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, M.S.

On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include:

  • Seven chlorinated solvents;
  • Six phthalates;
  • Four flame retardants;
  • Formaldehyde (which has been studied by EPA’s Integrated Risk Information System (IRIS) program for many years);
  • A fragrance additive; and
  • A polymer pre-curser.

EPA is also currently determining whether to conduct a risk evaluation of two additional phthalates.  The 20 low priority candidate chemicals have been selected from EPA’s Safer Chemicals Ingredients List, which includes chemicals that have been evaluated and determined to meet EPA's safer choice criteria. 

Alexandra Dapolito Dunn, Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, stated that initiating a chemical for high or low prioritization “does not mean EPA has determined it poses unreasonable risk or no risk to human health or the environment,” however.  EPA states that is it releasing this list “to provide the public an opportunity to submit relevant information such as the uses, hazards, and exposure for these chemicals.”  EPA is scheduled to publish the notice regarding this list in the Federal Register on March 21, 2019.  The pre-publication notice is available here.  Comments will be due 90 days after publication in the Federal Register.  EPA is opening a docket for each of the 40 chemicals.  EPA is then directed to complete the prioritization process in the next nine to 12 months, allowing EPA to designate 20 chemicals as high priority and 20 chemicals as low priority. 

Please be on the lookout for our memorandum that will contain more information regarding EPA’s list.  It will be posted on our Regulatory Developments webpage.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 18, 2018, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) issued an order granting in part respondent U.S. Environmental Protection Agency’s (EPA) motion for partial voluntary remand of certain provisions of its final rule on Procedures for Chemicals Risk Evaluation under the Toxic Substances Control Act (TSCA).  Specifically, EPA’s motion for partial voluntary remand, filed August 6, 2018, sought remand with vacatur of 40 C.F.R. Section 702.31(d) (Penalty Provision) and remand without vacatur of 40 C.F.R. Sections 702.37(b)(4) (Relevancy Provision) and 702.37(b)(6) (Consistency Provision).  The Ninth Circuit granted EPA’s motion to remand and to vacate the Penalty Provision, but referred EPA’s motion to remand without vacatur for the Relevancy and Consistency Provisions.  The Penalty Provision states that “[s]ubmission to EPA of inaccurate, incomplete, or misleading information pursuant to a risk evaluation … is a prohibited act … subject to penalties.”

EPA stated in its motion that its “request to remand the Penalty, Relevancy, and Consistency provisions is reasonable, timely, and will serve the interests of judicial economy,” but it has not yet decided on a specific course of action.  EPA sought remand to address the potential concerns that petitioners stated in their opening brief.  EPA stated that vacatur was only appropriate for the Penalty Provision, however, as “nothing in the proposed rule or rulemaking record gave any indication that EPA was contemplating extending the Penalty Provision beyond manufacturers, and EPA did not purport to make that change in response to public comments, the Penalty Provision is not a logical outgrowth of the proposed rule.” 

As for the Relevancy and Consistency Provisions, EPA stated that they should be remanded but not vacated for the following reasons:

  1. EPA believes that the concerns about these provisions can be addressed through modifications to the language of the regulations;
  2. The unintended consequences of the Relevancy and Consistency Provisions that Petitioners allege are not serious; even if a manufacturer were to rely on those provisions to withhold information, EPA has independent authority to collect that information or require development of new information as needed to conduct its risk evaluations; and
  3. The disruptive effects to EPA could be considerable if these regulations were vacated while EPA completes its remand process; if the provisions are vacated, manufacturers could (intentionally or unintentionally) submit junk science or irrelevant material, requiring EPA to consume limited resources and take time out of the statutorily-mandated schedule to review the information.  Further, vacatur of the Relevancy Provision would be particularly disruptive because it would eliminate altogether the affirmative requirement for manufacturers to submit lists of information when requesting risk evaluations; and could delay EPA’s information gathering if it had to request or order such information from the outset.

More information on the appeals to the TSCA framework rule on risk evaluation is available on our blog.


 

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.   


 
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