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By Lynn L. Bergeson and Carla N. Hutton
 
On Wednesday, November 13, 2019, at 3:00 p.m. (EST), the U.S. Environmental Protection Agency (EPA) will hold a webinar on the Green Chemistry Challenge Awards Program.  Participants will learn more about applying for the 2020 Green Chemistry Challenge Awards.  The webinar presentation will cover award eligibility, the application process, and evaluation criteria.  There will also be time for questions from the webinar participants.
 
As reported in our September 20, 2019, blog item, EPA is now accepting nominations for the 2020 Green Chemistry Challenge Awards for companies or institutions that have developed a new process or product that helps protect public health and the environment.  EPA defines green chemistry as the design of chemical products and processes that reduce both the generation and use of chemicals that are hazardous to the environment and people’s health.  Nominations for innovative technologies featuring the design of greener chemicals and products, greener chemical syntheses and reactions, or greener chemical processes are due to EPA by December 31, 2019.  EPA anticipates giving awards to outstanding green chemistry technologies in five categories in June 2020


 

By Lynn L. Bergeson and Carla N. Hutton

On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 60363.  EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for certain CBI claims.  Specifically, EPA is proposing two additional questions that manufacturers and processors would be required to answer to substantiate certain CBI claims for specific chemical identities and is proposing procedures for manufacturers and processors to use in amending certain previously submitted substantiations to include responses to the additional questions.  Comments on the supplemental notice are due December 9, 2019.

EPA notes that these proposed revisions supplement the proposed rule issued in the April 23, 2019, Federal Register and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated on August 11, 2017.  More information on the proposed rule is available in our April 11, 2019, memorandum, “EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory,” and more information on the final rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”


 

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 13, 2019, at 10:00 a.m. (EST), the House Committee on Science, Space, and Technology will hold a hearing on “Strengthening Transparency or Silencing Science?  The Future of Science in EPA Rulemaking.”  The Committee will hear from the following witnesses:
 
Panel 1

  • Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant Administrator for Science, U.S. Environmental Protection Agency (EPA) Office of Research and Development (ORD); EPA Science Advisor.

Panel 2

  • Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-2019;
     
  • Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard Medical School; Pulmonary and Critical Care Physician, Beth Israel Deaconess Medical Center;
     
  • Dr. David Allison, Dean, School of Public Health, Indiana University-Bloomington; Member, “Reproducibility and Replicability in Science” Committee, The National Academies of Sciences, Engineering, and Medicine; and
     
  • Dr. Todd Sherer, Chief Executive Officer (CEO), The Michael J. Fox Foundation for Parkinson’s Research.

 

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 Carla N. Hutton
 
On October 30, 2019, the U.S. Environmental Protection Agency (EPA) announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims.  According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims.  EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision.
 
EPA notes that the supplemental notice is limited in scope and that “[‌i]t impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.”  Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.

Tags: CBI, Inventory,

 

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

The U.S. Environmental Protection Agency (EPA) announced on October 23, 2019, that it settled with Miles Chemical Company Inc. for failing to report timely chemical substances it imported.  Under the settlement, the company will pay a $45,000 penalty.  According to EPA, between 2012 and 2015, Miles Chemical Company failed to submit timely forms to EPA documenting the import of large quantities of two chemicals.  EPA notes that under the Toxic Substances Control Act (TSCA), chemical importers and manufacturers are required to submit Chemical Data Reporting (CDR) information to EPA every four years.  This reporting allows EPA to track the chemicals being imported, assess potential human health and environmental effects of these chemicals, and make the non-confidential business information it receives available to the public.  EPA notes that chemical substances listed on the TSCA Inventory that are manufactured or imported at volumes of 25,000 pounds or greater must be reported to EPA, as required by TSCA’s CDR rule.

Tags: CDR,

 

By Lynn L. Bergeson and Carla N. Hutton

On October 17, 2019, the House Committee on Science, Space, and Technology unanimously approved the Sustainable Chemistry Research and Development Act (H.R. 2051), a companion bill to legislation introduced in the Senate by Senators Chris Coons (D-DE), Susan Collins (R-ME), Amy Klobuchar (D-MN), and Shelley Moore Capito (R-WV).  Representative Dan Lipinski (D-IL) introduced the House bill on April 3, 2019.  It is co-sponsored by Representative John Moolenaar (R-MI).  The bill is intended to improve coordination of federal activities, including research and development of more sustainable chemicals, processes, and systems by establishing a coordinating entity under the National Science and Technology Council within the Office of Science and Technology Policy.  The legislation would allow the agencies involved in this entity to work, in consultation with qualified stakeholders, to assess the state of sustainable chemistry in the United States and encourage the validation of tools for assessment of sustainable chemistry processes or products.  The agencies would include the U.S. Environmental Protection Agency, the National Institute of Standards and Technology, the National Science Foundation, the Department of Energy, the Department of Agriculture, the Department of Defense, the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and other related federal agencies, as appropriate.  The bill also supports improved education and training in sustainable chemistry.


 
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