[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Notices]
[Pages 39704-39705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15715]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Draft Guidance for Industry on Voluntary Third-Party 
Certification Programs for Foods and Feeds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Voluntary 
Third-Party Certification Programs for Foods and Feeds.'' This draft 
guidance describes the general attributes FDA believes a voluntary 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 
from certified establishments are safe and meet applicable FDA 
requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by September 8, 2008.

ADDRESSES: Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:  Sharon Lindan Mayl, Food and Drug 
Administration, 5600 Fishers Lane (HF-11), Rockville, MD 20857, 301-
827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Voluntary Third-Party Certification Programs for Foods and 
Feeds.'' This draft guidance is issued in response to the 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 help 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 notice requesting comments on the use of third-party certification 
programs for foods and animal feeds. FDA received approximately 70 
comments in response to that notice. 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.
    This draft guidance, when finalized, will represent FDA's current 
thinking on the certification process and will describe the general 
attributes FDA believes a voluntary third-party certification program 
should have in order to provide FDA with confidence in that 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 the certified establishment are safe and meet 
applicable FDA requirements. Such recognition would be tailored to 
particular categories of products and would occur in a separate 
document that builds upon the general attributes set forth in this 
document. Therefore, this draft 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.
    To further that process, FDA is also announcing, in a separate 
notice issued in this Federal Register, a voluntary pilot program for 
third-party certification bodies that certify foreign processors of 
aquacultured shrimp. This pilot is intended to gather technical and 
operational information that will assist

[[Page 39705]]

FDA in determining its infrastructure needs, as well as the process for 
evaluating third-party certification programs. The criteria for 
selection for that pilot are based upon the attributes set forth in the 
draft guidance.
    As with the pilot, the 12 attributes discussed in the draft 
guidance are intended to provide a model that could be tailored for 
particular categories of products and incorporated by FDA as it 
recognizes third-party certification programs for those products. These 
attributes incorporate such things as the authority of the 
certification body to adequately inspect the establishments seeking 
certification, qualifications, and training for the third-party 
inspectors, self-assessment of the certification programs and its 
inspectors, elements of an effective inspection program, notification 
to FDA, and preventing conflicts of interest. While FDA invites 
comments on all aspects of the draft guidance, FDA is particularly 
interested in receiving comments on this list of attributes for the 
certification program. More specifically, we would like to know whether 
there are some attributes that should be removed or added and whether 
the draft guidance provides sufficient information about each 
attribute. We are also interested in knowing how this list compares 
with existing, well-accepted guidelines or requirements for 
certification programs.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent FDA'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

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Division of Dockets Management (see ADDRESSES) 
written or electronic comments regarding the draft 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 draft 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 at http://www.regulations.gov.

III. Electronic Access

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

    Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15715 Filed 7-9-08; 8:45 am]
BILLING CODE 4160-01-S