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 September 25, 2017, Petitioners Safer Chemicals Healthy Families and Environmental Defense Fund (EDF) (collectively Petitioners) in Ninth Circuit Case Nos. 17-72260 and 17-72501 (regarding review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation) filed a joint opposition to the U.S. Environmental Protection Agency’s (EPA) motion to transfer to the Fourth Circuit and hold cases in abeyance.  On September 14, 2017, EPA filed a motion for these Ninth Circuit cases to be moved to the Fourth Circuit where there is currently another challenge to a TSCA framework rule (Alliance of Nurses for Healthy Environments, et al. v. EPA, Case Nos. 17-1926, et al.; Petition for Review of Procedures for Chemical Risk Evaluation under TSCA).  Petitioners oppose EPA’s request for the case to be moved to the Fourth Circuit, stating that “Congress expressly gave Petitioners the right to select a forum” and “eleven of the fifteen Petitioners elected to file their petition in [the Ninth Circuit] … now believe that both sets of petitions should be consolidated in this Court.”  The Motion to Intervene of American Chemistry Council, et al. on EPA’s behalf is still pending.  On September 25, 2017, EPA filed a response to the motion to intervene stating that they took no position on it.  The Petitioner’s briefs in both cases are still due October 30, 2017.

On September 28, 2017, in Fourth Circuit Case Nos. 17-1796, et al. (referenced above), the court granted the Motion to Intervene on EPA’s behalf of American Chemistry Council, et al.  A new briefing schedule has still not been set. 

On September 29, 2017, in D.C. Circuit Case No. 17-1201 (EDF v. EPA; Petition for Review of TSCA Inventory Notification (Active-Inactive) Requirement), EPA filed a motion to extend deadlines in scheduling order, stating that “in light of the potential for other parties to file additional petitions in this Court until October 24, 2017, the parties now jointly request that the Court extend all deadlines in the Court’s September 5, 2017, order by an additional 35 days.”  The court has not ruled on EPA’s request yet; if it denies it, the briefing schedule will begin on October 5, 2017.

More information on these petitions for review is available on our blog under key phrases framework rules and petition for review.   


 

By Lynn L. Bergeson and Margaret R. Graham

On August 10, 2017, and on August 11, 2017, petitions for review of two of the U.S. Environmental Protection Agency’s (EPA) final “framework rules” issued under the amended Toxic Substances Control Act (TSCA) were filed in federal court.  These six lawsuits seek review of the final rule Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA.  The petitions were filed by Safer Chemicals, Healthy Families, et al. on August 10, 2017 (Cases 17-72260 and 17-72259); the Alliance of Nurses for Healthy Environments, et al. (including the Natural Resources Defense Council) on August 11, 2017 (Cases 17-1926 and 17-1927 (consolidated)); and the Environmental Defense Fund (EDF) on August 11, 2017 (Cases 17-2464 and 17-2403), in the U.S. Court of Appeals for the Ninth, Fourth, and Second Circuits, respectively.  In the Ninth Circuit, the Petitioner’s Briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017; in the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017; in the Second Circuit, a briefing schedule has not been posted yet. 

In its petitions for review, Safer Chemicals, Healthy Families, et al. state that they challenge the rules as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.” On the Safer Chemicals, Healthy Families’ website, the organization states that the petitions allege the rules “fail to provide the protections against unsafe chemicals that Congress required in the critical priority-setting and risk evaluation provisions of the new law, which are intended to ensure that unreasonable risks to health and the environment are fully assessed and eliminated.”  In its petitions for review, EDF does not list any details as to why it is seeking review (nor do the rules require petitioners to do so), but on its website it states that “EPA has issued framework rules that violate the letter and intent of the law,” and that EDF has filed lawsuits challenging those rules and “will continue to monitor EPA’s actions to ensure EPA complies with the law and protects public health.”  The petitions for review filed by the Alliance of Nurses for Healthy Environments, et al. do not list any details as to why they are seeking review. 


