EPA Publishes Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials

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On January 12, 2017, EPA published a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) establishing reporting and recordkeeping requirements for certain chemical substances that are manufactured or processed at the nanoscale. Manufacturers and processors, or persons who intend to manufacture or process new discrete forms of certain existing chemical nanoscale materials not previously reported to EPA, must also report certain information to EPA prior to manufacture or processing. The information to be reported includes the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. There is no independent requirement to test materials to find this information, but manufacturers and processors must use information that is known to or reasonably ascertainable by them when reporting.

Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to the effective date of the final rule must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a new discrete form of a reportable existing chemical substance on or after the effective date of the rule. These persons are required to report to EPA at least 135 days before manufacture or processing of that discrete form with certain exceptions. The final rule will be effective on May 12, 2017.

EPA Proposes to Limit the Use of Two Toxic Chemicals in Paint Removers

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The EPA is proposing to place limits on the use of two common chemicals in paint removers in order to protect consumers and workers from serious health risks associated with this use. The chemicals are methylene chloride and N-methylpyrrolidone (NMP).

In a 2014 assessment, EPA concluded that methylene chloride can cause a range of adverse health effects, including harm to the central nervous system, liver toxicity, and cancer. EPA is now proposing to prohibit manufacture (including import), processing, and distribution in commerce of methylene chloride when used as a paint remover, except for commercial furniture refinishing which the Agency will address in a separate proposal. EPA is also proposing to require manufacturers, processors, and distributors to notify retailers and others in their supply chains of the prohibitions.

EPA assessed NMP in 2015 and identified risks to people, particularly pregnant women and women of childbearing age, who have high exposure to NMP through paint or coating removal. EPA is inviting comments on two approaches to address the risks from NMP. One approach would prohibit manufacture (including import), processing, and distribution in commerce of NMP when used as a paint remover, as well as require various notification measures on the restrictions to downstream processors and users. The other approach would put in place a combination of requirements to address unreasonable risks, including limiting the amount of NMP in paint remover products, providing warning labels for consumers, and requiring workers to wear specialized gloves and other equipment. EPA is seeking comment on both approaches. In addition, EPA is proposing to exempt certain national security uses of methylene chloride and NMP from the requirements of this rule.

Comments on the proposed rule must be received 90 days after date of publication in the Federal Register.

Read the pre-published proposed rule here.

EPA plans to limit TSCA CBI protections.

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This summer, EPA published a proposal to modify regulations governing significant new uses of chemical substances (SNUR) under the Toxic Substances Control Act (TSCA) that could significantly impact protections for Confidential Business Information (CBI).  The proposed rule would modify the bona fide intent procedures in 40 CFR 721.11 to allow EPA to disclose the confidential significant new use designations to a manufacturer or processor who has established a bona fide intent to manufacture (including import) or process a chemical substance. Specifically, the proposed regulatory language redefines the scope of “confidential business information” to exclude new use designations. Industry groups voiced their concerns with the proposal in comments submitted to the Agency last month. Some comments urged EPA to withdraw the proposal and re-propose it in conformity with the disclosure authorized by the Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act).

Section 14 of the Lautenberg Act prohibits the disclosure of “information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code,” the Public Information Section of the Administrative Procedure Chapter of this Title. The provision explicitly provides that this protection extends to “processes used in the manufacturing or processing of a chemical substance or mixture.” Several commenters stressed that it appears that the proposed regulation goes beyond what the statute allows.

The American Chemistry Council (ACC) noted in its comments that EPA needs only to respond to the bona fide intent requestor with a “yes” or “no” to address whether the proposed use of the SNUR substance is a new use. Therefore, the ACC stressed, the proposed amendment to 40 CFR 721.11 would disclose more confidential information than is necessary to answer the requestor’s question. Other comments, from the American Fuel & Petrochemical Manufacturers, argue that the Agency’s plans to disclose this information would create an anticompetitive environment by giving an advantage to those who submit bona fide intent notices.

