The Chemical Compound—December 2021
This quarterly newsletter provides essential updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our primary focus continues to be on chemical substances which are the subject of regulatory activity or scrutiny by various federal and state government agencies and potential litigants. This includes emerging contaminants as well as substances identified by the Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, or regulation. The change in administrations has prompted a considerable increase in emphasis on chemical regulation and significant new initiatives at EPA.
Table of Contents
- Petitioners and EPA Asked Ninth Circuit to Set Briefing Schedule for DecaBDE Rule
- Settlements Set Timeline and Scope for Part 2 of Asbestos Risk Evaluation
- Chemical Importers Agreed to Pay Penalties for Violations of 2016 Chemical Data Reporting Rule
- Challenge to Denial of PFAS Testing Petition Stayed After EPA Granted Administrative Reconsideration
- Plaintiffs Asked Court to Finalize Action on Proposed TRI Listing of DINP
- Trump EPA’s Methylene Chloride Risk Management Rule Upheld
- Infrastructure Act Provided Funding for Pollution Prevention and Emerging Contaminant Measures
- EPA Announced Increases in TSCA Fees
- EPA Denied Petitions Seeking TSCA Regulation of Chemicals in Cigarettes and Cosmetics
- EPA Releases, SAB Will Consider, New Scientific Documents on PFAS Exposure
- EPA Revised Mercury Inventory Reporting Rule in Response to 2020 Second Circuit Decision
- EPA Inspector General Commenced Audit of New Chemicals Review Program; EPA Announced Steps Related to New Chemical Reviews
- EPA Finalized Human Health Toxicity Assessment for Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt
- EPA Finalized Short-Term Compliance Date Extension for PIP (3:1) Ban; Longer-Term Extension Proposed
- EPA Proposed the Addition of 12 Chemicals to the Toxics Release Inventory List
- EPA Released PFAS Roadmap and National PFAS Testing Strategy
- EPA Said Codification of “Parent Company” Definition Would Improve TRI Reporting Efficiency
- EPA Granted More Time for Health and Safety Data Reporting Under TSCA Rule for High-Priority Substances and Organohalogen Flame Retardants
- TSCA Risk Evaluation Roundup: Progress on Manufacturer-Requested Risk Evaluations and Revisiting Initial 10 Evaluations
- EPA Issued Guidance on Petitions for Exemptions from CDR Reporting
Petitioners and EPA Asked Ninth Circuit to Set Briefing Schedule for DecaBDE Rule
EPA and plaintiffs challenging the January 2021 TSCA risk management rule for the flame retardant decabromodiphenyl ether (decide) filed a joint motion in the Ninth Circuit Court of Appeals to set a briefing schedule for the challenge.1 The proceedings had been stayed since April 2021 at EPA’s request. EPA requested the stay because of the change in presidential administration; President Biden’s Executive Order 13990, which directed EPA to review rules adopted during the Trump Administration; and EPA’s March 2021 notice seeking renewed public comment on the decaBDE rule as well as on TSCA risk management rules for four other persistent, bioaccumulative, and toxic (PBT) substances. In the briefing schedule requested by the parties, the petitioners’ opening brief would be due March 11, 2022, EPA’s brief would be due May 20, 2022, and the petitioners’ reply brief would be due June 24, 2022. In October 2021, EPA said it planned to issue a proposed rule in 2023 that could result in revisions to the decaBDE rule as well as the rules for the other four PBT substances.
Settlements Set Timeline and Scope for Part 2 of Asbestos Risk Evaluation
In October 2021, EPA and plaintiffs/petitioners agreed to settle lawsuits related to the risk evaluation of asbestos under TSCA Section 6. In a consent decree filed in a suit in federal district court in California in which the plaintiffs asserted that EPA had failed to perform a non-discretionary obligation under TSCA to evaluate risks of the use and disposal of legacy asbestos by June 2020, EPA agreed to complete Part 2 of its risk evaluation of asbestos—which will consider these issues—by December 1, 2024.2 EPA currently anticipates issuing a draft scope document for Part 2 by December 31, 2021. In a proceeding challenging Part 1 of the risk evaluation in the Ninth Circuit, EPA and the petitioners reached an agreement in which EPA agreed to address legacy uses and associated disposals for six asbestos fiber types in Part 2 of the risk evaluation.3 In order for the Ninth Circuit proceeding to be dismissed, the final scope and draft risk evaluation must include the following elements: the human health hazard endpoints and exposures associated with all six asbestos fiber types; any evidence of associations between exposure to asbestos and cancer; any evidence of non-cancer human health hazard endpoints; risks of human health hazard endpoints resulting from all environmental pathways of exposure and inhalation, dermal, and ingestion routes of exposure to asbestos; the association between exposure to asbestos in talc and talc-containing products and human health hazard endpoints; risks of human health hazard endpoints for potentially exposed or susceptible subpopulations; and any circumstances of known, intended, or reasonably foreseen manufacture, processing, distribution in commerce, use, or disposal not evaluated in Part 1.
