Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Margaret R. Graham

On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register:

These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published.  EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations:

More information on these final rules and the guidance are available in our memorandum EPA Issues Final TSCA Framework Rules.  


 

By Lynn L. Bergeson and Margaret R. Graham

On July 7, 2017, the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing the availability of the scope documents for the risk evaluations of the first ten chemicals that it will be conducting under the amended Toxic Substances Control Act (TSCA).  82 Fed. Reg. 31592.  The notice states that each scope document includes “the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the EPA expects to consider in conducting the risk evaluation.”  The direct links to the scope documents are available in our blog item EPA Issues Much Anticipated Three Final TSCA Framework Rules, Guidance on Draft Risk Evaluations, and Scoping Documents on Risk Evaluations of First Ten Chemicals under Revised TSCA.

The notice also reiterates that EPA is re-opening existing dockets for the first ten chemicals to “allow for the public to provide additional data or information that could be useful to the Agency in conducting problem formulation, the next step in the process of conducting the risk evaluations for these chemicals.”  More information on the reopening of the dockets for public comments, including links to the individual dockets, is available in our blog item EPA Opens Comment Period on Risk Evaluations for First Ten Chemicals under Revised TSCA.  As stated in the memo reopening the dockets, but curiously not stated in the published notice (no dates were included), comments are due September 19, 2017.


 

By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, Oscar Hernandez, Ph.D., and Richard E. Engler, Ph.D.

On June 26, 2017, Bergeson & Campbell, P.C. (B&C®) issued a summary and analysis of the three final Toxic Substances Control Act (TSCA) framework rules released by the U.S. Environmental Protection Agency (EPA) on June 22, 2017, EPA Issues Final TSCA Framework Rules.  The final rules include the prioritization process rule, which establishes EPA’s process and criteria for identifying High-Priority chemicals for risk evaluation and Low-Priority chemicals for which risk evaluation is not warranted at this time; the risk evaluation process rule, which establishes EPA’s process for evaluating High-Priority chemicals to determine whether or not they present an unreasonable risk to health or the environment; and the TSCA Inventory active-inactive rule, which requires industry to report chemicals manufactured, imported, or processed in the U.S. over the past ten years.  EPA also published pre-publication notices concerning the scopes of the risk evaluations to be conducted for the first ten chemical substances under new TSCA and a guidance document to assist interested persons in developing and submitting draft risk evaluations.

B&C states that on the whole, the final rules improve upon the proposed rules, adding clarity and specificity where needed, and eliminating provisions and or preamble text that, in our view, enhance the clarity of the rules.  Not everyone will be happy, however, as the rules reconsider, revise, and in some instances retreat from positions taken in the proposed rules issued under the Obama Administration. Our analysis identifies these changes.


 

By Lynn L. Bergeson

As required by the amended Toxic Substances Control Act (TSCA), on June 22, 2017, one year after passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the U.S. Environmental Protection Agency (EPA) has issued the three framework rules in final.  EPA also released draft guidance to assist in developing and submitting draft risk evaluations.  The final rules are:

  1. Procedures for Chemical Risk Evaluation;
  2. Procedures for Prioritization of Chemicals for Risk Evaluation; and
  3. TSCA Inventory Notification (Active-Inactive) Requirements

EPA also released scoping documents of the risk evaluations and supplemental resources on the first ten chemicals under amended TSCA, as it stipulated in its annual report on risk evaluations.  Links to the scoping documents for these ten chemicals, as well as strategies for conducting literature searches, are below:

  1. 1, 4-Dioxane;
  2. Methylene Chloride;
  3. 1-Bromopropane;
  4. N-Methylpyrolidone (NMP);
  5. Asbestos;
  6. Pigment Violet 29;
  7. Carbon Tetrachloride;
  8. Trichloroethylene;
  9. Cyclic Aliphatic Bromide Cluster (HBCD); and
  10. Tetrachloroethylene (perchloroethylene).

Administrator Scott Pruitt signed them and they were released to the general public shortly thereafter.  They are expected to be effective 60 days after publication in the Federal Register.  Bergeson & Campbell, P.C. (B&C®) will provide feedback on the final rules in upcoming memoranda on each final rule, as well as a memorandum on the draft guidance on developing risk evaluations.  Please look for these memoranda on our website under “Regulatory Developments.”


