EPA Evaluation of PFAS Leaching in Fluorinated Containers

On September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers.  Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers.  The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers.  EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers.   In both cases the Agency found varying levels of PFAS in the contents of the containers.

The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products.  The Agency also reported that the amount of PFAS that leach into the products could increase over time.   EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.

The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products.  Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.”  Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.

The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule  for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA).  Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use.  TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.

Implementing Statutory Addition of Certain PFAS Substances to the Toxics Release Inventory Reporting

In July 2022, EPA released a final rule adding five PFAS to the list of chemicals required to be reported to the Toxics Release Inventory (TRI) under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). TRI tracks the management of certain toxic chemicals that may pose a threat to human health or the environment and provides this information to the public. Pursuant to the National Defense Authorization Act (NDAA), EPA is required to automatically add PFAS to the TRI whenever it takes one of the following actions:

  • EPA finalizes a toxicity value for a PFAS or class of PFAS;
  • EPA determines that a PFAS or a class of PFAS is covered by a TSCA Significant New Use Rule (SNUR);
  • EPA adds PFAS or a class of PFAS to an existing SNUR; or
  • EPA finds that a PFAS or class of PFAS is active in commerce (under TSCA Section 8).

Under this rule, facilities in specific industry sectors that manufacture, process, distribute, or use any of the five PFAS added to the TRI, must submit a TRI report if they exceed the PFAS reporting threshold of 100 pounds. Four of the substances are added to the list effective January 1, 2022, and the remaining substance is effective January 1, 2021, meaning TRI reporting due in 2023 must account for these substances.

CoverGirl Cosmetics and Coty Inc PFAS Suit

CoverGirl Cosmetics and Coty Inc. are facing a class action lawsuit for marketing their TruBlend Pressed Powder as sustainable and safe while allegedly it contained PFAS.  The complaint was filed in the U.S. District Court for the Southern District of California.  According to the complaint, independent lab testing found that the product contained increased fluorine levels, an indicator of the presence of PFAS.   The complaint also notes that defendants misrepresent the product in their marketing materials which state that they hold themselves to the highest quality standards when it comes to safety and efficacy of their products.  Plaintiffs argued that these acts violate the California Unfair Competition Law and the California False Advertising Law, and constitute fraud and negligent misrepresentation.

The plaintiff asserts that the presence of PFAS is a concern because PFAS exposure through inhalation, ingestion, and skin contact can result in PFAS entering the body. The makeup in question is applied directly to the face and is prolonged skin contact.  Plaintiff contends that PFAS are present at a greater concentration than recommended by the current EPA health advisory limit for safe consumption.

Biological Opinion Proposes Malathion Mitigation Measures

The U.S. Fish and Wildlife Service’s (FWS) nationwide final biological opinion (BiOp) for Malathion has prompted EPA to take steps to protect a number of endangered species that were identified as being threatened by the insecticide.  Malathion is an organophosphate insecticide use on a wide variety of food and non-food crops to kill insects systemically and on contact.  It is also used as a mosquito adulticide.  The BiOp was prompted after EPA released a biological evaluation on malathion in January 2017EPA’s evaluation found the insecticide was likely to affect both aquatic and terrestrial animals by inhibiting and enzyme necessary for synapse and neuromuscular function, leading to sublethal effects and mortality.

FWS collaborated with EPA and the malathion technical registrants to create the BiOp.  The BiOp also includes information provided by stakeholders, non-governmental organization, and members of the public who commented on EPA’s initial evaluation.  The BiOp states that malathion is likely to jeopardize 78 different species and destroy or adversely affect 23 habitats.  FWS proposed mitigation measures that would reduce the application rates, create no spray zones, and apply label changes for the pesticide users to follow.  One proposed mitigation measure for reducing the application rates would restrict application when rain is predicted and when certain types of crops are in bloom. The purpose of these mitigation measures is to minimize the likelihood of exposure to different species and reduce the affects to their development and habitats.

