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.

EPA Proposed Rule Making Changes to Clean Air Act Risk Management Program

On August 31, 2022, EPA published a proposed rule, Accidental Release Prevention Requirements: Risk Management Programs Under the Clean Air Act; Safer Communities by Chemical Accident Prevention. The proposed rule aims to address several changes and amplifications to the accident prevention program requirements, enhancements to the emergency preparedness requirements, increase the public availability of chemical hazard information, and provide changes and clarity to definitions currently lacking. The proposed rule applies to a variety of industries, including but not limited to chemical manufacturing.


Below is a summary of the key changes and additions within the proposed rule. A table that identifies the full scope of proposed changes and additions can be found here.


Subpart C – Program 2 Prevention Program

40 CFR § 68.58 Compliance audits.

The proposed rule revises paragraph (a), advising that a third-party audit may be required under added paragraph (f) of this section. Additionally, the proposed rule adds paragraphs (f), (g), and (h) to this section. Paragraph (f) states that a third-party audit is required when one or more of the following apply: (1) two accidental releases have occurred within five years, meeting the criteria in § 68.42(a) from a covered process at a stationary source; (2) one accidental release as occurred within five years meeting the criteria in § 68.42(a) from a covered process at a stationary source in NAICS code 324 or 325, located within one mile of another stationary source in NIACS code 324 or 325; or (3) an implementing agency requires a third-party audit due to conditions at the stationary source that could lead to an accidental release of a regulated substance or when a previous third-party audit failed to meet the competency or independence requirements of § 68.59(c).


40 CFR § 68.59 Third-party audits.

Section 68.59 is added in its entirety. The 2019 reconsideration rule rescinded third-party compliance audit requirements, but EPA seeks to reinstate these requirements stating it found there “are likely no legitimate reliance interests associated with the 2019 reconsideration rule’s elimination of these requirements.” EPA has ensured that the proposed section is consistent with existing OSHA PSM requirements.


40 CFR § 68.62 Employee participation.

The proposed rule adds § 68.62 in its entirety and addresses employee participation in Program 2 prevention programs. Paragraph (a) of this section requires the owner or operators to “develop a written plan of action regarding the implementation of the employee participation required [by paragraphs (b) and (c) of this section].” Paragraph (b) requires the owner or operators “to develop and implement a process to allow employees and their representatives to anonymously report unaddressed hazards that could lead to a catastrophic release, unreported RMP-reportable accidents, or any other non-compliance with 40 CFR part 68.” Paragraph (c) states that the owner or operator must “provide to employees and their representative’s access to the hazard reviews and to all other information required to be developed under this rule.”


Subpart D – Program 3 Prevention Program

40 CFR § 68.79 Compliance audits.

The modifications to this section mirror those in 40 CFR § 68.58 detailed above.


40 CFR § 68.80 Third-party audits.

The modifications to this section mirror those in 40 CFR § 68.59 detailed above.


40 CFR § 68.83 Employee participation.

The modifications to this section mirror those in 40 CFR § 68.62 detailed above.


Subpart E – Emergency Response

40 CFR § 68.90 Applicability.

The proposed rule amends paragraph (b)(1) to extensively detail all components required within the facility’s community response plan, which under the current regulation is only referenced as “the community response plan developed under 42 U.S.C. 11003.” The proposed rule also revises paragraph (b)(3) to include specific relevant information that should be included when notifying emergency responders that there is a need for a response, whereas the current regulation states only that “appropriate mechanisms” to notify must be in place. The proposed rule further adds paragraph (b)(6), requiring that “the owner or operator maintains and implements, as necessary, procedures for informing the public and the appropriate Federal, state, and local emergency response agencies about accidental releases of RMP-regulated substances and ensure that a community notification system is in place to warn the public within the area potentially threatened by the release.”


40 CFR § 68.95 Emergency response program.

Paragraph (c) is completely rewritten to address issues with responding facilities notifying the public of releases. The revision requires facilities to provide necessary entities with initial RMP accidental release information during the release of regulated substances to efficiently convey such information to the public and the appropriate federal, state, and local emergency agencies. This information includes the regulated substance released, the estimated time the release began, the estimated quantity of the substance already released, the potential quantity to be released, and the potential consequences of the release on human health and the environment.


Subpart G – Risk Management Plan

40 CFR § 68.160 Registration.

The proposed rule adds paragraph (b)(22), which requires adding the method of communication and location of the notification of a chemical hazard to the public residing within six miles of the stationary source to the registration form included in the RMP.


