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

On December 6, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened a much anticipated public meeting on implementing changes to the new chemicals review program under the amended Toxic Substances Control Act (TSCA).  EPA offered brief prepared remarks and previously solicited questions from stakeholders.  Stakeholders expressed their appreciation to EPA for developing the draft Points to Consider and related documents made available in advance of the meeting, and for OPPT’s continuing interest on new chemical issues.  For more information, see our blog “EPA Posts Agenda and Other Meeting Materials for December 6, 2017, New Chemicals Review Program Implementation Meeting.”  Below are some key takeaways regarding the meeting as related to EPA’s presentations and input from industry and non-governmental organizations (NGO).

Conditions of Use, SNURs, and PMNs:  EPA stated that one of its main concerns is when EPA does not identify unreasonable risk for intended use, but nonetheless has concerns with reasonably foreseen conditions of use. EPA stated that it will assess whether those concerns can be addressed through significant new use rules (SNUR) that it would promulgate prior to making its Section 5 finding.  EPA stated that, in identifying reasonably foreseeable uses, it will rely on knowledge, experience, and facts to support what is foreseen, not simply what is possible.  Several commenters requested clarification and examples on the information that will support such identifications.  This is plainly an area of intense interest and on which EPA pledged to clarify.

EPA confirmed that the SNUR would mirror the premanufacture notice (PMN) in a way that would clearly state what deviations would be permitted to ensure protections for portions of the PMN about which EPA had identified concerns.  In response to a direct question, Jeff Morris, Ph.D., OPPT Director, confirmed that he personally is looking at each new chemical notification decision to ensure a consistent and coherent approach to chemical reviews.  Dr. Morris assured stakeholders that his engagement would not slow down the PMN review process.

NGO groups, that were ably represented at the meeting, expressed disappointment that they were not a part of the pilot testing component of the new chemicals Points to Consider document. OPPT clarified that the purpose of the pilot was to have parties who are actually preparing PMNs pilot use of the document while preparing PMNs and that as a result, non-PMN submitters were not a part of the pilot.  Following a request from several NGOs, EPA stated that it would of course make the original and redline versions of the Points to Consider document publicly available to ensure full transparency.  Several NGOs also voiced concern with the delay of EPA getting PMN information posted online.  Commenters noted the need for access to more content related to the new chemicals review, such as detailed PMN determinations, as the determinations that are publicly available at this point are boilerplate. Interestingly, concerns were expressed on issues not germane to the workshop, such as existing and accidental releases of chemicals (not related to TSCA).

Of the parties that weighed in on the issue, industry representatives who addressed the issue were supportive of using SNURs to cover reasonably foreseeable conditions of use that are not reflected in the submitted PMNs.  Some NGOs were supportive of the use of SNURs to reduce consent orders, while others stated that SNURs are not an adequate substitute for consent orders and that Congress intended for Section 5(e) orders to come first and to trigger SNURs.  The concern over the use of SNURs rather than consent orders may relate to a concern of chemicals being introduced prior to the SNUR being published in final.  Industry representatives also suggested that EPA seek to scale its information needs appropriately.  For instance, less detailed exposure information should be required for EPA to determine that it has sufficient information on a low hazard chemical.  Similarly, EPA should adjust the hazard profile requirements for a chemical with low exposure.

Chemical Categories:  EPA reviewed the ongoing effort to develop four new chemical categories that could be used in future new chemical reviews.  These are:

  1. Lung Effects Categories:  Polycationic substances (cationic binding); general surfactants; waterproofing agents; and insoluble polymer lung overload;
  2. Photo-Acid Generators (PAG) Category;
  3. Tracer Chemical; and
  4. Perfluorinated Chemicals.

EPA asked for input and ideas on how to move forward with chemical categories -- either by updating existing categories or reviewing internal data to identify new categories -- and how the information should be presented (e.g., to publish separately or together in one document).