The BiOp states specific measures and mandatory label instructions will be available through EPA’s Bulletins Live! Two website, which provides information on endangered species, along with other relevant information.  Registrants were asked to submit amended labels to EPA by June 29, 2022.

State of Washington Regulates PFAS In Lieu of Cosmetics Ban

A proposal in Washington state has stalled in the state House, after passing their Senate, that would have banned cosmetics that contain phthalates, formaldehyde, and PFAS.   The proposal, Senate Bill 5703, states that legislature finds certain chemicals in cosmetic products to be linked with various negative health effects, such as cancer, birth defects, and damage to the reproductive system. It further states that if enacted, it would have prohibited the sale and distribution of any cosmetics containing these and an additional 31 different substances such as ortho-phthalates, phenolic compounds, parabens, and lead compounds beginning January 1, 2025.

Although Senate Bill 5703 did not progress, the governor did sign into law House Bill 1694, which allows the state department of ecology to recognize and regulate consumer products containing PFAS.  The bill gives the ecology depart the authority to restrict PFAS product to any limit.   The state’s department of ecology is directed to determine an initial set of regulatory actions regarding PFAS consumer products by June 1, 2024 and must adopt rules to implement the initial set of determinations of regulatory actions by December 1, 2025.  Washington has also created a $266,00 fund for identifying and testing cosmetics for the purpose of determining which cosmetics present harmful effects.

Washington is not the first state to ban hazardous substances from cosmetics.  In 2020, California passed a ban on cosmetics containing harmful substances, identifying some PFAS chemicals.  Maryland took the same course of action in 2021.  In addition, several other states, such as New Hampshire, Minnesota, Michigan, and Maine have begun drafting legislature to restrict PFAS in cosmetics.

PFAS Found in L’Oréal Cosmetics

A class action lawsuit has been filed in a New York federal court alleging that L’Oréal USA failed to disclose its Waterproof Mascara Products contain PFAS. Third-party testing revealed that PFAS are present in several of L’Oréal’s waterproof mascaras. PFAS are commonly found in cosmetics because of their durability, spreadability, and waterproof and oilproof properties While PFAS are largely unregulated in cosmetics at the federal level although the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Office of Cosmetics and Colors has authority to do so under the Federal Food Drug and Cosmetic Act, consumer demand for PFAS-free products has led companies such as Sephora and Ulta Beauty to designate PFAS-free brands as “clean” beauty brands.

The Complaint states that since at least 2018, the company has misleadingly and fraudulently advertised its Waterproof Mascara Products. Plaintiffs allege that the mascaras were labeled as safe, effective, and high quality, utilizing phrases such as “ophthalmologist tested’ and “hypoallergenic,” yet packaging and ingredient lists failed to disclose the presence of PFAS.

According to the Complaint, L’Oréal, with exclusive knowledge of the formulas, ingredients, and suppliers, knew or should have known the waterproof mascara products contained or had a material risk of containing PFAS. Additionally, Plaintiffs assert that L’Oréal should have known that the presence or material risk of PFAS was a material consideration to consumers. The Complaint alleges that had consumers been aware of the presence of PFAS they would not have purchased the products or would not have purchased them at a premium price.

The case is Hicks v. L’Oreal USA Inc., S.D.N.Y., No. 1:22-cv-01989, 3/9/22.

EPA Releases Final Scope Document for Manufacturer-Requested Risk Evaluation of D4

On March 7, 2022, EPA published the final scope of the risk evaluation for octamethylcyclotetra-siloxane (D4). This risk evaluation may affect producers of goods comprised of and/or utilizing the following: adhesives, sealants, synthetic rubber, electrical equipment, appliances, paint, ink/toner, aircraft maintenance components, automotive care components, cleaning products, fabrics/textile products. This is not intended to serve as an exhaustive list. The publication of this risk evaluation originated from a request made by the American Chemistry Council’s Silicones Environmental, Health, and Safety Center (SEHSC). The scoping document addresses conditions of use, exposures, hazards, and potentially exposed or susceptible subpopulations.

