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

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  EPA also released draft guidance to assist in developing and submitting draft risk evaluations.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will provide feedback on the final rules in upcoming memoranda on each final rule, as well as a memorandum on the draft guidance on developing risk evaluations.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.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) issued its 2017 Annual Report on Risk Evaluations.  Per Section 26(n)(2) of the amended Toxic Substances Control Act (TSCA), EPA is directed to publish an annual plan at the beginning of each calendar year identifying the chemical substances that will undergo risk evaluations during that year – both risk evaluations that will be initiated and that will be completed -- the resources necessary for completion, and the status and schedule for ongoing evaluations.

Per amended TSCA Section 6(b)(4), on December 19, 2016, EPA designated ten chemical substances for evaluation to determine whether they presented an unreasonable risk of injury to health or the environment.  Those chemicals are:

  • 1, 4 Dioxane;
  • Methylene Chloride;
  • 1-Bromopropane;
  • N-Methylpyrolidone;
  • Asbestos;
  • Pigment Violet 29;
  • Carbon Tetrachloride;
  • Trichloroethylene;
  • Cyclic Aliphatic Bromide Cluster (HBCD); and
  • Tetrachloroethylene.

The report provides an update pertaining to the risk evaluations of these ten chemicals.  Risk evaluations on these chemicals have already begun, and EPA anticipates issuing a scoping document for each of them by June 19, 2017.  The scoping document will 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 established a docket for each of the ten chemicals and is holding a public meeting on February 14, 2017, to present information on the specific uses and conditions of use for the chemicals.  EPA is currently accepting written comments and materials in the individual dockets until March 15, 2017.

Under Section 6(4)(G) of TSCA, EPA is required to complete these risk evaluations within three to three and a half years.  EPA’s initial report to Congress issued on January 18, 2017, detailed the resources it needed for completion of the risk evaluations.

More information on EPA’s proposed processes for prioritizing and evaluating chemicals beyond these first ten is available in our memoranda EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA and EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment period for the two recently proposed rules issued under Section 6 of the Toxic Substances Control Act (TSCA) to ban certain uses of trichloroethylene (TCE):  proposed rule to ban certain uses of TCE in aerosol degreasing and as a spot cleaner in dry cleaning facilities (issued December 16, 2017); and proposed rule to regulate the use of TCE in vapor degreasing (issued January 19, 2017).  EPA is extending the comment period for the proposed ban on TCE as an aerosol degreaser and for spot cleaning in dry cleaning facilities from the initial deadline of February 14, 2017, to March 16, 2017, and for the proposed ban on TCE as a commercial vapor degreaser from the initial deadline of March 20, 2017, to April 19, 2017.  EPA did not state any information on why it was extending the deadline, but requests for extensions were filed in both dockets.

More information on the proposed rules is available in our memorandum EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a) and in our blog item EPA Proposes Prohibiting Use of TCE.


 

By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham

On January 27, 2017, the U.S. Customs and Border Protection (CBP) issued in the Federal Register a notice of delay of an effective date of a final rule issued on December 27, 2016 (81 Fed. Reg. 94980).  The final rule announced amendments to CBP regulations regarding the requirement to file a Toxic Substances Control Act (TSCA) certification when importing into the customs territory of the United States chemicals in bulk form or as part of mixtures and articles containing a chemical or mixture.  82 Fed. Reg. 8590.  Specifically, the final rule amends CBP’s regulations under 19 C.F.R. Parts 12 and 127 to establish an electronic option for importers to file the required U.S. Environmental Protection Agency (EPA) TSCA certifications, to clarify and add certain definitions, and to eliminate the paper-based blanket certification process.  

The effective date of the final rule was initially set at January 26, 2017, but is now delayed until March 21, 2017, in accordance with the Presidential directive entitled “Regulatory Freeze Pending Review” issued January 20, 2017, directing heads of executive departments and agencies temporarily to postpone the effective date for 60 days from the date of the memorandum, of all regulations that had been published in the Federal Register, but had not taken effect.  In the notice, CBP states that this additional time is not unwelcome, as it will allow affected entities more time to “become familiar with the increased flexibilities and new processes of the final regulations.”


 
 1 2 3 >