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FDA Issues FSMA Rules on Foreign Suppliers

WASHINGTON — The Food and Drug Administration released two proposed rules as part of the Food Safety Modernization Act that deal with food imported into the United States.

The foreign supplier verification programs rule requires importers to have a plan for verifying their suppliers are following the same food safety standards as U.S. growers/producers that were outlined in the earlier produce safety and preventive controls FSMA rules.

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FDA will be able to audit the importer’s plan and can stop imports from coming in if we find the plan to be inadequate or its implementation to be inadequate. It really boils down to expecting our importers to know their supplier, to know the food and its potential hazards that they’re bringing into the country, and to verify that preventive steps have been taken to minimize those hazards,” Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said in a media call.

A second rule outlines the accreditation process for third-party auditors, which are currently used in certain circumstances to monitor high-risk farms and as part of the voluntary qualified importer program. FDA officials said third-party audits are likely to expand in order to enforce the FSMA rules.

FDA Commissioner Margaret Hamburg noted that the U.S. imports food from about 150 countries. Imports account for about 15% of the total food supply, as well as 50% of fresh fruit and 20% of fresh vegetables.

The current import procedures allow the FDA to inspect just 2% of the food that enters the U.S. and analytically test only a small portion of that.


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“Without question, it’s important that food imported into the U.S. must meet the same level of public health protection as food produced domestically,” said Hamburg.

As with the two earlier rules, there are exemptions for smaller firms. Importers with less than $500,000 in sales will only need to obtain written assurances from suppliers that they are following food safety protocols rather than perform on-site inspections.

FDA officials reiterated the need for more financial resources to implement and enforce FSMA rules, but noted the significant funding increases for FSMA in President Obama’s 2014 budget request.

There will be a 120-day comment period for the two new proposed rules. In addition, FDA is again extending the comment period for the produce safety and preventive controls rules for an additional 60 days so stakeholders will have a chance to review all the rules together.

Read more: FDA Must Finalize FSMA Rules by 2015

Industry groups expressed support for the release of the two rules on imports but remained cautious about the rules’ specifics.

“The release and the coordinated comment periods of these proposals are evidence that FDA is listening to industry’s needs,” Bryan Silbermann, president and CEO of Produce Marketing Association said in a statement. 

“Initially, we don’t see any surprises in FDA’s draft rules on imported foods and third-party auditor accreditation,” said Dr. David Gombas, senior vice president for food safety and technology at United Fresh in a statement. “However, it’s important that we thoughtfully review them in a line-by-line fashion, including analysis of their interaction with other FSMA draft rules, to ensure they advance food safety and are workable for the industry.”

A judge ruled last month that FDA must release all FSMA rules by Nov. 30, and issue the final rules by June 30, 2015.

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