EPA Issues Next Test Order Under National PFAS Testing Strategy — PFAS Used in Plastics at Issue

EPA has issued its second round of Test Orders under its National PFAS Testing Strategy. The test orders require companies to conduct and submit testing on trifluoro (trifluoromethyl) oxirane (HFPO) (CASRN 428-59-1), a PFAS substance used in making plastics. According to EPA’s Chemical Data Reporting (CDR) database, more than 1,000,000 points of HFPO are manufactured each year. EPA has concluded, using existing hazard and exposure data, that HFPO may present an unreasonable risk of injury to health or the environment, finding that exposure may result in neurotoxicity, reproductive effects, and cancer. The Tier 1 testing will address human health from exposure via inhalation and hydrolysis. Tier 2 testing, if required, will look at reproductive toxicity, developmental neurotoxicity, and carcinogenicity.

The companies that are subject to the test order include The Chemours Company, DuPont De Nemours Inc., E.I. du Pont de Nemours and Company, and 3M Company. These companies are required to submit the results of testing data to EPA within 415 days of the effective date of the order. All data produced from this test order will subsequently be published on EPA’s website.

EPA Publishes Final IRIS Assessment of PFBA

In December, EPA published the IRIS Toxicological Review of Perfluorobutanoic Acid and Related Salts. The Agency’s assessment addresses potential cancer and noncancer human health effects of exposure to perfluorobutanoic acid (PFBA) and its related salts. The most significant of the IRIS findings is that sufficient oral exposure to PFBA likely causes disruptions to normal thyroid hormone production, liver damage, and developmental effects. The Agency stated there was inadequate evidence to determine whether reproductive effects might represent a potential human health hazard following PFBA exposure.

PFBA and its related salts are members of the PFAS family.  It is a breakdown product of other PFAS that are used in a variety of products, including stain-resistant fabrics, carpets, and paper food packaging. PFBA can also be used in the manufacturing process of photo film and is used as a substitute for a type of PFAS, longer chain perfluoroalkyl carboxylic acids in consumer products. The substance can accumulate in agriculture crops, household dust, soils, food products, and surface, ground, and drinking water. Exposure to PFBA can occur through inhalation of indoor or outdoor air, ingesting contaminated drinking water and food, and dermal contact with PFBA-containing products.

As part of its PFAS Strategic Roadmap, EPA has been actively working on IRIS assessments for five PFAS: PFBA, PFHxA, PFHxS, PFNA, and PFDA. The PFBA IRIS is the first in this series to be released.

EPA Releases Initial Regulatory Flexibility Analysis for the Proposed PFAS Reporting Rule

On November 25, 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) for public comment as part of its development of a rule to collect information about PFAS. The IRFA follows the Agency’s June 2021 proposed rule, which would require all manufacturers and importers of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. In the proposed rule, EPA certified that the rule would not have a significant impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). In response to public comments from the June 2021 proposed rule and additional data sources on PFAS-containing imports, EPA convened a Small Business Advocacy Review Panel and prepared the IRFA to investigate further the burdens the proposed rule would place on small businesses.

EPA significantly increased its cost estimates for the proposed rule, stating social costs would be approximately $875 million, from the original $10.8 million estimate, and Agency costs would be approximately $1.5M,  from the originally estimated $948,078.  The IRFA anticipates that in order to report years of production and importation data, small businesses would be expected to pay the lion’s share of these costs, $863.5 million, not the originally anticipated $1.8 million. Additionally, the IRFA details the percentage of small firms that will be impacted by the rule, finding that approximately 93% of manufacturers and 97.3% of article importers affected by the proposed rule are small businesses. The total number of small businesses expected to be impacted is 127,794.