Conditions of Use

Conditions of use for D4 risk evaluation can be sub-divided into the following life cycle stages: manufacturing, processing, distribution in commerce, industrial use, commercial uses, consumer uses, and disposal. EPA’s evaluation will address each of the aforementioned life cycle stages. Notably, processing is the most nuanced of these stages. Specifically, the processing stage is comprised of three subcategories: processing as a reactant; incorporation into formulation, mixture, or reaction product; and repackaging.

Exposures

In the forthcoming risk evaluation, EPA will evaluate human and environmental exposures as well as releases into the environment resulting from these conditions of use identified in the scoping document. The evaluation will contemplate the physical and chemical properties of D4; environmental fate and transport processes, exposure pathways, and potential human and environmental receptors; releases to the environment; environmental exposures (both aquatic and terrestrial); occupational exposures; consumer exposures; and general population exposures.

Hazards

Regarding environmental hazards, EPA will assess the following potential hazard effects of D4 to aquatic and terrestrial organisms including: absorption, distribution, metabolism, and excretion (collectively referred to as “ADME”), developmental, gastrointestinal, mortality, neurological, nutritional, metabolic, reproductive, and respiratory. The scoping document notes that D4 can degrade into dimethylsilanediol (DMSD) under certain environmental conditions. Accordingly, EPA has indicated that it may factor toxicity information regarding DMSD into its risk evaluation.

With respect to human health hazards, EPA intends to examine the relation of D4 exposure to the following: ADME, cancer, endocrine, gastrointestinal, hematological, immunology, hepatic, mortality, neurological, nutritional/metabolic, ocular/sensory, renal, reproductive, developmental, respiratory, and skin/connective tissue. The scope of EPA’s assessment of the human health hazards of D4 may also contemplate hazards associated with exposure to DMSD as mentioned above.

Potentially Exposed or Susceptible Subpopulations (PESS)

In accordance with the requirement of TSCA section 6, the following groups will be considered potentially exposed or susceptible subpopulations in the D4 risk evaluation: children, women who may become pregnant, workers, occupational non-users (ONU), consumers, bystanders, fence line communities, and indigenous and native populations. Environmental justice considerations will also be factored into the PESS analysis. These considerations will follow the best practices discussed within EPA’s Technical Guidance for Assessing Environmental Justice in Regulatory Analysis.

EPA Releases 2020 TRI National Analysis

In March 2022, EPA released the 2020 Toxics Release Inventory (TRI) National Analysis, showing a decline of 10% for environmental releases of TRI chemicals from the previous year.  EPA states that part of the reason for making the information public is to incentivize companies to reduce pollution.  EPA is also offering $23 million in grants to states and Tribes for developing and providing businesses with aid in adopting pollution prevention practices.

The National Analysis now includes a map information for individuals to display international transfers of chemical waste by different facilities. This information includes the facility that shipped the waste, country of destination, and how the country managed the waste.  Along with these data, users can view greenhouse gas emissions for electric utilities, chemical manufacturing, cement manufacturing, and other industrial sectors.  The mapping tool also provides data for local communities within each state.

Facilities in the 2020 TRI National Analysis used recycling, energy recovery, and treatment as methods to prevent the release of more than 89 percent of the chemical-containing waste that they created and managed. Air pollution was also decreased by 52 million pounds from YEAR.  EPA encourages facilities to use the Agency’s Pollution Prevention Search Tool to discover additional methods of reducing pollution.

The 2020 National Defense Authorization Act added 172 PFAS to the list of TRI reportable substances.  The 2020 National Analysis was the first to cover reporting of these chemicals.  Nine thousand pounds of the 800,000 pounds of PFAS that were produced in 2020 were reported as releases, with most of the releases coming from the chemical manufacturing sector.  EPA continues to focus on PFAS by contacting facilities that may have reporting errors and those that did not report but were expected to. EPA plans to propose a rulemaking in the summer of 2022 to remove the de minimis exemption for PFAS, which allows facilities to disregard certain minimal concentrations of chemicals. EPA expects the removal of the de minimis exemption will result in more data on releases in future TRI reporting for an expanded perspective on the releases these substances.

