FSVP and Third-party Accreditation Rules Released; AFIA Gives Initial Response
The U.S. Food and Drug Administration this morning released the long-awaited Foreign Supplier Verification Program (FSVP) and third-party accreditation final rules.The U.S. Food and Drug Administration this morning released the long-awaited
The FSVP rule takes effect in 18 months after publication of the final rule.
FSVP requires importers to perform certain risk-based activities to verify that food imported into the U.S. is produced in a manner that provides the same level of public health protection that is required of domestic food processors.
"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. 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 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. 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. 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 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. AFIA looks forward to doing a more in-depth assessment of the final rule as a whole.
The final rule on "Accreditation of Third-party Auditors" provides requirements for accreditation bodies seeking recognition by FDA as well as requirements for third-party auditors/certification bodies (CBs) seeking accreditation. FDA will use certifications issued by accredited CBs in deciding whether to admit certain imported food into the U.S. that FDA has determined poses a food safety risk under section 801(q) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 381), and in deciding whether an importer is eligible to participate in the Voluntary Qualified Importer Program. These requirements will help ensure the competence and independence of the accreditation bodies and third-party auditors participating in the program. AFIA expressed its support of the rule during the comment period process; however, noted concerns that the final rule may not achieve its targeted goal because of the onerous notification and reporting requirements FDA set on accredited third-party auditors/CBs.
FDA divided audits into "regulatory," done by a FDA-recognized auditor, and consultative audits requested by the firm from a non-recognized auditor. Recently, FDA published notice regarding how the agency would recognize certification bodies and the potential charges to do so.
"AFIA is concerned with requirements in the FSMA final rule regarding the record requirements for certifying bodies to report to FDA about regulatory audits. The relationship between a certifying body and a facility or company should be considered confidential, including audit reports," stated Sellers.
FDA requires CB's to report any deficiencies discovered during an audit to FDA in its final report. This includes corrective actions, testing results and any major changes at the facility.
"FDA evaluating complete audit reports is irrelevant," Sellers said. "In order for a facility to meet certification, all non-conformities will need to be corrected. The certificate acknowledging the facility meets the certification requirement is sufficient. FDA's access to sensitive information makes facilities unnecessarily vulnerable to inappropriate public access and use of confidential information."
FDA should only request the certificate or audit summary. Requesting information beyond these two items raises concerns. AFIA's concerns pertain to the Freedom of Information Act and how FDA will use the information. Even though this is a lowering of the requirements, AFIA notes few firms will seek regulatory audits due to data being sent to FDA by the auditor.
"In our initial brief of the final rule, it appears FDA has not adjusted the notification and reporting requirements that were originally proposed," said Sellers. "We could not be more disappointed with FDA's decision as any requirements that discourage use of audits or constrain the free exchange of information between the auditor and the audited facility would be highly counter-productive."
FSVP and third-party accreditation will be covered in AFIA's daylong FSMA Phase III trainings. The organization currently has two scheduled, both will cover identical material. The first training is Dec. 8, in Arlington, Va., following the , Dec. 9-10, at the same venue. The second seminar is slated for Wednesday, Jan. 27, 2016, at the in Atlanta, Ga. and final rules. The American Feed Industry Association's initial reaction is as follows:Tweet