The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) issued a press release on Wednesday, December 5, 2012, announcing that companies producing raw ground chicken and turkey and similar products will be required to reassess their sanitation procedures and pathogen control plans over the next few months. Specifically, over the next 90 days, producers of raw ground chicken and turkey must conduct a thorough examination of its current Hazard Analysis and Critical Control Points (HACCP) to confirm its ability to identify hazards and better prevent foodborne illness. After the 90 day period, FSIS inspection program personnel will begin verifying that establishments that manufacture raw ground turkey or chicken products have indeed reassessed their HACCP plans.
FSIS will be documenting whether establishments made any changes to their HACCP plans in response to the required reassessment and will later evaluate those changes. Later, the agency intends to publish guidance materials for the industry on best practices to reduce Salmonella in ground and comminuted (further processed by mechanical separation or deboning and chopped, flaked, minced or broken down) poultry.
In making this announcement, officials at FSIS are hoping to lower the prevalence of Salmonella contamination within these types of products. This attention to the ground poultry product industry with a focus on Salmonella comes as a response to recent outbreaks that have sickened hundreds across the country in the past few years. Just in the last two years there have been two major Salmonella outbreaks associated with ground poultry products that affected consumers nationwide.
In conducting these reassessments, FSIS is advising companies to look at, among other things, the following:
[E]stablishments should evaluate the adequacy of their sanitation procedures for processing equipment, including grinders, blenders, pipes, and other components and surfaces in contact with the product. Thus, Sanitation SOPs, other prerequisite programs, or HACCP plans should address procedures that ensure that all slaughter and further processing equipment, employee hands, tools, and clothing, and food contact surfaces are maintained in a sanitary manner to minimize the potential for cross contamination within and among lots of production. In addition, FSIS expects establishments to ensure that slaughter and dressing procedures are designed to prevent contamination to the maximum extent possible. Such procedures should, at a minimum, be designed to limit the exterior contamination of birds before exsanguination, as well as minimize digestive tract content spillage during dressing process.
Other FSIS recommendations include validating cooking instructions, examining lotting practices that minimize contact between lots, and requiring suppliers to show that they have used a Salmonella intervention step.
In FSIS’s notice, the agency also announced that it will be expanding the Salmonella verification sampling program to include other raw comminuted poultry products, in addition to ground product; it will be increasing the sample size for laboratory analysis from 25 grams to 325 grams to provide consistency as the Agency moves toward analyzing samples for Salmonella and Campylobacter; and it will be conducting sampling to determine the prevalence of Salmonella in raw comminuted poultry products.
Although these new procedures are intended for producers of ground or comminuted chicken and turkey products, FSIS is recommending that manufacturers of comminuted products derived from cattle, hogs, and sheep or comminuted poultry products derived from poultry other than chicken or turkeys also consider assessing whether their food safety systems present food safety vulnerabilities.
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:
|January 2011||Authority to require import certification.|
|July 2011||Require importers to notify the FDAof any country tot which food was denied access.|
|January 2012||FDA to publish guidance AND regulations for the Foreign Supplier Verification Program.|
|July 2012||Establish program for Voluntary Qualified Importer Program.|
|January 2013||Effective date for Foreign Supplier Verification Program.|