of Federal Regulations, 2010 CFR

2010-07-01

... HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1701 In Prince William Sound...

27 CFR 7.54 - Prohibited statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...

27 CFR 7.54 - Prohibited statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...

27 CFR 7.54 - Prohibited statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...

27 CFR 7.54 - Prohibited statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., DEPARTMENT OF THE TREASURY ALCOHOL LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...

27 CFR 7.54 - Prohibited statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., DEPARTMENT OF THE TREASURY LIQUORS LABELING AND ADVERTISING OF MALT BEVERAGES Advertising of Malt Beverages... statement of alcoholic content permitted under § 7.71 may be depicted in any advertising media. The... statement of alcoholic content permitted under § 7.71 may be displayed in any advertising media. (d) Class...

Improving Precautionary Communication in the EMF Field? Effects of Making Messages Consistent and Explaining the Effectiveness of Precautions.

PubMed

Boehmert, Christoph; Wiedemann, Peter; Croft, Rodney

2016-10-09

Many radiation health agencies communicate precautionary measures regarding the use of mobile communication devices, e.g. the use of a headset while talking on the phone. These precautionary messages have, however, been shown to unintentionally increase risk perceptions about radiofrequency electromagnetic fields (RF-EMFs). The current study tested two potential ways of amending precautionary messages in order to minimise this unintentional effect. Firstly, the messages' potential to be perceived as inconsistent and thereby raise suspicions was addressed; secondly, the effectiveness of the precautions was explained. An experimental design was applied in which a quota sample of 1717 Australian residents was randomly assigned to one of six message conditions. Three different risk perception measures served as dependent variables, two of them are conditional measures. The original effect of precautionary messages to amplify risk perceptions could not be replicated. Furthermore, amending precautionary messages in favour of more consistency had no effect, while explaining the effectiveness of the precautions increased conditional risk perception under the condition that no precautions are taken. This was contrary to our assumptions. We infer from these results that changing precautionary messages in terms of consistency and effectiveness in order to reduce risk perception is hardly possible. The use of conditional risk perception measures seems fruitful for studies looking at the effects of precautionary or protective messages, given that previous studies have only investigated effects on unconditional risk perception. However, the present results should not be over-interpreted as the measures' validity in the EMF context still needs further investigation.

Improving Precautionary Communication in the EMF Field? Effects of Making Messages Consistent and Explaining the Effectiveness of Precautions

PubMed Central

Boehmert, Christoph; Wiedemann, Peter; Croft, Rodney

2016-01-01

Many radiation health agencies communicate precautionary measures regarding the use of mobile communication devices, e.g. the use of a headset while talking on the phone. These precautionary messages have, however, been shown to unintentionally increase risk perceptions about radiofrequency electromagnetic fields (RF-EMFs). The current study tested two potential ways of amending precautionary messages in order to minimise this unintentional effect. Firstly, the messages’ potential to be perceived as inconsistent and thereby raise suspicions was addressed; secondly, the effectiveness of the precautions was explained. An experimental design was applied in which a quota sample of 1717 Australian residents was randomly assigned to one of six message conditions. Three different risk perception measures served as dependent variables, two of them are conditional measures. The original effect of precautionary messages to amplify risk perceptions could not be replicated. Furthermore, amending precautionary messages in favour of more consistency had no effect, while explaining the effectiveness of the precautions increased conditional risk perception under the condition that no precautions are taken. This was contrary to our assumptions. We infer from these results that changing precautionary messages in terms of consistency and effectiveness in order to reduce risk perception is hardly possible. The use of conditional risk perception measures seems fruitful for studies looking at the effects of precautionary or protective messages, given that previous studies have only investigated effects on unconditional risk perception. However, the present results should not be over-interpreted as the measures’ validity in the EMF context still needs further investigation. PMID:27735851

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGRICULTURAL USE REQUIREMENTS in the labeling. (e) Spanish warning statements. If the product is classified as... appear in Spanish in addition to English followed by the statement, “Si Usted no entiende la etiqueta... some one to explain it to you in detail.)” The Spanish signal word “PELIGRO” shall be used for products...

Psychopaths are impaired in social exchange and precautionary reasoning.

PubMed

Ermer, Elsa; Kiehl, Kent A

2010-10-01

Psychopaths show a profound lack of morality and behavioral controls in the presence of intact general intellectual functioning. Two hallmarks of psychopathy are the persistent violation of social contracts (i.e., cheating) and chronic, impulsive risky behavior. These behaviors present a puzzle: Can psychopaths understand and reason about what counts as cheating or risky behavior in a particular situation? We tested incarcerated psychopaths' and incarcerated nonpsychopaths' reasoning about social contract rules, precautionary rules, and descriptive rules using the Wason selection task. Results were consistent with our hypotheses: Psychopaths (compared with matched nonpsychopaths) showed significant impairment on social contract rules and precautionary rules, but not on descriptive rules. These results cannot be accounted for by differences in intelligence, motivation, or general antisocial tendency. These findings suggest that examination of evolutionarily identified reasoning processes can be a fruitful research approach for identifying which specific mechanisms are impaired in psychopathy.

40 CFR 156.210 - Notification-to-workers statements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Notification-to-workers statements. 156.210 Section 156.210 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Worker Protection Statements § 156.210...

Precautionary measures reduce risk of definite neuroleptic malignant syndrome in newly typical neuroleptic-treated schizophrenia inpatients.

PubMed

Shiloh, Roni; Valevski, Avi; Bodinger, Liron; Misgav, Sagit; Aizenberg, Dov; Dorfman-Etrog, Pnina; Weizman, Abraham; Munitz, Hanan

2003-05-01

Neuroleptic malignant syndrome (NMS) is a potentially lethal antipsychotic drug (APD)-induced thermoregulatory disturbance. We hypothesized that several precautionary measures taken after administeration of APDs might prevent progression to definite NMS. The study group included 657 consecutively admitted drug-free schizophrenia inpatients who received various typical APDs for 28 days. Specific predefined precautionary measures were employed for this group. The comparison group (n=192) consisted of typical APD-treated schizophrenia inpatients in whom such precautionary measures were not imposed. The study group exhibited a significantly lower incidence of definite NMS (1/657=0.2% versus 4/192=2.1%; P=0.01, odds ratio=13.96; 95% confidence interval 1.55-125.63). Antipsychotics were discontinued in 28 patients (28/657=4.3%) from the study group due to NMS (n=1) or early detection of potential NMS-related signs (probable abortive NMS) (n=27). Our findings suggest that specific precautionary measures can effectively reduce the incidence of definite NMS by approximately one order in newly medicated schizophrenia inpatients.

PRN 94-7: Label Improvement Program for the Revision of Use Directions for Commensal Rodenticides and Statement of the Agency's Policies on the Use of Rodenticide Bait Stations

EPA Pesticide Factsheets

This Notice requires registrants of certain pesticide products claimed to control commensal rodents and registered under FIFRA to revise the labeling of such products to bear certain statements concerning tamper-resistant bait stations.

Policy on synthetic biology: deliberation, probability, and the precautionary paradox.

PubMed

Wareham, Christopher; Nardini, Cecilia

2015-02-01

Synthetic biology is a cutting-edge area of research that holds the promise of unprecedented health benefits. However, in tandem with these large prospective benefits, synthetic biology projects entail a risk of catastrophic consequences whose severity may exceed that of most ordinary human undertakings. This is due to the peculiar nature of synthetic biology as a 'threshold technology' which opens doors to opportunities and applications that are essentially unpredictable. Fears about these potentially unstoppable consequences have led to declarations from civil society groups calling for the use of a precautionary principle to regulate the field. Moreover, the principle is prevalent in law and international agreements. Despite widespread political recognition of a need for caution, the precautionary principle has been extensively criticized as a guide for regulatory policy. We examine a central objection to the principle: that its application entails crippling inaction and incoherence, since whatever action one takes there is always a chance that some highly improbable cataclysm will occur. In response to this difficulty, which we call the 'precautionary paradox,' we outline a deliberative means for arriving at threshold of probability below which potential dangers can be disregarded. In addition, we describe a Bayesian mechanism with which to assign probabilities to harmful outcomes. We argue that these steps resolve the paradox. The rehabilitated PP can thus provide a viable policy option to confront the uncharted waters of synthetic biology research. © 2013 John Wiley & Sons Ltd.

16 CFR 500.4 - Statement of identity.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...

16 CFR 500.4 - Statement of identity.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...

16 CFR 500.4 - Statement of identity.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...

16 CFR 500.4 - Statement of identity.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...

16 CFR 500.4 - Statement of identity.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Statement of identity. 500.4 Section 500.4... PACKAGING AND LABELING ACT § 500.4 Statement of identity. (a) The principal display panel of a consumer commodity shall bear a specification of the identity of the commodity. (b) Such specification of identity...

40 CFR 205.55-4 - Labeling-compliance.

Code of Federal Regulations, 2011 CFR

2011-07-01

... PROGRAMS TRANSPORTATION EQUIPMENT NOISE EMISSION CONTROLS Medium and Heavy Trucks § 205.55-4 Labeling... contrasts with the background of the label: (i) The label heading: Vehicle Noise Emission Control...) The statement: This Vehicle Conforms to U.S. EPA Regulations for Noise Emission Applicable to Medium...

27 CFR 4.32 - Mandatory label information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Mandatory label information. (a) There shall be stated on the brand label: (1) Brand name, in accordance... the bottle. (c) There shall be stated on the brand label or on a back label a statement that the... the Office of Management and Budget under Control Number 1512-0469) [T.D. 6521, 25 FR 13835, Dec. 29...

21 CFR 701.11 - Identity labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Identity labeling. 701.11 Section 701.11 Food and... COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

[How to be prudent with synthetic biology. Synthetic Biology and the precautionary principle].

PubMed

Rodríguez López, Blanca

2014-01-01

Synthetic biology is a new discipline that is twofold: firstly it offers the promise to pay benefits that can alleviate some of the ills that plague mankind; On the other hand, like all technologies, holds risks. Given these, the most critical and concerned about the risks, invoke the application of the precautionary principle, common in cases where an activity or new technology creates risks to the environment and/or human health, but far from universally accepted happens to be currently one of the most controversial principles. In this paper the question of the risks and benefits of synthetic biology and the relevance of applying the precautionary principle are analyzed. To do this we proceed as follows. The first part focuses on synthetic biology. At first, this discipline is characterized, with special attention to what is novel compared to the known as "genetic engineering". In the second stage both the benefits and the risks associated with it are discussed. The first part concludes with a review of the efforts currently being made to control or minimize the risks. The second part aims to analyze the precautionary principle and its possible relevance to the case of Synthetic Biology. At first, the different versions and interpretations of the principle and the various criticisms of which has been the subject are reviewed. Finally, after discarding the Precautionary Principle as an useful tool, it is seen as more appropriate some recent proposals to treat technologies that take into account not only risks but also their benefits.

A precautionary principle for dual use research in the life sciences.

PubMed

Kuhlau, Frida; Höglund, Anna T; Evers, Kathinka; Eriksson, Stefan

2011-01-01

Most life science research entails dual-use complexity and may be misused for harmful purposes, e.g. biological weapons. The Precautionary Principle applies to special problems characterized by complexity in the relationship between human activities and their consequences. This article examines whether the principle, so far mainly used in environmental and public health issues, is applicable and suitable to the field of dual-use life science research. Four central elements of the principle are examined: threat, uncertainty, prescription and action. Although charges against the principle exist - for example that it stifles scientific development, lacks practical applicability and is poorly defined and vague - the analysis concludes that a Precautionary Principle is applicable to the field. Certain factors such as credibility of the threat, availability of information, clear prescriptive demands on responsibility and directives on how to act, determine the suitability and success of a Precautionary Principle. Moreover, policy-makers and researchers share a responsibility for providing and seeking information about potential sources of harm. A central conclusion is that the principle is meaningful and useful if applied as a context-dependent moral principle and allowed flexibility in its practical use. The principle may then inspire awareness-raising and the establishment of practical routines which appropriately reflect the fact that life science research may be misused for harmful purposes. © 2009 Blackwell Publishing Ltd.

[In the consumers' interest: precautionary principles for protection against electromagnetic fields].

PubMed

Dehos, A; Weiss, W

2002-12-01

The considerable increase in using mobile communication which will increase when new technologies, such as UMTS, are introduced has resulted in further public interest concerning the possible health risks from electromagnetic fields of cellular phone networks. In view of evaluating the scientific state-of-the art, it has been shown that based on the available scientific results, the individual risk in view of proved health consequences is considered low. There are, however, indications of biological effects of high-frequency electromagnetic fields, even at intensities below the currently applied limit values or recommendations for limit values. Although the health relevance of these effects is still unclear, they give reason to precautionary measures with the object to minimise possible health risks which might affect a large number of persons. The precautionary measures recommended by the Federal Office for Radiation Protection include three principles: 1. Exposure of the general public to electromagnetic fields should be as low as possible. This applies for both the fixed parts of cellular phone networks and for mobile phones. 2. The population should be informed of risks in an objective and comprehensive way and be involved in the decisions on the construction and operation of cellular phone networks. 3. Scientific uncertainties should be reduced by means of well-directed research programmes. These precautionary measures and the significance of limit values are explained below.

9 CFR 381.125 - Special handling label requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... consumers, hotels, restaurants, or similar institutions and shall appear on the label. The information shall... such conspicuousness (as compared with other words, statements, designs or devices in the labeling) as...

21 CFR 801.6 - Medical devices; misleading statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...

21 CFR 801.6 - Medical devices; misleading statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading...

33 CFR 167.201 - In the approaches to Chesapeake Bay: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.201 In the...

33 CFR 167.201 - In the approaches to Chesapeake Bay: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.201 In the...

33 CFR 167.201 - In the approaches to Chesapeake Bay: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.201 In the...

33 CFR 167.201 - In the approaches to Chesapeake Bay: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.201 In the...

33 CFR 167.201 - In the approaches to Chesapeake Bay: Precautionary area.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.201 In the...

40 CFR 1042.135 - Labeling.

Code of Federal Regulations, 2011 CFR

2011-07-01

... label. (e) For engines requiring ULSD, create a separate label with the statement: “ULTRA LOW SULFUR... power (in kW), and power density (in kW/L) as needed to determine the emission standards for the engine family. You may specify displacement, maximum engine power, or power density as a range consistent with...

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...

40 CFR 156.206 - General statements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... (i.e., an organophosphorus ester that inhibits cholinesterase) or an N-methyl carbamate (i.e., an N-methyl carbamic acid ester that inhibits cholinesterase), the label shall so state. The statement shall...

21 CFR 701.11 - Identity labeling.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

21 CFR 701.11 - Identity labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

21 CFR 701.11 - Identity labeling.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

21 CFR 701.11 - Identity labeling.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

27 CFR 5.40 - Statements of age and percentage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...

27 CFR 5.40 - Statements of age and percentage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...

43 CFR 418.24 - Precautionary drawdown and spills from Lahontan Reservoir.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Lahontan Reservoir. 418.24 Section 418.24 Public Lands: Interior Regulations Relating to Public Lands... RECLAMATION PROJECT, NEVADA Operations and Management § 418.24 Precautionary drawdown and spills from Lahontan Reservoir. (a) Even though flood control is not a specifically authorized purpose of the Project, at the...

43 CFR 418.24 - Precautionary drawdown and spills from Lahontan Reservoir.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Lahontan Reservoir. 418.24 Section 418.24 Public Lands: Interior Regulations Relating to Public Lands... RECLAMATION PROJECT, NEVADA Operations and Management § 418.24 Precautionary drawdown and spills from Lahontan Reservoir. (a) Even though flood control is not a specifically authorized purpose of the Project, at the...

How not to criticize the precautionary principle.

PubMed

Hughes, Jonathan

2006-10-01

The precautionary principle has its origins in debates about environmental policy, but is increasingly invoked in bioethical contexts. John Harris and Søren Holm argue that the principle should be rejected as incoherent, irrational, and representing a fundamental threat to scientific advance and technological progress. This article argues that while there are problems with standard formulations of the principle, Harris and Holm's rejection of all its forms is mistaken. In particular, they focus on strong versions of the principle and fail to recognize that weaker forms, which may escape their criticisms, are both possible and advocated in the literature.

Evacuee injuries and demographics in transport airplane precautionary emergency evacuations : final report.

DOT National Transportation Integrated Search

2000-03-01

During a nine-year period from January 1, 1988, through December 31, 1996, there were more than 500 transport airplane precautionary emergency evacuations (PEEvacs), occurring on average about once a week. Each year as many as 6,000 persons participa...

Precautionary principles: a jurisdiction-free framework for decision-making under risk.

PubMed

Ricci, Paolo F; Cox, Louis A; MacDonald, Thomas R

2004-12-01

Fundamental principles of precaution are legal maxims that ask for preventive actions, perhaps as contingent interim measures while relevant information about causality and harm remains unavailable, to minimize the societal impact of potentially severe or irreversible outcomes. Such principles do not explain how to make choices or how to identify what is protective when incomplete and inconsistent scientific evidence of causation characterizes the potential hazards. Rather, they entrust lower jurisdictions, such as agencies or authorities, to make current decisions while recognizing that future information can contradict the scientific basis that supported the initial decision. After reviewing and synthesizing national and international legal aspects of precautionary principles, this paper addresses the key question: How can society manage potentially severe, irreversible or serious environmental outcomes when variability, uncertainty, and limited causal knowledge characterize their decision-making? A decision-analytic solution is outlined that focuses on risky decisions and accounts for prior states of information and scientific beliefs that can be updated as subsequent information becomes available. As a practical and established approach to causal reasoning and decision-making under risk, inherent to precautionary decision-making, these (Bayesian) methods help decision-makers and stakeholders because they formally account for probabilistic outcomes, new information, and are consistent and replicable. Rational choice of an action from among various alternatives--defined as a choice that makes preferred consequences more likely--requires accounting for costs, benefits and the change in risks associated with each candidate action. Decisions under any form of the precautionary principle reviewed must account for the contingent nature of scientific information, creating a link to the decision-analytic principle of expected value of information (VOI), to show the

16 CFR 1500.123 - Condensation of label information.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

16 CFR 1500.123 - Condensation of label information.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

16 CFR 1500.123 - Condensation of label information.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

16 CFR 1500.123 - Condensation of label information.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Condensation of label information. 1500.123 Section 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... Condensation of label information. Whenever the statement of the principal hazard or hazards itself provides...

