A New Administration: The Food Regulatory Impact
The new administration is officially onboard and moving initiatives forward at a brisk pace. What might that mean for the food industry and the actions of its regulatory bodies? Past experience has shown us that Democratic administrations can certainly be more focused on food safety regulation and enforcement, so we thought it worth looking into the crystal ball to see what may be coming from the new administration.
We have already seen some indications that focus on food safety regulations, with new leaders nominated to lead the USDA and the FDA. Currently, the USDA faces new petitions on Salmonella strains as adulterants and the withdrawal of a pending rule on poultry line speeds. The FDA is releasing its findings on E. coli in California related to leafy greens – that will likely also make the interface between live animals and produce space a key area of focus. Add to that, the ongoing focus on the Food Traceability List, the 10-year anniversary of the signing of FSMA, and FDA’s “New Era” blueprint – and 2021 could be an interesting year for food.
We also anticipate a greater focus on cannabis-containing edibles. Recently, there have been two recalls of cannabis-containing gummies due to mold. More states have joined the growing list of approval of recreational cannabis products, and the new administration has signaled that marijuana will be a focus for them. This all points to changes in the cannabis edible space in the next four years.
USDA. With Obama-Era Agriculture Secretary Tom Vilsack nominated by President Biden to again lead the USDA, we can likely expect a quick start here as well – particularly as Vilsack has already “sketched out his agenda.” That agenda, according to the NY Times article, includes five “very, very large challenges ahead that have to be dealt with very quickly.” Topping the list are the COVID-related issues of protecting USDA employees and food workers and determining vaccine logistics. The following issues are providing hunger relief, promoting social justice, fighting climate change, and revitalizing the rural economy. However, during his prior tenure at USDA it took more than a year to get an Under Secretary of Food Safety in FSIS; thus, we may anticipate a long gap with the accent appointment now, as well.
Beyond Vilsack’s agenda, however, there are two key situations for which we see USDA as having to set a focus:
- Poultry line speeds. On January 22, the Biden government withdrew a pending rule that would have allowed chicken slaughter lines to speed up from 140 to 175 birds per minute. Withdrawn by an office of OMB, the Maximum Line Speed under the New Poultry Inspection System, proposed last spring, would have amended the regulations “to permit young chicken slaughter establishments operating under the NPIS to operate at line speeds up to 175 bpm if certain criteria are met.”
- Salmonella adulterants. Following a petition proposed in January 2020, requesting that certain outbreak strains of Salmonella be considered adulterants in meat and poultry, a supplemental petition was filed on January 25, 2021, that “lays out a regulatory framework and process for achieving the goals of that petition in poultry, while also addressing risks from Campylobacter.” The petition, filed by Bill Marler on behalf of numerous groups and individuals, asks that FSIS “modernize its food safety standards by establishing enforceable standards targeting Salmonella types of greatest public health concern while reducing all Salmonella and Campylobacter in poultry.” The petition also asks that FSIS require slaughterhouses to adopt science-based tools to prevent animals from being infected by these bacteria on the farm, including by vaccinating live poultry and monitoring farms for the presence of dangerous bacteria, and that it publish finalized versions of its DRAFT FSIS Compliance Guidance for Controlling Salmonella and Campylobacter in Raw Poultry.
FDA. Several factors lead us to expect that the “drug” side will continue to be the major focus at FDA over the “food” side of FDA including the agency’s continuing role in COVID-19 vaccine authorization; the naming of Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER), as Acting Commissioner of Food and Drugs; and the basic fact that the 2021 budget for food safety (including cannabis) is 1/5th that of medical products and COVID-19.
Without knowing who the new FDA Commissioner will be, it is hard to determine exactly what the agency’s focus will be. But we feel safe in predicting that focus on public health and reaction to food-related issues will be swift and heavy.
However, there are a number of food safety initiatives that TAG sees as taking prominence in 2021:
- Produce Safety. In January, FDA published leafy greens outbreak investigation findings that confirm the presence of a recurring strain of E. coli O157:H7 in a region within Salinas Valley, “which could serve as a potential source to be associated with future contamination events.” With the traceback investigation having found the outbreak strain in a sample of cattle feces “collected on a roadside about a mile upslope from a produce farm”, we fully expect the FDA to focus on animal-produce contamination and its prevention throughout the year. The findings have drawn FDA’s attention, once again, to the potential of contamination by cattle grazing near leafy greens fields, leading the agency to increase its focus on adjacent land use – and very likely could bring FDA to attempt (once again) to set the agricultural water provisions of the Produce Safety Rule. This concern is likely to expand beyond leafy greens as FDA has indicated that proximity to animals may be involved in other outbreaks from last year involving products other than leafy greens.
- FSMA & the New Era. In fact, with 2021 being the 10-year anniversary of the signing of the Food Safety Modernization Act, what better celebration for the agency could there be than the finalization of those provisions? And what better lead in to 2021 implementation of its New Era of Smarter Food Safety blueprint – which has a strong focus on traceability and predictive analytics, which were stated in July 2020 as “can be seen in our most recent efforts to improve the safety of romaine lettuce and other leafy greens, which have too often been implicated in outbreaks of Shiga-toxin producing E. coli (STEC) infections.” It seems to us that actions need to be put to the “efforts” sooner rather than later.
- Traceability. And with the pending proposed Rule for Food Traceability with its Food Traceability List, there is no doubt that this will take a top spot for FDA in 2021
- Cannabis. Without knowing exactly how this will play out, we anticipate a much greater focus on cannabis-containing edibles over the next four years. It is unclear if this will take a FSMA route, a dietary supplement route, or a combination of both, but we will likely see this space evolve significantly from a regulatory perspective.
While we see these as key regulatory aspects of 2021 and beyond, as 2020 taught us, you can never be too sure of what may be lurking around the corner. In fact, it was this very month last year, that we saw the first real inklings of what was to turn our lives inside out. So, even while we place our best bets on the leanings and anticipated actions from the regulators of the Biden Administration, we recommend a high degree of resilience and readiness to move in the direction needed to both comply with whatever regulation may follow, and, more importantly, simply keep your food – and your people – safe.