HR4958-119

What This Bill Does

The GRAS Act substantially tightens how food substances can be treated as generally recognized as safe. It amends the Food, Drug, and Cosmetic Act so food additives include substances that are generally recognized as safe, then defines generally recognized as safe based on qualified expert recognition through scientific procedures or pre-1958 common use. Manufacturers or other persons intending to treat a new food substance use as GRAS must notify FDA, submit public supporting data on identity, composition, manufacturing process, intended effect, safety, cumulative effects, exposure, dose response, protective safety factors, carcinogenicity, reproductive toxicity, developmental toxicity, and other safety information, and may use the substance only after FDA issues a written statement of no objection. FDA must object if the notice lacks required data, uses conflicted experts, or fails to support safety. FDA must make notices and data public, reassess at least 10 food additives, GRAS substances, color additives, prior-sanctioned substances, or food contact substances every three years, may require updated safety evaluations from manufacturers, may revoke prior no-objection statements, and must assess civil penalties for violations.

Who Benefits and How

Consumers benefit because FDA would review GRAS notices before new uses enter the food supply and periodically reassess older substances. Food safety researchers benefit because notices, supporting data, and FDA decisions must be publicly available in one FDA website location. Public health advocates benefit from required attention to cumulative effects, carcinogenicity, reproductive toxicity, developmental toxicity, and endocrine effects. FDA food safety staff benefit from clearer statutory authority to demand safety evaluations and revoke no-objection statements when safety concerns arise.

Who Bears the Burden and How

Food additive manufacturers must submit GRAS notices with detailed public safety data before using substances for new uses. Food companies using GRAS substances must wait for FDA no-objection statements and face civil penalties for violations. Expert reviewers with conflicts of interest can cause FDA objection to GRAS notices. FDA food safety staff must review notices within 180 days or one extended 90-day period and reassess at least 10 substances every three years.

Key Provisions

• Amends the food additive definition to include substances generally recognized as safe.
• Requires GRAS notices with public safety data before new uses of food substances.
• Requires FDA written no-objection before a noticed GRAS substance may be used.
• Directs FDA to reassess at least 10 food substances or classes every three years.
• Authorizes FDA to require safety evaluations, revoke no-objection statements, post decisions publicly, and assess civil penalties.