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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.

One 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 perchloroethylene.  As reported in our December 17, 2020, memorandum, of the 61 conditions of use that EPA reviewed for perchloroethylene, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders.  The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.  EPA found no unreasonable risks to the environment.

The second Panel will focus on a risk management rulemaking for n-methylpyrrolidone (NMP).  As reported in our December 29, 2020, memorandum, of the 37 conditions of use that EPA reviewed for NMP, EPA found that 26 present unreasonable risks to workers and consumers.  These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use.  These uses also include an unreasonable risk to consumers from one consumer use.  EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial and commercial and consumer applications.  EPA also determined that NMP does not present an unreasonable risk to the environment and the general population.

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 companies, communities, or organizations and advise the Panels 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 rules’ 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 January 19, 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 regulations.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 18, 2019, that it is extending the public comment period for the draft risk evaluation of N-methylpyrrolidone (NMP) to give stakeholders more time to review and comment on the draft document.  Comments are now due January 21, 2020.  EPA states that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals (SACC), to inform the final risk evaluation for NMP.  If the final risk evaluation for NMP finds there are unreasonable risks under any of the specific conditions of use, EPA will propose actions to address those risks within the timeframe required by the Toxic Substances Control Act (TSCA).  EPA notes that these actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical, as applicable.  EPA will publish a Federal Register notice announcing the comment period extension.  More information on the draft risk evaluation is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 7, 2019, announcing the availability of the draft risk evaluation for N-methylpyrrolidone (NMP) and soliciting public comment.  84 Fed. Reg. 60087.  EPA’s draft risk evaluation findings include:

  • EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment, bystanders, or occupational non-users from NMP.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use.  EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use.

The draft risk evaluation will be peer reviewed by the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on December 5-6, 2019.  EPA will hold a preparatory virtual meeting on November 12, 2019.  Stakeholders must register online 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 on or before 10:00 a.m. (EST) on November 12, 2019.  EPA requests comments on the draft risk evaluation by November 26, 2019, to allow SACC time to review and consider them before the peer review meeting.  EPA states that it will use feedback received from the public comment and peer review processes to inform the final risk determinations.  Comments on the draft risk evaluation are due January 6, 2020.  More information is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 4, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft risk evaluation for N-methylpyrrolidone (NMP), which includes more than 30 uses of NMP in adhesives, sealants, paints and arts and craft paints, paint and coating removers, adhesive removers, and degreasers.  EPA’s draft risk evaluation findings include:

  • EPA did not find risk to the environment, bystanders, or occupational non-users.  For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment, bystanders, or occupational non-users from NMP.
     
  • EPA’s draft risk evaluation preliminarily found unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use.  EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use.

EPA notes that these initial determinations are based on a draft risk evaluation of the reasonably available information and are not EPA’s final determinations on whether NMP presents unreasonable risks under the conditions of use.  EPA will publish a Federal Register notice announcing the availability of the draft risk evaluation and beginning a 60-day comment period.  The draft risk evaluation will be peer reviewed by the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on December 5-6, 2019.  EPA requests comments on the draft risk evaluation by November 26, 2019, to allow SACC time to review and consider them before the peer review meeting.  EPA states that it will use feedback received from the public comment and peer review processes to inform the final risk determinations.  More information will be available in our forthcoming memorandum.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules:  (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping (issued January 19, 2017); and (2) to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N-methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping (issued January 19, 2017).  82 Fed. Reg. 20310.

This is the second extension of the comment period for the proposed rule to ban TCE use in vapor degreasing and the first extension of the comment period for the proposed rule to ban the uses of NMP and methylene chloride for consumer and most types of commercial paint and coating removal.  Comments on both proposed rules are now due on May 19, 2017.