Food

Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR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

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How to Comment

Although you can submit comments on any guidance at any time (see 21 CFR 10.115(g)(2)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Submit electronic comments to
http://www.regulations.gov 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

Questions?

Online:

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

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).

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Draft - Not for Implementation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’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.

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).

The FSVP regulation requires importers to develop, maintain, and follow an FSVP that provides adequate assurances that their foreign suppliers are using processes and procedures that provide the same level of public health protection as those required under part 112 or the preventive controls requirements in part 117[1] or part 507[2], if any is applicable. As incorporated in 21 CFR 1.502(a), this means that importers may import food consistent with the FSVP regulation even if their foreign supplier uses a process or procedure that varies in some way from the processes and procedures required under the applicable requirements in these regulations, provided that the importer follows an FSVP that provides adequate assurance that the processes or procedures that the supplier uses nevertheless provide the same level of public health protection as those required under the specified FDA requirement. Similarly, a provision in the FSVP requirements for dietary supplements, in 21 CFR 1.511(c), also requires that foreign supplier verification activities performed under that section must provide adequate assurances that a supplier is producing the dietary supplement in accordance with processes and procedures that provide the same level of public health protection as those required under part 111 (the dietary supplement current good manufacturing practice regulations). In addition, the Produce Safety regulation includes certain provisions whereby farms may use measures different from those required under part 112, provided all relevant requirements are met, including that those measures must provide the same level of public health protection as the corresponding FDA-established requirement (§§ 112.12, 112.49, and 112.171-182 (Subpart P – Variances)).

In the FSVP and Produce Safety final rules, FDA responded to public comments regarding whether and how SLPHP fits into the various provisions of the FSVP and Produce Safety regulations (80 FR 74226 at 74259 and 80 FR 74354 at 74416; November 27, 2015). This draft guidance contains further information about this concept and FDA’s expectations for how an SLPHP evaluation should be conducted and an SLPHP determination should be reached.

The SLPHP and similar concepts appear in national and international texts related to public health and safety. For example, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) uses the same phrase, “same level of public health protection,” in relation to its equivalence determination of a foreign country’s regulatory system for meat, poultry, and egg products.[3] In addition, the U.S. Safe Drinking Water Act refers to “alternative water” supplied for residential or similar uses for drinking or cooking, to achieve the “equivalent level of public health protection” provided by the applicable national primary drinking water regulation (42 U.S.C. § 300f).

In the international context, under Article 4 of the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) (the SPS Agreement), each member nation of the WTO, including the United States, is obligated to accept as equivalent a food regulatory system of another country if it provides the same level of health protection as is provided to consumers by its own system. The SPS Agreement uses the phrase “appropriate level of sanitary or phytosanitary protection” and defines it as follows:

Appropriate level of sanitary or phytosanitary protection – The level of protection deemed appropriate by the Member establishing a sanitary or phytosanitary measure to protect human, animal or plant life or health within its territory.
NOTE: Many Members otherwise refer to this concept as the “acceptable level of risk” (Annex A of the SPS Agreement[4]).

This phrase is also used in Codex guidelines related to equivalence and to food import and export inspection and certification systems (CAC/GL 53-2003[5], CAC/GL 34-1999[6], and CAC/GL 26-1997[7]).

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not create any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. 

Download 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


[1] The preventive controls requirements, which implement section 418 of the FD&C Act, are primarily located in subparts C and G. Part 117 includes additional requirements that do not implement section 418 of the FD&C Act (i.e., requirements related to current good manufacturing practices (CGMPs)). The SLPHP requirement in the FSVP rule applies only to the requirements in part 117 that implement section 418 of the FD&C Act; it does not apply to the CGMP requirements in part 117.
[2] The preventive controls requirements, which implement section 418 of the FD&C Act, are primarily located in subparts C and E.  Part 507 includes additional requirements that do not implement section 418 of the FD&C Act (i.e., requirements related to current good manufacturing practices (CGMPs)). The SLPHP requirement in the FSVP rule applies only to the requirements in part 507 that implement section 418 of the FD&C Act; it does not apply to the CGMP requirements in part 507.
[3] USDA FSIS. “Process for evaluating the equivalence of foreign meat, poultry, and egg products food regulatory systems,” July 2011 (hereafter referred to as “FSIS’ equivalence evaluation process”).
[4] The World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Accessible online at: https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm.
[5] Codex Guidelines on the judgement of equivalence of sanitary measures associated with food inspection and certification systems, CAC/GL 53-2003. Accessible at http://www.fao.org/docrep/009/y6396e/Y6396E05.htm.
[6] Codex Guidelines for the development of equivalence agreements regarding food import and export inspection and certification systems, CAC/GL 34-1999. Accessible at http://www.fao.org/docrep/005/X4489E/x4489e04.htm.
[7] Codex Guidelines for the design, operation, assessment and accreditation of food import and export inspection and certification systems, CAC/GL 26-1997. Accessible at http://www.fao.org/docrep/009/y6396e/Y6396E03.htm.

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