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 Carla N. Hutton
 
On September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.”  The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance.  EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document.  EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents.  The final rule will be effective 30 days after publication in the Federal Register.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule.  EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.”  The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
     
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
     
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
     
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020.  85 Fed. Reg. 15396.  EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.”  On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020.  EPA anticipates promulgating a final rule later in 2020.  More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 

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.