[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Pages 17989-17991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6705]



Food and Drug Administration

[Docket No. FDA-2008-N-0183]

Third-Party Certification Programs for Foods and Feeds; Request 
for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.


SUMMARY:  The Food and Drug Administration (FDA) is requesting comments 
on the use of third-party certification programs for foods and feeds, 
including pet foods. An increasing number of firms that sell foods to 
the public, such as retailers and food service providers, are 
requesting that their suppliers become certified as meeting food (and 
feed) safety and quality standards as a condition of doing business. 
FDA seeks more information on the existence and use of these types of 
programs to better understand how they can help to ensure that food 
products are safe, secure, and meet FDA requirements.

DATES:  Submit written or electronic comments by May 19, 2008.

ADDRESSES:  Submit written comments 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.

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


I. Background

    Ensuring the safety of food for human and animal use is a shared 
responsibility between the public and private sectors. FDA has the 
authority to establish regulatory standards, inspect facilities, and 
take action if there are violations, but it is ultimately the 
responsibility of industry to ensure that food and feed intended for 
consumption in the United States meet applicable FDA standards. An 
increasing number of firms that sell foods and feeds (hereinafter 
foods) to the public, such as retailers and food service providers, are 
requesting that their suppliers, both foreign and domestic, become 
certified as meeting food safety and quality standards as a condition 
of doing business. In addition, domestic and foreign suppliers (such as 
producers, co-manufacturers, or re-packers) are increasingly looking to 
third parties to assist them in meeting U.S. requirements. FDA is 
seeking comment on current practices of third-party certification 
programs that work with food products and to ensure the supply chain is 
safe, secure, and meet FDA requirements.

A. Current Use of Voluntary Third-Party Certification Programs for 

    A growing number of food firms require their suppliers to ensure 
their products are produced using ``best practices'' for food safety, 
quality, and security and that the supply chain is safe and secure. 
These firms often require their suppliers to meet nationally or 
globally recognized food safety standards and to verify that these 
standards are met through a third-party certification program. For 
example, the Global Food Safety Initiative requires food suppliers to 
have a factory audit certification against internationally recognized 
standards, which include the Safe Quality Food, British Retail 
Consortium, International Food Standard, and GlobalGAP. The Global 
Aquaculture Alliance has also established standards for aquaculture 
production and processing and created an accrediting body for 
certifiers from 30 countries. These types of private sector developed 
programs are being used in many foreign countries, as well as the 
United States.

B. Interagency Working Group on Import Safety

    On July 18, 2007, the President issued Executive Order 13439 to 
establish the Interagency Working Group on Import Safety (Working 
Group). On November 6, 2007, the Working Group released an ``Action 
Plan for Import Safety: A Roadmap for Continual Improvement'' (Action 
Plan) (http://www.importsafety.gov/report/actionplan.pdf). The Action 
Plan contains 14 broad recommendations and 50 specific short- and long-
term action steps to better protect consumers and enhance the safety of 
the increasing volume of imports entering the United States. The Action 
Plan stresses the importance of the private sector's responsibility for 
the safety of its products and the importance of ongoing private-sector 
mechanisms and experience as a basis for ongoing, substantive public-
private collaboration. The public and private sectors have a shared 
interest in import safety, and substantive improvement will require the 
careful collaboration of the entire importing community.

[[Page 17990]]

