On November 16, 2015, the Food and Drug Administration (“FDA”) finalized the Foreign Supplier Verification Programs rule (“FSVP”) for importers of food for humans and animals under the Food Safety Modernization Act (“FSMA”).

The final rule lays out risk-based requirements for importers to follow that would verify that the food imported in the United States meets applicable U.S. food production safety standards. The rule aims to reduce the risk of Americans contracting a serious foodborne illness or encountering other safety problems from contaminated food that is produced outside of the United States. Imported food accounts for about 19 percent of the U.S. food supply, including about 52 percent of the fresh fruits and 22 percent of the fresh vegetables consumed by Americans (2013 statistics, according to the USDA, Economic Research Service). The FDA first proposed this rule in 2013 and issued a supplemental notice of proposed rulemaking in September 2014.

For the final rule, the FDA took into account modern supply and distribution chains in order to allow greater flexibility for importers to meet certain requirements.

Implications for the Industry

The FSVP rule is very comprehensive and creates significant risk assessment, verification, corrective actions, periodic assessment, and recordkeeping responsibilities for the industry. The rule shifts many of the compliance and supplier verification duties to the importers and furthermore, requires an FSVP for each type of food that is imported.  Therefore, the major implications for importers are increased costs and efforts for training on the recordkeeping, periodic assessment, and verification activities; implementing these new requirements; and allocating these new duties to personnel.  Also, industry members have between 6 to 18 months to comply with these new requirements, and, therefore, importers should start making efforts to understand and comply with the FSVP rule soon.  Importers should monitor the FDA website for new guidance on the FSVP rule to learn more about the FDA’s expectations for the industry.  The FDA will be hosting a webinar on the FSVP rule on November 23, 2015 that can assist industry members in understanding these requirements.

Effective and Compliance Dates

The final rule on FSVPs would become effective on January 26, 2016, which is 60 days after November 27, 2015, the date that on which the rule will be published in the Federal Register.

Generally, importers would be required to come into compliance with the FSVP regulation 18 months after the publication date. However, there are some modified requirements for certain entities. For applicable entities, the date that importers must comply with the FSVP regulation will be the latest of the following:

  • 18 months after the publication of the final rule on November 27, 2015;
  • For the importation of food from a supplier that is subject to the preventive controls regulations for human food or animal food or the produce safety regulation, 6 months after the foreign supplier of the food is required to comply with the relevant regulations; or
  • For an importer that is also subject to the supply-chain program provisions in the preventive controls regulations for human food or animal food, the date the importer, as a receiving facility, is required to comply with the supply-chain program provisions of the relevant regulation

Covered Entities Under FSVP

An importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.

Importers are responsible for actions that include:

  • determining known or reasonably foreseeable hazards with each food;
  • evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance;
  • using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities;
  • conducting supplier verification activities; and
  • conducting corrective actions

The final rule reflects the FDA’s goal to align the FSVP requirements with the supply-chain provisions of the preventive control regulations. In keeping with this aim, the final rule specifies that importers who are in compliance with the supply-chain program provisions in the preventive controls regulations, who implement preventive controls for the hazards in the food they import, or who are not required to implement a preventive control under certain provisions of the preventive controls regulations, are deemed in compliance with most of the FSVP requirements.

Hazard Analysis

An importer of foreign food must identify and evaluate the known or possible hazards of each food item that it imports in order to determine if there is a hazard that requires control to be avoided. The different types of hazards include:  biological hazards, such as parasites; chemical hazards, such as natural toxins or food allergens; and physical hazards, such as glass.

Importers should assess the likelihood of these hazards occurring without any controls and the illness or injury that could result. In order to come to a hazard determination, the importer should consider these factors:

  • formulation of the food;
  • condition, function and design of the establishment and equipment of a typical entity that produces the food;
  • raw materials and other ingredients;
  • transportation practices;
  • harvesting, raising, manufacturing, processing and packing procedures;
  • packaging and labeling activities;
  • storage and distribution;
  • intended or reasonably foreseeable use; or
  • sanitation, including employee hygiene

In light of the FDA’s goal of making the requirements more flexible for the importers of foreign food, the FSVP rule allows for an exception to the hazard analysis requirement in certain situations. Where another entity has analyzed the known or reasonably foreseeable hazards for the food, using qualified sources, to determine whether there are any hazards requiring a control, and the importer reviews and verifies the accuracy of the analysis, the importer can rely on the entity’s analysis to meet the hazard analysis requirements.

Moreover, the final rule excludes from most of the FSVP requirements, certain types of food from a foreign supplier in a country whose food safety system the FDA has officially recognized as comparable or determined to be equivalent to that of the United States, provided that:

  • the food is within the scope of the relevant official recognition or equivalency determination;
  • the importer determines that the foreign supplier of the food is in good compliance standing with the relevant food safety authority; and
  • the food is not intended for further processing in the United States, e.g., packaged food products and raw agricultural commodities (RACs) that will not be processed further before consumption

Supplier Verification

In addition to conducting the hazard analysis, the importer must verify the entity, such as the foreign supplier, who will be minimizing or preventing the hazards identified in the hazard analysis. Also, the importer must review the foreign supplier’s procedures and practices in place that are related to the food’s safety.  In addition to reviewing the applicable FDA food safety regulations, the importer must evaluate information regarding the foreign supplier’s compliance with these regulations and the supplier’s food safety history.

Furthermore, the evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light regarding a potential hazard.

Importers are not required to evaluate the food and supplier or conduct supplier verification activities if a subsequent entity in the distribution chain is processing the food for food safety in accordance with FSVP requirements. This information must be disclosed in documents accompanying the food.

Corrective Action

Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection as required under the produce safety and preventive controls regulations, as applicable, or that the supplier produces food that is adulterated or misbranded with respect to allergen labeling.

In response to comments to the proposed rule stating that certain proposals were too burdensome or duplicative, the FDA changed the corrective action requirements in the final rule. Now §1.508(a) of the final rule states that a determination that a corrective action is needed could be, but is not required to be, based on a review of consumer, customer, or other complaints related to food safety. The FDA determined that reviews of consumer complaints are more useful for providing feedback for continuous improvement of food safety, instead of verification of preventive controls and therefore, the requirement for importers to review consumer complaints was removed from the final rule.

Excluded Categories and Reduced Requirements

While the FDA estimates that there are approximately 56,800 persons who meet the definition of importer set forth in the final rule and are therefore subject to its information collection requirements, the final rule exempts many types of food from the requirements.

The following types of food are excluded from the FSVP requirements:

  • certain juice and seafood products and ingredients;
  • food for research or evaluation;
  • food for personal consumption;
  • certain alcoholic beverages and ingredients imported for use in alcoholic beverages;
  • food that is transshipped through the United States;
  • food that is imported for processing and future export;
  • food that is produced in the United States, exported, and returned to the United States without further manufacturing/processing in a foreign country; and
  • meat, poultry, and egg products that at the time of importation are subject to the requirements of the U.S. Department of Agriculture.

Additionally, the final rule provides modified requirements for dietary supplements, small importers[1], and importers of food from certain small suppliers[2].

[1] The definition of very small importer is consistent with the definition of very small business in the preventive controls rules: a sales ceiling of $1 million for human food and $2.5 million for animal food.

[2] Small suppliers include facilities subject to modified requirements under the preventive controls rules because they are qualified facilities; farms that are not covered farms under the produce safety rule because they average $25,000 or less in annual produce sales or because they meet requirements for a qualified exemption; and shell egg producers with fewer than 3,000 laying hens.