FDA’s Ostroff details pressure to use new FSMA recall tools

MIDDLEBURG, VIRGINIA, U.S. — Under pressure from the Inspector General of the Department of Health and Human Services, the Food and Drug Administration is exploring more aggressive steps to reduce the incidence of food-borne illness in the United States, said Stephen Ostroff, deputy commissioner for foods and veterinary medicine at the FDA.

Ostroff described a number of changes in the FDA approach toward food inspection during a presentation Sept. 9 at the annual meeting of the North American Millers’ Association at the Salamander Resort and Spa in Middleburg, Virginia, U.S.

The Inspector General report, issued earlier this year, was harsh, titled “The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process.” Ostroff said the conclusions were based on a review of thousands of recalls in the period between 2013 and 2015 with a close look at 30.

Specifically, the IG looked at recalls “that took the longest time period to actually accomplish … and the most challenging and the most unusual of the recall situations,” Ostroff said.

He continued, “And out of these 30 they focused on 2, and they used that as the basis to say we don’t have a good process.”

The report urged the FDA to, rather than depending so heavily on a cooperative voluntary recall system, to more frequently utilize draconian tools that are part of the Food Safety Modernization Act — administrative detention of products, mandatory recalls and the suspension of the registration of involved facilities.

“We’ve always believed that these are tools that we would use sparingly, only when we can’t get voluntary compliance by the regulate,” Ostroff said.

Even before the IG report, the FDA had begun moving in new directions to improve its food recall system, Ostroff said. In particular, he mentioned the creation six months ago of a team dubbed Strategic Coordinated Outbreak Response and Evaluation (SCORE). The SCORE team, bringing together senior leadership from different parts of the food side of the FDA, meets regularly. FDA groups represented include the Center for Food Safety and Applied Nutrition, the Office of Regulatory Affairs, the Office of the Chief Counsel and the Office of Media Affairs.

“FDA has lots and lots and lots of experience in the area of food recalls,” Ostroff said. “And this group meets on a weekly basis, more frequently if necessary, and they review very complicated or unusual recall situations to help drive decisions about what the appropriate response should be. They also will look at recall situations that, for one reason or another, prove to be stuck.

“We know that they’re out there, but they’re not progressing in the way that they ought to progress,” Ostroff said.

While only a small minority of recalls fall into the group reviewed by the SCORE team, Ostroff said both flour recalls from the spring/summer of 2016 were placed in this category.

He said the SCORE process is being reviewed to examine whether it is making the FDA “more assertive” in recall situations “in terms of doing what we can to maximize consumer protections and also to assure that we meet our public health responsibilities.”

Separate from the IG report, Ostroff said the FDA is motivated to try new approaches by a lack of progress over time in efforts to reduce food-borne illness in the United States. To the contrary, he showed data indicatingSalmonella outbreaks at about 12 individuals per 100,000 in 2004, and about 14 in 2015. Similar trends were evident over this period for illnesses from other microbial pathogens.

It is clear that objectives set several years ago by the Centers for Disease Control and Prevention under its Healthy People 2020 program to meaningfully reduce such outbreaks will not be met, Ostroff said.

“To change the trajectory, we need to do things differently,” he said. “That was the basis for the Food Safety Modernization Act.”

He described FSMA as a “very delicate” balancing act between sustaining food industry practices that have been effective while using regulatory pathways to address “areas where we haven’t been doing as well.”

The key for the FDA is to identify companies with effective practices when it comes to areas of concern and standardize adoption of these best practices, Ostroff said.

“We would like to promote those things they’ve been doing if they are science based and have been demonstrated to work,” he said. “At the same time this move (FSMA) was ultimately all about trying to change the food safety paradigm.”

Toward that end, FSMA has a number of what Ostroff called “central tenets,” beginning with a fundamental shift away from a regulatory system built on reaction to outbreaks and a move toward a “preventive mode where we keep them from happening in the first place.”

Progress will require high rates of compliance and parity between domestic producers and food suppliers outside the United States, Ostroff said.

Offering the industry support services such as education and technical assistance also will be important for the FDA, he said. The establishment of training and education networks “before and while we regulate” also are needed for FSMA, he added.

Partnerships with state agencies as well as with food safety regulatory authorities in Canada and other countries also will be needed, Ostroff said.

FSMA was signed into law in 2011, and subsequent rulemaking took far longer than expected. The road forward will not be easy, he said.

“Developing all the regulations was hard, but actually now translating that into implementation and compliance is going to be even harder than that,” he said. “All of these rules have staggered implementation dates, and you need a kind of scorecard to figure out when they all get started.”

Also of interest to the food industry are supplemental rules under FSMA related to accrediting laboratories, the Reportable Food Registry (a portal for industry to provide consumers with information when there is a reasonable risk a food product may make people ill) and the imposition of traceability requirements for food commodities.

One of the major 2016 flour recalls, initiated due to traces of peanut contamination, has triggered intense milling industry interest in the sanitary transportation rule.

“This rule was developed based on assessing risks in transport of foods, especially as it relates to microbial contamination and based on experience that has to do with what was in the conveyance prior to loading food commodities, issues of cross contamination and also issues related to temperature control when in transport,” Ostroff said. “This rule was meant to build upon best practices within the industry, and so there was a lot of work that was done to gather information. We put out the proposed rule. We got a lot of feedback, including a lot of feedback from many of you in the room, and we made a number of changes based on feedback that we received from groups like these.”

Changes to FSMA include a shift toward focusing the rules on food safety risk rather than quality. Intended use of the food now determines sanitation requirements, he said.

Ostroff elaborated further on transportation and FSMA.

“While there were a fair number of changes made to the sanitary transportation bill, I think the one that’s been most challenging and difficult for us, especially in terms of discussions with this group, has to do with the issue that the final version of the rule places the responsibility on the shipper for the sanitary conditions of transport unless there’s been a written agreement with the carrier,” he said. “And I can tell you that I’ve had a number of discussions with the folks who developed the rule. I know that you all have been in discussions about this issue. We are aware of your concerns, and all I can say at this point is we’re very closely examining what the options happen to be.”

Another significant change in the FDA approach toward food safety relates to inspection work.

“By and large over the years (this system) has been based on (inspectors) being generalists, and so the inspector that may come to your particular facility on a particular day next week may be examining a pharmaceutical company,” he said.

What is involved in conducting an FDA inspection has become much more sophisticated than in the past, Ostroff said.

“In the old days … you could get away with being a jack of all trades and master of none, but it doesn’t work really well these days,” he said. “So what we have decided is that we will specialize our inspection workforce. We will have inspectors who only work on food. We will have inspectors who only work on pharmaceuticals. We will have inspectors who will only work on medical devices and inspectors who will only work on import-related activities.”

This transition together with an organizational restructuring of field offices will begin in 2016 and continue into 2018, Ostroff said.