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Ostroff says FDA soon to release FSMA Intentional Adulteration draft guide

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FDA is making progress on implementing the Food Safety Modernization Act (FSMA) and is now working on guidance that should help producers navigate the mandates of the Intentional Adulteration (IA) Rule, the last of FSMA’s seven foundational rules that has yet to go into effect.

At the Grocery Manufacturers Association’s (GMA) Science Forum in Washington D.C. on Tuesday (March 28), Stephen Ostroff, FDA’s deputy commissioner for foods and veterinary medicine, said the agency is working “very actively” on the guidance and hopes to release it “very soon.”

The guidance, Ostroff said, should answer many of the questions that industry might have about FSMA’s IA rule, which seeks to prevent the U.S. food supply against terrorism and is set to go into effect for large companies in July 2019.

When it goes into effect, the IA rule for the first time will require domestic and foreign food facilities to implement a food defense plan that highlights both vulnerabilities and ways to reduce the risk of intentional adulteration.

Recognizing that the new mandate is a hot topic of discussion for the food industry, Ostroff said the agency is drafting the new guidance to offer companies more information on completing the vulnerability assessments that will be required under the rule and will offer more insight on monitoring, corrective actions and verification, as well as specific issues related to cost and flexibility.

The guidance will come out in three parts, the first of which should be issued in the very near future, Ostroff said.

“We are very actively working and we’ve had many discussions with GMA over the past year – including lots of folks in this room – about this rule,” Ostroff said. “You know that food defense is an important element of food safety. This is in an era, [when] there are lots of folks out there that want to do not so good things. We have had this extensive dialogue with industry about the requirements and associated costs.”

The rule, however, is designed to be flexible and it will left to the companies to decide how it should be implemented within their individual facilities, Ostroff stressed.

“Things that you already do for food safety may not necessarily work for food defense,” he said. However, food safety remains a priority, so “you should never do anything in the context of food defense that may inadvertently pose a food safety risk,” Ostroff told industry Tuesday.

Ostroff used his presentation as an opportunity to update industry on a host of FSMA-related activities, providing the latest number of FSMA-related inspections, outlining the agency latest efforts related to the Voluntary Qualified Importer Program (VQIP), the third-party accreditation program and enforcement discretion.

However, he also related some FDA concerns about the challenges that the agency has been facing in trying to measure the impact of all of FSMA’s new mandates.

New tests make measuring FSMA progress a challenge

Ostroff shared some of the agency’s frustration with the use of new tests, which are making it harder for FDA to assess trends in incidents of foodborne illness.

More specifically, Ostroff talked about a new report released March 23 by the Centers for Disease Control and Prevention (CDC). The report compared data from 2017 versus data from 2014-16 on foodborne illness incidence for a number of pathogens and found that – despite heightened efforts focused on reducing foodborne illness – there has been either an increase or no change in the incidence of some of those pathogens.

The report found that incidence of Salmonella and shigella decreased by 5% and 3%, respectively. Incidence of other pathogens increased significantly – including a 166% jump for Yersinia, 489% increase for Cyclospora, 54% increase for Vibrio, 26% for Listeria, 26% increase for Shiga-producing E.Coli and 10% increase for Vibrio.

“There’s even been an increase in Listeria, which is [a pathogen] we monitor very closely because of concerns about that organism,” Ostroff said.

And while incidence of foodborne illness by pathogens is certainly not going down, data from the CDC report suggests that FDA is far from the goals that were set for those pathogens in the Healthy People 2020, a 10-year agenda for improving the nation’s health, Ostroff noted.

For Campylobacter, for instance, the goal was 8.5, compared to the 2017 incidence of 19.1, and for Salmonella, the goal was 11.4, compared the 16.0 incidence in 2017. Only in the case of Listeria, the 2017 incidence (0.3) was actually lower than the Healthy People goal of 0.2.

