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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 16, 2020, that it is inviting small businesses, governments, and not-for-profits to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.  There will be one Panel for methylene chloride and one Panel for 1-bromopropane (1-BP).  According to EPA, each Panel will focus on EPA’s development of proposed rules to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  As reported in our June 25, 2020, memorandum, and August 11, 2020, memorandum, EPA’s final risk evaluations showed unreasonable risks to workers and consumers under certain conditions of use.  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 evaluations.
 
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 Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels 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 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 for the methylene chloride and 1-BP SBAR Panels and must be received by September 30, 2020.
 
EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes one-on-one meetings with stakeholders and 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 regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) posted a September 2, 2020, blog item by Alexandra Dapolito Dunn, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, entitled “Advancing Chemical Safety by Listening to You.”  Dunn describes how EPA will move from risk evaluation to risk management.  As reported in our September 9, 2020, blog item, EPA will hold webinars on September 16 and September 30, 2020, on its final risk evaluations for methylene chloride and 1-bromopropane, as well as one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  Dunn states that EPA will use these opportunities “to educate the public and our stakeholders on what we found in our final risk evaluations, the risk management process required by TSCA, which options are available to us for managing unreasonable risk, and what that means for all of you moving forward.”  EPA will also seek input on potential risk management approaches, their effectiveness, and any impacts those approaches might have on businesses.  According to Dunn, EPA will use this feedback to develop proposed regulations “that are both protective and practical.”  Dunn notes that there are several actions EPA can take to address the unreasonable risks it has found, “including banning or phasing out certain uses of a chemical, requiring warning labels and other special instructions on how a chemical can be used, recordkeeping/testing, and requiring manufacturers to notify distributors of any unreasonable risks.”  Dunn encourages stakeholders to take advantage of these engagement opportunities.  EPA is “relying on you to ask questions, raise concerns, bring things to our attention that we may not have considered, and to provide us with information we may not already have.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 8, 2020, a “broad public engagement and outreach effort” to discuss how EPA will approach the rulemaking process to address unreasonable risks found in final Toxic Substances Control Act (TSCA) chemical risk evaluations.  After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA states that it “is moving into the risk management phase and is hosting a robust process to gain important feedback from stakeholders on the options for managing those risks.”  EPA will hold two public webinars to kick off this outreach effort:

  • The first webinar, scheduled for September 16, 2020, will feature a discussion of the findings from the final risk evaluation for methylene chloride.  More information on EPA’s final risk evaluation is available in our June 25, 2020, memorandum; and
  • The second webinar, scheduled for September 30, 2020, will include a discussion of the findings from the final risk evaluation for 1-bromopropane.  More information on EPA’s final risk evaluation is available in our August 11, 2020, memorandum.

According to EPA, each webinar will provide an overview of the TSCA risk management process and the tools available to manage the unreasonable risks.
 
EPA intends to schedule additional public webinars as it begins the risk management process for chemicals with unreasonable risks.  EPA states that it will also begin one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses.  EPA notes that there will be an open public comment period on any draft risk management regulation.
 
According to EPA, there are several actions it can take under TSCA to address unreasonable risks, including banning a chemical; restricting the manufacturing, processing, distribution, or use; requiring warning labels/testing; and requiring manufacturers to notify distributors of any unreasonable risks. EPA has up to one year after issuing a final risk evaluation to propose and take public comments on any risk management actions.


 

By Lynn L. Bergeson and Carla N. Hutton

On July 16, 2020, a coalition of non-governmental organizations (NGO) filed a petition in the U.S. Court of Appeals for the Ninth Circuit, challenging the U.S. Environmental Protection Agency’s (EPA) final risk evaluation for methylene chloride.  The NGOs seek review of EPA’s determination “that the chemical methylene chloride does not present an unreasonable risk of injury to health or the environment under certain conditions of use” and its decision not to consider “certain uses and pathways through which members of Petitioners are exposed and face risks of exposure to methylene chloride.”  The coalition includes the Neighbors for Environmental Justice; the New Jersey Work Environment Council; Sierra Club; the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO; and the Natural Resources Defense Council.  According to Earthjustice’s July 16, 2020, press release, the NGOs “represent workers who manufacture and use methylene chloride and communities that are exposed to methylene chlorid[]e from their air and water.”

