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By Lynn L. Bergeson and Margaret R. Graham

On November 29, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has scheduled the first public meetings of the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  The first meeting, a preparatory virtual meeting, and will be held on January 8, 2019, from 2:00 p.m. to 4:00 p.m. (EST).  The second meeting, a four-day in-person meeting, will be held on January 29, 2019, from 1:00 p.m. (EST) to 5:30 p.m. and on January 30, 31, and February 1, 2019, from 9 a.m. to 5:30 p.m. (EST).  The official announcement is scheduled to be published in the Federal Register on November 30, 2018.  Further information, including the location of the in-person meeting and how to register, will be posted on EPA’s TSCA Scientific Peer Review Committees website.

The topic for this first series of meetings is the peer review of the draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 and associated documents developed under EPA’s existing chemical substance process under TSCA.  EPA states that the two-hour preparatory virtual meeting on January 8, 2019, will consider the scope and clarity of the draft charge questions for this peer review -- included with EPA’s Transmission of Background Materials and Charge to the Panel for the TSCA SACC Reviewing the Draft Risk Evaluation for C.I. Pigment Violet 29 (Attachment 23).  The 4-day, in-person, public meeting will be comprised of the peer review panel deliberations and a general TSCA orientation for the TSCA SACC.  A portion of the in-person meeting will be closed to the public, however, for the discussion of information claimed as confidential business information (CBI).

During these upcoming meetings, EPA states that the public is invited to provide oral comments for the peer review on the draft risk evaluation for C.I. Pigment Violet 29 and related documents; comments submitted by January 14, 2019, on the draft risk evaluation will be provided to the peer review panel members before the in-person meeting.  Comments on the draft charge questions will be accepted prior to and during the 2-hour preparatory virtual meeting (but preferably by January 7, 2019); the TSCA SACC peer review panel will consider these comments during their discussions. 

More information on the draft risk evaluation for C.I. Pigment Violet 29 is available in our memorandum EPA Publishes First Draft TSCA Chemical Risk Evaluation.


 

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

The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on November 15, 2018, announcing the availability of and seeking public comment on the first draft chemical risk evaluation under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).  The draft risk evaluation for Colour Index (C.I.) Pigment Violet 29 is intended to determine whether C.I. Pigment Violet 29 presents an unreasonable risk to health or the environment under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation.  According to the notice, EPA is also submitting these same documents to the TSCA Science Advisory Committee on Chemicals (SACC) to peer review the draft risk evaluation.  EPA intends to publish a separate Federal Register notice containing the peer review meeting details.  Comments on the draft risk evaluation are due January 14, 2019.  EPA will provide all comments submitted on the draft risk evaluation to the TSCA SACC peer review panel, which will have the opportunity to consider the comments during its discussions.  More information is available in the full memorandum.


 

By Lynn L. Bergeson

On August 7, 2018, EPA is expected to announce the extension of the comment period on the problem formulations for the risk evaluations for the first 10 chemicals under Toxic Substances Control Act (TSCA) Section 6.  The notice extends the comment period on the problem formulations and the document titled Application of Systematic Review of TSCA Risk Evaluations, an additional 21 days, until August 16, 2018.  Reportedly EPA received several requests to extend the deadline.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 31, 2018, the U.S. Environmental Protection Agency (EPA) announced the release of its 2018 Annual Report on Risk Evaluations.  Pursuant to 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. The plan is to include 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.  The 2018 annual plan identifies the next steps for the first ten chemical reviews currently underway and describes EPA’s work in 2018 to prepare for future risk evaluations.

EPA issued scoping documents on the first ten chemical reviews in June 2017.  The plan states that in early calendar year 2018, EPA will be making refinements to these scope documents in the form of “problem formulation documents” that will include additional elements such as conceptual models.  EPA will publish a notice in the Federal Register announcing the release of these problem formulation documents and will invite comments for 45 days.  

The plan also states that EPA will initiate prioritization for 40 chemicals (at least 20 Low-Priority and 20 High-Priority candidates) by the end of calendar year 2018.  By December 22, 2019, EPA plans to have designated 20 substances as Low-Priority and initiated risk evaluations on 20 High-Priority substances.  Further, EPA will be proposing the much-anticipated TSCA Fees Rule in early-mid fiscal year (FY) 2018, and anticipates issuing a final rule in late FY2018.

Information on EPA’s 2017 Annual Report is available in our blog item EPA Publishes 2017 Annual Report on Chemical Risk Evaluations.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  The Framework Document, as it has come to be called, is the “final rule” at issue and was posted in EPA’s docket opened for comments related to its two Toxic Substances Control Act (TSCA) public meetings that took place in December. It is reasonable to assume that the Framework Document is not referred to by EPA as a final rule and was not published in the Federal Register as a final rule because EPA believes it is a document that outlines a conceptual approach to how EPA may go about making decisions on new chemicals.  EPA specifically states the document, referred to as a “draft” in the Federal Register notice that announced the two public meetings, “outlines EPA’s approach to making decisions on new chemical notices submitted to EPA under TSCA section 5, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act,” and includes EPA’s “general decision framework for new chemicals” and a breakdown of how EPA “intends to approach each of the five types of new-chemical determinations required under the statute.” 