In the IRFA, EPA proposed and requested comment on a variety of regulatory flexibility alternatives, including:

  • Exemptions for businesses with less than $12 million in sales.
  • Exemptions for businesses with less than $6 million in sales.
  • Exemptions for article importers with less than $6 million in sales.
  • Exemptions for article importers with less than $2 million in sales.
  • Limiting the scope of PFAS subject to the rule to a finite list of PFAS, removing the structural definition. (Although EPA expressed concern over the Agency’s inability to list substance identities based on CBI claims.)
  • Exemption for reporting thresholds of either 2,500 lbs. per year or 25,000 lbs. per year.
  • Allow for small businesses, providing a six-month deferral of data submission.
  • Simplified reporting forms for R&D substances manufactured in volumes less than 10 kg. per year — including limiting reporting to company information, generic chemical name, and production volume.
  • Simplified reporting forms for article importers– excluding requiring information on existing environmental and health effects data, environmental release and disposal data, or occupational exposure data.
  • Exemptions for R&D substances, byproducts, impurities, recyclers, and intermediates. (However, EPA stated that these exemptions would limit the Agency’s ability to achieve its goal of better understanding the entire scope of existing information on PFAS.)

The Agency also requested information and comment on items pertaining to CBI, including treatment of chemical identity claims, notice prior to publication on the public TSCA Inventory, and the generic naming of PFAS. These issues were not included in the IRFA and the Updated Economic Analysis. Regarding the treatment of CBI claims, EPA sought to clarify language related to an entity’s knowledge of a specific chemical identity stating:

[A]n entity that does not have knowledge of a specific chemical identity must initiate a joint submission with its supplier or other manufacturer. In these cases, the secondary submitter would be responsible for providing the specific chemical identity and for asserting and substantiating any CBI claims concerning the specific chemical identity. See, e.g.,40 CFR 711.15(b)(3); 711.30(c).

Regarding notice prior to publication on the public TSCA Inventory, EPA sought to clarify that if a submitter reports a PFAS substance by a specific chemical identity and does not assert CBI, that chemical identity will be published on the public Inventory without notice to the submitter. Importantly, EPA requested comment on aligning this provision with the language in the proposed CBI Procedures rule indicating that persons who previously made a CBI claim for the same specific chemical identity will not receive prior notice before the specific chemical identity is moved to the public Inventory. Lastly, EPA clarified that generic names must sufficiently identify the chemical as a PFAS; for example, under TSCA Section 14(c)(1)(C), a generic name for a PFAS that does not contain “fluor” would be rejected as insufficient.

Earthjustice Files Petition Requesting EPA Revoke LVE and LoREX Exemptions for 600 PFAS

On October 13, 2022, Earthjustice, on behalf of numerous environmental organizations and community advocates throughout the country, filed a petition with EPA requesting that the Agency revoke the approval of approximately 600 PFAS Low Volume Exemptions (LVEs) and Low-Exposure Exemptions (LoREXs) to the TSCA Premanufacture Notice (PMN) requirement. The petition argues that EPA has a regulatory and statutory duty under 40 C.F.R. § 723.50(h)(2)(i)(A) to review previously granted LVEs and LoREXs to ensure they meet legal standards for exemption under TSCA section 5 (h)(4). (Earthjustice states that 40 C.F.R. § 723.50(h)(2)(i)(A) implicitly requires EPA to notify a manufacturer “at any time after the [initial] review period,” if it determines that a previously granted exemption no longer meets the legal standard, is that EPA must continue to evaluate chemicals’ eligibility for PMN exemptions in light of new information.)

PMN exemptions require that a substance “will not present an unreasonable risk.” The petition argues that this conclusion cannot be scientifically supported for the exposure levels allowed under the LVEs and LoREXes that have been granted.  The petition notes that EPA has the authority to revoke a previously granted exception at any time if it no longer meets TSCA’s legal standards.  When it issued the LVE rule in 1985, the Agency detailed its revocation authority, explaining that the authority “ensure[s] that eligibility for the exemption will be determined on the basis of the best available information [i.e., scientific evidence], regardless of when the information becomes available.” EPA made a similar statement regarding LoREXes in 1995.  The petition noted that this obligation is further stressed in case law that holds that EPA and other federal agencies have a general duty to consider new scientific information that may bear on whether the Agency’s past decisions or standards are health-protective, and to modify past decisions to ensure legal requirements are met.

