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 September 1, 2017, the Environmental Defense Fund (EDF) filed a petition for review in the U.S Court of Appeals for the D.C. Circuit (No. 17-1201) of the U.S. Environmental Protection Agency’s (EPA) final Toxic Substances Control Act (TSCA) framework rule TSCA Inventory Notification (Active-Inactive) Requirements, published on August 11, 2017 (82 Fed. Reg. 37520). 

This is the third and final challenge by EDF to the framework rules implementing amended TSCA (there are only three framework rules), but the seventh total challenge, as other parties have also petitioned for review.  On August 11, 2017, EDF petitioned for review of the TSCA framework rules Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation, filed on August 11 (Second Cir. Case Nos. 17-2464 and 17-2403, respectively).  Per the Consolidation Orders of the United States Judicial Panel on Multidistrict Litigation, both of EDF’s August 11 petitions have now been consolidated with other petitions for review of the same orders.  Case No. 17-2464 was moved to the Fourth Circuit, and Case No. 2403 was moved to the Ninth Circuit. 

In the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017.  In the Ninth Circuit, the Petitioners’ briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017.                                       


 

By Lynn L. Bergeson and Margaret R. Graham

On August 10, 2017, and on August 11, 2017, petitions for review of two of the U.S. Environmental Protection Agency’s (EPA) final “framework rules” issued under the amended Toxic Substances Control Act (TSCA) were filed in federal court.  These six lawsuits seek review of the final rule Procedures for Chemical Risk Evaluation under TSCA and the final rule Procedures for Prioritization of Chemicals for Risk Evaluation under TSCA.  The petitions were filed by Safer Chemicals, Healthy Families, et al. on August 10, 2017 (Cases 17-72260 and 17-72259); the Alliance of Nurses for Healthy Environments, et al. (including the Natural Resources Defense Council) on August 11, 2017 (Cases 17-1926 and 17-1927 (consolidated)); and the Environmental Defense Fund (EDF) on August 11, 2017 (Cases 17-2464 and 17-2403), in the U.S. Court of Appeals for the Ninth, Fourth, and Second Circuits, respectively.  In the Ninth Circuit, the Petitioner’s Briefs are due October 30, 2017, and Respondent EPA’s briefs are due November 28, 2017; in the Fourth Circuit, the opening brief, record from agency, and the appendix are due September 20, 2017, and the response brief is due October 20, 2017; in the Second Circuit, a briefing schedule has not been posted yet. 

In its petitions for review, Safer Chemicals, Healthy Families, et al. state that they challenge the rules as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; in excess of statutory jurisdiction, authority, or limitations; and without observance of procedure required by law.” On the Safer Chemicals, Healthy Families’ website, the organization states that the petitions allege the rules “fail to provide the protections against unsafe chemicals that Congress required in the critical priority-setting and risk evaluation provisions of the new law, which are intended to ensure that unreasonable risks to health and the environment are fully assessed and eliminated.”  In its petitions for review, EDF does not list any details as to why it is seeking review (nor do the rules require petitioners to do so), but on its website it states that “EPA has issued framework rules that violate the letter and intent of the law,” and that EDF has filed lawsuits challenging those rules and “will continue to monitor EPA’s actions to ensure EPA complies with the law and protects public health.”  The petitions for review filed by the Alliance of Nurses for Healthy Environments, et al. do not list any details as to why they are seeking review. 


 

By Lynn L. Bergeson and Margaret R. Graham
  
On August 7, 2017, the U.S. Environmental Protection Agency (EPA) issued a press release stating that it has eliminated the new chemical backlog of over 600 chemicals:  “[t]he current caseload is back at the baseline and now in line with the typical active workload.”  The press release also announces improvements to new chemical safety reviews, which include operating principles, improvement of EPA’s Toxic Substances Control Act (TSCA) new chemicals program, and further transparency, as detailed below. 

EPA states it is committing to the following operating principles in its review of new chemicals:

  • Where the intended uses in premanufacture notices (PMN) or other TSCA Section 5 notices (such as low volume exemption (LVE) requests) raise risk concerns, EPA will work with submitters, and, if the submitters submit timely amended PMNs addressing those concerns, EPA will generally make determinations based on those amended submissions.
  • Where EPA has concerns with reasonably foreseen uses, but not with the intended uses as described in a PMN or LVE application, as a general matter, those concerns can be addressed through significant new use rules.
  • As described in the risk evaluation rule released on June 22, 2017, identification of reasonably foreseen conditions of use will be fact-specific.  It is reasonable to foresee a condition of use, for example, where facts suggest the activity is not only possible, but, over time under proper conditions, probable. 
  • The purpose of testing in a Section 5 order is to reduce uncertainty in regard to risk.  Specifically, it is to address risk concerns that gave rise to a finding of “may present unreasonable risk” or another Section 5 finding other than “not likely to present unreasonable risk.”  In addition, consistent with the statute, any request for testing by EPA will be structured to reduce and replace animal testing as appropriate.

EPA states it will continue to improve of its TSCA new chemicals program in the following ways:

  • Redeploying staff to increase the number of Full-Time Equivalent (FTE) staff working on new chemicals;
  • Initiating a LEAN exercise (via EPA’s new time-saving and cost-effective tools) to streamline work processes around new chemicals review; and
  • Institutionalizing a voluntary pre-submission consultation process so that submitters have a clear understanding of what information will be most useful for EPA’s review of their new chemical submission, and of what they can expect from EPA during the review process.  While such engagement prior to submission is an additional up-front time and resource commitment by submitters and EPA, it should more than pay for itself with faster, better-informed EPA reviews.

EPA states it needs to be more transparent in how it makes decisions on new chemicals under TSCA, and will be instituting the following to implement that goal:

  • In Fall 2017, EPA’s Office of Pollution Prevention and Toxics (OPPT) intends to release, for public comment and stakeholder engagement, draft documents that will provide the public with more certainty and clarity regarding how EPA makes new chemical determinations and what external information will help facilitate these determinations;
  • EPA will facilitate a public dialogue on its goal of continued improvement in the new chemicals review program; and
  • EPA will continue posting weekly web updates of program statistics, so that manufacturers and the public can determine the disposition of cases as quickly as possible.

 
 < 1 2 3