Over the past year and a half, much attention has been given the federal government’s commitment to prioritizing prosecution of food companies that engage in criminal behavior. In some instances, this has been used as a scare tactic, shining a spotlight on the executive responsibility of company executives. Although focusing on executive liability isn’t necessarily a bad thing, Stephen Ostroff, M.D., deputy commissioner for foods and veterinary medicine at FDA, wants food manufacturers to know that FDA isn’t out to get them.
During yesterday’s opening keynote presentation at the 2016 Food Safety Consortium, Ostroff commented on FDA’s approach to enforcement. “I often have to scratch my head as why this has been such a tremendous concern in a regulated industry…sitting at FDA, we have not had any change in our thinking and approach about liability,” said Ostroff. “FDA pursues legal action against companies that are clearly negligent and clearly violating the law.” He emphasized that FDA’s goal moving into the FSMA compliance phase hasn’t changed; it’s about implementing a food safety system focused on preventive controls.
Ostroff encouraged attendees to look at the areas in which their food safety system is vulnerable, take proactive action and build redundancies into their system. “The best defense is to comply with the new requirements, and document how you are creating a food safety culture where everyone understands the expectations,” he added. “If you’re making a good faith attempt—our goal is to help you accomplish that goal, not to punish you for the attempts that you’ve made in good faith.”
The deputy commissioner also commented on the agency’s progress since FSMA’s seven rules were finalized in May, pointing out that these rules are foundational, and additional rules are to come. These rules will address lab accreditation, traceability related to imported products and a reportable food registry tool.
“If when we visit we identify very significant food safety hazards that we think pose an imminent risk of foodborne illness, we will have to take action.” – Stephen Ostroff, M.D.
Other key areas Ostroff discussed regarding agency progress and initiatives included:
Initial compliance date for FSMA Preventive Controls Rule (for large companies). FDA wants to be a partner in assisting companies with the preventive controls requirements. “That for us will require a lot of work on the part of those who are going to be conducting these inspections, but our goal is to help you and tell you in which areas you’re doing quite well and in which areas you can do better,” said Ostroff, adding that many of the aspects of the preventive controls rule are very similar to what many companies have already done.
Foodborne outbreaks. With several outbreaks in the 2015–2016 timeframe (ice cream–Listeriosis; cilantro–cyclospora; cucumbers–Salmonellosis; Mexican-style fast food–E.coli O26; flour–E.coli O121), the Inspector General expressed concern over the FDA recall process and criticized the agency for not having better defined timeframes. In response to that report, FDA implemented the SCORE (Strategic Coordinated Outbreak Response and Evaluation) team, which guides concrete action plans for measures that the agency must take in the areas of recalls, for example. The team consists of decision makers from key operations and enforcement offices with a goal of expediting the evaluation of compliance and enforcement options. Since April, SCORE has addressed flour contaminated with peanut protein, facilities contaminated with Listeria, Salmonella in pistachios, and baby food that was not manufactured in compliance with infant formula regulations.
Antimicrobial resistance. The issue is “getting attention at the highest levels of government,” said Ostroff, adding that the best way to address antimicrobial resistance is to not have to treat it in the first place—and to do this is through reducing the incidence foodborne illness. The agency is moving forward in several areas here, including addressing non-judicial use of food animals and veterinary settings; enhancing NARMS data and isolate collection; and collecting data on antimicrobial sales by species.
During the Town Hall part of the presentation, Ostroff was asked, with the finalization of the FSMA rules, are they cast in stone? His answer: Not necessarily. “It took five years to get in place…because we did it in a very systematic way with a lot of stakeholder input. When you put together rules that are this complicated, there’s no guarantee that you got everything right,” he said. “[We] have to recognize that sometimes some of the flaws don’t become apparent into you implement them. You always have to be of the mindset that if everything didn’t work out exactly the way things were anticipated…we always have to be open to the fact that as we move forward and implement the rules, we might have to make course corrections.”
