Ferd Hoefner, Policy Director, National Sustainable Agriculture Coalition (NSAC), talks about S. 510, the FDA Food Safety Modernization Act.
The contents of the FDA Food Safety Modernization Act represent a major new approach to food safety. Looking at it with the customary cautious optimism characteristic of many food trade organizations is the National Sustainable Agriculture Coalition. Few people doubt that a fresh approach to the nuts and bolts of a sane and effective program is necessary and the need to get it done is immediate. It’s the details that can kill it.
The real test will be the FDA’s ability to execute the program, whatever the final bill might contain. Any increase in oversight requires a corresponding increase in manpower and cash, something the Feds have too often been unwilling to supply. It’s a problem recognized by the National Sustainable Agriculture Coalition. I asked Ferd Hoefner, their policy director, to talk about his concerns.
In Part I, Hoefner talks about what the National Sustainable Agriculture Coalition likes about S. 510, what concerns the coalition has with the bill, and whether proposed amendments to S. 510 that have been introduced to help small, sustainable agriculture will jeopardize food safety.
Q: A recent Food Safety News article about the food safety bill wrote about ‘important improvements’ urged by your organization (See Farmers Gain in Senate Food Safety Battle, April 15). Let’s look closely at the FDA Food Safety Modernization Act. What provisions can the National Sustainable Agriculture Coalition applaud and what were the points that concerned you as a spokesperson for small, sustainable organic agriculture?
A: The bill that was passed out of the Health, Education, Labor and Pensions (HELP) Committee last November included practical, common sense improvements to the Produce Standards section of the bill that simultaneously improve food safety outcomes and support a stronger family farm system. These Committee-approved amendments include provisions to require the FDA to coordinate with USDA, EPA, and Fish and Wildlife Service to ensure that any on-farm food safety standards they develop are not in conflict with conservation and environmental standards. It also includes strengthened language requiring science-based risk analysis before proceeding to regulations.
The changes from Committee markup also include language directing FDA to consider farm scale and diversity issues as well as special consideration for certified organic farms and ranches and language instructing FDA and USDA to coordinate to establish food safety standards that are relevant to certified organic production.
These provisions make sense because they recognize that conservation practices many farmers use to mitigate food safety risks by establishing vegetative buffers that can filter pathogens from streams and runoff and protect cropland from windborne pathogens. FDA sensitivity to farm scale and diversity will also be critical. Ensuring that new food safety regulations do not undermine existing National Organic Program food safety standards helps protect the market viability of one of the fastest growing sectors in the American agriculture.
Farmers are concerned with more than just the Produce Standards section of the bill, however. The remaining improvements the National Sustainable Agriculture Coalition hopes to see in the final legislation include:
i) Adopting a risk-based approach to farm facility regulation that recognizes the broad spectrum of types of farm facilities and tailors requirements to the degree of risk that the operations could introduce into the food system.
ii) Directing FDA to reduce the amount and type of regulation and paperwork for farm facilities and for farms subject to produce standards so that food safety goals are met without creating such a complex system that it would be financially unsupportable except by very large or non-diverse farms.
iii) Ensuring that traceback requirements are practicable for farmers, including recognizing that direct marketers and identity-preserved products have traceability inherent in the market relationship and so should be exempted from further record keeping and that farmers should just be required to maintain records on the first point of sale beyond that farm gate.
iv) Including a new authority for a USDA-delivered competitive grants program for food safety training for farmers, small processors and wholesalers to help translate rules and guidance into the real world of farming and local and regional food systems.
Q: Proponents of a stronger food safety bill are delighted that both the House and Senate version of the bill give the FDA ‘mandatory recall authority, require more frequent inspections, and ask food facilities to implement food safety plans.’ You want a lessening of the bill’s requirements for small producers. First, define ‘small producer’ and then talk about the reasons behind your position.
A: First, we support mandatory recall authority.
Second, we want FDA to do a rulemaking, open to public comment and based on a scientific risk analysis, to determine which farming activities and on-farm processing activities are high risk and therefore truly require that farmers develop expensive HACCP-type plans, regular on-farm FDA inspections, and full-scale traceback requirements beyond basic recordkeeping of farmgate sales. The bill reported by the Senate Committee, and the House-passed bill, did not require such a rulemaking. Many farmers will be surprised that things they may well consider normal farming activities that carry little or no food safety risk will make them subject to major new regulatory requirements with substantial new costs involved.
The Senate sponsors of the bill have now agreed to incorporate a proposal sponsored by Senator Sanders of Vermont to require FDA to do such a risk analysis and publish a rule for public comment, with direct authority to exempt or modify new regulatory requirements for low risk on-farm activities. This is an important, common sense improvement to the bill–it reduces unnecessary regulatory burdens on farmers while focusing precious FDA human and financial resources on high risk activities. Hence, it will help produce better real world food safety outcomes.
Third, we did not ask for this provision to be limited to farms that qualify as small businesses, nor did Senator Sanders to our knowledge. That restriction came from FDA and the staff of the bill’s sponsors. It was agreed to in the process of negotiation.
Q: Improvements in food safety, first and foremost, is the goal of the bill. According to the Food Safety News article, an amendment sponsored by Senator Michael Bennet (D-CO) is “intended to reduce paperwork and excess regulation and FDA will be instructed to provide flexibility for small processors including on-farm processing, minimize the burden of compliance with regulations, and minimize the number of different standards that apply to separate foods.
“FDA will also be prohibited from requiring farms and other food facilities to hire consultants to write food safety plans or to identify, implement, certify, or audit those plans.” While it certainly gives the little guy a significant break financially, doesn’t it also unnecessarily expose the public to health risks?
A: Like the Sanders amendment, the Bennet amendment is an important, common sense provision that improves the bill. Without the new Bennet language, the bill would require FDA to do separate food safety regulations on each crop even if a substantial amount of the rule would be common across a
ll or most crops. It would have also required separate rules even where a single rule for a particular category of crops makes more sense.
In our view, it is very important that the bill, as amended by Senator Bennet, now directs FDA to reduce unnecessary paperwork burden on farmers and small processors. It is also very important that the legislation is clear that FDA as a general rule will not require food facilities, including farms that are declared food facilities, from hiring expensive consultants or auditors. FDA has always said that was never its intent, but now that statement of intent is actually in the bill, where it appropriately belongs.
Editor’s Note: This article was written by Chuck Jolley, special to Food Safety News.
See Food Safety News tomorrow for Part II of the discussion about the FDA Food Safety Modernization Act.