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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.  


 

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 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.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 6, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register in which it will announce two meetings to discuss implementation activities under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 20th Century Act, as well as request public comments.  The meetings are:

  • New Chemicals Review Program Implementation Meeting:  December 6, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s first 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.  EPA will describe its review process for new chemical substances under the amended statute and interested parties will have the opportunity to provide input and to ask questions.  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.govRegistration for this meeting is available online.
  • Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations Meeting:  December 11, 2017, from 9:00 a.m. to 5:00 p.m. (EST).  EPA’s second meeting will focus on possible approaches for identifying potential candidate chemical substances for EPA’s prioritization process under TSCA.  As amended, TSCA required that EPA establish processes for prioritizing and evaluating risks from existing chemical substances.  EPA will describe and take comment on a number of possible approaches that could guide it in the identification of potential candidate chemical substances.  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.govRegistration for this meeting is available online.

Online requests to participate in either meeting must be received on or before December 5, 2017.  Both meetings will be held 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. EPA states that more information on the specifics of the meetings will be made available in the dockets and on EPA’s website prior to the meeting.


 

By Lynn L. Bergeson and Kathleen M. Roberts

On October 12, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register announcing the cancellation of the fourth meeting of the Negotiated Rulemaking Committee for Chemical Data Reporting (CDR) requirements for inorganic byproducts (Reg Neg Committee) scheduled for October 25-26, 2017.  82 Fed. Reg. 47423. 

During their September 13-14, 2017, meeting, the members of the Reg Neg Committee concluded that further dialogue within the Committee context would be unproductive, and that the fourth meeting was not necessary.  EPA is, however, still providing the public an opportunity to weigh in on the legislative directive to reduce the CDR reporting burden for inorganic substances that are recycled, while maintaining EPA’s access to exposure information needed for risk assessment purposes.  The notice states that the Reg Neg Committee docket will remain open until December 11, 2017, to allow for public comment.

The Reg Neg Committee was established to respond to the legislative mandate under Section 8(a)(6)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which states:

The [EPA] Administrator shall enter into a negotiated rulemaking … to develop and publish … a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.

During the first set of Reg Neg Committee meetings, EPA stressed its desire to implement the outcome of the Reg Neg Committee work during the next CDR reporting cycle in 2020.  To achieve this timeline, the Committee would need to reach a consensus on an approach or approaches by the October 2017 meetings.   While several different stakeholder organizations offered proposals for consideration, it became clear to Committee members during the September 14-15, 2017, meeting that those proposals would not have consensus support because they either required considerable further refinement and discussion beyond the October 2017 timeframe; did not provide EPA with appropriate exposure information needed for risk assessment; or did not adequately achieve the mandated goal of limiting reporting requirements. 

It is unclear if EPA will be able to complete the myriad of tasks needed to take a proposal received during the public comment period to final implementation before the 2020 CDR reporting cycle, as this would require EPA to complete a thorough analysis of additional proposals, consider potential impacts to the EPA offices, develop a proposed rulemaking, obtain public review and comment on the proposal, issue a final rulemaking, and provide clear and detailed guidance on the new approaches for reporting on recycled inorganic products prior to the 2020 CDR reporting cycle. 

More information on the negotiated rulemaking process as related to inorganic byproducts is available on our blog under key phrases negotiated rulemaking and inorganic byproducts.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 18, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish a notice in the Federal Register stating that it will be holding the third and fourth committee meetings of the Negotiated Rulemaking Committee (NRC) on September 13, 2017, from 9:00 a.m to 5:00 p.m. (EDT) to September 14, 2017, from 9:00 a.m to 3:00 p.m. (EDT); and on October 25, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) to October 26, 2017, from 9:00 a.m. to 3:00 p.m. (EDT).  The third meeting will take place at the Ronald Reagan Building and International Trade Center, Oceanic Suite, 1300 Pennsylvania Avenue N.W., Washington, D.C. 20004, while the fourth meeting will be held at the William Jefferson Clinton East Building, Room 1153, 1201 Constitution Avenue N.W., Washington, D.C. 20004.  Both meetings are open to the public.

