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GUIDANCE DOCUMENT

Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 January 2018

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2017-D-0397
Issued by:
Guidance Issuing Office
Office of Foods and Veterinary Medicine

This guidance describes FDA’s current thinking on considerations for determining whether a measure or procedure used in lieu of an FDA requirement in 21 CFR part 112, 117, or 507 provides the same level of public health protection (SLPHP) as the corresponding FDA requirement.

FDA established several key regulations, as required under the FDA Food Safety Modernization Act (FSMA), including those related to: (1) foreign supplier verification programs (FSVP; 21 CFR part 1, subpart L); (2) produce safety standards (Produce Safety; 21 CFR part 112); (3) preventive controls for human food (PC Human Food; 21 CFR part 117); and (4) preventive controls for animal food (PC Animal Food; 21 CFR part 507).

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

The use of the word should in Agency guidance documents means that something is suggested or recommended, but not required.

Download the Draft Guidance

Related Resources

Questions?

Online:

For questions regarding this document, you may contact the FSMA Technical Assistance Network.

By Mail or Phone:

Food and Drug Administration
5001 Campus Drive; Wiley Building, HFS-009; Attn: FSMA Outreach
College Park, MD, 20740
Phone: 1-888-SAFEFOOD (1-888-723-3366).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-0397.