The Chemical Compound—August 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 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 change in emphasis and new activities at EPA that are significant and which are noted in this edition.
Table of Contents
- EPA and Environmental Groups Reported Negotiations to Settle Claims About New Chemical Notice and Disclosure
- EPA Development of PFAS Testing Strategy Cited as Reason to Extend Deadlines in Challenge to Denial of PFAS Testing Petition
- Ninth Circuit Granted EPA’s Request for Remand Without Vacatur of No-Unreasonable-Risk Determinations for Three Substances
- EPA in Settlement Talks Regarding Asbestos Risk Evaluation; Lawsuits Delayed
- EPA Sought Continued Abeyance of Case Challenging DecaBDE Risk Management Rule
- Citizen Suits Alleged CDR Violations Against Chemical Importers and Manufacturers
- EPA Agreed to Develop Asbestos Reporting Rule to Address “Information-Gathering Deficiencies”
- Ninth Circuit Said EPA Lead Paint Rule Violated TSCA Title IV
- Senate Passed Bill to Require Development of Resources to Prevent Emergency Responder PFAS Exposure
- Comprehensive PFAS Bill Passed House
- Bills Introduced that Would Ban PFAS in Cosmetics
- Bill in Senate Would Ban Defense Department Procurement of Many PFAS-Containing Products
- House and Senate Bills Would Require Drinking Water Standards for PFAS
- EPA to Revisit First 10 Risk Evaluations to Incorporate Policy Changes
- EPA Released Preliminary Proposal for Tiered Data Reporting to Support Work on Existing Chemicals
- EPA Proposed One-Time TSCA Reporting Rule for PFAS
- Draft IRIS Assessment Released for Perfluorobutanoic Acid
- EPA Added Substances to Safer Chemical Ingredients List
- ATSDR Released Final Toxicological Profile for Certain PFAS and Six Draft Updated Profiles for Chemicals on Substance Priority List
- Preliminary 2020 TRI Dataset Shows “Seemingly Limited” Scope for PFAS Reporting
- Three More PFAS Added to Toxics Release Inventory List for 2021 Reporting Year; EPA Announced Plans for More Additions to List
- EPA Sought Information to Inform Regulation of 1-Bromopropane as Hazardous Air Pollutant
- Draft Contaminant Candidate List Included All PFAS
- EPA Required Health and Safety Data Reporting for 50 Substances
- EPA Withdrew Compliance Guide for the Long-Chain Perfluoroalkyl Carboxylate Significant New Use Rule
- EPA Announced Electronic Option for TSCA Export Notifications; Other TSCA Communications Also Now Available Via CDX
- EPA’s Spring 2021 Regulatory Agenda Contained Multiple TSCA Rulemaking Actions
- “Secret Science” Rule Formally Removed
- EPA Denied TSCA Section 21 Petition Regarding Phosphogypsum
- EPA Rescinded Procedural Rule for Issuing Guidance Documents
EPA and Environmental Groups Reported Negotiations to Settle Claims About New Chemical Notice and Disclosure
In environmental groups’ action alleging that EPA failed to comply with TSCA’s Section 5 requirements for notice and disclosures related to applications to manufacture new chemical substances, the parties reported to the federal district court for the District of Columbia that they had met three times in June, July, and August 2021 to evaluate the potential for settlement.1 The parties also reported that they continued to negotiate over whether there are administrative records for EPA actions and whether there should be discovery related to the groups’ claim that EPA engaged in a pattern or practice of violating TSCA’s notice and disclosure requirements. The court directed the parties to file an update on the progress of their negotiations by September 3, 2021.
EPA Development of PFAS Testing Strategy Cited as Reason to Extend Deadlines in Challenge to Denial of PFAS Testing Petition
In a lawsuit challenging EPA’s January 2021 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, the parties agreed to extend the time for EPA to respond to the complaint until September 27, 2021.2 The lawsuit is pending in the federal district court for the Northern District of California. The stipulation noted that EPA had announced that the Agency is developing a PFAS testing strategy that could impact the 54 PFAS in the petition. The stipulation also said an extension would provide EPA with more time to consider an administrative request for reconsideration of the petition denial.
Ninth Circuit Granted EPA’s Request for Remand Without Vacatur of No-Unreasonable-Risk Determinations for Three Substances
In July and August 2021, the Ninth Circuit Court of Appeals granted EPA’s motions to remand without vacatur the no-unreasonable-risk determinations for methylene chloride, 1,4-dioxane, and hexabromocyclododecane (HBCD) issued following risk evaluations conducted under TSCA Section 6.3 In all three cases, remand was granted for the limited purpose of allowing EPA to reconsider the no-unreasonable-risk determinations. The cases will be held in abeyance, and EPA will file status reports every 90 days about the progress of its reconsideration proceedings. EPA said remand would allow the Agency to revisit certain legal, policy, and scientific assumptions, approaches, and decisions. Specific issues identified in EPA’s remand motions included the Agency’s approach of making risk determinations “on a condition-of-use by condition-of-use basis rather than a determination for the chemical as a whole”; assumptions regarding workers’ use of personal protective equipment (PPE); decisions not to analyze certain populations as “potentially exposed or susceptible subpopulations”; and decisions not to consider certain environmental exposure pathways. EPA said it would continue to move forward with the risk management process for uses of the three substances found to present an unreasonable risk while reconsidering the no-unreasonable risk determinations. Petitioners in all three cases opposed remand, arguing that EPA had not admitted any error and that remand would not resolve all the disputed issues. They also urged the Ninth Circuit to vacate the no-unreasonable-risk determinations if remand was granted, and also to impose conditions such as time limits and reporting requirements. The petitioners contended that leaving the no-unreasonable-risk determinations in place risked allowing claims that the determinations preempted state regulation. The issues EPA said it would consider on remand in these three cases overlap with policy changes EPA announced at the end of June that will require changes, to some extent, to each of the first 10 risk evaluations. EPA’s June announcement is discussed below.
