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 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.


 

In a June 22, 2016, blog post on The Hill's Congress Blog, Lynn L. Bergeson laid out four reasons why the American public has reason to celebrate the signing into law of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, “a comprehensive and vastly improved domestic chemical management law”:

  • Reformed Toxic Substances Control Act (TSCA) strikes the requisite balance between Congressional specificity and Agency discretion.
  • Reformed TSCA addresses the law’s most celebrated deficits.
  • Reformed TSCA gives the U.S. Environmental Protection Agency (EPA) authority to do its job:  manage chemical risks.
  • Reformed TSCA ensures greater transparency and public engagement in the chemical evaluation process.

Read the full blog post at The Hill: TSCA reform: renewing public confidence in chemical control.

 


 
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