FDA reported “high rates of compliance” with rules adopted to implement the most groundbreaking reform of the nation’s food safety laws in generations: the Food Safety Modernization Act (FSMA).

“Overall, we are seeing high rates of compliance with the FSMA rules,” Taryn Sjursen, an FDA spokeswoman, said in an email.

An important aspect of FSMA’s implementation and success to date can be summed up in one word: education.

“Education has been and continues to be a key element of successful implementation of our FSMA programs,” Sjursen said.

But FDA also has begun to more aggressively enforce FSMA, some regulatory experts said. Attorney Claudia Lewis attributed increased enforcement, in part, to small businesses now being subject to rules crafted under the law.

“FDA has to enforce the regulations eventually,” said Lewis, a partner in Washington with Venable LLP who counsels clients on FDA matters involving conventional food, dietary supplements and other products.

Foreign Supplier Verification Program

Many businesses remain unaware of the new regulations adopted under FSMA or struggle to comply with them, according to several regulatory experts.

In fiscal year 2018 (FY18)—the 12 months that ended on Sept. 30, 2018—FDA cited 278 U.S. importers of food and beverages for not developing a Foreign Supplier Verification Program (FSVP), comprising the year’s most common inspection violation, disclosed Registrar Corp, a company that offers assistance with FDA compliance and whose U.S. headquarters are based in Hampton, Virginia.

In FY17, FDA cited 108 importers for not developing a FSVP, Registrar Corp reported. That was the year compliance took effect for importers whose foreign supplier is not subject to certain regulations under FSMA, including produce safety and preventive controls rules.

The FSVP requirements are intended to ensure imported food is produced in a way that meets U.S. safety standards. Among the requirements: importers must identify “known or reasonably foreseeable hazards with each food.” Beginning in March 2018, most food importers were required to develop a FSVP for their foreign suppliers and monitor the compliance statuses of their suppliers, according to Registrar Corp.

“I think that for small businesses these types of regulations always are a burden,” Lewis said, “but eventually … those who really want to be in the market for the long haul get into compliance and figure out how to get it done.”

A Proactive Approach

FSVP is one of seven cornerstone rules adopted by FDA to implement FSMA, which former President Barack Obama signed on Jan. 4, 2011 following several high-profile outbreaks of foodborne illness.

“The ethos behind the Food Safety Modernization Act and all of these rules is to be proactive and try to identify issues … before they get out there … or get to a certain scale,” said Marc Sanchez, a lawyer with offices in Washington and North Carolina who advises companies on FDA regulations.

In adopting the rules, FDA recognized “ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food,” according to an FDA webpage devoted to FSMA.

“The importers will be that line of defense at the port,” said Fabiola Negrón, a regulatory specialist with Registrar Corp, in an interview.

Importers are still becoming accustomated to the new requirements, which “small businesses” needed to comply with by March 2018.

“Because this is a completely new requirement for importers, they are not used to this,” Negrón said. The regulatory professional said she isn’t surprised importers are not compliant with the rules since so many of them lack the expertise to develop a FSVP.

“It’s hard for them to comply with this requirement if they do not have the expertise to identify hazards or are not familiarized with food science or other aspects of … food safety,” Negrón said.

Developing an FSVP “can be intimidating in some situations because it’s akin to the food safety plan,” Sanchez observed. “Depending on the type of food, it could be very involved.”

Maile Gradison Hermida, a partner in Washington with Hogan Lovells US LLP who has worked on FSMA since it was signed into law, said importers are still working to comprehend FDA’s expectations under the FSVP rule.

“FSVP is a complex rule that requires a lot of documentation for compliance,” the lawyer said in an email, “and there are still plenty of importers who either do not know that they are under the rule or do not yet recognize that they need to develop a new program to come into compliance.”

Preventive Controls

FSVP is not the only FSMA rule FDA targets during its inspections. Combined, FDA reported 396 citations related to preventive controls requirements, including failing to have a hazard analysis and risk-based preventive controls plan (HARPC) and not identifying a hazard that requires a preventive control in a HARPC, Registrar Corp wrote in a recent article that summarized FDA FY18 inspection data. (See https://www.registrarcorp.com/fda-2018-inspection-observations/).

FDA also cited firms for not using a preventive controls qualified individual to prepare or oversee a HARPC and failing to implement adequate procedures for monitoring allergen controls or sanitation, the regulatory consulting firm reported.

The preventive controls requirements in 21 C.F.R. 117 are similar to, but distinguishable from, food safety principles known as HACCP (hazard analysis and critical control points).

