Understanding the Proposed Rule: FSMA s Foreign Supplier Verification Program FDA s proposed rule creates a fundamental shift in oversight of imported foods from that of inspection/examination at the port of entry to responsibility placed in the hands of the foreign supplier and importer. BY CLIFF PAPPAS 6 SEPTEMBER/OCTOBER 2013 AIB UPDATE
An FDA consumer safety officer working at the border crossing prepares tomato samples for testing by the FDA mobile laboratory unit. On July 29, 2013, the FDA released its proposed Foreign Supplier Verification Program (FSVP) rule. This proposed rule falls under section 301 of the Food Safety Modernization Act (FSMA) and impacts food facilities worldwide that export food to the United States. It is available for comment until November 26, 2013. Under the proposed rule, all importers of food for human and animals, unless exempt or subject to modified requirements, would be required to develop, maintain, and follow a FSVP. This is a fundamental shift in oversight of imported foods from one relying on inspection/examination of imported foods at the port of entry to a system that places the responsibility for food safety on the foreign supplier and importer. FDA maintains that the proposed rule represents a flexible, risk-based approach to foreign supplier verification that is intended to be sufficiently general and flexible to apply to a variety of circumstances without being unduly burdensome or restrictive of trade. AIB UPDATE SEPTEMBER/OCTOBER 2013 7
WHO IS THE IMPORTER? An importer is defined as the person in the U.S. who purchased the food. If the food has not been sold to a person in the U.S., it would be the U.S. consignee. If there is no owner or consignee, this is the U.S. agent or representative of the foreign supplier. WHO IS THE FOREIGN SUPPLIER? A foreign supplier is defined as the farm that raised the animal or harvested the imported food or the last foreign establishment that manufactured or processed the imported food in more than a minimal manner. (Examples of minimally processed are adding a label, packing, or holding.) KEY FEATURES For each imported food, unless otherwise exempt or subject to modified requirements, the importer would be required to maintain and follow an FSVP with certain standard requirements, including: 1. A qualified individual as defined in the proposed rule would be required to develop the FSVP and perform most verification activities. A qualified individual is someone with the necessary education, training, and experience to perform each of the activities within the FSVP, including on-site auditing. This person would perform verification activities related to preventive controls and must have training or experience in preventive controls. The qualified individual is not required to be an employee of the importer. These requirements are similar to those proposed in the preventive controls rule. 2. A list of its foreign suppliers. 3. A review of the compliance status of the food and supplier. 4. A hazard analysis to determine the hazards reasonably likely to occur in the imported food. This evaluation would include: Ingredients of the food. Condition, function, and design of the foreign supplier s establishment and equipment. Transportation practices. Harvesting, raising, manufacturing, processing, and packing procedures. Packaging and labeling activities. Storage and distribution. Intended or foreseeable use of the food. Sanitation, including employee hygiene. Any other relevant factors, such as a natural disaster, affecting the foreign supplier facility. 5. Determine and document appropriate Foreign Supplier Verification (FSV) activities to provide adequate assurances that the hazards identified as reasonably likely to occur are adequately controlled: Verification Option 1. For any hazard that has a reasonable probability of causing serious adverse health consequences of death to humans or animals (SAHCODHA), the importer would be required to conduct or obtain documentation of an on-site audit before importing the food and at least annually thereafter. For all other 8 SEPTEMBER/OCTOBER 2013 AIB UPDATE
FDA consumer safety officers work at the border crossing preparing samples for testing by the FDA mobile laboratory. At left, officers prepare samples of yellow squash. At right, the officer prepares pepper samples. hazards (food), the importer would be able to choose from a series of verification activities that include on-site audits, periodic or lot-by-lot sampling and testing, periodic review of the foreign supplier s food safety records, and/or other appropriate practices (not defined). The on-site inspection goes beyond the requirements for seafood and juice, both of which are considered high risk foods. Verification Option 2. For any hazard the importer could choose from the verification activities identified above for non-sahcodha hazards and establish written procedures for conducting FSV activities. For thermal processed low-acid foods packaged in hermetically sealed containers, the importer would have to have a FSVP. If the food is produced in accordance with 21 CFR 113, then biological verification can be through the supplier s compliance with 113. 6. A review of all complaints, instances of adulteration, or misbranding, and associated appropriate corrective actions, which could include discontinuing the use of a foreign supplier. 