“You can see that we are way off on what we predicted the incidents would be for 2020,” Ostroff noted. “For Campylobacter we were off more than twofold, and none of these are really close to where we thought we would be.”   

The increase in incidence of foodborne illness cases highlights a specific challenge that, according to Ostroff, is really disrupting the agency’s ability to evaluate trends in the incidence of foodborne illness – the increased use of culture-independent diagnostic tests (CIDTs).

While those tests are fast, easy to use, and help detect some illnesses that would otherwise have been missed, they also have made it harder to find outbreaks and monitor disease trends, because they do not provide certain information needed to characterize organisms that cause infections.

“You can’t do subtyping, you can’t do anti-microbial resistance testing, at least for right now,” Ostroff said. “I can say without question that this does have a major impact on data that is collected in the FoodNet system … . CIDTs are making it really difficult for us to monitor foodborne disease.”

On the positive side, Ostroff noted that the use of the new tests appears to be picking up infections that in the past might have gone undetected – particularly when it comes to Vibrio, Yersinia and non-O157 STECs.

“This has major implications for those of us that work in food safety because of the limited ability that we have to subtype and do whole genome sequencing of organisms and be able to compare them,” he said.

But more importantly, this also affects the agency’s ability to measure the impact of FSMA, Ostroff suggested.

“If the trends are going in funny directions because of different types of diagnostics, it makes it really difficult for us to be able to monitor what the ultimate impact is in terms of the outcome of the work we are doing with FSMA,” he said.

FSMA inspections picking up  

Yet FSMA efforts are moving along, Ostroff said. “We have reached the compliance dates for six of the seven rules,” he said.

FSMA-related inspections have also picked up and since the beginning of 2018, FDA has already completed 1,610 domestic and state FSMA-related inspections, as well as 144 foreign inspections. That is significantly more than the 1,253 domestic inspections the agency completed in all of 2017, Ostroff noted. The reason is that this year more large- and medium-sized companies have come into compliance with FSMA’s Preventive Controls, modernized Good Manufacturing Practices (GMPs), GMPs for Animal Food, and Foreign Supplier Verification Program (FSVP) requirements, Ostroff said.

“We have made a commitment to try to make these [inspections] as educational in nature as possible to try and help you come into compliance,” Ostroff told industry.

The agency has also taken other steps to make FSMA provisions more palatable and has allowed for enforcement discretion in areas where there is a need for more guidance or additional rulemaking, Ostroff said. For example, the agency said in January that it will allow enforcement discretion for certain facilities under the Preventive Controls rule and is now trying to find a way to “regulate ‘like’ activities that have similar risks in the same way.”  

The agency also is allowing for enforcement discretion for the written assurance requirement under the PC rules for human and animal food, the Produce Safety rule and the Foreign Supplier Verification Rule, Ostroff noted.

“This will be in place until we come up with a practical solution to the issues that have been raised by all of you,” he said. “So, this is something that we will be working on.”

Third-party certification efforts moving ahead

FDA has also moved on with efforts to set up the voluntary, third-party certification program, for accreditation of third-party certification bodies to conduct food safety audits and issue certification of foreign entities and the foods they produce. The agency launched the initiative in June 2017 and in January recognized ANSI-ASQ National Accreditation Board (ANAB) as the first accreditation body under the program. Earlier this month, the agency was also able to approve the American National Standards Institute (ANSI), the second accreditation body for the program, Ostroff noted.

Third party accreditation bodies are also key for the Voluntary Qualified Importer Program (VQIP), a fee-based program that provides expedited review and import entry in the United States for participating importers.

 “This is important for the FSVP and it is important for the VQIP program,” Ostroff said. “In order to qualify for the VQIP, you have to be accredited by a third party. That is why it has been important for us to get the accreditation bodies accredited, so they can do this work and enable companies … to be able to apply for VQIP status.”

The program just began accepting applications from companies in January and should start work by October, Ostroff said.

 

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