The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  Kathleen M. Roberts, Vice President of B&C® Consortia Management, L.L.C. (BCCM), an affiliate of Bergeson & Campbell, P.C. (B&C®), is on the NRC on behalf of a BCCM client.  EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than one week prior to the meeting dates (September 6, 2017; and October 19, 2017).  Information about attending these meetings and their agendas will be posted to the NRC website.   More information regarding the NRC is available on our blog under key phrase Negotiated Rulemaking


 

By Lynn L. Bergeson and Margaret R. Graham

On June 5, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice of public meetings and a notice regarding the establishment of the Negotiated Rulemaking Committee (NRC).  The NRC’s objective is to “negotiate a proposed rule that would limit chemical data reporting requirements under Section 8(a) of the Toxic Substances Control Act (TSCA), [as amended], for manufacturers of any inorganic byproduct chemical substances when such byproduct chemical substances are subsequently recycled, reused, or reprocessed.”  The prepublication version is available online.  

EPA’s notice lists the stakeholder groups from which EPA plans to invite representatives to participate as members of the Committee -- all of whom have been “identified as having a definable stake in the outcome of the proposed requirements”: 

  • Inorganic chemical manufacturers and processors, including metal mining and related activities;
  • Recyclers, including scrap recyclers;
  • Industry advocacy groups;
  • Environmental advocacy groups; and
  • Federal, State, and Tribal governments.

The first meeting will be held on June 8, 2017, from 9 a.m. to 5 p.m. (EDT) and on June 9, 2017, from 9 a.m. to 3:00 p.m. (EDT).  The second Committee meeting will be held on August 16, 2017, from 9 a.m. to 5 p.m. (EDT) and on August 17, 2017, from 9 a.m. to 3:00 p.m. (EDT).  Both meetings will be held at EPA’s Headquarters in Washington, D.C.

More information on the NRC is available on our blog under key phrase negotiated rulemaking.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 2, 2017, the U.S. Environmental Protection Agency (EPA) announced it would convene a public meeting to clarify and discuss the process of negotiated rulemaking on changes to Chemical Data Reporting (CDR) requirements for inorganic byproducts.  The meeting will be held on May 9, 2017, from 9:00 a.m. to 5:00 p.m. (EDT) and on May 10, 2017, from 9:00 a.m. to 3:00 p.m. (EDT), in Washington, D.C. at the Capital Hilton, 1001 16th Street, N.W, in the General Session Room (South American AB). 

On December 15, 2017, EPA published a notice in the Federal Register of its intention to establish a Negotiated Rulemaking Committee (NRC) under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act.  81 Fed. Reg. 90843.  The NRC will implement the amended Toxic Substances Control Act (TSCA) Section 8(a)(6) requirement that EPA “enter into a negotiated rulemaking … to develop and publish, not later than 3 years after the date of enactment … a proposed rule providing for limiting the reporting requirements under this subsection for manufacturers of any inorganic byproducts, if the byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed.”  EPA states that it is holding this public meeting prior to the establishment of that NRC to “exchange information and clarify a number of aspects of inorganic byproduct identification and reporting.”

EPA states that written comments can be submitted at any time during the negotiated rulemaking process, but is asking for written comments to be e-mailed to .(JavaScript must be enabled to view this email address) no later than May 8, 2017.  Parties interested in making an oral presentation at the meeting should submit requests by e-mail to .(JavaScript must be enabled to view this email address) no later than May 8, 2017, to be placed on the list of public speakers.  As there are many questions about the scope of the negotiated rulemaking and the process that the initiative will follow, interested stakeholders are urged to participate.

Information about attending this meeting and its agenda will be posted to the NRC website.  More information on the establishment of the NRC is available in our blog item EPA To Establish Negotiated Rulemaking Committee Under Amended 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.


 
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