OSHA Focus:  On behalf of the TSCA New Chemicals Coalition (TSCA NCC), Richard E. Engler, Ph.D., Bergeson & Campbell, P.C., provided comments that included feedback to EPA that it needs to develop a consultation process with the U.S. Occupational Safety and Health Administration (OSHA) per the Section 5(f) legislative language.  Dr. Engler suggested that EPA’s assessments could be communicated to submitters and OSHA to inform both on the endpoints of concern and EPA’s assessments of safe exposure limits.  In this way, employers are obligated under the Occupational Safety and Health Act to assess hazards and exposures, provide information to workers, and ensure that exposures are controlled under OSHA’s authority, thereby satisfying EPA’s obligation to regulate “to the extent necessary” to protect such workers.

Sustainable Futures Program:  EPA asked for input as to whether it should continue the Sustainable Futures Program.  Some commenters supported the Sustainable Futures Program; no commenters spoke against it.

The presentations from the meeting are listed below and available online:

EPA’s next public meeting on TSCA’s implementation of Existing Chemicals Prioritization is coming up on December 11, 2017.  More information on this upcoming meeting is available on our blog under key phrase public meeting.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 8, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice that it is withdrawing its direct final rule issued on October 25, 2017, to update the voluntary consensus standards that were originally published in the Toxics Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016.  EPA issued both a direct final rule and a proposed rule on October 25, 2017.  EPA states that, due to its receipt of adverse comment on the rule, it must withdraw the direct final rule and proceed with issuing a final rule only after it has considered all of the comments received during the comment period which ended on November 9, 2017. 

The proposed updates apply to emissions testing methods and regulated composite wood product construction characteristics.  EPA states that several of those voluntary consensus standards (i.e., technical specifications for products or processes developed by standard-setting bodies) were updated, withdrawn, and/or superseded through the normal course of business by these bodies to take into account new information, technology, and methodologies.

As a reminder, EPA has extended the compliance dates for the formaldehyde emission standards for composite wood products final rule that was issued on December 12, 2016.  The extensions for compliance are:

  • Emission standards, recordkeeping, and labeling provisions -- from December 12, 2017, to December 12, 2018;
  • Import certification provisions -- from December 12, 2018, to March 22, 2019;
  • Laminated product producer provisions -- from December 12, 2023, to March 22, 2024; and
  • The conclusion of the transition period for California Air Resources Board (CARB) Third-Party Certifiers (TPC) -- from December 12, 2018, to March 22, 2019.

Visit our TSCA Reform News & Information page for more TSCA implementation news and analysis.  You can also sign up for TSCABlog updates to be delivered to your inbox.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 6, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the public comment period to receive information on the five persistent, bioaccumulative, and toxic (PBT) chemicals that are subject to Section 6(h) of the Toxic Substances Control Act (TSCA) which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  Comments were initially due on December 9, 2017; they are now due on January 12, 2018.  EPA states it is interested in information from the public about these chemicals, including uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  Very few comments have been filed regarding these chemicals thus far.  The chemicals and corresponding docket numbers are:

More information on the PBTs is available on our blog under keyword PBTs.

 


 

By Lynn L. Bergeson and Margaret R. Graham

On November 29, 2017, the Senate Environment and Public Works Committee approved the nomination of Andrew R. Wheeler, Esquire for U.S. Environmental Protection Agency (EPA) Deputy Administrator.  Mr. Wheeler currently works as a Principal at Faegre Baker Daniels Consulting providing guidance on federal regulatory and legislative environmental and energy issues.  He began his environmental policy career at EPA in 1991 when he was Special Assistant to the Information Management Division Director in the Office of Pollution Prevention and Toxics (OPPT) during the George H.W. Bush and Bill Clinton administrations.  He also spent many years on Capitol Hill as Chief Counsel to U.S. Senator James Inhofe, and Staff Director and Chief Counsel for two Senate Committees:  the U.S. Senate Committee on Environment and Public Works (EPW) and the U.S. Senate Subcommittee on Clean Air, Climate Change, Wetlands, and Nuclear Safety.  Mr. Wheeler received his JD from Washington University in St. Louis School of Law, and his MBA from George Mason University.  


 

By Lynn L. Bergeson and Margaret R. Graham

On November 30, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of its final determination on whether revision to the current size standards for small manufacturers and processors, which are used in connection with reporting regulations under the Toxic Substances Control Act (TSCA) Section 8(a), is warranted.