In their comments, these industry groups also recommended EPA expand the SNUR CBI provision to impose additional requirements on both the Agency and chemical manufacturers. The ACC asserted that EPA should be required to inform the original PMN submitter when it discloses any confidential information to a requestor similar to the existing provision regarding the Confidential Inventory (40 CFR 720.25(b)(6)). Another set of comments, from the American Petroleum Institute, suggested that the Agency use consent order and SNUR requirements to compel manufacturers to inform downstream customers of all potentially applicable compliance requirements related to a substance.

The proposed amendments to the SNUR CBI provisions could affect EPA’s treatment of CBI under TSCA more generally. The Lautenberg Act requires manufacturers and importers to reassert CBI claims during the Inventory Reset process. The proposal for that process may also attempt to limit CBI protections.

Litigating the obligation to report substantial risk information and pay penalties under TSCA section 8(e).

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(This post is an adaptation of an article published in the December 2016 newsletter of the Pesticides, Chemical Regulation, and Right-to-Know Committee, within the American Bar Association’s Section of Environment, Energy, and Resources. A PDF of the article is available here.)

By Irene Hantman

On December 9, 2016, four major chemical manufacturers filed a motion to dismiss [PDF] the Toxic Substances Control Act (TSCA) section 8(e) claims filed against them by the law firm Kasowitz, Benson, Torres & Friedman LLP (Kasowitz) under the False Claims Act (FCA).  Under the qui tam provision of the FCA, individuals may pursue claims against any person who “knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit money or property to the Government, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit money or property to the Government.”  In this case, Kasowitz asserts that BASF, Bayer (Convestro), Dow, and Huntsman failed to pay penalties allegedly owed under the Environmental Protection Agency’s (EPA) TSCA section 8(e) Compliance Audit Program (CAP).  The case was originally filed in the U.S. District Court, Northern District of California in May 2015.  In November 2016 the case was transferred to U.S. District Court for the District of Columbia, and a status hearing was held December 1, 2016.

EPA’s Compliance Audit Program (CAP) and Substantial Risk Information

In the early 1990s, EPA used the CAP to encourage companies to come into compliance with TSCA section 8(e) requirements regarding the immediate reporting of “new information that reasonably supports a conclusion that a chemical substance or mixture presents a substantial risk of injury to health or the environment” (“substantial risk information”).  In the Federal Register notice announcing the program, EPA explained that section 8(e) is very important to the Agency’s ability to obtain information needed to set priorities and perform risk assessments.   More than 100 companies participated in the program.

The CAP invited companies to enter into Agreements with EPA to audit their past compliance with section 8(e).  Companies entering into CAP Agreements were assured that the Agency would pursue only limited penalties and that it would forgo late and/or nonreporting TSCA section 8(e) civil penalties.  This could represent substantial savings to companies; in its Enforcement Response Policy, EPA asserts that a section 8(e) violation is a continuing violation.  That is, the violation continues from the date when the substantial risk information should have been disclosed through every day on which it has not been disclosed.  There is no “Statute of Limitations” for continuing violations.  Although the CAP provided significant protections to participants, EPA reserved its rights to take appropriate enforcement action if the Agency later determined that a company was required to submit a study or report under the CAP but failed to do so.

Litigation

While pursuing personal injury litigation against the chemical manufacturers over exposure to certain isocyanate chemicals, Kasowitz identified information that led to filing this lawsuit. The isocyanates involved are: methylene diphenyl diisocyanate (MDI), polymeric MDI (PMDI), and toluene diisocyanate (TDI).  Isocyanates are used in the manufacture of polyurethane materials including liquid coatings, paints, and adhesives, flexible and rigid foam, and elastomers.

This complaint [PDF] alleges that the defendants withheld substantial risk information regarding respiratory injury when inhaled at levels below applicable inhalation exposure limits and from de minimis dermal contact.  According to Kasowitz, none of the substantial risk information at issue in the case was published in the scientific literature or otherwise available to EPA.

