ARLINGTON, VIRGINIA, U.S. — The U.S. Food and Drug Administration (FDA) released on Nov. 13 the Foreign Supplier Verification Program (FSVP) and third-party accreditation final rules.
The FDA FSMA rule on FSVP for Importers of Food for Humans and Animals compliance dates for some businesses begin in 18 months.
The final rule requires that importers perform certain risk-based activities to verify that food imported into the U.S. has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a 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 said. 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 foods.
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 said.
The FDA is responsible for ensuring that importers meet the FSVP requirements, and will also provide guidance, outreach and training.
"Based off of an initial, and relatively brief, review of the rule, it appears FDA overlooked the majority of AFIA's comments on the supplemental proposed rule," said Richard Sellers, AFIA senior vice-president of legislative and regulatory affairs.
"One thing AFIA is pleased to see in the final rule is that FDA modified the definition of 'importer' and 'U.S. owner or consignee,'" said Sellers, which provides clarification and ensures the entity responsible for FSVP compliance is the one who has a financial interest, knowledge and control over the supply chain.
FDA left modified FSVP requirements in place for certain types of importers and foreign suppliers; however, FDA aligned this with the regulations on preventive controls for human food and animal food, AFIA said. An example of this is imported animal food; FDA amended the definition of "very small importer" to be consistent with a "very small business" under the preventive controls for animal food regulation.
The modified FSVP requirements for "very small foreign suppliers" were amended to be applicable to "certain foreign suppliers" and are identified by three types of foreign suppliers, rather than an annual monetary sales value. AFIA expressed objection to the inclusion of modified FSVP requirements in its December 2014 comments for "very small importer" and "very small foreign suppliers," as it would create an unfair advantage to smaller foreign suppliers and importers over larger ones, AFIA said. Despite AFIA's disappointment, it appreciates the qualifications are aligned with the preventive controls for the animal food regulation.
FDA dedicated a section in the final rule to address certain circumstances where a hazard requiring a control is identified in food/feed, but foreign supplier verification is unnecessary, such as when the foreign supplier's customer controls the hazard, AFIA said. However, the final rule still requires an importer to obtain assurances from its customer that controls the hazard. In AFIA's comments on the supplemental FSVP rule, the organization expressed concern that this requirement was neither practical nor reasonable and as it is beyond what a customer/supplier relationship should be, AFIA said.
AFIA said it is pleased to see the final FSVP rule corresponds with the requirements and definitions of the supply-chain program under the final rule on preventive controls for animal food. This will assist with consistency and application of the final rules.
To read the FSVP rules and regulations click here.