7. A reassessment of the FSVP at least once every three years and upon becoming aware of new information about potential hazards associated with the imported food. 8. The Dun and Bradstreet Data Universal Numbering System (DUNS) number for each foreign supplier when filing entry with Customs and Border Protection (CBP). 9. Record retention in English for at least two years, making records available to FDA upon request, and sending records electronically in response to a written request. VERIFICATION DETAILS The importer would be required to verify only its foreign supplier. The importer would not be required to verify any entities before the foreign supplier. The importer would only have to verify those issues identified in the importer s hazard analysis as reasonably likely to occur. In instances where there are other FDA regulations (produce standards), these could take precedence over control of the hazard. Where a hazard is controlled by the importer s customer, FSVP may not be required. The importer would be required to provide documentation, at least annually, that the importer or customer is following procedures that adequately control the hazard or obtain at least annually written documentation from the customer they are following procedures that adequately control the hazard. MODIFICATIONS AND EXEMPTIONS Modified requirements would apply to dietary supplements components, including direct contact packaging or if the importer s customer is required to meet Part 111. The importer must verify the dietary supplement is produced in compliance with 21 CFR Part 111. If the importer is in compliance with Part 111 (determine such requirements have AIB UPDATE SEPTEMBER/OCTOBER 2013 9
been met), then the importer would only be required to: Maintain all records in English for at least two years, make records available to FDA upon request, and send records electronically in response to a written request. Modified requirements would apply to finished dietary supplements, in which the importer must: Develop, maintain, and follow a FSVP. Have a qualified individual develop the FSVP and complete the verification activities. Complete a compliance review. Review complaints, instances of adulteration, instances or misbranding, and associated corrective actions. Reassess the FSVP as required. Follow written procedures for conducting foreign supplier verification, including on-site audits; periodic or lot-by-lot sampling and testing; periodic review of the foreign supplier s food safety records; and/or other appropriate practices (not defined). There may be an exemption where the importer is the same corporate family as the foreign supplier. Since both parties could be subject to a single company-wide approach to food safety in which hazards are controlled and verified by a common supply chain management system. FDA is seeking comment on this exemption. Similar requirements would be in place for food from a very small supplier. There are some modified rules for very small importers with annual sales less than $500,000. These include: Document annually they still meet the definition. Develop, maintain, and follow a FSVP. Have a qualified individual develop the FSVP and complete the verification activities. Complete a compliance review. Obtain written assurance (brief description of the foreign supplier s processes and procedures) before FDA mobile lab analysts prepare to test produce crossing the border for Salmonella and E. coli. Mobile laboratories help FDA quickly test food and drugs for contaminants. When not deployed, the mobile labs are stationed at FDA s Jefferson, Arkansas Regional Laboratory. importing the food and every two years thereafter. Promptly take and document corrective action if it is determined that a foreign supplier is not producing food in compliance with the appropriate standard or is adulterated under section 402. Maintain all records in English for at least two years, make records available to FDA upon request, and send records electronically or by mail in response to a written request. There also are modified requirements for foods from countries whose food safety systems have been officially recognized by FDA as comparable or equivalent to that of the U.S. New Zealand is currently the only country with this designation; however, FDA has initiated systems recognition assessment with Canada. COMPLIANCE Importation of certain foods: juice and seafood produced in compliance with juice/ seafood HACCP regulations, alcoholic beverages, food imported for research or evaluation, food for personal consumption, and food transshipped through the U.S. or imported for export are exempt. An article of food offered for import would be subject to refusal if it even appears that the importer is not in compliance with the FSVP requirements. Generally compliance would be 18 months after publication of the final rules. However, FDA recognized that an importer cannot be expected to verify its foreign supplier s compliance with preventive controls before the foreign supplier is required to comply with the preventive controls. Therefore, FSVP will be required six months after the date that the foreign supplier of the specific food is required to comply with the relevant preventive controls rule. If the food is a raw agriculture commodity (RAC), compliance will be 18 months after the date of publication of the FSVP rule or six months after required compliance to the produce safety rule, whichever is later. AIB The author is Senior Advisor, Quality Systems and HACCP for AIB International. 10 SEPTEMBER/OCTOBER 2013 AIB UPDATE