As reported in our June 25, 2020, memorandum, “Final Risk Evaluation for Methylene Chloride Is First Completed under Lautenberg Act Amendments,” after evaluating 53 conditions of use of methylene chloride, EPA determined that 47 conditions of use present an unreasonable risk of injury to health, while six do not present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under any conditions of use.  Release of a final risk evaluation is the last step in the Toxic Substances Control Act (TSCA) Section 6(b) process and will guide EPA’s efforts in applying Section 6(a) to reduce human exposure to methylene chloride “so that the chemical . . . no longer presents such risk.”  EPA “will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.”  EPA could prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of methylene chloride.  Any regulatory action will include opportunities for public comment.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on June 24, 2020, announcing the availability of the final Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride.  85 Fed. Reg. 37942.  This is the first risk evaluation that EPA has completed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA.  After evaluating 53 conditions of use of methylene chloride, EPA determined that six conditions of use do not present an unreasonable risk of injury to health, while 47 present an unreasonable risk.  EPA also determined that methylene chloride does not present an unreasonable risk to the environment under the conditions of use.  In its June 19, 2020, press release, EPA notes that the next step in the process required by TSCA is addressing the identified risks.  According to EPA, there are several actions it could take to address these risks, including regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical substance, as applicable.  EPA will now begin the process of developing ways to address the unreasonable risks identified and has up to one year to propose and take public comments on any risk management actions.  EPA states that as with any chemical product, it “strongly recommends that users continue to carefully follow all instructions on the product’s label/safety data sheet.”  As reported in our November 22, 2019, blog item, EPA’s March 27, 2019, final regulation prohibited the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use after November 22, 2019.  More information on the final risk evaluation for methylene chloride will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019.  Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for consumer use, including e-commerce sales.  EPA states that it “is encouraging all consumers to stop using methylene chloride products that they may have already purchased for paint and coating removal.”  EPA also reminds all retailers that sales of these products to consumers are prohibited by EPA regulations under the authority of Section 6 of the Toxic Substances Control Act (TSCA).  EPA promulgated the final regulation on methylene chloride for consumer paint and coating removal use on March 27, 2019, and the prohibition related to manufacturing, processing and distribution of methylene chloride for consumer paint and coating removal use is now in effect.  According to EPA, “[a] variety of effective, less harmful substitutes are readily available for paint removal.”  EPA notes that it “is continuing to work through the process outlined in TSCA to review the risks associated with other uses of methylene chloride.  This process is designed to thoroughly evaluate available science before taking action to manage the risk associated with the other uses of the chemical.”

More information on EPA’s actions concerning methylene chloride are available in the following memoranda:


 

By Lynn L. Bergeson and Carla N. Hutton
 
On October 29, 2019, the U.S. Environmental Protection Agency published a Federal Register notice announcing the availability of the draft Toxic Substances Control Act (TSCA) risk evaluation for methylene chloride (MC).  84 Fed. Reg. 57866.  As reported in our October 26, 2019, blog item, EPA is submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review.  SACC will convene an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed on or before November 12, 2019, to receive the webcast meeting link and audio teleconference information.  Written comments for the preparatory virtual meeting and requests for time to present oral comments are due by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Comments on the draft risk evaluation are due December 30, 2019.
 
The draft risk evaluation states that EPA’s initial determinations of unreasonable risk for the specific conditions of use of MC listed below are based on health risks to workers, occupational non-users (ONU), consumers, or bystanders from consumer use.  According to the draft risk evaluation, risks to the general population either were not relevant for these conditions of use or were evaluated and not found to be unreasonable.

  • Unreasonable Risk to Workers:  EPA determined that the conditions of use that presented unreasonable risks included processing MC into a formulation or mixture; all but two industrial and commercial uses; and disposal;
     
  • Unreasonable Risks to ONUs:  For ONUs, EPA determined that the conditions of use that presented unreasonable risks included import of MC, processing MC as a reactant in several industrial sectors, some industrial and commercial uses, and disposal.  EPA determined in some cases that a condition of use presented an unreasonable risk not only to workers but also to ONUs; in other cases, EPA determined that a condition of use presented an unreasonable risk only to one or the other.
     
  • Unreasonable Risk to Consumers:  EPA determined that all but two consumer conditions of use present unreasonable risks.
     
  • Unreasonable Risk to Bystanders (from Consumer Uses):  When EPA determined that a condition of use presented risks to consumers, unreasonable risks were often, but not always, identified for bystanders.