The petition further argues that EPA’s prior initiatives to address PFAS LVEs do not adequately address health risks.  Earthjustice highlights numerous studies related to PFAS and human, animal, and environmental health, as well as EPA’s own statements indicating that it expects that chemicals entering commerce through both LVE and LoREX will result in levels of contaminations that far exceed what are now thought to be safe levels for PFAS.

This petition builds on Earthjustice’s 2021 petition that asked the Agency to amend the regulations that create exemptions from the PMN process—the LVE, the LoREX, the Byproducts Exemption, and the Polymer Exemption—to prohibit their use for PFAS.  The Agency has not yet responded to that request. TSCA section 21 permits any person to petition EPA to initiate a proceeding for the issuance, amendment, or repeal of a rule or order under TSCA section 4 (rules or order requiring chemical testing), section 5(d) or (f) (orders affecting new chemical substances) section 6 (rules imposing regulatory controls on chemicals), and section 8 (rules requiring information).

EPA Proposes Adding PFAS to TRI List of Chemicals of Special Concern and Amending Supplier Notifications Requirements

On December 5, 2022, EPA released a proposed rule which, if implemented, will automatically designate PFAS on the Toxic Release Inventory (TRI) to the list of Lower Threshold Chemicals of Special Concern (“Chemicals of Special Concern”). The chemicals on this list have profiles that are categorized as persistent bioaccumulative toxic and are referred to as PBT chemicals. Currently, only 16 PBT Chemicals of Special Concern are on this list. Chemicals of Special Concern are subject to different reporting requirements than the other chemicals that are subject to TRI reporting. PBTs on the TRI chemical list have reporting thresholds that are either 10 pounds or 100 pounds, several orders of magnitude lower than most other TRI-listed chemicals. (Reporting thresholds for TRI chemicals are usually set at 10,000 pounds or 25,000 pounds.) Another characteristic of Chemicals of Special Concern is that they are ineligible for the de minimus exemption.

The de minimus exemption allows facilities to avoid reporting small concentrations of most TRI chemicals.  The exemption applies to threshold determinations such as release and waste management calculations. The Agency’s rationale is that eliminating the de minimus exemption for PFAS will give it a more complete picture of the releases and waste management practices for these substances. Use of the de minimus exemption, EPA believes, has allowed significant quantities of PFAS to avoid TRI reporting.

The rule further proposes removing the de minimus exemption for purposes of Supplier Notification Requirements for all chemicals on the list of Chemicals of Special Concern. Supplier notifications require that suppliers of products that contain one or more of the EPCRA section 313 chemicals notify their customers that the substance(s) is present. (EPCRA section 313 chemicals are those for which EPA is required to establish an inventory of routine toxic chemical emissions from manufacturing.) Suppliers are currently exempt from this requirement when the chemical is in an article or part of a consumer product.

As with PFAS, the Agency is concerned that significant quantities of chemicals of special concern can be overlooked by reporting facilities by using the de minimus exemption. The de minimus exemption threshold for non-PBT TRI-listed chemicals is 1% percent; for carcinogens, the threshold is .01%. EPA provided the following example:

“If a mixture or trade name product contains 0.9% of a listed PFAS and 100,000 pounds of the product is purchased, the supplier need not provide notification, and the purchaser could be unaware of and not account for 900 pounds of PFAS. The impact of this exemption for the PBT chemicals with 10-pound reporting thresholds is even greater. Using the same 100,000-pound example, if mercury [a PBT with a reporting lower threshold] were present at 0.9%, then that same 900 pounds would be 90 times the mercury reporting [i.e., the threshold for mercury reporting for nonexempt releases is 10 pounds].”