EPA in Settlement Talks Regarding Asbestos Risk Evaluation; Lawsuits Delayed
Briefing was delayed in the Ninth Circuit proceeding challenging EPA no-unreasonable-risk determinations made in its initial TSCA Section 6 risk evaluation for certain uses of asbestos. The litigation was delayed to allow EPA and the petitioners to continue settlement negotiations.4 The opening brief is now due October 27. In a related case filed in the Northern District of California in May to compel EPA to address use and disposal of “legacy” asbestos in a TSCA Section 6 risk evaluation, the deadline for EPA’s response to the complaint has been extended to October 18 to allow continued settlement negotiations.5 EPA has acknowledged that it must address legacy asbestos and has said it plans to prepare a second (supplemental) risk evaluation to do so. The district court complaint alleges that TSCA required EPA to complete the asbestos risk evaluation by June 19, 2020 and asks the court to issue an order setting a schedule for completion of the risk evaluation.
EPA Sought Continued Abeyance of Case Challenging DecaBDE Risk Management Rule
On June 30, 2021, EPA filed a motion in the Ninth Circuit requesting that the court continue to hold in abeyance through October 7, 2021 a case challenging the Agency’s TSCA Section 6(h) risk management rule for decabromodiphenyl ether (decaBDE).6 DecaBDE is a brominated flame retardant that EPA selected for expedited regulatory action under Section 6(h), which was added to TSCA in 2016 to require EPA to take risk management action to reduce exposures to the extent practicable on certain persistent, bioaccumulative, and toxic (PBT) substances. EPA finalized a risk management rule for decaBDE and four other PBT substances in early January.7 After President Biden took office, EPA undertook a review of the rules pursuant to Executive Order 13990 on “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis.”8 In March, EPA published a notice inviting public comment on all five final PBT rules.9 In its June 30 motion, EPA reported that it had received 19 sets of comments addressing decaBDE, that it was reviewing all comments, and that it was possible that its review of the rule and comments “could obviate the need for further proceedings here or refine the questions presented.” Petitioners opposed continuation of the abeyance, arguing that EPA would not face hardship from having to simultaneously review and defend the rule, that the petitioners and the public would be harmed by further delay due to “EPA’s illegal and under-protective regulation,” and that “the orderly course of justice would not be served by delaying these proceedings based on EPA’s purely speculative assertion that it might decide to amend the Final Rule in some fashion at some indeterminate date in the future.” Briefing on the motion was completed on July 19.
Citizen Suits Alleged CDR Violations Against Chemical Importers and Manufacturers
On June 28, 2021, Center for Environmental Health filed TSCA Section 20 citizen suits in federal court in the District of Columbia against three companies alleging violations of the Chemical Data Reporting (CDR) rule.10 In the first complaint, the Center alleged that a chemical manufacturer and importer headquartered in Akron, Ohio, had failed to report 843,047 pounds of tetrabromobisphenol A bis(2,3-dibromopropyl ether) and five other substances that it imported during the 2013–2015 reporting period. In the second complaint, the Center alleged that a chemical importer, also headquartered in Akron, failed to report at least seven chemical substances that it imported during 2013–2014. In the third complaint, the Center alleged a chemical manufacturer and importer headquartered Philadelphia had failed to report 43.4 million pounds of benzene that it imported during 2013–2015 as well as large quantities of three other substances. The Center sought declaratory relief as well as orders requiring the defendants to file Form Us for its imports of the chemicals identified in the complaints and to conduct audits to identify any other ongoing violations. The Center also sought costs and attorney and expert witness fees.
EPA Agreed to Develop Asbestos Reporting Rule to Address “Information-Gathering Deficiencies”
On June 7, 2021, EPA and the plaintiffs in cases seeking to compel EPA to require additional TSCA Section 8(a) reporting on asbestos and asbestos-containing products filed a stipulation and order informing the federal district court for the Northern District of California that they had reached a settlement.11 In the settlement agreement, EPA agreed to initiate a rulemaking proceeding to require asbestos reporting under Section 8(a) in a manner that addresses “information-gathering deficiencies” identified by the court in a December 2020 decision. (The court’s decision found that “loopholes” in the Chemical Data Reporting rule prevented EPA from collecting information about asbestos-containing articles, asbestos impurities in products, and asbestos processing.) EPA agreed to sign a proposed action within nine months and a final action within 18 months. The court approved the stipulation and order the same day.
Ninth Circuit Said EPA Lead Paint Rule Violated TSCA Title IV
On May 14, 2021, the Ninth Circuit granted a petition seeking review of EPA’s update to lead-based paint hazard standards under TSCA Title IV, the Residential Lead-Based Paint Hazard Reduction Act.12 EPA promulgated the challenged rule in 2019 in response to the Ninth Circuit’s issuance of a writ of mandamus in 2017. In its 2021 decision, the Ninth Circuit found that the current dust-lead standard (which the 2019 rule lowered) and soil-lead hazard standard (which the 2019 rule did not change and which had been in place since 2001), as well as the regulations’ lead-based paint definition (which had not been updated since Congress defined the term in 1992), did not identify all levels of lead that result in adverse human health effects, and that the standards therefore violated the statute. The court also directed EPA to reconsider clearance levels (i.e., the maximum amount of lead in dust allowable in order for an abatement of lead-based paint to be considered successful) in the same proceeding as the dust-lead hazard standard, rather than in a separate rulemaking proceeding. The Ninth Circuit said the separate proceedings “appear to ignore the close relationship between [the dust-lead hazard level] and the associated clearance levels.”
Senate Passed Bill to Require Development of Resources to Prevent Emergency Responder PFAS Exposure
On July 29, 2021, the Senate passed the Protecting Firefighters From Adverse Substances Act (PFAS Act) (S. 231), which would require the Secretary of Homeland Security to work with other agencies to develop guidance and a curriculum to reduce and eliminate exposure to PFAS from firefighting foam and PPE. The bill also would require creation and regular updating of an online repository of tools and best practices for firefighters and other emergency response personnel to reduce, limit, and prevent release of and exposure to PFAS. The bill was introduced in the House on August 6 and referred to the Committees on Science, Space, and Technology and on Transportation and Infrastructure (H.R. 4954).
