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By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar:

  • Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number of chemicals reported.
    • EPA responded that the changes to CDR discussed in the webinar presentation would reduce the data collected per chemical and would not impact which chemicals were required to be reported under CDR.
  • Whether the data expected to be used to inform the identification of potential candidate chemicals for prioritization was limited to CDR.
    • EPA responded that the webinar presentation was not intended to identify all sources of information that would be used for the various steps of the overall existing chemicals process, including informing the identification of the pool of potential candidate chemicals for the prioritization process. Rather, the intent was to identify the data that would be available from either CDR or TDR for use for each step in the process.
  • Reasoning behind EPA’s decisions regarding timing of the collection tiers and selected data elements.
    • EPA responded that the specifics of what data elements would be included in which collection tiers was under development and that the Agency is interested in comments from EDF or other stakeholders to help inform the TDR proposal.
  • Whether EPA had any more details about the post-risk management stage, which was included in the webinar presentation as “TBD.”
    • EPA responded that there were no additional details at this time.

According to the meeting summary, EDF provided additional comments during the meeting, including concern about scaling back CDR; belief that data should be collected earlier in the existing chemicals process to be more useful and enable EPA to make better use of TSCA Section 4; and a request to make the reported data publicly available in a timely manner to inform public comment. EDF “also reiterated their concern with the length of the comment period following the webinar.” The meeting summary states that EPA will accept supplemental comments after August 16, 2021, that are e-mailed to Susan Sharkey (.(JavaScript must be enabled to view this email address)), but that such comments should be provided as soon as possible. EPA noted that interested parties could comment during interagency review and following the publication of the proposal.

More information on EPA’s July 27, 2021, webinar is available in our July 29, 2021, memorandum. As reported in our August 6, 2021, blog item, EPA posted a memorandum in Docket ID EPA-HQ-OPPT-2021-0436 stating that it will not extend the August 16, 2021, comment period stemming from the July 27, 2021, public webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements.  Specifically, petitioners claimed that:  (1) TSCA requires EPA to evaluate risks associated with a chemical’s uses collectively before determining that the chemical is safe; (2) EPA must consider all of a chemical’s conditions of use in that evaluation; and (3) when considering conditions of use, EPA must evaluate past disposals of all chemicals, as well as the use and subsequent disposal of chemicals not currently or prospectively manufactured or distributed in commerce for that use.  Petitioners maintained that various provisions of the risk evaluation rule demonstrate that EPA will not do any of these three things.  The court held that it lacks jurisdiction to review petitioners’ first challenge, and that their second challenge fails on the merits.  The court granted in part the petition for review with respect to petitioners’ third challenge to EPA’s exclusion of “legacy uses” and “associated disposals” from the definition of “conditions of use,” and those portions of the risk evaluation rule’s preamble are vacated.  The court notes that because petitioners’ challenges to EPA’s prioritization rule are “entirely encompassed” within their challenges to the risk evaluation rule, the challenges rise or fall together.  The court thus focused only on the risk evaluation rule.
 
More information on the case is available in the following blog items:


 

By Lynn L. Bergeson and Carla N. Hutton
 
On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary remand.”  As to the remainder of petitioners’ claims, EPA maintains that their allegations “are based on hypotheticals and other non-final agency actions currently being considered by the agency.”  EPA argues that the court should dismiss petitioners’ challenges to:  (1) EPA’s preamble statements about the potential scope of future risk evaluations; (2) EPA’s regulatory provisions leaving the door open to issue early risk determinations; and (3) the remaining information-gathering provisions still at issue.  EPA states that if it “ever takes final agency actions based on the decisions Petitioners hypothesize, those would be the proper actions for Petitioners’ challenges.”
 
A coalition of industry associations filed a supplemental brief in support of EPA on June 28, 2019.  The coalition states:  “Although it is theoretically possible that EPA could exclude a use of a particular chemical that could affect the risk evaluation in a way that could cause the agency not to regulate some use of a chemical that could injure Petitioners’ members, that does not create a justiciable controversy now, before the Rules have been applied.”  (Emphasis in original.)  The coalition asks the court to dismiss the petitions for lack of jurisdiction.
 
As reported in our June 26, 2019, blog item, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments on May 16, 2019, and afterward ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court.  NRDC responded that it does, arguing that EPA’s rules violate the statutory requirements of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  The court suggested that petitioners could wait to see whether EPA will ignore certain uses of chemicals in its risk evaluations.  EPA maintained that petitioners were raising a challenge to a hypothetical scenario and that EPA has the legal discretion to study whichever chemical uses it sees fit.  Following oral argument, on May 16, 2019, the court ordered petitioners to file a supplemental brief addressing why they should be allowed to bring a lawsuit against EPA.  The petitioners filed their supplemental brief on June 3, 2019, arguing that they have standing because the Toxic Substances Control Act (TSCA) Framework Rules threaten their members’ concrete interests in minimizing toxic chemical exposures; they have information standing for each of their challenges to the Framework Rules; and their claims are ripe.  EPA was granted an extension and its response is due June 28, 2019.