43 CFR 418.24 - Precautionary drawdown and spills from Lahontan Reservoir.

Code of Federal Regulations, 2012 CFR

2012-10-01

..., precautionary drawdown of Lahontan Reservoir may be made to limit potential flood damage along the Carson River... will be determined by comparison with other years' data and normalized by comparison of differences in... objective in subsequent months will be reduced by one-half of the difference between that month's storage...

43 CFR 418.24 - Precautionary drawdown and spills from Lahontan Reservoir.

Code of Federal Regulations, 2014 CFR

2014-10-01

..., precautionary drawdown of Lahontan Reservoir may be made to limit potential flood damage along the Carson River... will be determined by comparison with other years' data and normalized by comparison of differences in... objective in subsequent months will be reduced by one-half of the difference between that month's storage...

43 CFR 418.24 - Precautionary drawdown and spills from Lahontan Reservoir.

Code of Federal Regulations, 2013 CFR

2013-10-01

..., precautionary drawdown of Lahontan Reservoir may be made to limit potential flood damage along the Carson River... will be determined by comparison with other years' data and normalized by comparison of differences in... objective in subsequent months will be reduced by one-half of the difference between that month's storage...

76 FR 251 - Country of Origin Labeling of Packed Honey

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

...-AC89 Country of Origin Labeling of Packed Honey AGENCY: Agricultural Marketing Service, USDA. ACTION... addressing country of origin labeling for packed honey bearing any official USDA mark or statement. Also, the... origin labeling requirements are not met for packages of honey containing official USDA grade marks or...

[Application criteria of the precautionary principle].

PubMed

Moccaldi, R

2011-01-01

The precautionary principle, according to the European Commission (February 2, 2000) must be applied when there is a possibility of a danger to humans, animals and/or environment health, i.e. when the potential harmful effects have been identified by a scientific and objective evaluation, but this evaluation does not allow the risk to be determined with sufficient certainty. However this principle has been invoked, without the identification, even partial, of harmful effects, to justify preventive and protective measures deemed necessary by policy maker mainly due to a high (but unjustified) risk perception by the population. We analyze the examples of the limits imposed by Italian legislation for the protection from EMF, and measures of "prudent avoidance" in the use of mobile phones.

Moving further upstream: from toxics reduction to the precautionary principle.

PubMed

Mayer, Brian; Brown, Phil; Linder, Meadow

2002-01-01

Early policies to reduce the amount of toxic waste in the environment focused on cleaning up downstream sources of pollution, such as toxic disposal sites. Public attention in the 1980s encouraged both industry and government to develop an alternative to this command-and-control approach. This article describes the emergence of that alternative-pollution prevention-and its application in Massachusetts through the 1989 Toxics Use Reduction Act. Pollution prevention focuses on the sources of pollution, both metaphorically and physically, more upstream than its predecessors. The success of the Toxics Use Reduction Act in Massachusetts helped create an opportunity where an alternative pollution prevention paradigm could develop. That paradigm, the precautionary principle, is popular among environment activists because it focuses further upstream than pollution prevention by calling attention to the role the social construction of risk plays in decisions regarding the use of hazardous substances. The authors examine the evolution of the precautionary principle through an investigation of three major pathways in its development and expansion. The article concludes with a discussion of the increased potential for protecting public health and the environment afforded by this new perspective.

Preacutionary labelling of cross-reactive foods: The case of rapeseed.

PubMed

Fiocchi, Alessandro; Dahdah, Lamia; Riccardi, Carla; Mazzina, Oscar; Fierro, Vincenzo

2016-01-01

Food allergic individuals are exposed to unnecessary dietary restrictions due to precautionary food allergy labelling (PFAL). Two forms of PFAL exist: type I identifies the possible presence of allergenic contaminaion in foods ('may content…'), type II indicates as potentially dangerous ingredients or contaminants that do no belong to official list of food allergens. PFAL type II is based on the fear of cross-reactivity with foods belonging to that list. PFAL type II is less known, but may be tempting for the legal offices of food companies, for clinicians in a 'defensive medicine' key, and even for legislators. We identify here a case of PFAL type II, allergy to rapeseed (belonging to the family of Brassicaceae ). Increasingly used for their nutritional and nutraceutic value in asthma prevention, rapeseed has been indicated by regulatory authorities in Canada and Europe as potential cross-reactor with mustard. In this review, we provide the elements for a risk assessment of cross-reactivity of rapeseed/mustard allergy in the general population both clinically and from the point of view of the molecular allergy. Three findings emerge: 1. Allergic reactions to rapeseed are exceptional 2. The allergens identified in rapeseed and mustard are similar, but not identical 3. Reactions to rapeseed have never been described in mustard-allergic patients. On the ground of existing evidence, a precautionary labeling for rapeseed as potentially dangerous for patients allergic to mustard is not justified. In the interest of patients with multiple food allergy, PFAL type II must be avoided.

33 CFR 167.501 - In the approaches to Los Angeles/Long Beach: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.501 In the...

33 CFR 167.251 - In the approaches to the Cape Fear River: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.251 In the...

33 CFR 167.501 - In the approaches to Los Angeles/Long Beach: Precautionary area.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.501 In the...

33 CFR 167.501 - In the approaches to Los Angeles/Long Beach: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.501 In the...

33 CFR 167.251 - In the approaches to the Cape Fear River: Precautionary area.

Code of Federal Regulations, 2012 CFR

2012-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.251 In the...

33 CFR 167.501 - In the approaches to Los Angeles/Long Beach: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.501 In the...

33 CFR 167.251 - In the approaches to the Cape Fear River: Precautionary area.

Code of Federal Regulations, 2013 CFR

2013-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.251 In the...

33 CFR 167.501 - In the approaches to Los Angeles/Long Beach: Precautionary area.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.501 In the...

33 CFR 167.251 - In the approaches to the Cape Fear River: Precautionary area.

Code of Federal Regulations, 2014 CFR

2014-07-01

..., DEPARTMENT OF HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Atlantic East Coast § 167.251 In the...

21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

21 CFR 338.50 - Labeling of nighttime sleep-aid drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of nighttime sleep-aid drug products. 338... SERVICES (CONTINUED) DRUGS FOR HUMAN USE NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE Labeling § 338.50 Labeling of nighttime sleep-aid drug products. (a) Statement of identity. The labeling of...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 347.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active... Labeling § 347.60 Labeling of permitted combinations of active ingredients. The statement of identity.... (1) Combinations of skin protectant and external analgesic active ingredients in § 347.20(b). In...

21 CFR 331.30 - Labeling of antacid products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...

21 CFR 331.30 - Labeling of antacid products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of antacid products. 331.30 Section 331.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED....” (d) Drug interaction precaution. The labeling of the product contains the following statement “Ask a...

Use of Symbols in Labeling. Final rule.

PubMed

2016-06-15

The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement "Rx only" or "[rx] only" in the labeling for prescription devices.

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 352.60 Section 352.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... INDEFINITELY] Labeling § 352.60 Labeling of permitted combinations of active ingredients. Statements of...

76 FR 19237 - Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... exemption from nutrition labeling for food that is served in restaurants or other establishments in which... the selection button that includes a clear and conspicuous statement disclosing the number of calories... Act also requires certain restaurants and similar retail food establishments to provide calorie and...

16 CFR § 1500.123 - Condensation of label information.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Condensation of label information. § 1500.123 Section § 1500.123 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS... § 1500.123 Condensation of label information. Whenever the statement of the principal hazard or hazards...

The precautionary principle within European Union public health policy. The implementation of the principle under conditions of supranationality and citizenship.

PubMed

Antonopoulou, Lila; van Meurs, Philip

2003-11-01

The present study examines the precautionary principle within the parameters of public health policy in the European Union, regarding both its meaning, as it has been shaped by relevant EU institutions and their counterparts within the Member States, and its implementation in practice. In the initial section I concentrate on the methodological question of "scientific uncertainty" concerning the calculation of risk and possible damage. Calculation of risk in many cases justifies the adopting of preventive measures, but, as it is argued, the principle of precaution and its implementation cannot be wholly captured by a logic of calculation; such a principle does not only contain scientific uncertainty-as the preventive principle does-but it itself is generated as a principle by this scientific uncertainty, recognising the need for a society to act. Thus, the implementation of the precautionary principle is also a simultaneous search for justification of its status as a principle. This justification would result in the adoption of precautionary measures against risk although no proof of this principle has been produced based on the "cause-effect" model. The main part of the study is occupied with an examination of three cases from which the stance of the official bodies of the European Union towards the precautionary principle and its implementation emerges: the case of the "mad cows" disease, the case of production and commercialization of genetically modified foodstuffs. The study concludes with the assessment that the effective implementation of the precautionary principle on a European level depends on the emergence of a concerned Europe-wide citizenship and its acting as a mechanism to counteract the material and social conditions that pose risks for human health.

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not been...

Communicating Earthquake Preparedness: The Influence of Induced Mood, Perceived Risk, and Gain or Loss Frames on Homeowners' Attitudes Toward General Precautionary Measures for Earthquakes.

PubMed

Marti, Michèle; Stauffacher, Michael; Matthes, Jörg; Wiemer, Stefan

2018-04-01

Despite global efforts to reduce seismic risk, actual preparedness levels remain universally low. Although earthquake-resistant building design is the most efficient way to decrease potential losses, its application is not a legal requirement across all earthquake-prone countries and even if, often not strictly enforced. Risk communication encouraging homeowners to take precautionary measures is therefore an important means to enhance a country's earthquake resilience. Our study illustrates that specific interactions of mood, perceived risk, and frame type significantly affect homeowners' attitudes toward general precautionary measures for earthquakes. The interdependencies of the variables mood, risk information, and frame type were tested in an experimental 2 × 2 × 2 design (N = 156). Only in combination and not on their own, these variables effectively influence attitudes toward general precautionary measures for earthquakes. The control variables gender, "trait anxiety" index, and alteration of perceived risk adjust the effect. Overall, the group with the strongest attitudes toward general precautionary actions for earthquakes are homeowners with induced negative mood who process high-risk information and gain-framed messages. However, the conditions comprising induced negative mood, low-risk information and loss-frame and induced positive mood, low-risk information and gain-framed messages both also significantly influence homeowners' attitudes toward general precautionary measures for earthquakes. These results mostly confirm previous findings in the field of health communication. For practitioners, our study emphasizes that carefully compiled communication measures are a powerful means to encourage precautionary attitudes among homeowners, especially for those with an elevated perceived risk. © 2017 Society for Risk Analysis.

CCUS Policy: an Argument for the Implementation of the Precautionary Principle

NASA Astrophysics Data System (ADS)

Augustin, C. M.; Broad, K.; Swart, P. K.

2013-12-01

Too often in crafting national energy and environmental policy, US lawmakers follow the reactionary rather than precautionary principle. This 'wait and see' approach encourages a state of deregulation that inhibits widespread commercial adoption of new technologies because it provides no framework for those technologies to operate within. [1] Reactionary policy encourages risk taking that can only be curbed once incontrovertible evidence of harm has been presented. [2] Despite the fact that private and public entities have embraced carbon capture, utilization, and storage (CCUS) the implementation of the technology raises serious concerns problems that have been largely ignored. Notably, the United States is guided by the reactionary principle with respect to CCUS legislation. The US lacks a clear accounting not only of what happens to injected carbon dioxide, but it also does not have clear of legal guidelines covering other CCUS issues such as subsurface ownership or environmental remediation. Absent a comprehensive suite of CCUS regulation, states are forced to self-regulate, setting the stage for significant transboundary conflict in the event of leakage. This is not an unknown issue, in fact the 2005 IPCC report on CCUS identified as primary research concerns 1) the lack of clear regulatory framework, 2) the lack of probabilistic methods for risk analysis and 3) lack of understanding of potential leakages. Answers to these three concerns were described as essential for CCUS deployment. In the seven years since the IPCC report was published, there has been an exponential rise in industry and government managed injection sites, with no corresponding rise in research-based law. The result of this imbalance is that law is proposed and interpreted at all levels, from the local to federal to international, leading to overlapping and conflicting regulatory regimes. This has led to a near-universal reluctance to invest in the technology, and an assumption that CCUS

Quantitative risk assessment of foods containing peanut advisory labeling.

PubMed

Remington, Benjamin C; Baumert, Joseph L; Marx, David B; Taylor, Steve L

2013-12-01

Foods with advisory labeling (i.e. "may contain") continue to be prevalent and the warning may be increasingly ignored by allergic consumers. We sought to determine the residual levels of peanut in various packaged foods bearing advisory labeling, compare similar data from 2005 and 2009, and determine any potential risk for peanut-allergic consumers. Of food products bearing advisory statements regarding peanut or products that had peanut listed as a minor ingredient, 8.6% and 37.5% contained detectable levels of peanut (>2.5 ppm whole peanut), respectively. Peanut-allergic individuals should be advised to avoid such products regardless of the wording of the advisory statement. Peanut was detected at similar rates and levels in products tested in both 2005 and 2009. Advisory labeled nutrition bars contained the highest levels of peanut and an additional market survey of 399 products was conducted. Probabilistic risk assessment showed the risk of a reaction to peanut-allergic consumers from advisory labeled nutrition bars was significant but brand-dependent. Peanut advisory labeling may be overused on some nutrition bars but prudently used on others. The probabilistic approach could provide the food industry with a quantitative method to assist with determining when advisory labeling is most appropriate. Copyright © 2013 Elsevier Ltd. All rights reserved.

The precautionary principle in fisheries management under climate change: How the international legal framework formulate it?

NASA Astrophysics Data System (ADS)

Latifah, E.; Imanullah, M. N.

2018-03-01

One of the objectives of fisheries management is to reach long-term sustainable benefits of the fish stocks while reducing the risk of severe or irreversible damage to the marine ecosystem. Achieving this objective needs, the good scientific knowledge and understanding on fisheries management including scientific data and information on the fish stock, fishing catch, distribution, migration, the proportion of mature fish, the mortality rate, reproduction as well as the knowledge on the impact of fishing on dependent and associated species and other species belonging to the same ecosystem, and further the impact of climate change and climate variability on the fish stocks and marine ecosystem. Lack of this scientific knowledge may lead to high levels of uncertainty. The precautionary principle is one of the basic environmental principles needed in overcoming this problem. An essence of this principle is that, in facing the serious risk as a result of the limited scientific knowledge or the absence of complete evidence of harm, it should not prevent the precautionary measures in minimizing risks and protecting the fish stocks and ecosystem. This study aims to examine how the precautionary principle in fisheries management be formulated into the international legal framework, especially under the climate change framework.

9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

Code of Federal Regulations, 2011 CFR

2011-01-01

... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

9 CFR 317.17 - Interpretation and statement of labeling policy for cured products; special labeling requirements...

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling policy for cured products; special labeling requirements concerning nitrate and nitrite. 317.17..., sodium phosphate, sodium nitrate, and sodium nitrite or other permitted substances which are added to any... nitrate or nitrite is permitted or required to be added may be prepared without nitrate or nitrite and...

21 CFR 312.6 - Labeling of an investigational new drug.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Section 312.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION General Provisions § 312.6 Labeling of... human use shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States...

33 CFR 167.1315 - In the Strait of Juan de Fuca: Precautionary area “PA.”

Code of Federal Regulations, 2012 CFR

2012-07-01

... HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1315 In the Strait of Juan de...

33 CFR 167.1315 - In the Strait of Juan de Fuca: Precautionary area “PA.”

Code of Federal Regulations, 2013 CFR

2013-07-01

... HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1315 In the Strait of Juan de...

33 CFR 167.1315 - In the Strait of Juan de Fuca: Precautionary area “PA.”

Code of Federal Regulations, 2014 CFR

2014-07-01

... HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1315 In the Strait of Juan de...

33 CFR 167.1315 - In the Strait of Juan de Fuca: Precautionary area “PA.”

Code of Federal Regulations, 2011 CFR

2011-07-01

... HOMELAND SECURITY (CONTINUED) PORTS AND WATERWAYS SAFETY OFFSHORE TRAFFIC SEPARATION SCHEMES Description of Traffic Separation Schemes and Precautionary Areas Pacific West Coast § 167.1315 In the Strait of Juan de...

The Precautionary Principle and Electric and Magnetic Fields

PubMed Central

Jamieson, Dale; Wartenberg, Daniel

2001-01-01

Current environmental regulation represents a paternalistic policy, more concerned to avoid false positives than false negatives, limiting opportunities for individuals to make choices between risk-avoidance and risk-taking alternatives. For example, many exposures to magnetic fields could be reduced at little or no cost but are not considered seriously, owing to the uncertainty of risk and the concern to avoid false positives. Even though precautionary approaches that focus on avoiding false negatives often do not lead to adverse economic consequences or irrational choices, such approaches usually are not taken. The value of autonomy and the proper role of governmental paternalism with respect to environmental policy need to be considered more carefully in environmental decision making. PMID:11527754

PRN 97-5: Use of Common Names for Active Ingredients on Pesticide Labeling

EPA Pesticide Factsheets

This notice announces EPA policy to expand the use of common names on pesticide labeling. EPA will permit the use of common names approved by ANSI in the label ingredients statement without the accompanying scientific chemical name.

[Theoretical risk management and legitimacy of the precautionary principle in medicine. Look back at HIV contamination through blood transfusion in France, twenty years ago].

