American Cheese Society Conference
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. |
FDA's Right To Photograph In Your Plant
The FDA asserts in its inspection manual its right to photograph in your plant. Yet the FDA does not have statutory authority to photograph. The manual cites the following cases as authority for its right to photograph the inside of a plant: Dow Chem. Co. v. United States, 476 U.S. 227 (1986), and United States v. Acri Wholesale Grocery Co., 409 F. Supp. 529 (S.D. Iowa 1976). But these cases rely on the theory of implied consent or a minimal expectation of privacy. These cases do not hold that FDA has the right to photograph the interior of a food facility when the facility has a strict policy against photography and does not consent to the photography.
So, should you resist FDA's request to photograph?
The first thing you need to do is to ask yourself the following two questions:
- Do you have a policy against photography in your plant?
- If you do, is the policy strictly enforced?
If the answer to either question is no, then you're on shaky footing in resisting the FDA's request. By not having a policy or by not strictly enforcing the policy, FDA's legal authority based on implied consent is that much stronger.
Assuming your plant does have a no-photography policy that is strictly enforced, you need to assess whether the photography is worth the fight. It may be. Resisting the request for photos may be worthwhile to protect potential disclosure of trade secrets and to prevent out-of-context photographs from being used adversely by FDA. The problem is that the harder you push against FDA, the more likely that it will seek more information and the more likely that it will seek enforcement action.
In a future entry, we'll explore what legal remedies might be available to prevent the FDA from photographing the inside of your plant.
Learn How to Prepare for an FDA Inspection
Next Wednesday at the ACI Food Regulatory Summit in Chicago I'll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here.
Topics that I plan to cover include:
- FDA's plan to increase frequency of inspections and how it plans to do it
- How to be prepared for FDA's greatly expanded records access authority
- How to avoid new fees that will be imposed by FDA
- Developing an appropriate strategy to deal with FDA
- Preparing a privileged FDA inspection plan and training
More information about the ACI conference and registration can be found here.
Michigan Company Announces Frozen Pasta Recall
A Michigan maker of frozen pasta products has issued a recall for products that were distributed to seven states. Canton, Mich.-based Mucci Food Products is recalling an undetermined amount of frozen meat and poultry pasta products because the food was prepared without federal inspection.
The products were produced from May 1, 2008 to April 24, 2009 and distributed to California, Florida, Georgia, Illinois, Michigan, Missouri, and Ohio. The recalled products bear the establishment number “19177” or “P-19177” inside the USDA mark of inspection and the dates “1218” to “1149” located at the bottom of the product box.
The U.S. Department of Agriculture’s Food Safety and Inspection Service has complete details of the products subject to the recall, including images of the product labels. The USDA has not received any reports of illness as a result of consumption of the products.
Georgia House Unanimously Passes Food Safety Bill; Kellogg CEO Calls for Food Safety Reforms
Update to today’s earlier post: the Georgia House of Representatives unanimously passed a bill today that would strengthen food safety laws in Georgia. The Georgia House and Senate now will resolve minor differences in the proposed legislation and send a final version to Georgia Gov. Sonny Perdue for his signature.
Also today, the AP reports that the chief executive of Kellogg Co. is urging food safety reforms, including written safety plans for all food companies and annual inspections of facilities that make “high-risk foods.” The AP article notes Kellogg lost $70 million worth of peanut products in the recent salmonella outbreak linked to Peanut Corporation of America.