Chemours Securities Fraud Litigation to Continue

The New York State Teachers’ Retirement System and others (Teachers) will be able to continue pursuing claims that Chemours kept investors in the dark about the billions in potential environmental liabilities.  On February 24th, a federal judge in Delaware ruled that Teachers’ claims of securities fraud plead sufficient facts to survive Chemours’ motion to dismiss.  Specifically, plaintiffs allege that Chemours financial statements “dramatically mischaracterized Chemours’ true financial condition and vastly understated Chemours’ liabilities from decades of environmental pollution.”

The court found that starting in February 2017, Chemours disclosed that “higher clean-up costs that might result ‘under adverse changes in circumstances, although deemed remote.’ … once Chemours chose to make that disclosure-even if not required by [Generally Accepted Accounting Practices] GAAP or otherwise-it had to speak truthfully … [and that] a reasonable investor could have plausibly inferred from the language Defendants used to ‘provide’ in the challenged SEC reports Chemours’ ‘higher clean-up costs’ that Chemours was disclosing its maximum potential remediation liabilities.”  The court explained that “the question then is whether Plaintiff has alleged in the Complaint facts sufficient to plausibly imply that Defendants did not in fact believe that Chemours’ s environmental remediation liabilities were capped at the sums disclosed in the SEC reports.”

Teachers drew on two sources to supports their claim that Chemours did not in fact believe that its environmental remediation liabilities were capped at the sums disclosed in the SEC reports.  First, Teachers argued that Chemours “specifically itemized” $2.5 billion of inherited liabilities as of the time it was spun-off from DuPont, in a complaint against DuPont in a 2019 Delaware Chancery Court Complaint – in that unrelated case, Chemours asserted that “DuPont violated New Jersey law by spinning off Chemours on the basis of underestimated environmental liabilities without providing the State with the ‘financial assurance necessary to ensure’ that the necessary clean-up can be done.”  Second, Teachers asserted that a 2018 internal evaluation of total environmental remediation costs company-wide identified costs of more than $2 billion.  The court held that Chemours’s allegations in the Chancery Court Complaint do not plausibly imply that the company made false representations about its maximum potential environmental remediation liabilities in the challenged SEC reports.  However, it also found that “a rational juror could plausibly infer from the [internal evaluation] that … Defendants believed that Chemours’ s environmental remediation liabilities were approximately two billion dollars,” a significantly greater amount than Chemours had said its liabilities were; that is, that Chemours had made false statements about liability.

Chemours argued that “even if Plaintiff had identified any error in Chemours’ environmental liability disclosures, they would nevertheless be inactionable because they were accurate statements of opinion.” However, the court held that “statements of opinion … are ‘actionable under the securities laws if they are not honestly believed and lack a reasonable basis.’”  In addition, the court explained that Teachers’ allegations plausibly implied that Chemours did not consider the maximum remediation liability disclosures accurate, and therefore, those disclosures could be actionable opinions.

The court also held the Teachers had adequately pleaded its claims against Chemours’ President and CEO and the company’s Senior Vice President and COO (previously its CFO) for the two to continue as defendants in the case.

 

IRIS Review of PFHxA and its Related Salts

EPA’s Integrated Risk Information System (IRIS) program is developing assessments for five PFAS:  perfluorobutanoic acid [PFBA], perfluorohexanoic acid [PFHxA], perfluorohexane sulfonate [PFHxS], perfluorononanoic acid [PFNA], perfluorodecanoic acid [PFDA], and their associated salts.  On February 2, EPA released the draft IRIS assessment for PFHxA.

The IRIS assessment followed a systemic review protocol that outlines the related scoping and problem formulation efforts, including a summary of other federal and state assessments of PFHxA. The protocol also lays out the systematic review and dose-response methods used to conduct the review.

The review found that PFHxA exposure is likely to cause hepatic, developmental, and hematopoietic effects in humans.  In addition, the review reported that current evidence suggests that PFHxA exposure might cause endocrine effects in humans.