By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on February 11, 2021, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to a Small Business Advocacy Review (SBAR) Panel for asbestos, part 1: chrysotile asbestos. The Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for asbestos, part 1: chrysotile asbestos. As reported in our January 4, 2021, memorandum, of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories. EPA found no unreasonable risk to the environment. EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluation.
According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities. The SBAR Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The SBAR Panel will select SERs to provide comments on behalf of their company, community, or organization and advise the Panel on the potential impacts of the proposed rule on small entities. EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rule’s requirements. EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations may be submitted online and must be received by February 25, 2021.
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.” EPA notes that there will also be an open public comment period on any draft risk management regulation.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a webinar on February 3, 2021, “to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for Asbestos Part 1: Chrysotile Asbestos.” EPA states that the webinar will also give the public an opportunity to provide input on considerations the agency should take into account for managing these unreasonable risks. Stakeholders who wish to provide oral comments must register by 5:00 p.m. (EST) on January 29, 2021, and those who will only listen may register up to the end of the meeting. EPA will provide a transcript and recording on EPA’s Asbestos Part 1: Chrysotile Asbestos web page following the webinar. According to EPA’s January 19, 2021, announcement, EPA will begin formal consultations with state and local governments, tribes, environmental justice communities, and small businesses. There will also be an open public comment period on any draft risk management regulation. More information on EPA’s final risk evaluation is available in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for Asbestos, Part 1: Chrysotile Asbestos.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2020, that the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) will meet from June 8 to 11, 2020, to peer review the draft risk evaluation for asbestos. The public meeting will be virtual, with participation by phone and webcast only. There will be no in-person gathering for this meeting. EPA postponed the previously announced virtual meeting for SACC to review the draft risk evaluation for asbestos due to changes in the availability of members for the peer review. Stakeholders must register online to receive the webcast meeting link and audio teleconference information for participation in this meeting. Stakeholders may register and participate as listen-only attendees at any time up to the end of the meeting. Requests to make brief oral comments to SACC during the virtual meeting should be submitted when registering online on or before noon (12:00 p.m. EDT) on June 2, 2020.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) has postponed the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) peer review virtual meeting scheduled for April 27-30, 2020, due to recent changes in the availability of SACC members for the review. EPA states that given the importance of the draft risk evaluation for asbestos, it believes that “rescheduling for a time when more members are available is critical and will allow for a more robust review of the evaluation.” As a result, EPA will reschedule the SACC meeting “as soon as practicable.” EPA notes that while it does not anticipate extending the written public comment period on the draft risk evaluation past June 2, 2020, “as needs arise EPA will review and respond appropriately.” EPA will provide all written comments received by June 2, 2020, to SACC for their review prior to the meeting. Once EPA has selected a new date for the SACC meeting, EPA will provide an update on public commenting, including registering to provide oral public comments during the SACC meeting. EPA states that it “remains committed to completing this process as expeditiously as possible.” More information on EPA’s draft risk evaluation is available in our April 1, 2020, memorandum, “EPA Publishes Draft Risk Evaluation of Asbestos, Will Hold Virtual Peer Review Meeting.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published the draft risk evaluation of asbestos on March 30, 2020. EPA reviewed a suite of potential asbestos exposures and made the following initial determinations on risk:
- EPA did not find risk to the environment. For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment under any of the conditions of use.
- EPA’s draft risk evaluation preliminarily found unreasonable risk to workers, occupational non-users, consumers, and bystanders. EPA found that workers, occupational non-users, consumers, and bystanders could be adversely affected by asbestos under certain conditions of use.
EPA states that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not final determinations on whether asbestos presents unreasonable risks under the conditions of use. EPA will use feedback received from the public comment and peer review processes to inform the final risk determinations.
By Lynn L. Bergeson and Carla N. Hutton
On June 28, 2019, a coalition of 11 state attorneys general filed a lawsuit in the U.S. District Court for the Northern District of California against the U.S. Environmental Protection Agency (EPA) for its failure to initiate an asbestos reporting rule under Section 8(a) of the Toxic Substances Control Act (TSCA). The complaint argues that EPA wrongfully denied the states’ January 31, 2019, petition, filed under TSCA Section 21, to issue a rule for the reporting of the manufacture, import, and processing of asbestos. More information on the petition is available in our February 1, 2019, blog item, and more information on EPA’s denial is available in our January 4, 2019, blog item.