 

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 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 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, Carla N. HuttonCharles M. Auer, and Oscar Hernandez, Ph.D.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule in the January 17, 2017, Federal Register that would establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time.  The pre-publication version of the proposed rule 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 finalizing designations of priority.  EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to the Toxic Substances Control Act (TSCA).  Publication of the notice will begin a 60-day comment period.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.


 

By Lynn L. Bergeson

On November 7, 2016, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received a pre-publication proposed rule on Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) from the U.S. Environmental Protection Agency.  Also referred to as the “Prioritization Process Rule,” this procedural rule will stablish EPA's process and criteria for identifying high priority chemicals for risk evaluation and low priority chemicals.  As stated in our memorandum TSCA Reform:  EPA Publishes First Year Implementation Plan, this rule is the first of three “Framework Action” rules that the Frank L. Lautenberg Chemical Safety for the 21st Century Act (new TSCA) has directed EPA to issue in final within one year of enactment, or by mid-June 2017.  For all three of these rules, the interim milestone for the proposed rules is mid-December 2016; therefore, it is anticipated that the three other rules will soon be sent to OMB for review as well. The two others are:

  • Risk Evaluation Process Rule:  A Procedural rule to establish EPA's process for evaluating the risk of high priority chemicals; and
  • Inventory Rule:  Rule to require industry reporting of chemicals manufactured/processed in the previous ten years. Results will be used to designate active and inactive chemicals on the TSCA Inventory of existing chemicals.

There is a fourth Framework Action rule that new TSCA has directed EPA to issue as well, but it does not have a deadline for issuance in final; new TSCA only species the mid-June 2017 date as a goal:

  • Fees Rule:  EPA is authorized to collect fees to help defray the cost of implementing certain provisions and to fully defray the cost of industry-requested risk evaluations, but must put a rule in place to require fees. There is no deadline in the bill, but authority to require fees will be needed as soon as possible.

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


 

By Lynn L. Bergeson and Margaret R. Graham

On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA).  Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance, and offer the following highlights.

On August 9, many speakers across different stakeholder groups flagged issues in terms of how EPA should conduct the chemical risk evaluation process:

  • EPA must determine compatibility of information from third parties, e.g., assessment documents from other groups including within EPA, with TSCA Section 26 standards;
  • EPA needs to improve its exposure methodologies, and develop new ones; EPA needs to modify its exposure ranking to acknowledge that chemical intermediates are typically consumed in the manufacture of a product and do not represent a primary source of exposure, especially outside of the production facility;
  • Transparency throughout the risk evaluation process is critical;
  • EPA is required to use best available science and weight-of-evidence;
  • Potentially exposed and susceptible subpopulations should include workers, pregnant women, infants, fence-line populations, and consider the lifestyles (especially diets) of native populations as appropriate under the conditions of use; and
  • EPA should undertake a tiered approach to testing, to minimize vertebrate testing and cost, as new TSCA requires.

As for the content of the actual chemical risk evaluation rule, stakeholders made the following comments:

  • The rule should include more content beyond procedures by incorporating definitions for key items such as “weight of scientific evidence” and other scientific standards, and codifying criteria for evidence evaluation;
  • The final reports should explicitly identify low exposure/low risk uses considered in the development of the Risk Evaluation; and
  • Whether legal scientific requirements under TSCA Sections 6 and 26 need to be reflected in the procedural rule, and not be relegated to guidance documents – there was some disagreement on the best course of action on this issue.

A link to the agenda for the August 9, 2016, public meeting is available hereEPA’s risk evaluation meeting presentation is available here.

On August 10, comments made during the prioritization procedural rule meeting sessions were similar to those made at the August 9 meeting, with an emphasis on the application of Section 26 scientific standards.  A few speakers expressed reservations about the prioritization methodology that EPA currently uses and suggested some alternative approaches.

A link to the agenda for the August 10, 2016, public meeting is available hereEPA’s prioritization procedural rule meeting presentation is available here.