The Food and Drug Administration recently sent a revised rule to the White House Office of Management and Budget (OMB) that will be an important tool in FDA’s future oversight of foods and ingredients imported into the United States.
Under FSMA, FDA has increased regulatory authority over imported foods. For example, it can block a food from entry if the facility has refused inspection by U.S. officials. Of course, resource-related constraints prevent FDA inspection of more than a handful of foreign producers annually. Lawmakers recognized these limitations and included other provisions in section 301 to increase oversight of imports.
On July 26, 2013, FDA released proposed Foreign Supplier Verification Program (FSVP) regulations that would require importers to verify that food imported into the United States is produced in a way that “provides the same level of public health protection as is required for domestic food producers.” The revised rule will not be publicly available until OMB completes its review.
However, many proposed elements will certainly be included in the final document. Under the proposed FSVP, importers must have a foreign supplier verification program; they must review the compliance status of the food, and of the potential foreign supplier, before importing the food. These reviews would take into account any FDA warning letters, import alerts, and certification requirements issued by FDA.
Importers would also be required to identify the hazards associated with each food they import. Among other tasks, they would be required to review any complaints they receive about the foods they import, take corrective actions and revise their FSVPs as needed.
As originally proposed, FDA set out two risk-based options for supplier verification activities. Either foreign suppliers will control the hazards, or will verify that the hazards are being controlled by its raw material or ingredient supplier.
Under Option 1, if the foreign supplier controls the hazard at its establishment and there is a reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals (SAHCODHA), the importer would be required to show documentation of onsite auditing of the foreign supplier. For non-SAHCODHA hazards that the foreign supplier controls, the importer would be required to conduct one of more of the verification activities (onsite auditing, sampling and testing, review of the supplier’s food safety records, or some other appropriate procedure) before using or distributing the food.
Under Option 2, for all hazards that the foreign supplier will either control or verify that its supplier is controlling, importers would need to choose a verification procedure from among onsite auditing, sampling and testing, review of supplier food safety records, or some other appropriate procedure.
If the importer’s customer will be controlling a hazard identified by the importer, the importer would need to obtain written assurance, at least annually, that its customer is following procedures (identified in the written assurance) that adequately control the hazard.
The proposed rule also states FDA’s intent is to align the supplier verification provisions in the FSVP regulations with any other supplier verification provisions that may be included in the final rules on preventive controls for human and animal food. This would avoid duplicative requirements for an entity that is both a food importer and a registered food facility.
Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:
- Importation of a dietary supplement or dietary supplement component;
- Importation of food by a very small importer or importation of food from a very small foreign supplier; and
- Importation of food from a foreign supplier in good standing with a food safety system that FDA has officially recognized as comparable or determined to be equivalent to that of the United States.
- The proposed rule would exempt importation of the following foods from FSVP requirements:
- Juice and seafood from facilities that are in compliance with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;
- Food imported for research or evaluation purposes;
- Food imported for personal consumption;
- Alcoholic beverages; and
- Food that is transshipped or imported for further processing and export.
Deciding which food products are high-risk will be an especially difficult part of the implementation of the FSVP. The term “reasonable probability” of exposure to a hazard is imprecise and likely to be contested. Adequate control of hazards will not mean a “high risk” product becomes non-high risk no matter how many safety measures they put in place. The fact that such controls are needed determines the high risk status of a food.
Posted in Foods, FSMA Perspective and tagged Charles Breen.