PubMed

Moutel, G; Hergon, E; Duchange, N; Bellier, L; Rouger, P; Hervé, C

2005-02-01

The precautionary principle first appeared in France during the health crisis following the contamination of patients with HIV via blood transfusion. This study analyses whether the risk associated with blood transfusion was taken into account early enough considering the context of scientific uncertainty between 1982 and 1985. The aim was to evaluate whether a precautionary principle was applied and whether it was relevant. First, we investigated the context of scientific uncertainty and controversies prevailing between 1982 and 1985. Then we analysed the attitude and decisions of the French authorities in this situation to determine whether a principle of precaution was applied. Finally, we explored the reasons at the origin of the delay in controlling the risk. Despite the scientific uncertainties associated with the potential risk of HIV contamination by transfusion in 1983, we found that a list of recommendations aiming to reduce this risk was published in June of that year. In the prevailing climate of uncertainty, these measures could be seen as precautionary. However, the recommended measures were not widely applied. Cultural, structural and economic factors hindered their implementation. Our analysis provides insight into the use of precautionary principle in the domain of blood transfusion and, more generally, medicine. It also sheds light on the expectations that health professionals should have of this principle. The aim of the precautionary principle is to manage rather than to reduce scientific uncertainty. The principle is not a futile search for zero risk. Rather, it is a principle for action allowing precautionary measures to be taken. However, we show that these measures must appear legitimate to be applied. This legitimacy requires an adapted decision-making process, involving all those concerned in the management of collective risks.

9 CFR 412.1 - Label approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... foreign language or printing labels that bear a statement of the quantity of contents in accordance with... Policy Book, (except for “natural” and negative claims (e.g., “gluten free”)), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims...

21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.17 Food labeling..., or are sold for use in food service establishments, may be provided on cartons or in labeling, e.g... the Public Health Service Act (PHS Act), any State or locality that is willing and able to assist the...

21 CFR 640.70 - Labeling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...

21 CFR 640.70 - Labeling.

Code of Federal Regulations, 2011 CFR

2011-04-01

... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Source Plasma § 640.70 Labeling. (a) In addition to the... container of Source Plasma: (1) The proper name of the product. (2) The statement “Caution: For... size and type of print as the proper name. If the Source Plasma has a reactive screening test for...

40 CFR 156.62 - Toxicity Category.

Code of Federal Regulations, 2010 CFR

2010-07-01

... being the highest toxicity category. Most human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide product as sold or...

40 CFR 156.62 - Toxicity Category.

Code of Federal Regulations, 2011 CFR

2011-07-01

... being the highest toxicity category. Most human hazard, precautionary statements, and human personal protective equipment statements are based upon the Toxicity Category of the pesticide product as sold or...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

21 CFR 349.79 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Labeling of permitted combinations of active ingredients. 349.79 Section 349.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... § 349.79 Labeling of permitted combinations of active ingredients. Statements of identity, indications...

16 CFR 1500.15 - Labeling of fire extinguishers.

Code of Federal Regulations, 2011 CFR

2011-01-01

... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

16 CFR 1500.15 - Labeling of fire extinguishers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

16 CFR 1500.15 - Labeling of fire extinguishers.

Code of Federal Regulations, 2012 CFR

2012-01-01

... hazard “Dangerous gas formed when used to extinguish flame or on contact with heat” are required labeling...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

21 CFR 201.6 - Drugs; misleading statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... representation with respect to another drug or a device or a food or cosmetic. (b) The labeling of a drug which... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; misleading statements. 201.6 Section 201.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS...

Conflict of Interest Disclosure in Off-Label Oncology Clinical Trials

PubMed Central

Irwin, Blair; Hirsch, Bradford R.; Samsa, Gregory P.; Abernethy, Amy P.

2012-01-01

Purpose: We sought to determine the prevalence, reliability, and predictors of conflict of interest (COI) and funding disclosure statements for studies of anticancer targeted therapies conducted in the off-label prescribing setting. Methods: As a part of a federally funded systematic review, manuscripts were included in the analysis if they were used to support one of 19 indications for cancer targeted therapies that were off-label but reimbursable according to compendia published in 2006 or before. Studies were categorized according to trial design, trial results, average impact factor of journals, and presence of COI and funding disclosure statements. Results: Among the 69 included studies, prevalence of COI and funding disclosures was low, at 33% and 58% respectively; time trends showed some improvement between 2002 to 2007, but only 60% of studies had disclosures by 2007. Predictors of COI disclosure were publication in high-impact-factor journals (P < .001), large study sample size (P = .001), enrollment exclusively in the United States (P = .04), and study of the targeted therapy in combination with other agents as opposed to the study drug alone (P = .03). Conclusion: Disclosure of potential sources of bias in COI and funding statements in studies of off-label indications for anticancer targeted therapies was low and did not increase substantially over time. PMID:23277767

A Precautionary Approach to City Building: Interpreting the Relationship between Urban Form and Mobility

ERIC Educational Resources Information Center

Marzoughi, Reihane; Vanderburg, Willem H.

2010-01-01

The literature on the impact of urban form design on travel behavior reveals mixed results. Instead of interpreting this finding as an insufficient basis for warranting action, this article suggests that a precautionary approach be introduced. This approach should be based on two interdependent modes of knowing and doing to establish and evolve…

10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

Code of Federal Regulations, 2014 CFR

2014-01-01

.... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...

10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

Code of Federal Regulations, 2010 CFR

2010-01-01

... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

Code of Federal Regulations, 2012 CFR

2012-01-01

... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

Code of Federal Regulations, 2011 CFR

2011-01-01

... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

Code of Federal Regulations, 2013 CFR

2013-01-01

.... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...

Multi-Case Review of the Application of the Precautionary Principle in European Union Law and Case Law.

PubMed

Garnett, Kenisha; Parsons, David J

2017-03-01

The precautionary principle was formulated to provide a basis for political action to protect the environment from potentially severe or irreversible harm in circumstances of scientific uncertainty that prevent a full risk or cost-benefit analysis. It underpins environmental law in the European Union and has been extended to include public health and consumer safety. The aim of this study was to examine how the precautionary principle has been interpreted and subsequently applied in practice, whether these applications were consistent, and whether they followed the guidance from the Commission. A review of the literature was used to develop a framework for analysis, based on three attributes: severity of potential harm, standard of evidence (or degree of uncertainty), and nature of the regulatory action. This was used to examine 15 pieces of legislation or judicial decisions. The decision whether or not to apply the precautionary principle appears to be poorly defined, with ambiguities inherent in determining what level of uncertainty and significance of hazard justifies invoking it. The cases reviewed suggest that the Commission's guidance was not followed consistently in forming legislation, although judicial decisions tended to be more consistent and to follow the guidance by requiring plausible evidence of potential hazard in order to invoke precaution. © 2016 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

The optimisation approach of ALARA in nuclear practice: an early application of the precautionary principle. Scientific uncertainty versus legal uncertainty.

PubMed

Lierman, S; Veuchelen, L

2005-01-01

The late health effects of exposure to low doses of ionising radiation are subject to scientific controversy: one view finds threats of high cancer incidence exaggerated, while the other view thinks the effects are underestimated. Both views have good scientific arguments in favour of them. Since the nuclear field, both industry and medicine have had to deal with this controversy for many decades. One can argue that the optimisation approach to keep the effective doses as low as reasonably achievable, taking economic and social factors into account (ALARA), is a precautionary approach. However, because of these stochastic effects, no scientific proof can be provided. This paper explores how ALARA and the Precautionary Principle are influential in the legal field and in particular in tort law, because liability should be a strong incentive for safer behaviour. This so-called "deterrence effect" of liability seems to evaporate in today's technical and highly complex society, in particular when dealing with the late health effects of low doses of ionising radiation. Two main issues will be dealt with in the paper: 1. How are the health risks attributable to "low doses" of radiation regulated in nuclear law and what lessons can be learned from the field of radiation protection? 2. What does ALARA have to inform the discussion of the Precautionary Principle and vice-versa, in particular, as far as legal sanctions and liability are concerned? It will be shown that the Precautionary Principle has not yet been sufficiently implemented into nuclear law.

Audit of manufactured products: use of allergen advisory labels and identification of labeling ambiguities.

PubMed

Pieretti, Mariah M; Chung, Danna; Pacenza, Robert; Slotkin, Todd; Sicherer, Scott H

2009-08-01

The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels. We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy. Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices. Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (> or = 40%). Categorically, advisory warnings included "may contain" (38%), "shared equipment" (33%), and "within plant" (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as "natural flavors" and "spices," were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of "contains" and "may contain" for the same allergen, among others. Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.

21 CFR 101.15 - Food; prominence of required statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...

21 CFR 101.15 - Food; prominence of required statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...

21 CFR 101.15 - Food; prominence of required statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...

21 CFR 101.15 - Food; prominence of required statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...

21 CFR 101.15 - Food; prominence of required statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Food; prominence of required statements. 101.15 Section 101.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.15 Food; prominence of required...

40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

40 CFR 168.66 - Labeling of pesticide products and devices intended solely for export.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Labeling of pesticide products and... PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS STATEMENTS OF ENFORCEMENT POLICIES AND INTERPRETATIONS Export Policy and Procedures for Exporting Pesticides § 168.66 Labeling of pesticide products and devices...

47 CFR 95.1217 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-10-01

... programmer/control transmitters shall be labeled as provided in part 2 of this chapter and shall bear the... where it is not feasible to place the statement on the device. (b) Where a MedRadio programmer/control... specified in this section is required to be affixed only to the main control unit. (c) MedRadio transmitters...

78 FR 4153 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-18

...; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug Administration, HHS. ACTION... dietary supplements to notify us that they are marketing a dietary supplement product that bears on its... supplements that they are marketing a dietary supplement product that bears on its label or in its labeling a...

40 CFR 600.306-08 - Labeling requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... required to bear range values as required by paragraph (b) of this section, or determined by the... minimum tax-free value, the following statement must appear on the specific label: “[Manufacturer's name... sold or not or whether the vehicle has been relabeled or not. (b) Fuel economy range of comparable...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

21 CFR 501.3 - Identity labeling of animal food in package form.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

21 CFR 369.20 - Drugs; recommended warning and caution statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., INCLUDING ASPIRIN AND SALICYLAMIDE (EXCEPT METHYL SALICYLATE, EFFERVESCENT SALICYLATE PREPARATIONS, AND... out of reach of children.” If the article is an aspirin preparation, it should bear the first of the... aspirin tablets, but such a statement is not required on the labels of other salicylates clearly offered...

Risk communication and the Precautionary Principle.

PubMed

Biocca, Marco

2004-01-01

The perception of risks for environment and health deriving from globalization processes and an uncontrolled use of modern technologies is growing everywhere. The greater the capacity of controlling living conditions, the larger is the possibility of misusing this power. In environmental and occupational health research we tend to reduce the complexity of the observed phenomena in order to facilitate conclusions. In social and political sciences complexity is an essential element of the context, which needs to be continuously considered. The Precautionary Principle is a tool for facing complexity and uncertainty in health risk management. This paper is aimed at demonstrating that this is not only a problem of technical risk assessment. Great attention should also be paid to improve risk communication. Communication between the stakeholders (experts, decision makers, political and social leaders, media, groups of interest and people involved) is possibly the best condition to be successful in health risk management. Nevertheless, this process usually runs up against severe obstacles. These are not only caused by existing conflicts of interest. Differences in values, languages, perceptions, resources to have access to information, and to express one's own point of view are other key aspects.

21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...

21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...

21 CFR 101.17 - Food labeling warning, notice, and safe handling statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... any other labeling. (e) Dietary supplements containing iron or iron salts. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts... concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of...

Environmental Decision Making on Acid Mine Drainage Issues in South Africa: An Argument for the Precautionary Principle.

PubMed

Morodi, T J; Mpofu, Charles

2017-06-28

This paper examines the issue of acid mine drainage in South Africa and environmental decision making processes that could be taken to mitigate the problem in the context of both conventional risk assessment and the precautionary principle. It is argued that conventional risk assessment protects the status quo and hence cannot be entirely relied upon as an effective tool to resolve environmental problems in the context of South Africa, a developing country with complex environmental health concerns. The complexity of the environmental issues is discussed from historical and political perspectives. An argument is subsequently made that the precautionary principle is an alternative tool, and its adoption can be used to empower local communities. This work, therefore, adds to new knowledge by problematising conventional risk assessment and proposing the framing of the acid mine drainage issues in a complex and contextual scenario of a developing country-South Africa.

The Effect of Cancer Warning Statements on Alcohol Consumption Intentions

ERIC Educational Resources Information Center

Pettigrew, Simone; Jongenelis, Michelle I.; Glance, David; Chikritzhs, Tanya; Pratt, Iain S.; Slevin, Terry; Liang, Wenbin; Wakefield, Melanie

2016-01-01

In response to increasing calls to introduce warning labels on alcoholic beverages, this study investigated the potential effectiveness of alcohol warning statements designed to increase awareness of the alcohol-cancer link. A national online survey was administered to a diverse sample of Australian adult drinkers (n = 1,680). Along with…

16 CFR 1500.15 - Labeling of fire extinguishers.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling of fire extinguishers. 1500.15 Section 1500.15 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT...)(1), the signal word “Danger” and the statement of hazard “Poisonous gases formed when used to...

The Precautionary principle: its misunderstandings and misuses in relation to "GMOs".

PubMed

Tagliabue, Giovanni

2016-06-25

References to the Precautionary principle (PP) in relation to "GMOs" are commonplace. Those who oppose the DNA recombinant approach to create new agricultural products either have not read the PP (misunderstanding), or they want to exploit the PP for their propaganda while forcing it (misuse). Proponents of a stricter approach to the regulation of biotechnologies must forge a new expression, since the PP is something else - historically and theoretically. In any case, a legitimate very circumspect attitude, to be coherent, must be applied to each and every biotechnology, not only to "GMOs". Copyright © 2016 Elsevier B.V. All rights reserved.

21 CFR 344.52 - Labeling of ear drying aid drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Indications. The labeling of the product states, under the heading “Use,” the following: “dries water in the...] washing the hair”). Other truthful and nonmisleading statements, describing only the indications for use...

21 CFR 812.5 - Labeling of investigational devices.

Code of Federal Regulations, 2012 CFR

2012-04-01

... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...

21 CFR 812.5 - Labeling of investigational devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...

21 CFR 812.5 - Labeling of investigational devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...

21 CFR 812.5 - Labeling of investigational devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...

21 CFR 812.5 - Labeling of investigational devices.

Code of Federal Regulations, 2013 CFR

2013-04-01

... device is safe or effective for the purposes for which it is being investigated. (c) Animal research. An investigational device shipped solely for research on or with laboratory animals shall bear on its label the following statement: “CAUTION—Device for investigational use in laboratory animals or other tests that do...

Child Nutrition Labeling for Meat and Poultry Products.

ERIC Educational Resources Information Center

Wade, Cheryl; And Others

Prepared for food manufacturers, this publication contains instructions for calculating the contribution that a meat or poultry product makes toward the meal pattern requirements of child nutrition programs. It also contains instructions on how to apply for and obtain the approval for a label containing a child nutrition statement. These…

PRN 2001-1: First Aid Statements on Pesticide Product Labels

EPA Pesticide Factsheets

This PR notice is intended to provide guidance for what the Agency believes is the most updated appropriate first aid language for pesticide product labels to ensure that they continue to adequately protect the public.

The precautionary principle and chemicals management: The example of perfluoroalkyl acids in groundwater.

PubMed

Cousins, Ian T; Vestergren, Robin; Wang, Zhanyun; Scheringer, Martin; McLachlan, Michael S

2016-09-01

Already in the late 1990s microgram-per-liter levels of perfluorooctane sulfonate (PFOS) were measured in water samples from areas where fire-fighting foams were used or spilled. Despite these early warnings, the problems of groundwater, and thus drinking water, contaminated with perfluoroalkyl and polyfluoroalkyl substances (PFASs) including PFOS are only beginning to be addressed. It is clear that this PFAS contamination is poorly reversible and that the societal costs of clean-up will be high. This inability to reverse exposure in a reasonable timeframe is a major motivation for application of the precautionary principle in chemicals management. We conclude that exposure can be poorly reversible; 1) due to slow elimination kinetics in organisms, or 2) due to poorly reversible environmental contamination that leads to continuous exposure. In the second case, which is relevant for contaminated groundwater, the reversibility of exposure is not related to the magnitude of a chemical's bioaccumulation potential. We argue therefore that all PFASs entering groundwater, irrespective of their perfluoroalkyl chain length and bioaccumulation potential, will result in poorly reversible exposures and risks as well as further clean-up costs for society. To protect groundwater resources for future generations, society should consider a precautionary approach to chemicals management and prevent the use and release of highly persistent and mobile chemicals such as PFASs. Copyright © 2016 Elsevier Ltd. All rights reserved.

Presence of undeclared peanut protein in chocolate bars imported from Europe.

PubMed

Vadas, Peter; Perelman, Boris

2003-10-01

Peanut allergens are both stable and potent and are capable of inducing anaphylactic reactions at low concentrations. Consequently, the consumption of peanuts remains the most common cause of food-induced anaphylactic death. Since accidental exposure to peanuts is a common cause of potentially fatal anaphylaxis in peanut-allergic individuals, we tested for the presence of peanut protein in chocolate bars produced in Europe and North America that did not list peanuts as an ingredient. Ninety-two chocolate bars, of which 32 were manufactured in North America and 60 were imported from Europe, were tested by the Veratox assay. None of the 32 North American chocolate products, including 19 with precautionary labeling, contained detectable peanut protein. In contrast, 30.8% of products from western Europe without precautionary labeling contained detectable levels of peanut protein. Sixty-two percent of products from eastern Europe without precautionary labeling contained detectable peanut protein at levels of up to 245 ppm. The absence of precautionary labeling and the absence of the declaration of "peanut" as an ingredient in chocolate bars made in eastern and central Europe were not found to guarantee that these products were actually free of contaminating peanut protein. In contrast, North American manufacturers have attained a consistent level of safety and reliability for peanut-allergic consumers.

How pregnant workers see their work, its risks and the right to precautionary leave in Québec.

PubMed

Turcotte, G

1992-01-01

In 1981, the Québec government passed a law providing "precautionary leave" or reassignment to other jobs for pregnant workers exposed to a risk for their health or that of their fetus. This measure was much more popular than expected, with about 30% of pregnant workers taking leave in 1987. Uncertainty about what constitutes a risk for pregnancy, conflicts between views of pregnancy as a social or private act, and differing ideas on employers' responsibility for protection of pregnant workers have combined with worries about cost to stimulate debate on this law. Since 1986, there has been pressure on the government to restrict access to precautionary leave. This article describes research designed to answer some of the questions raised during the debate. Data banks of the Health and Safety Commission and responses of 2500 women workers were examined to characterize the jobs of women who did and those who did not take leave. Leave was usually taken by those who worked in sectors traditionally associated with risks, and women who applied for precautionary leave more often reported their working conditions to be difficult. Women taking leave accorded more importance to their maternal and domestic roles, but equal value to their roles in the workplace. The article concludes that the popularity of the measure is not due to laziness or lack of responsibility on the part of women workers, but to poor conditions in women's traditional jobs. It is suggested that more emphasis be placed on improving conditions rather than on early leave from work.

