Food Court continues its series discussing the new Foreign Supplier Verification Program (FSVP) rule issued by the US FDA under the Food Safety Modernization Act (FSMA). To read the previous posts click here, here, and here. The posts to date are covering the basics from a high level, subsequent posts will dive into more details, like how the rule defines an audit or how an outbreak impacts an importer’s FSVP under the rule. Today we look at the exemptions provided in the rule and to what extent they truly exempt importers from any required activities. If you read no further the one take away is to know the rule rarely exempts a food or dietary supplement importer fully. The rule is replete with supplier verification activities for all parts of industry.
The two most notable modifications are for dietary supplements and juice and seafood facilities.
The proposed rule provides two sets of standards depending on whether a finished dietary supplement or dietary ingredient is imported. It’s important to recall dietary supplements are regulated as food products under the Food Drug and Cosmetic Act. Deep within the rule the two-pronged approach is explained. An importer of unfinished dietary supplements or ingredients is exempt from the proposed rule so long as the foreign facility is in compliance with 21 CFR Part 111 (the code section regulation Good Manufacturing Practices GMPs for dietary supplements). The FDA is clear an importer must verify the supplier does in fact comply with Part 111. The rule allows the Agency to refuse admittance to unfinished dietary supplements/components found not to be in compliance with the code section. The basis for refusal would be both adulteration and assuming no FSVP in place violation of the FSVP rule. Such an importer would have a choice of coming into compliance with Part 111 or develop and implement a FSVP. Here we see compliance with an existing code section acting as a substitute for the FSVP, but only so long as its verified and followed.
Whereas unfinished dietary supplements are subject to very few FSVP requirements finished dietary supplements imported are subject to most FSVP requirements. The rule doesn’t require a hazard analysis if the supplier if maintaining compliance with part 111. The importer, however, still must develop verification activities that “provide adequate assurances” the supplier is producing the dietary supplement in accordance with the requirements of part 111. Verification activities will include the same list as for other foods, on-site audits, lot testing, review of compliance history and so on. Finished dietary supplement products are subject to the most requirements in large part because further processing will not catch or remedy potential hazards.
Juice and Seafood HACCP
Juice and seafood foreign suppliers following a compliant HACCP program are in compliance with the proposed rule. The most natural exemption would come from a sector of industry already following a hazard analysis program. As mentioned in earlier posts the proposed rule adopts a HACCP style approach to managing hazards from imports. Yet, the exemption doesn’t allow importers to ignore foreign juice and seafood suppliers. Instead an importer must verify the supplier is in compliance with HACCP. That is, rather than place an obligation to ensure hazards are controlled by a facility using the FSVP rule and importer must ensure, and verify, the hazards are controlled using HACCP. The obligation to use a HACCP program already exists and now there is a new affirmative obligation on the importer to ensure the HACCP program is in fact in place and followed.
The FDA also states an interest in revising juice and seafood regulations in the FSVP. The Agency acknowledges the proposed rule offers a “more comprehensive approach to verification than the existing juice and seafood HACCP regulations.” It goes on to suggest the HACCP regulations may require an update to be on par with the FSVP rule. It will be interesting to note how long before the Agency makes the changes.
Full Exemptions Provided Criteria Met
Perhaps the one true exemption in the rule allows food imported for research or personal consumption to bypass the regulations. The importer remains under an obligation to ensure the criteria of the rule is met and the proper declaration is made when importing. Otherwise, the food imported for this purpose is exempt from compliance with the proposed rule. Alcoholic beverages are exempt as are food products transshipped through the US (i.e. foods passing through the US, but never sold in the US). The provisions covering alcoholic beverages warrants further review because the rule modifies requirements for important of alcoholic beverages and food products.
Other Modified Requirements
The proposed rule also would establish modified requirements for food imported by very small importers and very small foreign suppliers. A very small facility is one whose average annual monetary value of sales of food during the previous 3-year period on a rolling basis is no more than $500,000, adjusted for inflation. The limitation of $500,000 in annual food sales is consistent with the sales limitation in the definitions of “qualified facility” in the Preventive Controls Proposed Rule and “small business” in the Produce Safety Proposed Rule, which demonstrates parity between domestic and foreign products. An importer still must document, at the end of each calendar year, that it meets the definition of very small importer i or that the foreign supplier meets the definition of very small foreign supplier as defined in the rule.
Modified requirements also would apply to food from a foreign supplier in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as “comparable” to that of the United States (e.g., through a signed systems recognition arrangement or other agreement between FDA and the country establishing official recognition of the foreign food safety system) or determined to be equivalent to that of the United States, provided the importer documents that certain conditions are met. These conditions are that (1) the foreign supplier must be in, and under the regulatory oversight of, a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent, and (2) the food must be within the scope of the relevant official recognition or equivalency determination. When these conditions are met, the importer would be required to determine and document whether the foreign supplier of the food is in good compliance standing with the food safety authority of the country in which the foreign supplier is located. To date this includes one country – New Zealand.
As can be seen from the exploration of exemptions and modifications importers must always be verifying some component or aspect of their foreign supplier. This is a detailed and highly active rule in that regard.