The citizen action petition raises novel and interesting legal questions, and is quite different from the other petitions for review, one for each framework final rule, that are  pending. Whether the newest legal challenge will survive procedural motions that EPA can be expected to file to dismiss the action remains to be seen. More information on the framework rule 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 December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit.  This was not entirely unexpected, as the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) recently denied the U.S. Environmental Protection Agency’s (EPA or respondent) motions to transfer to the Ninth Circuit the consolidated cases on the petition for review of one of the other TSCA framework rules, Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)) to the Fourth Circuit.  Now both of these cases will be decided in the Ninth Circuit.  In the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) case on the petition for review of the TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements (EDF v. EPA, Case No. 17-1201), neither the petitioner or the respondents have moved to transfer this case so it will in all likelihood stay in the D.C. Circuit.

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 November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions.  It granted the American Chemistry Council’s (ACC) (and other industry groups) motion to intervene on behalf of respondent U.S. Environmental Protection Agency (EPA); denied the respondents’ motions to transfer Case Nos. 17-72260 and 17-72501 to the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit); denied respondents’ requests to hold Case Nos. 17-72260 and 17-72501 in abeyance; granted the motions to consolidate Case Nos. 17-72260, 17-72501, and 17-72968; and set an amended briefing schedule.  The consolidated opening brief is now due January 23, 2018; the consolidated answering brief and the intervenors’ brief are due February 22, 2018; and the optional reply brief is due within 21 days after service of the answering and intervenors’ briefs.

In the Fourth Circuit case on the petition for review of the TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the petitioners’ motions to transfer to the Ninth Circuit are still pending; on November 21, 2017, the Fourth Circuit deferred the ruling until the Ninth Circuit ruled on its own pending motions to transfer.  As the Ninth Circuit has now denied the motions to transfer (per above), the Fourth Circuit will soon make a decision about whether this case should also be heard by the Ninth Circuit.  A new briefing schedule has not been set.

In the U.S. Court of Appeals for the D.C. Circuit (D.C. Circuit) case on the petition for review of the TSCA framework rule TSCA Inventory Notification (Active-Inactive) Requirements (EDF v. EPA, Case No. 17-1201), there are no current delays due to transfers or consolidations.  Respondent EPA filed a motion to extend time to file its brief on November 7, 2017; petitioner Environmental Defense Fund (EDF) filed its statement of intent regarding appendix deferral on November 8, 2017, and filed its initial submissions including the statement of issues on November 8-9, 2017; and respondent EPA filed the certified index to the record on November 27, 2017.  ACC and other industry groups were granted leave to intervene on behalf of respondent EPA on November 13, 2017.  The briefing schedule has not been set. 

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 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 September 14, 2017, the U.S. Environmental Protection Agency (EPA) filed a motion in the two Ninth Circuit Court of Appeals cases regarding review of the EPA Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA:  Safer Chemicals Healthy Families v. EPA, Case No. 17-72260 (filed August 10, 2017); and Environmental Defense Fund v. EPA, Case No. 17-72501 (filed September 6, 2017), requesting that the cases be transferred to the Fourth Circuit and to hold the cases in abeyance.  In the motion, EPA states three reasons why these cases should be transferred:

  1. "It is in the interest of judicial economy for the same court to hear the challenges to both EPA Rules,” and “[a]lthough the two Rules are distinct and have separate administrative records, the parties anticipate that there will be some overlap of issues.”
  2. “It would be more convenient for the parties and conserve travel resources for these cases to be heard in the Fourth Circuit, because all counsel of record are located in Washington, DC, or New York.”
  3. “The Fourth Circuit may be able to resolve the petitions for review more quickly than this Court given the respective complexity of the courts’ dockets.”

In this motion, EPA also requests for these cases to be held in abeyance as it “will conserve party resources to wait until resolution of EPA’s motion to transfer before completing any scheduled filings, particularly because the two have different schedules” and “the deadline for interested persons to file petitions for review of the Prioritization and Risk Evaluation Rules has not yet expired…. additional petitions for review … could be filed as late as October 2, 2017.” 

In Case No. 17-72260, Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.  A briefing schedule has not been scheduled yet in Case No. 17-72501.  On September 11, 2017, in Alliance of Nurses for Healthy Environments, et al. v. EPA, Case No. 17-1926, the Fourth Circuit case regarding review of EPA’s TSCA framework rule Procedures for Chemical Risk Evaluation under TSCA, the Fourth Circuit rescinded the briefing schedule.  A new briefing schedule has not been set. 

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. 


 
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