21 CFR 501.15 - Animal food; prominence of required statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Animal food; prominence of required statements. 501.15 Section 501.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.15 Animal food; prominence of required...

Why should the baby live? Human right to life and the precautionary principle.

PubMed

Rocchi, Benedetto

2013-05-01

This paper discusses the issue of 'post-birth abortion' from an applied perspective. Three hypothetical situations where a newborn considered as a 'potential person' is at risk of being killed are proposed to highlight the potential controversial outcomes of post-birth abortion. The internal consistency of the argument proposed by Giubilini and Minerva to morally justify newborn killing is contested as well. Finally, an alternative moral strategy based on the precautionary principle and excluding any distinction between potential and actual persons is proposed as rational.

21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...

21 CFR 358.750 - Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... dandruff, seborrheic dermatitis, or psoriasis. 358.750 Section 358.750 Food and Drugs FOOD AND DRUG... Dermatitis, and Psoriasis § 358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis. (a) Statement of identity. The labeling of the product contains the established...

78 FR 47154 - Food Labeling; Gluten-Free Labeling of Foods

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

...The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

How to take deontological concerns seriously in risk-cost-benefit analysis: a re-interpretation of the precautionary principle.

PubMed

John, S D

2007-04-01

In this paper the coherence of the precautionary principle as a guide to public health policy is considered. Two conditions that any account of the principle must meet are outlined, a condition of practicality and a condition of publicity. The principle is interpreted in terms of a tripartite division of the outcomes of action (good outcomes, normal bad outcomes and special bad outcomes). Such a division of outcomes can be justified on either "consequentialist" or "deontological" grounds. In the second half of the paper, it is argued that the precautionary principle is not necessarily opposed to risk-cost-benefit analysis, but, rather, should be interpreted as suggesting a lowering of our epistemic standards for assessing evidence that there is a link between some policy and "special bad" outcomes. This suggestion is defended against the claim that it mistakes the nature of statistical testing and against the charge that it is unscientific or antiscientific, and therefore irrational.

21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs; Spanish-language version of certain...; Spanish-language version of certain required statements. An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico...

21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drugs; Spanish-language version of certain...; Spanish-language version of certain required statements. An increasing number of medications restricted to... where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One required...

PRN 87-1: Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation)

EPA Pesticide Factsheets

This Notice requires registrants of pesticide products registered under FIFRA and applied through irrigation systems to revise the labeling for such products to include additional use directions and other statements described in this Notice.

Message on a bottle: are alcohol warning labels about cancer appropriate?

PubMed

Miller, Emma R; Ramsey, Imogen J; Baratiny, Genevieve Y; Olver, Ian N

2016-02-11

Although most Australians are unaware of the risk, there is strong evidence for a direct link between alcohol consumption and many types of cancer. Warning labels on alcohol products have been proposed as a cost-effective strategy to inform the community of this health risk. We aimed to identify how Australians might respond to such an approach. We conducted a national online survey canvassing responses to four separate cancer warning messages on labels. The graphically presented messages were informed by qualitative data from a series of focus groups among self-identified 'light-to-moderate' drinkers. For each label, participants were asked their level of agreement with impact statements about raising awareness, prompting conversation, influencing drinking behaviour and educating others about cancer risk. We analysed responses according to demographic and other factors, including self-reported drinking behaviour (using the 3-item Alcohol Use Disorder Test - AUDIT-C - scores). Approximately 1600 participants completed the survey, which was open to all Australian adults over a period of 1 month in 2014. Overall, the labels were well received, with the majority (>70 %) agreeing all labels could raise awareness and prompt conversations about the cancer risk associated with alcohol. Around 50 % or less agreed that the labels could influence drinking behaviour, but larger proportions agreed that the labels would prompt them to discuss the issue with family and friends. Although sex, AUDIT-C score and age were significantly associated with agreement on bivariate analysis, multivariate analyses demonstrated that being inclined to act upon warning label recommendations in general was the most important predictor of agreement with all of the impact statements. Having a low AUDIT-C score also predicted agreement that the labels might prompt behaviour change in friends. The findings suggest that providing detailed warnings about cancer risk on alcohol products is a viable

[The precautionary principle, research and drugs].

PubMed

Joly, P

2000-01-01

The research, in general, the medical research and the research of new drugs are following the same rules. To be fruitful, they have not to be "a priori" censured, but they have to be prudent on the means they are using and the aims they are pursuing. It's up to the researcher to explain to the public the necessity of the used means and the utility of his discovery. The public, indeed, may be not significantly informed and can be afraid by what is difficult to understand or by what is changing its customs. At the end of the pre-clinic period of research, the discovered substance has to confirm on human being its innocuity and its efficiency. At this time, the experimentation is controlled by several procedures under the control of French and European administrations. All these procedures have to be conducted according to several "Good Practices". The aims are to protect the human being, to define if the new drug is well-tolerated and efficient and what is the ratio Benefit/Risk. Even after the marketing of the new drug, the usage of the new drug is controlled (Drug Safety). So we can consider that precautionary principle is soon applied to the drug according to a very sophisticated and evolutionary mechanism. But as satisfactory it can appear, we must keep vigilant because the zero risk does not exist.

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c). ...

Cell phones and children: follow the precautionary road.

PubMed

Rosenberg, Suzanne

2013-01-01

Children are increasingly using cell phones. "Family package" deals make it easy for parents to obtain phones for their children, and the phones provide parents with the comfort of easy access to their children. However, cell phones emit radio frequency (RF) radiation (Bucher & the Committee on Appropriations, 2010). While the government has deemed RF radiation to be safe, there is no current significant research to make this claim. To determine the relationship between cell phone radiation and brain cancer requires long-term studies lasting decades and with inclusion of frequent users in the subject pool. Further, to extend the results of any study to children requires controlling for the differences between juveniles and adults regarding the composition of the head, and bone density and neural tissue. Dr. L. Hardell of the University Hospital of Sweden noted that "it is necessary to apply the precautionary principle in this situation," especially for long-term exposure that is likely to affect children (Hardell as cited in Mead, 2008, p. 1). There is cause for concern.

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2010 CFR

2010-04-01

... statement of identity sections of the applicable OTC drug monographs. For a combination drug product that... applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses... the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and...

21 CFR 352.60 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... statement of identity sections of the applicable OTC drug monographs. For a combination drug product that... applicable OTC drug monographs. (b) Indications. The labeling of the product states, under the heading “Uses... the applicable OTC drug monographs, unless otherwise stated in this paragraph. Other truthful and...

Risk analysis under uncertainty, the precautionary principle, and the new EU chemicals strategy.

PubMed

Rogers, Michael D

2003-06-01

Three categories of uncertainty in relation to risk assessment are defined; uncertainty in effect, uncertainty in cause, and uncertainty in the relationship between a hypothesised cause and effect. The Precautionary Principle (PP) relates to the third type of uncertainty. Three broad descriptions of the PP are set out, uncertainty justifies action, uncertainty requires action, and uncertainty requires a reversal of the burden of proof for risk assessments. The application of the PP is controversial but what matters in practise is the precautionary action (PA) that follows. The criteria by which the PAs should be judged are detailed. This framework for risk assessment and management under uncertainty is then applied to the envisaged European system for the regulation of chemicals. A new EU regulatory system has been proposed which shifts the burden of proof concerning risk assessments from the regulator to the producer, and embodies the PP in all three of its main regulatory stages. The proposals are critically discussed in relation to three chemicals, namely, atrazine (an endocrine disrupter), cadmium (toxic and possibly carcinogenic), and hydrogen fluoride (a toxic, high-production-volume chemical). Reversing the burden of proof will speed up the regulatory process but the examples demonstrate that applying the PP appropriately, and balancing the countervailing risks and the socio-economic benefits, will continue to be a difficult task for the regulator. The paper concludes with a discussion of the role of precaution in the management of change and of the importance of trust in the effective regulation of uncertain risks.

Social determinants that lead to poor knowledge about, and inappropriate precautionary practices towards, avian influenza among butchers in Kathmandu, Nepal

PubMed Central

2013-01-01

Background Avian influenza (AI) is a global public health threat. Understanding the knowledge that butchers have about it and the precautionary practices they take against it is crucial for designing future preparedness programs. This study aimed to identify the social determinants of knowledge and precautionary measures of AI among butchers in the Kathmandu district in Nepal. Methods The study was based on a cross-sectional study design using structured interview questionnaires and checklists to observe social determinants and the precautionary measures of 120 butchers aged 15 years and above from the Kathmandu district. Results The majority of the respondents were male (69.2%) and more than half (53.3%) were from the age group of 25–39 years (mean: 31.08, SD: ±9.82). Nearly two-thirds (61.3%) of the respondents had a ‘poor knowledge’, and the remaining had ‘some knowledge’, about AI. More than half (55.4%) of the respondents were in the category of displaying ‘poor practice’ towards AI and the remaining half were in the ‘satisfactory practice’ category. None of the respondents had ‘adequate knowledge’ or displayed ‘good practice’. The respondents in the >25 years of age group were less likely [OR 0.169; 95% CI (0.056-0.512)] compared to those in the <25 years age group to have a poor knowledge about AI; and the respondents with ‘primary education’ were more likely [OR 3.265; 95% CI (1.326-8.189)] to have a poor knowledge about AI as compared to those who had a secondary or above level of education. Respondents who did not know the correct definition of AI were more likely to follow poor practices [OR 4.265; 95% CI (1.193-15.242)]; and the respondents who did not know the risk groups associated with AI were also more likely to follow poor practices [OR 3.103; 95% CI (1.191-8.083)]. Conclusion This study points out the need to address butchers to improve their knowledge of, and more importantly their compliance with, the precautionary

A precautionary public health protection strategy for the possible risk of childhood leukaemia from exposure to power frequency magnetic fields

PubMed Central

2010-01-01

Background Epidemiological evidence showing a consistent association between the risk of childhood leukaemia and exposure to power frequency magnetic fields has been accumulating. This debate considers the additional precautionary intervention needed to manage this risk, when it exceeds the protection afforded by the exposure guidelines as recommended by the International Commission on Non-Ionizing Radiation Protection. Methods The Bradford-Hill Criteria are guidelines for evaluating the scientific evidence that low frequency magnetic fields cause childhood leukaemia. The criteria are used for assessing the strength of scientific evidence and here have been applied to considering the strength of evidence that exposures to extremely low frequency magnetic fields may increase the risk of childhood leukaemia. The applicability of precaution is considered using the risk management framework outlined in a European Commission (EC) communication on the Precautionary Principle. That communication advises that measures should be proportionate, non-discriminatory, consistent with similar measures already taken, based on an examination of the benefits and costs of action and inaction, and subject to review in the light of new scientific findings. Results The main evidence for a risk is an epidemiological association observed in several studies and meta-analyses; however, the number of highly exposed children is small and the association could be due to a combination of selection bias, confounding and chance. Corroborating experimental evidence is limited insofar as there is no clear indication of harm at the field levels implicated; however, the aetiology of childhood leukaemia is poorly understood. Taking a precautionary approach suggests that low-cost intervention to reduce exposure is appropriate. This assumes that if the risk is real, its impact is likely to be small. It also recognises the consequential cost of any major intervention. The recommendation is controversial

Environmental protection: applying the precautionary principle and proactive regulation to biotechnology.

PubMed

Richmond, Robert H

2008-08-01

Biotechnology is a broad field encompassing diverse disciplines from agriculture to zoology. Advances in research are occurring at a rapid pace, and applications that have broad implications socially, economically, ecologically and politically are emerging. Along with notable benefits, environmental consequences that affect core quality-of-life issues for present and future generations are materializing. The precautionary principle should be applied to biotechnology research, activities and products, and a strengthened, enforceable and proactive regulatory framework is needed. The environmental impacts of agriculture, aquaculture, genetically modified organisms (GMOs) and even pharmaceuticals are raising public concerns and demonstrate the need for guidance from a variety of social, economic and scientific disciplines to insure the benefits of biotechnology are enjoyed without unacceptable and irreversible environmental costs.

Theory of mind broad and narrow: reasoning about social exchange engages ToM areas, precautionary reasoning does not.

PubMed

Ermer, Elsa; Guerin, Scott A; Cosmides, Leda; Tooby, John; Miller, Michael B

2006-01-01

Baron-Cohen (1995) proposed that the theory of mind (ToM) inference system evolved to promote strategic social interaction. Social exchange--a form of co-operation for mutual benefit--involves strategic social interaction and requires ToM inferences about the contents of other individuals' mental states, especially their desires, goals, and intentions. There are behavioral and neuropsychological dissociations between reasoning about social exchange and reasoning about equivalent problems tapping other, more general content domains. It has therefore been proposed that social exchange behavior is regulated by social contract algorithms: a domain-specific inference system that is functionally specialized for reasoning about social exchange. We report an fMRI study using the Wason selection task that provides further support for this hypothesis. Precautionary rules share so many properties with social exchange rules--they are conditional, deontic, and involve subjective utilities--that most reasoning theories claim they are processed by the same neurocomputational machinery. Nevertheless, neuroimaging shows that reasoning about social exchange activates brain areas not activated by reasoning about precautionary rules, and vice versa. As predicted, neural correlates of ToM (anterior and posterior temporal cortex) were activated when subjects interpreted social exchange rules, but not precautionary rules (where ToM inferences are unnecessary). We argue that the interaction between ToM and social contract algorithms can be reciprocal: social contract algorithms requires ToM inferences, but their functional logic also allows ToM inferences to be made. By considering interactions between ToM in the narrower sense (belief-desire reasoning) and all the social inference systems that create the logic of human social interaction--ones that enable as well as use inferences about the content of mental states--a broader conception of ToM may emerge: a computational model embodying

21 CFR 333.160 - Labeling of permitted combinations of active ingredients.

Code of Federal Regulations, 2011 CFR

2011-04-01

... combination, as established in the statement of identity sections of the applicable OTC drug monographs. For a... sections of the applicable OTC drug monographs. (b) Indications. The labeling of the product states, under... the “Indications” sections of the applicable OTC drug monographs, unless otherwise stated in this...

40 CFR 600.307-86 - Fuel economy label format requirements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... § 600.209 (a) and (b), (iii) The fuel pump logo, and (iv) The phrase “Compare this [vehicle/truck] to... the next higher integer value. (iii)(A) A statement: “For comparison shopping, all [vehicles/trucks...) If manufacturer chooses to enlarge the label from that depicted in appendix VIII the logo and the...

10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2014 CFR

2014-01-01

... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

Code of Federal Regulations, 2013 CFR

2013-01-01

... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

Economic motivation of households to undertake private precautionary measures against floods

NASA Astrophysics Data System (ADS)

Kreibich, H.; Christenberger, S.; Schwarze, R.

2011-02-01

Flood damage is on the increase due to a combination of growing vulnerability and a changing climate. This trend can be mitigated only through significantly improved flood risk management which, alongside the efforts of public authorities, will include improvements in the mitigation measures adopted by private households. Economically "reasonable" efforts to self-insure and self-protect should be expected from households before the government steps in with publicly-funded relief programmes. To gain a deeper understanding of the benefits of households' precautionary measures, telephone interviews with private home owners were conducted in the Elbe and Danube catchments in Germany after the floods of 2002 and again after the floods in 2005 and 2006. Only detached, solid single-family houses were included in this study, which is based on 759 interviews. In addition, market-based cost assessments were solicited based on a "model building". Expert interviews and a literature review - including catalogues and price lists for building materials and household appliances - were used as back-up information for the cost assessments. The comparison of costs and benefits shows that large investments, such as building a sealed cellar, are only economically efficient if the building is flooded very frequently, that is, if it is located in a high flood risk area. In such areas it would be preferable in economic terms not to build a new house at all - or else to build a house without a cellar. Small investments, however, such as oil tank protection, can prevent serious damage at low cost. Such investments are still profitable even if the building is flooded every 50 years or less on average. It could be argued that these low-cost measures should be made mandatory through the enforcement of building codes. Financial incentives built into insurance contracts coupled with limits set on governmental relief programmes would provide an economic motivation for people to invest in

Precautionary policies in local government: green chemistry and safer alternatives.

PubMed

Raphael, Debbie O; Geiger, Chris A

2011-01-01

Local governments like the City and County of San Francisco have shouldered the burden of toxic chemicals released into the environment through the substantial costs of health care, environmental cleanup, and infrastructure to purify drinking water, manage wastewater, and manage solid waste. Cities can no longer afford to wait for federal regulation to prevent toxic chemicals from appearing in products used locally. San Francisco's Precautionary Principle Policy calls on the City to act on early warning signs of harm and to use the best available science to identify safer alternatives. Under its umbrella, a wide array of policy tools have been utilized including financial incentives through procurement contracts, certification and promotion of safer business practices, requirements for information disclosure, and bans and restrictions on the sale of products when safer alternatives are readily available. These policies can often become the models for regional, state, and national change.

Food Allergen Labeling and Purchasing Habits in the United States and Canada.

