Exhibit 560 ยท Federal Register proposed rule
Substances Generally Recognized as Safe, proposed rule (62 FR 18938; Docket 97N-0103)
FDA recognizes that a decision to submit a notice is voluntary.
Proposed to replace the GRAS affirmation petition with a notification procedure in which any person may notify FDA of a GRAS determination. FDA states the decision to submit a notice is voluntary and that the rulemaking-based petition process deterred many persons who independently determine a use is GRAS from informing the agency.
- Source
- U.S. Food and Drug Administration
- Date
- 17 April 1997
- Quoted from
- 62 FR 18946, section 'B. Specific Requirements' (proposed 170.36(c))
- Grade
- Primary record
- Document
- https://www.govinfo.gov/content/pkg/FR-1997-04-17/pdf/97-9706.pdf
- Accessed
- 2026-11-09
- Cited by
- Findings citing this exhibit
- Note
- A second passage, 62 FR 18944: 'FDA believes that the lengthy rulemaking associated with the GRAS petition process deters many persons who independently determine that use of a substance is GRAS from informing the agency of such determinations.'