A year after President Obama signed the Food Safety Modernization Act into law, the Food and Drug Administration says it is preparing to unveil a variety of new regulations.
An FDA official told members of the Western Growers Association during an early-January Webinar that it has started its traceability studies mandated under the act and will look at tomatoes and a prepared food containing peanuts and meat.
The FDA also told industry groups including the Produce Marketing Association that a third-party auditing proposal that applies to foods produced overseas and imported into the U.S. is expected to be released in March or April.
The Foreign Supplier Verification proposal, another regulation that affects imports, is expected early this year, the FDA official said.
Last fall, the FDA published a schedule of fees it intended to impose on food imports subject to re-inspections, and gave an Oct. 1 date for imposition of the fees.
The FDA withdrew the fees schedule following a barrage of criticism and said it would study the issue further.
The Food Safety and Modernization Act enacted this year requires the FDA to conduct two examinations of imported food before the agency is authorized to charge for services related to the second and subsequent examinations.
“Unfortunately for importers, the FDA has so broadly defined what constitutes the ‘first examination’ that virtually every imported food shipment detained for an apparent food safety reason will become subject to the new FDA re-examination fee,” said Benjamin England, and attorney and president of regulatory consultant FDAimports.com. England also worked for the FDA for 17 years in a variety of capacities, ranging from regulatory counsel to compliance officer.
Despite postponing the fees, the FDA continues to receive comments on the proposal. The Produce Marketing Association is among the groups opposing the fee plan. “The FDA defined a re-inspection more broadly than the law allows or Congress intended,” the PMA said in comments submitted to the agency. The group said the FDA identified activities that would trigger a fee in cases where those activities are not re-inspections.
“FDA proposes to charge a fee when an importer produces evidence to overcome an FDA action to detain food,” the PMA said. “For example, an importer may produce laboratory analysis that disproves the FDA assumption that a product may be adulterated and the notice would charge an importer for FDA’s time in reviewing the information. As written, the fee serves as a penalty to importers who challenge the FDA’s rule and discourages the submission of information that proves the safety of the food. Similarly, food ordered destroyed is not a re-inspection, but simply part of the original inspection activity.”
The PMA said there is a separate problem in the fees rules: They redefine the liabilities faced by a U.S. agent for a foreign supplier or facility.
Existing FDA regulations say a U.S. agent “acts as a communications link between the FDA and the foreign facility for both emergency and routine communications,” the PMA said. That definition to make the U.S. agent responsible for re-inspection fees should not be until after careful consideration that is made subject to proper rule-making, the group said.
Another piece of the law expected to be translated into proposed rules this year applies directly to transportation providers. The Sanitary Food Transportation Act of 2005 made the FDA the agency in charge of regulating the safety of food during transportation. In 2010, the agency asked for public comment on truck and rail transport of food.
Any regulation of carriers by the FDA was delayed by passage of the Food Safety Modernization Act, but that law required the FDA to issue rules within 18 months for the transportation sector. The FDA is expected to release draft rules in late spring or early summer.
“In 2010, we submitted comments on food transportation to the FDA and said new regulations should follow the lines of current industry best practices,” said Jon Samson, head of the Agricultural and Food Transporters Conference of the American Trucking Associations. “Our industry does a good job, and food transportation in this country is quite safe.
“No big changes are needed to keep the food chain safe,” Samson said. “Our hope is that the agency recognizes that.”
Brokers and warehouse companies also will keep a close eye on that piece of the food safety legislation because of a question of liability.
The FDA in its 2010 notice asked for recommendations for determining when food products have been transferred between companies in the supply chain.
The question raises the issue of who has ownership of goods in transit — or, more importantly, who has liability.
“Whether or not an article of food has been transferred from a customer to the 3PL warehouse is a significant issue for the 3PL industry,” Joel D. Anderson, president and CEO of the International Logistics Warehouse Association, said during the comment period.
“A 3PL never takes title to or ownership of the products in the warehouse,” he said. “Rather, he serves as a logistics intermediary in the supply chain. Although the customer ships product to a 3PL warehouse to be held until further direction, no transfer of legal title of the food has occurred.”
The IWLA wants to make sure the transfer of liability goes along with the change of ownership, not simple “physical possession,” he said.
Contact Stephanie Nall at email@example.com.