Definitions

(a) In general Section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348), as amended by sections 3 and 4, is further amended by adding at the end the following: (n) Definitions In this section: (1) Carcinogenic The term carcinogenic means, with respect to a substance, that such substance has been found— (A) to induce cancer when ingested by humans or animals; or (B) after evaluation through appropriate testing methods, by research or assessment conducted by an authoritative scientific body (such as the Environmental Protection Agency, the International Agency for Research on Cancer, or the National Toxicology Program), to induce cancer in humans or animals. (2) Class The term class, with respect to a substance, means a group of chemicals that are chemically similar or cause similar or related pharmacological effects. (3) Conflict of interest The term conflict of interest means a personal or financial interest that could potentially compromise the professional judgment or objectivity of an individual in designing, conducting, reporting, or reviewing research or the applicability of research, potentially undermining the integrity of such research. (4) Cumulative effects The term cumulative effects means, with respect to a substance, the combined health effects of all chemically or pharmacologically-related substances. (5) Developmental toxicity The term developmental toxicity means, with respect to the effect of exposure to a substance on a human or animal, an adverse effect on the development of such human or animal that results from such exposure— (A) to the mother prior to conception of, or during the prenatal period for, such human or animal; or (B) to such human or animal before the time of sexual maturity. (6) Food contact substance The term food contact substance means any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. (7) New use The term new use means a use other than— (A) a use of a substance generally recognized as safe before, on, and after the date of enactment of this subsection; (B) a use of a substance treated as generally recognized as safe under subsection (l); or (C) a use of a prior-sanctioned substance (as described in subparagraph (D) of section 201(s)(1)). (8) Reproductive toxicity The term reproductive toxicity means, with respect to the effect of exposure to a substance on a human or animal, an adverse effect on the reproductive system of such human or animal, which may include alterations to reproductive system development, the endocrine system, fertility, pregnancy, pregnancy outcomes, or modifications in other functions that are dependent on the integrity of the reproductive system.. (b) Conforming amendments (1) Section 201(q)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(q)(1)(B)(ii)) is amended by striking section 409(h)(6) and inserting section 409(n). (2) Section 409(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(h)) is amended by striking paragraph (6).