H.R. 4958 — GRAS Act

This section revises the definition of food additive in the Federal Food, Drug, and Cosmetic Act (FDCA) to eliminate the exemption for substances generally recognized as safe (GRAS)—previously excluded if qualified experts consider them safe under intended use conditions based on scientific procedures or (for pre-1958 uses) common experience—and instead explicitly includes GRAS substances within the definition. (As background, GRAS status currently exempts such substances from premarket approval as food additives under FDCA section 409; thus, this change subjects them to those requirements while adding an explicit definition of GRAS tied to expert consensus on safety.) It also makes a conforming amendment to update a cross-reference in the pesticide residue tolerances provision (FDCA section 408(k)(2)).

This section revises the food additive safety provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a food additive safe if it is generally recognized as safe (GRAS) and meets the procedural requirements of new subsection (l) (in addition to the prior criteria of exemptions, regulations, or notifications for food contact substances). (As background, GRAS substances have historically been exempt from the FFDCA's premarket food additive approval process if qualified experts consider them safe based on scientific data or safe use prior to 1958; this amendment requires FDA review of notices for new GRAS uses or substances not previously marketed in the U.S. prior to use.) Subsection (l) requires submitters to provide FDA with a notice—including publicly available data on the substance's identity, composition, manufacturing process, intended effect, and safety (e.g., investigation methods and controls, cumulative effects, hazard/dose-response/exposure analyses, protective safety factors, evidence of no carcinogenicity, and no reproductive/developmental toxicity)—in a form specified by FDA regulations; prohibits use of the substance unless FDA issues a written non-objection statement within 180 days (extendable once by 90 days); authorizes FDA objection for inadequate data, expert conflicts of interest, or insufficient support for GRAS status; requires public posting of notices/data upon acceptance with at least 60 days for comment and posting of FDA statements thereafter; and authorizes necessary appropriations. (Thus, GRAS determinations shift from self-affirmation to mandatory pre-use FDA notification and non-objection.)

This section establishes a food additive reassessment program under new subsection 409(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348). Not later than 3 years after enactment and at least every 3 years thereafter, the Secretary of Health and Human Services (HHS), through the Food and Drug Administration (FDA), must systematically reassess the safety (including conditions of use) of at least 10 substances (or classes thereof) from the following categories: (1) food additives approved pursuant to an order under subsection (c); (2) substances previously considered generally recognized as safe (GRAS) prior to enactment; (3) color additives; (4) prior-sanctioned substances; or (5) food contact substances. (As background, GRAS substances are exempt from premarket approval under current law if experts consider them safe based on scientific procedures or historical safe use; food contact substances are materials that contact food without becoming part of it.) In conducting reassessments, the Secretary may require persons that manufacture, introduce into interstate commerce, deliver for introduction, or receive such substances to submit safety evaluations including (A) U.S. population dietary exposure estimates; (B) cumulative effects; (C) hazard, dose-response, and exposure data; (D) protective safety factors accounting for uncertainties and sensitivities; (E) evidence on non-carcinogenicity; (F) evidence on lack of reproductive or developmental toxicity (including endocrine effects); and (G) other information specified by regulation. (Thus, new data could lead to restrictions on substances previously deemed safe without FDA pre-approval.) For GRAS substances under paragraph (1)(B), if safety concerns arise from submitted or public information, the Secretary may revoke prior written statements not objecting to GRAS status and must post the revocation on the FDA website specified in subsection (l)(7). The Secretary also may require notifications from persons marketing such GRAS substances before, on, or after enactment. Violations of this subsection incur civil monetary penalties under section 307 of the act, and such sums as necessary are authorized to be appropriated.

This section adds a new subsection (n) to section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)—which governs FDA approval of food additives and food contact substances—defining eight terms: (1) "carcinogenic" (i.e., a substance found to induce cancer in humans or animals); (2) "class" (i.e., chemically or pharmacologically similar substances); (3) "conflict of interest"; (4) "cumulative effects" (i.e., combined health effects of related substances); (5) "developmental toxicity"; (6) "food contact substance"; (7) "new use"; and (8) "reproductive toxicity." It further makes conforming amendments by (1) revising a cross-reference in section 201(q)(1)(B)(ii) to the new subsection (n) (from section 409(h)(6)); and (2) striking paragraph (6) of section 409(h).

This section amends the food additive user fee program (i.e., FDA fees under section 743 to support review of food and color additives) by (1) expanding the types of assessable fees to include each person filing a petition or notice for a food additive under section 409 (i.e., to prescribe safe use conditions) and each person manufacturing, introducing into interstate commerce, or receiving a food substance subject to GRAS reassessment under section 409(m); (2) basing fees for these activities on 100% of FDA's estimated costs and updating statutory cross-references accordingly; and (3) extending the program's authorization through FY2026 (from FY2010) and certain reporting requirements through FY2025 (from FY2009).