Comprehensive PFAS Bill Passed House
On July 21, 2021, the House of Representatives passed the PFAS Action Act of 2021 by a 241-183 vote. The House bill (H.R. 2467) retains elements discussed in the May edition of the Chemical Compound, including requirements for EPA to take actions to regulate PFAS under multiple federal environmental laws, including the Comprehensive Environmental Response, Compensation, and Liability Act; the Clean Air Act; TSCA; the Safe Drinking Water Act; the Resource Conservation and Recovery Act; and the Clean Water Act. The bill also would establish a grant program under the Safe Drinking Water Act for assistance to community water systems affected by PFAS to pay for capital costs associated with treatment technologies. Grant programs would also provide assistance to owners and operators of publicly owned treatment works to implement effluent limitations guidelines and standards and provide funds for PFAS testing and filtration in schools. In addition, the bill would require changes to EPA’s Safer Choice Program to establish a voluntary label for covered products including pots, pans, carpet, and clothing that do not contain PFAS. It also would require development of guidance on minimizing use and contact with firefighting foam and other related PFAS-containing equipment; creation of a website with information about testing household well water; and development of a risk communication strategy “to inform the public about the hazards or potential hazardous of [PFAS].” The bill directs EPA to require submission by manufacturers of an analytical reference standard for each PFAS with at least one fully fluorinated carbon atom that was manufactured in the past 10 years. In the Senate, the bill has been referred to the Committee on Environment and Public Works.
Bills Introduced that Would Ban PFAS in Cosmetics
In June 2021, Senator Susan Collins (R-ME) and Representative Debbie Dingell (D-MI) introduced the “No PFAS in Cosmetics Act” (H.R. 3990/S. 2047). The bills would require the Department of Health and Human Services to promulgate a rule banning use of intentionally added PFAS in cosmetics. In the Senate, the bill has been referred to the Committee on Health, Education, Labor, and Pensions. In the House, it has been referred to the Committee on Energy and Commerce.
Bill in Senate Would Ban Defense Department Procurement of Many PFAS-Containing Products
On May 25, 2021, Senator Richard Blumenthal (D-CT) introduced a stand-alone bill (S. 1796)—the PFAS Military Purchasing Act—that would bar the Department of Defense from procuring or purchasing certain “covered items” containing PFAS. The bill includes the following items within the definition of “covered item”: non-stick cookware or food service ware for use in galleys or dining facilities; food packaging materials; floor waxes; carpeting, rugs, curtains, or upholstered furniture; personal care items; dental floss or toothpaste; sunscreen; umbrellas, luggage, or bags; ski wax; car wax and car window treatments; cleaning products; and shoes and clothing for which treatment with PFAS is not currently necessary for an essential function. In addition, the sale of any covered item containing PFAS on property under Defense Department jurisdiction would be prohibited. The bill would repeal a section of the National Defense Authorization Act for Fiscal Year 2021 that imposes a ban on Department of Defense procurement of certain PFAS-containing products, but which has a significantly narrower scope. That provision prohibits—starting on April 1, 2023—procurement of nonstick cookware and cooking utensils and upholstered furniture, carpets, and rugs treated with stain-resistant coatings if they contain perfluorooctane sulfonate (PFOS) or perfluorooctanoic acid (PFOA).13
House and Senate Bills Would Require Drinking Water Standards for PFAS
On May 17, 2021, Representative Brendan F. Boyle (D-PA) introduced the Protect Drinking Water from PFAS Act of 2021 (H.R. 3267), which would amend the Safe Drinking Water Act to require EPA to set a maximum contaminant level goal (MCLG) and a national primary drinking water regulation for “total per- and polyfluoroalkyl substances.” The House legislation does not define “total PFAS.” It would require the MCLG and the drinking water regulation to “be protective of the health of subpopulations at greater risk, as described in section 1458” of the Safe Drinking Water Act. The bill was referred to the House Committee on Energy and Commerce. On July 21, 2021, Senator Kirsten Gillibrand (D-NY) introduced a bill also called the “Protect Drinking Water from PFAS Act of 2021” that would require EPA to set an MCLG and national primary drinking water regulation for PFAS, “including, at a minimum,” PFOA and PFOS (S. 2406). The Senate bill specifies that the health risk reduction and cost analysis in support of the drinking water standards “may rely on information available to the Administrator with respect to 1 or more specific perfluoroalkyl or polyfluoroalkyl substances to extrapolate reasoned conclusions with respect to the health risks and effects of a class of perfluoroalkyl or polyfluoroalkyl substances of which the specific perfluoroalkyl or polyfluoroalkyl substances are a part,” including techniques described in EPA’s Generalized Read-Across (GenRA) or the Toxicity Estimation Software Tool (or a successor document or tool). The bill was referred to the Committee on Environment and Public Works.
EPA to Revisit First 10 Risk Evaluations to Incorporate Policy Changes
On June 30, 2021, EPA announced policy changes that affect how the Agency will develop risk evaluations for existing chemical substances under TSCA Section 6.14 The changes will require EPA to revisit its first 10 risk evaluations, all of which were completed by the Trump Administration. First, EPA found that the Trump Administration’s approach of excluding certain exposure pathways—air, water, and disposal—for the general population because they were regulated or could be regulated under other statutes resulted in “a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations, including fenceline communities (i.e., communities near industrial facilities).” Second, EPA said it was reconsidering the Trump Administration’s assumptions that workers would be provided with and use PPE because such an assumption could underestimate risk. Third, EPA said it would continue to assess and analyze each condition of use in risk evaluations but that the Agency would make a determination of unreasonable risk for the “whole chemical” rather than a separate risk determination for each condition of use.
The ramifications for the first 10 risk evaluations of these policy changes are as follows:
- For all 10 risk evaluations, EPA intends to withdraw the previously issued orders for conditions of use for which no unreasonable risk was found, and to issue revised unreasonable risk determinations for the chemicals as a “whole substance.”
- EPA intends to re-open the risk evaluation for 1,4-dioxane to consider whether to include additional exposure pathways (ambient air, drinking water) and conditions of use where 1,4-dioxane is generated as a byproduct; EPA also will examine whether the assumption of use of PPE by workers affected its risk determinations.