Subpart H – Other Requirements

40 CFR § 68.210 Availability of information to the public.

The proposed rule amends § 68.210, adding paragraphs(d), (e), and (f). Paragraph (d) details the chemical hazard information a facility must provide to any requesting member of the public residing within six miles of the stationary source. This information includes (1) regulated substance information, (2) SDS for all regulated substances at the facility, (3) five-year accident history, (4) the emergency response program, (5) a list of the scheduled and required exercises, and (6) LEPC contact information. Paragraph (e) dictates that the company must provide ongoing notification on its website, social media platforms, or through other publicly accessible means. Such notifications should convey that the information in paragraph (d) is available and accessible to community members living within 6 miles of the RMP facility. Paragraph (f) requires that the owner or operator of the facility provide the information outlined in paragraph (d) within 45 days of receiving the request.

EPA Releases Draft Toxicological Review of Hexavalent Chromium

EPA recently released its draft Integrated Risk Information System (IRIS) toxicological review of hexavalent chromium (also known as chromium-6). Hexavalent chromium is used in pigment manufacturing, metal finishing and chrome plating, stainless steel production, leather tanning, and wood preservatives. It has various other industrial applications as well. The metal is also emitted into the air when fossil fuels are burned.

The metal gained significant attention in 2000 with the release of the movie Erin Brokovich. The film detailed the story of a class action lawsuit by Californians against Pacific Gas & Electric Company for dumping wastewater containing chromium into ponds, subsequently polluting groundwater supplies.

Hexavalent chromium is a known carcinogen in humans when inhaled, including increased lung cancer rates found in workers exposed at higher than normal levels in industries that process or use chromium or chromium compounds. The metal is also known to cause nasal and sinus cancers, kidney and liver damage, nasal and skin irritation, and other adverse health effects.

Less information has been known about the effects of ingesting hexavalent chromium. EPA’s current standard for the metal in drinking water is a maximum contaminant level of 100 parts per billion. The draft IRIS reports that ingestion through drinking water is likely carcinogenic, and once finalized, EPA will use the IRIS review to make assessments of risk related to ingestion exposure.

The draft is currently open for public comment until December 19, 2022. EPA Scientific Advisory Board will hold a hearing to discuss hexavalent chromium following the closing of the comment period.

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.

EPA Proposes to Stop Authorized Use of Certain PFAS in Pesticide Products

EPA is proposing to remove 12 PFAS substances from the current list of inert ingredients approved for use in pesticide products. Under EPA’s 2021 PFAS Strategic Roadmap the Agency is reviewing substances approved as inert ingredients in pesticides and potentially taking action to limit their use. Inert ingredients in pesticides serve to increase effectiveness and product performance including improving the ease of pesticide application and extending shelf life.

The 12 chemical substances proposed for removal are no longer in any registered pesticide product, but EPA believes it is important to remove these chemicals.  This means that a review of available information for these chemicals would be required for their future use in pesticide products. In discussing the proposal Michal Freedhoff, EPA’s Assistant Administrator for the Office of Chemical Safety and Pollution Prevention stated, “ensuring that these 12 chemicals can no longer be used in pesticides is an important step to protect workers, the public, and our planet from unnecessary PFAS exposure.”

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.

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.

EPA Takes Enforcement Action Against Companies for Misbranded Pesticide

On September 21, 2022, EPA announced settlements with two New Jersey companies for the sale and distribution of the pesticide Zoono Microbe Shield. The companies made false and misleading claims stating that the registered pesticide was suitable for use as a disinfectant or sanitizer against the virus which causes COVID-19. The companies’ claims were a violation of the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) which prohibits false and misleading claims of registered pesticide products.

The two companies, Zoono USA and Zoono Holdings, advertised and sold the Zoono Micro Shield product on their own company websites as well as on Amazon. The product’s labeling contained public health claims that EPA stated differ substantially from statements submitted to the Agency in connection with its pesticide registration; in other words, the companies were committing misbranding under FIFRA, The product’s registration allows only for labeling claims related to effectiveness against odor-causing bacteria, bacteria that cause staining and discoloration, fungi, and algae. The product is not registered for use as a disinfectant or sanitizer, nor is it registered for any public health purpose. Therefore, it was a violation of the statute to make such claims. The settlements included civil penalties in the amounts of $205,000 and $120,000.