FDA Seeks Comments on Voluntary Third-Party Certification Programs for Food and Feed

(The FDA request follows an increase in the number of firms requesting that their suppliers become certified for meeting certain quality/safety standards as a condition of doing business. In addition, the FDA states that 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.)

According to the FDA, this notice represents a first step in soliciting public input in the design and development or recognition of voluntary third-party certification programs and in understanding how such programs can help ensure that food products are safe, secure, and meet FDA requirements.

Comments are due by May 19, 2008.

Voluntary Third Party Certification Program Would Partly Fulfill "Action Plan"

In November 2007, the President's Interagency Working Group on Import Safety released its "Action Plan for Import Safety" which, among other things, called for the development of voluntary third-party certification programs, the creation of incentives for foreign firms to participate in voluntary certification programs, and for importers to purchase only from certified firms. (See ITT's Online Archives or 11/09/07 news, 07110910, for BP summary on the working group's recommendations, with link to previous summary.)

In conjunction with the Action Plan, in November 2007, the FDA released its Food Protection Plan (FPP), in which the FDA proposed, among other things, to seek the legislative authority to accredit third parties (or recognize entities that accredit) to evaluate compliance with FDA requirements in voluntary food inspections. (See ITT's Online Archives or 11/14/07 news, 07111415, for BP summary.)

FDA to accredit independent third parties, etc. According to the FDA, one action it 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.

(The FDA adds that before it would consider recognizing a third-party certification program, it would need sufficient confidence in the quality of the audits performed, the validity of the decisions, and the independence of the third parties.)

Third Party Certification Programs Would Not Replace FDA Inspections, Etc.

The FDA also states that if it were to develop or recognize (or accredit) one or more independent third-party certification programs, such a program would be voluntary, open to foreign and domestic firms, and would not replace FDA inspections.

Third parties should include government. The FDA believes that eligible third parties should include other Federal government, State government, and foreign government agencies and officials.

FDA Seeks Comments on Current Programs, Possible Obstacles/Incentives, Etc.

In addition to seeking general information from the public, the FDA has posed the following specific questions related to third party certification:

(1) What domestic and foreign third party certification programs for suppliers are currently in use by U.S. companies?

(2) Do the current third-party certification programs ensure compliance with FDA requirements?

(3) What are the obstacles to private sector participation in these third-party certification programs?

(4) What incentives would increase participation in these third-party certification programs?

-comments are due by May 19, 2008

FDA contact - Sharon Mayl (301) 827-3360

FDA notice (D/N FDA-2008-N-0183, FR Pub 04/02/08) available at http://edocket.access.gpo.gov/2008/pdf/E8-6705.pdf