- EPA intends to use a screening-level approach to assess whether the exclusion of exposure pathways from the following six evaluations will lead to a failure to identify exposures to people located in fenceline communities near manufacturing and processing facilities: methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, n-methylpyrrolidone (NMP), and 1-bromopropane.
- EPA intends to examine whether its assumption of the use of PPE by workers affected its conclusions about risk for six substances (including 1,4-dioxane): methylene chloride, 1-bromopropane, HBCD, NMP, perchloroethylene, and 1,4-dioxane.
- EPA believes that the risk evaluations for HBCD, C.I. Pigment Violet 29, and chrysotile asbestos are likely to be found to be sufficient and that the Agency can move expeditiously to reissue its risk determinations. EPA expects that the risk management rules for these three substances likely will be the first the Agency will propose.
EPA Released Preliminary Proposal for Tiered Data Reporting to Support Work on Existing Chemicals
In July 2021, EPA introduced its preliminary concept for a Tiered Data Reporting (TDR) rule for collecting information under TSCA Section 8 to assist the Agency in its prioritization, risk evaluation, and risk management work on existing chemical substances under TSCA Section 6.15 The Agency held a public webinar on July 27 and accepted comments to inform development of a TDR rule through August 15, 2021. Slides from EPA’s webinar are available here. The TDR rule would be an outgrowth of CDR and would involve three data sets: the COU (Condition of Use) Data Set, the Prioritization Data Set, and the RE/RM (Risk Evaluation/Risk Management) Data Set. COU reporting would be triggered by the publication of a list of chemicals under consideration for the prioritization process, and Prioritization reporting would be triggered by the identification of a substance for prioritization. The reporting for these two data sets would be due three months after the triggering event; annual “changes only” COU reporting would be required until a determination is made regarding whether a chemical will enter prioritization or return to the pool of other existing chemical substances on the TSCA Inventory. RE/RM reporting would be triggered by the designation of a substance as high priority. During the first year following such designation extensive reporting would be required, with annual “changes only” reporting required in subsequent years through the risk management phase. EPA envisions shrinking the scope of CDR reporting in conjunction with the promulgation of the TDR rule. CDR would be used primarily to identify potential candidate chemicals. EPA is considering requiring manufacturers (including importers), processors, and, for RE/RM reporting, distributors to submit information to EPA under the TDR rule. Information to be reported could include information about chemical identity, production, processing, use, environmental and health effects, monitoring and product testing data, and health and safety studies, with more detailed information required for the RE/RM Data Set.
EPA Proposed One-Time TSCA Reporting Rule for PFAS
In June 2021, EPA published a proposed rule under TSCA Section 8(a)(7) that the Agency will use to collect information on a one-time basis from manufacturers (including importers) of PFAS in any year since 2011.16 Information to be collected includes information about chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. The National Defense Authorization Act for Fiscal Year 2020 requires EPA to promulgate this rule by January 1, 2023. The scope of the proposed rule is broader than other TSCA reporting requirements, such as the CDR rule. For example, the scope includes reporting on PFAS manufactured as a byproduct and on articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings). In addition, small manufacturers would not be exempt from the proposed rule’s requirements. The proposed rule includes a non-exhaustive list of 1,364 PFAS subject to the rule but also provides that all substances meeting the proposed rule’s structural definition would be subject to reporting. The proposed rule would require manufacturers to report to the EPA during a six-month submission period beginning six months following the effective date of the final rule. Manufacturers must report information “to the extent that the information is known to or reasonably ascertainable by the manufacturer,” which includes “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” EPA notes submitters would need to “conduct a reasonable inquiry within the full scope of their organization,” which could include inquiries outside the organization to better understand the activities of upstream suppliers and downstream users or other agents. The proposed rule includes provisions to avoid potentially duplicative reporting under the CDR rule and provisions addressing confidential information, and also would establish a five-year recordkeeping period that would begin on the last date of the submission period (i.e., one year after the effective date of the final rule). The deadline for comments on the proposed rule is September 27, 2021.
Draft IRIS Assessment Released for Perfluorobutanoic Acid
In August, EPA announced a 60-day comment period on a draft Integrated Risk Information System (IRIS) assessment for perfluorobutanoic acid (PFBA) and the related compound ammonium perfluorobutanoic acid.17 PFBA is one of five PFAS for which the IRIS program is developing an assessment. The draft report said available evidence indicated that developmental, thyroid, and liver effects in humans are likely caused by PFBA exposure in utero or during adulthood. The draft report derived oral lifetime reference doses (RfD) and subchronic RfD for these health effects, with an overall RfD of 1 x 10-3 mg/kg-day as the estimate of human exposure that was likely to be without an appreciable risk of adverse health effects over a lifetime, based on thyroid and liver effects. The draft report said evidence was inadequate to determine whether reproductive effects might be a potential human health hazard; information was also inadequate to assess carcinogenic potential or to derive inhalation RfDs.
EPA Added Substances to Safer Chemical Ingredients List
On August 10, 2021, EPA announced that it had added 36 chemicals to the Safer Chemical Ingredients List (SCIL), which the Agency described as “a living list of chemicals, by functional-use class, that EPA’s Safer Choice program has evaluated and determined meet Safer Choice criteria.”18 The Safer Choice program evaluates chemical ingredients against Master and Functional-Class Criteria documents that define the characteristics and toxicity thresholds for ingredients that are acceptable in Safer Choice products. There are nine functional-use classes that include surfactants, solvents, chelating and sequestering agents, and fragrances. Information about the SCIL criteria is available here. A downloadable spreadsheet of the SCIL that shows the recently added ingredients is available here.
ATSDR Released Final Toxicological Profile for Certain PFAS and Six Draft Updated Profiles for Chemicals on Substance Priority List
On July 29, 2021, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the availability for public comment of six draft updated toxicological profiles.19 The draft profiles are for acetone, aldrin/dieldrin, chlorophenols, 3,3-dichlorobenzidine, disulfoton, and pentachlorophenol. All of these substances are on ATSDR’s Substance Priority List (SPL),20 which includes 275 hazardous substances that ATSDR and EPA have determined pose the most significant potential threat to human health based on their known or suspected toxicity and potential for human exposure at Superfund sites. CERCLA requires ATSDR to prepare and update Toxicological Profiles for each substance on the SPL. The six draft updated toxicological profiles reflect new health effects and other information that has become available since their initial release. In the notice of their availability, ATSDR solicited any additional relevant studies for possible inclusion in the profiles. The deadline for comments is October 27, 2021.