EPA considered including a small quantity exemption instead of a de minimus exemption for supplier notification purposes. However, the Agency ultimately decided against this option. The Agency has concerns that this type of exemption would not provide adequate information to facilities receiving multiple shipments over the course of a year. The facilities would have insufficient information to address TRI reporting requirements that may apply to them based on the total aggregated quantity received. Without this data on the TRI-listed chemical, EPA is not confident the receiving facility would have sufficient data to fulfill its TRI reporting obligations.

Verdant Law Gives Presentation on the PFAS Regulatory Landscape at Annual Product Stewardship Conference

Verdant Law is pleased to announce that Irene Hantman gave a presentation on the PFAS Regulatory Landscape at the annual Product Stewardship Conference. Hantman presented brief case studies on how different states are regulating PFAS in their communities, including but not limited to:

  • California’s ban on food packaging containing PFAS that is intentionally added to a product or more than 100 ppm of PFAS. (Effective date January 2023)
  • Colorado’s ban on certain products containing additionally added PFAS, including carpets and rugs, cosmetics, food, packaging, children’s toys and more. (Effective date January 2024)
  • Maryland’s ban on food packaging designed for direct food contact that contains intentionally added PFAS. (Effective date January 2024)
  • North Carolina’s petition to EPA for PFAS Testing under TSCA Section 21 requesting testing on a variety of PFAS manufactured by Chemours.

Additionally, Hantman discussed PFAS regulations on the federal level. She highlighted EPA’s proposed PFAS reporting rule under TSCA (87 FR 33926), which would require all manufacturers and importers of PFAS listed on the active TSCA Inventory to report uses, volumes manufactured, environmental and health effects, worker exposure, and disposal. Hantman further detailed the reporting the comprehensive reporting standard and industry commentary on the proposed rule.

Also discussed was the National PFAS Testing Strategy released in October 2021, permitting EPA to issue test orders to manufacturers of PFAS substances and the first set of test orders EPA just recently issued. EPA’s ending of LVE exemptions for PFAS, the imposition of SNURs on approximately 150 PFAS, and the new regulation of PFAS under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was also included in Hantman’s presentation. Briefly mentioned were PFAS consumer product litigation including:

  • A lawsuit against Burger King over PFAS in Whopper Wrapping. (April 2022; voluntarily dismissed in August 2022)
  • Class action lawsuits against Burt’s Bees, L’Oreal, Cover Girl Cosmetics, and Shiseido over the use of PFAS in various cosmetic products. (2021 & 2022)
  • A class action lawsuit against REI over PFAS in “sustainable gear” including waterproof jackets. (April 2022; voluntarily dismissed in July 2022)

If you have questions about the topics of this presentation, please contact Irene Hantman.

 

EPA Issues First Test Order for PFAS in Commercial Firefighting Foam

EPA recently issued a test order under TSCA section 4 to select companies requiring that they develop and submit certain information on 6:2 fluorotelomer sulfonamide betaine, a PFAS. The order is part of the Agency’s National PFAS Testing Strategy which will evaluate a large number of PFAS for potential human and ecological effects as “most PFAS lack data for robustly characterizing their potential toxicity.

The test order was issued to Chemours Company, DuPont De Nemours Inc., National Foam Inc., and Johnson Controls Inc.  6:2 fluorotelomer sulfonamide betaine is used to make commercial firefighting foam and certain floor finishes.  The test order explains that EPA found insufficient data on 6:2 fluorotelomer sulfonamide betaine to determine or predict the effects on human health specifically by the inhalation route.  The order applies a tiered testing strategy.  EPA has ordered the companies to generate of data on certain physical-chemical properties (e.g., density, particle size, hydrolysis as a function of pH).  The Agency will use those data to determine whether further testing (e.g., inhalation toxicokinetic study, acute inhalation study) is needed.  Under TSCA section 4(a)(4), EPA is required to employ a tiered screening and testing process under which the results of screening-level tests or assessments of available information inform the decision as to whether additional tests are necessary.

EPA intends to issue additional test orders to other PFAS manufacturers in the coming months. A detailed overview of the activities involved in issuing a TSCA Section 4 order can be found here.