GRAS Oversight and Transparency

Full Title:
GRAS Oversight and Transparency Act

Summary#

This measure would create a temporary board at the Department of Health and Human Services to review certain "generally recognized as safe" (GRAS) determinations made by food manufacturers before 2000 that were not previously notified to the Food and Drug Administration. The Board would include federal agency voting members and two nonvoting appointees. It must identify covered GRAS designations, sort them into three priority tiers, review them, and report results publicly. If the Board determines a substance has not been shown to be safe, it must notify the Secretary and Congress and recommend revocation of the GRAS designation.

What it means for you#

  • If you are a food manufacturer: you must tell the Board, within 90 days after enactment, which pre-2000 GRAS designations are attributable to your company. If you do not comply, the Secretary may impose civil penalties or treat the substance as an unapproved food additive and deem it unsafe. If a designation is challenged, the company gets 180 days to supply scientific evidence to show the substance is safe.
  • If you are a consumer or member of the public: the Board must post reports and recommendations on the FDA website. Reviews are scheduled by tier (tier 1 within 2 years, tier 2 within 4 years, tier 3 within 10 years).

Expenses#

No publicly available information on overall funding or cost estimates. The text says Board members serve without compensation. The measure does not specify appropriations or budget amounts.

Proponents' View#

No publicly available information.

Opponents' View#

No publicly available information.