Arguing that the violations began as early as 1980 and continued up until the complaint was filed,  Kasowitz claims that the defendants owe billions in penalties under section 8(e).  In addition, penalties under the FCA can more than triple.  The qui tam provisions of the FCA grant up to 30 percent of any settlement to the private plaintiff.

Kasowitz has put forth a complex legal argument positing that, while BASF, Bayer, Dow, and Huntsman participated in CAP, they:

  • Had substantial risk information which section 8(e) obligated them to submit to EPA;
  • Were contractually obligated to submit all previously unreported substantial risk information through CAP;
  • Knowingly concealed or knowingly and improperly avoided a contractual obligation to transmit civil penalties for their failure to comply with section 8(e) reporting requirements in violation of the FCA; and
  • Made, used, or caused to be made or used, a false record or statement material to an obligation to pay or transmit money to the United States government in violation of the FCA.

In their motion to dismiss, the defendants argue that Kasowitz has failed to meet the required elements of claim under FCA.  Specifically, they explain that penalties not assessed by EPA do not comprise an “obligation to pay” under the FCA.  Kasowitz’s response to the motion is due on February 7, 2017.

Implications

The enrollment period for the CAP expired more than 20 years ago.  Today, companies interested in addressing liability for failing to timely submit substantial risk information to EPA must seek the protection of the Audit Policy, using the Agency’s new eDisclosure system.

If this case is successful, companies defending toxic tort litigation may see discovery expanded in search of similar substantial risk information.

Lautenberg Act: EPA names ten Work Plan chemicals for initial risk evaluations.

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The U.S. Environmental Protection Agency (EPA) has announced the ten Work Plan chemicals for review under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which updated the Toxic Substances Control Act (TSCA). Yesterday, the agency released the list of substances, which will be the first to undergo risk evaluations under the new law. The list is mainly made up of flame retardants and industrial solvents, many of which are used in consumer products, as well as asbestos, the notoriously carcinogenic mineral used in building materials.

The chemicals are:

  • 1,4-Dioxane
  • Bromopropane
  • Asbestos
  • Carbon Tetrachloride
  • Cyclic Aliphatic Bromide Cluster
  • Methylene Chloride
  • N-methylpyrrolidone (NMP)
  • Pigment Violet 29
  • Tetrachloroethylene, also known as perchloroethylene
  • Trichloroethylene (TCE)

Under the Lautenberg Act, EPA must select ten chemicals from the 2014 Work Plan by December 19, 2016. The Work Plan contains 90 chemicals with potential for high hazard and exposure, as well as considerations including persistence and bioaccumulation. The agency notes that in choosing the ten chemicals, it “took into account recommendations from the public, industry, environmental and public health groups, and members of Congress and tried to give weight to chemicals where work on assessing risks were underway.”

Among the listed chemicals, EPA has already completed risk assessments for methylene chloride, NMP, and TCE, and taken early steps towards assessments for 1,4-Dioxane and the Cyclic Aliphatic Bromides. For methylene chloride, NMP, and TCE, the agency plans to proceed with Section 6(a) rulemaking for the limited uses defined for the completed risk assessments; the chemicals’ remaining uses will now be newly evaluated. The ongoing rulemaking for these chemicals were included as “Immediate Actions” in EPA’s First Year Implementation Plan for the Lautenberg Act.

The reformed TSCA requires that EPA evaluate existing chemicals to determine whether they “present an unreasonable risk of injury to health or the environment.” The list’s publication in the Federal Register will trigger the three-year statutory deadline for completing the risk evaluations. In the next six months, EPA must release a scoping document for each chemical. The remaining 80 Work Plan chemicals will also be reviewed, as the law requires EPA to begin a new evaluation for every completed evaluation, with half of all EPA-initiated evaluations drawing from the Work Plan list until it is exhausted. In addition, EPA must have at least 20 chemical risk evaluations ongoing by the end of 2019.

