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  EPA also released draft guidance to assist in developing and submitting draft risk evaluations.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will provide feedback on the final rules in upcoming memoranda on each final rule, as well as a memorandum on the draft guidance on developing risk evaluations.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 March 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register reopening the comment period on the risk evaluation scoping efforts under the Toxic Substances Control Act (TSCA) for the ten chemical substances that were designated on December 19, 2016:

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

The prepublication version is available on the Federal Register website.  The initial notice, issued in the Federal Register on January 19, 2017, announced a public meeting which took place on February 14, 2017, and solicited “comments to receive input and information to assist the Agency in its efforts to establish the scope of risk evaluations under development for the ten chemicals substances.”  This notice will extend the comment period for 14 days, from March 1, 2017, to March 15, 2017, in response to a request from the interested public.  

More information is available in our blog items EPA To Hold Public Meeting on Uses and Conditions of Use for the Initial Ten Chemicals to be Evaluated under TSCA Section 6 and EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation

 


 

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 January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing it will be holding a public meeting to receive public input and information on uses and conditions of use for the initial ten chemicals to be evaluated under Section 6(b)(2)(A) of the amended Toxic Substances Control Act (TSCA) on February 14, 2017, from 9:00 a.m. to 3:00 p.m. (EST), at the Ronald Reagan Building and International Trade Center, Polaris Room, 1300 Pennsylvania Avenue Northwest, Washington, DC 20004.  82 Fed. Reg. 6545.  EPA states that the information it gathers on uses and the conditions of use will assist it in identifying potential exposure scenarios for the ten chemicals.

Registration is available online and remote access will be available for registered participants.  Public dockets for each chemical have been established. Written comments and materials will also be accepted in these dockets on www.regulations.gov.  EPA requests for them to be submitted by March 1, 2017.

Additional information, including links to the public dockets, is available on EPA’s website and in our blog item EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.


 

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

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish 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.  The process would not consider costs or other nonrisk factors.  Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under recent amendments to the Toxic Substances Control Act (TSCA).  The proposed rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  EPA proposes that this process 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.  The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests.  EPA posted a pre-publication version of the proposed rule on its website.  When the proposed rule is published in the Federal Register, it will begin a 60-day comment period.  This is the third foundational rule released during the week of January 9, 2017.  An in-depth memorandum on the proposed risk evaluation process, as well as memoranda regarding EPA’s proposed requirements for TSCA Inventory notification and prioritization process for reviewing existing chemicals, will be available on our website under the key phrase TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called “high priority” chemicals.  This is the second rule of three Framework Action rules that amended TSCA has directed EPA to issue in final within one year of enactment, or by mid-June 2017.  The Inventory rule, which will require industry reporting of chemicals manufactured/processed in the previous ten years, is expected to be sent to OMB soon.  Whether election transition issues will complicate and perhaps slow the review process is unclear but certainly not unlikely.

More information on the implementation of amended TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.


 

By Lynn L. Bergeson

On October 11, 2016, the U.S. Environmental Protection Agency (EPA) announced that it would be taking expedited action on reducing exposures to the following persistent, bioaccumulative, and toxic chemicals (PBT).  As stated in our blog item Deadline for Requesting Risk Evaluation for PBT Chemicals Fast Approaching, Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, outlines a procedure requiring “expedited” regulatory action that is intended to reduce exposures to these chemicals to the “extent practicable.”  Instead of conducting a standard risk evaluation, EPA immediately will proceed to assess and identify appropriate risk management actions for these chemicals:

  • Decabromodiphenyl ethers (DecaBDE), used as a flame retardant in textiles, plastics and polyurethane foam;
  • Hexachlorobutadiene (HCBD), used in the manufacture of rubber compounds and lubricants and as a solvent;
  • Pentachlorothio-phenol (PCTP), used as an agent to make rubber more pliable in industrial uses;
  • Tris (4-isopropylphenyl) phosphate, used as a flame retardant in consumer products and other industrial uses; and
  • 2,4,6-Tris(tert-butyl)phenol, used as a fuel, oil, gasoline or lubricant additive.

Manufacturers were given until September 19, 2016, to request that EPA conduct a risk evaluation prior to risk management decisions on any of the PBT chemicals listed on EPA’s 2014 Work Plan; EPA states that requests for risk evaluations were made for two chemicals that can be used in fragrance mixtures, but for the remaining PBT chemicals, “it must move ahead to take expedited action to reduce exposure those chemicals.”  The two requests were made for:

  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl); and
  • Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl.

As a result of the requests, EPA has excluded these two chemicals from the expedited action requirements under Section 6(h).  The statutory deadline for EPA to propose action is June 22, 2019More information on these PBTs and EPA’s implementation of the amended TSCA can be found on our blog under keyword:  PBTs.


 
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