The Food and Drug Administration (FDA) has announced that January 2, 2012, will be the Uniform Compliance Date for any new labeling regulations finalized between January 1, 2009, and December 31, 2010. The current Uniform Compliance Date--for labeling regulations dated between January 1, 2007, and December 31, 2008--is January 1, 2010.

FDA has issued Guidance for FDA staff in the form of a Compliance Policy Guide, CPG 7108.16, relating to “Processed and/or Blended Seafood Products.” The Guidance deals specifically with the labeling of surimi and “to permit the use of ‘and/or’ labeling for various fish species used...,” for example, “fish protein (contains one or more of the following: Pollock, cod, and/or Pacific whiting).” The Guidance also discusses products labeled as “imitation” and “fish protein blended with ________.”

FDA published an update on its 2007 Food Protection Plan, “Food Protection Plan One-Year Progress Summary.” The Summary spells out FDA’s accomplishments and attentiveness to issues in the Plan’s three key areas of prevention, intervention and response. The Summary evidences FDA’s continuing interest in third-party certification, both foreign and domestic, and describes specific actions related to border interventions and on-site, foreign-based FDA offices. Specific regulatory proposals for third-party certification programs remain on FDA’s to-do list. As part of the enhanced food safety program, FDA announced the hiring of an additional 130 investigatory personnel and completion of a “high-risk” initiative, including over 5,000 inspections of high-risk domestic facilities.

The U.S. Department of Agriculture (USDA), Food Safety Inspection Service (FSIS) has issued instructions to field personnel in the Office of Public Health on how to handle investigations of foodborne illnesses believed to originate from FSIS-inspected establishments (meat, eggs and poultry). The directive is 8080.3, “Foodborne Illness Investigations.” Instruction is also offered to related offices that may assist or be involved in an FSIS foodborne illness investigation. Foodborne Disease Investigations Branch (FDIB) personnel evaluate any data provided from any source, evaluate the “surveillance data,” assess the “strength of the surveillance data” and initiate or recommend initiation (based on identified criteria) of further actions. Actions resulting from the surveillance and investigation range from a recall (directed by a Recall Committee applying the criteria of Directive 8080.1); a public health alert (if a public health concern is linked to a product category, but an individual brand or source cannot be identified); in-creased inspec-tion depth and frequency; suspension of inspection; or criminal enforcement under Directive 8010.5. Each surveillance or investigation under 8080.3 after closure would be followed by a review of the investigation, with emphasis on areas for improvement or modification.pf


Mark Hostetler is an attorney at Husch Blackwell Sanders LLP. Experienced in advising consumer product companies and focusing primarily in the food industry, he has guided producers, advertisers and marketers through regulatory proceedings, product recalls, new product introductions, and new advertising and promotional campaigns. He can be reached at Mark.Hostetler@huschblackwell.com.