Enforcing FSMA: examining how state, federal agencies will partner in enforcement

February 17, 2016

In May 2014, the FDA published “Operational Strategy for Implementing the Food Safety Modernization Act (FSMA),” which describes guiding principles for FSMA implementation.

Liz Freedman, communications and public engagement for FDA, notes that during this rulemaking process, the FSMA implementation teams have been working concurrently on developing strategies and frameworks to operationalize the new FSMA prevention-focused food safety standards, including the produce safety rule.

“FDA’s implementation of the produce safety rule will entail a broad, collaborative effort to foster awareness and compliance through guidance, education and technical assistance, coupled with accountability for compliance from multiple public and private sources, including FDA and partner agencies, USDA audits, marketing agreements and private audits required by commercial purchasers,” she said.

John Shapiro, a partner in the Food Industry Team at Freeborn & Peters in Chicago, notes that FSMA represents a major shift in the manner in which the government will enforce growing, manufacturing and distributing food that is safe to eat.

“FSMA imposes a new regime—proactive risk management designed to eliminate the likelihood of unsafe food entering the consumer marketplace,” he said. “But rather than placing the burden of that proactive risk management squarely on the back of the government, FSMA places primary responsibility for food safety on food growers, manufacturers and others in the food supply chain.”

Working a Plan

“In the wake of FSMA, food producers and manufacturers have to be on their A game moving forward,” said Kevin Pollack, vice president of recalls at Stericycle Expert Solutions. “Food safety is top of mind with both regulators and consumers, so we will likely see food companies ramp up quality control efforts and increase the frequency of independent audits at food processing and manufacturing locations to ensure compliance and reduce risks.”

The stakeholder engagement is also central to operationalizing FSMA.

“The FDA has engaged and sought input from the farming community and other stakeholders consistently throughout this rulemaking process,” Freedman said. “In addition, the FDA held a public meeting on April 23–24, 2015, and opened a public docket to present our current thinking and gather stakeholder input on our operational work plans. The FDA intends to make the FSMA operational work plans public, once they are finalized.”

Shapiro notes that in keeping with this broad vision, FDA intends to focus its efforts on deploying a cadre of produce safety experts in headquarters and the field with the depth and breadth of capacity to develop the guidance needed to support implementation and provide technical support to government and industry parties working to foster compliance; actively support education and technical assistance for farms, primarily through collaboration with other public and private parties; support public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support; and conduct targeted on-farm surveys and inspections to understand current practices and identify gaps in compliance.

“FDA’s inspection resources will be targeted based on risk. In addition to conducting its own inspections, FDA also plans to rely heavily on states to conduct a large proportion of the routine inspections on farms,” he said. “Thus, inspection will play an important role in the overall compliance effort.”

Partnering in Enforcement

The FDA has entered into a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) to obtain critical information related to implementation of the produce safety rule, in partnership with state regulatory agencies.

As part of the cooperative agreement, NASDA will conduct an assessment of the current foundation of state law, the resources needed and options for states to adopt and/or implement the produce rule, as well as develop a timeline for successful implementation.

“FDA anticipates that the majority of domestic on-farm inspections will be conducted by state agencies, with assistance from FDA as needed, and that FDA staff will conduct the majority of foreign inspections of farms,” Freedman said. “The FDA plans to provide education and assistance in local languages to reach farmers exporting covered produce into the United States, and will work with organizations and other sources of information that are familiar and accessible to the produce farming community, such as the alliances, international organizations, universities, trade associations, foreign partners, JIFSAN and federal agencies (such as USAID and USDA), among others.”

Timing and Money Matters

There are no inspection frequency mandates under FSMA for farms. The produce safety rule becomes effective on January 26, 2016, and compliance dates are staggered based on business size and other factors such as qualified exemptions and type of produce.

FSMA section 201 mandates that FDA inspect all domestic high-risk facilities within five years of FSMA’s enactment and at least once every three years thereafter. Other domestic facilities are to be inspected within seven of enactment and at least once every five years thereafter.

Within one year of enactment, the law also directs FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.

The FY 2016 President’s Budget includes an increase of $109.5 million in budget authority, for a total of $1.3 billion in budget authority for FDA’s food safety programs, including FSMA implementation. This funding is critical to ensuring that FDA is able to move forward in 2016 towards successful implementation of FSMA.

Patricia Buck, Center for Foodborne Illness Research & Prevention’s director and director of outreach and education, said the implementation will depend on how much funding Congress provides to FDA.

“For fiscal year 2016, FDA asked for an increase of $109 million to implement FSMA, but the Senate and House only appropriated about $40+ million,” she said. “Having this large of a cost differential means that many of the FDA plans for FSMA’s implementation will have to be downsized. Therefore, funding FSMA is the major problem we are facing at this moment in time.”

Shapiro said many question whether sufficient funds have been, and will be, appropriated to allow the FDA to fully implement FSMA, but that it’s important to remember that FSMA is designed to alleviate the FDA of the lion’s share of the burden to keep consumers safe by placing on food companies directly the onus to take those steps necessary to produce safe food and protect consumers from foodborne illness and misbranded food.

“Regardless, the FDA is no toothless watchdog,” he said. “FSMA provides the FDA with an array of tools by which it can verify compliance and, when a company is found noncompliant or even is suspected to be noncompliant, enforce FSMA.”

Even with the compliance and enforcement mechanisms identified, some continue to question whether food companies will be able to operate under the radar of FSMA and the FDA given the limited resources allocated to implement and enforce the law.

Congress, however, built into FSMA a powerful deterrent for any food company that might consider skirting the preventative processes—whistleblower protection. FSMA encourages employees to blow the whistle on unlawful practices and prohibits a company from discharging or otherwise retaliating against an employee who reasonably believes the employer has not complied with FSMA.

— Keith Loria, contributing writer


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