Chemical Importers Agreed to Pay Penalties for Violations of 2016 Chemical Data Reporting Rule
On October 6, 2021, EPA announced that two chemical importers with facilities in southern California would pay penalties totaling more than $117,000 to resolve violations of the Chemical Data Reporting (CDR) requirements under TSCA Section 8.4 EPA inspectors found that the two companies failed to submit timely quadrennial reports regarding their imports of five chemical substances between 2012 and 2015 under the 2016 CDR Rule. Under the settlement agreements, one of the companies agreed to pay a $98,813 penalty, and the other company agreed to pay a $23,452 penalty.
Challenge to Denial of PFAS Testing Petition Stayed After EPA Granted Administrative Reconsideration
On September 29, 2021, the federal district court for the Northern District of California approved a stipulation between EPA and environmental groups that holds in abeyance the groups’ lawsuit challenging EPA’s denial of a TSCA Section 21 petition requesting that EPA order health and environmental effects testing for 54 per- and polyfluoroalkyl substances (PFAS) that the petitioners said were manufactured at a facility in North Carolina.5 On September 16, EPA informed the plaintiffs that EPA had decided to grant the plaintiffs’ administrative request for reconsideration. EPA intends to complete its reconsideration of the petition denial within 90 days of the district court’s order approving the stipulation, which would be December 28. The case is held in abeyance until that time.
Plaintiffs Asked Court to Finalize Action on Proposed TRI Listing of DINP
On September 22, 2021, four organizations filed a complaint in the federal district court for the Northern District of California seeking to compel EPA to conclude a rulemaking initiated by the Agency in 2000 to add diisononyl phthalate (DINP) to the Toxics Release Inventory (TRI) list.6 The plaintiffs alleged that EPA had determined in 2000 that DINP satisfied the Emergency Planning and Community Right-to-Know Act criteria for listing but that EPA had unreasonably delayed finalizing the proposed rule and failed to conclude a matter presented to it “within a reasonable time” in violation of the Administrative Procedure Act. The complaint noted that EPA is conducting a risk evaluation of DINP in response to a manufacturer request and alleged that adding DINP to the TRI would help EPA identify facilities that release or dispose of substantial quantities of DINP as well as “communities that face heightened exposure to DINP due to environmental releases of the chemical.”
Trump EPA’s Methylene Chloride Risk Management Rule Upheld
On September 1, 2021, the Second Circuit Court of Appeals upheld the TSCA risk management rule for methylene chloride issued by the Trump Administration in 2019.7 The rule restricts consumer uses of the substance, which is used in paint removal products, and was challenged both by industry and by environmental groups and other petitioners, with the latter groups arguing that the rule also should have restricted commercial uses. The court rejected a trade group’s claims that the rule should be set aside because of its incidental commercial restrictions on small businesses and because of inadequate consideration of the rule’s costs. Instead, the Second Circuit held that the rule’s retailer distribution ban to prevent consumer uses was “a reasonable means” to ensure that the risks posed by consumer uses of methylene chloride were “no longer present[ed],” as required by TSCA. The court also rejected the contention that the final rule’s retailer ban and the final rule’s definition of “retailer” were not a logical outgrowth of the proposed rule. Regarding the environmental petitioners’ claims, the Second Circuit found that EPA’s consideration of commercial uses of methylene chloride was “prudentially unripe” for judicial review. The court noted that on the same day EPA finalized the rule, the agency also published an advance notice of proposed rulemaking indicating its intent to address the issue of commercial uses; the court also cited EPA’s issuance of a TSCA Section 6 risk evaluation for methylene chloride in June 2020 that triggered a statutory deadline for risk management. The Second Circuit said the record did not support the environmental petitioners’ contention that EPA’s deferral of the issue of commercial uses was “a device to stall resolution indefinitely.”
Infrastructure Act Provided Funding for Pollution Prevention and Emerging Contaminant Measures
The Infrastructure Investment and Jobs Act signed by President Biden on November 15, 2021 includes funding for states and communities to address pollution prevention and emerging contaminants in drinking water and wastewater.8 The provisions include $1 billion allocated across five fiscal years for capitalization grants for Clean Water State Revolving Funds to address emerging contaminants; $4 billion allocated across five fiscal years for capitalization grants for Drinking Water State Revolving Funds to address emerging contaminants in drinking water with a focus on PFAS; and $5 billion allocated across five fiscal years to support drinking water projects and activities that address emerging contaminants in underserved, small, and disadvantaged communities. In addition, the infrastructure law provides $100 million for the Pollution Prevention Act grants to states for programs to promote businesses’ use of source reduction techniques. The funds for these initiatives are exempted from otherwise applicable cost-sharing requirements.
EPA Announced Increases in TSCA Fees
On November 23, 2021, EPA announced inflation-based adjustments to the fees that must be paid to defray EPA’s costs of administering TSCA Sections 4, 5, 6, and 14.9 Using a formula set forth in the 2018 TSCA Fees Rule, EPA calculated a fee increase of 18.9% over the fees set in the 2018 rule. The adjustment takes effect on January 1, 2022. TSCA provides for adjustment of fees every three years. Consistent with recent statements by EPA leaders and the EPA Inspector General that the TSCA programs were challenged by staffing and finding shortages, EPA also said it plans to propose additional revisions to the TSCA Fees Rule in 2022 to supplement the proposed rule issued by the Agency in January 2021. The proposed revisions will have the goal of ensuring that TSCA fee amounts capture up to 25% of EPA’s actual costs for TSCA activities, as provided in TSCA Section 24; up to now, TSCA fees collected pursuant to the 2016 amendments have covered only half of the targeted 25% share of EPA’s costs. EPA also said the proposed revisions would be intended to ensure that fees are distributed equitably, and that fee payers are identified through a transparent process.
