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The FSMA Countdown: Enacting Act through FITs and FOTs
by Ted Agres
Facing court-imposed deadlines to finalize seven major food safety regulations within the next two years, FDA will adopt a carrot-and-stick strategy to obtain industry compliance with the Food Safety Modernization Act (FSMA). For example, FDA will create “incentives” for companies to comply with FSMA’s preventive control rules for food and feed facilities by reducing inspections of firms having a record of “good behavior” and targeting high-risk firms with “enhanced” surveillance and inspections, according to the agency’s latest strategic plan for implementing FSMA.
When preventive control problems do arise, FDA will first seek voluntary corrections at the facility level. If that fails, the agency will next use its enhanced administrative powers, such as detention and mandatory recalls, and only afterwards seek court-ordered injunctions, seizures, or criminal prosecutions. Overall, FDA hopes to encourage industry compliance through education and technical assistance by partnering with other federal, state, and local agencies. For instance, FDA will partner with USDA and private auditors when it comes to on-farm inspections related to produce safety standards. Internationally, FDA will partner with foreign governments and accredited third-party auditors to assess imported food.
In May, FDA published its “Operational Strategy for Implementing the FDA FSMA.” As mandated by a federal court-ordered consent decree, FDA must finalize and publish rules for preventive controls for human and animal foods by Aug. 30, 2015 and publish final rules for produce safety, the Foreign Supplier Verification Program, and accreditation of third-part auditors by Oct. 31, 2015. The sanitary transport of food and feed rule must be finalized by March 31, 2016 and the intentional adulteration final rule by May 31, 2016.
These rules “intersect and cover an incredibly diverse spectrum of people and companies located all over the world,” says Roberta F. Wagner and Joanne Givens, co-chairs of the FSMA Operations Team Steering Committee and, respectively, deputy director for regulatory affairs at FDA’s Center for Food Safety and Applied Nutrition and an acting regional food and drug director in FDA’s Office of Regulatory Affairs. “Our team is talking with those most affected by the proposed rules—including farmers, importers, industry representatives, and state officials—for their feedback on the most reasonable and practical ways to carry out our preventive and enforcement activities,” Wagner and Givens state in a May 8, 2014 FDA blog posting. State regulatory partners will play an increasingly active role in industry oversight once the agency moves into post-final rule implementation in late 2015 and early 2016, Wagner adds.
This state-level collaboration will be critical, “especially when it comes to the new and unique challenge of implementing the produce safety rule,” explains Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine. “We aspire to rely heavily on state agriculture departments and other state and tribal departments with on-farm food safety responsibility, taking advantage of their food safety commitment, their knowledge of local conditions and practices, and their local presence to deliver training, technical assistance, and compliance oversight,” Taylor writes in a May 2, 2014 FDA blog posting coauthored by Howard Sklamberg, deputy FDA commissioner for global regulatory operations and policy. “But we have to work closely with our state partners to convert this aspiration to reality. That work includes finding the funding they will need to play an expanded role on produce safety and other areas of FSMA implementation.”
“Good luck with getting more funding for the states; that’s probably not going to happen,” says David Acheson, MD, CEO, The Acheson Group and a former FDA associate commissioner for foods. “States are already doing inspections on behalf of FDA and any expansion of this will depend on more resources. The states are in at least as much budget trouble if not more so than FDA in that regard,” Dr. Acheson tells Food Quality & Safety magazine.
Illustrating this point, the National Environmental Health Association released an analysis in May of the capacity of local and state governments to investigate and respond to foodborne illness outbreaks. The survey of environmental health and regulatory food safety managers at local, tribal, and state agencies found that budget cuts and other financial strains have resulted in high employee turnover, less experienced staff, and decreased capacity to respond to foodborne outbreaks. Not unexpectedly, small municipalities and local agencies have been hardest hit.