This year is a big year for food safety at FDA. All seven of the FSMA rules have been finalized, and the first compliance date is right around the corner (compliance with the Preventive Controls for Human Food rule starts in September for large companies). Stephen Ostroff, M.D., just took the helm from Michael Taylor as the agency’s deputy commissioner for foods and veterinary medicine. And finally, FDA is taking a hard line in both improving the tools and methods used to detect outbreaks as well as working with the Department of Justice to prioritize enforcement actions against companies that introduce adulterated foods into the supply chain.
Yesterday Ostroff provided an update on FDA’s recent initiatives and its plan of action to achieve success in FSMA implementation and pathogen detection at the IAFP annual meeting in St. Louis. Ostroff highlighted several tenets of FSMA:
Keys to FSMA success will be dependent upon achieving high rates of compliance
Domestic and import parity
Education before and while regulating (establishment of training and education networks)
Taking a risk-based approach to inspection and planning
Partnerships are critical
Industry can expect three more rulemakings as required by FSMA in the areas of lab accreditation, a reportable food registry and product tracing. In addition, FDA is working on guidances related to the preventive controls, produce, and foreign supplier verification program rules. “We’re tantalizingly close so stay tuned,” Ostroff said.
Expect to see more program alignment with the Office of Regulatory Affairs as well. The inspection and compliance staff will be trained as specialists and there will be horizontal integration of programs between field activity and agency headquarters. Although the next fiscal year will be a transition year, Ostroff is hopeful that changes that need to be made at the agency, along with program alignment, will be in place by fiscal year 2018.
Other notable actions at FDA over the past year include:
In response to the OIG’s conclusion that FDA’s food recall program is not efficient or effective, the agency is ramping up its use of the strategic CORE (Coordinated Outbreak Response and Evaluation) network in order to examine recalls that might not be moving as smoothly or quickly as the agency prefers. FDA is also leveraging greater application of whole genome sequencing (WGS).
GenomeTrakr network and WGS. More than 50,000 genome sequences have been added to the database (largely Salmonella). Ostroff called WGS a game changer that holds the opportunity to more quickly identify problems and detect outbreaks while they’re still quite small. In partnership with the CDC, FDA set up a successful module for WGS of Listeria and the agency hopes to expand the model for use with other pathogens.
Nutrition (Not just what consumers are eating, but how much of it): The move that declared partially hydrogenated oils as no longer GRAS with compliance required by 2018. The agency also issued a final guidance on menu and vending labeling in May, issued levels for arsenic in infant rice cereal, made determination for folic acid fortification in corn/masa, made revisions to nutrition facts labels that takes effect in 2018, issued a draft guidance on voluntary sodium reduction, and will continue to exam the terms “natural” and “healthy”.
Genetic engineering. FDA approval of GE salmon following one of the longest reviews in the history of FDA (20-year review), along with issuing voluntary labeling guidance.
Monitoring antimicrobial resistance through NARMS (National Antimicrobial Resistance Monitoring System). FDA will be collecting antimicrobial sales by species and, in cooperation with USDA, hopes to release farm-based data about antimicrobial use at the farm level.
Ostroff emphasized FDA’s strategic 10-year plan, released this year, pointing to public health as a first priority, maintaining partnerships as a key to success (including re-establishing overseas offices), continuing research as a foundation, and maintaining transparently.
With less than a week under his belt as the new Deputy Commissioner for Foods and Veterinary Medicine, Stephen Ostroff, M.D., has made one of his first official statements about food safety. Calling the FSMA final rules a paradigm shift in prevention versus response, he emphasized the importance of the implementation stage on FDA Voice, the agency’s blog.
“The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system,” said Ostroff in the blog.
Although industry has “miles to go” during implementation, Ostroff emphasized the behind-the-scenes work that made FSMA happen—thanking specific members of Congress, consumer activists such as STOP Foodborne Illness, public policy organizations, national associations such as the Grocery Manufacturers Association, government organizations and global regulatory counterparts.