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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on November 3, 2020, that it will hold webinars to consult with environmental justice communities on risk management for methylene chloride and 1-bromopropane (1-BP).  EPA states that the webinars are open to the public and will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final Toxic Substances Control Act (TSCA) risk evaluations for these chemicals.  EPA will hold “identical” consultation webinars on November 16, 2020, and November 19, 2020.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations for methylene chloride and 1-BP, the tools available to manage the unreasonable risks from methylene chloride and 1-BP, and discussion of environmental justice concerns.  In addition to being open to the public, EPA is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.  EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort on risk management that includes one-on-one meetings with stakeholders and formal consultations with small businesses, state and local governments, and tribes.”  EPA notes that there will also be an open public comment period on proposed risk management regulations.


 

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
 
On August 12, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of the final risk evaluation for 1-bromopropane (1-BP).  85 Fed. Reg. 48687.  After evaluating 25 conditions of use, EPA determined that 16 present an unreasonable risk to workers, occupational non-users (ONU), consumers, and bystanders.  For those conditions of use for which EPA has found an unreasonable risk, EPA states that it must take regulatory action to address that unreasonable risk through risk management measures enumerated in the Toxic Substances Control Act (TSCA).  EPA has also determined that specific conditions of use do not present unreasonable risk of injury to health or the environment.  EPA notes that for those conditions of use for which EPA has found no unreasonable risk to health or the environment, its determination is a final agency action and is issued via order in the risk evaluation.  A detailed analysis and commentary is available in our August 11, 2020, memorandum, “EPA Publishes Final Risk Evaluation for 1-BP.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency’s (EPA) Toxic Substances Control Act Science Advisory Committee on Chemicals (TSCA SACC) will peer review EPA’s draft risk evaluation for 1-bromopropane (1-BP) on September 10-12, 2019.  The meeting will be held at the Hyatt Regency Crystal City at Reagan National Airport, 2799 Jefferson Davis Highway, Arlington, Virginia.  As reported in our August 9, 2019, blog item, EPA released the draft risk evaluation for 1-BP on August 9, 2019.  EPA made the following initial determinations on risk:

  • Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use.  EPA notes that these initial determinations are not its final determinations on whether 1-BP presents unreasonable risks under the conditions of use.  EPA states that it will use feedback received from the public and peer review processes to inform the final risk evaluations.
     
  • No unreasonable risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA found no unreasonable risks to the environment from 1-BP.

EPA requests comments on the draft risk evaluation by August 30, 2019, to allow SACC time to review and consider them before the peer review meeting.  Comments received after August 30, 2019, and prior to the end of the oral public comment period during the meeting will still be provided to the SACC for their consideration.  EPA will continue to accept comments on the draft risk evaluations until October 11, 2019.  EPA will consider all comments received on the draft risk evaluations by the October 11, 2019, deadline when developing the final risk evaluation.  More information is available in our August 12, 2019, memorandum, “EPA Draft Risk Evaluation for 1-BP Finds Unreasonable Risks to Workers, Occupational Non-Users, Consumers, and Bystanders under Certain Specific Uses.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on August 9, 2019, the draft risk evaluation for 1-bromopropane (1-BP), the fourth of the first ten chemicals undergoing risk evaluation under the amended Toxic Substances Control Act (TSCA).  EPA made the following initial determinations on risk:

  • Unreasonable risks to workers, occupational non-users, and consumers under certain conditions of use.  EPA notes that these initial determinations are not its final determinations on whether 1-BP presents unreasonable risks under the conditions of use.  EPA states that it will use feedback received from the public and peer review processes to inform the final risk evaluations.
  • No unreasonable risk to the environment.  For all the conditions of use included in the draft risk evaluation, EPA found no unreasonable risks to the environment from 1-BP.

EPA states that these initial determinations may change as its evaluation becomes more refined through the public and peer review process.  The draft risk evaluation, including initial risk determinations as to whether the chemical under the conditions of use presents an unreasonable risk to human health or the environment, is not final.  If unreasonable risk is found for one or more conditions of use in a final risk evaluation, EPA will propose actions to address those risks within the timeframe required by TSCA.

The TSCA Science Advisory Committee on Chemicals (SACC) will peer review the draft risk evaluation at a September 10-12, 2019, meeting.  EPA will hold a preparatory virtual meeting on August 21, 2019, to discuss the scope and clarity of the draft charge questions to SACC.  EPA requests comments on the draft risk evaluation by August 30, 2019, to allow SACC time to review and consider them before the peer review meeting.  Comments received after August 30, 2019, and prior to the end of the oral public comment period during the meeting will still be provided to the SACC for their consideration.  EPA will continue to accept comments on the draft risk evaluations until October 11, 2019.  EPA will consider all comments received on the draft risk evaluations by the October 11, 2019, deadline when developing the final risk evaluation.  More information is available in our August 12, 2019, memorandum, "EPA Draft Risk Evaluation for 1-BP Finds Unreasonable Risks to Workers, Occupational Non-Users, Consumers, and Bystanders under Certain Specific Uses."