Third Party Certification Programs for Foods and Feeds

May 19, 2008 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 RE: Docket No. FDA-2008-N-0183; Third-Party Certification Programs for Foods and Feeds; Request for Comments; 73 Federal Register 17989; (April 2, 2008) Dear Sir or Madam: The Grocery Manufacturers Association (GMA) represents the world's leading food, beverage and consumer products companies. The association promotes sound public policy, champions initiatives that increase productivity and growth and helps to protect the safety and security of the food supply through scientific excellence. The GMA board of directors is comprised of chief executive officers from the association's member companies. The $2.1 trillion food, beverage and consumer packaged goods industry employs 14 million workers, and contributes over $1 trillion in added value to the nation's economy. GMA provides the following comments on the docket listed above. Specifically, GMA does not support application of limited FDA resources to administer third-party certification or audit systems as described. FDA resources would be better applied in other arenas such as evaluating effectiveness of other countries' regulatory programs. GMA feels that third-party certification by FDA should be avoided because FDA should not become a licensing agency but rather leave enforcement action to the government, not third parties. General Comments GMA strongly agrees that the food industry is ultimately responsible to ensure that food and feed intended for consumption in the United States meet all applicable FDA standards. This view is reflected by the recently released 2008 GMA Food Supply Chain Handbook, which provides guidance to industry in establishing comprehensive food safety systems. To meet this responsibility, many firms conduct their own audits of their suppliers' facilities or contract for third-party audits and/or review the supplier's last FDA inspection report. Responsible food companies conduct routine internal audits to ensure their own facilities, where food is manufactured or imported into the U.S. market, meet or exceed FDA standards. Additionally they need to meet regulatory and hygiene standards for other countries where they are manufacturing or marketing, in addition to their own internal standards to protect the consumer and their business. GMA understands that FDA's resources for foreign inspection are limited and the use of third-party audits may help FDA inspection efforts at our ports. A third- party audit/certification against a harmonized and internationally recognized food safety certification standard could be useful to the FDA and the food industry and allow more efficient use of agency resources. GMA would expect that such certification would result in expedited entry for products or reduced inspection frequency of facilities. GMA would expect FDA would have some oversight, including ability to review the audit results. In attempting to address U.S. import security concerns while continuing to facilitate trade, U.S. Customs and Border Protection (CBP) initiated the Customs- Trade Partnership Against Terrorism (C-TPAT) program. C-TPAT is a voluntary government-business initiative to build cooperative relationships that strengthen and improve overall international supply chain and U.S. border security. GMA suggests that FDA evaluate the C-TPAT program that was developed and agreed to in partnership between industry and CBP, with public comment, to facilitate U.S. entry of low risk imports as a model approach. Information on the C-TPAT program is available from CBP at http://www.customs.ustreas.gov/xp/cgov/trade/cargo_security/ctpat/what_ctpat/ In considering third party certification programs, GMA emphasizes the importance of recognizing trade obligations as members of the World Trade Organization (WTO). The Agreement on Technical Barriers to Trade (TBT) prohibits…