According to the coalition, the rulemaking they requested is necessary under TSCA, and the denial of their petition was arbitrary and capricious and violates EPA’s obligations under TSCA. The coalition asks the court to compel EPA to initiate a rulemaking and issue a new asbestos reporting rule to:
- Eliminate “naturally occurring substance” as an exemption for asbestos reporting;
- Require processors of asbestos, as well as manufacturers, including importers, of the chemical substance to adhere to reporting requirements;
- Ensure that the impurities exemption in the Chemical Data Reporting (CDR) rule does not apply to asbestos; and
- Require reporting with respect to imported articles that contain asbestos.
The coalition includes the Attorneys General of California, Connecticut, Hawaii, Maine, Maryland, Massachusetts, Minnesota, New Jersey, Oregon, Washington, and the District of Columbia.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham
On January 31, 2019, the U.S. Environmental Protection Agency (EPA) was petitioned by the Attorneys General of 14 states (Massachusetts, Pennsylvania, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Rhode Island, Vermont, and Washington) and the District of Columbia under Toxic Substances Control Act (TSCA) Section 21(a) to issue an asbestos reporting rule to require reporting under TSCA Section 8(a) of information necessary for EPA to administer TSCA as to the manufacture (including importation), processing, distribution in commerce, use, and disposal of asbestos. Specifically, the petition states that the Attorneys General are petitioning EPA’s Administrator to:
- [I]nitiate a rulemaking and issue a new asbestos reporting rule to: (i) eliminate any applicability of the “naturally occurring substance” (NOCS) exemption in the [Chemical Data Reporting (CDR)] for asbestos reporting; (ii) apply the CDR reporting requirements to processors of asbestos, as well as manufacturers, including importers, of the chemical substance; (iii) ensure that the impurities exemption in the CDR does not apply to asbestos; and (iv) require reporting with respect to imported articles that contain asbestos.
In support of their requests in the petition, the Attorneys General state the following:
- NOCS Exemption: “The identified uses of imported raw asbestos represent pathways of exposure that present risks to health and the environment that EPA must consider in conducting its risk evaluation and regulating asbestos, and accordingly EPA should promulgate an asbestos reporting rule to require reporting of such information. Moreover, the required asbestos reporting must capture information with respect to the quantities imported, and these potential exposure pathways so this information can be made available to inform the states’ and the public’s knowledge regarding asbestos exposure risks.”
- Reporting from Processors: “[T]o enable EPA to carry out its responsibility to impose requirements on processors to eliminate unreasonable risks of injury to health or the environment arising from exposures to asbestos, EPA must promulgate new regulations to apply the reporting requirements of the CDR to processors of asbestos notwithstanding that the current CDR does not expressly require such reporting. Should EPA fail to do so, EPA would be violating TSCA, acting arbitrarily and capriciously, and abusing its discretion in implementing TSCA.”
- Exemptions for “Impurities” and “Articles”: “[W]hile the CDR exempts reporting with respect to ‘impurities’ and for chemical substances imported as ‘part of an article,’ neither of these exceptions should be applied to reporting with respect to the presence of asbestos if EPA is to satisfy TSCA’s mandate to prevent unreasonable risks associated with exposures to this highly toxic chemical.”
- Reporting for Asbestos: “EPA must account for the many tons of asbestos that are imported into the U.S., whether as a raw material or processed, to evaluate adequately the current and likely future risks of exposure to asbestos, and must also account for asbestos in consumer products, whether or not the asbestos is intentionally included in those products. These data … are needed for EPA to be able to make informed technically complex decisions regarding the regulation of asbestos. Without these data to rely on, the agency will be unable to meet its obligations under TSCA to make its decisions based on the weight of the scientific evidence and using the best available science …. Accordingly, EPA must issue an asbestos reporting rule to ensure that the NOCS, the impurities, and the articles exemptions do not apply to asbestos, and that processors of asbestos are required to report.”
The petition cites EPA’s denial of a petition submitted by a group of non-governmental organizations (NGO) seeking similar action that the Attorneys General are requesting, but does not address the many reasons that EPA denied the first petition. Why the Attorneys General would follow up EPA’s well-reasoned denial with a petition of their own with very similar requests and only marginal additional facts, is unclear. More information on the NGO petition is available in our blog item "EPA Denies Section 21 Petition Seeking Increased Asbestos Reporting."
