FDA Seeks Public Comment On Revised Sections Of FSVP
By Laurel Maloy, contributing writer, Food Online
The revisions associated with FSMA’s Foreign Supplier Verification Program have been published in the Federal Register and will be open for public comment through December 15
As a whole, the original concept and objective FSMA’s Foreign Supplier Verification Program (FSVP) rule has not changed. However, some of the language has. The newly-proposed language aligns the FSVP more closely with the FSMA’s Preventive Control rule, which combines Current Good Manufacturing Practices (CGMPs), and Hazard Analysis and Risk-Based Preventive Controls (HARPC). The FSVP, as does the Preventive Control rule, contains regulatory language on both human and animal foods.
The need for FSVP became painfully apparent following a couple of food-safety debacles with wide-reaching consequences. The most-recent incident was that of melamine-tainted vegetable proteins imported from China and used to manufacture pet foods in the U.S. A large number of family pets required veterinary intervention, while many more perished. The final outcome was that two Chinese companies and the associated Chinese executives — along with a U.S. company and its president and CEO — were indicted. The FSVP is calculated to control supply-chain risk for imported human and animal foods, preventing this type of tragedy from occurring in the future.
FSMA Friday: Further Discussions Regarding FSVP 2nd Review Cycle
The FDA has filed the revisions in the Federal Register and has reopened a comment period on the revisions only. The remainder of the FSVP ruling has been approved for finalization, with the final rule set to take effect in October of next year. The corresponding regulation is Title 21, Code of Federal Regulation (CFR), with parts 1, 16, 106, 110, 114, 117, 120, 123, 129, 179, and 211 being revised and reopened for public comment.
The changes expected to garner the most attention and comment are:
Definition Of Very Small Importer: The definition of a very small importer will now align with the standards set in the Preventive Control rule. A very small importer is one with sales of $1 million or less annually.
FDA Audit Requirements: On-site audits are required when an importer identifies hazards that could be potentially injurious or that could result in severe adverse health effects or death. However, more flexibility is being granted than in the previous version. If an importer can demonstrate how the risk is being effectively managed and how it ensures its suppliers can be verified successfully, the importer is free to utilize those tools. This then reduces the frequency and the costs associated with on-site audits.
FSVP And/Or Preventive Controls: In the event a food manufacturer is subject to the Preventive Controls rule and relies upon its exporting suppliers to control the significant hazards, the manufacturer — importer — will not be required to implement an additional plan to comply with FSVP.
Evaluation Of Supplier Risk: In addition to an importer’s evaluation of product risk, a similar assessment of its suppliers will be required. Specifically, a supplier’s history of regulatory compliance, its testing results, its motivation, and ability to correct and identify problems, and any other relevant factors should be included.
List Of Approved Suppliers: This is no longer a necessity, as long as the importer can effectively demonstrate its process to approve suppliers.
Each of these revisions raises a whole new set of questions and concerns; hence the necessity for additional public comment. You can comment electronically now by clicking here. Written submissions may be sent by mail, hand delivery, or by courier to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The docket number (FDA-2011-N-0143) must be on all correspondence. You may also read all 229 submitted comments here.