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.
One of the most fundamental issues for which FDA has asked for comment is the definition of “food” for the purpose of FSVP:
Proposed § 1.500 would define food as having the meaning given in section 201(f) of the FD&C Act (21 U.S.C. 321(f)), except that it would not include pesticides as defined in 7 U.S.C. 136(u). As discussed in the preamble to the interim final rule entitled “Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,” pesticides, including those used in or on food for human or animal use, are comprehensively regulated by the Environmental Protection Agency (69 FR 58974 at 58986, October 10, 2003). For the same reason, we tentatively conclude that pesticides were not intended to be considered “food” for purposes of section 805 of the FD&C Act and the FSVP regulations. We request comment on this exclusion and on whether there should be additional exclusions from the definition of food. Comments seeking additional exclusions should provide specific justifications.
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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