On Nov. 27, 2015, the FDA published its Final Rule outlining how the food industry, already in the midst of implementing Hazard Analysis and Risk Based Preventive Controls, or HARPC (see our previous three-part series on HARPC here: 1, 2, 3), will be responsible for ensuring that foreign suppliers of food and food ingredients are implementing HARPC food safety plans and FDA current Good Manufacturing Practices (or cGMPs).
This new Rule entitled, “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (or FSVP), is the most recent Rule promulgated under the Food Safety and Modernization Act, or FSMA, and places new responsibility on industry members to ensure that foreign suppliers follow the FDA’s HARPC requirements, that compliance is documented, and that importers include this new supply chain verification system in their HARPC food safety plans.
The FSVP applies to anyone who is considered an “Importer” under the new Rule. An Importer is defined as “the U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative” of the foreign food supplier at the time of entry into the U.S. While this definition means that the FSVP rule applies to the vast majority of companies accepting food or food ingredient products into the U.S., there are some exceptions, wherein the FSVP Rule either does not apply or, in some cases, modified or reduced FSVP rules apply:
FSVP does not apply to:
- Fish and other seafood produced under a HACCP plan;
- Juice and juice products produced under a HACCP plan;
- Food for research and evaluation;
- Certain alcoholic beverages and their ingredients;
- Meat, poultry and egg products regulated by the USDA;
- Food imported for personal consumption;
- Food that is transshipped;
- Food that is imported for processing and subsequent export;
- U.S. food that is exported and re-imported without further processing in a foreign country; and
- Manufacturers, processors and holders exempt from HARPC regulation.
Modified or reduced FSVP requirements apply to:
- Dietary supplements subject to cGMPs under 21 C.F.R. § 111;
- Very small importers;
- Importers that import from certain very small suppliers; and
- Importers that import from countries that have food safety regulatory controls that have been recognized by the FDA or found to be equivalent to those required by FSVP and HARPC.
Application of FSVP regulations
The new FSVP Rule consists of the following seven steps for which the Importer is responsible for completing and documenting when importing any food or food ingredient:
- Identify the hazards with each food or food ingredient that are reasonably likely to cause illness or injury. This identification process should be uniform and consistent across all food or food ingredient products.
- Evaluate the risk of the hazard as identified and posed by each imported food and evaluate the foreign supplier’s performance in mitigating these risks.
- Conduct supplier verification to determine that the foreign supplier is engaging in processes relevant and appropriate to the importation of safe foods. This includes ensuring that the foreign supplier has implemented and is following HARPC and other related food safety regulations. The actual verification process of the Importer can vary based on the foreign supplier, the foods being imported and the nature of the hazards identified. Verifications activities include sampling and testing of food and review of the foreign supplier’s food safety records. In all cases, the Importer should document the verification activities and integrate the verification activities and records into their own HARPC food safety plan. The default verification activity is an annual on-site audit of the supplier’s facilities to confirm compliance with the Importer’s FSVP and all applicable FDA regulatory standards.
- Perform appropriate activities as the nature of the food and identified hazards demand based on the realities of the business. Importers, for example, do not need to conduct supplier verification for hazards that are to be controlled later in the distribution chain in the U.S. In such cases, the Importer must nonetheless document this in its HARPC food safety plan and obtain written assurance that the hazard will be controlled for by that customer or, if by an entity further down the distribution chain, that the customer will itself assume the obligation to obtain assurance that the hazard will be controlled for. Furthermore, the new Rule requires the Importer to disclose to the customer the existence of the hazard and that the food has not yet been processed to control for that hazard.
- Conduct corrective actions where: (i) an identified hazard is realized and a food product is adulterated or misbranded; or (ii) an Importer learns that a foreign supplier is not producing the food in compliance with the same public health protection as those required domestically under food cGMPs, HARPC food safety plans and the new Produce Safety Rule.
- Identify themselves as the Importer of the food for each line of food product offered for importation into the United States.
- Retain records of FSVP activities.
These responsibilities represent significant costs for both Importers and the foreign suppliers they use. Implementation of the FSVP programs requires two parallel sets of activities. The domestic Importer must create its HARPC food safety plan, including the implementation of the HARPC supply chain verification processes. These steps require food manufacturers, holders, processors and packers to be aware of each step in the supply chain that provides raw ingredients for the products they make, and be responsible for ensuring that each ingredient is safe and wholesome for human or animal consumption. With the implementation of FSVP requirements, this also includes foreign suppliers. The second step is the creation of the internal procedures and personnel to ensure foreign suppliers are similarly compliant with HARPC food safety plan requirements, as well as documenting the verification activities.
The final Rule will be enforced 18 months after publication. The FDA, during a Nov. 23, 2015 conference stated that FDA inspections after the effective date will include checks for compliance with FSVP integration with HARPC food safety plans for those companies that import food or food ingredient products. Furthermore, with HARPC food safety plan compliance dates less than a year away and considering the integrated nature of FSVPs within HARPC food safety plans, it is vital that importing food companies begin the process of creating these processes and procedures and contact regulatory counsel early and often, as soon as possible in order to ensure timely compliance.
At Thompson Coburn, we have a group of attorneys with substantial experience in assisting companies manufacturing, holding, processing and packing human and animal foods with FDA compliance, FDA inspections, managing foreign suppliers and implementing regulatory compliance programs. If you have any questions about FSVPs, HARPC, the FSMA or and other food safety issues, please feel free to contact Diane Romza-Kutz.
Diane Romza-Kutz is a partner in Thompson Coburn's Health Law Practice Group.