80 FR 44137 - Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 142 (July 24, 2015)

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards.'' The draft guidance, when finalized, will contain FDA recommendations on third-party auditor/ certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA).

[Federal Register Volume 80, Number 142 (Friday, July 24, 2015)]
[Notices]
[Pages 44137-44138]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-18142]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0146]


Third-Party Auditor/Certification Body Accreditation for Food 
Safety Audits: Model Accreditation Standards; Draft Guidance for 
Industry and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry and FDA staff entitled 
``Third-Party Auditor/Certification Body Accreditation for Food Safety 
Audits: Model Accreditation Standards.'' The draft guidance, when 
finalized, will contain FDA recommendations on third-party auditor/
certification body qualifications for accreditation to conduct food 
safety audits and to issue food and/or facility certifications under an 
FDA program required by the FDA Food Safety Modernization Act (FSMA).

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that we consider your comment on this draft 
guidance before we begin work on the final version of the guidance, 
submit either electronic or written comments by October 7, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Charlotte A. Christin, Office of Compliance, Center for 
Food Safety and Applied Nutrition (HFS-605), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food 
Safety and Applied Nutrition (HFS-605), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-3708.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Third-Party Auditor/Certification Body 
Accreditation for Food Safety Audits: Model Accreditation Standards'' 
(draft guidance). This draft guidance is being made available 
consistent with our good guidance practices regulation (21 CFR 10.115). 
The draft guidance, when finalized, will represent our current thinking 
on ``Third-Party Auditor/Certification Body Accreditation for Food 
Safety Audits: Model Accreditation Standards.'' It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such an approach 
satisfies the requirements of the applicable statutes and regulations.
    Section 808 of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 384d) was added by FSMA and directs FDA to establish a 
program for the recognition of accreditation bodies that accredit 
third-party auditors/certification bodies to conduct food safety audits 
and to issue food and/or facility certifications that FDA may use in 
certain circumstances to facilitate the entry of foods presented for 
import.

[[Page 44138]]

Section 808(b)(2) of the FD&C Act requires FDA to develop model 
accreditation standards that recognized accreditation bodies shall use 
to qualify third-party auditors/certification bodies for accreditation, 
and in so doing, to look to existing standards for certification bodies 
(as of the date of enactment of FSMA) to avoid unnecessary duplication 
of efforts and costs. This draft guidance, when finalized, will 
constitute the model accreditation standards referred to in section 
808(b)(2) of the FD&C Act. The draft guidance contains FDA 
recommendations on third-party auditor/certification body 
qualifications for accreditation to conduct food safety audits and to 
issue food and/or facility certifications under an FDA program required 
by FSMA.
    FDA was guided in developing this draft guidance, in part, by the 
National Technology Transfer and Advancement Act of 1995, which directs 
Federal Agencies to use voluntary consensus standards in lieu of 
government-unique standards, except where inconsistent with law or 
otherwise impractical.
    In developing the draft guidance, FDA considered several voluntary 
consensus standards for their relevance to the qualifications of third-
party auditors/certification bodies that would certify foreign food 
facilities and/or their foods for conformance with the requirements of 
the FD&C Act. FDA also sought to identify the standards most commonly 
used by stakeholders (e.g., other governments, public and private 
accreditation bodies, the food industry, and the international 
standards community) in qualifying third-party auditors/certification 
bodies for conducting food safety audits. As a result, FDA was guided 
in developing the draft model accreditation standards guidance document 
by International Organization for Standardization (ISO)/International 
Electrotechnical Commission (IEC) ISO/IEC 17021: Conformity 
Assessment--Requirements for bodies providing audit and certification 
management systems (2011) (``ISO/IEC 17021:2011'') and included an 
appendix containing a crosswalk between ISO/IEC 17021:2011 and ISO/IEC 
17065: Conformity assessment--Requirements for bodies certifying 
products, processes and services (``ISO/IEC 17065:2012'').
    The draft guidance document is issued as a companion to the 
proposed rule ``Accreditation of Third-Party Auditors/Certification 
Bodies to Conduct Food Safety Audits and to Issue Certifications'' that 
was published in the Federal Register of July 29, 2013 (78 FR 45781). 
When this guidance is finalized, it will serve as a companion guidance 
document to the final rule.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information 
described in FDA's July 29, 2013, proposed rule on Accreditation of 
Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits 
and to Issue Certifications, which this draft guidance is intended to 
interpret. The proposed collections of information in the proposed rule 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
As required by the PRA, FDA has published an analysis of the 
information collection provisions of the proposed rule (see 78 FR 45781 
at 45825, reference 25, pages 216-239, available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm) and 
has submitted the proposed collections to OMB for approval.

III. Comments

    Interested persons may submit either electronic comments regarding 
the draft guidance to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to 
the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/FoodGuidances or http://www.regulations.gov. Use the FDA Web site listed in the previous 
sentence to find the most current version of the guidance.

    Dated: July 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-18142 Filed 7-23-15; 8:45 am]
 BILLING CODE 4164-01-P