[Federal Register Volume 74, Number 11 (Friday, January 16, 2009)]
[Notices]
[Pages 3058-3059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-861]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0381]


Guidance for Industry on Voluntary Third-Party Certification 
Programs for Foods and Feeds; 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 guidance for industry entitled ``Voluntary Third-
Party Certification Programs for Foods and Feeds.'' This guidance 
describes the general attributes FDA believes a voluntary third-party 
certification program should have in order to help ensure its 
certification is a reliable reflection that the foods and feeds 
(hereinafter foods) from certified establishments meet applicable FDA 
requirements, as well as other certification criteria.

DATES: Submit written or electronic comments on agency guidance 
documents at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Office of Policy, Office of the Commissioner, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4337, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your requests. The guidance can also be 
obtained by mail by calling 301-796-4840. Submit written comments on 
the guidance to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.regulations.gov. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Sharon Lindan Mayl, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, rm. 4337, Silver 
Spring, MD 20993-0002, 301-796-4840.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Voluntary Third-Party Certification Programs for Foods and 
Feeds.'' This guidance represents FDA's current thinking on the 
certification process and describes the general attributes FDA believes 
a voluntary third-party certification program should have in order to 
provide FDA with confidence in its certification program. If FDA has 
such confidence, we may choose to recognize the program and provide 
incentives for establishments to obtain certification by recognized 
certification programs. Recognition in this context means that FDA has 
determined that certification may be a reliable reflection that the 
foods from an establishment certified by that certification body meet 
applicable FDA requirements, as well as other certification criteria.
    This guidance is intended as one of the steps in FDA's future 
recognition of one or more voluntary third-party certification programs 
for particular product types. In the future, FDA (we) may issue 
guidance that addresses third-party certification programs in 
particular product areas.
    This guidance is issued in response to the recommendations 
contained in the Action Plan for Import Safety: A Roadmap for Continual 
Improvement (Action Plan) issued on November 6, 2007, by the 
Interagency Working Group on Import Safety (Working Group) established 
by Executive Order 13439, as well as FDA's Food Protection Plan 
released on the same date. Both those plans emphasize certification as 
a way to improve our capacity to verify the safety of products from a 
growing food establishment inventory, both domestic and foreign.
    In the Federal Register of April 2, 2008 (73 FR 17989), FDA issued 
a document requesting comments on the use of third-party certification 
programs for foods and animal feeds. FDA received approximately 70 
comments in response to that document. The comments were generally 
supportive of the use of third-party certification programs. Many 
encouraged FDA to recognize such programs as a way to increase 
participation and improve the safety and security of foods.
    On July 10, 2008, we announced the availability of a draft guidance 
for industry entitled ``Voluntary Third-Party Certification Programs 
for Foods and Feeds'' (73 FR 39704). In response to the draft guidance, 
we received 19 comments from a variety of sources, including trade 
associations, individual companies, standards development 
organizations, and other domestic and foreign Government agencies. 
These comments were considered as the guidance was finalized.
    Also on July 10, 2008, FDA issued a document announcing a pilot on 
Voluntary Third-Party Certification Programs for Imported Aquacultured 
Shrimp (73 FR 39705). We are currently in Phase II of the pilot in 
which we will conduct onsite audits of selected third-party 
certification bodies and targeted sampling of imported shrimp products. 
The goal of the pilot is to gather technical and operational 
information that will assist FDA in determining its infrastructure 
needs, as well as the process for evaluating third-party certification 
programs. Based on our experience with the pilot, we may make 
additional changes to the guidance being announced in this document.
    The guidance makes several changes from the draft guidance. For 
example, the section on verification that the establishment meets 
certification criteria no longer includes detailed criteria on specific 
safety and security systems. Instead, the guidance only recommends that 
the audit provide the certification body with reasonable assurance that 
the food or feed is safe and in compliance with certification criteria, 
which should include FDA requirements. As FDA recognizes third-party 
certification programs in particular product areas, FDA plans to 
provide additional guidance on specific certification criteria for 
those product areas.
    In order to help minimize confusion, the guidance uses terminology 
that is generally consistent with accepted international definitions, 
such as those used in documents by the International Organization for 
Standardization (ISO) and the Codex Alimentarius Commission (Codex). 
There may be some divergence, however, when uses of the terms by these 
organizations are inconsistent or when use of the internationally 
accepted terminology

[[Page 3059]]

would not make sense in a particular context.
    The guidance states that a certification body should immediately 
notify FDA and the establishment it is certifying if an auditor finds 
or discovers a situation in which there is a reasonable probability 
that the food or feed from the audited establishment will cause serious 
adverse health consequences or death to humans or animals. We believe 
that such reporting is appropriate. Although the certification body is 
not a regulatory entity, we believe it would help protect public health 
for such circumstances to be reported to FDA so that we can investigate 
the situation. The guidance also notes that an establishment that 
receives this information may be subject to the requirement imposed by 
section 1005 of the Food and Drug Administration Amendments Act of 2007 
to report certain information to FDA via an electronic portal.
    The guidance states that while FDA may provide incentives for 
participation, neither establishments nor certifying bodies are under 
an obligation to participate. FDA does not intend to target uncertified 
establishments or products for inspection or sampling, for example, 
based solely on their lack of certification.
    One comment raised a concern regarding the ability of a foreign 
Government to serve as a certification body. As in the draft guidance, 
the guidance states that foreign Governments may be certification 
bodies. More specifically, the definition of certification body states 
that it could be a Federal, State, local, or foreign Government agency, 
as well as a non-Government entity that is independent of the 
businesses it certifies and free from conflicts of interest.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on voluntary third-party certification 
programs for foods and feeds. 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 approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding the guidance. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in the 
brackets in the heading of this document. A copy of the guidance and 
received comments are available for public examination in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS athttp://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either http://www.fda.gov/oc/guidance/thirdpartycert.html or http://www.regulations.gov.

    Dated: January 12, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-861 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S