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REGULATORY OUTLOOK: FSMA to be dominated by PC and FSVP this year, while states build produce safety

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For the rest of 2018, implementation of the Food Safety Modernization Act (FSMA) will focus on the preventive controls and foreign supplier verification rules, while states begin the long climb to educate and enforce the produce safety rule, say FSMA experts.

This is the first in a series of outlook stories in IEG Policy this week as our reporters look into what to expect in food regulation for 2018.  

The Trump administration continues to implement the 2011 law, despite the deregulatory revolution at agencies directed by the White House to abandon two regulations for every new one.

The good news for industry is FDA continues to crank out guidances in recent months to explain the preventive controls (PC) program for human and animal food and the Foreign Supplier Verification Program (FSVP).

“I think the FSMA focus will be enforcement of the PC rules (human and animal) and FSVP,” said David Acheson, founder of The Acheson Group. “The PC rule and FSVP have a big public health impact, hence the focus on them.” Acheson predicted FDA’s swab-a-thons during PC inspections to increase this year.

He suggested other programs will follow.

“Produce will lag behind, I think – lots to be done with the states to make that work,” he said. “Sanitary Transport won’t get much focus either.”

During the past year, FDA has kicked out numerous guidance documents to help industry comply with the 2011 law as new parts of the law go into effect in 2018.

The Grocery Manufacturers Association (GMA) is keeping an eye out for additional advice from FDA.

“We also look forward to seeing guidance on other key regulations such as FSVP and a broad range of specific preventive controls (e.g. food allergens, chemical hazards, physical hazards and recall plans),” said Leon Bruner, GMA’s senior vice president for scientific and regulatory affairs and chief science officer, told IEG Policy.

“We anticipate the issuance of guidance on other important issues, such as sanitation control, Listeria and Salmonella control and contract manufacturer supplier verification, just to name a few.  In addition, we anticipate the release of the Laboratory Accreditation regulations,” Bruner said.

At the request of GMA and other groups, FDA is opting not to enforce four FSMA provisions at this time, including a troublesome one that required written assurance from customers where a hazard requiring a preventive control needs to be managed downstream. Manufacturers, processors, importers and farmers must still disclose to their customers which relevant hazards have not been controlled.

FDA made clear this rule is one of the few agency priorities in its fall 2017 Unified Agenda, as it plans to proposed a rule in August that removes the written assurance requirement. 

“Although that manufacturer/processor would still be required to provide documentation that the food has not been processed to control the identified hazard, that manufacturer/processor would no longer be required to obtain written assurance from the customer that the identified hazard will be controlled. This action, if finalized, also will remove analogous requirements that apply to importers of food for humans and animals,” FDA said in its regulatory agenda.

Produce safety 

In recent months, FDA has pushed back the clock on the water testing requirements to at least 2022 and announced plans to clarify the registration requirements to better align farms and facilities that carry out similar activities under the preventive controls and produce safety rule.

“One consistent and clear message we received throughout our outreach to farmers and state agriculture officials is that the microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented,” FDA Commissioner Scott Gottlieb said in September. He also announced plans for FDA to hold a summit this year on the water testing requirements to gather input from stakeholders.

Enforcement will rely heavily on the partnership between FDA and the National Association of State Departments of Agriculture (NASDA), and regulators are feeling the pressure to stand up the program, as large operations are required to comply with the produce safety rule (except for water and manure provisions) on Jan. 26, 2018.

But due to the learning curve for inspectors and industry, routine inspections for the large firms won’t start until spring 2019, Gottlieb said at a NASDA meeting.

NASDA plans to spend this year on its On-farm Readiness Program that allows farmers to be audited by state officials, cooperative extension agents, and FDA produce experts to see whether they are on track with the massive new requirements.

“We know people are doing a lot of good things … but do we know if it’s clearly understood what’s been taught?” asked Bob Ehart, NASDA’s senior policy and science advisor.

The first training courses start in February and will wrap up in May for the voluntary program. “It will have a huge potential benefit for FSMA implementation and the farmer to jump start where they think they are,” he said.

FDA is about to roll out inspector training, and NASDA is trying to make sure it all dovetails together with other training programs, he said. Gottlieb emphasized that education should be the focus of the first visit on the farm, so training will be key.

Not surprisingly, buyers may not be waiting for FDA’s enforcement schedule. Ehart said he has heard some growers are being told by buyers to meet the produce safety rule before enforcement dates are triggered.

On whether there has been any major changes in regulatory attitude from the past administration, Ehart said the Trump administration recognizes this is an “extremely large program” and it has to make “a logical sense on how it’s implemented,” he said.

NASDA received $30.9 million for 43 states to develop safety programs last year, with the remaining seven states deciding whether to apply for money this year.  

“If there’s not more funding, programs will not be able to stay on the schedule that was initially considered. We need to have that conversation with appropriators,” Ehart said.

FSMA funding is a critical piece of the puzzle for consumer groups.

“FDA and NASDA are doing everything they can to be ready,” said Sandra Eskin, director of the Pew Charitable Trusts’ safe food project. “How successful it will be in January 2019 will rest primarily on getting produce operations ready.”

But overall, if there is not adequate FSMA funding in the upcoming FY 2019 budget request, after six years of solid funding to implement the law, it would be “very discouraging” to see significant cutbacks, she said.

In the eyes of the produce industry, the biggest FSMA issue facing FDA is "consistency and capacity," said Jennifer McEntire, vice president of food safety & technology at the United Fresh Produce Association.

