Protections for Subjects in Human Research Involving Pesticides (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Protections for Subjects in Human Research Involving Pesticides (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Protections for Subjects in Human Research Involving Pesticides (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 EPA is finalizing narrowly tailored amendments to the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendments also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). The amendments make no changes to the current Federal Policy for the Protection of Human Subjects (the "Common Rule"), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies. This book contains: - The complete text of the Protections for Subjects in Human Research Involving Pesticides (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section




Protections for Subjects in Human Research (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Protections for Subjects in Human Research (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Protections for Subjects in Human Research (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 With this final rule, EPA bans research for pesticides involving intentional exposure of human subjects, when the subjects are pregnant women or children. The rule further strengthens existing protections for subjects in research conducted or supported by EPA, by prohibiting such research if it would involve intentional exposure of human subjects who are pregnant women or children. The rule also extends new protections to adult subjects in research for pesticides conducted by others who intend to submit the research to EPA, when it involves intentional exposure of human subjects who are non-pregnant adults, and creates a new, independent Human Studies Review Board to advise the Agency on the ethical and scientific issues arising in such research. This final rule focuses on third-party intentional dosing human studies for pesticides and sets the stage for further Agency actions. In addition, in order to display the OMB control number for the information collection requirements contained in this final rule, EPA is amending the table of OMB approval numbers for EPA regulations that appears in 40 CFR part 9. This book contains: - The complete text of the Protections for Subjects in Human Research (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section




Intentional Human Dosing Studies for EPA Regulatory Purposes


Book Description

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.










Spinosad - Pesticide Tolerance (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Spinosad - Pesticide Tolerance (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Spinosad - Pesticide Tolerance (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 This regulation establishes tolerances for residues of Spinosad in/on the following commodities: Alfalfa seed; alfalfa seed screenings; banana; food commodities; animal feed, nongrass, group 18, forage; animal feed, nongrass, group 18, hay; peanut, hay; vegetable, bulb, group 3, except green onion; onion, green; grass, forage, fodder and hay, group 17, forage; grass, forage, fodder and hay, group 17, hay; grain, cereal, group 16, stover, except rice; grain, cereal, group 16, forage, except rice; grain, cereal, group 16, hay, except rice; grain, cereal, group 16, straw, except rice; peppermint, tops; and spearment tops. The Interregional Research Project Number 4 (IR-4)] on behalf of the registrant, Dow AgroScience, LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA). In addition, EPA is deleting certain spinosad tolerances that are no longer needed as a result of this action. Also, the term "Food commodities" replaces the commodity name "all commodities in connection with the quarantine eradication programs against exotic, non-indigenous, fruit fly species, where a separate higher tolerance in not already established" as previously listed under §180.495(b). This book contains: - The complete text of the Spinosad - Pesticide Tolerance (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section




Recognition and Management of Pesticide Poisonings (5th Ed. )


Book Description

This 5th ed. is an update and expansion of the 1989 4th ed. This EPA manual provides health professionals with information on the health hazards of pesticides currently in use, and current consensus recommendations for management of poisonings and injuries caused by them. As with previous updates, this new ed. incorporates new pesticide products that are not necessarily widely known among health professionals. Contents: (1) General Information: Introduction; General Principles in the Management of Acute Pesticide Poisonings; Environmental and Occupational History; (2) Insecticides; (3) Herbicides; (4) Other Pesticides; (5) Index of Signs and Symptoms; Index of Pesticide Products. Charts and tables.




Tebuconazole - Pesticide Tolerances (Us Environmental Protection Agency Regulation) (Epa) (2018 Edition)


Book Description

Tebuconazole - Pesticide Tolerances (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) The Law Library presents the complete text of the Tebuconazole - Pesticide Tolerances (US Environmental Protection Agency Regulation) (EPA) (2018 Edition). Updated as of May 29, 2018 This regulation establishes tolerances for residues of tebuconazole in or on wheat, barley, and tree nuts. Bayer CropScience LP requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This book contains: - The complete text of the Tebuconazole - Pesticide Tolerances (US Environmental Protection Agency Regulation) (EPA) (2018 Edition) - A table of contents with the page number of each section







Regulation of Pesticides


Book Description