In May 2021, ATSDR released its final Toxicological Profile for Perfluoroalkyls.21 The profile discusses information on 10 PFAS that have been measured in the serum collected from a representative U.S. population 12 years of age and older and two other PFAS identified in other monitoring studies. ATSDR derived oral minimal risk levels (MRLs) for four of the PFAS: PFOA (3x10-6 mg/kg/day), PFOS (2x10-6 mg/kg/day), perfluorohexane sulfonic acid (PFHxS) (2x10-5 mg/kg/day), and perfluorononanoic acid (PFNA) (2x10-5 mg/kg/day). The database was not adequate for derivation of oral MRLs for the other substances or for inhalation MRLs. The MRLs are screening tools that represent an estimate of daily human exposure to a hazardous substance that is likely to be without appreciable risk of adverse noncancer health effects for a specified route and duration of exposure.
Preliminary 2020 TRI Dataset Shows “Seemingly Limited” Scope for PFAS Reporting
On July 29, 2021, EPA published preliminary Toxics Release Inventory (TRI) data for 2020 reporting, which for the first time included reporting on PFAS added to the TRI pursuant to the National Defense Authorization Act for Fiscal Year 2020.22 EPA said it received 89 TRI reporting forms for 44 discrete PFAS chemicals filed by 38 individual facilities. These facilities released or otherwise managed more than 700,000 pounds of production-related PFAS waste during 2020. EPA said the Agency would be conducting additional analysis of the PFAS reporting to provide insights regarding “the seemingly limited scope of the reporting” and would “take action as appropriate,” potentially including “compliance assistance, enforcement, or proposing modifications to the TRI reporting requirements for PFAS.” EPA plans to publish an updated TRI dataset in the fall, which the Agency will use to develop the 2020 TRI National Analysis, which it intends to publish in early 2022 and which will provide more detailed information. The preliminary dataset is available here.
Three More PFAS Added to Toxics Release Inventory List for 2021 Reporting Year; EPA Announced Plans for More Additions to List
Effective July 6, 2021, EPA has added three additional PFAS to the Toxics Release Inventory reporting list: perfluorooctyl iodide; potassium perfluorooctanoate; and silver(I) perfluorooctanoate.23 The addition of these chemicals is required by the National Defense Authorization Act for Fiscal Year 2020 (NDAA), which identified certain regulatory activities that automatically add PFAS or PFAS classes to the TRI. In this case, the triggering activity for the three PFAS was their addition to an existing significant new use rule.24 The three PFAS are reportable for the 2021 reporting year (i.e., reports due July 1, 2022). At the end of April, EPA announced other steps it would take to expand TRI reporting to protect underserved communities, including by continuing to add PFAS to the TRI list as required by the NDAA.25 EPA identified perfluorobutane sulfonic acid (PFBS) as a substance that it anticipated adding, following EPA’s publication in early April of a toxicity assessment for PFBS. EPA also said it planned to propose adding TSCA Workplan chemicals and High-Priority Substances to the TRI list, as well as chemicals included in a 2014 petition from the Toxics Use Reduction Institute.
EPA Sought Information to Inform Regulation of 1-Bromopropane as Hazardous Air Pollutant
On June 11, 2021, EPA published an advance notice of proposed rulemaking (ANPRM) regarding the addition of 1-bromopropane (1-BP) to the Clean Air Act Section 112 list of hazardous air pollutants (HAP).26 The ANPRM followed EPA’s granting in June 2020 of petitions requesting the listing of 1-BP as a HAP. It will be the first time a substance has been added to the list since the 1990 Clean Air Act Amendments established the initial list in 1990. The purpose of the ANPRM was to gather data and information to assist EPA in identifying and evaluating regulatory impacts of the addition of 1-BP to the HAP list. EPA sought the following categories of information: (1) types of applications or processes that employ 1-BP (e.g., chemical production, spray coating, solvent cleaner/degreaser); (2) the amount of 1-BP used in specific applications; (3) whether 1-BP is used in a separate process from other HAP or is used in combination with other HAP; (4) the types of facilities where 1-BP is used; (5) whether the facility using 1-BP is classified as a large or small business; (6) any available information on the reasons for the selection of 1-BP (e.g., particular effectiveness, replacement for HAP); (7) whether the processes are controlled or uncontrolled for 1-BP or HAP emissions and, if controlled, what types of control devices or practices are utilized; and (8) any other information that the respondent believes is important to consider. Other information sought by EPA included information about any controls currently used to control 1-BP emissions, information about any efforts to evaluate alternatives to 1-BP, information on potential impacts on small entities and small businesses, and comments about measures to ensure mitigation of unnecessary compliance burden due to regulation of 1-BP under both TSCA and the Clean Air Act. EPA said it was not reopening the decision to grant the petitions to list 1-BP as a HAP for comments. The comment period on the ANPRM closed on July 26, 2021.
Draft Contaminant Candidate List Included All PFAS
In the July 19, 2021 issue of the Federal Register, EPA published notice of the availability of a draft Fifth Contaminant Candidate List (CCL 5) that identifies contaminants known or anticipated to be present in public water systems and that may require regulation under the Safe Drinking Water Act (SDWA).27 The draft CCL 5 includes 66 chemicals, three chemical groups (including PFAS), and 12 microbial contaminants. The CCL is the first step for screening and evaluating the subset of contaminants that may require SDWA regulation. Most unregulated contaminants for which EPA has required monitoring have been selected from the CCL; in addition, EPA must make determinations regarding whether to regulate under the SDWA for at least five contaminants on the CCL every five years. In the draft CCL 5 notice, EPA defined the PFAS group to be “inclusive of any PFAS (except for PFOA and PFOS).” (EPA has already made final determinations to regulate PFOA and PFOS under the SDWA earlier in 2021.) In the notice, EPA also provided a structural definition of PFAS for draft CCL 5 purposes. The full list of contaminants on the draft CCL 5 is available here. The comment period on the draft CCL 5 was scheduled to close on September 17, 2021.