"On the capacity side, FDA is challenged by having to write so much guidance while trying to train inspectors to assess compliance with multiple rules and continue to respond to industry – and sometimes political -- questions and concerns," she said. "The industry is also challenged in needing to ensure staff keep up with all the guidances, notices, etc." And McEntire said she's concerned there just aren’t enough food safety experts, on the industry side or within the government, to get everything done.

On the consistency issue, McEntire said the produce industry is still waiting for clarity on some issues, and "because enforcement discretion is being applied in some instances, it creates a knowledge void that is being filled with misinformation or market requirements that are not always aligned with the rules." 

Imports

The true impact of FSMA’s verification program on importers will not come until March.

“The vast majority of imported food shipments are not yet subject to FSVP, but they will be come late March 2018,” said Ben England, founder and CEO of FDAImports.com.

The new requirements are not applicable to food facilities with less than 500 full-time equivalents (FTEs), which is the vast amount of food facilities around the world, England said.

In March, the imported food shipments from suppliers that are not very small food processors all fall under the preventive controls or produce safety rule.

“FDA expects to conduct FSVP inspections in the thousands this year. They probably won't reach that, but it will certainly be substantially more than the paltry numbers from last year,” he predicted.

“Of course, FDA could not find many companies actually subject to FSVP last year because of the phased-in enforcement cutoff at 500 FTEs,” he said.

England criticized the fact importers still can’t use the Voluntary Qualified Import Program (VQIP), the fast lane for participating importers.

“Because VQIP requires third-party certified foods you cannot have VQIP without having an operating Third Party Certification Program and Third Party Accreditation Program. That's the problem. So, VQIP is 4 years away – at least,” England said.

Animal feed

FDA kicked off 2018 with a draft guidance to help animal feed businesses comply with the Current Good Manufacturing Practices (CGMPs) and new preventive controls.

More guidance is on the way on the preventive controls provisions and the supply chain program, FDA says.

While larger animal feed facilities were required to comply in September 2017, FDA said it would delay preventive control inspections until fall 2018 to give the industry time to get up the speed with the new program.

FDA’s animal feed regulations are “overkill” and come with a steep price tag for businesses that was never factored into the rulemaking, said Richard Sellers, senior vice president of public policy and education at the American Feed Industry Association (AFIA).

Sellers said his group continues to advocate for FDA to reopen the regulation but has yet to be successful. Small companies will have difficulty complying with the preventive controls, he said, and all companies have been largely in the dark trying to comply with parts of FSMA without adequate guidance.

Inspections began in 2017 for large companies to comply with the revamped CGMPs. Sellers said late last year, that before FDA issued another guidance in October, members were taking about “discrepancies in the issues raised from inspection-to-inspection.”

Laboratories

By fall 2018, FDA is expected to propose a FSMA laboratory accreditation rule that would allow FDA to use analytical data from third-party labs.

Food testing by an accredited laboratory is a key piece of FSMA regulations, as the law required FDA by July 2013 to only accept, for food regulatory purposes, analytical packages from private labs that are accredited.

But the agency said it had to put the laboratory rule on the back-burner to focus efforts on getting out the other “foundational” regulations, but now it’s back on the agenda.

Intentional adulteration

Another looming requirement is FSMA’s Intentional Adulteration (IA) rule, which requires large businesses by July 26, 2019 to implement written food defense plans. It is far from a popular regulation.

The rule directs food facilities to prevent acts of wide-scale harm, by protecting four vulnerable activities in their operations: bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling, and mixing and similar activities. As compliance dates approach for FSMA’s IA rule, FDA officials are hard at work developing the training for inspectors who will be checking facilities for implementation of the rule.

Some food trade groups have criticized the anti-terrorism program as “overly prescriptive,” and imposing unnecessary costs in relation to the public health payout.

Peanut processors, for example, criticized the rule for not letting food facilities count “foundational” food defense measures when performing vulnerability assessments. Other groups are calling for FDA to extend the compliance date, or at the very least, to allow for training.

GMA’s Bruner singled out the program as needing more work.

“In 2018, we will continue to engage with FDA through the public comment process on FSMA regulations and guidance that are under development, the most important of which is guidance and possible revision of the intentional adulteration rule,” Bruner said.

Facilities will not see any enforcement of the IA rule in 2018, but inspectors may start to ask to see food defense plans, suggested TAG’s Roland Gonzalez, senior director of scientific and technical affairs.

TAG is advising large establishments to start writing food defense plans this year, instead of waiting until July 2019. Small businesses have until July 2020, while very small businesses have until July 2121 to write food defense plans.

Food recalls

Eskin said the recent Office of Inspector General (OIG) report critical of FDA’s handling of food recalls is a concern for Pew.

The Dec. 26 report examined FDA food recall practices in 30 food recalls and found FDA was not always effective and efficient in its oversight in recall initiation, in the monitoring of recalls and in collecting and maintaining complete and accurate recall information.

Even though FSMA is a prevention-based system, recalls are the “last line of defense” for consumers, she said. FDA needs to do the right thing in improving its recall process, particularly as FDA said it plans to rely on voluntary recalls in the future as the fastest way to get potentially tainted products off supermarket shelves.

Consumer groups will continue to push for FDA to disclose the names and addresses of firms selling recalled products. Eleven groups sent Gottlieb a letter in August insisting the agency follow USDA’s lead when it changed its policy to disclosing the names and locations of retailers that sold recalled products in 2008.

It’s not an easy argument to win. FDA officials maintain the relationship between food companies may be bound by confidentiality requirements.

Gottlieb has committed to a new guidance that he said will be issued in 2018.

     

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