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, Carla N. Hutton, Charles M. Auer, and Oscar Hernandez, Ph.D.

On January 13, 2017, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would establish a process for conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use.  The process would not consider costs or other nonrisk factors.  Risk evaluation is the second step, after prioritization, in a new process of existing chemical substance review and management established under recent amendments to the Toxic Substances Control Act (TSCA).  The proposed rule identifies the steps of a risk evaluation process, including scope, hazard assessment, exposure assessment, risk characterization, and finally a risk determination.  EPA proposes that this process be used for the first ten chemical substances to be evaluated from the 2014 update of the TSCA Work Plan for Chemical Assessments, chemical substances designated as High-Priority Substances during the prioritization process, and those chemical substances for which EPA has initiated a risk evaluation in response to manufacturer requests.  The proposed rule also includes the required “form and criteria” applicable to such manufacturer requests.  EPA posted a pre-publication version of the proposed rule on its website.  When the proposed rule is published in the Federal Register, it will begin a 60-day comment period.  This is the third foundational rule released during the week of January 9, 2017.  An in-depth memorandum on the proposed risk evaluation process, as well as memoranda regarding EPA’s proposed requirements for TSCA Inventory notification and prioritization process for reviewing existing chemicals, will be available on our website under the key phrase TSCA.


 

By  Lynn L. Bergeson and Molly R. Blessing


As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA).  Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m.  Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.

EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.”  Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.

More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.

Commentary

As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders.  Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”

Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.

This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B))  that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).”  The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination.  We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).  

While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.


 

By Lynn L. Bergeson and Margaret R. Graham

On November 10, 2016, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) reportedly received the U.S. Environmental Protection Agency’s (EPA) draft proposed risk evaluation rule under the amended Toxic Substances Control Act (TSCA), Procedures for Evaluating Existing Chemical Risks Under the Toxic Substances Control Act.  This is a much anticipated procedural rule that will establish EPA’s process for evaluating the risk of so called “high priority” chemicals.  This is the second rule of three Framework Action rules that amended TSCA has directed EPA to issue in final within one year of enactment, or by mid-June 2017.  The Inventory rule, which will require industry reporting of chemicals manufactured/processed in the previous ten years, is expected to be sent to OMB soon.  Whether election transition issues will complicate and perhaps slow the review process is unclear but certainly not unlikely.

More information on the implementation of amended TSCA is available in our TSCA Reform News & Information website and in our TSCA Reform memoranda.


 

By Lynn L. Bergeson and Margaret R. Graham

On July 25, 2016, the U.S. Environmental Protection Agency (EPA) announced its intention to hold two public meetings on August 9, and August 10, 2016, to obtain input on the processes that will be used to prioritize and evaluate chemicals under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act:

  • August 9, 2016:  EPA states that this public meeting will inform its proposed rule on conducting risk evaluations to determine whether a chemical presents an unreasonable risk of injury to health or the environment; and
  • August 10, 2016:  EPA states that this public meeting will inform its proposed rule to establish a risk-based process for chemical prioritization.

The public meetings are scheduled for 9:30 a.m. to 4:30 p.m., and will be held at the Ronald Reagan Building and International Trade Center, Horizon Ballroom, 1300 Pennsylvania Avenue, N.W., Washington, D.C. EPA states that the input obtained during these meetings will be considered as the EPA develops its proposed procedural regulations for risk evaluation and chemical prioritization.  EPA is recommending that any interested participants register in advance.  

More information concerning EPA’s implementation of the amended TSCA is available in our memorandum EPA Publishes First Year Implementation Plan, as well as on the Bergeson & Campbell, P.C. (B&C®) website under Regulatory Developments: TSCA.

Commentary

It is critically important that stakeholders attend and participate in these meetings. While the timing is regrettable in light of vacation schedules, EPA is under intense pressure to issue rules later this year and EPA has no choice other than to keep the process moving.  EPA is to be commended for scheduling these opportunities as quickly as it has, and its efforts should be acknowledged by robust stakeholder engagement.


 

Bergeson & Campbell, P.C. (B&C®) has learned that the U.S. Environmental Protection Agency (EPA) is planning to convene a stakeholder workshop in Washington, D.C. on August 9-10, 2016, for a public dialogue on prioritization and risk evaluation.  We also understand that EPA may host an industry meeting on August 11-12, 2016, to consult on fees.  The dates and topics will be confirmed when EPA makes announcements in the Federal Register.


 

On June 22, 2016, the U.S. Environmental Protection Agency (EPA) rolled out its new Frank R. Lautenberg Chemical Safety for the 21st Century Act Frequent Questions webpage.  This webpage will be a resource for Toxic Substances Control Act (TSCA) reform-related updates and implementation plans.  EPA has also posted a summary of key provisions, its six essential principles for reform of chemicals management legislation, the presentation from its informational webinar on June 30, 2016, in which EPA provided an overview of the new TSCA, and an unofficial version of TSCA as recently amended.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 29, 2016, the U.S. Environmental Protection Agency (EPA) posted an Implementation Plan that outlines EPA’s plans for early activities and actions under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, legislation that significantly amends many of the provisions of the Toxic Substances Control Act (TSCA).  The amended TSCA has been identified as Public Law Number (Pub. L. No.) 114-182.  EPA notes that the new law imposes new responsibilities on EPA, while providing “comparatively short” deadlines to implement them.  EPA “takes these responsibilities and deadlines seriously,” and intends for the Implementation Plan to be a roadmap of the major activities on which EPA will focus during the initial year of implementation.  EPA organizes the Implementation Plan by the statutory timeframes during which the activities must be completed, rather than by what is of importance to EPA.  EPA states that the Implementation Plan is a living document, and EPA will further develop it over time.  EPA cautions that the Implementation Plan “is NOT intended to be a comprehensive listing of all requirements in the new law.” 

Bergeson & Campbell, P.C. (B&C®) is pleased that EPA is making strong early efforts to communicate and engage with stakeholders about its early implementation of the new TSCA and its thinking regarding specific provisions.  Completing the items listed in the Implementation Plan represents a prodigious amount of work for EPA over the coming months and years.  Stakeholders will need to be prepared to respond thoughtfully to rules, lists, and process descriptions as they appear in the Federal Register, or as they are posted.

More information on EPA’s Implementation Plan is available in our memorandum TSCA Reform: EPA Publishes First Year Implementation Plan.


 
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