“What you really want is for everybody to be at a high standard of food production and growing with regard to produce,” Dr. Acheson says. Many food companies are already at that level or beyond it, but many others are not. “Small- and medium-sized businesses are still fairly clueless about what it all means and what they need to do,” Dr. Acheson says, adding that the FDA needs to find better mechanisms for getting information to these firms. “So there’s a big messaging and education component that has to happen. How do you get these firms to understand the importance of environmental and process controls? FDA’s strategic plan doesn’t get into that level of detail, and that’s the challenge,” he says.
FDA organized groups of interdepartmental teams to review and recommend how the thousands of pages of proposed FSMA rules and regulations should be put into practice. FSMA Implementation Teams (FITs) are developing regulations and guidance documents, inspection and compliance strategies, and administrative enforcement tool protocols. Concurrently, FSMA Operational Teams (FOTs) are creating plans to make the rules, programs, and policies operational while developing specific strategies to prepare for implementation. Transparency will remain a priority throughout the process. “We are engaging with external public/private sector and internal stakeholders to elicit input to inform the development of post-final rule implementation strategies and determine reasonable and practical ways to implement the standards,” Wagner says.
Based on its strategic plan, FDA will tailor implementation of each FSMA rule according to the nature and degree of risk posed by specific commodities, sectors, and facilities; by the availability of interventions to reduce risk; and by the availability of resources and tools to provide oversight, among other factors. When it comes to implementing the preventive control rules for food and feed facilities, for example, FDA will significantly expand its inspection and surveillance tools to include a wider range of inspections, testing, and data collection activities conducted through its own field force and through collaboration with partner agencies and the food industry. The types and purposes of inspection and surveillance will include:
- Providing incentives for compliance through reduced scrutiny of firms having records of good performance;
- Assessing the compliance of individual companies through a range of inspection and sampling techniques;
- Making in-depth assessments of individual firms when needed to increase incentives for compliance and to determine the need for compliance or enforcement actions; and
- Collecting data on sector-wide hazards and practices and on compliance rates.
FDA acknowledges that “there is no reasonable expectation” that it has the resources and expertise to conduct routine on-farm inspections when it comes to implementing the produce safety rules. Rather, FDA notes congressional mandates to coordinate education and enforcement with state and local officials and for
USDA to provide technical assistance grants for implementation, especially to small growers. As a result, the FDA will focus on:
- Deploying a cadre of produce safety experts in headquarters and the field to educate and foster compliance;
- Supporting education, technical assistance, and audits and accountability functions through collaborations with public and private parties; and
- Conducting targeted on-farm surveys, inspections, and environmental assessments to understand current practices and to identify gaps.
FSMA requires imported foods be produced using preventive measures that achieve the same level of food safety as domestic foods. Key features of implementing the Foreign Supplier Verification Program and Third-Party Accreditation rules include:
- Reconfiguring current import field exam activities to complement oversight of foreign supplier verification;
- Implementing the Voluntary Qualified Importer Program and other measures to expedite entries for good performers; and
- Developing the skills and processes to audit accrediting bodies and accredited third-party certifiers.
Despite the effort spent in planning, drafting legislation, and writing the food safety regulations, some experts don’t believe the results will be worth it. “I don’t object to FSMA, I just don’t expect a lot from it,” says Douglas Powell, a former professor of food safety at the University of Guelph, Ontario, Canada and of diagnostic medicine at Kansas State University and now publisher of www.barfblog.com.
“Food safety becomes very important when there’s an outbreak. The challenge is how you make it important in the absence of an outbreak,” Powell tells Food Quality & Safety. “The FDA sets minimum standards for the food service industry, restaurants, and others to follow. But the best companies go above and beyond those standards and should brag about doing so. Companies should hold themselves to higher standards because if they don’t, they will get sued.”
Dr. Acheson is concerned that FDA inspectors may know less about the rules than food manufacturers and growers. While FDA plans to focus on education, “many of its inspectors are not wired to be educators; they are regulators and don’t have the personality or skill set to be educators,” he says. He foresees situations where an inspector says something needs to be done a certain way but the company disagrees. “We will end up with potentially awkward situations where the food company says it knows it’s doing things the right way and the regulator disagrees, but is wrong. It’s going to get a little tricky.”
Agres is based in Laurel, Md. Reach him at firstname.lastname@example.org.