EPA Denied Petitions Seeking TSCA Regulation of Chemicals in Cigarettes and Cosmetics
On October 29, 2021, EPA published notice of its denial of a TSCA Section 21 rulemaking petition seeking a rule “eliminat[ing] the hazardous chemicals used in a mixture with tobacco” in cigarettes.10 EPA concluded that because TSCA explicitly excludes “tobacco or any tobacco product” from the statute’s definition of “chemical substance,” the Agency was unable to adopt any requirements under TSCA Section 6(a) that would apply to tobacco or cigarettes. EPA also concluded that a combination of chemicals with tobacco would not be considered a “mixture” under TSCA and that such combinations therefore cannot be subject to a TSCA Section 6(a) rule.
On November 17, 2021, EPA published notice of a similar denial of a petition (submitted by the same petitioner) under TSCA Section 21 requesting that EPA issue a rule to “eliminate the hazardous chemicals used in mixtures” in cosmetics.11 Because TSCA excludes “cosmetic” as defined under the Federal Food, Drug, and Cosmetic Act from the definition of “chemical substance” when the cosmetic is manufactured, processed, or distributed in commerce for use as a cosmetic, the Agency concluded that the petition requested actions outside EPA’s jurisdiction under TSCA. To the extent that the petition sought action that would be within EPA’s jurisdiction, such as action to address disposal of cosmetics, EPA found that the petitioner did not demonstrate facts that could support a determination of unreasonable risk to the environment.
In addition, because TSCA Section 21 only authorizes petitions requesting initiation of certain specific TSCA actions (such as a Section 6(a) rule) and “does not provide an avenue” for other types of requests, EPA’s responses to the cigarette and cosmetics petitions did not address the petitions’ requests for other EPA actions such as a determination whether chemical mixtures contained within cigarettes and cosmetics present an unreasonable risk or “any other prudent [methods] of toxic mixture substance control” that the Agency deems “due and fit.”
See our post in the Environmental Edge blog for analysis of how EPA’s denial of the cigarette rulemaking petition may shed light on differences between the Trump and Biden Administrations’ approaches to TSCA implementation.
EPA Releases, SAB Will Consider, New Scientific Documents on PFAS Exposure
On November 16, 2021, EPA announced that it had transmitted four draft documents to the Agency’s Science Advisory Board (SAB) that provide recent scientific data and new analyses regarding the potential negative health effects of exposure to perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and mixtures of PFAS.12 EPA said the draft documents indicated “that negative health effects may occur at much lower levels of exposure to PFOA and PFOS than previously understood.” EPA said it would use this information, after it undergoes peer review, to inform regulation of PFOA and PFOS under the Safe Drinking Water Act. The SAB’s PFAS Review Panel will hold four public meetings in December and January to review the four draft documents, which are: (1) Proposed Approaches to the Derivation of a Draft Maximum Contaminant Level Goal (MCLG) for PFOA in Drinking Water; (2) Proposed Approaches to the Derivation of a Draft MCLG for PFOS in Drinking Water; (3) Analysis of Cardiovascular Disease Risk Reduction as a Result of Reduced PFOA and PFOS Exposure in Drinking Water; and (4) Draft Framework for Estimating Noncancer Health Risks Associated with Mixtures of PFAS.13
EPA Revised Mercury Inventory Reporting Rule in Response to 2020 Second Circuit Decision
On November 8, 2021, EPA published a final rule deleting from the TSCA mercury reporting regulations an exemption for persons who import pre-assembled products that contain a mercury-added component.14 The Second Circuit vacated this exemption in June 2020, finding that reporting on imports of pre-assembled products that contain a mercury-added component would not be duplicative, unnecessary, or unduly burdensome and noting that without such reporting “EPA cannot accurately estimate the volume of mercury introduced into the United States market within imported products.”15 The next submission deadline for mercury reporting is July 1, 2022; reports submitted then will reflect data from the 2021 reporting year.
EPA Inspector General Commenced Audit of New Chemicals Review Program; EPA Announced Steps Related to New Chemical Reviews
In an October 26, 2021 letter, the EPA Office of Inspector General (OIG) informed Assistant Administrator Michal Freedhoff that OIG planned to begin fieldwork on an audit of EPA’s new chemical review process.16 The letter said the audit was “self-initiated based on OIG’s oversight plan for fiscal year 2022 and to address complaints submitted to the OIG Hotline.” The objective of the audit is “to determine the extent to which EPA is using and complying with applicable records-management requirements, quality-assurance requirements, and employee performance standards to review and approve new chemicals under the Toxic Substances Control Act to manage human health and environmental risks.” OIG requested that the Office of Chemical Safety and Pollution Prevention provide certain materials, including training materials related to review of new chemicals, resource allocations for the New Chemicals Review Program, guidance documents, organization charts, and scopes of work for contracts related to the new chemicals review process.
