Food Liability Law Blog : Food Safety and Liability Lawyer & Attorney : Stoel Rives Law Firm : Food Safety, Organic Food, Recalls

In its latest step to increase the safety of the American food supply, the U.S. Food and Drug Administration (FDA) announced a Retail Food Safety Action Plan that includes several measures to help assure the safety of food sold in stores, restaurants, schools, and other foodservice operations. In support of the Action Plan, FDA also unveiled a cooperative agreement with the National Association of County and City Health Officials . FDA and the Association will promote the use of best practices by local authorities and attempt to increase retail food safety oversight as well as encourage the implementation of  FDA’s Voluntary National Retail Food Regulatory Program Standards for retail food programs.

FDA today also released a Supplement to the 2009 FDA Food Code. The Food Code contains  model food-safety regulations for  retail and food-service operations including restaurants, schools and food stores. Local, authorities use the Food Code to develop food safety rules consistent with national regulatory policy.

Key changes contained in the new Supplement include:

• Requiring that food establishments have a certified food protection manager  with the following additional requirements:
  • that all operating procedures required by the Food Code are developed and implemented;      
  • that it can be verified that all employees are informed about their obligation to report certain health conditions that relate to transmission of food borne illness; and
  • that any food the establishment receives after operating hours is delivered in a manner that does not create a food safety hazard;  

• Requiring that food establishments have a plan for responding to and properly cleaning-up after an employee or other becomes physically ill in areas where food may be prepared, stored or served;  

• Clarifying appropriate exceptions to the prohibition of bare hand contact with ready-to-eat foods prepared in the establishment;

• Clarifying the requirements for the safe storage and display of ground and whole-muscle meat and poultry;

• New requirements for devices used to generate chemical sanitizers on- site in the food establishment;

• Establishing clearer guidelines for the amount time a food establishment should be given to correct violations of different types of provisions in the Food Code.

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I attended the American Cheese Society conference in Montreal earlier in the month. The conference was attended by cheese producers and suppliers from around the world. At the conference I presented a PowerPoint on Food Safety Modernization Act  (FSMA) .  There were several talks on Food Safety and clearly, the industry is concerned about the new provisions where cheese in particular has been identified as one of the high-risk foods that will be subject to some of the more stringent new regulations.

Because of the conferences’ location, FSMA’s features related to import and export certifications and foreign inspections were of particular interest (see below). It is clear that imported food will garner additional attention under FSMA. This is particularly true given accounts of food safety issues in China involving vinegar, meat and bread. 

FSMA IMPORT REQUIREMENTS

1.   The FDA has a stepped up their foreign facility inspection program to be carried out in a manner to be negotiated with the relevant foreign authority. If inspections are not allowed within 24 hours of the request, a ban on the importation from that facility is authorized.

2.  FSMA contains a new section (sec. 808) that requires the FDA to create a system for the accreditation of third party auditors for certification of eligible foreign facilities. The certification in turn will be used for the Foreign Voluntary Qualified Importer Program (see below) to provide assurance for food imports and to target foreign inspection resources. There are express requirements for auditors and certifications set out in this statute.

3.  The Foreign Supplier Verification Program (sec. 805) requires every United States importer to perform risk-based reviews of foreign suppliers to verify that the food they import is produced in compliance with the Food and Drug Administration (FDA) standards (produce and hazard analysis and preventive controls) and is not altered or misbranded. In January 2012, the FDA is required to issue regulations specifying the contents of the specific verification programs. Each importer is required to perform foreign supply verification activities which may include monitoring records, inspections or annual on site inspections. It may also require reviewing the hazard prevention programs for foreign suppliers, periodic sampling and testing of shipments. 

4.  The law has clarified the definition of inspection to include: An “importer,” for this program, is defined as the United States owner or consignee of the article of food at the time of entry of such articles into the United States, or, if there is no United States owner or consignee, the importer is defined as the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry into the United States. (Note that FDA seafood and juice facilities subject to Hazard Analysis and Critical Control Points (HACCP) or low-acid canned food requirements are exempt.)

5.  In January 2012, the FDA is required to issue a guidance document to assist importers in developing their foreign verification program.

6.  Each importer is required to maintain records related to the Foreign Supplier Verification program for at least two years.

7.  The FDA is required to maintain on its website a current list of the names, locations and other information deemed necessary by the importers in compliance with Section 2805 exemptions. 

8.  There is also a Foreign Voluntary Qualified Importer Program (FVQIP) (sec. 806) which requires the FDA to establish in consultation with the Department of Homeland Security a “voluntary” program to expedite movement of materials through the process. Under this program, an “importer” is defined as the person that brings food, or causes the food to be brought from a foreign country into the United States.  This is an important distinction from the definition under FSVP because it could mean that foreign manufacturers may be allowed to participate in this program.  The deciding factors will not be known until the final regulations are issued. FVQIP regulations are not required to be finalized by the U.S. FDA until July 2013. In July 2012, the FDA is required to issue a guidance document regarding participation, revocation, reinstatement compliance of the qualified importer program. To be eligible the importer must be importing food from its facility that has been certified by a third party auditor that year.

9.  The FDA is authorized to require as a condition to granting admission to an article of food imported or offered for export to certification or such other assurances FDA deems appropriate.

In short, the following is the relevant time table:

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