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FDA’s Definition of a “Qualified Individual” for the Foreign Supplier Verification Program (FSVP)

On July 26, 2013, FDA issued the new proposed regulation, the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP), in accordance with section 301 of the Food Safety Modernization Act (FSMA). In the proposed rule, FDA has asked interested parties to comment on various aspects of the proposed regulation.

The notice and comment process enables anyone to submit a comment on any part of the proposed rule. FDA is not permitted to base its final rule on the number of comment in support of the rule over those in opposition to it. Instead, FDA must base its reasoning and conclusions on the rulemaking record, consisting of the comments, scientific data, expert opinions, and facts accumulated during the pre-rule and proposed rule stages. To move forward with a final rule, FDA must conclude that its proposed solution will help accomplish the goals or solve the problems identified. FDA must also consider whether alternate solutions would be more effective or cost less.

If the rulemaking record contains persuasive new data or policy arguments, or poses difficult questions or criticisms, FDA may decide to terminate the rulemaking. Or, the agency may decide to continue the rulemaking but change aspects of the rule to reflect these new issues. If the changes are major, the agency may publish a supplemental proposed rule. If the changes are minor, or a logical outgrowth of the issues and solutions discussed in the proposed rules, FDA may proceed with a final rule.

An issue for which FDA has asked for comment regards FDA’s definition of a “qualified individual” as it pertains to FSPV:

Proposed § 1.500 would define qualified individual as a person who has the necessary education, training, and experience to perform the activities needed to meet the requirements of this subpart; this person may be, but is not required to be, an employee of the importer.” FDA request comment on whether the definition of qualified individual should include additional requirements regarding education, training, and experience.

Your comments regarding the qualifications of the “qualified individual” is important as FDA proposes that a “qualified individual” must develop an Importer’s FSVP and perform each of the required activities, including:

– Review of the compliance status of foods and foreign suppliers
– Analysis of hazards reasonably likely to occur with foods
– Determination and performance of appropriate foreign supplier verification activities
– Review of complaints, investigation of adulteration or misbranding, and taking of corrective actions
– Periodic Reassessment of the FSVP
– Importer Identification At Entry
– FSVP Recordkeeping

Comments must be submitted by November 26, 2013. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

You may submit comments on the proposed Foreign Supplier Verification Program rule, identified by Docket No. FDA-2011-N-0143 and/or Regulatory Information Number (RIN) 0910-AG64 at this link: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0143-0023

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