Earlier in October, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced several changes related to the new chemicals program.17 The actions included creation of a New Chemicals Advisory Committee (NCAC), an internal advisory body that will review scientific and science policy issues related to the new chemicals program. OCSPP also formed the OSCPP Science Policy Council, which will be chaired by a science policy advisor who will serve in the Assistant Administrator’s office as a “direct report.” The Council will provide “support and recommendations on science policy and scientific integrity issues that arise” within either the Office of Pollution Prevention and Toxics or the Office of Pesticide Programs. OCSPP also reported that, in response to feedback from the staff in the new chemicals division, it has implemented changes to its new chemicals review processes that are intended to provide opportunities for resolution of differing scientific opinions within the program. It is unclear whether these new processes will have an impact on the timing of EPA’s review of new chemical substances and new uses for which EPA authorizations must be granted before manufacture and processing can be commenced in the US.
EPA Finalized Human Health Toxicity Assessment for Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt
In October 2021, EPA published a final version of its human health toxicity assessment for hexafluoropropylene oxide dimer acid and its ammonium salt.18 The assessment included reference doses for these chemicals of 0.000003 mg/kg-day (chronic/lifetime) and 0.00003 mg/kg-day (subchronic). A reference dose is the amount of a chemical that a person can ingest daily that is unlikely to lead to adverse health effects.
EPA Finalized Short-Term Compliance Date Extension for PIP (3:1) Ban; Longer-Term Extension Proposed
In September 2021, EPA issued a final rule extending the compliance date from March 8, 2021 to March 8, 2022 for halting processing and distribution in commerce of certain articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) and the PIP (3:1) used to make those articles.19 The extension also applies to associated recordkeeping requirements. The PIP (3:1) prohibition is a provision of a final risk management rule promulgated in the last days of the Trump Administration.20 In March 2021, EPA announced that it would exercise its discretion not to enforce the compliance date for the original prohibitions for up to 180 days after industry stakeholders informed the Agency that the compliance date would disrupt supply chains for a wide variety of consumer and commercial products.21
In October 2021, EPA issued a proposed rule that would further extend the compliance date to October 31, 2024.22 EPA also announced that it intends to commence a new rulemaking effort in 2023 on PIP (3:1) as well as four other PBT substances for which EPA promulgated risk management rules alongside the PIP (3:1) rule in January 2021. In the October 2021 proposed PIP (3:1) rule, EPA sought comments on the adequacy of the extensions contained in the proposed rule. EPA stated that to the extent any industry sector believes that it needs a compliance date beyond October 31, 2024, specific information and documentation supporting a further extension should be submitted, including, for example, estimates of the time required to identify, test, and qualify substitutes with supporting documentation and documentation of the specific need for PIP (3:1)-containing replacement parts. The comment deadline is December 27, 2021.
For further analysis of EPA’s actions related to PIP (3:1), please see our Environmental Edge post.
EPA Proposed the Addition of 12 Chemicals to the Toxics Release Inventory List
In a notice published on October 18, 2021, EPA proposed to add 12 chemicals to the Toxics Release Inventory list and to classify one of the 12 as a PBT chemical and designate it as a chemical of special concern with a 100-pound reporting threshold.23 EPA proposed the listing in response to a petition submitted by the Toxics Use Reduction Institute in 2014 requesting the addition of 25 chemicals to the TRI list. In the proposed rule, EPA noted that it previously added three of the 25 chemicals to the TRI list and that one of the chemicals (octabromodiphenyl ether) had been phased out by industry more than 10 years ago so that it was likely that there was only a negligible remaining amount of the chemical that is processed or otherwise used in the United States. EPA found that available data for the other nine chemicals was not sufficient for EPA to find that they met the criteria for listing under Section 313 of the Emergency Planning and Community Right-to-Know Act. The deadline for comments is December 17, 2021.
EPA Released PFAS Roadmap and National PFAS Testing Strategy
On October 18, 2021, EPA Administrator Michael S. Regan announced the Agency’s PFAS Strategic Roadmap.24 The Roadmap sets forth actions EPA plans to take from 2021 to 2024 and is focused on three central directives: (1) Research; (2) Restrict; and (3) Remediate. The approach to these tasks is centered on five principles: (1) “Consider the Lifecycle of PFAS” (account for PFAS’s unique properties, ubiquity of uses, and multiple exposure pathways), (2) “Get Upstream of the Problem” (prevent PFAS from entering the environment); (3) “Hold Polluters Accountable” (e.g., for PFAS remediation); (4) “Ensure Science-Based Decision-Making” (gap-filling research and development of methods to test, measure, remove, and destroy PFAS); and (5) “Prioritize Protection of Disadvantaged Communities” (collect more data and develop methodologies to better under PFAS exposure in disadvantaged communities). The Roadmap describes key actions within EPA’s program offices. Within OCSPP, the key actions are:
- Publish a national PFAS testing strategy. EPA published a National Testing Strategy simultaneously with its release of the Roadmap.25 It describes how EPA has identified candidate PFAS in 24 categories for which the Agency will require companies to perform testing under TSCA Section 4. The Strategy also describes a tiered-testing approach for each candidate PFAS that will inform whether additional testing within a category is necessary. EPA will implement the strategy in phases with Phase IA focused on human health data and Phase II on ecological toxicity. EPA plans to initiate Phase IA before the end of 2021 by issuing TSCA Section 4 test orders to the makers of the 24 candidate PFAS identified. Phase IB will involve refinement of the initial structural categories.