 

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 October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified pursuant to TSCA Section 6(b)(2)(B).  Comments are due by November 15, 2018

The document, A Working Approach for Identifying Potential Candidate Chemicals for Prioritization, lays out EPA’s thinking regarding a near-term approach for identifying potential chemicals for prioritization, the initial step in evaluating the safety of existing chemicals under TSCA.  The approach document also includes a longer-term risk-based strategy for managing the larger TSCA chemical landscape that, according to the portion of the TSCA Chemical Substance Inventory (Inventory) that includes the substances designated as active (TSCA Active Inventory), is expected to include over 38,000 chemicals reported as “active” under the TSCA Inventory Notification (Active-Inactive) Requirements final rule.  More information is available in our memorandum “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under TSCA.”


 

By Lynn L. Bergeson and Margaret R. Graham

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was releasing the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA) titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” (Working Approach).  EPA states that the information set forth in this document is “intended to describe the general approaches EPA may consider to identify existing chemicals as potential candidates for prioritization,” and the ultimate goal of these approaches “is to identify potential candidates from which EPA will select candidates for prioritization, consistent with its regulations at 40 C.F.R. § 702.5.” 

EPA also released the pre-publication version of the Federal Register notice of availability of the Working Approach and “A Summary of Public Comments By Topic” (Summary).  The pre-publication notice states that EPA will be opening a public docket to accept comments on the Working Approach until November 15, 2018.  These comments will inform a public meeting to be held in early 2019.  Upon publication of the Federal Register notice, EPA will open 74 chemical-specific public dockets, one for each of the 73 remaining chemicals on the 2014 Update to the TSCA Work Plan for Chemical Assessments that have not received manufacturer requests for EPA evaluation and an additional general docket for chemicals not on the Work Plan.  These dockets will be open until December 1, 2019.  A link to the list of these dockets is available here

More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation


 

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 Kathleen M. Roberts, Richard E. Engler, Ph.D., and Lynn L. Bergeson

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s Office of Research and Development (ORD).

The presentations from the meeting are listed below and available on EPA's website:

Nancy Beck, Ph.D. opened the workshop by welcoming attendees and provided some overview remarks.  Dr. Beck noted that the workshop could result in more than one approach being considered, or could result in no process being adopted.  Dr. Beck explained why EPA does not wish to prioritize chemicals with poor datasets.  Unless EPA has sufficient information to conclude there is no unreasonable risk, EPA must proceed with risk evaluations within the specified timelines with increased uncertainties.  This will result in a risk management process that has numerous default assumptions and uncertainty that will be difficult to defend.  Such risk management results will likely be subject to litigation, which will be costly in terms of time and resources to both EPA and the stakeholders. 

Dr. Morris stated that EPA hopes to implement a pre-prioritization approach by June 2018 to help ensure prioritization can begin in December 2018.

In its review of potential adjustments to the TSCA Work Plan for Chemical Assessments (TSCA Work Plan) approach, EPA staff clarified that there would be no changes to the current TSCA Work Plan chemical list last updated in 2014.  It was suggested that EPA could rely on the current TSCA Work Plan approach as an interim method for pre-prioritization as EPA works to refine other approaches.  EPA acknowledged that neither the current TSCA Work Plan approach nor the SCIL process included screens for certain criteria articulated in the amended TSCA legislation, including storage near significant sources of drinking water. 

Based on comments by presenters at the workshop and references in EPA documentation, it appears that chemical substances of unknown or variable composition, complex reaction products and biological materials (UVCB) will be difficult to screen in the pre-prioritization approaches reviewed.

In response to EPA’s comment that active substances will be the starting point for pre-prioritization screening, one non-governmental organization (NGO) group raised concerns with legacy issues that might be associated with inactive substances (e.g., substances contained in products or materials that have been in use for years).  NGO groups also commented that the hurdle for identifying a high priority chemical should be relatively low; whereas the hurdle for identifying a low priority chemical should be very high and could potentially include a required minimum data set.

All stakeholders expressed appreciation to EPA for the presentations and the various approaches reviewed.  During the public comments, there did not appear to be specific support for any one approach. 

We note that none of the approaches included specifics as to how EPA would assess whether the chemical being reviewed had sufficient data available to initiate prioritization and potential risk evaluation.  Given EPA’s clear objective to avoid having data-poor chemicals being prioritized, this issue needs to be clearly and definitively addressed in EPA’s practices.  Nor was there consideration as to how other governmental regulatory assessments could be incorporated into a pre-prioritization approach.

EPA will be accepting comments on the approach to prioritizing chemicals until January 25, 2018, in Docket ID EPA-HQ-OPPT-2017-0586.  More information on the December 6, 2017, public meeting on EPA’s new chemicals review program is available in our blog under key phrase public meeting.  


 
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