“Midsized and smaller companies continue to struggle with how much to invest in updating compliance [with FSMA],” said Laura Bentele, an attorney in St. Louis, Missouri with Armstrong Teasdale LLP and co-leader of the firm’s agribusiness and food team, in an email. “There is undoubtedly some temptation to shoehorn prior HACCP plans and procedures to work for current preventive control requirements.”

The reasons for noncompliance with FSMA are varied from limited resources to language barriers, regulatory experts said. Jaheon Koo, Ph.D., senior regulatory specialist with Registrar Corp, said in his company’s experience, some foreign suppliers are more familiar with regulations in the European Union than in the United States.

Education vs. Enforcement

Initially after the rules were adopted, FDA was more lenient with the industry to help companies understand them, Negrón said. Sanchez said the agency has transitioned from a phase of educating companies on FSMA to “traditional enforcement.”

In 2016, when large businesses needed to comply with certain rules under FSMA, including the preventive controls and cGMP (current good manufacturing practice) requirements, an FDA official, Joann Givens, wrote that her agency was primarily focused “on education, training and technical assistance to help companies comply with the new requirements.”

She concluded: “We are very committed to educating while we regulate to align understanding and expectations.”

Since her written comments, many of the FSMA compliance dates have passed. Others have been extended and/or aren’t due until 2019, 2020 or beyond. (See FDA chart here on FSMA compliance dates).

“Protecting public health is the highest priority of the industry, and FDA is doing its job to help make that happen,” said Betsy Booren, senior vice president of science and technology with the Grocery Manufacturers Association (GMA), a trade association representing food, beverage and consumer product companies. “The phase-in compliance process for the FSMA rules is ongoing, and the industry is committed to meeting these regulatory timeframes.”

When FDA reports the types of inspection violations as those related to FSVP and preventive control requirements, “facilities are taking immediate corrective actions to address the issues,” she added in an email.

Hermida said FDA remains focused on education.

“FDA continues to take an ‘educate while we regulate’ approach to preventive controls and FSVP inspections,” she said.

According to an FDA database issued from an electronic system, FDA in FY18 issued 2,583 inspection reports—known as Form 483s—for alleged violations of its food regulations. The database does not represent all 483s issued because some of them were manually prepared.

Shelly Burgess, an FDA spokeswoman, said the inspection data neglects to capture talks between FDA investigators and company officials that may have avoided “the issuance of a list of inspectional observations.”

At the end of an inspection, FDA investigators orally share feedback or so-called discussion points to highlight areas requiring improvement to be compliant for an ensuing inspection, Hermida said. Such discussion points are shared with nearly all companies subject to an inspection under the preventive control and FSVP rules, she added.

“Thus, thanks to discussion points, nearly every company comes away from an inspection with an increased awareness of FDA’s expectations for compliance and a list of areas where they can make improvements,” the lawyer said. “It is critically important for companies to act on the discussion points, just like they would with 483 observations. When FDA comes back for their next inspection, they’re sure to focus on the areas flagged through discussion points last time.”

FDA has steadily pushed back compliance and enforcement, and in early 2018 guidance, the agency revealed “an intent not to enforce various FSMA requirements at that time,” Bentele said.

For example, in a guidance document issued in January 2018, FDA disclosed its intent to “exercise enforcement discretion” regarding certain requirements under FSMA, including preventive controls for particular facilities until the agency completed a future rulemaking related to farm activities.

“Whether there is a true shift from the ‘educate while we regulate’ approach in the near term depends on which FSMA rule is at issue,” Bentele said. “For example, it seems increasingly likely that the FDA will pursue enforcement actions relating to FSVP in 2019, but given prior delays, there is still uncertainty.”

Sjursen, the FDA spokeswoman, said the agency can “focus less on education” in some areas where firms are becoming more knowledgeable of the FSMA rules after compliance dates have passed.

“However, an element of education will continue to be an aspect of our FSMA regulatory programs, especially as our programs continue to evolve,” she noted.

Ryan Talbott is a staff attorney with the Center for Food Safety, a nonprofit advocacy group in Washington. He said he understood FDA wanting to take a collaborative approach with industry as the FSMA rules are implemented. 

“That makes sense to a degree,” Talbott said in an interview.

A collaborative approach, he observed, depends on such things as the severity and frequency of the violations.

“FDA’s job is to protect public health,” the attorney said in a follow-up email. “While FDA has said that it wants to focus on education efforts as FSMA compliance dates come into effect, it does not excuse the agency from exercising its authority to reduce threats to public health to a minimum.”

Talbott said there is an expectation FDA will “take a more aggressive approach to enforcement” if it identifies “serious or repeated violations” during its inspections of food facilities.

“Otherwise,” he concluded, “the rules will have no teeth.”