The notice states that EPA has made its final determination that revision is warranted based upon three factors, listed below.

  1. Its preliminary determination.  EPA states in the notice that it preliminarily determined that a revision to the size standards is warranted “because of the magnitude of the increase in the [Producer Price Index (PPI)] since the last revision of the size standards and because the current annual sales standard is comparatively low given current revenue-based size standards developed by [the Small Business Administration (SBA)].”  When EPA reviewed the change in the PPI for Chemicals and Allied Products between 1988 and 2015 it found that the PPI has changed by 129 percent, which far exceeds the 20 percent inflation index specified as a level above which EPA may adjust annual sales levels in the current standard if deemed necessary. 
  2. A review of the comments on the preliminary determination.  EPA states that most commenters agreed with its preliminary determination that an update is warranted and several also provided their opinions on how the standards should be revised.  EPA states the actual changes to the standards were out of the scope of this determination, but it will address those issues in the subsequent proposed rulemaking.
  3. Feedback from consultation with the SBA.  SBA’s Office of Advocacy substantively agreed with EPA’s preliminary determination (that a revision to the current size standards is warranted), but it had requested EPA to consider additional factors in reaching that conclusion which EPA did not.  Specifically, the SBA wanted EPA to consider whether the standard is structured appropriately, and wanted EPA evaluate a broader set of factors related to firm and industry characteristics and percentage of firms impacted by Section 8 rules.

More information on these standards is available on our blog item under key phrase size standards.


 

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 Richard E. Engler, Ph.D. and Margaret R. Graham

On November 22, 2017, the U.S. Environmental Protection Agency (EPA) announced it was releasing a preliminary list of chemical substances reported under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) rule that includes substances reported to EPA through November 10, 2017, and that it will be updated approximately once per month.  EPA states that it is making this list available to help keep the stakeholder community informed of the status of reporting under the TSCA Inventory Notification (Active-Inactive) rule.  EPA is providing the list in a downloadable, searchable spreadsheet.  The total number of chemicals on the list is 10,730.  

This total adds substantially to the 13,209 substances that appear on EPA’s list of substances exempt from Form A reporting.  It is important to note that the new list is not an update to the list of interim active substances or to the list of substances exempt from Form A reporting; it is only a list of substances reported via Form A notices of activity through the specified date.  The new list of substances reported by Form As will be useful to processors, allowing them to ensure that key substances are reported as active, but it does not relieve manufacturers or importers from the Form A reporting obligations of the rule.

More information on the TSCA Inventory Notification (Active-Inactive) rule is available on our blog item under key phrase TSCA Inventory


 

By Lynn L. Bergeson and Margaret R. Graham

On December 9, 2016, the U.S. Environmental Protection Agency (EPA) opened five dockets to collect information on five persistent, bioaccumulative, and toxic (PBT) chemicals.  EPA requested information on uses, products containing these chemicals, exposed populations, and alternatives to these chemicals.  These five chemicals were selected on October 11, 2016, to receive expedited action under Section 6(h) of the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which requires EPA to take expedited regulatory action to address risks from certain PBT chemicals.  The deadline to submit comments is fast approaching:  December 9, 2017.  The five chemicals and their corresponding dockets are:

In August 2017, EPA provided background information for each of the five PBT chemicals in the form of use documents which provide a preliminary summary of available information collected by EPA on the manufacturing (including importing), processing, distribution in commerce, use, and disposal of each chemical.  Amended TSCA gives EPA three years to propose rules to reduce risks and exposures from these PBT chemicals to the extent practicable (until June 22, 2019), and EPA must issue the rules in final within 18 months of when they are proposed. 

More information on the PBTs is available on our blog under keyword PBTs.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting.  EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on possible approaches.  Under amended TSCA, EPA is required to establish processes for prioritizing and evaluating risks from existing chemicals.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics:  identifying potential candidates for prioritization:  background, goal, guiding principles, and milestones; overview of TSCA Work Plan methodology; TSCA Work Plan as a tool for identifying potential candidates; Canada’s Chemicals Management Plan; EPA’s Safer Chemicals Ingredients List; Functional Category Approach, based on use and exposure potential; Functional Category Approach, based on chemical structure and function; and systematic integration of traditional and new approaches.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT). 
  • Discussion Document -- Possible Approaches and Tools for Identifying Potential Candidate Chemicals for Prioritization.  EPA states that the discussion document introduces a set of approaches that it is considering to help guide the identification of potential candidates for prioritization, and is intended to be a starting point for a dialogue with stakeholders on best practices for EPA’s activities during this phase.  EPA is asking for input on the approaches presented here, as well as any additional recommendations.