PubMed

Marchisotto, Mary Jane; Harada, Laurie; Kamdar, Opal; Smith, Bridget M; Waserman, Susan; Sicherer, Scott; Allen, Katie; Muraro, Antonella; Taylor, Steve; Gupta, Ruchi S

Mandatory labeling of products with top allergens has improved food safety for consumers. Precautionary allergen labeling (PAL), such as "may contain" or "manufactured on shared equipment," are voluntarily placed by the food industry. To establish knowledge of PAL and its impact on purchasing habits by food-allergic consumers in North America. Food Allergy Research & Education and Food Allergy Canada surveyed consumers in the United States and Canada on purchasing habits of food products featuring different types of PAL. Associations between respondents' purchasing behaviors and individual characteristics were estimated using multiple logistic regression. Of 6684 participants, 84.3% (n = 5634) were caregivers of a food-allergic child and 22.4% had food allergy themselves. Seventy-one percent reported a history of experiencing a severe allergic reaction. Buying practices varied on the basis of PAL wording; 11% of respondents purchased food with "may contain" labeling, whereas 40% purchased food that used "manufactured in a facility that also processes." Twenty-nine percent of respondents were unaware that the law requires labeling of priority food allergens. Forty-six percent were either unsure or incorrectly believed that PAL is required by law. Thirty-seven percent of respondents thought PAL was based on the amount of allergen present. History of a severe allergic reaction decreased the odds of purchasing foods with PAL. Almost half of consumers falsely believed that PAL was required by law. Up to 40% surveyed consumers purchased products with PAL. Understanding of PAL is poor, and improved awareness and guidelines are needed to help food-allergic consumers purchase food safely. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Nutrition Labeling and Education Act of 1989. Hearing before the Committee on Labor and Human Resources. United States Senate, One Hundred First Congress, First Session.

ERIC Educational Resources Information Center

Congress of the U.S., Washington, DC. Senate Committee on Labor and Human Resources.

This hearing on the Nutrition Labeling and Education Act of 1989, S. 1425, which requires mandatory nutrition labels on all food products regulated by the Food and Drug Administration, covered specific details on labeling procedures which will enable consumers to make intelligent choices on food selection. Prepared statements are included from…

Precaution or Integrated Responsibility Approach to Nanovaccines in Fish Farming? A Critical Appraisal of the UNESCO Precautionary Principle.

PubMed

Myhr, Anne Ingeborg; Myskja, Bjørn K

2011-04-01

Nanoparticles have multifaceted advantages in drug administration as vaccine delivery and hence hold promises for improving protection of farmed fish against diseases caused by pathogens. However, there are concerns that the benefits associated with distribution of nanoparticles may also be accompanied with risks to the environment and health. The complexity of the natural and social systems involved implies that the information acquired in quantified risk assessments may be inadequate for evidence-based decisions. One controversial strategy for dealing with this kind of uncertainty is the precautionary principle. A few years ago, an UNESCO expert group suggested a new approach for implementation of the principle. Here we compare the UNESCO principle with earlier versions and explore the advantages and disadvantages by employing the UNESCO version to the use of PLGA nanoparticles for delivery of vaccines in aquaculture. Finally, we discuss whether a combined scientific and ethical analysis that involves the concept of responsibility will enable approaches that can provide a supplement to the precautionary principle as basis for decision-making in areas of scientific uncertainty, such as the application of nanoparticles in the vaccination of farmed fish.

10 CFR Appendix A to Subpart S of... - Compliance Statement for Metal Halide Lamp Ballasts

Code of Federal Regulations, 2011 CFR

2011-01-01

... Equipment: Metal Halide Lamp Ballasts Manufacturer's or Private Labeler's Name and Address: [Company name] (“the company”) submits this Compliance Statement under 10 CFR Part 431 (Energy Efficiency Program for... Reports submitted by or on behalf of this company. All information in such Certification Report(s) and in...

The changes in hazard classification and product notification procedures of the new European CLP and Cosmetics Regulations.

PubMed

de Groot, Ronald; Brekelmans, Pieter; Herremans, Joke; Meulenbelt, Jan

2010-01-01

The United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN-GHS) is developed to harmonize the criteria for hazard communication worldwide. The European Regulation on classification, labeling, and packaging of substances and mixtures [CLP Regulation (European Commission, EC) No 1272/2008] will align the existing European Union (EU) legislation to the UN-GHS. This CLP Regulation entered into force on January 20, 2009, and will, after a transitional period, replace the current rules on classification, labeling, and packaging for supply and use in Europe. Both old and new classifications will exist simultaneously until 2010 for substances and until 2015 for mixtures. The new hazard classification will introduce new health hazard classes and categories, with associated new hazard pictograms, signal words, Hazard (H)-statements, and Precautionary (P)-statements as labeling elements. Furthermore, the CLP Regulation will affect the notification of product information on hazardous products to poisons information centers (PICs). At this moment product notification widely varies in procedures and requirements across EU Member States. Article 45 of the CLP Regulation contains a provision stating that the EC will (by January 20, 2012) review the possibility of harmonizing product notification. The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) is recognized as an important stakeholder. For cosmetic products, the new Cosmetics Regulation will directly implement a new procedure for electronic cosmetic product notification in all EU Member States. Both the CLP Regulation and the Cosmetics Regulation will develop their own product notification procedure within different time frames. Harmonization of notification procedures for both product groups, especially a common electronic format, would be most effective from a cost-benefit viewpoint and would be welcomed by PICs.

Nutrition marketing on food labels.

PubMed

Colby, Sarah E; Johnson, LuAnn; Scheett, Angela; Hoverson, Bonita

2010-01-01

This research sought to determine how often nutrition marketing is used on labels of foods that are high in saturated fat, sodium, and/or sugar. All items packaged with food labels (N = 56,900) in all 6 grocery stores in Grand Forks, ND were surveyed. Marketing strategy, nutrient label information, if the product was fruit/or milk based, and target age. Frequency distributions were computed. Forty-nine percent of all products contained nutrition marketing and of those, 48% had both nutrition marketing and were high in saturated fat, sodium and/or sugar (11%, 17%, and 31% respectively). Seventy-one percent of products marketed to children had nutrition marketing. Of those, 59% were high in saturated fat, sodium and/or sugar content, with more than half being high in sugar. The most commonly used nutrition marketing statements were "good source of calcium", "reduced/low/fat free", and "food company's health symbol". Nutrition marketing is commonly used on products high in saturated fat, sodium and/or sugar and is more often used on products marketed toward children than products marketed toward adults. Current food industry symbols may not be helping consumers select foods low in saturated fat, sodium or sugar. Published by Elsevier Inc.

21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2010 CFR

2010-04-01

... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...

21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2014 CFR

2014-04-01

... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...

21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2012 CFR

2012-04-01

... because of usefulness in reducing or maintaining body weight shall bear: (1) Nutrition labeling in... in § 101.13(q)(2) of this chapter for soft drinks, a food may be labeled with terms such as “diet... “diet” that clearly shows that the food is offered solely for a dietary use other than regulating body...

Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement

PubMed Central

Diamanti-Kandarakis, Evanthia; Bourguignon, Jean-Pierre; Giudice, Linda C.; Hauser, Russ; Prins, Gail S.; Soto, Ana M.; Zoeller, R. Thomas; Gore, Andrea C.

2009-01-01

There is growing interest in the possible health threat posed by endocrine-disrupting chemicals (EDCs), which are substances in our environment, food, and consumer products that interfere with hormone biosynthesis, metabolism, or action resulting in a deviation from normal homeostatic control or reproduction. In this first Scientific Statement of The Endocrine Society, we present the evidence that endocrine disruptors have effects on male and female reproduction, breast development and cancer, prostate cancer, neuroendocrinology, thyroid, metabolism and obesity, and cardiovascular endocrinology. Results from animal models, human clinical observations, and epidemiological studies converge to implicate EDCs as a significant concern to public health. The mechanisms of EDCs involve divergent pathways including (but not limited to) estrogenic, antiandrogenic, thyroid, peroxisome proliferator-activated receptor γ, retinoid, and actions through other nuclear receptors; steroidogenic enzymes; neurotransmitter receptors and systems; and many other pathways that are highly conserved in wildlife and humans, and which can be modeled in laboratory in vitro and in vivo models. Furthermore, EDCs represent a broad class of molecules such as organochlorinated pesticides and industrial chemicals, plastics and plasticizers, fuels, and many other chemicals that are present in the environment or are in widespread use. We make a number of recommendations to increase understanding of effects of EDCs, including enhancing increased basic and clinical research, invoking the precautionary principle, and advocating involvement of individual and scientific society stakeholders in communicating and implementing changes in public policy and awareness. PMID:19502515

Interrelationships between the precautionary principle, prediction strategies, and sustainable use of the planet.

PubMed Central

Cairns, John

2003-01-01

In this article, I examine the relationships between new concepts of human activity in the environment and several prevention strategies used to plot a course toward sustainable use. Natural capitalism and industrial ecology are relatively new concepts that provide a framework for environmental management. Although the precautionary principle puts into policy a determination to prevent environmental damage before it occurs, natural capitalism and industrial ecology go beyond the prevention of environmental damage to the optimization of environmental interactions. The risk assessment tools necessary for preventive management continue to be essential. However, additional tools are needed to go beyond prevention to optimization. A holistic, scientific approach to the human place within the environment is needed, including both interdisciplinary and large-scale research. PMID:12782485

What's in a Name? Evaluating the Effects of the "Sex Offender" Label on Public Opinions and Beliefs.

PubMed

Harris, Andrew J; Socia, Kelly M

2016-10-01

Particularly over the past two decades, the terms sex offender and juvenile sex offender (JSO) have attained increasingly common usage in media and public policy discourse. Although often applied as factual descriptors, the labels may evoke strong subconscious associations with a population commonly presumed to be compulsive, at high risk of re-offense, and resistant to rehabilitation. Such associations, in turn, may exert considerable impact on expressions of support for certain policies as well as public beliefs and opinions about adults and youth who have perpetrated sexual offenses. The current study systematically evaluated the impact of the "sex offender" and "JSO" labels through series of items administered to a nationally stratified and matched sample from across the United States. The study employed an experimental design, in which one group of participants (n = 498) ranked their levels of agreement with a series of statements utilizing these labels, and a control group (n = 502) responded to a matched set of statements substituting the labels with more neutral descriptive language. Findings support the hypothesis that use of the "sex offender" label strengthens public support for policies directed at those who have perpetrated sexual crimes, including public Internet disclosure, residency restrictions, and social networking bans. The "JSO" label is demonstrated to produce particularly robust effects, enhancing support for policies that subject youth to public Internet notification and affecting beliefs about youths' propensity to re-offend as adults. Implications for public policy, media communication, and research are explored and discussed. © The Author(s) 2014.

77 FR 5696 - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-06

... products in the SNS that are approved, licensed, or cleared for marketing.\\2\\ Labels on investigational... the implementation of this rule, when investigational products were ultimately approved for marketing... that any statements concerning preemption can be justified under legal principles governing preemption...

Position Statements, Issue Briefs, Resolutions and Consensus Statements. Revised

ERIC Educational Resources Information Center

National Association of School Nurses (NJ1), 2012

2012-01-01

This article presents position statements, issue briefs, and resolutions and consensus statements of the National Association of School Nurses (NASN). The Position Statements include: (1) Allergy/Anaphylaxis Management in the School Setting; (2) Caseload Assignments; (3) Child Mortality in the School Setting; (4) Chronic Health Conditions, Managed…

Herbal products containing Hibiscus sabdariffa L., Crataegus spp., and Panax spp.: Labeling and safety concerns.

PubMed

Nunes, Maria Antónia; Rodrigues, Francisca; Alves, Rita C; Oliveira, Maria Beatriz P P

2017-10-01

Herbs have been used from ancient times for infusion preparation based on their potential health effects. In particular, the consumption of Hibiscus sabdariffa L., Crataegus spp. and Panax spp. has been largely associated to cardiovascular benefits. In this work, the label information of 52 herbal products for infusion preparation containing the referred herbs was analyzed and discussed, taking into consideration the European Union regulation for herbal products, which intends to protect public health and harmonize the legal framework in Member States. Details about the cardiovascular-related statements and warning notifications about consumption were considered. Also, regulatory issues and possible herb-drug interactions were explored and discussed. A total of 14 of the 52 herbal products selected presented health claims/statements on the label. Hibiscus was present in the majority of the products and, in some cases, it was mentioned only in the ingredients list and not on the product front-of-pack. Despite the promising outcomes of these plants to modulate cardiovascular risk markers, consumers with some sort of cardiovascular dysfunction and/or under medication treatments should be aware to carefully analyze the labels and consult additional information related to these herbal products. Manufacturers have also a huge responsibility to inform consumers by presenting awareness statements. Lastly, health professionals must advise and alert their patients about possible interactions that could occur between the concomitant consumption of drugs and herbs. Overall, there is still a real need of additional studies and clinical trials to better understand herbs effects and establish a science-based guidance to assess their safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effect of lie labelling on children's evaluation of selfish, polite, and altruistic lies.

PubMed

Cheung, Him; Chan, Yawen; Tsui, Wan Chi Gigi

2016-09-01

This study investigates how 5- and 6-year-olds' evaluations of selfish, polite, and altruistic lies change as a result of whether these false statements are explicitly labelled as lies. We are also interested in how interpretive theory of mind may correlate with such evaluations with and without a lie label. Our results showed that labelling lowered children's evaluations for the polite and altruistic lies, but not for the selfish lies. Interpretive theory of mind correlated positively with the evaluation difference between the polite and altruistic lies and that between the selfish and altruistic lies in the label, but not in the non-label condition. Correlation between the selfish and altruistic lies and that between the polite and altruistic lies were stronger with than without labelling, after controlling for age, and verbal and non-verbal intelligence. We conclude that lie labelling biases children towards more negative evaluations for non-selfish lies and makes them see lies of different motives as more similar. If a lie label is applied, whether lies of different motives are still evaluated differently depends on interpretive theory of mind, which reflects the child's ability to represent and allow different interpretations of an ambiguous reality. © 2016 The British Psychological Society.

Medical devices; ovarian adnexal mass assessment score test system; labeling; black box restrictions. Final rule.

PubMed

2011-12-30

The Food and Drug Administration (FDA) is amending the regulation classifying ovarian adnexal mass assessment score test systems to restrict these devices so that a prescribed warning statement that addresses a risk identified in the special controls guidance document must be in a black box and must appear in all labeling, advertising, and promotional material. The black box warning mitigates the risk to health associated with off-label use as a screening test, stand-alone diagnostic test, or as a test to determine whether or not to proceed with surgery.

Precautionary Savings in Mexico: Evidence from the Mexican Health and Aging Study

PubMed Central

Velandia Naranjo, Durfari; van Gameren, Edwin

2016-01-01

Precautionary saving is the additional saving done by individuals to protect them financially in situations of uncertainty and reduce their vulnerability for negative shocks that may affect their consumption levels. This paper investigates the existence and extent of savings motivated by precaution in Mexico for people aged between 50 and 75, using data from the Mexican Health and Ageing Study 2003. The empirical strategy is based on a test of the direct relationship between the accumulated wealth and the uncertainty generated by the social security status, in particular the availability of health insurance, accounting also for the expectation to receive a retirement pension. The endogeneity-corrected estimates do not yield results that unequivocally support the existence of private savings as a risk protection mechanism, implying that the public protection system has an important role in reducing the vulnerability of the population studied. PMID:27698512

ACHP | ACHP Policy Statements

Science.gov Websites

Search skip specific nav links Home arrow The National Historic Preservation Program arrow ACHP Policy Statements ACHP Policy Statements ACHP Policy Statement on Controversial Commemorative Works ACHP Policy Statement on Historic Preservation and Community Revitalizations Policy Statement on the ACHP's Interaction

29 CFR 1910.1045 - Acrylonitrile.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., equipment failure, rupture of containers, or failure of control equipment, which results in an unexpected... decontamination is completed. (l) Waste disposal. AN waste, scrap, debris, bags, containers, or equipment shall be.... (3) Labels. (i) The employer shall assure that precautionary labels are affixed to all containers of...

Uncertainty, imprecision, and the precautionary principle in climate change assessment.

PubMed

Borsuk, M E; Tomassini, L

2005-01-01

Statistical decision theory can provide useful support for climate change decisions made under conditions of uncertainty. However, the probability distributions used to calculate expected costs in decision theory are themselves subject to uncertainty, disagreement, or ambiguity in their specification. This imprecision can be described using sets of probability measures, from which upper and lower bounds on expectations can be calculated. However, many representations, or classes, of probability measures are possible. We describe six of the more useful classes and demonstrate how each may be used to represent climate change uncertainties. When expected costs are specified by bounds, rather than precise values, the conventional decision criterion of minimum expected cost is insufficient to reach a unique decision. Alternative criteria are required, and the criterion of minimum upper expected cost may be desirable because it is consistent with the precautionary principle. Using simple climate and economics models as an example, we determine the carbon dioxide emissions levels that have minimum upper expected cost for each of the selected classes. There can be wide differences in these emissions levels and their associated costs, emphasizing the need for care when selecting an appropriate class.

Secondhand Smoke in the Operating Room? Precautionary Practices Lacking for Surgical Smoke

PubMed Central

Steege, Andrea L.; Boiano, James M.; Sweeney, Marie H.

2016-01-01

Background Consensus organizations, government bodies, and healthcare organization guidelines recommend that surgical smoke be evacuated at the source by local exhaust ventilation (LEV) (i.e., smoke evacuators or wall suctions with inline filters). Methods Data are from NIOSH’s Health and Safety Practices Survey of Healthcare Workers module on precautionary practices for surgical smoke. Results Four thousand five hundred thirty-three survey respondents reported exposure to surgical smoke: 4,500 during electrosurgery; 1,392 during laser surgery procedures. Respondents were mainly nurses (56%) and anesthesiologists (21%). Only 14% of those exposed during electrosurgery reported LEV was always used during these procedures, while 47% reported use during laser surgery. Those reporting LEV was always used were also more likely to report training and employer standard procedures addressing the hazards of surgical smoke. Few respondents reported use of respiratory protection. Conclusions Study findings can be used to raise awareness of the marginal use of exposure controls and impediments for their use. PMID:27282626

Smokers' and E-Cigarette Users' Perceptions about E-Cigarette Warning Statements.

PubMed

Wackowski, Olivia A; Hammond, David; O'Connor, Richard J; Strasser, Andrew A; Delnevo, Cristine D

2016-06-30

Cigarette warning labels are important sources of risk information, but warning research for other tobacco products is limited. This study aimed to gauge perceptions about warnings that may be used for e-cigarettes. We conducted six small focus groups in late 2014/early 2015 with adult current e-cigarette users and cigarette-only smokers. Participants rated and discussed their perceptions of six e-cigarette warning statements, and warnings in two existing Vuse and MarkTen e-cigarette ads. Participants were open to e-cigarette warnings and provided the strongest reactions to statements warning that e-liquid/e-vapor or e-cigarettes can be poisonous, contain toxins, or are "not a safe alternative to smoking". However, many also noted that these statements were exaggerated, potentially misleading, and could scare smokers away from reducing their harm by switching to e-cigarettes. Opinions on the Food and Drug Administration's proposed nicotine addiction warning and warnings that e-cigarettes had not been approved for smoking cessation or had unknown health effects were mixed. Participants perceived MarkTen's advertisement warning to be stronger and more noticeable than Vuse's. Care should be taken in developing e-cigarette warnings given their relative recentness and potential for harm reduction compared to other tobacco products. Additional research, including with varied audiences, would be instructive.

