FDA to Hold Hearing on Comparability of Int'l Food Safety Systems, Etc.

(See ITT’s Online Archives or 03/11/11 news, 11031123, for second FDA notice on a March 29, 2011 public meeting to discuss implementation of the major import provisions found in the FDA Food Safety Modernization Act (FSMA), requiring a foreign supplier verification program, voluntary qualified importer program, importer certifications, and third party auditors.)

Seeking Info on Int’l Practices, Comparability as Part of New Focus on Prevention

FDA recognizes that to ensure the safety of imported foods and animal feed and fulfill its public health mission in a global age, it must embrace new approaches that take into account the entire supply chain and its complexity. Therefore, consistent with the principles of prevention laid out in the newly enacted FSMA and the recommendation of the President's Food Safety Working Group, FDA is focusing on preventing problems at appropriate points along the global food supply chain. This public hearing is an opportunity for FDA to obtain views from interested persons concerning certain key aspects of these food safety initiatives: (1) international comparability assessments and (2) gathering information on the policies, practices, and programs used by foreign regulators to ensure the safety of imported foods and animal feed.

First Day on International Comparability Assessments

The first day of the hearing will focus on international comparability assessments. Under FDA's proposed model, FDA will consider the food safety system of a foreign country to be "comparable" to the U.S. food safety system if, based on a complete assessment, FDA determines the foreign food safety system is: (1) Similar, though not identical, to the U.S. food safety system, (2) comprises elements that are analogous to those within the U.S. food safety system, and (3) a system for which FDA has determined provides the same level of public health protection as that of the United States.

To help set regulatory priorities and improve the efficient use of FDA resources for import safety, FDA has developed a tool it proposes to use in assessing the overall food safety systems of other countries and comparing them to the U.S. food safety system.

FDA will seek public comment on FDA's proposed comparability assessment process. In particular, FDA will be inviting the public to share its views on the following topic areas: comparability as a tool, maintaining comparability status, lessons learned through equivalence, etc.

Day Two to Focus on Foreign Regulator Activities to Ensure Food Safety

The second day of the hearing will be for the policies, practices and programs used by foreign regulators to ensure the safety of imported food and animal feed.

FDA states it is interested in learning more about the policies, practices, and programs (including import and export certification programs) used by foreign regulators to ensure the safety of foods and animal feed imported into their countries and will engage directly with countries over the next several months to learn about their programs.

Through these conversations with regulators from other countries, FDA is also interested in learning how countries measure the effectiveness of their import control and export certification activities. The information obtained from these conversations will allow FDA to explore using the innovation and improvements that are being adopted in other countries to improve the safety of imported food and animal feed products.

For example, FDA seeks to better understand the control systems used by other countries for importation of ingredients used in processed food as well as the control systems for transshipment of products.

During Day Two of the public hearing, FDA will also seek input from countries and international organizations that have undertaken activities to gather information on currently implemented import policies, practices, and programs, and to provide capacity building assistance in support of safe imports.

Must Register for Hearing by March 21, No Webcast Will Be Available

Those wishing to participate in the hearing must register by March 21. No webcast of the event will be offered.

(See ITT’s Online Archives or 03/07/11 news, 11030720, for BP summary of an FDA summary of the FSMA, including the provisions affecting importers.

See ITT’s Online Archives or 01/04/11 news, 11010426, for a comprehensive BP summary of the FSMA.

See ITT’s Online Archives or 03/04/11 news, 11030435, for BP summary of an FDA official describing the FSMA’s importer verification activities as similar to those required for seafood as they will require importers to establish “standards and proof” of compliance.)

FDA contact: Juanita Yates, 301-436-1731, email: Juanita.Yates@fda.hhs.gov