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

On Friday, July 22, 2016, the U.S. Environmental Protection Agency (EPA) posted the first four Toxic Substances Control Act (TSCA) Section 5(a) determinations made following review of pre-manufacture notifications (PMN) according to TSCA as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, Pub. L. No. 114-182 (Lautenberg).  EPA’s determination on all four chemical substances was “not likely to present and unreasonable risk,” under new TSCA Section 5(a)(C)(3).  The PMN Case Numbers, Chemical Identities, a summary of the determination, the decision dates, as well as the links to the determinations themselves are below.  The review start date for all of these determinations was the date of Lautenberg’s enactment, June 22, 2016.  Bergeson & Campbell, P.C. (B&C®) is reviewing these determinations and will provide an analysis.

  • P-16-0281:  Generic: Fatty Alcohols-Dimers, Trimers, Polymers.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low health hazard concern and low environmental toxicity.”  The decision was issued on July 15, 2016.
  • P-16-0292:  Generic: Depolymerized Waste Plastics.  EPA determined that “[t] he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.  Although EPA estimated that the new chemical substance would be very persistent, this did not indicate a likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.”  The decision was issued on July 20, 2016.
  • P-16-0301: Generic:  Propyl Silsesquioxanes, Hydrogen-Terminated.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental hazard.”  The decision was issued on July 20, 2016.
  • P-16-0302:  Generic:  Organic Modified Propyl Silsesquioxane.  EPA determined that “[t]he chemical substance is not likely to present an unreasonable risk based on low human health hazard and low environmental toxicity. Although EPA estimated that the new chemical substance would be very persistent, this did not indicate likelihood that the chemical substance would present an unreasonable risk, given that the chemical substance has low potential for bioaccumulation, low human health hazard, and low environmental hazard.”  The decision was issued on July 20, 2016.

 

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 30, 2016, from 2:00 p.m. to 3:00 p.m. (EDT), the U.S. Environmental Protection Agency (EPA) hosted an informational webinar on the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Public Law No. 114-182.  A link to the presentation is available online. The topics from the webinar included:

  • Major Improvements over Current Law;
  • Specific Requirements for Existing Chemicals;
  • Testing Authority;
  • Confidential Business Information;
  • Source of Funding; and
  • State-Federal Partnership, among others.

More information concerning EPA’s implementation of the Act is available on EPA’s website.

 

Tags: EPA, TSCA, webinar

 

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.


 

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.

 


 

On June 7, 2016, the Senate passed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) by voice vote and sent it to President Obama for signature. As reported in our May 26, 2016, memorandum, "An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA," the Act includes new requirements in Sections 4, 5, 6, and 8 of the Toxic Substances Control Act (TSCA). These new requirements, among others, will need to be met in promulgating currently proposed regulations, as well as in proposing/promulgating future regulations.

One important change in this regard is the way that Lautenberg changes the requirements on the U.S. Environmental Protection Agency (EPA) when it includes articles within the scope of Section 5(a)(2) Significant New Use Rules (SNUR). Several relatively recent SNURs, as proposed, included imported/processed articles within their scope and would be affected by this amendment if the article provisions are retained in a final rule. Examples include proposed SNURs on certain polybrominated diphenylethers (PBDE), toluene diisocyanates (TDI), and long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemicals.

One interesting question to consider is the need for EPA to re-propose these SNURs if it intends to retain the requirements on imported/processed articles in the final rule. If these provisions are retained, it appears that EPA would need to re-propose the rule at a minimum to satisfy the requirement at Lautenberg Section 5(a)(5) that EPA make an affirmative finding that the reasonable potential for exposure to the chemical through the article or category of articles justifies notification.

In addition, EPA's Spring 2016 Regulatory agenda lists several SNURs under TSCA that are at the proposed rule stage, including SNURs for alkylpyrrolidone products and certain uses of trichloroethylene (TCE). These rulemakings would need to address the Lautenberg changes in the proposal.

The Spring 2016 Regulatory agenda also lists three proposed rulemakings under TSCA Section 6(a), and a TSCA Section 4 test rule. The former will be affected by Lautenberg while the latter may be affected depending on the approach taken as discussed in our memorandum.

Read the full memorandum,  TSCA:  What Effect Will the TSCA Amendments Have on Proposed and Future Rulemakings?, online.


 
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