Efficacy and consumer preferences for different approaches to calorie labeling on menus.

PubMed

Pang, Jocelyn; Hammond, David

2013-01-01

To evaluate the efficacy and consumer preferences of calorie labeling on menus. Between-group experiment. Participants were randomized to view menu items according to 1 of 4 experimental conditions: no calorie information, calorie-only information, calorie plus health statement (HS), and calorie plus the Physical Activity Scale. Participants selected a snack and then rated menus from all conditions on the level of understanding and perceived effectiveness. University of Waterloo, Canada. A total of 213 undergraduate university students recruited from classrooms. The calorie amount of menu selection and ratings of understandability and perceived effectiveness. Linear regression models and chi-square tests. Participants who selected items from menus without calorie information selected snacks with higher calorie amounts than participants in the calorie-only condition (P = .002) and the calorie plus HS condition (P = .001). The calorie plus HS menu was perceived as most understandable and the calorie plus calorie plus Physical Activity Scale menu was perceived as most effective in helping to promote healthy eating. Calorie labeling on menus may assist consumers in making healthier choices, with consumer preference for menus that include contextual health statements. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule.

PubMed

2007-12-19

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.

Ethical and legal framework and regulation for off-label use: European perspective.

PubMed

Lenk, Christian; Duttge, Gunnar

2014-01-01

For more than 20 years the off-label use of drugs has been an essential part of the ethical and legal considerations regarding the international regulation of drug licensing. Despite a number of regulatory initiatives in the European Union, there seems to remain a largely unsatisfactory situation following a number of critical descriptions and statements from actors in the field. The present article gives an overview of the ethical and legal framework and developments in European countries and identifies existing problems and possible pathways for solutions in this important regulatory area. In addition to the presentation of the ethical and legal foundations, some attention is given to criticisms from medical practitioners to the current handling of off-label drug use. The review also focuses on the situation confronted by patients and physicians when off-label prescriptions are necessary. Through legal descriptions from a number of countries, possible solutions for future discussion of European health care policy are selected and explained.

[Off-label drug use of the misoprostol in gynecology & obstetrics: From a medico-economics benefit to a potential legal risk].

PubMed

Decamps-Mini, D; Pelofi, J; Treisser, A

2015-06-01

The scandal of the Mediator® case led the legislature to take measures in order to regulate off-label drugs prescriptions. Indeed the law issued in December 29th, 2011 on strengthening the safety of drugs and all derivative health products came to pave the way for an "over-cautious" practice of medicine in line with the precautionary principle erected as a constitutional principle. The supervision of off-label prescribing has had a direct impact on the exercise of the medical profession and has resurrected the issues related to the freedom of prescription, the obligation to provide information to patients and in general their whole responsibility. It is important to mention that the prescribing act is part of the freedom and the strict prerogative of those skilled in the art: the physician in this case. The off-label prescription is commonly accepted in certain specialties, such as anesthesia and intensive care, oncology or pediatrics where it is even subject of a memorandum of use because of concerns regarding the availability of forms adapted to children. However, the physician must ensure that no appropriate therapeutic alternative is available and inform the patient, fundamental principle of the right to respect for the will of the person. Off-label use of the prostaglandin-E1 analogue misoprostol in obstetrics and gynecology is a good example. In fact, this drug obtained a marketing authorization for the treatment or prevention of peptic ulcers and other stomach disorders, is commonly used off-label when inducing labour or intrauterine device insertion. These are the issues that need to be clarify and carefully assessed in order to help physicians to understand the impact of the law and the state of the jurisprudence on the exercise of their profession. Copyright © 2015. Published by Elsevier SAS.

Smokers’ and E-Cigarette Users’ Perceptions about E-Cigarette Warning Statements

PubMed Central

Wackowski, Olivia A.; Hammond, David; O’Connor, Richard J.; Strasser, Andrew A.; Delnevo, Cristine D.

2016-01-01

Cigarette warning labels are important sources of risk information, but warning research for other tobacco products is limited. This study aimed to gauge perceptions about warnings that may be used for e-cigarettes. We conducted six small focus groups in late 2014/early 2015 with adult current e-cigarette users and cigarette-only smokers. Participants rated and discussed their perceptions of six e-cigarette warning statements, and warnings in two existing Vuse and MarkTen e-cigarette ads. Participants were open to e-cigarette warnings and provided the strongest reactions to statements warning that e-liquid/e-vapor or e-cigarettes can be poisonous, contain toxins, or are “not a safe alternative to smoking”. However, many also noted that these statements were exaggerated, potentially misleading, and could scare smokers away from reducing their harm by switching to e-cigarettes. Opinions on the Food and Drug Administration’s proposed nicotine addiction warning and warnings that e-cigarettes had not been approved for smoking cessation or had unknown health effects were mixed. Participants perceived MarkTen’s advertisement warning to be stronger and more noticeable than Vuse’s. Care should be taken in developing e-cigarette warnings given their relative recentness and potential for harm reduction compared to other tobacco products. Additional research, including with varied audiences, would be instructive. PMID:27376310

Textual Analysis of General Surgery Residency Personal Statements: Topics and Gender Differences.

PubMed

Ostapenko, Laura; Schonhardt-Bailey, Cheryl; Sublette, Jessica Walling; Smink, Douglas S; Osman, Nora Y

Applicants to US general surgery residency training programs submit standardized applications. Applicants use the personal statement to express their individual rationale for a career in surgery. Our research explores common topics and gender differences within the personal statements of general surgery applicants. We analyzed the electronic residency application service personal statements of 578 applicants (containing 3,82,405 words) from Liaison Committee on Medical Education-accredited medical schools to a single ACGME-accredited general surgery program using an automated textual analysis program to identify common topics and gender differences. Using a recursive algorithm, the program identified common words and clusters, grouping them into topic classes, which are internally validated. We identified and labeled 8 statistically significant topic classes through independent review: "my story," "the art of surgery," "clinical vignettes," "why I love surgery," "residency program characteristics," "working as a team," "academics and research," and "global health and policy." Although some classes were common to all applications, we also identified gender-specific differences. Notably, women were significantly more likely than men to be represented within the class of "working as a team." (p < 0.01) Furthermore, men were significantly more likely than women to be represented within the class of "clinical vignettes" (p < 0.01). Applying textual analysis to a national cohort, we identified common narrative topics in the personal statements of aspiring general surgeons, noting differences between the statements of men and women. Women were more likely to discuss surgery as a team endeavor while men were more likely to focus on the details of their surgical experiences. Our work mirrors what has been found in social psychology research on gender-based differences in how men and women communicate their career goals and aspirations in other competitive professional

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

Wireless smart meters and public acceptance: the environment, limited choices, and precautionary politics.

PubMed

Hess, David J; Coley, Jonathan S

2014-08-01

Wireless smart meters (WSMs) promise numerous environmental benefits, but they have been installed without full consideration of public acceptance issues. Although societal-implications research and regulatory policy have focused on privacy, security, and accuracy issues, our research indicates that health concerns have played an important role in the public policy debates that have emerged in California. Regulatory bodies do not recognize non-thermal health effects for non-ionizing electromagnetic radiation, but both homeowners and counter-experts have contested the official assurances that WSMs pose no health risks. Similarities and differences with the existing social science literature on mobile phone masts are discussed, as are the broader political implications of framing an alternative policy based on an opt-out choice. The research suggests conditions under which health-oriented precautionary politics can be particularly effective, namely, if there is a mandatory technology, a network of counter-experts, and a broader context of democratic contestation.

Applying the precautionary principle to nutrition and cancer.

PubMed

Gonzales, Joseph F; Barnard, Neal D; Jenkins, David J A; Lanou, Amy J; Davis, Brenda; Saxe, Gordon; Levin, Susan

2014-01-01

Research has identified certain foods and dietary patterns that are associated with reduced cancer risk and improved survival after cancer diagnosis. This research has formed the basis for dietary guidance issued by cancer organizations. Unfortunately, gaps within nutrition research have made it difficult to make recommendations in some areas. This review specifies suggested dietary guidance in which evidence of a dietary influence on cancer risk is substantial, even if not conclusive. Evidence summaries within the review are based on the 2007 report of the World Cancer Research Fund/American Institute for Cancer Research. This review also describes advantages and disadvantages of following the suggested dietary guidance and includes putative mechanisms involved in cancer progression. Suggested dietary guidance where evidence is sufficiently compelling include (1) limiting or avoiding dairy products to reduce the risk of prostate cancer; (2) limiting or avoiding alcohol to reduce the risk of cancers of the mouth, pharynx, larynx, esophagus, colon, rectum, and breast; (3) avoiding red and processed meat to reduce the risk of cancers of the colon and rectum; (4) avoiding grilled, fried, and broiled meats to reduce the risk of cancers of the colon, rectum, breast, prostate, kidney, and pancreas; (5) consumption of soy products during adolescence to reduce the risk of breast cancer in adulthood and to reduce the risk of recurrence and mortality for women previously treated for breast cancer; and (6) emphasizing fruits and vegetables to reduce risk of several common forms of cancer. By adopting the precautionary principle for nutrition research, this review aims to serve as a useful tool for practitioners and patients.

Category labels versus feature labels: category labels polarize inferential predictions.

PubMed

Yamauchi, Takashi; Yu, Na-Yung

2008-04-01

What makes category labels different from feature labels in predictive inference? This study suggests that category labels tend to make inductive reasoning polarized and homogeneous. In two experiments, participants were shown two schematic pictures of insects side by side and predicted the value of a hidden feature of one insect on the basis of the other insect. Arbitrary verbal labels were shown above the two pictures, and the meanings of the labels were manipulated in the instructions. In one condition, the labels represented the category membership of the insects, and in the other conditions, the same labels represented attributes of the insects. When the labels represented category membership, participants' responses became substantially polarized and homogeneous, indicating that the mere reference to category membership can modify reasoning processes.

Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries.

PubMed

Hallersten, Anna; Fürst, Walter; Mezzasalma, Riccardo

2016-06-01

In the European Union, labels (Summaries of Product Characteristics, SmPCs) of biosimilars and their reference products are in many instances almost identical (following a generic approach) despite different data requirements for the authorization of biosimilars and generics. To understand physicians' preferences on type and detail of information in the biosimilar label and their use of information sources when prescribing biologics including biosimilars, EuropaBio surveyed 210 physicians across seven European countries. Among surveyed physicians, 90.5% use the label frequently or occasionally as an information source and 87.2% deemed a clear statement on the origin of data helpful or very helpful. When comparing excerpts from the label of an authorized biosimilar and modified texts with additional information, 78.1-82.9% preferred the samples with additional information. This survey shows that the label is an appropriate vehicle for providing physicians with information about biologics and that physicians prefer more product-specific information in the biosimilar label. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2014 CFR

2014-01-01

... criteria set forth for such foods in § 381.460. (d) “Reduced calorie” foods and other comparative claims. A... misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative...

78 FR 13082 - Draft Environmental Impact Report/Environmental Impact Statement/Environmental Impact Statement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-26

... Impact Statement/ Environmental Impact Statement, Upper Truckee River and Marsh Restoration Project, El... Statement (EIR/EIS/EIS) for the Upper Truckee River Restoration and Marsh Restoration Project (Project). The... prepare email comments for the Project. The public hearings will be held at 128 Market Street, Stateline...

20 CFR 335.3 - Execution of statement of sickness and supplemental doctor's statement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false Execution of statement of sickness and supplemental doctor's statement. 335.3 Section 335.3 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT SICKNESS BENEFITS § 335.3 Execution of statement of...

20 CFR 335.3 - Execution of statement of sickness and supplemental doctor's statement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 20 Employees' Benefits 1 2013-04-01 2012-04-01 true Execution of statement of sickness and supplemental doctor's statement. 335.3 Section 335.3 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT SICKNESS BENEFITS § 335.3 Execution of statement of...

20 CFR 335.3 - Execution of statement of sickness and supplemental doctor's statement.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 20 Employees' Benefits 1 2011-04-01 2011-04-01 false Execution of statement of sickness and supplemental doctor's statement. 335.3 Section 335.3 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT SICKNESS BENEFITS § 335.3 Execution of statement of...

20 CFR 335.3 - Execution of statement of sickness and supplemental doctor's statement.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true Execution of statement of sickness and supplemental doctor's statement. 335.3 Section 335.3 Employees' Benefits RAILROAD RETIREMENT BOARD REGULATIONS UNDER THE RAILROAD UNEMPLOYMENT INSURANCE ACT SICKNESS BENEFITS § 335.3 Execution of statement of...

40 CFR 156.64 - Signal word.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Signal word. 156.64 Section 156.64... REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.64 Signal word. (a... signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to...

40 CFR 156.64 - Signal word.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 24 2011-07-01 2011-07-01 false Signal word. 156.64 Section 156.64... REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.64 Signal word. (a... signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to...

40 CFR 156.64 - Signal word.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 25 2012-07-01 2012-07-01 false Signal word. 156.64 Section 156.64... REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.64 Signal word. (a... signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to...

40 CFR 156.64 - Signal word.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 25 2013-07-01 2013-07-01 false Signal word. 156.64 Section 156.64... REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.64 Signal word. (a... signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to...

40 CFR 156.64 - Signal word.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 24 2014-07-01 2014-07-01 false Signal word. 156.64 Section 156.64... REQUIREMENTS FOR PESTICIDES AND DEVICES Human Hazard and Precautionary Statements § 156.64 Signal word. (a... signal word, reflecting the highest Toxicity Category (Category I is the highest toxicity category) to...

Substance Abuse. Policy Statement.

ERIC Educational Resources Information Center

National Collaboration for Youth, Washington, DC.

This paper presents the policy statement on substance abuse from the National Collaboration for Youth (NCY). The policy statement section lists programs and activities supported by the NCY. A section on background includes a statement of the issue of substance abuse. Areas examined in this section include alcohol abuse and drunk driving among…

78 FR 59659 - Correction to the Final Environmental Impact Statement/Overseas Environmental Impact Statement...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-27

... Statement/Overseas Environmental Impact Statement for Hawaii-Southern California Training and Testing AGENCY... Final Environmental Impact Statement (EIS)/Overseas EIS (OEIS) for Hawaii- Southern California Training.... Navy Training and Testing Activities in the Hawaii- Southern California Training and Testing Study Area...

Don’t Like RDF Reification? Making Statements about Statements Using Singleton Property

PubMed Central

Nguyen, Vinh; Bodenreider, Olivier; Sheth, Amit

2015-01-01

Statements about RDF statements, or meta triples, provide additional information about individual triples, such as the source, the occurring time or place, or the certainty. Integrating such meta triples into semantic knowledge bases would enable the querying and reasoning mechanisms to be aware of provenance, time, location, or certainty of triples. However, an efficient RDF representation for such meta knowledge of triples remains challenging. The existing standard reification approach allows such meta knowledge of RDF triples to be expressed using RDF by two steps. The first step is representing the triple by a Statement instance which has subject, predicate, and object indicated separately in three different triples. The second step is creating assertions about that instance as if it is a statement. While reification is simple and intuitive, this approach does not have formal semantics and is not commonly used in practice as described in the RDF Primer. In this paper, we propose a novel approach called Singleton Property for representing statements about statements and provide a formal semantics for it. We explain how this singleton property approach fits well with the existing syntax and formal semantics of RDF, and the syntax of SPARQL query language. We also demonstrate the use of singleton property in the representation and querying of meta knowledge in two examples of Semantic Web knowledge bases: YAGO2 and BKR. Our experiments on the BKR show that the singleton property approach gives a decent performance in terms of number of triples, query length and query execution time compared to existing approaches. This approach, which is also simple and intuitive, can be easily adopted for representing and querying statements about statements in other knowledge bases. PMID:25750938

Reading and understanding financial statements.

PubMed

White, Joseph P

2005-01-01

Feeling comfortable reading and understanding financial statements is critical to the success of healthcare executives and physicians involved in management. Businesses use three primary financial statements: a balance sheet represents the equation, Assets = Liabilities + Equity; an income statement represents the equation, Revenues - Expenses = Net Income; a statement of cash flows reports all sources and uses of cash during the represented period. The balance sheet expresses financial indicators at one particular moment in time, whereas the income statement and the statement of cash flows show activity that occurred over a stretch of time. Additional information is disclosed in attached footnotes and other supplementary materials. There are two ways to prepare financial statements. Cash-basis accounting recognizes revenue when it is received and expenses when they are paid. Accrual-basis accounting recognizes revenue when it is earned and expenses when they are incurred. Although cash-basis is acceptable, periodically using the accrual method reveals important information about receivables and liabilities that could otherwise remain hidden. Become more engaged with your financial statements by spending time reading them, tracking key performance indicators, and asking accountants and financial advisors questions. This will help you better understand your business and build a successful future.

What's in a Name? The Incorrect Use of Case Series as a Study Design Label in Studies Involving Dogs and Cats.

