Earlier this month, we posted an article discussing the federal crackdown on levels of PFAS in food and water, and the consequences of “chasing zero.” It didn’t take long to see exactly what the consequences would be, as two processors recalled product due to FDA’s finding of “detectable levels” of PFAS in a survey of seafood samples purchased at retail. With these samples being tested down to parts per trillion (ppt), and EPA’s recent definition of safe levels in drinking water reduced from 70 ppt (sum of PFOA and PFOS) to 0.004 ppt (PFOA) and 0.02 ppt (PFOS), there is justified concern in the food industry as to when and how it will all impact their product. For reference, 0.004 ppt is equal to 4 miles on a journey of 170 light years – that’s how close it is getting to zero.
To assist food businesses, TAG is closely following the issue and will be providing information, analyses and recommendations on the issue. To follow up on our previous article which provided facts, regulatory action and general industry impact, this article provides information and perspective on the overall risk to businesses and some remaining questions.
Seeing the risk to businesses as falling into three buckets, health, regulatory, and perception, we provide the following assessments:
1. Human Health Risk. EPA updated its risk values for two specific PFAS chemicals: PFOS and PFOA. (PFAS represent a whole host of compounds with ranging toxicological significance; PFOA and PFOS represent two of the most studied and pervasive.). In 2016, the reference dose for both chemicals was 2 x 10-5 mg/kg/day; the new RfDs are: 7.9 x 10-9 mg/kg/day and 1.5 x 10-9 mg/kg/day, respectively. For PFOA, that’s a 13,333x decrease.
TAG Assessment. Whether meeting these levels is pragmatic or even achievable is quite controversial, but internal corporate risk assessors will need to conduct their own assessments and determine the appropriate approach.
2. Regulatory Risk. With its retail survey and the resulting recalls, FDA has set a precedent. However, we don’t have a full picture of the agency’s current thinking on EPA’s RfD and its applicability to food. We also don’t know how FDA determined risk. They provided clues to acceptable exposure on a monthly basis, etc., but have not divulged their risk formula. From our calculations, it appears, though, that it must be more practical than the preliminary EPA conclusion, otherwise levels in cod, crab meat, etc. would have been called into question as well. Additionally, the greatest risk of detection outside of seafood and fish is packaging, especially in grease-proofing applications.
TAG Assessment. From all this, we see that businesses need to be prepared with a pragmatic, well-thought risk assessment based on human health (above). When FDA asks if you have conducted a risk assessment, you need to be prepared to say “Yes” and explain the assessment from a toxicological and risk standpoint.
3. Perceived Risk. Consumer perception is always a key consideration of businesses because perception has a direct link with purchasing decisions. Perceived safety issues should never be used as marketing or branding opportunities; however, businesses will be forced to make decisions based on perception alone and respond if and when NGOs and consumer advocacy groups randomly test products in the marketplace.
TAG Assessment. As a food business, you need to determine how much you’re willing to “fight.” That is:
1. Can you detect any PFAS in your finished products?
2. If so, what are the levels?
3. Do you want to defend these levels?
Most large businesses will not want to fight, and instead will take a generalized approach, such as stating, “The safety of our consumers is our #1 priority, and we are closely monitoring our supply chain for PFAS levels and are following the science and regulatory landscape to ensure our products remain safe.” Most will stop short of committing to zero, knowing that it is not attainable, though they may mention that they’re working with their suppliers to ensure that levels are significantly minimized, etc. Such tactics will likely work – for the short term. But the discussion and debate on the issue is spreading rapidly and consumers’ ongoing demand for transparency is unlikely to stay out of this realm for long. So decisions will have to be made.
Unfortunately, this decision-making is encumbered by a number of unanswered questions. For example, while bioavailability in food will, undoubtedly, be different than water, it is unknown how different it will be. The science and risk assessment will need to evolve based on this question, as we simply don’t know the bioavailability of some of these compounds across the food/feed supply chain. There also are state-to-state differences in RfDs for PFAS compounds, so what will this mean for enforcement?
The evolving science suggests that there are risks (such as immune suppression in children, liver effects, etc.) at lower exposure levels. While these are unlikely at the ppt and sub-ppt levels, we don’t know how this will translate to regulatory risk as FDA and consumer groups continue to sample products in the marketplace. Just how much is too much and what are the triggers for regulatory action without pragmatic limits? Neither the science nor FDA has the answers at this point. But, while we do believe that true and accurate health risk should be the primary assessment, it is likely that consumer perception will take precedence. Although detection does not equal true risk, too often, perceptually, detection does equal risk. Because of this, we are at a point where we need a threshold of regulation, below which the health impact is negligible.
At this point there are far more questions than answers. But regulatory action has been taken, as noted above, and likely this will not be the last time. In fact, on July 13, the White House Office of Science and Technology Policy (OSTP) issued a request for input from on data gaps in research and development regarding several aspects of per- and polyfluoroalkyl substances (PFAS). The information will be used to inform a strategic plan for federal coordination and development of an implementation plan for federal agencies. Comments are due by August 29, 2022.
TAG’s advice to all in the food industry is to fully understand your level of exposure in this space; establish a process to be able to rapidly undertake a health hazard evaluation should that be needed when you are confronted with findings in your products – and provide any input you may have on the above. TAG has the expertise and experience to support the food industry in your efforts, so call us if you need help.