
[Federal Register Volume 81, Number 235 (Wednesday, December 7, 2016)]
[Rules and Regulations]
[Pages 88099-88101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29278]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

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


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

AGENCY: Food and Drug Administration, HHS.

[[Page 88100]]


ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry and FDA staff entitled ``Third-
Party Certification Body Accreditation for Food Safety Audits: Model 
Accreditation Standards.'' The guidance contains FDA recommendations on 
third-party 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). The guidance is intended to describe the 
standards for accreditation of third-party certification bodies as 
required under the final rule entitled ``Accreditation of Third-Party 
Certification Bodies to Conduct Food Safety Audits and to Issue 
Certifications.'' In addition, this guidance discusses specific clauses 
of ISO/IEC 17021: 2015 and industry practice that are currently being 
used by third-party certification bodies and that FDA recommends 
accreditation bodies consider as a model when making accreditation 
decisions.

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2011-N-0146 for ``Third-Party Certification Body Accreditation for 
Food Safety Audits: Model Accreditation Standards; Guidance for 
Industry and Food and Drug Administration Staff.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the 
Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug 
Administration, 5001 Campus Dr., 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 guidance.

FOR FURTHER INFORMATION CONTACT: Charlotte A. Christin, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD 20993, 301-796-7526.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry and 
FDA staff entitled ``Third-Party Certification Body Accreditation for 
Food Safety Audits: Model Accreditation Standards.'' We are issuing 
this guidance consistent with our good guidance practices regulation 
(21 CFR 10.115). The guidance represents the current thinking of FDA on 
this topic. It does not establish 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.
    In the Federal Register of July 24, 2015 (80 FR 44137), we made 
available a draft guidance entitled ``Draft Guidance for Industry and 
Food and Drug Administration Staff: Third-Party Auditor/Certification 
Body Accreditation for Food Safety Audits: Model Accreditation 
Standards'' and gave interested parties an opportunity to submit 
comments by October 7, 2015, for us to consider before beginning work 
on the final version of the guidance. 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 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 88101]]

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 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 guidance constitutes the model accreditation 
standards referred to in section 808(b)(2) of the FD&C Act. The 
guidance contains FDA recommendations on third-party 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 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 guidance, FDA considered several voluntary 
consensus standards for their relevance to the qualifications of third-
party 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 certification bodies for conducting food 
safety audits. As a result, FDA was guided in developing the 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 (2015) (ISO/IEC 
17021:2015) and ISO/IEC 17065: Conformity Assessment--Requirements for 
bodies certifying products, processes and services (2012) (ISO/IEC 
17065:2012).
    We received several comments on the draft guidance and have 
modified the final guidance where appropriate. We revised the guidance 
for clarity and conformance with the final rule. We also updated 
references to the ISO/IEC standards. The guidance announced in this 
notice finalizes the draft guidance dated July 2015.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collection of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information regarding ``Accreditation of Third Party 
Certification Bodies to Conduct Food Safety Audits and Issue 
Certifications,'' have been approved under OMB control number 0910-
0750.

III. Electronic Access

    Persons with access to the Internet may obtain the 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: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29278 Filed 12-6-16; 8:45 am]
 BILLING CODE 4164-01-P