EPA Required Health and Safety Data Reporting for 50 Substances
In the June 29, 2021 issue of the Federal Register, EPA published a final rule adding 50 chemical substances to the TSCA Section 8(d) Health and Safety Data Reporting rule. The 50 substances comprise the 20 High-Priority Substances currently undergoing risk evaluations under TSCA Section 6 and 30 organohalogen flame retardants. 28 The 50 substances also appear on the Interagency Testing Committee’s TSCA Section 4(e) Priority Testing List; ITC requested that EPA add them to the Section 8(d) rule. The June 29 final rule requires entities that have manufactured (including imported) the listed chemical substances within the 10-year period preceding the rule’s effective date of July 29, 2021 to submit lists and copies of unpublished health and safety studies to EPA by September 27, 2021.
EPA Withdrew Compliance Guide for the Long-Chain Perfluoroalkyl Carboxylate Significant New Use Rule
On June 10, 2021, EPA withdrew the compliance guide issued in January 2021 for the 2020 significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) chemical substances.29 The guide was intended to provide direction with respect to the LCPFAC SNUR’s elimination of the exemption for importers of LCPFAC substances as part of a “surface coating” on articles. EPA characterized the guide as weakening the LCPFAC SNUR and said it “inappropriately narrowed the scope.” EPA also said the guide was “never deemed necessary by career staff and its development was directed by political officials serving in the last Administration.” In addition, EPA said the guidance was finalized without considering or addressing public comments.
EPA Announced Electronic Option for TSCA Export Notifications; Other TSCA Communications Also Now Available Via CDX
On June 14, 2021, EPA announced the availability of an electronic option for submitting export notifications under TSCA Section 12(b), which requires exporters to submit a notice to EPA for each country to which certain chemical substances are exported.30 Notification is required prior to making export shipments of a chemical substance or mixture for which submission of information is required under TSCA Section 4 or 5(b), and for a chemical substance or mixture for which an order has been issued under Section 5 or 6, a rule has been proposed under Section 5 or 6, or with respect to which an action is pending or relief has been granted under Section 5 or 7. As of June 14, exporters of such substances may submit the notifications through the Central Data Exchange (CDX), which is EPA’s secure portal for submission of information. EPA expects the electronic option to help streamline submissions and reduce administrative costs and burdens both for submitters and for the Agency. Exporters may continue to use hard copies if they prefer to do so. Earlier in the year, EPA launched a new application in the CDX that allows submission of certain TSCA communications electronically, including: General Confidential Correspondence, Requests for Chemical Information, Premanufacture Notice (PMN) Corrections for Submissions made Prior to 2016, and Copy of Record Requests.31
EPA’s Spring 2021 Regulatory Agenda Contained Multiple TSCA Rulemaking Actions
In June 2021, the Spring 2021 agenda for rulemaking was published, which included 29 items for the Office of Chemical Safety and Pollution Prevention. The full EPA rule list is available here, with links to the individual entries. OCSPP highlights included:
- Section 8(a) reporting rule for certain chemicals on the TSCA Work Plan to inform the prioritization and risk evaluation of existing chemicals (i.e., the Tiered Data Reporting rule discussed above) (proposed rule anticipated in February 2022);
- Fees rule amendments (final rule anticipated in October 2021);
- Section 8(a)(7) PFAS reporting rule (proposed rule out now; final rule anticipated in July 2022);
- New and amended rules for asserting and maintaining confidentiality claims under TSCA (proposed rule anticipated in September 2021);
- Section 6(a) risk management rules for the initial 10 chemical substances (proposed rules anticipated starting in June 2021 through January 2022);
- PBT rules reconsideration and extension of certain compliance dates (interim final rule anticipated by September 2021); and
- Mercury inventory reporting rule in response to Second Circuit vacatur of certain provisions (final rule anticipated in November 2021).
“Secret Science” Rule Formally Removed
Effective May 28, 2021, EPA formally removed the Trump Administration’s “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information” final rule, which a federal court in Montana vacated in February.32 The rule, sometimes referred to as the “secret science” rule, would have required that EPA give greater consideration to studies where the underlying dose-response data allowed for independent validation in certain situations where EPA was promulgating significant regulatory actions or developing influential scientific information. EPA also would have had to make publicly available, to the extent practicable, the science that served as the basis for a proposed significant regulatory action. The former rule was codified at 40 C.F.R. part 30.
EPA Denied TSCA Section 21 Petition Regarding Phosphogypsum
On May 5, 2021, EPA denied the portion of a petition submitted pursuant to TSCA Section 21 that requested that the Agency issue a TSCA rule requiring testing of phosphogypsum and process wastewater from phosphoric acid production (process wastewater).33 EPA found that the petitioners did not meet their burden under TSCA Sections 4(a)(1)(A) and 21(b)(2) because they did not provide the facts necessary for EPA to determine that existing information and experience on the health and environment effects of phosphogypsum and process wastewater were insufficient, and that testing with respect to such effects was necessary to develop such information. EPA treated the other requests in the petition, including those involving TSCA, as a petition under the Administrative Procedure Act and has not yet provided EPA’s response to those requests. The other TSCA requests were for EPA to initiate the TSCA Section 6 prioritization process for designating phosphogypsum and process wastewater as High-Priority Substances and for EPA to determine that use of phosphogypsum in road construction is a significant new use under TSCA Section 5.
EPA Rescinded Procedural Rule for Issuing Guidance Documents
Effective May 18, 2021, EPA has rescinded its final rule that dictated procedures for issuance, revision, and withdrawal of guidance documents.34 EPA’s rationale for rescinding the rule was that it “deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts and circumstances, and unduly restricts the EPA's ability to provide timely guidance on which the public can confidently rely.” EPA said a notice-and-comment process was not required for rescission because of the guidance rule’s procedural nature.
