Since June 2019, when the U.S. Food and Drug Administration (FDA) released its testing results from three studies, questions have arisen about food as a source of PFAS exposure.
The main routes by which PFAS enter the food supply are environmental contamination—such as from nearby chemical manufacturing facilities, airports or Department of Defense operations—and from food packaging and processing equipment.
With greater attention on PFAS in food, we’ve noticed several misleading PFAS manufacturers’ talking points asserting that FDA review and acceptance is required for any PFAS to be used in contact with food, and that, due to this review, PFAS that go through this process are safe.
However, their claims that the agency demands scientific data, including toxicity and exposure, and conducts a rigorous review before allowing the use of the chemicals in contact with food are not accurate.
We have written extensively about FDA’s flawed process that has led to accepting 31 PFAS food contact notifications (FCNs) and, therefore, allowing them to be used in contact with food.
In the last 15 months we detailed breakdowns in an opaque regulatory system driven by outdated scientific assumptions. In this blog, we focus on clarifying common mischaracterizations of FDA’s review process for PFAS as food contact substances.
Setting the record straight should help ensure the public and policy makers understand the shortcomings of FDA’s review and questions regarding the safety of PFAS in food packaging.
Some PFAS in food packaging may have bypassed FDA review
A very common claim by manufacturers is that before a food contact substance, such as PFAS, can be marketed and sold, its safety must be reviewed by FDA.
This is simply not true. While the “Generally Recognized as Safe” (GRAS) exemption was created by Congress for common food ingredients such as oil and vinegar, private companies with clear conflicts of interest now abuse the loophole by bypassing FDA review and making safety determinations without oversight.
We maintain that this practice is illegal and, along with Center for Food Safety and represented by Earthjustice, have challenged FDA’s rule in court.
FDA does not require extensive test data and scientific information when allowing a food contact substance on the market
Despite claims to the contrary, FDA does not require extensive toxicology studies before allowing a food contact substance like PFAS to be used in food packaging. The only requirement is that the company provide the agency with all relevant chemical, toxicological, and environmental data it has.
In our review of 31 PFAS FCNs accepted by FDA, we saw varying amounts of information submitted by seven manufacturers seeking agency review, but the notices have something in common: the toxicity data on PFAS was consistently poor and mostly focused on genetic toxicity.
While genetic toxicity testing has value, it is insufficient to fully assess the range of health effects seen for PFAS and many other chemicals.
In one case, a company withheld important information from the agency. We have previously reported that in several of its FCNs, Daikin had failed to inform FDA about two animal studies showing tooth, liver and kidney effects after only one month of exposure. These types of results are warning signs for PFAS.
No long-term studies to assess human exposure over time, including potential accumulation in the body, were submitted to FDA for review of the FCNs.
Overall, FDA’s safety decisions are driven by the estimated exposure to PFAS and its impurities. The agency uses 50 parts per billion concentration in the overall diet as a threshold below which it assumes there are no health risk as long as the PFAS are not genotoxic.
This despite the fact that other government agencies have concluded that for some PFAS, such as PFOA and PFOS, the exposure levels should be 100 to 1,000 times lower.
FDA has publicly committed to reassessing the safety of short-chain PFAS it previously reviewed
Once FDA allows a food contact substance to be used, there is no systematic process to reassess those decisions, and manufacturers have no obligation to alert the agency to problems unless there is evidence it has injured consumers.
This means that, the agency is generally unaware of new toxicology or exposure studies unless those are brought to its attention and it has no duty to reassess any of its decisions except in rare circumstances when it is confronted with a challenge, which has already happened for some forms of PFAS as well as ortho-phthalates.
Given this flawed system, it is extraordinary that FDA publicly acknowledged that it needs to reassess its previous decisions for a type of PFAS known as short-chain.
We think the agency acted because its own scientists have concluded that the short-chain PFAS that replaced PFOA and PFOS and have been touted as having an “improved health and safety profile” may also bioaccumulate in the body, potentially contributing to similar or additional health problems.
Anyone arguing that PFAS in food packaging are safe simply because the use was accepted by FDA must think again. In truth, based on current scientific information, an FDA-accepted PFAS offers little assurance that the ongoing use of the chemical is safe.
- The agency does not actually approve an FCN. Rather it “accepts” the notice by allowing it to become effective; if FDA does not act within 120 days of the filing, the notice is automatically deemed effective. In essence, FDA only has authority to veto it, rather than approving it. Approvals are handled through the more rigorous food additive petition process. In practice, FDA acts within the 120 days or the company withdraws the notice in response to FDA concerns.
- As of October 22, 2019, there were 70 effective FCNs for PFAS and seven had been voluntarily ceased by the manufacturer. While, technically, these seven are still effective, we dropped them from our count. Note than 63 is one more than we reported in our August 5 blog because FDA posted one more acceptance after our blog.
- In its guidance for industry, FDA states that 50 ppb in the diet is equivalent to 150 ug/person/day. For a 60 kg person this is 2.5 µg/kg body weight per day. Separate from its FCN reviews, on its current PFAS webpage, FDA states that it uses the U.S. Environmental Protection Agency’s reference dose (RfD) for PFOA and PFOS of 0.02 µg/kg-bw/day in its safety assessments. This is 100 times lower than the default level used in the FCNs. In 2018, the Agency for Toxic Substances and Disease Registry concluded that EPA’s values should be 10 times lower.
Published on blogs.edf.org