PubMed

Sargeant, J M; O'Connor, A M; Cullen, J N; Makielski, K M; Jones-Bitton, A

2017-07-01

Study design labels are used to identify relevant literature to address specific clinical and research questions and to aid in evaluating the evidentiary value of research. Evidence from the human healthcare literature indicates that the label "case series" may be used inconsistently and inappropriately. Our primary objective was to determine the proportion of studies in the canine and feline veterinary literature labeled as case series that actually corresponded to descriptive cohort studies, population-based cohort studies, or other study designs. Our secondary objective was to identify the proportion of case series in which potentially inappropriate inferential statements were made. Descriptive evaluation of published literature. One-hundred published studies (from 19 journals) labeled as case series. Studies were identified by a structured literature search, with random selection of 100 studies from the relevant citations. Two reviewers independently characterized each study, with disagreements resolved by consensus. Of the 100 studies, 16 were case series. The remaining studies were descriptive cohort studies (35), population-based cohort studies (36), or other observational or experimental study designs (13). Almost half (48.8%) of the case series or descriptive cohort studies, with no control group and no formal statistical analysis, included inferential statements about the efficacy of treatment or statistical significance of potential risk factors. Authors, peer-reviewers, and editors should carefully consider the design elements of a study to accurately identify and label the study design. Doing so will facilitate an understanding of the evidentiary value of the results. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

EMC: Mission Statement

Science.gov Websites

EMC: Mission Statement Mesoscale Modeling Branch Mission Statement The Mesoscale Modeling Branch , advanced numerical techniques applied to mesoscale modeling problems, parameterization of mesoscale new observing systems. The Mesoscale Modeling Branch publishes research results in various media for

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY 2016 OUTPATIENT GLUCOSE MONITORING CONSENSUS STATEMENT.

PubMed

Bailey, Timothy S; Grunberger, George; Bode, Bruce W; Handelsman, Yehuda; Hirsch, Irl B; Jovanovič, Lois; Roberts, Victor Lawrence; Rodbard, David; Tamborlane, William V; Walsh, John

2016-02-01

This document represents the official position of the American Association of Clinical Endocrinologists and American College of Endocrinology. Where there were no randomized controlled trials or specific U.S. FDA labeling for issues in clinical practice, the participating clinical experts utilized their judgment and experience. Every effort was made to achieve consensus among the committee members. Position statements are meant to provide guidance, but they are not to be considered prescriptive for any individual patient and cannot replace the judgment of a clinician.

17 CFR 230.252 - Offering statement.

Code of Federal Regulations, 2010 CFR

2010-04-01

... misleading. (b) Paper, printing, language and pagination. The requirements for offering statements are the... directors or other governing body, and each selling security holder shall sign the offering statement. If a... an amendment to the offering statement that contains the following language: This offering statement...

17 CFR 230.252 - Offering statement.

Code of Federal Regulations, 2012 CFR

2012-04-01

... misleading. (b) Paper, printing, language and pagination. The requirements for offering statements are the... directors or other governing body, and each selling security holder shall sign the offering statement. If a... an amendment to the offering statement that contains the following language: This offering statement...

17 CFR 230.252 - Offering statement.

Code of Federal Regulations, 2011 CFR

2011-04-01

... misleading. (b) Paper, printing, language and pagination. The requirements for offering statements are the... directors or other governing body, and each selling security holder shall sign the offering statement. If a... an amendment to the offering statement that contains the following language: This offering statement...

17 CFR 230.252 - Offering statement.

Code of Federal Regulations, 2014 CFR

2014-04-01

... misleading. (b) Paper, printing, language and pagination. The requirements for offering statements are the... directors or other governing body, and each selling security holder shall sign the offering statement. If a... an amendment to the offering statement that contains the following language: This offering statement...

17 CFR 230.252 - Offering statement.

Code of Federal Regulations, 2013 CFR

2013-04-01

... misleading. (b) Paper, printing, language and pagination. The requirements for offering statements are the... directors or other governing body, and each selling security holder shall sign the offering statement. If a... an amendment to the offering statement that contains the following language: This offering statement...

78 FR 33122 - Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0081] Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of Principles and Policy for the Agreement State Program AGENCY: Nuclear.... Nuclear Regulatory Commission (NRC) is proposing revisions to its policy statements on Agreement State...

7 CFR 1218.51 - Financial statements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false Financial statements. 1218.51 Section 1218.51... § 1218.51 Financial statements. (a) As requested by the Secretary, the Council shall prepare and submit financial statements to the Secretary on a periodic basis. Each such financial statement shall include, but...

Objectives of Financial Statements. Report of the Study Group on the Objectives of Financial Statements.

ERIC Educational Resources Information Center

American Inst. of Certified Public Accountants, New York, NY.

This report discusses the objectives of financial statements. Emphasis is placed on the function of objectives; users, their goals, and their information needs; the primary enterprise goal and earning power; accountability and financial statements; financial statements--reporting on the goal attainment of business enterprises; financial…

Teaching Philosophy Statements

ERIC Educational Resources Information Center

Faryadi, Qais

2015-01-01

This article examines the rationale for my teaching philosophy. Using a personal perspective, I explain my objectives, mission, and vision in writing my philosophy of teaching statements. This article also creates a road map and reference points for educators who want to write their own teaching philosophy statements to help them make informed…

Institutional VVM Statements on Websites

ERIC Educational Resources Information Center

Calder, Wm. B.

2011-01-01

Educational leaders rely on compelling statements of institutional beliefs, strategic direction, and purpose (i.e., values, vision, and mission statements or VVM statements) as the three major pillars by which to launch new program/service initiatives, to enhance academic and administrative operations, and to chart sustainable options in building…

3 CFR - Presidential Signing Statements

Code of Federal Regulations, 2010 CFR

2010-01-01

... 3 The President 1 2010-01-01 2010-01-01 false Presidential Signing Statements Presidential Documents Other Presidential Documents Memorandum of March 9, 2009 Presidential Signing Statements Memorandum for the Heads of Executive Departments and Agencies For nearly two centuries, Presidents have issued statements addressing constitutional or other...

78 FR 50118 - Policy Statement on Adequacy and Compatibility of Agreement State Programs; Statement of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-16

... Agreement State Programs; Statement of Principles and Policy for the Agreement State Program AGENCY: Nuclear... Agreement State Programs'' and the ``Statement of Principles and Policy for the Agreement State Programs... No. ML12202B165. The proposed revisions to the ``Statement of Principles and Policy for the Agreement...

Secondhand smoke in the operating room? Precautionary practices lacking for surgical smoke.

PubMed

Steege, Andrea L; Boiano, James M; Sweeney, Marie H

2016-11-01

Consensus organizations, government bodies, and healthcare organization guidelines recommend that surgical smoke be evacuated at the source by local exhaust ventilation (LEV) (i.e., smoke evacuators or wall suctions with inline filters). Data are from NIOSH's Health and Safety Practices Survey of Healthcare Workers module on precautionary practices for surgical smoke. Four thousand five hundred thirty-three survey respondents reported exposure to surgical smoke: 4,500 during electrosurgery; 1,392 during laser surgery procedures. Respondents were mainly nurses (56%) and anesthesiologists (21%). Only 14% of those exposed during electrosurgery reported LEV was always used during these procedures, while 47% reported use during laser surgery. Those reporting LEV was always used were also more likely to report training and employer standard procedures addressing the hazards of surgical smoke. Few respondents reported use of respiratory protection. Study findings can be used to raise awareness of the marginal use of exposure controls and impediments for their use. Am. J. Ind. Med. 59:1020-1031, 2016. Published 2016. This article is a U.S. Government work and is in the public domain in the USA. Published 2016. This article is a U.S. Government work and is in the public domain in the USA.

Have personal statements become impersonal? An evaluation of personal statements in anesthesiology residency applications.

PubMed

Max, Bryan A; Gelfand, Brian; Brooks, Meredith R; Beckerly, Rena; Segal, Scott

2010-08-01

To evaluate personal statements submitted to a major academic anesthesiology program to determine the prevalence of common features and overall subjective quality, and to survey anesthesiology program directors as to how they utilized these statements during the resident selection process. Structured analysis of de-identified personal statements and Internet-based survey of program directors. Large academic anesthesiology training program. 670 applicant personal statements and academic anesthesiology program directors. Prevalence of 13 specific essay features and 8 quality ratings were calculated for the essays and correlated with other aspects of the residency application, as abstracted from the Electronic Residency Application Service (ERAS) files. A 6-question survey regarding use of personal statements was collected from program directors. 70 of 131 program directors queried responded to our survey. Interest in physiology and pharmacology, enjoyment of a hands-on specialty, and desire to comfort anxious patients were each mentioned in more than half of the essays. Candidates invited for an interview had essays that received higher quality ratings than essays of those not invited (P = 0.02 to P < 0.0001). Higher quality ratings were also strongly associated with graduation from a U.S. or Canadian medical school, applicant file screening score, female gender, and younger age. Interrater reliability was good (kappa 0.75-0.99 for structural features, and 0.45-0.65 for quality features). More than 90% of program directors found proper use of English to be a somewhat or very important feature of the essay. Only 41% found the personal statement to be very or somewhat important in selecting candidates for interview invitations. However, over 90% stated that they used the statements during actual interviews with invited applicants. The data showed a high prevalence of common features found within personal statements and a general ambivalence amongst those program

An In vitro evaluation of the reliability of QR code denture labeling technique

PubMed Central

Poovannan, Sindhu; Jain, Ashish R.; Krishnan, Cakku Jalliah Venkata; Chandran, Chitraa R.

2016-01-01

Statement of Problem: Positive identification of the dead after accidents and disasters through labeled dentures plays a key role in forensic scenario. A number of denture labeling methods are available, and studies evaluating their reliability under drastic conditions are vital. Aim: This study was conducted to evaluate the reliability of QR (Quick Response) Code labeled at various depths in heat-cured acrylic blocks after acid treatment, heat treatment (burns), and fracture in forensics. It was an in vitro study. Materials and Methods: This study included 160 specimens of heat-cured acrylic blocks (1.8 cm × 1.8 cm) and these were divided into 4 groups (40 samples per group). QR Codes were incorporated in the samples using clear acrylic sheet and they were assessed for reliability under various depths, acid, heat, and fracture. Data were analyzed using Chi-square test, test of proportion. Results: The QR Code inclusion technique was reliable under various depths of acrylic sheet, acid (sulfuric acid 99%, hydrochloric acid 40%) and heat (up to 370°C). Results were variable with fracture of QR Code labeled acrylic blocks. Conclusion: Within the limitations of the study, by analyzing the results, it was clearly indicated that the QR Code technique was reliable under various depths of acrylic sheet, acid, and heat (370°C). Effectiveness varied in fracture and depended on the level of distortion. This study thus suggests that QR Code is an effective and simpler denture labeling method. PMID:28123284

Developing consumer-centered, nonprescription drug labeling a study in acetaminophen.

PubMed

King, Jennifer P; Davis, Terry C; Bailey, Stacy Cooper; Jacobson, Kara L; Hedlund, Laurie A; Di Francesco, Lorenzo; Parker, Ruth M; Wolf, Michael S

2011-06-01

In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that <50% of participants routinely examine product label information. Only 31% know acetaminophen is in Tylenol®. The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

The implications of the precautionary principle for biological monitoring

NASA Astrophysics Data System (ADS)

Macgarvin, M.

1995-03-01

Marine biological monitoring programmes frequently attempt to determine “safe” levels of contamination, based on assumptions about the assimilative capacity of the environment. This paper argues that such assumptions lack scientific rigour, and do not form the basis upon which a precautionary policy can be built. It notes the problems associated with assessing toxicological effects, but centres its attention on the crucial (yet far less discussed) weaknesses in theoretical ecology that make it extremely unlikely that biological monitoring can determine safe levels of contamination that leave ecosystems unaffected. It is argued that many marine biologists, if pressed, would concede these shortcomings but believe that, in the face of the technical difficulties and high costs of pollution prevention, we have no choice but to use such methods. This paper argues, with examples, that pollution prevention, often with considerable economic savings, is becoming a reality for even the most problematic substances. The difficulty is that the development of “clean production” methods lie outside the sphere of interest of those carrying out monitoring, so that measures that attempt to determine safe levels of contamination continue to be advocated. This gulf needs to be bridged so that the continuation of monitoring programmes that are part of dilute and disperse policies become regarded as inappropriate, indeed unethical. The paper concludes that this does not mean the end of marine monitoring. Instead, reliable methods for assessing physical levels of contamination will be required to determine whether the reduction targets set—as part of the introduction of clean production—are being met. Formidable difficulties will remain, requiring a precautious approach. Nevertheless, monitoring will no longer carry the burden of attempting to demonstrate that a particular level of environmental contamination is safe, which is currently destroying its scientific credibility.

Quantifying risk: the role of absolute and relative measures in interpreting risk of adverse reactions from product labels of antipsychotic medications.

PubMed

Citrome, Leslie

2009-09-01

Pharmaceutical product labeling as approved by regulatory agencies include statements of adverse event risk. Product labels include descriptive statements such as whether events are uncommon or rare, as well as percentage occurrence for more common events. In addition tables are provided with the frequencies of the latter events for both product and placebo as observed in clinical trials. Competing products are not mentioned in a specific drug's product labeling but indirect comparisons can be made using the corresponding label information for the alternate product. Two types of tools are easily used for this purpose: absolute measures such as number needed to harm (NNH), and relative measures such as relative risk increase (RRI). The calculations for both of these types of quantitative measures are presented using as examples the oral first-line second-generation antipsychotic medications. Among three sample outcomes selected a priori, akathisia, weight gain, and discontinuation from a clinical trial because of an adverse reaction, there appears to be differences among the different antipsychotics versus placebo. Aripiprazole was associated with the highest risk for akathisia, particularly when used as adjunctive treatment of major depressive disorder (NNH 5, 95% CI 4-7; RRI 525%, 95% CI 267%-964%). Although insufficient information was available in product labeling to calculate the CI, olanzapine was associated with the highest risk for weight gain of at least 7% from baseline (NNH 6, RRI 640% for adults; NNH 4, RRI 314% for adolescents), and quetiapine for the indication of bipolar depression was associated with the highest risk of discontinuation from a clinical trial because of an adverse reaction (NNH 8, RRI 265% for 600 mg/d; NNH 15, RRI 137% for 300 mg/d). In conclusion, with certain limitations, it is possible for the clinician to extract information from medication product labeling regarding the frequency with which certain adverse reactions can be

Participation of racial/ethnic groups in clinical trials and race-related labeling: a review of new molecular entities approved 1995-1999.

PubMed Central

Evelyn, B.; Toigo, T.; Banks, D.; Pohl, D.; Gray, K.; Robins, B.; Ernat, J.

2001-01-01

Few recent data are available from formal evaluations of approved new drug applications to address perceptions that racial and ethnic groups are under-represented in clinical trials of new drugs. This study reviews racial and ethnic group participation in clinical trials and race-related labeling for new molecular entities approved during a five-year period by the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). This was a retrospective review of FDA medical officers' reviews of clinical trial protocols and product labeling for 185 new molecular entities (NME's) approved by CDER between January 1,1995, and December 31, 1999. Enrollment data were obtained from the reviews and tabulated according to race/ethnicity. The approved product labeling was searched for statements related to product testing in various racial/ethnic groups. All data were compiled and analyzed using Microsoft Access. This study quantifies the participation of racial/ethnic groups in clinical trials by year and therapeutic category. Additionally, the study categorizes labeling based on the types of effects described as related to race/ethnicity. Racial and ethnic groups appear to participate in clinical trials to varying degrees. African Americans participated in trials to the greatest extent; however, their participation steadily declined from 12% in 1995 to 6% in 1999. Among trials known to be conducted only in the U.S., African-American participation is comparable to their representation in the U.S. population. In all cases, participants designated as Hispanic appear to be far below their representation in the population. Some differences in participation for all racial and ethnic groups are seen when comparisons from year-to-year or among drug classes are made. Labeling for 45% (84/185) of the products contained some statement about race, although in only 8% (15/185) were differences related to race described. Fifty percent (50%) of the effects were

Meaning of counterfactual statements in quantum physics

NASA Astrophysics Data System (ADS)

Stapp, Henry P.

1998-10-01

David Mermin suggests that my recent proof pertaining to quantum nonlocality is undermined by an essential ambiguity pertaining to the meaning of counterfactual statements in quantum physics. The ambiguity he cites arises from his imposition of a certain criterion for the meaningfulness of such counterfactual statements. That criterion conflates the meaning of a counterfactual statement with the details of a proof of its validity in such a way as to make the meaning of such a statement dependent upon the context in which it occurs. That dependence violates the normal demand in logic that the meaning of a statement be defined by the words in the statement itself, not by the context in which the statement occurs. My proof conforms to that normal requirement. I describe the context-independent meaning within my proof of the counterfactual statements in question.

Attitudes and preferences of consumers toward food allergy labeling practices by diagnosis of food allergies.

PubMed

Ju, Se-Young; Park, Jong-Hwan; Kwak, Tong-Kyoung; Kim, Kyu-Earn

2015-10-01

The objective of this study was to investigate food allergens and prevalence rates of food allergies, followed by comparison of consumer attitudes and preferences regarding food allergy labeling by diagnosis of food allergies. A total of 543 individuals living in Seoul and Gyeonggi area participated in the survey from October 15 to 22 in 2013. The results show that the prevalence of doctor-diagnosed food allergies was 17.5%, whereas 6.4% of respondents self-reported food allergies. The most common allergens of doctor-diagnosed and self-reported food allergy respondents were peaches (30.3%) and eggs (33.3%), respectively, followed by peanuts, cow's milk, and crab. Regarding consumer attitudes toward food labeling, checking food allergens as an item was only significantly different between allergic and non-allergic respondents among all five items (P < 0.001). All respondents reported that all six items (bold font, font color, box frame, warning statement, front label, and addition of potential allergens) were necessary for an improved food allergen labeling system. PLSR analysis determined that the doctor-diagnosed group and checking of food allergens were positively correlated, whereas the non-allergy group was more concerned with checking product brands. An effective food labeling system is very important for health protection of allergic consumers. Additionally, government agencies must develop policies regarding prevalence of food allergies in Korea. Based on this information, the food industry and government agencies should provide clear and accurate food labeling practices for consumers.

76 FR 54637 - Board Policy Statements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-01

...The Farm Credit Administration (FCA) Board recently undertook its 5-year review of FCA Board policy statements. This review resulted in revisions to 14 policy statements that are mostly technical, grammatical, or syntactical. However, a few of the revisions add clarity to the policy statements and other revisions incorporate changes required either by new laws or by changes in the functional statement of operations for some FCA offices.

17 CFR 250.28 - Inconsistent financial statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Accounts § 250.28 Inconsistent financial statements. Except as otherwise authorized or required by the..., financial statements which are inconsistent with the book accounts of such company or financial statements... prevent the distribution or publication of reasonable condensations or of unaudited financial statements...

