FDA rolls out four food-safety proposals under the Food Safety Modernization Act
FDA rolls out four food-safety proposals under the Food Safety Modernization Act
WASHINGTON — Early this morning, the Food & Drug Administration released four rewrites of the Food Safety Modernization Act rules, including some critical water quality and testing changes advocated by the industry to make produce safety regulations more workable.
Stakeholders will have 75 days to dig deep into hundreds of pages of regulations on produce safety, preventive controls for human and animal food, and the new Foreign Supplier Verification Program for importers.
“Based on valuable input from farmers, consumers, the food-industry and academic experts, the FDA is proposing to update these four proposed rules to ensure a more flexible and targeted means to ensure future safety,” said Mike Taylor, deputy commissioner for foods and veterinary medicine.
FDA opted for the 2012 Environmental Protection Agency recreational water quality standard, backed away from the weekly testing requirement and will allow farmers whose agriculture water don’t meet the new microbial standard to establish a sufficient interval of days between last irrigation and harvest for microbes to die off.
The agency completely abandoned its prescribed intervals between application of raw manure and crop harvest, and instead plans a multi-year risk assessment on the practice with the help of the U.S. Department of Agriculture.
“At first blush, we got some of the things we told FDA was not developed appropriately, and some things we didn’t,” said David Gombas, United Fresh Produce Association’s senior vice president of food safety and technology. He said it will take some time for United Fresh working groups to analyze the hefty rule changes.
Gombas said operations would have to develop two-year baselines and conduct verification testing five times a year. Collecting 20 samples over two years is not as burdensome as the original proposal, he said.
FDA also revised the rule to no longer require farms to register as facilities if they pack or hold raw agricultural commodities grown on another farm under a different ownership.
Although FDA appears to have heard many of the criticisms about the rule, some areas remain troublesome.
FDA expanded which farms are excluded from the rule by proposing that farms or farm mixed-type facilities with an average annual monetary value of produce sales, rather than all food sales, of $25,000 or less are not covered.
“We think that’s the wrong way to go,” Gombas said. United Fresh has found that small operations can comply with the food safety controls.
The agency also did not tackle the exemption for commodities consumed raw, and, as expected, introduced new supplier controls, product testing and environmental monitoring in the proposed changes to the preventive controls for human foods.
Product testing, even as a tool to verify whether preventive controls are working, is going to be burdensome and the science is not yet clear on its value, Gombas noted.
For more information on the new proposals, go to FDA’s web site at: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm415132.htm.