Intentional Adulteration Rule is designed to protect the food supply from widespread public harm. Large businesses become subject to the rule in July. FDA is releasing draft guidance in installments throughout the year.
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Explore This IssueFebruary/March 2019
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Voluntary Qualified Importer Program (VQIP) gives U.S. companies with a high level of control over the safety and security of their import supply chain expedited review and importation of their foods. Applications are being accepted through May, and the first VQIP starts in October.
Other Regulatory Activities
Other activities taking place in the coming year include the following.
Enhancing food recalls. This year, FDA plans to disclose the names and addresses of stores where recalled products may have been sold. Previously, the agency had felt constrained because of confidentiality agreements between suppliers and retailers. Now, FDA will disclose retailer information when the recalled product is not easily identifiable from its packaging (such as without a barcode or Universal Product Code) and when the food is likely to still be in the consumer’s possession based on shelf life or perishability.
GMO labels. Starting this year, food manufacturers may begin using USDA’s approved “Bioengineered” symbol on labels to disclose the presence of GMO ingredients. Under a final rule issued last December, food manufacturers must disclose the presence of foods or ingredients made from genetic engineering when the bioengineered portion exceeds 5 percent by weight of each ingredient. Mandatory disclosure starts Jan. 1, 2022, but companies can voluntarily begin disclosure starting Feb. 19, 2019, when the final rule takes effect.
Cell-based meat. USDA and FDA this year may hammer out draft regulations for overseeing the production and distribution of cell-based meat, or animal tissue produced without growing or slaughtering animals. FDA will oversee cell collection, cell banks, and cell growth and differentiation. USDA oversight will begin from the cell harvest stage, and will continue during the production and labeling of food products.
Inspections and Enforcement
Of wide industry interest, FDA inspectors this year will ramp up testing for pathogens. “FDA will be pressing to make sure there are no more repeats of past outbreaks,” says Shawn K. Stevens, food industry attorney with Food Industry Counsel LLC, Milwaukee, Wis. “The agency will be working very aggressively to make sure food companies are following the rules,” he tells Food Quality & Safety.
Stevens recommends manufacturers “play FDA for a day” and do their own extensive testing using WGS or other environmental sampling. “You should find out what’s there and respond to those findings aggressively and appropriately before the FDA arrives,” he suggests. Dr. Acheson agrees. “It’s better to know what’s going on in your food plant before the FDA tells you,” he says.
However, possessing that information is probably discoverable by FDA. If a manufacturer does have a resident bacterial strain in the plant and is trying to eradicate it, “the agency needs to be lenient and not penalize the company for it,” Dr. Acheson says. “We need more regulatory clarity on this point because sometimes oversight shuts down good food safety practices at the plant level out of fear of discovery.”
Failure to develop a FSVP was the single-most frequent food safety violation cited by FDA investigators last year, with 278 Form 483s issued to U.S. companies for not having verified that the food they import meets the same safety standards as domestically produced items.
FSVP requires all U.S. food importers (not just those registered with FDA) to develop plans to and actively monitor their foreign suppliers’ compliance with FSMA provisions.
Late last year, FDA’s Office of Regulatory Affairs released summaries of routine field inspections and enforcement activities conducted during fiscal 2018 (Oct. 1, 2017, through Sept. 30, 2018). The summaries identify the statutory areas under which thousands of Form 483s were issued to companies having conditions or practices that may violate FDA requirements.