GRAS Oversight and Transparency Act
Summary
What This Bill Does
The GRAS Oversight and Transparency Act creates a board led by HHS and FDA with USDA and EPA participants to review old manufacturer-made generally recognized as safe, or GRAS, designations for substances used in food before 2000. Food manufacturers must notify the board within 90 days of covered GRAS designations attributable to them. The board must identify designations, prioritize them into tier 1, tier 2, or tier 3 categories, review validity, and report results publicly to HHS and Congress within two, four, or ten years depending on tier. If a manufacturer fails to comply, HHS may impose civil penalties or treat the substance as an unapproved and unsafe food additive. If the board finds a substance has not been shown safe, the Secretary may notify the manufacturer, give 180 days for scientific evidence, review that evidence, revoke the designation, and set timelines for ceasing distribution and recalls. The board and Act terminate after 10 years.
Who Benefits and How
Consumers benefit because older self-determined GRAS food substances receive formal safety review and public reporting. FDA, USDA, and EPA food-safety officials benefit from a structured inventory of pre-2000 designations that may not have been petitioned or reported. Academic toxicology experts and public-health researchers benefit from public board reports and review categories. Food manufacturers with well-supported safety data benefit if valid designations are confirmed and made more transparent.
Who Bears the Burden and How
Food manufacturers must identify covered GRAS designations within 90 days, provide information the board requires, defend challenged designations with scientific evidence within 180 days, and comply with revocation, distribution-stop, or recall procedures. FDA, HHS, USDA, and EPA officials must staff the board, categorize designations, review safety evidence, report publicly, and enforce civil penalties or unapproved-additive treatment. Manufacturers whose designations are revoked must stop distributing or recall affected substances on the Secretary's timeline.
Key Provisions
- Establishes a GRAS review board with HHS, FDA, USDA, EPA, academic, and industry participation.
- Requires food manufacturers to notify the board within 90 days of covered pre-2000 GRAS designations.
- Authorizes civil penalties, unapproved food additive treatment, revocation, distribution stops, and recalls for unsafe or unreported designations.
- Requires tiered public reports within two, four, and ten years and terminates the board after 10 years.
Evidence Chain:
This summary is generated from the full bill text using AI analysis. Expand "Detailed Analysis" below for identified beneficiaries/burden bearers with clause-level evidence links.
At a Glance
What This Bill Does
Creates an HHS/FDA-led GRAS review board to inventory and review manufacturer-made pre-2000 food-safety designations, impose penalties or unapproved-additive treatment for nonreporting manufacturers, revoke unsafe designations, publish tiered reports, and sunset after 10 years.
Key Policy Areas
Food & Beverage, Healthcare, Government Oversight
Primary Purpose
Creates an HHS/FDA-led GRAS review board to inventory and review manufacturer-made pre-2000 food-safety designations, impose penalties or unapproved-additive treatment for nonreporting manufacturers, revoke unsafe designations, publish tiered reports, and sunset after 10 years.
Policy Domains
Substantive provisions
Identified Gains
- Consumers
- Food and Drug Administration
- Academic toxicology experts
- Public-health researchers
Identified Costs
- Food manufacturers
- Health and Human Services Department
- Food and Drug Administration
- USDA food-safety offices
- Environmental Protection Agency
Sponsors
Legislative Progress
In CommitteeReferred to the House Committee on Energy and Commerce.
Introduced in House
Mr. Lawler introduced the following bill; which was referred to …
Stakeholder Effects
cui bono?How this legislation distributes effects. Mention counts reflect frequency, not effect magnitude.
Environmental Protection Agency, Food and Drug Administration, Health and Human Services Department
Positive-direction: Food and Drug Administration
Negative-direction: Environmental Protection Agency, Health and Human Services Department
Bill Structure & Actor Mappings
Who is "The Secretary" in each section?
We use a combination of our own taxonomy and classification in addition to large language models to assess meaning and potential beneficiaries. High confidence means strong textual evidence. Always verify with the original bill text.
Learn more about our methodology