Environmental groups mostly praised the decision to prioritize asbestos, a fire-resistant material that causes mesothelioma cancer which outgoing Senator Barbara Boxer (D-CA) called “the poster child for TSCA reform.” However, Earthjustice criticized EPA’s failure to include lead, citing children’s exposure to the neurotoxin via “ongoing, unnecessary uses of lead in consumer products.”

In a statement, the American Chemistry Council emphasized that a chemical’s inclusion in the list was only the first step in a process based on high quality data and the weight of scientific evidence. The industry group also said “it is imperative that EPA engage stakeholders early and often throughout the risk evaluation process, including through peer review and public comment.”

Flurry of Lautenberg Act rulemaking actions begin.

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A series of rulemaking actions have begun to implement the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which recently modernized the Toxic Substances Control Act (TSCA). Last week, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), received two key proposed rules from the U.S. Environmental Protection Agency (EPA). The proposed rules, which are not yet publicly available, establish the process for prioritization and risk evaluation under the Lautenberg Act changes to TSCA’s framework. The prioritization process rule will establish procedures and criteria for designating chemicals as either “high priority” or “low priority.” The risk evaluation rule sets out the process for evaluating risks in “high priority” chemicals.

According to EPA’s First Year Implementation Plan, the agency’s goal is to publish these proposed rules in mid-December. Finalization of both rules is required by mid-June 2017, the deadline set by the law. The Plan also set mid-December 2016 as a milestone for publishing proposed rules for inventory reporting and fees. In addition, the Lautenberg Act requires the agency to release the list of ten Work Plan chemicals chosen for initial risk evaluations by the same time.

EPA names five PBT chemicals for expedited action.

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Yesterday, the U.S. Environmental Protection Agency (EPA) announced that five chemicals will be subject to expedited action under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which overhauls the Toxic Substances Control Act (TSCA). The affected chemicals and their uses, as described by EPA, are:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
  • Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
  • Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
  • Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
  • 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.

Last month, we wrote that as required by the Lautenberg Act, EPA would fast-track the regulation of certain persistent, bioaccumulative, and toxic (PBT) chemicals unless manufacturers nominated them for risk evaluation by September 19. Two of the seven PBT chemicals, which are used in fragrance mixtures, Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl) and Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl), were nominated for risk assessment.

Under the Lautenberg Act, EPA must skip conducting risk assessments for these five chemicals and take expedited action to reduce exposure to the extent practicable. The agency will first determine “where these chemicals are used and how people are exposed to them” before proposing limitations on use. According to agency guidance, EPA may restrict the chemicals in one or more of the following ways:

  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce.
  • Prohibit or otherwise restrict manufacturing, processing, or distribution in commerce for particular uses or for uses in excess of a specified concentration.
  • Require minimum warning labels and instructions.
  • Require record keeping or testing.
  • Prohibit or regulate any manner or method of commercial use or disposal.
  • Direct manufacturers and processors to notify distributors and the public and replace or repurchase chemicals substances or mixtures.

EPA must propose expedited actions for these chemicals by June 22, 2019, and final rules must be issued within the following 18 months.

EPA to Extend CDR Submission Deadline by One Month

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EPA is amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2016 reports from September 30, 2016 to October 31, 2016. This is a one-time extension for the 2016 submission period only, and will be reported in the Federal Register. The deadline is being extended in response to comments from the regulated community that raised concerns about the ability to make timely reports due to issues with the electronic filing system — EPA’s Central Data Exchange system.

The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory to report current data on the manufacturing, processing, and use of the chemical substances. For the 2016 submission period, a company must report under CDR if, at one or more U.S. sites, it manufactured or imported at least 25,000 pounds of a reportable chemical substance during any year between 2012 and 2015. For some substances, which are subject to certain other TSCA restrictions or requirements, the reporting threshold is 2,500 pounds per year per site.

