Federal Insecticide, Fungicide, and Rodenticide Act

#any nitrogen stabilizer, except that the term "pesticide" shall not include any article that is a "new animal drug" within the meaning of section 321(w)[1] of title 21, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 321(x)[1] of title 21 bearing or containing a new animal drug. The term "pesticide" does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 321 of title 21. For purposes of the preceding sentence, the term "critical device" includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term "semi-critical device" includes any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

#any nitrogen stabilizer, except that the term "pesticide" shall not include any article that is a "new animal drug" within the meaning of section 321(w)[1] of title 21, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 321(x)[1] of title 21 bearing or containing a new animal drug. The term "pesticide" does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 321 of title 21. For purposes of the preceding sentence, the term "critical device" includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term "semi-critical device" includes any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

An applicant will have to prove that the pesticide active ingredient, pesticide product, or proposed new use of a registered pesticide will not cause unreasonable adverse effects on human health and environment.<ref name=Statutes /> An unreasonable adverse effect is "(1) any risk that is unreasonable to man or the environment that takes social, economic, and environmental costs as well as benefits into consideration and (2) any dietary risk that could be the result of a pesticide used with any food lacking consistency with the standards listed under Section 408 of the [[Federal Food, Drug, and Cosmetic Act]]"(FDCA).<ref name=EPA/> The applicant must provide scientific data from any combinations of over 100 different tests conducted under EPA guidelines to assess these potential adverse short-term and long-term effects.<ref name=Statutes /><ref name="EPA, Registration">{{cite web|title=Chapter 1 - Overview of Requirements for Pesticide Registration and Registrant Obligations|url=http://www.epa.gov/pesticides/bluebook/chapter1.html|archive-url=https://archive.today/20121212020535/http://www.epa.gov/pesticides/bluebook/chapter1.html|url-status=dead|archive-date=December 12, 2012|access-date=1 April 2012}}</ref> There is considerable public interest in the contents of pesticide registration studies, which has led to conflict over public access to these materials. These competing interests as well as legislation addressing access has been covered separately under [[Pesticide regulation in the United States]]. In some cases, manufacturers choose to conduct addition work to satisfy requirements for peer-reviewed literature, as was the case for the herbicide, cloransulam-methyl.<ref>Wolt, J. D., J.K. Smith, J.K. Sims, and D.O. Duebelbeis. 1996. Products and kinetics of cloramsulam-methyl aerobic soil metabolism. J. Agric. Food Chem. 44:324-332. https://pubs.acs.org/doi/full/10.1021/jf9503570</ref> Publication of registration studies in the peer-reviewed literature not only provides unlimited public access, but also ensures sufficient rigor to satisfy the scientific community at large.

An applicant will have to prove that the pesticide active ingredient, pesticide product, or proposed new use of a registered pesticide will not cause unreasonable adverse effects on human health and environment.<ref name=Statutes /> An unreasonable adverse effect is "(1) any risk that is unreasonable to man or the environment that takes social, economic, and environmental costs as well as benefits into consideration and (2) any dietary risk that could be the result of a pesticide used with any food lacking consistency with the standards listed under Section 408 of the [[Federal Food, Drug, and Cosmetic Act]]"(FDCA).<ref name=EPA/> The applicant must provide scientific data from any combinations of over 100 different tests conducted under EPA guidelines to assess these potential adverse short-term and long-term effects.<ref name=Statutes /><ref name="EPA, Registration">{{cite web|title=Chapter 1 - Overview of Requirements for Pesticide Registration and Registrant Obligations|url=http://www.epa.gov/pesticides/bluebook/chapter1.html|archive-url=https://archive.today/20121212020535/http://www.epa.gov/pesticides/bluebook/chapter1.html|url-status=dead|archive-date=December 12, 2012|access-date=1 April 2012}}</ref> There is considerable public interest in the contents of pesticide registration studies, which has led to conflict over public access to these materials. These competing interests as well as legislation addressing access has been covered separately under [[Pesticide regulation in the United States]]. In some cases, manufacturers choose to conduct addition work to satisfy requirements for peer-reviewed literature, as was the case for the herbicide, [[cloransulam-methyl]].<ref>Wolt, J. D., J.K. Smith, J.K. Sims, and D.O. Duebelbeis. 1996. Products and kinetics of cloramsulam-methyl aerobic soil metabolism. J. Agric. Food Chem. 44:324-332. https://pubs.acs.org/doi/full/10.1021/jf9503570</ref> Publication of registration studies in the peer-reviewed literature not only provides unlimited public access, but also ensures sufficient rigor to satisfy the scientific community at large.

Under Section 408 of the [[Federal Food, Drug, and Cosmetic Act]] (FFDCA), the EPA can also regulate the amount of pesticide residues permissible on or in food/feed items, by establishing a "safe" level meaning there is "a reasonable certainty of no harm" from the exposure to the residue whether directly from the consumption of such food or from other non-occupational sources.<ref name=Statutes /><ref name="EPA, Registration"/> For food crops, the EPA is required to establish a "tolerance" level, the maximum "safe" level of pesticide present on or in the particular food/feed commodity. The EPA may also choose to provide an exemption to the requirement of an established tolerance level, allowing any amount of a pesticide residue to remain on or in food or feed as long as the exemption meets FFDCA safety standards.<ref name=Statutes /><ref name="EPA, Registration"/> Successfully registered pesticides must conform to approved uses and conditions of use, which the registrant must state on the label.<ref name=Statutes />

Under Section 408 of the [[Federal Food, Drug, and Cosmetic Act]] (FFDCA), the EPA can also regulate the amount of pesticide residues permissible on or in food/feed items, by establishing a "safe" level meaning there is "a reasonable certainty of no harm" from the exposure to the residue whether directly from the consumption of such food or from other non-occupational sources.<ref name=Statutes /><ref name="EPA, Registration"/> For food crops, the EPA is required to establish a "tolerance" level, the maximum "safe" level of pesticide present on or in the particular food/feed commodity. The EPA may also choose to provide an exemption to the requirement of an established tolerance level, allowing any amount of a pesticide residue to remain on or in food or feed as long as the exemption meets FFDCA safety standards.<ref name=Statutes /><ref name="EPA, Registration"/> Successfully registered pesticides must conform to approved uses and conditions of use, which the registrant must state on the label.<ref name=Statutes />