- Ensure a robust review process for new PFAS. EPA said it will use its TSCA authorities to apply “a rigorous premanufacture notice review process for new PFAS to ensure these substances are safe before they enter commerce” and noted that it had announced earlier this year that the Agency generally expects to deny pending and future submissions for low-volume exemptions (LVEs) for PFAS.
- Review previous TSCA decisions on PFAS. EPA mentioned its program encouraging companies to withdraw previously-granted LVEs for PFAS and said it also plans to revisit past regulatory decisions on PFAS and address decisions that are insufficiently protective. EPA also stated it would issue TSCA Section 5(e) orders with rigorous safety requirements when significant new use notices are filed for existing PFAS, and that it plans to improve tracking and enforcement for requirements in new chemical consent orders and significant new use rules.
- Close the door on abandoned PFAS and uses. EPA said it will use its TSCA authority to define abandoned uses of PFAS as “significant new uses” to ensure that EPA receives notifications and can review such uses to make affirmative determinations on potential risks and needed restrictions before the uses may resume.
- Enhance PFAS reporting under the Toxics Release Inventory. EPA plans to propose a rulemaking to categorize PFAS on the TRI list as “Chemicals of Special Concern” and to remove the de minimis exemption from supplier notification requirements for all Chemicals of Special Concern. EPA also expects to add more PFAS to the TRI list.
- Finalize new PFAS reporting under TSCA Section 8. EPA said it expected to finalize an information-gathering rule under TSCA Section 8(a)(7) during the winter of 2022 to collect information about sources and quantities of PFAS manufactured in, or imported to, the United States to assist the Agency in future research, monitoring, and regulatory efforts.
Key actions in other program offices included establishment of national drinking water standards for PFOA and PFOS and leveraging National Pollutant Discharge Elimination System permitting to reduce PFAS discharges to waterways (Office of Water); proposed designation of PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act and consideration of whether to designate other PFAS as hazardous substances (Office of Land and Emergency Management); work to build a technical foundation to address PFAS air emissions (Office of Air and Radiation); development and validation of methods to detect and measure PFAS in the environment and research to assess potential human health and environmental risks (Office of Research and Development); and use of enforcement tools under multiple environmental statutes to identify past and ongoing PFAS releases and identification of PFAS categories to help EPA prioritize future actions to address PFAS (Cross-Program).
EPA Said Codification of “Parent Company” Definition Would Improve TRI Reporting Efficiency
In September 2021, EPA proposed to codify the definition of “parent company” for the purposes of TRI reporting, with the aim of improving “reporting efficiency for TRI facilities and the Agency’s data quality efforts.”26 Generally the proposed definition would define “parent company” as “the highest-level company(s) of the facility's ownership hierarchy as of December 31 of the year for which data are being reported,” but the definition also would include instructions for addressing specific situations such as facilities owned by multiple companies. The proposed rule also would require that facilities use standardized conventions for naming a parent company as provided in the TRI reporting instructions. EPA said the proposed change would make the TRI and CDR definitions of parent company “nearly identical,” which would support EPA’s ability to compare the databases for data quality purposes. EPA took comment on the proposed rule through November 29, 2021.
EPA Granted More Time for Health and Safety Data Reporting Under TSCA Rule for High-Priority Substances and Organohalogen Flame Retardants
In the October 1, 2021 issue of the Federal Register, EPA announced that it was extending the submission deadlines for manufacturers and importers of 50 chemical substances to report certain lists and copies of unpublished health and safety studies to EPA pursuant to TSCA Section 8(d).27 EPA published a final rule requiring the reporting in June 2021.28 Submissions originally were due on September 27, 2021, but EPA extended the deadline to December 1, 2021 for 20 High-Priority Substances for which the Agency is preparing risk evaluations pursuant to TSCA Section 6. For the 30 organohalogen flame retardants, EPA postponed the deadline to January 25, 2022.
TSCA Risk Evaluation Roundup: Progress on Manufacturer-Requested Risk Evaluations and Revisiting Initial 10 Evaluations
Since the last edition of the Chemical Compound, EPA has advanced the risk evaluation process for three manufacturer-requested risk evaluations. On August 31, 2021, EPA released final scope documents for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).29 EPA granted manufacturer requests for these risk evaluations in December 2019.30 The final scope for the DIDP risk evaluation is available here. The final scope for the DINP risk evaluation is here. In September 2021, EPA made a draft scope for the manufacturer-requested risk evaluation of octamethylcyclotetra-siloxane (D4) available for public comment.31 The comment period closed on October 25. The draft scope is available in the docket. EPA is still considering whether to grant a request for a risk evaluation of four chemical substances as the octahydro-tetramethyl-naphthalenyl-ethanone (OTNE) chemical category.
