Sec. 111. Regulation
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The Plant Protection Act ( 7 U.S.C. 7701 et seq. ) is amended by adding at the end the following new subtitle: Subject to subsection (b), it shall be unlawful to sell or offer for sale in interstate commerce a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant unless— the Secretary of Health and Human Services notified the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant in writing that the Secretary of Health and Human Services, in evaluating the food from the genetically engineered plant through the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act, has no objections to the entity’s determination that food produced from, containing, or consisting of the genetically engineered plant that is the subject of the notification is safe for use by humans or animals, as applicable, and lawful under the Federal Food, Drug, and Cosmetic Act; and the entity seeking evaluation of a food produced from, containing, or consisting of the genetically engineered plant submits to the Secretary of Agriculture the notification of the finding of the Secretary of Health and Human Services under subparagraph (A); or before the date of the enactment of the Safe and Accurate Food Labeling Act of 2015 , the Secretary of Health and Human Services— considered the consultation process referred to in section 424(a) of the Federal Food, Drug, and Cosmetic Act with respect to such genetically engineered plant to be complete; notified the consulting party in writing that all questions with respect to the safety of food produced from, containing, or consisting of the genetically engineered plant have been resolved; and published such notification on the public Internet website of the Food and Drug Administration.
Notwithstanding subsection (a), this section does not apply with respect to the sale or offering for sale in interstate commerce of a genetically engineered plant— for the purpose of research or development testing, including— testing conducted to generate data and information that could be used in a submission to the Secretary under this title or other regulatory submission; or multiplication of seed or hybrid and variety development conducted before submitting a notification under subsection (a)(1)(B); solely because a processing aid or enzyme produced from the genetically engineered plant is intended to be used to produce food; or solely because the genetically engineered plant is used as a nutrient source for microorganisms.
Nothing in subsection (b)(1) may be construed as authorizing the sale or offering for sale in interstate commerce of a nonregulated genetically engineered plant for use or application in food or a food produced from, containing, or consisting of a nonregulated genetically engineered plant. Subject to paragraph (2), the Secretary of Agriculture shall publish on the public Internet website of the Department of Agriculture, and update as necessary, a registry that includes— a list of each nonregulated genetically engineered plant intended for a use or application in food that may be sold or offered for sale in interstate commerce, in accordance with subsection (a); the petitions submitted to, and determinations made by, the Secretary of Agriculture with respect to such a plant; and the notifications of findings issued by the Secretary of Health and Human Services with respect to such a plant or the use or application of such a plant in food.
Notwithstanding paragraph (1), nothing in this section shall be construed to alter the protections offered by laws, regulations, and policies governing disclosure of confidential commercial or trade secret information, and any other information exempt from disclosure pursuant to section 552(b) of title 5, United States Code, as such provisions would be applied to the documents and information referred to in subparagraphs
(A)through
(C)of paragraph (1). In the case of food imported into the United States that is food produced from, containing, or consisting of a plant that meets the definition of a nonregulated genetically engineered plant or a plant that, if sold in interstate commerce, would be subject to regulation under part 340 of title 7, Code of Federal Regulations (or any successor regulations), the provisions of this section shall apply to such food in the same manner and to the same extent as such provisions apply to a food that is not so imported. In this subtitle: The term food has the meaning given such term in section 201(f) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(f) ). The term nonregulated genetically engineered plant means a genetically engineered plant— for which the Secretary of Agriculture has approved a petition under section 340.6 of title 7, Code of Federal Regulations (or any successor regulations), for a determination that the genetically engineered plant should not be regulated under this Act; or that— is not subject to regulation as a plant pest under this Act; contains genetic material from a different species; and has been modified through in vitro recombinant deoxyribonucleic acid
(DNA)techniques. .
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