A more detailed summary of the draft risk evaluation and commentary will be available in our forthcoming memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency will publish a Federal Register notice on October 29, 2019, announcing the availability of and soliciting public comment on the draft Toxic Substances Control Act (TSCA) risk evaluation of methylene chloride (MC).  EPA states that it is also submitting the same document to the TSCA Science Advisory Committee on Chemicals (SACC) for peer review and that SACC will hold an in-person public meeting to consider and review the draft risk evaluation on December 3-4, 2019.  Preceding the in-person meeting, there will be a preparatory virtual public meeting on November 12, 2019, for SACC to consider the scope and clarity of the draft charge questions for the peer review.  Registration for the preparatory virtual meeting must be completed on or before November 12, 2019, to receive the webcast meeting link and audio teleconference information.  Written comments for the preparatory virtual meeting and requests for time to present oral comments are due by 12:00 p.m. on November 8, 2019.  Written comments on the draft risk evaluation that are submitted to EPA on or before November 26, 2019, will be provided to SACC for review and consideration before the December 3-4, 2019, meeting.  Requests to present oral comments at the in-person meeting are due December 3, 2019.  Publication of the Federal Register notice on October 29, 2019, will begin a 60-day comment period on the draft risk evaluation.  The draft risk evaluation is not yet publicly available and is not expected to be until the notice is published on October 29, 2019, and Docket ID EPA-HQ-OPPT-2019-0437 is created at http://www.regulations.gov.  More information is available in our October 25, 2019, memorandum, “EPA Will Publish Draft Risk Evaluation of Methylene Chloride on October 29.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 4, 2019, the U.S. Environmental Protection Agency (EPA) released new guidance intended to help methylene chloride processors and distributors comply with EPA’s March 2019 rule issued under Section 6(a) of the Toxic Substances Control Act (TSCA) prohibiting the manufacture (including import), processing, or distribution in commerce of methylene chloride for consumer paint and coating removal.  The final rule became effective on May 28, 2019.  Each person who manufactures, processes, or distributes in commerce methylene chloride for any use after August 26, 2019, must comply with the requirements for downstream notification and recordkeeping.  The guidance describes the requirements EPA established to address unreasonable risks from the use of methylene chloride in consumer paint and coating removal.  The guidance also:

  • Defines key terms;
  • Identifies the regulated entities;
  • Describes the required or prohibited activities; and
  • Summarizes the downstream notification and recordkeeping requirements.

EPA notes that the small entities directly regulated by the rule include:

  • Processors (since they formulate paint and coating removers containing methylene chloride);
  • Distributors of methylene chloride;
  • Distributors of paint and coating removers containing methylene chloride; and
  • Retailers.

EPA states that the rule is fully effective on November 22, 2019, when prohibitions on manufacturing (including importing), processing, or distributing methylene chloride for consumer paint and coating removal go into effect.  This ban includes a prohibition on distributing any methylene chloride for paint and coating removal to or by retailers, including e-commerce retailers.  More information on EPA’s final rule is available in our March 20, 2019, memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”


 

By Lynn L. Bergeson and Kathleen M. Roberts
 
In the March 27, 2019, Federal Register, the U.S. Environmental Protection Agency (EPA) issued its final regulatory rulemaking that prohibits the manufacture (including import), processing, and distribution of methylene chloride for consumer paint and coating removal. 84 Fed. Reg. 11420.  See Bergeson & Campbell, P.C.’s memorandum, “EPA Bans Consumer Sales of Methylene Chloride Paint Removers, Seeks Comment on Program for Commercial Uses.”
 
Starting on August 26, 2019, which is 90 days after the effective date of the final rule, a company that manufactures, processes, or distributes in commerce methylene chloride is required to provide notification to downstream users of the consumer use paint remover restrictions via Safety Data Sheets (SDS).  We write to emphasize that this notification requirement applies to all manufacturers, processors, or distributors of methylene chloride and is not limited only to those companies engaged with paint remover products.  The EPA rulemaking provides the following specific text that must be included in the SDS:

  • SDS Section 1.(c):  “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”
     
  • SDS Section 15:  “This chemical/product is not and cannot be distributed in commerce (as defined in TSCA section 3(5)) or processed (as defined in TSCA section 3(13)) for consumer paint or coating removal.”

More information is available in our July 22, 2019, memorandum, “Communication and Recordkeeping Requirements Related to EPA Ban on Consumer Use Paint Removers Containing Methylene Chloride Go in Effect on August 26, 2019.”


 
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