By Lynn L. Bergeson, Carla N. Hutton, and Margaret R. Graham
On December 21, 2018, the U.S. Environmental Protection Agency’s (EPA) Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) Nancy B. Beck, Ph.D., signed a Federal Register document denying a Toxic Substances Control Act (TSCA) Section 21 petition requesting that EPA amend the Chemical Data Reporting (CDR) rule to increase asbestos reporting, exclude asbestos from certain exemptions, and lift Confidential Business Information (CBI) claims on asbestos information reported under the CDR rule. Due to the government shutdown, the notice has not yet been published in the Federal Register, but EPA has posted a prepublication version. EPA’s carefully reasoned response to the request is set forth in the notice.
The petition was filed on September 27, 2018, by the Asbestos Disease Awareness Organization, American Public Health Association, Center for Environmental Health, Environmental Working Group, Environmental Health Strategy Center, and Safer Chemicals, Healthy Families (Petitioners). According to EPA, Petitioners requested the following specific amendments to the existing CDR rule to collect information for the ongoing asbestos risk evaluation being conducted under TSCA Section 6(b) (required to be completed by December 22, 2019), and, if necessary, any subsequent risk management decisions under TSCA Section 6(a):
- Amend the CDR rule to require immediate submission, “from January 1, 2019, to April , 2019,” of reports on asbestos for the 2016 reporting cycle.
- Amend the naturally occurring chemical substance exemption at 40 C.F.R. § 711.6(a)(3) to make the exemption inapplicable to asbestos;
- Amend the articles exemption at 40 C.F.R. § 711.10(b) to require reporting pursuant to the CDR rule for all imported articles in which asbestos is present at detectable levels;
- Amend the CDR rule to exclude asbestos from the exemption at 40 C.F.R. § 711.10(c) to require the reporting of asbestos as a byproduct or impurity;
- Amend the reporting threshold for CDR at 40 C.F.R. § 711.8(b) to set a reporting threshold of ten pounds for asbestos; and
- Amend 40 C.F.R. § 711.8 to add processors of asbestos and asbestos-containing articles as persons required to report under the CDR rule.
In addition to the above requests, Petitioners also requested that EPA use its authority under TSCA Sections 14(d)(3) and 14(d)(7) to lift CBI claims on asbestos information reported under the CDR rule. EPA responds in detail as to why it is denying each of these requests. A short summary is below.
- 2016 Reporting Cycle: EPA states that based on the extensive research and data gathering already conducted during the asbestos risk evaluation process, EPA believes that “the requested amendments to the CDR rule would not lead to the reporting of new information that would contribute to EPA’s ongoing asbestos risk evaluation or, if needed, subsequent risk management decision(s)” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require immediate past reporting of the manufacturing and use of asbestos under the CDR rule for the 2016 reporting cycle.”
- Naturally Occurring Substances Exemption: EPA states that removing the exemption for reporting on naturally occurring substances for asbestos would not provide any additional data to EPA “given that the purpose of domestic manufacturing or importing of raw asbestos is to make asbestos diaphragms, for which EPA already has use and exposure information” and Petitioners have “failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the naturally occurring chemical substances exemption for asbestos under the CDR rule.”
- Articles Exemption: EPA states that it believes that lifting the articles exemption for the reporting of asbestos under the CDR rule “would not provide any new use information that would inform the ongoing risk evaluation or any subsequent risk management decisions, if needed” and that Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the articles exemption for asbestos under the CDR rule.”
- Reporting as a Byproduct or Impurity: EPA states that it does not believe that making the requested amendment to the CDR rule would result in “reporting of asbestos as an impurity or a byproduct, for uses that are known or reasonably ascertainable,” that Petitioners “have not provided evidence that there are such known uses that are ongoing but remain outside the scope of the asbestos risk evaluation,” and “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to lift the byproducts and impurities exemptions for asbestos under the CDR rule.”
- Reporting Threshold of Ten Pounds: EPA states that Petitioners “fail to show that lowering the reporting threshold would provide any new information to EPA” and, therefore, finds that the Petitioners “have failed to set sufficient facts to establish that it is necessary to issue the requested amendment to lower the CDR reporting threshold for asbestos.”
- Adding Processors to CDR: EPA states that it does not believe that “requiring processors of asbestos under the CDR rule will provide useful information not already in its possession,” Petitioners “have failed to indicate what additional information EPA would collect by requiring asbestos processors to report under the CDR rule” and, therefore, EPA finds that the Petitioners “have failed to set forth sufficient facts to establish that it is necessary to issue the requested amendment to require processors of asbestos to report under the CDR rule.”