EPA also has reported on steps it is taking as it revisits the first 10 risk evaluations. In a status report submitted to the Ninth Circuit in proceedings challenging the TSCA Section 6 methylene chloride risk evaluation, EPA reported that the Agency was developing a “screening-level approach for analysis of ambient air and drinking water chemical exposures to fenceline communities” in order to review environmental exposure pathways previously excluded from the risk evaluation and to evaluate whether there is risk to fenceline communities which differ from the various risks previously identified in the risk evaluation. EPA anticipates that the screening-level approach document and screening-level analysis of methylene chloride will be subject to intra-agency review, public comment, and review by EPA’s Science Advisory Committee on Chemicals (SACC). The status report did not specify when these review processes were anticipated to occur, but a Federal Register notice published on October 27 soliciting nominations for the SACC reported that review of the draft screening-level approach document is anticipated in early 2022.32 The notice said EPA will use the approach to reassess seven of the first 10 risk evaluations (including for methylene chloride) for the air emissions pathway and five of the first 10 (also including methylene chloride) for the water releases pathway. The notice also sought nominations for peer review of the draft of EPA’s revised TSCA Systematic Review Protocol, which is anticipated to be ready for SACC review in early 2022.
EPA Issued Guidance on Petitions for Exemptions from CDR Reporting
In August 2021, EPA released and solicited comments on guidance regarding the process and requirements for submitting petitions for (1) full exemption from CDR reporting requirements of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and (2) partial exemption of chemicals for which the CDR processing and use information has been determined to be of “low current interest” by the Agency.33 EPA established the byproduct exemption petition process in the 2020 revisions to the CDR rule. The partial exemption petition process was created by a 2003 rulemaking for the Inventory Update Rule, the predecessor to the CDR Rule. The deadline for comments on the guidance is December 21, 2021.
State Regulatory & Legislative Action
New California Laws Ban PFAS in Children’s Products and Food Packaging and Establish Chemical Disclosure Requirements for Cookware
In early October 2021, Governor Gavin Newsom signed two bills that restrict PFAS in certain types of products. The first bill, AB 652, will prohibit the sale and distribution in commerce of new “juvenile products” containing “regulated PFAS” beginning on July 1, 2023. Juvenile products are products designed for use by infants and children under 12 years of age, with certain exceptions specified in the law. The second bill, AB 1200, prohibits distribution, sale, or offering for sale of food packaging that contains regulated PFAS beginning on January 1, 2023. Both laws require use of the least toxic alternative when replacing PFAS. “PFAS” is defined very broadly in both statutes as a “class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” Furthermore, “regulated PFAS” has nearly the same definition in both statutes. It is defined as either (1) “PFAS that a manufacturer has intentionally added to a product and that have a functional or technical effect in the product, including … the PFAS components of intentionally added chemicals and PFAS that are intentional breakdown products of an added chemical that also have a functional or technical effect in the product” or (2) “[t]he presence of PFAS in a product or product component at or above 100 parts per million, as measured in total organic fluorine.” AB 1200 also establishes product labeling and disclosure requirements for cookware that contains chemicals listed as Candidate Chemicals in the California Department of Toxic Substances Control (DTSC) Safer Consumer Products program. Beginning January 1, 2023, cookware manufacturers must post information on their websites about the presence of such chemicals in their products. Product labeling requirements go into effect on January 1, 2024. Manufacturers may not make claims that their cookware is free of a specific chemical unless no individual chemical from the chemical group or class to which that specific chemical belongs is intentionally added to the cookware.
California Proposed Two New Priority Products in Safer Consumer Products Program
Since the last edition of the Chemical Compound, DTSC has initiated rulemaking to list two new Priority Products in its Safer Consumer Products program: (1) fingernail and toenail care products containing toluene34 and (2) treatments containing PFAS for use on converted textiles or leathers such as carpets, upholstery, clothing, and shoes.35 The comment period on the nail care products containing toluene proposal closed on November 18, 2021. The comment period on the PFAS-containing treatments proposal closed on November 8, 2021. If the listings are finalized, manufacturers, importers, assemblers, and retailers will be required to notify DTSC, and manufacturers or other responsible entities will be required to perform an Alternatives Analysis to determine how to limit exposure or reduce the level of public health or environmental harm.
Governor Whitmer Directive Requires Actions to Limit State Purchases of PFAS-Containing Products
On October 27, 2021, Governor Gretchen Whitmer issued an executive directive to limit the State of Michigan’s purchase of nonessential products containing intentionally added PFAS and to use the State’s purchasing power to create incentives for suppliers to offer products that do not contain intentionally added PFAS.36 The directive requires the Department of Technology, Management and Budget to take actions to ensure that proposals from potential suppliers disclose whether products contain intentionally added PFAS. If products do contain PFAS, suppliers’ proposals must include additional information about the PFAS in the products and identify any alternative products. The Department must develop policies and procedures for other departments and agencies to follow in connection with purchases of products to ensure preference is given to proposals from suppliers that offer products that do not contain PFAS and that PFAS-containing products are purchased only where there is not a comparable alternative available and no proposals have been submitted for a product free of intentionally added PFAS. The policies also must encourage submission of proposals by suppliers that offer products that do not contain intentionally added PFAS.
