FDA plans to publish the final rule for the Foreign Supplier Verification Program (FSVP) on October 31, 2015 under the Food Safety Modernization Act (FSMA). This rule will require U.S. food importers to adopt an FSVP, verifying that the foods they import are safe and their foreign suppliers are operating within the requirements of FDA’s other substantive food safety regulations. Importers that are not exempt from this rule will be required to comply within eighteen months of its publication date. Hence, we advise importers to begin making preparations for it now!
Will Your Products Be Exempted?
Foods exempt from the FSVP rule include foods that are: subject to the seafood Hazard Analysis and Critical Control Plan (HACCP), subject to juice HACCP, only for research or evaluation, alcoholic beverages, transshipped, for personal use only, or imported under FDA’s Import For Export program. In addition, foods subject to the low-acid canned food and acidified food regulations (LACF/AF) are exempt from addressing microbiological hazards under the FSVP rule, since those hazards are covered under FDA’s LACF/AF contols.
All other imported foods must be in compliance with the FSVP rule.
What Importers Should Know
Specifically, importers will be required to adopt an FSVP that identifies and addresses the risks and hazards associated with each type of food product they import, and write a plan (similar to a HACCP plan) for each imported food/foreign food suppler combination. Each importer will be required to maintain records indicating that it has met the FSVP requirements, and must present those records to FDA upon its request.
The FSVP provision requires reviewing the compliance status of their imported foods and of their foreign suppliers. Hence, importers should start checking into the regulatory history of their foreign suppliers. Importers might begin by checking to see if any of their suppliers are on an import alert or are subject to an FDA warning letter (posted on FDA’s website), and other records of violations of FDA regulations. As a word of caution, FDA’s import alerts page represents only a “snap shot” in time. FDA’s import alerts do not reflect the history of the firm – just its current status. (For a more robust regulatory report, contact us at FDAImports.com). Food importers should also check their suppliers’ food safety performance history.
Under the revised proposed FSVP rule, importers will be required to determine any known or reasonably foreseeable hazards of the foods they import and establish controls to minimize or prevent those hazards. Before distributing the food, the importer must verify that the controls are effective by performing a verification activity which may be conducting an onsite audit, sampling and testing of the foods, or reviewing the foreign supplier’s food safety records.
Also, importers will need to periodically reassess the effectiveness of their FSVPs by being aware of any new information about the potential risks associated with the foods they import and their suppliers, and they must revise any FSVPs that are inadequate. Remember, it is critical for importers to make and maintain adequate records of all FSVP activities!
Where are the Gaps in your FSVP?
We strongly encourage all importers subject to the FSVP rule to begin preparing their FSVPs now since they only have 18 months to comply once the rule is published! Start now by evaluating the risks and hazards associated with the foods you import, checking your suppliers’ compliance history with FDA, reviewing current food safety plans and SOPs, and begin drafting the plans.
Position yourself ahead of your competition in the race for FSVP compliance. Contact us today for help filling in the gaps in your existing plans.
For more information regarding FSVP please see our videos below:
