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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 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
 
Alexandra Dapolito Dunn, Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) stated on October 11, 2019, that EPA will provide more time for public comment on its draft risk evaluations before the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) meets to peer review the draft documents.  According to Dunn, the new schedule will include a comment period of at least 30 days before SACC meets.  EPA plans to complete ten chemical risk evaluations by June 22, 2020.  To date, EPA has released four draft chemical risk evaluations, and SACC has peer reviewed them.  For the remaining six chemicals, EPA intends to release four of the draft risk evaluations for public comment by the end of 2019 and the other two in January 2020.  SACC will peer review two of the draft risk evaluations in 2019 and the remaining four in 2020.  Dunn stated that EPA will meet the Lautenberg Act’s deadline to release all ten risk evaluations by June 2020.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 30, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the meeting minutes and final report for the June 18-21, 2019, meeting of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for Pigment Violet 29 (PV29).  SACC’s report addresses the scientific issues being considered by EPA regarding the peer review for the draft risk evaluation.  As reported in our November 16, 2018, memorandum, “EPA Publishes First Draft TSCA Chemical Risk Evaluation,” the draft risk evaluation states that EPA considered all reasonably available data for PV29 to make a determination of whether the risk it poses is unreasonable.  EPA “concludes that C.I. Pigment Violet 29 does not present an unreasonable risk of injury to human health or the environment, without considering costs or other non-risk factors, including no unreasonable risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use.”  EPA requested SACC to provide advice and recommendations on questions concerning:

  • The overall content, organization, and presentation of the draft risk evaluation;
  • Systematic review;
  • Physical chemical properties/environmental fate;
  • Exposure and releases;
  • Environmental effects;
  • Human health;
  • Risk characterization/risk determination; and
  • Supplemental analysis.

The report notes that this first SACC peer review is the first time the TSCA program is making non-TSCA confidential business information (CBI) available to peer reviewers.  According to the report, EPA requested comment on the process, integration, and clarity related to the use of the CBI that was provided.  EPA provided SACC members TSCA CBI training, and they were permitted to review the full studies as part of their peer review.  The report states that upon a comparison of the full (unredacted) studies with the redacted studies, SACC reached consensus that the nature of the redactions do not materially impact the draft risk characterization.  SACC agreed that the summary statistics provided in the unredacted version of the reproduction/development study were consistent with the animal data in the redacted version of the study.  SACC made recommendations to EPA about how to process CBI information for use by SACC and the public for future assessments.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Environmental Defense Fund (EDF) published a September 16, 2019, blog item entitled “EPA’s latest move to deflect criticism of its TSCA risk evaluations: Muzzle its science advisors.”  EDF notes that it has opposed a number of recent decisions made by the U.S. Environmental Protection Agency (EPA) “that aim to limit the risks it finds when evaluating the safety of chemicals under the Toxic Substances Control Act (TSCA),” including:

  • Excluding from its analysis known human and environmental exposures to a chemical, based on the assumption that those exposures are adequately managed by other statutes;
     
  • Claiming without support that workers are protected by assuming universal and universally effective use of personal protective equipment throughout chemical supply chains and the adequacy of the Occupational Safety and Health Administration (OSHA) regulations that either do not apply or are out of date;
     
  • Arbitrarily loosening EPA’s longstanding risk standards governing when cancer incidences are deemed unacceptably high; and
     
  • Choosing not to exercise its enhanced authorities under TSCA to require submission of robust information on chemicals’ hazard and exposures, instead making “questionable assumptions and relying on voluntarily submitted industry data that are unrepresentative or of poor or indeterminate quality.”