NYSDEC Proposed Water Quality Guidance Values for Three Emerging Contaminants
In October 2021, the New York State Department of Environmental Conservation (NYSDEC) announced the release of draft water quality guidance values for PFOA, PFOS, and 1,4-dioxane.37 The proposed guidance values are as follows:
|Chemical||Human Health||Aquatic Life: Chronic||Aquatic Life: Acute|
160 ppb (fresh)
41 ppb (saline)
| 710 ppb (fresh)
190 ppb (saline)
|1,4-dioxane||0.35 ppb|| 18,000 ppb (fresh)
7,000 ppb (saline)
| 160,000 ppb (fresh)
63,000 ppb (saline)
NYSDEC said the human health guidance values were set lower than New York’s maximum contaminant levels (MCLs) for PFOA (10 parts per trillion (ppt)), PFOS (10 ppt), and 1,4-dioxane (1 part per billion (ppb)) in drinking water because the guidance values are intended to protect source waters and to ensure the MCLs are not exceeded and that the need for drinking water treatment is avoided. NYSDEC is accepting comments on the draft guidance values and associated draft guidance documents through December 6, 2021.
NYSDEC Published Draft Lists of Chemicals for Regulation Under Toxic Chemicals in Children’s Products Law
In September 2021, NYSDEC announced the availability of lists of Chemicals of Concern and High Priority Chemicals currently under review for the Toxic Chemicals in Children’s Products program.38 The Toxic Chemicals in Children’s Products law was enacted in 2020 and requires NYSDEC to promulgate these lists, which will dictate which chemicals manufacturers of children’s products must disclose when present in a product. Chemicals of Concern may be listed if they are identified as being a carcinogen, reproductive or developmental toxicant, neurotoxicant, asthmagen, or endocrine disruptor; persistent, bioaccumulative, and toxic; or very persistent and very bioaccumulative. High Priority Chemicals must meet additional criteria related to their presence in humans, the home environment, or the natural environment. NYSDEC may also list chemicals as High Priority Chemicals if their sale or use or their sale or use in a children’s product has been banned in another state or states. The lists published by NYSDEC also include practical quantification limits. NYSDEC took comment on the lists until October 15, 2021.
NYSDEC Issued Guidance for Applications for Waivers from 1,4-Dioxane Restrictions in Household Cleansing, Personal Care, and Cosmetic Products
In August 2021, NYSDEC announced the availability of final guidance on the process for applying for waivers of 1,4-dioxane restrictions in household cleansing, personal care, and cosmetic products.39 A 2019 law established maximum concentrations of 1,4-dioxane that may be present in such products as of December 31, 2022. The law authorizes temporary waivers of the restrictions “upon such proof that the manufacturer has taken steps to reduce the presence of 1,4-dioxane in that product and is unable to comply with the requirements.” The final guidance provides that applications for a waiver must individually name each product for which a waiver is sought, but product-specific information may be aggregated into one manufacturer-wide waiver application. The guidance also specifies the proof that is required to establish that each product is not able to meet the applicable maximum 1,4-dioxane trace concentration.
Oregon Clarified that Children’s Product Manufacturers Must Use “Component Method” for Reporting Proportion of Chemicals
The Oregon Health Authority (OHA) adopted a temporary rule in August 2021 that amends its regulations implementing the Toxic Free Kids Act to clarify that manufacturers of children’s products sold or offered for sale in Oregon should base their reporting of the proportion of High Priority Chemicals of Concern for Children’s Health (HPCCCH) on the mass of HPCCCH in each component of a product.40 Manufacturers must use this “component method” when submitting biennial notifications that are due on January 1, 2022. In October 2021, OHA issued a proposed rule that would make this change permanent.41 OHA said it would use its enforcement discretion and not require manufacturers who might have used a “whole product method” in the past to submit those products for the 2018 and 2020 biennial notifications. The October 2021 proposed rule also would add five new HPCCCH and practical quantification limits and detection methods for the five HPCCCH.
Proposal to Set MCLs for PFOA and PFOS in Pennsylvania Moved Forward
On November 16, 2021, the Pennsylvania Department of Environmental Protection (PADEP) announced that the Environmental Quality Board had approved PADEP’s proposed rule to set MCLs for PFOS and PFOA of 14 ppt and 18 ppt, respectively.42 PADEP plans to publish the proposed rule in 2022. Publication will open a 60-day public comment period that will include at least five public hearings.
Department of Ecology Released Draft Report on Regulatory Actions to Address Chemicals in Consumer Products
In November 2021, the Washington State Department of Ecology (Ecology) published a draft report with regulatory determinations for each of several chemical-product combinations Ecology had previously identified as priority consumer products in earlier phases of the Safer Products for Washington program.43 The priority consumer products are electric and electronic enclosures containing organohalogen flame retardants; recreational polyurethane foam containing organohalogen flame retardants or certain other flame retardants; aftermarket stain- and water-resistance treatments, carpets and rugs, and leather and textile furnishings containing PFAS; paints and printing inks containing polychlorinated biphenyls; laundry detergent, thermal paper, and food and drink cans (linings) containing phenolic compounds; and personal care and beauty products (fragrances) and vinyl flooring containing phthalates. For each of these chemical-product combinations, Ecology found that safer alternatives are feasible and available. For almost all of the priority consumer products, Ecology made a draft regulatory determination to impose restrictions on the uses, except for certain organohalogen flame retardants and organophosphate flame retardants in covered wall padding, for which the draft regulatory determination is to require reporting. Ecology will accept comment on the draft report through January 14, 2022.