    Recommendation 2 of the Action Plan is to ``verify compliance of 
foreign producers with United States safety and security standards 
through certification.'' Third-party certification can augment the 
Federal Government's and the importing community's ability to ensure 
that products imported into the United States meet U.S. safety and 
security standards. The Action Plan states ``[f]or foreign producers, 
the ability to participate in voluntary certification programs could 
allow products from firms that comply with U.S. safety and security 
standards to enter the United States more quickly. This would 
facilitate trade, while allowing federal departments and agencies to 
focus their resources on products from non-certified firms or for which 
information suggests there may be safety or security concerns. This 
would allow federal departments and agencies to more effectively target 
their resources. It may not be necessary to establish certification 
programs for low-risk products.''
    Action Steps 2.2 and 2.4 of the Action Plan call for the 
development of voluntary third-party certification programs based on 
risk for foreign producers of certain products who export to the United 
States and the creation of incentives for foreign firms to participate 
in voluntary certification programs and for importers to purchase only 
from certified firms.
    In conjunction with the Action Plan, on November 6, 2007, FDA 
released its Food Protection Plan (FPP), a comprehensive initiative 
designed to bolster efforts to better protect the Nation's food supply 
    Although certification by an independent third party would not 
replace an FDA inspection, and FDA would continue to inspect a firm 
itself, as appropriate based on risk, third-party certification could 
provide additional assurances of safety. In addition, third-party 
certification could provide FDA with important information about the 
ability of specific food suppliers to meet FDA requirements and to 
better focus the use of our resources based on risk. FDA believes that 
eligible third parties should include other Federal government, State 
government, and foreign government agencies and officials.
    If FDA were to develop or recognize (or accredit) one or more 
independent third-party certification programs, we would provide an 
opportunity for both foreign and domestic firms to voluntarily 
participate. However, FDA would need sufficient confidence in the 
quality of the audits performed and the validity of the decisions to 
certify by the third parties as well as the independence of the third 
parties from the firms they certify before we would consider 
recognizing a third-party certification program.
    One action FDA will take to implement the Action Plan and the FPP 
is to accredit independent third parties, or to recognize entities that 
accredit, to evaluate compliance with FDA requirements. This notice 
represents FDA's first step in soliciting public input in the design 
and development or recognition of third-party certification programs.

II. Request for Information

    FDA is seeking information on the use of third-party certification 
programs. In addition to general information, we are posing several 
specific questions related to these types of programs.
1. What domestic and foreign third-party certification programs for 
suppliers are currently in use by U.S. companies?
    FDA is aware of several third-party certification programs that are 
currently being used in the United States. We would like more 
information regarding these and other certification programs, the 
standards on which they are based, and who is currently using these 
third-party programs. In addition, we would like information on the 
standards and procedures used to ensure that the third parties used are 
independent (i.e., without conflicts of interest), the standards used 
to accredit third parties, who accredits these third parties, and how 
and by whom these third parties are audited and evaluated for 
performance. We would also like to know how national government bodies 
interface with or recognize these certification programs.
2. Do the current third-party certification programs ensure compliance 
with FDA requirements?
    Third-party certification programs for foods are used widely in 
Europe. These types of certification programs are becoming more popular 
in other parts of the world, including the United States. FDA solicits 
comment on whether the requirements for certification used by these 
programs encompass FDA requirements. If not, what modifications need to 
be made for the U.S. marketplace? Should FDA recognize (or accredit) 
any of these programs? Should FDA participate in future modifications 
to any of these programs? If so, in what capacity?
3. What are the obstacles to private sector participation in these 
third-party certification programs?
    Although the use of third-party certification programs is growing, 
they are not used by the majority of U.S. food firms. FDA seeks 
information about any barriers that may exist to using third-party 
certification programs. Are retailers and suppliers aware of these 
programs? Are these programs widely available? Are they cost effective? 
Are there particular obstacles for small businesses?
4. What incentives would increase participation in these third-party 
certification programs?
    FDA recognizes that there are business and legal incentives to 
using third-party certification programs. We would like to know what 
incentives could increase participation in these certification 
programs. For example, would expedited treatment at U.S. ports of entry 
significantly encourage foreign suppliers to participate or domestic 
firms to make participation by foreign or domestic suppliers a 
condition of doing business with them? Would making the names of 
certified firms publicly available, such as through a publicly 
accessible database, significantly encourage participation in these 
programs by foreign or domestic suppliers? Would FDA considering 
certification as one factor in determining inspection priorities 
provide a significant incentive for foreign or domestic firms to 
participate? Are there other incentives that would increase 
participation for imported foods? For domestic foods?

III. How to Submit Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.regulations.gov 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 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.
    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

[[Page 17991]]

comments or submissions will be accepted by FDA through FDMS only.

    Dated: March 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6705 Filed 4-1-08; 8:45 am]