Expedited action chemicals: EPA posts guidance on requesting risk evaluation.

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Seven chemicals will be subject to the expedited action provision of the amended Toxic Substances Control Act (TSCA) unless manufacturers nominate them for risk evaluation by September 19. However, the scope of the risk evaluation will not be limited even if the manufacturer requests evaluation of only certain uses.

EPA recently posted online guidance interpreting the expedited action provision, which was added by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. EPA must propose rules by June 22, 2019 to restrict or regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals identified in the 2014 update to the TSCA Work Plan. The chemicals subject to expedited action are:

  • Decabromodiphenyl ethers (DecaBDE) (CASRN 1163-19-5)
  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl)- (CASRN 54464-59-4)
  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl)- (CASRN 54464-57-2)
  • Hexachlorobutadiene (CASRN 87-68-3)
  • Pentachlorothio-phenol (CASRN 133-49-3)
  • Phenol, isopropylated, phosphate (3:1) (iPTPP) (CASRN 68937-41-7)
  • 2,4,6-Tris(-tert-butyl)phenol (CASRN 732-26-3)

Under this provision, EPA is not required to conduct a risk assessment and may impose one or more of a variety of restrictions so that the chemical no longer presents an unreasonable risk of injury to health or the environment. The agency may levy prohibitions or restrictions on manufacturing, processing, or distribution for a certain use or in excess of a certain concentration. EPA is also authorized to set requirements for record-keeping, testing, or marking substances with warnings. These expedited actions must “address the risks of injury to health or the environment …presented by the chemical substance” and “reduce exposure to the substance to the extent practicable.”

The new guidance also provides instructions on how manufacturers should submit their requests for a risk evaluation, including new requirements for making claims for Confidential Business Information (CBI).

Manufacturers requesting risk revaluations will be required to pay a fee, which will be set by a rule which EPA expects to finalize by June 22, 2017. The guidance notes that risk evaluation requests may not be withdrawn and will be considered “a firm commitment …to pay for the risk evaluation.”

In addition to requesting a risk evaluation, a chemical may also be removed from expedited action eligibility if EPA designates it as a high-priority substance for risk evaluation. In either case, any subsequent regulation of the chemical must “reduce exposure to the substance to the extent practicable.”

Science advisors urge EPA to complete 1-BP risk assessment.

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The Chemical Safety Advisory Committee is urging the Environmental Protection Agency (EPA) to complete and publish its risk assessment of 1-bromopropane without delay, due to “the high risks of adverse effects” in occupational and consumer use scenarios that have already been evaluated. In meeting minutes [PDF] submitted to EPA last week, some Committee members commented that these risks might have been under-estimated. The chemical, also known as 1-BP, is used in spray adhesives, dry cleaning, and degreasing, and was among the chemicals identified in the 2012 Toxic Substances Control Act (TSCA) Work Plan.

The Committee, an independent panel of scientific advisors comprised of experts in toxicology, environmental risk assessment, exposure assessment and related fields, met in May to review the scientific and technical merit of EPA’s draft risk assessment for 1-BP, which was released in March 2016.

Overall, the Committee praised the draft risk assessment, concluding that “the conceptual model appropriately considers worker exposures and consumer uses, with the majority of exposure occurring via inhalation.” The Committee stressed the importance of including consumer uses with acute exposures, and several members called for better consideration of exposure from co-residence and community-level exposures near dry-cleaning facilities. The Committee provided recommendations “intended to improve the clarity and transparency of the scientific analyses,” including the adoption of systematic review processes to clarify how studies were selected and evaluated. Other recommendations include ways to refine occupational and consumer exposure assessments.

Under the new requirements of the Lautenberg Act, EPA must identify 10 Work Plan chemicals for risk evaluations to be initiated by December 2016. EPA will revamp the prioritization process for risk evaluations in 2017 and 2018, using new criteria to be established, through rule-making, by mid-June 2017.