State Regulatory & Legislative Action
PFAS-Containing Carpets and Rugs Listed as Priority Product
Effective July 1, 2021, the California Department of Toxic Substances Control (DTSC) has listed carpets and rugs containing PFAS as a Priority Product in California’s Safer Consumer Products program.35 The category does not include carpets and rugs intended for outdoor use or for use on airplanes, trains, ships, automobiles, or other vehicles. It also does not include resilient floor coverings, artificial turf, wall hangings and coverings, table mats, and camping sleeping mats.36 Manufacturers of carpets and rugs containing PFAS must submit Priority Product Notifications by August 30, 2021 identifying any such products. By December 28, they must submit either a Chemical Removal Intent/Confirmation Notification, a Product Removal Intent/Confirmation Notification, a Product-Chemical Replacement Intent/Confirmation Notification, or a Preliminary Alternatives Analysis Report.
Safer Consumer Products Program Issued Draft Documents for Hair Straightening Products and Motor Vehicle Tires
Other developments in California’s Safer Consumer Products program included the May 2021 publication of a background document on chemicals in hair straightening products.37 The background document will inform DTSC’s decision about which hair straightening products containing one or more Candidate Chemicals should be listed as Priority Products. The screening found that 114 of the 185 hair straightening products introduced to the US market from 1996 to 2020 contained one or more Candidate Chemicals. The document focused on formaldehyde, sodium hydroxide, parabens, cyclosiloxanes, diethanolamine, phthalates, and benzophenone-3, and triclosan, but sought input on additional chemicals that should be evaluated, as well as information on exposure and toxicity and the market presence of hair straightening products. The comment period closed on July 23, 2021.
In June 2021, DTCS released a Product-Chemical Profile discussion draft for motor vehicle tires containing 6PPD.38 The draft Profile explains DTSC’s determination that this product meets the criteria for designation as a Priority Product: (1) there is potential public and/or aquatic, avian, or terrestrial animal or plant organism exposure to the Candidate Chemical in the product; and (2) there is the potential for one or more exposures to contribute to or cause significant or widespread adverse impacts. DTSC said it would finalize the Profile after reviewing public comments, the deadline for which is September 17, 2021. DTSC may then start the rulemaking process to designate motor vehicle tires containing 6PPD as a Priority Product.
California EPA Released Technical Support Document for PFOA and PFOS Public Health Goals
On July 22, 2021, the California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) made available a draft technical support document for proposed Public Health Goals (PHGs) for PFOA and PFOS in drinking water.39 The State Water Resources Control Board considers PHGs—which are the levels of a contaminant at which adverse health effects are not expected over a lifetime of exposure—when setting drinking water regulatory standards. The proposed PHGs are 0.007 parts per trillion (ppt) for PFOA and 1 ppt for PFOS. They are set at a level of risk of one additional cancer case per one million persons exposed over a lifetime. The proposed noncancer health-protective concentrations are 3 ppt for PFOA and 2 ppt for PFOS. The comment period on the draft document is scheduled to end on September 28, 2021.
Connecticut Enacted Restrictions on PFAS in Firefighting Foam and Food Packaging
On July 13, 2021, Connecticut Governor Ned Lamont signed legislation imposing restrictions on firefighting foam and food packaging that contain PFAS. Effective July 13, the law banned local governments and state agencies from using class B firefighting foam containing intentionally added PFAS for training or testing purposes.40 The law also institutes a ban on use of such firefighting foam for vapor suppression or firefighting purposes on and after October 1, 2021 except for use on flammable liquid-based fires if the Commissioner of Energy and Environmental Protection fails to identify an alternative. Airport facilities must end their use of fire suppression systems using PFAS-containing class B firefighting foam no later than October 1, 2023, and in the meantime must implement measures to prevent releases into the environment. Chemical plants, oil refineries, terminals, and storage or distribution facilities for flammable liquids can request extensions of time for compliance. With respect to food packaging, the law bars manufacturers and distributors from offering for sale or for promotion purposes food packages to which PFAS has been intentionally introduced. The prohibition takes effect on December 31, 2023, but requires manufacturers and distributors to take action “[a]s soon as feasible.” The law includes a provision requiring that any replacement material in a package or packaging component not create a hazard “as great as, or greater than,” the hazard created by the regulated chemical.
Illinois Proposed Groundwater Quality Standards for Five PFAS
The Illinois Environmental Protection Agency proposed groundwater quality standards for five PFAS: PFOA, PFOS, PFNA, PFHxS, and PFBS.41 Illinois accepted public comment on the water quality standards, which include many elements not related to PFAS, until June 25, 2021. The proposed PFAS groundwater standards are as follows:
Maine Enacted PFAS Measures, Including 2030 Ban on PFAS-Containing Products
In June and July 2021, Maine enacted multiple laws that regulate PFAS both in products and in the environment. The laws included provisions setting an interim drinking water standard of 20 nanograms per liter for any regulated PFAS and requiring the Department of Health and Human Services to adopt maximum contaminant levels for PFAS by June 1, 2024.42 Another law requires manufacturers of products containing intentionally added PFAS to submit notifications to the Department of Environmental Protection beginning January 1, 2023.43 The law also prohibits sale of carpets and rugs and fabric treatments containing intentionally added PFAS, effective January 1, 2023, and authorizes Maine DEP to prohibit others categories or uses of products containing intentionally added PFAS. Effective January 1, 2030, all products containing intentionally added PFAS are to be prohibited except for any “currently unavoidable use.” A separate law restricted use of PFAS-containing firefighting or fire-suppressing foams beginning in 2022.44 Other laws established a Land Application Contaminant Monitoring Fund funded with fees on sludge or septage handling; required PFAS testing of locations of land application of sludge or septage and of landfill leachate; and required a comprehensive research study to identify and aid farmers affected by PFAS contamination.45
Maryland Enacted 2025 Ban on Cosmetic Products Containing Certain PFAS and Other Chemicals
Under a law enacted in Maryland at the end of May 2021, the manufacture, sale, delivery, holding, or offering for sale of cosmetic products containing certain chemicals is prohibited beginning on January 1, 2025.46 The prohibited chemical ingredients comprise 13 PFAS and 11 other substances, including formaldehyde, dibutyl phthalate, diethylhexyl phthalate, mercury, and methylene glycol.
