The public is generally pleased with the revised provisions of four rules under the Food Safety Modernization Act (FSMA), but the public comments at the Food and Drug Administration’s public meeting Thursday suggest that the agency may have more tweaking to do.
Certain aspects of the rules for produce safety, preventive controls for human food, preventive controls for animal food and Foreign Supplier Verification Programs (FSVP) have been modified to provide more flexibility to producers and suppliers.
A change in the definition of farms allows people to pack and hold their own and others’ raw agricultural commodities without being subject to the preventive controls rules because these activities are already covered in the produce safety rule. Several people commented Thursday that the definition did not extend far enough.
“Designations based on location or ownership are not risk-based designations, and they overlook an important reality about the majority of American farms: many farms consist of multiple parcels, buildings, and structures that may or may not be contiguous,” said Sophia Kruszewski, a policy specialist with the National Sustainable Agriculture Coalition.
“We’ve heard that from a lot of different folks and expect to get a lot of comment on that and are considering ourselves,” noted Rebecca Buckner, co-lead for preventive controls in FDA’s Office of Foods and Veterinary Medicine.
In the supplemental proposals, FDA decided to define a “very small business” producing human food as one with less than $1 million in annual sales and a small business as producing animal food as one with less than $2.5 million in annual sales. Several commenters expressed opposition to the $1 million threshold, arguing that it conflicts with the statutory framework of the legislation by expanding exemptions beyond what Congress had intended.
Patricia Buck, director of outreach and education for the Center for Foodborne Illness Research and Prevention, explained that the Tester Amendment — which exempts food producers that sell the majority of their food directly to consumers within the state and have less than $500,000 per year in sales — was critical for moving the FSMA bill through Congress.
“We are concerned that this proposed very small business definition upsets the delicate balance struck by legislators when they created this exemption provision: they wanted to minimize the regulatory burden on small operations and, at the same time, minimize any resulting harm to public health,” explained Sandra Eskin, director of food safety for the Pew Charitable Trusts.
Eskin, Buck and others also expressed their frustration that FDA proposed a process for reinstating an exemption after a qualified facility or grower has lost the status.
“We fear that, by creating a right to reinstatement, FDA will encourage food processors [and growers] that initially qualify for the exemption to sell contaminated products, knowing that they will be able to quickly fix a problem and regain an exemption,” Eskin explained.
Worrisome manure changes
Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, and Buck gave some of the most impassioned comments when they spoke about the changes to raw manure and compost intervals.
The original proposal set a nine-month minimum between the application of raw manure and harvest and a the 45-day minimum application interval for compost. The supplemental language eliminated these minimums deferring a decision on an appropriate interval until it conducts more research.
Although this was considered a “huge win” for organic farmers, to DeWaal it was a failure to protect public health.
“It is not good science, nor appropriate for public health, for FDA to simply walk away from its responsibility to set standards for this important but highly risky agricultural input,” she said in her prepared statement. “The agency claims that it can develop a more scientific standard for the application of raw manure and compost in five to 10 years. This is clearly too long to leave consumers unprotected.”
She and others called on FDA to adopt interim standards for raw manure and compost use and suggested codifying the National Organic Program’s (NOP) standards for conventional produce growers while the agency considers alternatives.
“Going from nine months to zero is not science-based and we challenge the agency to do better than that,” DeWaal said during the Q&A session.
Samir Assar, director of the produce safety staff within FDA’s Center for Food Safety and Applied Nutrition said that FDA had studied the NOP standards and didn’t feel the science was strong enough to indicate whether they were the appropriate standards for public health protection.
Following DeWaal in the Q&A, Buck asked the panelists what level of assurance the agency could provide that its manure research efforts would be completed in a timely fashion. “Waiting ten years is not appropriate,” she said.
Assar responded that FDA is committed to moving forward “as quickly as possible” to develop the risk assessment and transition producers to less-risky composting practices. “We’re thinking five to 10 years, but we’re hoping it will be more towards the five years,” he said.
“But that’s not helpful,” Buck shot back. “If it’s going to take you ten years — hopefully five — you need the interim standard now.”
Where things stand
FDA’s Buckner said that the agency was aware of and working to address many of the issues raised at Thursday’s meeting, adding that it’s important for stakeholders to submit detailed comments.
With regards to the other three FSMA rules that have not seen reproposed language, “we are aware that we have requests for supplemental proposals on those and we are considering those,” Buckner said.
The final day to submit written comments on the revised rules is Dec. 15.© Food Safety News