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Exhibit 560

Substances Generally Recognized as Safe, proposed rule (62 FR 18938; Docket 97N-0103)

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.'

Cited by

Finding AGR-1.2
Primary record FDA's 1997 proposal and 2016 final rule made notification of a GRAS conclusion voluntary. The 2016 rule treats a conclusion kept by its maker the same in law as one submitted to FDA, and it states that FDA lacks express statutory authority to require notices.