Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR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


How to Comment

Submit either electronic or written comments on the draft guidance by May 25, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Submit electronic comments on to docket number FDA-2017-D-0397.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2017-D-0397.

Contains Nonbinding Recommendations

Draft - Not for Implementation

January 2018

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Download the Draft Guidance for Industry



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).

Page Last Updated: 09/15/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English