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, Susan M. Kirsch, and Margaret R. Graham

On November 29, 2018, the U.S. Senate Committee on Environment and Public Works (EPW) held a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP).  The hearing was webcast and is available on the EPW Committee website.

In a rare sharing of bipartisan support for a Trump Administration nominee, Senator Sheldon Whitehouse (D-RI) introduced Ms. Dunn, stating “Ms. Dunn has a deep passion for working with communities, for environmental justice, and for leveraging the expertise of nongovernmental organizations.”  Senator Tom Carper (D-DE) stated he was encouraged by her plans for the office.  Ms. Dunn assured lawmakers that, if confirmed, she will “commit to implementing the law, following the law, and bringing all the provisions of the law to full effect.”  Dunn also emphasized her intention, if confirmed, to leverage the experience and expertise of EPA career staff, including establishing “open door” hours dedicated to connecting with career staff.  Dunn’s written testimony is available on the EPW Committee website.  Senators may submit additional questions for the record (QFR) through November 29, 2018, for Ms. Dunn’s response by December 3, 2018.  It is being reported that Ms. Dunn could be confirmed as early as next week assuming there are no objections.

Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year.  Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans.  More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.


 

By Lynn L. Bergeson and Margaret R. Graham

The U.S. Senate Committee on Environment and Public Works (EPW) will hold a hearing on the nomination of Alexandra Dapolito Dunn to be the U.S. Environmental Protection Agency (EPA) Assistant Administrator (AA) for EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) on Thursday, November 29, 2018, at 10:30 a.m. (EST) in room 406 of the Dirksen Senate Office Building.  The hearing will be webcast and will be available on the EPW Committee website.

Ms. Dunn has been serving as the Regional Administrator for EPA’s New England Region (Region 1) since January of this year.  Prior to joining EPA, Ms. Dunn served as Executive Director and General Counsel for the Environmental Council of the States (ECOS), a national nonprofit, nonpartisan organization committed to helping state agencies improve environment outcomes for Americans. While at ECOS, Ms. Dunn helped state governments improve water infrastructure, reduce air pollution, clean up contaminated sites, manage chemical safety, and enhance economic development.  Before joining ECOS, Ms. Dunn was Executive Director and General Counsel for the Association of Clean Water Administrators.  Ms. Dunn was also a former chair of the American Bar Association’s (ABA) Section of Environment, Energy, and Resources (SEER).  More information on Ms. Dunn’s experience and accolades is available in EPA’s press release announcing her nomination.


 

By Christopher R. Bryant and Lynn L. Bergeson

According to press reports, Nancy Beck, Ph.D., DABT has been hired as the Principal Deputy Assistant Administrator for the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP).  Dr. Beck holds a doctorate in environmental health from the University of Washington.  For the past five years she served as the Senior Director for Regulatory Science Policy at the American Chemistry Council (ACC).  For a decade prior to ACC, she was an analyst within the White House’s Office of Management and Budget (OMB).

Despite Dr. Beck’s compelling credentials, the appointment has displeased some stakeholders.  Dr. Beck has been a staunch critic of how EPA conducts chemical risk assessments and its Integrated Risk Information System (IRIS).  President Trump is proposing to eliminate IRIS; it thus is unlikely that Dr. Beck would revive or rely upon it in implementing the recently revised Toxic Substances Control Act (TSCA).  Less than two months ago, Dr. Beck provided testimony before the Senate Homeland Security and Government Affairs Subcommittee on Regulatory Affairs and Federal Management calling for changes to EPA’s risk assessment processes. 


 

By Lynn L. Bergeson, Oscar Hernandez, Ph.D., Lara A. Hall, MS, RQAP-GLP, and Margaret R. Graham

On December 29, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice regarding the availability of final test guidelines, OCSPP Series 850 Group A -- Ecological Effects, part of a series of test guidelines established by the Office of Chemical Safety and Pollution Prevention (OCSPP) for use in testing pesticides and chemical substances to develop data for submission to EPA under the Federal Food, Drug and Cosmetic Act (FFDCA), the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).  The notice states that these test guidelines “serve as a compendium of accepted scientific methodologies and protocols that are intended to provide data to inform regulatory decisions,” and they “provide guidance for conducting the test, and are also used by EPA, the public, and companies that submit data to EPA.”  The test guidelines will be accessible through EPA Docket ID Numbers EPA-HQ-OPPT-2009-0150 through EPAHQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576 on www.regulations.gov.

The changes to test guidelines are varied.  Some of the changes include:

  • Simple cosmetic changes, e.g., presentation of test conditions, test validity criteria, and equations for calculating response measurements;
  • Housekeeping changes, e.g., the addition of final versions of draft guidelines that had not been prepared in final yet;
  • The addition of a limit test option to several acute invertebrate toxicity tests;
  • Changes from “cut off” dosages in existing guidelines to limit concentrations and a change in the limit concentration for industrial chemicals from “1,000 milligrams/liter (mg/L)” to “100 mg/L” for acute toxicity tests and “10 mg/L” for chronic tests; and
  • Changes to terminology, e.g., to clarify 10-day versus acute exposures for sediment-dwelling invertebrate toxicity tests and saltwater versus marine conditions.

The final test guidelines may be of unique interest to TSCA stakeholders.  The addition of a limit test option aligns well with the new TSCA mandate to reduce vertebrate testing.  This change facilitates test plan design, including tiered approaches for initial testing for premanufacture notices (PMN).  EPA notes that certain guidelines were not issued in final, but remain available for reference as draft guidelines.  In that certain ecological effects guidelines relate to guidelines already developed for the Endocrine Disruptor Screening Program (EDSP), EPA notes that it will consider test design elements from the relevant EDSP guidelines in the development of OSCPP 850 series guidelines.

Bergeson & Campbell, P.C (B&C®) will prepare a more detailed comparison soon.