Deadline Approaches for Comment on New FDA FSMA Rules

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Only 1 month left to comment on U.S. FDA FSMA proposed rules. FDA released two new proposed rules on Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certified Bodies; Registrar Corp encourages the industry to comment.

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FDA is taking comments on both the FSVP and Accreditation of Third-Party Auditors/Certified Bodies until November 26, 2013.

On October 22 and 23, 2013, the U.S. Food and Drug Administration (FDA) hosted a public meeting to discuss FSMA proposed rules for the Foreign Supplier Verification Programs (FSVP) and the Accreditation of Third-Party Auditors/Certified Bodies. During this meeting, FDA took oral comments on the proposed rules. Currently, FDA is taking written comments online.

On July 26, 2013, the FDA released two proposed rules for the food and beverage industry as mandated in section 301 of the Food Safety Modernization Act (FSMA). FDA designed both rules to ensure the safety of imported food. The first of these rules, FSVP, requires food importers to take more responsibility for the food they import into the U.S. As part of FSVP, importers will have to ascertain that the food they import is produced in compliance with FDA regulations—e.g. produced under reasonably appropriate risk-based preventive controls, is not adulterated, and does not have misbranded labeling. FSVP regulations vary based on the type of food products and the category of the importer.

The second proposed rule is Accreditation of Third-Party Auditors/Certified Bodies. This program will allow for bodies other than the FDA to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. With this Accreditation program, FDA can ensure the competence of third-party auditors/certification bodies who conduct foreign food safety audits. Both of these rules will help FDA increase efficiency and reduce costs.

FDA is taking comments on both the FSVP and Accreditation of Third-Party Auditors/Certified Bodies until November 26, 2013. FDA's comment process allows anyone to submit a comment on any part of the proposed rule. FDA bases 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 publish a final rule, FDA must conclude that its proposed solution will help accomplish the goals or solve the problems identified. FDA must also determine whether alternate solutions would be more effective or cost less.

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.

You may submit comments on the proposed the Accreditation of Third Party Auditors/ Certified Bodies, Docket No. FDA-2011-N-0146-0024 at: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0146-0024.

Registrar Corp will be providing additional information on the Foreign Supplier Verification Program (FSVP) and the Accreditation for Third Party Auditors and will alert industry when the final rule is published. Tweet Registrar Corp (@RegistrarCorp) if you have specific questions. Or, for any questions related to U.S. FDA Regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

About Registrar Corp: Registrar Corp is a FDA Compliance Agency that helps companies with U.S. FDA Regulations. Founded in 2003, Registrar Corp has assisted more than 20,000 companies to comply with FDA requirements. With 19 Global Offices, Registrar Corp’s team of multilingual Regulatory Specialists can help your company to comply with U.S. FDA Regulations. For immediate assistance with U.S. FDA Regulations, phone Registrar Corp: +1-757-224-0177 or receive online http://www.registrarcorp.com/livehelp from our regulatory specialists.

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