EDF states that through these decisions, EPA increases the likelihood that it will either not find unreasonable risk and thereby avoid regulating the chemical, or find risks that are low enough that it can impose few restrictions.  According to EDF, in response to each of these decisions, EPA received critical comments on its draft risk evaluations from state and local governments, labor and health groups, environmental non-governmental organizations (NGO), and members of the scientific community.  EDF reports that during the first several peer reviews conducted by EPA’s Scientific Advisory Committee on Chemicals (SACC), many of the SACC members raised similar concerns.  According to EDF, EPA has directed SACC “that these issues are off-limits to the peer reviewers because they represent policy decisions that are beyond the charge given to the SACC.”  EDF states that “[t]his is beyond the pale” for the following reasons:

  1. Such issues fall squarely within SACC’s charge.  EPA’s charge questions to SACC for its most recent peer review of 1-bromopropane (1-BP) “specifically (and appropriately) call on the SACC to comment on the ‘assumptions, uncertainties and data limitations in the methodology used to assess risks from 1-BP’”;
     
  2. It is “absolutely” SACC’s role and responsibility to comment on the scientific consequences of EPA’s decisions that directly affect its characterization of exposure, hazard, and risk; and
     
  3. With respect to the adequacy of the information on which EPA relies, EPA “has recently made an additional claim to the SACC:  that EPA has no choice but to use the data it has readily at hand, however limited they are.”

EDF concludes that EPA’s direction to SACC “is but the latest in a series of moves to limit the scientific information and scientific advice that EPA can obtain and use to make decisions.”


 

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

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 44300.  The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance.  Comments are due November 21, 2019.  More information is available in our August 26, 2019, memorandum, "EPA Proposes to Designate 20 Chemical Substances as High-Priority Substances for Risk Evaluation under TSCA."


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 16, 2019, that it is opening a public comment period for manufacturer requests for the risk evaluations of diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP), two chemicals used in plastic production.  EPA notes that the manufacturer-requested risk evaluations “are among the first such evaluations of this kind to be requested” under the Toxic Substances Control Act (TSCA).  EPA is also taking public comments on additional conditions of use it identified to include in the risk evaluations.  Upon publication of the Federal Register notices, comments may be submitted to Docket ID EPA-HQ-OPPT-2018-0435 for DIDP and Docket ID EPA-HQ-OPPT-2018-0436 for DINP for 45 days.  EPA encourages comments on any information not included in the manufacturer requests that commenters believe would be needed to conduct a risk evaluation.  EPA also welcomes any other information relevant to the proposed determinations of the conditions of use, including information on other conditions of use of the chemicals than those included in the manufacturer requests or in EPA’s proposed determinations.  After the comment period closes, EPA will review the comments and within 60 days either grant or deny the requests to conduct risk evaluations.  If these requests are granted, the manufacturers would be responsible for half the cost of the risk evaluations.  More information is available in our August 19, 2019, memorandum, "EPA Begins Comment Period on Manufacturer Requests for Risk Evaluation of DIDP and DINP, and Identifies Additional Conditions of Use."


 

By Carla N. Hutton, Richard E. Engler, Ph.D., and Amanda Bland
 
On August 13, 2019, the U.S. Environmental Protection Agency (EPA) released the list of 20 chemical substances that it proposes to designate as low-priority substances for which risk evaluation under the Toxic Substances Control Act (TSCA) is not warranted at this time.  EPA’s August 15, 2019, proposed rule provides a summary of the approach used by EPA to support the proposed designations, the proposed designations for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance.  84 Fed. Reg. 41712.  EPA published its Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA (Approach Document), which describes the literature review process for the information used in the screening review for each proposed low-priority chemical substance.  Comments on the proposed designations and on EPA’s Approach Document are due November 13, 2019.

Commentary

As expected, EPA has formally proposed as low-priority substances the 20 substances that EPA proposed in March as potential low-priority substances.  Stakeholders will have 90 days to comment on whether EPA has met the statutory obligation to have information “sufficient to establish” that the substances do not meet the standard for high-priority substances (that the substances may present an unreasonable risk).  Comments were filed on only seven of the 20 substances initially identified as low priority, and all comments supported the designations as low priority. 
 
More information is available in our August 14, 2019, memorandum, “EPA Proposes to Designate 20 Chemical Substances as Low-Priority Substances.”


 
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