Chemical Currents – August 1, 2022

Chemical Currents provides real-time updates, legal observations, and actionable tips to navigate the constantly evolving legal challenges involving PFAS. In this edition, we discuss a National Academies report, EPA’s final rule adding five PFAS chemicals to its Toxics Release Inventory List, a suit against EPA concerning its recently issued Final Drinking Water Health Advisory on GenX chemicals, some new activity concerning PFAS in seafood, state legislative developments, and lastly we cover some newly filed PFAS-related claims.

Look for new editions approximately every two weeks and please feel free to reach out to the King & Spalding team if you have any questions regarding PFAS issues.

Focus on Science
Focus on EPA
Focus on FDA

What We Are Reading

• OMB Issues Statement Questioning Restrictions on Department of Defense Use of PFAS in Congress’s Defense Authorization Bill.  White House.
• Association of Prenatal Exposure to Endocrine-Disrupting Chemicals, Including PFAS, With Liver Injury in Children.  JAMA.
• “PFAS-Tox Database” Offers a Compilation of Health Studies on 29 PFAS (Other than PFOS and PFOA)

Focus on Science

National Academies Issue Recommendations for Clinicians
On July 28, the Committee on the Guidance on PFAS Testing and Health Outcomes at the National Academies of Sciences, Engineering, and Medicine released a report on “Guidance on PFAS Exposure, Testing, and Clinical Follow-Up.” Commissioned by ATSDR and NIEHS, the report offers feedback on “principles for biological testing and clinical evaluation, given substantial uncertainty about the health effects or the value of such measures in informing care.” The committee also reviewed the human health literature on PFAS and offered feedback on exposure reduction and advice on changes to ATSDR’s current clinical guidance. The report suggests blood levels below which additional clinical care is not needed, levels where clinicians should consider prioritizing certain evaluations, and levels where clinicians should assess additional testing.

Independent Expert Panel Provides Insights on Grouping of PFAS for Human Health Risk Assessment
To group or not to group, that is the question addressed by a panel of independent experts in a recent study. Recognizing that different PFAS have widely different physical, chemical and toxicological properties, the experts provided responses to a series of questions and feedback on each others’ responses, all without knowing who the other experts were. The published study compiles the independent results and describes where consensus did and did not occur. The majority of panelists agreed that grouping, as suggested by US EPA, is a pragmatic place to start in assessing effects, but not sufficient for health-based regulation. The panel split on when dose additivity would be justified beyond a screening step, and no consensus was reached on the utility of total organic fluorine measurement as a screening tool.

Focus on EPA

EPA Issues Final Rule Updating List of Chemicals Subject to Toxic Chemical Release Inventory Reporting to Include Five PFAS Chemicals. 
On July 18, 2022 EPA issued a final rule adding five PFAS to the Toxics Release Inventory List (TRI).  Earlier this year, this newsletter covered EPA’s January announcement that it would add four PFAS to the TRI.  EPA’s newly issued final rule includes those four PFAS chemicals that were part of the earlier announcement as well as one additional PFAS chemical (potassium perfluorobutane sulfonate (potassium PFBS)).  As highlighted in our prior issue, facilities that manufacture, process, or otherwise use chemicals listed on the TRI must submit annual reports to EPA that includes data about such chemicals’ release into the environment and the facilities’ waste management practices.  Four of the five PFAS chemicals are reportable for the 2022 year, with reports due July 1, 2023.  One of the five (with a scientific name about five lines long so we will just refer to it here by its CAS Registry Number: 65104-45-2) is reportable for 2021, and the rule notes that reports on this substance were previously due back on July 1 of this year. 

Manufacturer Sues EPA Over GenX Standards.   
Back in March, we covered the fact that a manufacturer had filed an Information Quality Act Petition requesting that EPA withdraw and correct its GenX Chemicals Toxicity Assessment, in which EPA proposed the lowest reference doses (RfDs) yet for any PFAS chemical: a chronic RfD of 0.003 µg/kg/day and a subchronic RfD of 0.02 µg/kg/day. 
On Jun 14, 2022, EPA issued its response to the petition, denying the manufacturer’s request for correction (RFC).  EPA informed the manufacturer that “[a]fter careful consideration, EPA has concluded that the underlying information and conclusions presented in the [GenX Chemicals Toxicity Assessment] and its supporting materials are consistent with EPA’s Information Quality Guidelines.  Therefore, the RFC is denied.”  The next day, EPA published its Final Drinking Water Health Advisory on GenX chemicals (GenX Drinking Water Advisory), which cited the earlier GenX Chemicals Toxicity Assessment as “the basis” of the toxicity assessment included in the GenX Drinking Water Advisory.   

Not long thereafter, the manufacturer filed a petition with the Third Circuit challenging the GenX Drinking Water Advisory.  The complaint raises a number of bases challenging the GenX Drinking Water Advisory, including that its enactment was arbitrary and capricious based on the methodological issues highlighted in the manufacturer’s earlier Information Quality Act Petition.  The manufacturer also claims that the enactment of the GenX Drinking Water Advisory exceeds EPA’s statutory authority and violates constitutional due process protections as well as the nondelegation doctrine. 
We’ll be sure to continue following this dispute as it moves forward through the courts. 

