The Food Safety Modernization Act (FSMA) issued by FDA regarding the Foreign Supplier Verification Program (FSVP) for importers of human and animal food.

The final rule requires that importers carry out certain risk-based activities to verify that food imported into the United States are produced in a way that meet all applicable American safety standards.  The regulation is the product of significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.

After input received during the comment period and during numerous engagements that included public meetings, webinars, and listening sessions, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions included providing importers flexibility in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in food.

The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.

The FDA is committed to helping importers to meet the FSVP requirements. In order to facilitate compliance FDA will provide guidance, outreach and training.

 

Who is covered by the FSMA rule?

For the purposes of 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.

However, there are exemptions discussed below.

What is an FSVP?

Importers covered by the rule must have the FSVP program in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterate and is not misbranded with respect to allergen labeling.

Importers are responsible for action 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;

Conducting corrective actions;

Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the suppliers’ performance or, when necessary, on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.

Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Similarly, if the importer obtains many different foods from a single supplier, a separate FSVP would be required for each food.

Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if

They are in compliance with the supply-chain program requirements under the preventive controls rules;

They implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or

They are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimizing or preventing identified hazards) and they comply with requirements for disclosures and written assurances.

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 about a potential hazard or the foreign supplier’s performance.

Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. FDA has extended the compliance date for obtaining these written assurances for two years. However, as required by the final rule, importers must disclose in documents accompanying the food that the food is not processed to control the identified hazard.