Enacting FSMA through FITs and FOTs

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.

Preventive Controls

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.

Produce Safety

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.

Imported Foods

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.