President Obama signed into law The Food Safety Modernization Act (FSMA – P.L. 111-353) on January 4, 2011. The Food and Drug Administration will publish their FSMA regulations this year. What this means for importers is:
- prepare to establish a risk-based foreign supplier verification program that guarantees imported food from each supplier is produced to the same U.S. safety standards required under the Food Drug and Cosmetic Act as amended by FSMA.
- maintain thorough documentation on your consignments, including ingredients and the manufacturing processes involved
- traceability of food products for humans and animals are the responsibility of the importer
- if food products for humans or animals are not allowed entry into the U.S. within 15 calendar days the goods may be placed in a warehouse at the importer’s risk and expense. If the goods are not allowed entry within six months from the date of importation, they can be sold at public auction or destroyed. Perishable items may be sold sooner. Destruction of any contaminated consignment(s) that are refused entry into the U.S. must be accomplished within the regulatory guidelines of the Environmental Protection Agency (EPA) and Custom and Border Protection (CBP).
- in cases where FDA has “reasonable probability” of the food article causing serious adverse health effects or death to humans or animals, FDA may suspend the registration of the food facility.
Background of the FSMA
As background, 15% of the total U.S. food supply is imported (seafood, 80%, fresh fruit, 50%, vegetables 20%). FDA relies heavily on a port of entry inspection system. But given the exponential increase in the level of imports over the last 10-15 years, FDA can no longer rely on these inspections to adequately ensure U.S. consumers of safe food and feed.
The prevention-based focus of the FSMA shifts more of the responsibility of prevention to the importer of food and feed into the U.S. Currently an importer of food and feed ingredients, or his/her representative, must file an entry notice and an entry bond with the U.S. Customs & Border Protection pending a decision regarding admissibility into the U.S. FDA has trained officials who review electronic entries to make decisions on product admissibility into the U.S. These officials have several options at their disposal:
- Request examination or a sample of the product
- Release the product
- Request additional information or documents
- Recommend detention of the entry
- Sample Collection and Analysis (About 2% to 3 % are examined or tested and are usually targeted exams of high risk or known violators)
Title III of the FSMA shifts the responsibility of assuring that imported food articles for humans and animals meets U.S. standards from the FDA to the importer. Importers will be responsible for implementing a risk-based foreign supplier verification program that guarantees the imported food from each supplier is produced to the same safety standards required under the Food Drug and Cosmetic Act as amended by FSMA. These programs will be both arduous and costly. If imported foods are found to be adulterated or misbranded, the importer is responsible for any corrective actions such as a product recall.
Importers are responsible for holding the product until released by both Customs and FDA. Importers face confiscation of their bond funds, prosecution or a recall of the product if not held until officially released. If a product is refused entry into the U.S. the owner or consignee has 90 days to destroy or export the product – although FDA does not typically allow the exportation of a product considered a significant health risk.
FDA has enhanced these regulatory processes in recent years in light of the (2007) FDA finding contaminants in vegetable proteins imported into the U.S. from China and used as ingredients in pet food, and the subsequent (2008) detection of melamine in milk products and infant formula. FDA imposed an Import Alert on these products that remains in effect today. Only importers who source food and feed ingredients from Chinese manufacturers that maintain an exemption are allow entry into the U.S.
Adulteration of protein meals with non-protein nitrogen sources that increase protein content levels have been known to occur in the food industry for decades. In recent years FDA has altered their investigation techniques to become more effective in stopping this form of economic fraud. For instance, countries like China price feed ingredients used for animal food by its level of protein content. Since melamine contains a high level of nitrogen it increases the measured protein content. FDA is increasingly investigating and testing high-priced feed ingredients from China.
Cansler Consulting & The Food Safety Modernization Act
As a food and agricultural lobbying firm, Cansler Consulting is well versed in the intricacies of the Food Safety Modernization Act.
- Strategic legislative and regulatory advice
- Act as the conduit between FDA and your organization to ensure regulations meet the realities of the industry
- Compliance advisory
Having two decades of experience working closely with congressional leaders on key Committees and regulatory officials, Tim Cansler, Founder and Chief Strategist of Cansler Consulting, continues to successfully achieve legislative and policy initiatives vital to client interests. Our successful strategies have consistently led to federal budget authorization and appropriations sought by clients including leading associations and Fortune 200 companies. Cansler Consulting has also been successful in working with regulatory officials to ensure programs beneficial to clients’ interests are implemented as intended.
If your company needs recommendations on how to comply with FSMA requirements or representation before FDA, please contact us today at (202) 714-2822 for a consultation today to see how we can help you.