New York Released Draft Method Performance Criteria for 1,4-Dioxane for Potential Inclusion in Consumer Products Rule
In June 2021, the New York State Department of Environmental Conservation (NYSDEC) made available draft 1,4-dioxane Method Performance Criteria (MPC) for public review and comment.47 DEC said it was considering whether to include the draft MPC in an upcoming rule to implement a 2019 law establishing maximum concentrations of 1,4-dioxane in household cleansing, personal care, and cosmetic products. The restrictions on 1,4-dioxane in such products are to take effect as of December 31, 2022. DEC is evaluating whether the draft MPC could provide guidance on acceptable test methods for manufacturers to use to determine whether their products comply with the law. DEC took comment on the draft MPC—which it developed in collaboration with the California Department of Toxic Substances Control’s Safer Consumer Products program and Environmental Chemistry Lab—until July 23, 2021.
Vermont Law Will Prohibit Certain PFAS-Containing Products, Add More PFAS to List of Chemicals of High Concern to Children
On May 18, 2021, Vermont Governor Phil Scott signed legislation restricting PFAS-containing firefighting foam, rugs, carpets, stain and water resistant treatments, ski wax, and food packaging.48 Effective July 1, 2022, the law prohibits use of class B firefighting foam containing intentionally added PFAS for training or testing purposes and prohibits its manufacture, sale, and distribution no later than October 1, 2023 unless otherwise required under federal law. The law also requires written notice to purchasers if personal protective equipment contains PFAS. The notice must provide the reason PFAS are added to the equipment. A prohibition on rugs, carpets, and aftermarket stain and water resistant treatments for rugs or carpets to which PFAS have been intentionally added takes effect on July 1, 2023, as does a ban on ski wax and related products to which PFAS have been added. The new law also prohibits, effective July 1, 2023, the manufacture, sale, and distribution of food packaging containing PFAS as well as food packages including inks, dyes, pigments, adhesives, stabilizers, coatings, plasticizers, or any other additives to which ortho-phthalates have been intentionally added and are present in any amount. In addition, the Department of Health may prohibit sale of food packages to which bisphenols have been intentionally added. The law also adds three PFAS to the list of chemicals of high concern to children: PFHxS, perfluoroheptanoic acid, and PFNA, effective July 1, 2022. The addition of these substances to the list imposes an obligation on manufacturers to provide information about children’s products containing the substances.
*Margaret Barry also contributed to this newsletter.
© 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.
Neighbors for Envtl. Justice v. EPA, Nos. 20-72091, 20-73276 (9th Cir. July 14, 2021); Envtl. Def. Fund v. EPA, No. 21-70162, 21-70194, 21-70684, 21-70727, 21-70930 (9th Cir. Aug. 10, 2021); Alaska Cmty. Action on Toxics v. EPA, No. 20-73099, 20-73578, 21-70009 (9th Cir. Aug. 10, 2021).
Ctr. for Envtl. Health v. 3N Int’l, Inc., No. 1:21-cv-01720 (D.D.C., filed June 28, 2021); Ctr. for Envtl. Health v. Harwick Standard Distrib. Corp., No. 1:21-cv-01723 (D.D.C., filed June 28, 2021); Ctr. for Envtl. Health v. Braskem America, Inc., No. 1:21-cv-01724 (D.D.C., filed June 28, 2021).
A Cmty. Voice v. EPA, 997 F.3d 983 (9th Cir. 2021).
Pub. L. No. 116-283, § 333.
News Release, EPA, EPA Announces Path Forward for TSCA Chemical Risk Evaluations (June 30, 2021).
86 Fed. Reg. 37152 (July 14, 2021).
86 Fed. Reg. 33926 (June 28, 2021).
See Perfluorobutanoic Acid (PFBA), EPA (last updated Aug. 19, 2021).
EPA Updates Safer Chemical Ingredients List, EPA (last updated Aug. 10, 2021).
86 Fed. Reg. 40844 (July 29, 2021).
ATSDR’s Substance Priority List, ATSDR (last review Jan. 17, 2020).
ATSDR, Toxicological Profile for Perfluoroalkyls (released May 2021; last update Mar. 2020).
News Release, EPA, EPA Releases Preliminary Data for 2020 Toxics Release Inventory Reporting, Including First Ever Reporting on PFAS (July 29, 2021).
86 Fed. Reg. 29698 (June 3, 2021).
See 85 Fed. Reg. 45109 (July 27, 2020).
News Release, EPA, EPA Announces Plan to Update Toxics Release Inventory to Advance Environmental Justice (Apr. 29, 2021).
86 Fed. Reg. 31225 (June 11, 2021).
86 Fed. Reg. 34147 (June 29, 2021).
News Release, EPA, EPA Continues to Take Action on PFAS to Protect the Public (June 10, 2021).
86 Fed. Reg. 31502 (June 14, 2021); see 15 U.S.C. § 2611(b).
News Release, EPA, EPA Launches New Paperless Communication Application for TSCA Data in Central Data Exchange (May 11, 2021).
86 Fed. Reg. 29515 (June 2, 2021).
86 Fed. Reg. 27546 (May 21, 2021).
86 Fed. Reg. 26842 (May 18, 2021).
Effective July 1, 2021: Carpets and Rugs with Perfluoroalkyl or Polyfluoroalkyl Substances (PFASs), DTSC (last visited Aug. 20, 2021); see Cal. Code Regs. tit. 22, § 69511(b)(4).
Safer Consumer Prods. Program, Cal. Dep’t of Toxic Substances Control, & Cal. Envtl. Prot. Agency, Work Plan Implementation: Chemicals in Hair Straightening Products Background Document (May 24, 2021).
Safer Consumer Prods. Program, Cal. Dep’t of Toxic Substances Control, & Cal. Envtl. Prot. Agency, Product – Chemical Profile for Motor Vehicle Tires Containing N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD): Discussion Draft (June 2021).
See Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonate (PFOS) in Drinking Water, OEHHA (last updated July 22, 2021).
P.A. No. 21-191 (S.B. No. 837).
620 Groundwater Quality, Ill. EPA (last visited Aug. 20, 2021).
See 1,4-Dioxane Limits for Household Cleansing, Personal Care, and Cosmetic Products, NYSDEC (last visited Aug. 20, 2021).