FDA won’t enforce certain FSMA requirements
The enforcement discretion guidance relates to some parts in four of the rules and applies to certain parties.
They are the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food and Food for Animals rules, Foreign Supplier Verification Programs rule (FSVP) and Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption rule (Produce Safety).
It relates to aspects of the ‘farm’ definition; written assurances provisions in all four rules on control of identified hazards or microorganisms that are a potential risk to public health; requirements related to certain human food by-products for use as animal food and FSVP requirements for importers of food contact substances.
Adjustments along the way
FDA said it was doing this to allow time to consider changes or other approaches to address concerns.
“The FDA has received feedback that certain product distribution chains would require vastly more written assurances and resources to comply than was anticipated by FDA during the rulemaking process,” it said in relation to the written assurance requirements.
Manufacturers, processors, importers and farmers are still required to disclose to their customer that relevant hazards have not been controlled.
Scott Gottlieb, FDA commissioner, said it recognised such a fundamental change in approach may require adjustments along the way to address issues not previously anticipated.
“We value the feedback we’ve received on the new rules and understand manufacturers, farmers and other stakeholders have faced certain challenges as they work to implement the new rules,” he said.
“We’re actively working to pursue permanent fixes to some of these remaining issues through rulemaking or other means, but this will take time.”
FDA had previously extended compliance dates for many provisions covered by the guidance, said law firm, Keller & Heckman.
Policies in the guidance will remain in place until and unless the agency takes further action.
Gottlieb said it was important to take time to get the new framework right so it can serve the needs of consumers in the long run.
“This action will help reduce the burdens on both industry and government and provide the agency the ability to consider the most effective and efficient way forward,” he said.
“We look forward to continued collaboration with the affected industry, regulatory partners and other stakeholders to make sure that they understand what’s required in a post-FSMA world and to provide the flexibility needed to implement these new standards across a very diverse food supply.”
CSPI: Delays undermine FSMA
Dr Peter G. Lurie, Center for Science in the Public Interest (CSPI) president, said the Trump administration is undermining FSMA by indefinitely delaying enforcement of rules that would put it into effect.
“FSMA was intended to cover the entire food chain, from farm to fork, and the Trump administration’s new guidance would create a gap in that safety chain by exempting, at least for now, some of those who harvest, package, and hold food produced on farms,” he said.
“In addition, the guidance would eliminate the written company-to-company food safety assurances required under the final FSMA rules that identify dangerous pathogens that should be addressed by downstream processors.”
Dr Lurie said when the food safety rules were created and then delayed under the Obama administration they were subject to public notice and comment before being published.
“During that period, industry had adequate opportunity to raise the very concerns used by FDA to justify [the] announcement. But under the Trump Administration, these indefinite delays are being unveiled in a surprise final guidance without public input.”