The December 11, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0586 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 25, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 9, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 6, 2017, New Chemicals Review Program Implementation meeting.  NOTE WELL: This is a critically important meeting for companies that innovate in the chemical space and are now preparing Toxic Substance Control Act (TSCA) Premanufacture Notifications (PMN) or will in the future.  EPA states that this meeting will update and engage with the public on EPA’s progress in implementing changes to the New Chemicals Review Program as a result of the 2016 amendments to TSCA, and will include a discussion of EPA’s draft New Chemicals Decision-Making Framework.  The meeting materials include:

  • Agenda for Public Meeting.  The Agenda includes the following topics: the decision-making framework; TSCA orders and Significant New Use Rules (SNUR) in the context of new chemicals review; the Points to Consider document as well as the pilot results and other questions; the decision guidelines manual; chemical categories; sustainable futures; a discussion of questions submitted in advance; and two public comment periods.  Featured speakers are Nancy Beck, Ph.D., Deputy Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OSCPP) and Jeff Morris, Ph.D., Director of the Office of Pollution Prevention and Toxics (OPPT).
  • New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.  EPA states that this document 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.
  • Points to Consider When Preparing TSCA New Chemical Notifications (Draft).  This draft document, dated November 6, 2017, provides concise information to assist submitters in preparing a PMN, Significant New Use Notice (SNUN), or exemption notice (e.g., Low Volume Exemption or LVE) that (1) meets the requirements of TSCA Section 5 and applicable regulations; and (2) facilitates EPA’s review of Section 5 notices by ensuring that the information received accurately and completely reflects the intended manufacture, processing, distribution in commerce, use, and disposal of the new chemical substances subject to the Section 5 notice.  EPA states this is a draft published for comment, but does not specify a deadline for submitting comments.
  • Overview of Comments Received on the Draft "Points to Consider" Document.  This document summarizes 151 comments received on the draft Points to Consider document.  It organizes them by topic.  The topics addressed are aquatic haz/tox; chemistry; data; engineering; environmental release and disposal information; fate; a general category; human health haz/tox; regulatory; release to water; standard review; uses; risk; exposure; and prenotice meetings.  These comments have not been posted in the docket for this meeting.
  • New Chemicals Decision Guidelines Manual – Detailed Outline.  EPA states that this manual will summarize how EPA reviews new chemical submissions and the policies and decision guidelines used in making decisions under TSCA Section 5.  It will provide an overview of both risk assessment and risk management approaches. Further, it is intended to help stakeholders determine what forms of regulation and restrictions on the manufacture, distribution, use, and/or disposal of a new chemical substance may arise from an EPA determination.

The December 6, 2017, meeting will take place from 9:00 a.m. to 5:00 p.m. (EST) at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., in Washington, D.C., and will be available by remote access for registered participants.  Online requests to participate must be received on or before December 5, 2017.  EPA states it plans to utilize the feedback it receives from the public meeting and comments received to improve policy and processes relating to the review of new chemicals under TSCA.  EPA will be accepting questions from the public in advance of the meeting, and will respond to these questions at the meeting as time allows, if such questions are received by November 20, 2017.  Questions and comments can be submitted in Docket No. EPA-HQ-OPPT-2017-0585 on www.regulations.gov with a copy to .(JavaScript must be enabled to view this email address)Registration for this meeting is available online.  In addition to hearing oral comments at the meeting, EPA is also accepting written comments and materials submitted to the docket for this meeting until January 20, 2018.

More information on the subsequent Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations meeting on December 11, 2017, is available in our blog item EPA Schedules Two Meetings to Discuss TSCA Implementation Activities, Requests Comments.


 
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