Ecology Issued Final PFAS Chemical Action Plan
In November 2021, the Department of Ecology also released a final Per- and Polyfluoroalkyl Substances Chemical Action Plan (PFAS CAP) that sets forth recommended regulatory actions to address PFAS contamination in the environment and potential impacts to animal and human health.44 A draft CAP was issued in October 2020 and public comments on that draft were considered in preparing the final CAP. The recommended actions fall under four categories: (1) ensure drinking water is safe; (2) manage environmental PFAS contamination; (3) reduce PFAS in products; and (4) understand and manage PFAS in waste. The PFAS CAP also summarizes major findings from Ecology’s assessment of PFAS, their presence in the environment, and their potential impacts. Washington law requires that Ecology coordinate with other agencies and interested parties on implementation of the final PFAS CAP.
© Arnold & Porter Kaye Scholer LLP 2021 All Rights Reserved. This newsletter is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.
News Release, EPA Region 9, SoCal Chemical Distributors Settle Toxic Substances Control Act Violations with U.S. EPA, Pay $117,000 in Fines (Oct. 6, 2021).
Labor Council for Latin Am. Advancement v. EPA, Nos. 19-1042(L), 19-1044, 19-2329 (2d Cir. Sept. 1, 2021).
Pub. L. No. 117-58 (Nov. 15, 2021).
News Release, EPA, EPA Announces First Mandated Adjustment for TSCA Fees (Nov. 23, 2021).
86 Fed. Reg. 59931 (Oct. 29, 2021).
86 Fed. Reg. 64129 (Nov. 17, 2021).
News Release, EPA, EPA Advances Science to Protect the Public from PFOA and PFOS in Drinking Water (Nov. 16, 2021).
86 Fed. Reg. 62526 (Nov. 10, 2021).
86 Fed. Reg. 61708 (Nov. 8, 2021).
Nat. Res. Def. Council, Inc. v. EPA, Nos. 18-2121-ag, 18-2670-ag (2d Cir. 2020).
See News Release, EPA, EPA Announces Next Steps to Enhance Scientific Integrity and Strengthen New Chemical Safety Reviews (Oct. 14, 2021).
See Human Health Toxicity Assessments for GenX Chemicals, EPA (last updated Nov. 9, 2021).
86 Fed. Reg. 51823 (Sept. 17, 2021).
86 Fed. Reg. 894 (Jan 6, 2021).
86 Fed. Reg. 14398 (Mar. 16, 2021).
86 Fed. Reg. 59684 (Oct. 28, 2021).
86 Fed. Reg. 57614 (Oct. 18, 2021).
EPA, No. EPA-100-K-21-002, PFAS Strategic Roadmap: EPA’s Commitments to Action 2021–2024 (Oct. 2021).
86 Fed. Reg. 53577 (Sept. 28, 2021).
86 Fed. Reg. 54386 (Oct. 1, 2021).
86 Fed. Reg. 34147 (June 29, 2021).
86 Fed. Reg. 50347 (Sept. 8, 2021).
86 Fed. Reg. 59382 (Oct. 27, 2021).
86 Fed. Reg. 47102 (Aug. 23, 2021).
Proposed Priority Product: Nail Products Containing Toluene, Cal. Dep’t of Toxic Substances Control (last visited Nov. 24, 2021).
Proposed Priority Product: Treatments Containing Perfluoroalkyl or Polyfluoroalkyl Substances for Use on Converted Textiles or Leathers, Cal. Dep’t of Toxic Substances Control (last visited Nov. 24, 2021).
Mich. Exec. Directive 2021-8 (Oct. 27, 2021).
DEC Releases DRAFT Guidance Values to Advance New York State's Regulation of Emerging Contaminants PFOA, PFOS, and 1,4-Dioxane, DEC (last visited Nov. 24, 2021).
The final guidance is available at 1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products, NYSDEC (last visited Nov. 24, 2021).
PH 40-2021 (Aug. 26, 2021).
Notice of Proposed Rulemaking, Toxic Free Kids Rule Revision to Clarify Reporting and Revise Reportable Chemical List (Oct. 28, 2021).
Press Release, Pa. Dep’t of Env’t Prot., DEP Proposal to Set Stricter PFAS Limits Approved by Environmental Quality Board (Nov. 16, 2021).
Wash. Dep’t of Ecol., No. 21-04-047, Draft Regulatory Determinations Report to the Legislature: Safer Products for Washington Implementation Phase 3 (Nov. 2021).
Wash. Dep’t of Ecol., No. 21-04-048, Per- and Polyfluoroalkyl Substances Chemical Action Plan (Nov. 2021).