Focus on FDA

FDA Announces Intent to Collect Data and Information on PFAS in Food Containers. 
On July 20, 2022, FDA announced that it is opening a docket to obtain information about the use of PFAS in food packaging, including collection of data on food packaging products that contain PFAS, review of potential exposures that could result from such packaging, and an evaluation of the health effects.  This announcement follows the Consumer Reports article that we reviewed earlier in the year and litigation that followed shortly thereafter.  Any submissions and data must be submitted by October 18, 2022.  We will be following the docket closely for any new data and information on PFAS in food packaging. 

FDA Releases Results on Testing in Seafood. 
With temperatures across the country climbing into the nineties (and higher), summer is officially in full swing.  And while summertime is typically the time to enjoy seafood while hitting the boardwalk along the beach, recent results of testing from FDA may lead some consumers to opt for lunchtime alternatives.  In recent months, FDA collected 81 samples of retail seafood and tested them using an LC-MS/MS methodology capable of detecting twenty different PFAS chemicals.  The results of this testing identified two samples of canned clams from China with elevated levels of PFOS (20.1 and 19.8 ppb, respectively) that were, according to EPA, “a potential health concern for consumers who eat more than approximately 10 ounces (oz) of these clams per month, except for young children, who should limit consumption to 2 oz per month.”  In response, the two retailers of these canned clams issued voluntary recalls of the products “in an abundance of caution” despite no reports of illnesses associated with the consumption of either product.  Good luck to those parents of the young children who will dearly miss their favorite Chinese canned clams. 

One Bonus Note on PFAS in Seafood: New Study from Researchers at FIU and Texas A&M Identifies PFAS in Oysters in Florida.
A forthcoming study from a team of researchers at Florida International University and Texas A&M collected oysters in three different locations along Florida’s coast and examined levels of PFAS and phthalate esters in the mollusks.  The study identified PFAS in at least one oyster collected at each of the three locations, with concentrations ranging from less than 1 ppb to over 100 ppb.  The study includes a neat graphic identifying the locations of the samples as well as some potential explanations for the levels of PFAS identified:

We will be sure to stay on the cutting edge for all news concerning PFAS in marine animals.

Focus on State Legislation
The group of states enacting prohibitions on food packaging containing intentionally added PFAS has two new members:

• Rhode Island (HB 7438) – The prohibition starts on January 1, 2024.
• Hawaii (HB 1644) – The prohibition, effective July 1, 2024, includes wraps and liners, plates, food boats, and pizza boxes.

Focus on Litigation Activity
Over the last several weeks, plaintiffs’ firms have filed several complaints in the consumer product and toxic tort areas:

• Plaintiff Marisol Baez recently filed a proposed class action complaint in the Eastern District of New York against The Clorox Company and The Burt’s Bees Products Company claiming that several mascara and lip gloss products contain PFAS based on testing performed by Mamavation and released in May of this year.  Like other similar complaints, plaintiff is seeking monetary compensation based on breaches of express and implied warranties, fraudulent concealment, and unjust enrichment. 

• Plaintiff Candace Seidl recently filed a proposed class action complaint in the Eastern District of Pennsylvania against Chicco USA, Inc. alleging that certain children’s car seats contain fabrics containing PFAS according to testing performed by The Ecology Center and released in April of this year (and covered in this newsletter).  As with most other similar complaints, plaintiff is seeking monetary compensation based on breaches of express and implied warranties, fraudulent concealment, unjust enrichment, and violations of consumer protection acts. 

• Plaintiffs Stephen, Elizabeth, and William Sutton filed a complaint in the District of Maryland related to Dr. Stephen Sutton’s prior employment at a WL Gore facility in Elkton, Maryland.  The plaintiffs allege that rheologist Dr. Stephen Sutton worked at the WL Gore facility and lived with his family less than one mile away.  The complaint claims that the family members developed a variety of different health effects including cancers allegedly as a result of exposure to PFAS chemicals PFOA and APFO both at the facility and through drinking water allegedly contaminated by the facility’s use of those materials.  The plaintiffs seek compensatory damages, punitive damages, costs for medical monitoring, costs for air testing, and remediation costs for property at issue. 

• Wisconsin Attorney General Joshua Kaul, at the request of Governor Anthony Evers, filed a complaint against nearly twenty companies for alleged PFAS contamination of water, air, and sediment within the state.  The complaint alleges that the alleged contamination will require “billions” of state taxpayer dollars to remediate the PFAS contamination, which the state will seek to recover from the companies sued in this complaint.  In addition, Attorney General Kaul seeks to impose punitive damages on the defendant companies.   

The authors will stay on the lookout for additional filings as PFAS litigation activity continues to increase.