12 CFR 327.2 - Certified statements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... ASSESSMENTS In General § 327.2 Certified statements. (a) Required. (1) The certified statement shall also be...) The quarterly certified statement invoice shall reflect the institution's risk assignment, assessment base, assessment computation, and assessment amount, for each quarterly assessment period. (b...

16 CFR 500.24 - Supplemental statements.

Code of Federal Regulations, 2010 CFR

2010-01-01

....24 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR... part shall prohibit supplemental statements, at locations other than the principal display panel... regarded as supplemental net quantity statements and shall be located on the principal display panel...

Conflict of interest reporting by authors involved in promotion of off-label drug use: an analysis of journal disclosures.

PubMed

Kesselheim, Aaron S; Wang, Bo; Studdert, David M; Avorn, Jerry

2012-01-01

Litigation documents reveal that pharmaceutical companies have paid physicians to promote off-label uses of their products through a number of different avenues. It is unknown whether physicians and scientists who have such conflicts of interest adequately disclose such relationships in the scientific publications they author. We collected whistleblower complaints alleging illegal off-label marketing from the US Department of Justice and other publicly available sources (date range: 1996-2010). We identified physicians and scientists described in the complaints as having financial relationships with defendant manufacturers, then searched Medline for articles they authored in the subsequent three years. We assessed disclosures made in articles related to the off-label use in question, determined the frequency of adequate disclosure statements, and analyzed characteristics of the authors (specialty, author position) and articles (type, connection to off-label use, journal impact factor, citation count/year). We identified 39 conflicted individuals in whistleblower complaints. They published 404 articles related to the drugs at issue in the whistleblower complaints, only 62 (15%) of which contained an adequate disclosure statement. Most articles had no disclosure (43%) or did not mention the pharmaceutical company (40%). Adequate disclosure rates varied significantly by article type, with commentaries less likely to have adequate disclosure compared to articles reporting original studies or trials (adjusted odds ratio [OR] = 0.10, 95%CI = 0.02-0.67, p = 0.02). Over half of the authors (22/39, 56%) made no adequate disclosures in their articles. However, four of six authors with ≥ 25 articles disclosed in about one-third of articles (range: 10/36-8/25 [28%-32%]). One in seven authors identified in whistleblower complaints as involved in off-label marketing activities adequately disclosed their conflict of interest in subsequent journal publications. This is a much

46 CFR 504.7 - Environmental impact statements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 9 2010-10-01 2010-10-01 false Environmental impact statements. 504.7 Section 504.7... POLICY ANALYSIS § 504.7 Environmental impact statements. (a) General. (1) An environmental impact... environmental impact statements. (1) A draft environmental impact statement (DEIS) will initially be prepared in...

32 CFR 651.23 - Environmental impact statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 4 2010-07-01 2010-07-01 true Environmental impact statement. 651.23 Section...) ENVIRONMENTAL QUALITY ENVIRONMENTAL ANALYSIS OF ARMY ACTIONS (AR 200-2) Records and Documents § 651.23 Environmental impact statement. An Environmental Impact statement (EIS) is a detailed written statement required...

48 CFR 37.602 - Performance work statement.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Performance work statement... CATEGORIES OF CONTRACTING SERVICE CONTRACTING Performance-Based Acquisition 37.602 Performance work statement. (a) A Performance work statement (PWS) may be prepared by the Government or result from a Statement...

Meaning of counterfactual statements in quantum physics

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

Stapp, H.P.

1998-10-01

David Mermin suggests that my recent proof pertaining to quantum nonlocality is undermined by an essential ambiguity pertaining to the meaning of counterfactual statements in quantum physics. The ambiguity he cites arises from his imposition of a certain criterion for the meaningfulness of such counterfactual statements. That criterion conflates the meaning of a counterfactual statement with the details of a proof of its validity in such a way as to make the meaning of such a statement dependent upon the context in which it occurs. That dependence violates the normal demand in logic that the meaning of a statement bemore » defined by the words in the statement itself, not by the context in which the statement occurs. My proof conforms to that normal requirement. I describe the context-independent meaning within my proof of the counterfactual statements in question. {copyright} {ital 1998 American Association of Physics Teachers.}« less

Probiotics for Trauma Patients: Should We Be Taking a Precautionary Approach?

PubMed

Vitko, Heather A; Sekula, L Kathleen; Schreiber, Martin A

The use of probiotics in the hospital setting is largely understudied and highly controversial. Probiotics are living organisms that, when taken internally, can produce an immunomodulating effect and improve the gastrointestinal (GI) mucosal barrier. Although used for centuries by healthy individuals for GI health, their use in the hospital setting is now gaining wide attention for the prevention of infectious complications such as antibiotic-associated diarrhea, Clostridium difficile infections, multiple-organ dysfunction syndrome, and ventilator-associated pneumonia. However, current understanding of the efficacy of probiotics in the acute care setting is confounded by the inconsistencies in the literature with regard to the strain of probiotic being studied, optimal dosage, and timing and duration of dosing, which make the formulation of clinical practice guidelines difficult. Although the safety of probiotics has been confirmed when used for the prevention and treatment of certain diseases, practitioners remain hesitant to administer them to their patients, citing the lack of high-quality studies clearly demonstrating efficacy and safety. Infection is a cause of late death in trauma patients, but only recently has research been conducted on the use of probiotics specifically for the prevention of hospital-acquired infections in trauma patients. In the face of such limited but promising research, is it reasonable to use probiotics for the prevention of infection in hospitalized trauma patients and improve outcomes? Use of the "precautionary principle" may be useful in this instance.

GASB Statement No. 3 Guides Deposits, Investments.

ERIC Educational Resources Information Center

Barker, Linda A.

1986-01-01

Discusses an April 1986 Governmental Accounting Standards Board statement concerning disclosures of repurchase and reverse repurchase agreements. The statement tries to help financial statement users assess the risks a goverment entity takes when investing public funds. It is effective for financial statement periods ending after December 15,…

42 CFR 460.208 - Financial statements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Financial statements. 460.208 Section 460.208... ELDERLY (PACE) Data Collection, Record Maintenance, and Reporting § 460.208 Financial statements. (a... must submit a certified financial statement that includes appropriate footnotes. (2) The financial...

Position Statement on Active Outdoor Play

PubMed Central

Tremblay, Mark S.; Gray, Casey; Babcock, Shawna; Barnes, Joel; Costas Bradstreet, Christa; Carr, Dawn; Chabot, Guylaine; Choquette, Louise; Chorney, David; Collyer, Cam; Herrington, Susan; Janson, Katherine; Janssen, Ian; Larouche, Richard; Pickett, William; Power, Marlene; Sandseter, Ellen Beate Hansen; Simon, Brenda; Brussoni, Mariana

2015-01-01

A diverse, cross-sectorial group of partners, stakeholders and researchers, collaborated to develop an evidence-informed Position Statement on active outdoor play for children aged 3–12 years. The Position Statement was created in response to practitioner, academic, legal, insurance and public debate, dialogue and disagreement on the relative benefits and harms of active (including risky) outdoor play. The Position Statement development process was informed by two systematic reviews, a critical appraisal of the current literature and existing position statements, engagement of research experts (N = 9) and cross-sectorial individuals/organizations (N = 17), and an extensive stakeholder consultation process (N = 1908). More than 95% of the stakeholders consulted strongly agreed or somewhat agreed with the Position Statement; 14/17 participating individuals/organizations endorsed it; and over 1000 additional individuals and organizations requested their name be listed as a supporter. The final Position Statement on Active Outdoor Play states: “Access to active play in nature and outdoors—with its risks— is essential for healthy child development. We recommend increasing children’s opportunities for self-directed play outdoors in all settings—at home, at school, in child care, the community and nature.” The full Position Statement provides context for the statement, evidence supporting it, and a series of recommendations to increase active outdoor play opportunities to promote healthy child development. PMID:26062040

Position Statement on Active Outdoor Play.

PubMed

Tremblay, Mark S; Gray, Casey; Babcock, Shawna; Barnes, Joel; Bradstreet, Christa Costas; Carr, Dawn; Chabot, Guylaine; Choquette, Louise; Chorney, David; Collyer, Cam; Herrington, Susan; Janson, Katherine; Janssen, Ian; Larouche, Richard; Pickett, William; Power, Marlene; Sandseter, Ellen Beate Hansen; Simon, Brenda; Brussoni, Mariana

2015-06-08

A diverse, cross-sectorial group of partners, stakeholders and researchers, collaborated to develop an evidence-informed Position Statement on active outdoor play for children aged 3-12 years. The Position Statement was created in response to practitioner, academic, legal, insurance and public debate, dialogue and disagreement on the relative benefits and harms of active (including risky) outdoor play. The Position Statement development process was informed by two systematic reviews, a critical appraisal of the current literature and existing position statements, engagement of research experts (N=9) and cross-sectorial individuals/organizations (N=17), and an extensive stakeholder consultation process (N=1908). More than 95% of the stakeholders consulted strongly agreed or somewhat agreed with the Position Statement; 14/17 participating individuals/organizations endorsed it; and over 1000 additional individuals and organizations requested their name be listed as a supporter. The final Position Statement on Active Outdoor Play states: "Access to active play in nature and outdoors--with its risks--is essential for healthy child development. We recommend increasing children's opportunities for self-directed play outdoors in all settings--at home, at school, in child care, the community and nature." The full Position Statement provides context for the statement, evidence supporting it, and a series of recommendations to increase active outdoor play opportunities to promote healthy child development.

It's Time to Implement GASB Statement 54

ERIC Educational Resources Information Center

Heinfeld, Gary; Nuehring, Bert

2012-01-01

In February 2009, the Governmental Accounting Standards Board (GASB) issued Statement No. 54, "Find Balance Reporting and Governmental Fund Type Definitions." This statement changes how a fund balance is classified on the face of the government fund financial statements and refines the definitions for government fund types. The statement's…

Flow-aggregated traffic-driven label mapping in label-switching networks

NASA Astrophysics Data System (ADS)

Nagami, Kenichi; Katsube, Yasuhiro; Esaki, Hiroshi; Nakamura, Osamu

1998-12-01

Label switching technology enables high performance, flexible, layer-3 packet forwarding based on the fixed length label information mapped to the layer-3 packet stream. A Label Switching Router (LSR) forwards layer-3 packets based on their label information mapped to the layer-3 address information as well as their layer-3 address information. This paper evaluates the required number of labels under traffic-driven label mapping policy using the real backbone traffic traces. The evaluation shows that the label mapping policy requires a large number of labels. In order to reduce the required number of labels, we propose a label mapping policy which is a traffic-driven label mapping for the traffic toward the same destination network. The evaluation shows that the proposed label mapping policy requires only about one tenth as many labels compared with the traffic-driven label mapping for the host-pair packet stream,and the topology-driven label mapping for the destination network packet stream.

Nutrition Label Viewing during a Food-Selection Task: Front-of-Package Labels vs Nutrition Facts Labels.

PubMed

Graham, Dan J; Heidrick, Charles; Hodgin, Katie

2015-10-01

Earlier research has identified consumer characteristics associated with viewing Nutrition Facts labels; however, little is known about those who view front-of-package nutrition labels. Front-of-package nutrition labels might appeal to more consumers than do Nutrition Facts labels, but it might be necessary to provide consumers with information about how to locate and use these labels. This study quantifies Nutrition Facts and front-of-package nutrition label viewing among American adult consumers. Attention to nutrition information was measured during a food-selection task. One hundred and twenty-three parents (mean age=38 years, mean body mass index [calculated as kg/m(2)]=28) and one of their children (aged 6 to 9 years) selected six foods from a university laboratory-turned-grocery aisle. Participants were randomized to conditions in which front-of-package nutrition labels were present or absent, and signage explaining front-of-package nutrition labels was present or absent. Adults' visual attention to Nutrition Facts labels and front-of-package nutrition labels was objectively measured via eye-tracking glasses. To examine whether there were significant differences in the percentages of participants who viewed Nutrition Facts labels vs front-of-package nutrition labels, McNemar's tests were conducted across all participants, as well as within various sociodemographic categories. To determine whether hypothesized factors, such as health literacy and education, had stronger relationships with front-of-package nutrition label vs Nutrition Facts label viewing, linear regression assessed the magnitude of relationships between theoretically and empirically derived factors and each type of label viewing. Overall, front-of-package nutrition labels were more likely to be viewed than Nutrition Facts labels; however, for all subgroups, higher rates of front-of-package nutrition label viewership occurred only when signage was present drawing attention to the presence and

18 CFR 706.405 - Supplementary statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 18 Conservation of Power and Water Resources 2 2011-04-01 2011-04-01 false Supplementary statements. 706.405 Section 706.405 Conservation of Power and Water Resources WATER RESOURCES COUNCIL... Supplementary statements. Changes in, or additions to, the information contained in an employee's statement of...

18 CFR 706.405 - Supplementary statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 18 Conservation of Power and Water Resources 2 2010-04-01 2010-04-01 false Supplementary statements. 706.405 Section 706.405 Conservation of Power and Water Resources WATER RESOURCES COUNCIL... Supplementary statements. Changes in, or additions to, the information contained in an employee's statement of...

18 CFR 706.405 - Supplementary statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 18 Conservation of Power and Water Resources 2 2014-04-01 2014-04-01 false Supplementary statements. 706.405 Section 706.405 Conservation of Power and Water Resources WATER RESOURCES COUNCIL... Supplementary statements. Changes in, or additions to, the information contained in an employee's statement of...

7 CFR 4280.140 - Financial statements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 15 2010-01-01 2010-01-01 false Financial statements. 4280.140 Section 4280.140... Efficiency Improvements Program Section B. Guaranteed Loans § 4280.140 Financial statements. (a) The... financial statements, at its sole discretion when the Agency is concerned about the applicant's credit risk. ...

29 CFR 1910.1018 - Inorganic arsenic.

Code of Federal Regulations, 2010 CFR

2010-07-01

... container in the change-room which prevents dispersion of inorganic arsenic outside the container. (vi) The.... (vii) The employer shall assure that the containers of contaminated protective clothing and equipment... apply precautionary labels to all shipping and storage containers of inorganic arsenic, and to all...

Drug Free Campus Statement.

ERIC Educational Resources Information Center

Casper Coll., WY.

These three brief documents, a policy statement, a summary of pertinent laws on alcohol and illegal drugs, and a substance addiction specialist curriculum description, taken together describe the Casper College (Wyoming) drug and alcohol abuse prevention program. The policy statement briefly summarizes the health risks associated with drug and…

Co-Labeling for Multi-View Weakly Labeled Learning.

PubMed

Xu, Xinxing; Li, Wen; Xu, Dong; Tsang, Ivor W

2016-06-01

It is often expensive and time consuming to collect labeled training samples in many real-world applications. To reduce human effort on annotating training samples, many machine learning techniques (e.g., semi-supervised learning (SSL), multi-instance learning (MIL), etc.) have been studied to exploit weakly labeled training samples. Meanwhile, when the training data is represented with multiple types of features, many multi-view learning methods have shown that classifiers trained on different views can help each other to better utilize the unlabeled training samples for the SSL task. In this paper, we study a new learning problem called multi-view weakly labeled learning, in which we aim to develop a unified approach to learn robust classifiers by effectively utilizing different types of weakly labeled multi-view data from a broad range of tasks including SSL, MIL and relative outlier detection (ROD). We propose an effective approach called co-labeling to solve the multi-view weakly labeled learning problem. Specifically, we model the learning problem on each view as a weakly labeled learning problem, which aims to learn an optimal classifier from a set of pseudo-label vectors generated by using the classifiers trained from other views. Unlike traditional co-training approaches using a single pseudo-label vector for training each classifier, our co-labeling approach explores different strategies to utilize the predictions from different views, biases and iterations for generating the pseudo-label vectors, making our approach more robust for real-world applications. Moreover, to further improve the weakly labeled learning on each view, we also exploit the inherent group structure in the pseudo-label vectors generated from different strategies, which leads to a new multi-layer multiple kernel learning problem. Promising results for text-based image retrieval on the NUS-WIDE dataset as well as news classification and text categorization on several real-world multi

78 FR 39736 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-02

... Labeling; Notification Procedures for Statements on Dietary Supplements AGENCY: Food and Drug... information entitled ``Food Labeling; Notification Procedures for Statements on Dietary Supplements'' to OMB... collection of information entitled ``Food Labeling; Notification Procedures for Statements on Dietary...

40 CFR 82.108 - Placement of warning statement.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 40 Protection of Environment 18 2014-07-01 2014-07-01 false Placement of warning statement. 82.108....108 Placement of warning statement. The warning statement shall be placed so as to satisfy the requirement of the Act that the warning statement be “clearly legible and conspicuous.” The warning statement...

40 CFR 82.108 - Placement of warning statement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 17 2010-07-01 2010-07-01 false Placement of warning statement. 82.108....108 Placement of warning statement. The warning statement shall be placed so as to satisfy the requirement of the Act that the warning statement be “clearly legible and conspicuous.” The warning statement...

40 CFR 82.108 - Placement of warning statement.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 40 Protection of Environment 18 2013-07-01 2013-07-01 false Placement of warning statement. 82.108....108 Placement of warning statement. The warning statement shall be placed so as to satisfy the requirement of the Act that the warning statement be “clearly legible and conspicuous.” The warning statement...

40 CFR 82.108 - Placement of warning statement.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 18 2012-07-01 2012-07-01 false Placement of warning statement. 82.108....108 Placement of warning statement. The warning statement shall be placed so as to satisfy the requirement of the Act that the warning statement be “clearly legible and conspicuous.” The warning statement...

40 CFR 82.108 - Placement of warning statement.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 40 Protection of Environment 17 2011-07-01 2011-07-01 false Placement of warning statement. 82.108....108 Placement of warning statement. The warning statement shall be placed so as to satisfy the requirement of the Act that the warning statement be “clearly legible and conspicuous.” The warning statement...

Biological Awareness: Statements for Self-Discovery.

ERIC Educational Resources Information Center

Edington, D.W.; Cunningham, Lee

This guide to biological awareness through guided self-discovery is based on 51 single focus statements concerning the human body. For each statement there are explanations of the underlying physiological principles and suggested activities and discussion ideas to encourage understanding of the statement in terms of the human body's functions,…