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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.


 

By Lynn L. Bergeson and Margaret R. Graham

On January 19, 2017, the U.S. Environmental Protection Agency (EPA) issued a Federal Register notice announcing it will be holding a public meeting to receive public input and information on uses and conditions of use for the initial ten chemicals to be evaluated under Section 6(b)(2)(A) of the amended Toxic Substances Control Act (TSCA) on February 14, 2017, from 9:00 a.m. to 3:00 p.m. (EST), at the Ronald Reagan Building and International Trade Center, Polaris Room, 1300 Pennsylvania Avenue Northwest, Washington, DC 20004.  82 Fed. Reg. 6545.  EPA states that the information it gathers on uses and the conditions of use will assist it in identifying potential exposure scenarios for the ten chemicals.

Registration is available online and remote access will be available for registered participants.  Public dockets for each chemical have been established. Written comments and materials will also be accepted in these dockets on www.regulations.gov.  EPA requests for them to be submitted by March 1, 2017.

Additional information, including links to the public dockets, is available on EPA’s website and in our blog item EPA Announces Initial List of TSCA Section 6 Chemicals for Risk Evaluation.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) has just announced that its Office of Pollution Prevention and Toxics (OPPT) is holding a meeting on December 14, 2016, from 9:00 a.m. to 12:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act.  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.”  During the meeting, interested parties will have the opportunity to provide input on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMN), microbial commercial activities notices (MCAN), and significant new use notices (SNUN), under TSCA Section 5.  EPA states that information obtained during this meeting and from submitted written comments will be considered as it works to implement the new requirements and increase efficiency in its review process under TSCA. 

There has been considerable concern with the impact of new TSCA on EPA’s New Chemicals Program.  EPA is to be recognized for seeking stakeholder input, and interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can reasonably achieve from 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.

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.  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.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 9 and August 10, the U.S. Environmental Protection Agency (EPA) held two public meetings to obtain input prior to development of a proposed rule for chemical risk evaluation (August 9) and a proposed procedural rule regarding prioritization of chemicals for further risk evaluation (August 10) under the new Toxic Substances Control Act (TSCA).  Bergeson & Campbell, P.C.’s (B&C®) Oscar Hernandez, Ph.D. and Richard E. Engler, Ph.D. were in attendance, and offer the following highlights.

On August 9, many speakers across different stakeholder groups flagged issues in terms of how EPA should conduct the chemical risk evaluation process:

  • EPA must determine compatibility of information from third parties, e.g., assessment documents from other groups including within EPA, with TSCA Section 26 standards;
  • EPA needs to improve its exposure methodologies, and develop new ones; EPA needs to modify its exposure ranking to acknowledge that chemical intermediates are typically consumed in the manufacture of a product and do not represent a primary source of exposure, especially outside of the production facility;
  • Transparency throughout the risk evaluation process is critical;
  • EPA is required to use best available science and weight-of-evidence;
  • Potentially exposed and susceptible subpopulations should include workers, pregnant women, infants, fence-line populations, and consider the lifestyles (especially diets) of native populations as appropriate under the conditions of use; and
  • EPA should undertake a tiered approach to testing, to minimize vertebrate testing and cost, as new TSCA requires.

As for the content of the actual chemical risk evaluation rule, stakeholders made the following comments:

  • The rule should include more content beyond procedures by incorporating definitions for key items such as “weight of scientific evidence” and other scientific standards, and codifying criteria for evidence evaluation;
  • The final reports should explicitly identify low exposure/low risk uses considered in the development of the Risk Evaluation; and
  • Whether legal scientific requirements under TSCA Sections 6 and 26 need to be reflected in the procedural rule, and not be relegated to guidance documents – there was some disagreement on the best course of action on this issue.

A link to the agenda for the August 9, 2016, public meeting is available hereEPA’s risk evaluation meeting presentation is available here.

On August 10, comments made during the prioritization procedural rule meeting sessions were similar to those made at the August 9 meeting, with an emphasis on the application of Section 26 scientific standards.  A few speakers expressed reservations about the prioritization methodology that EPA currently uses and suggested some alternative approaches.

A link to the agenda for the August 10, 2016, public meeting is available hereEPA’s prioritization procedural rule meeting presentation is available here.


 

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.