Are Your Foreign Suppliers Ready For FSMA?

The Food Safety Modernization Act (FSMA) plays a large role in global food safety, and the Foreign Supplier Verification Program (FSVP) rule is something every U.S. importer needs to be aware of, since compliance to FSVP begins May 2017. Let’s review how to help your suppliers be ready.

The rule was created for two protective reasons: to prevent potentially adulterated food from being exported to the U.S., and to ensure imported food is produced under the same food safety requirements as domestic products.

Two players in this program are domestic importers of food product to the U.S. and foreign suppliers (the establishment which manufactures/processes food, raises animals [including fish], or harvests food exported to the U.S. without further manufacturing/processing by another establishment). Both have active roles in the FSVP and responsibilities and requirements to ensure proper food safety.

The importer is responsible for verifying that the food produced by the foreign supplier was manufactured, raised, or harvested in accordance with relevant sections of the FD&C Act, depending on the type of food being imported. The importer will be held responsible by FDA for the food safety of all imported food products, including food-contact substances.

What is needed to demonstrate that FSVP requirements are being met? For the most part, the importer’s responsibilities are the same as those of a U.S. manufacturer who sources raw materials and ingredients locally.

To help meet FSVP compliance, the importer needs to:

1. Develop a written hazard analysis for each type of food being imported to determine whether there are any hazards requiring a control.
2. Determine the foreign supplier’s compliance history with food safety regulations, to include those of country of origin, other “ship to” countries, and FDA. The compliance history should include results, corrective actions, and verification of those actions.
3. Assess the applicability of other food safety factors such as storage and transportation practices.
4. Approve or disapprove the supplier based on the verified activities.

The importer also will have to develop, implement, manage, and document certain verification activities designed to meet the requirements of the rule. These include:

• Use of foreign suppliers. Establish a plan and follow written procedures to ensure foods are being imported only from foreign suppliers.
• Foreign supplier verification procedures. Establish and follow written procedures for ensuring that appropriate foreign supplier verification activities are conducted in respect to the imported foods.
• Supplier verification. The FSVP activities must show that the hazards requiring a control in the imported food have been minimized or prevented.
• Frequency of verification activities. The verification activities must be carried out within appropriate timeframes to ensure timely evaluation of control measures, and effective corrections and corrective actions.
• Appropriate verification activities. Some examples of appropriate activities include, but are not limited to: initial and ongoing on-site audits, initial and annual on-site audits for identified hazards needing a preventive control which can cause serious adverse health effects or death in humans and animals (SAHCODHA), sampling and testing of the food product, review of the foreign supplier’s relevant food safety records, and other supplier verification activities that are appropriate based on foreign supplier performance and the risk associated with the food, such as storage and transportation activities essential for food safety or temporal/seasonal changes that might affect food safety.

Auditing is a mandatory requirement for this program. The FSVP rule requires that the program is audited by qualified individuals. The importer can use external qualified individuals to undertake the product hazard analysis and supplier evaluation, and develop and implement the verification activities to assure compliance. However, the importer must document the review of external evaluations and verification activities, assess their conclusions, approve/disapprove, and sign off.

Finally, the FSVP has to be re-evaluated every three years or when failures occur that would affect the safety of the imported product, such as doubt of the effectiveness of a preventive control, the food safety performance of the foreign supplier, or importer awareness of information that might affect the safety of the product.