- Lifting CBI Claims: EPA states that Petitioners’ request to lift CBI claims on asbestos information reported under the CDR rule is "not appropriate for a TSCA Section 21 petition, as a TSCA Section 21 only pertains to the “issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4 or 5(e) or (f),” therefore, a TSCA Section 21 petition “is not a vehicle to petition EPA to initiate an action under TSCA section 14.” Further, EPA states that it believes that “disclosure of CBI would have no practical relevance to the risk evaluation or risk determination as the CBI claims are limited and EPA retains the ability to characterize the information without revealing the actual protected data.”
Please look for the full analysis in our upcoming memorandum that will be posted on our Regulatory Developments page.
By Lynn L. Bergeson and Carla N. Hutton
On August 29, 2018, the Democrats on the House Committee on Energy and Commerce issued a press release announcing that they have renewed their request for a hearing on the U.S. Environmental Protection Agency’s (EPA) implementation of the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act to the Toxic Substances Control Act (TSCA). The Democrats note this is the fourth request they have made for hearings to be held on EPA’s management of toxic chemicals. According to the press release, the Democrats “remain concerned that EPA’s implementation of the reformed TSCA program contradicts the new law’s language and intent and undermines public confidence in the program.” The press release states that the Democrats “are concerned that EPA is ignoring its own scientific evidence and the recommendations of its experienced career staff regarding TSCA implementation at the expense of public health. They point to a recent report from the New York Times that found EPA officials proposed a rulemaking to review applications for use of asbestos in consumer products over the objections of EPA attorneys and scientists.” The Democrats “also charge that EPA has abandoned its statutory mandate to review all new and existing chemicals known or foreseeable uses and exposure putting human health and the environment at risk,” possibly resulting in an incomplete evaluation of the health and environmental risk of a number of “extremely toxic chemicals, including asbestos, perchloroethylene (PERC), methylene chloride, and trichloroethylene (TCE).” The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Environment Subcommittee Ranking Member Paul Tonko (D-NY), Raul Ruiz (D-CA), Scott Peters (D-CA), Gene Green (D-TX), Diana DeGette (D-CO), Jerry McNerney (D-CA), Tony Cardenas (D-CA), Debbie Dingell (D-MI), and Doris Matsui (D-CA).
By Lynn L. Bergeson and Margaret R. Graham
On June 1, 2018, the U.S. Environmental Protection Agency (EPA) released the much anticipated first ten problem formulation documents; its systematic review approach document; and a significant new use rule (SNUR) proposal enabling it to prevent new uses of asbestos for public comment. Links and short summaries are provided below.
EPA states that the problem formulation documents refine the conditions of use, exposures, and hazards presented in the scope of the risk evaluations for the first ten chemicals to be evaluated under the Toxic Substances Control Act (TSCA) and present refined conceptual models and analysis plans that describe how EPA expects to evaluate the risks and that they are an important interim step prior to completing and publishing the final risk evaluations by December 2019. Comments on the problem formulation documents will be due 45 days after these documents are published in the Federal Register. The problem formulation documents are:
- 1-Bromopropane (1-BP);
- Carbon Tetrachloride;
- Cyclic Aliphatic Bromide Cluster (HBCD Cluster);
- Methylene Chloride;
- N-Methylpyrrolidone (NMP);
- Pigment Violet 29; and
- Trichloroethylene (TCE).
EPA states the systematic review approach document will guide its selection and review of studies in addition to providing the public with continued transparency regarding how the Agency plans to evaluate scientific information. Comments will be due 45 days after publication in the Federal Register. Also included on the systematic review web page is EPA’s Response to Public Comments Related to the Supplemental Files Supporting the TSCA Scope Documents for the First Ten Risk Evaluations.
For asbestos, EPA is proposing an asbestos SNUR for certain uses of asbestos (including asbestos-containing goods) that would require manufacturers and importers to receive EPA approval before starting or resuming manufacturing, and importing or processing of asbestos. EPA states that this review process, the first such action on asbestos ever proposed, would provide EPA with the opportunity to evaluate the intended use of asbestos and, when necessary, take action to prohibit or limit the use. Comments will be due 60 days after publication in the Federal Register.
More information on the first ten chemical evaluations is available on our blog. A more detailed analysis will be available next week on our regulatory developments webpage.