 

By Lynn L. Bergeson and Margaret R. Graham

On June 19, 2017, the U.S. Environmental Protection Agency posted a memo authorizing the opening of comment periods for the public to comment on the risk evaluation process for the first ten chemicals it is evaluating under the revised Toxic Substances Control Act (TSCA) to determine whether they “present an unreasonable risk of injury to health or the environment.”  Specifically, EPA states it is interested in “information from the public that could be useful to the Agency in conducting problem formulation,” which is the “next step in the process of conducting the required risk evaluations for these chemicals.”  Comments are due September 19, 2017.

EPA’s 2017 Annual Report on Risk Evaluations issued in February stated that it expected to issue a scoping document on each of the individual chemicals by June 19, 2017, which must include “the hazard(s), exposure(s), condition(s) of use, and the potentially exposed or susceptible subpopulation(s) the Administrator expects to consider in the evaluation.”  EPA has not yet issued the scoping documents, but is expected to do so soon. After the scoping documents have been published, EPA stated that it would “continue with the risk evaluation process as described in the statute and the associated Risk Evaluation Rule [to be issued in final on June 22, 2017], with the expectation to complete the risk evaluation in the 3-3.5 year timeframe required by law.”

The list of ten chemicals and their corresponding docket ID numbers are:

  1. 1, 4 Dioxane, EPA-HQ-OPPT-2016-0723;
  2. Methylene Chloride, EPA-HQ-OPPT-2016-0742;
  3. 1-Bromopropane, EPA-HQ-OPPT-2016-0741;
  4. N-Methylpyrolidone (NMP), EPA-HQ-OPPT-2016-0743;
  5. Asbestos, EPA-HQ-OPPT-2016-0736;
  6. Pigment Violet 29, EPA-HQ-OPPT-2016-0725;
  7. Carbon Tetrachloride, EPA-HQ-OPPT-2016-0733;
  8. Trichloroethylene, EPA-HQ-OPPT-2016-0737;
  9. Cyclic Aliphatic Bromide Cluster (HBCD), EPA-HQ-OPPT-2016-0735; and
  10. Tetrachloroethylene, EPA-HQ-OPPT-2016-0732.

Revised TSCA requires that the three framework rules, which include the procedures for evaluating existing chemical risks rule (Risk Evaluation Rule), the procedures to prioritize chemicals for risk evaluation rule, and the requirements for TSCA Inventory notification (active-inactive) rule, be issued in final by June 22, 2017.   

More information on these framework rules will be available on our blog after they are issued in final.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.”  While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations.  EPA must publish the final rule in the Federal Register by June 22, 2017.

More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 1, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Evaluating Existing Chemical Risks under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  

EPA’s proposed rule describes a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use; and identifies the steps of a risk evaluation process including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  This process would be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests. Comments were due March 20, 2017; 87 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and preparing final priority designations.  EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation.  Comments were due March 20, 2017; 70 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.


 

By Lynn L. Bergeson

On March 15, 2017, the U.S. Environmental Protection Agency (EPA) announced it would be extending the comment period on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) proposed rule issued on January 13, 2017.  On March 16, 2017, however, EPA rescinded this extension, stating it was issued in error, but did state that it would “make every effort to consider comments received outside of the formal comment period, if provided by March 24, 2017.”  EPA is accepting comments in Docket ID EPA-HQ-OPPT-2016-0426 on the www.regulations.gov website.  More information on this proposed rule is available in our memorandum EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive).


 

By Lynn L. Bergeson

On February 21, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice delaying the effective date from March 20, 2017, to March 21, 2017, of the notice issued on January 19, 2017. 82 Fed. Reg. 11218. The February 21 notice appears to correct a miscalculation of the 60-day freeze period required under the Regulatory Freeze Pending Review memorandum issued on January 20, 2017, to the notice EPA issued on January 19, 2017, titled Statutory Requirements for Substantiation of Confidential Business Information (CBI) Claims Under the Toxic Substances Control Act (TSCA). 82 Fed. Reg. 6522. Counting calendar days is never easy.


 
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