By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Margaret R. Graham, M.S.
On February 20, 2019, during a cold, snow-filled winter day, the rugged staff of Bergeson & Campbell, P.C. (B&C®) as well as several hearty senior U.S. Environmental Protection Agency (EPA) officials got together over some steaming cups of coffee and discussed the upcoming fate of the Toxic Substances Control Act (TSCA) during a Bloomberg-hosted, B&C-developed webinar: Chemical Policy Summit Series Part V: Chemical Regulation After the Mid-Terms: What We Can Expect to See in 2019.
In attendance were: The Honorable Alexandra Dapolito Dunn, the newly appointed Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP); Jeffery T. Morris, Ph.D., Director, Office of Pollution Prevention and Toxics (OPPT); Rick P. Keigwin, Jr., Director of the Office of Pesticide Programs (OPP); Beau Greenwood, Executive Vice President, Government Affairs, CropLife America; Lynn L. Bergeson, Managing Partner of B&C; and James V. Aidala, Senior Government Affairs Consultant, B&C. Ms. Dunn, Dr. Morris, and Mr. Keigwin described their priorities in the webinar. Ms. Dunn stated 2019 “is going to be one of those buckle-your-seat-belt kind of years” in relation to getting everything done as required under TSCA. Some of the takeaways from that webinar are listed below.
TSCA Milestones: 2019 and Beyond
- EPA must complete the first ten risk evaluations by December 2019, with a possible extension up to June 2020; EPA may need to take advantage of the extension;
- By April 2019, EPA will need to release the “20 high- and 20 low-” priority candidate chemicals;
- EPA released its first draft chemical risk evaluation -- Colour Index (C.I.) Pigment Violet 29 -- on which many comments were submitted. EPA realized that this selection was challenging given certain data ownership issues and restrictions on those data occasioned by European Union’s (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation issues; therefore, this initial evaluation was not the best representation of how the other evaluations will be conducted (more information on the risk evaluation is available in our memo EPA Publishes First Draft TSCA Chemical Risk Evaluation);
- EPA is using a new risk assessment program process called “Systematic Review” that has been used in non-risk assessment fields; EPA is the first agency to use this process. EPA welcomes input on the process and stated that the National Academy of Sciences (NAS) will be reviewing this process as well;
- In March 2019, EPA will release a proposed rule outlining how it will review and substantiate all Confidential Business Information (CBI) claims seeking to protect the specific chemical identities of substances on the confidential portion of the TSCA Inventory; and
- EPA will be proposing its rule to regulate five persistent, bioaccumulative, and toxic chemicals by June 2019; EPA will be using a different approach than what is typically used for risk assessments.
Approving New Chemicals:
- EPA intends to explore its process for new chemical review to be more predictable and to make reviews final within 90 days;
- EPA will post “frequently asked questions” documents to help chemical manufacturers submit clearer applications online;
- EPA is urging pre-submission meetings between premanufacture notice (PMN) submitters and EPA staff prior to submitting a PMN for a new product to reduce agency time spent clarifying omissions; and
- EPA has pledged to make all PMNs, all health and safety studies, attachments, amendments and other associated information available in public dockets.
B&C’s other upcoming seminars and webinars are available here. Some other resources of interest are B&C’s newly minted TSCA Tutor™ Modular Training Program which provides live in-person training at a company’s site, live online training, and pre-recorded webinar training modules -- all designed to offer expert, efficient, and essential TSCA training; as well as B&C’s All Things Chemical™ Podcasts, which provide intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals.
By Lynn L. Bergeson
On February 5, 2019, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced the launch of its Twitter account, @EPAChemSafety. EPA states that this account will post the latest news on chemicals and pesticides including updates on its chemical review initiatives under the Toxic Substances Control Act (TSCA) and information on upcoming webinars and public meetings.
By Lynn L. Bergeson, Christopher R. Bryant, and Margaret R. Graham
In the last hours of the 115th Congress, the Senate on January 2, 2019, approved the nominations of three individuals to serve in key environmental posts:
- Alexandra Dapolito Dunn -- EPA Toxics Office: The Senate approved the nomination of Alexandra Dunn to serve as the Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). Ms. Dunn had been serving as the administrator for EPA Region 1. She previously was executive director and general counsel for the Environmental Council of the States (ECOS). Prior to joining ECOS, Ms. Dunn served as executive director and general counsel for the Association of Clean Water Administrators. Ms. Dunn also has extensive experience in environmental education, having served as dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University. In addition, she has taught at the Columbus School of Law, Catholic University of America, and, most recently, as an adjunct associate professor of law at the American University’s Washington College of Law. Ms. Dunn received a B.A. in political science from James Madison University and a J.D. from the Columbus School of Law. More information on Ms. Dunn’s confirmation hearing is available in our blog item Senate EPW Committee Holds Hearing on Nomination of Alexandra Dunn to Lead OCSPP.
- Mary Neumayr -- CEQ: The Senate also approved the nomination of Mary Neumayr to head the White House’s Council on Environmental Quality (CEQ). Ms. Neumayr currently serves as chief of staff for the CEQ. Prior to joining CEQ in March of 2017, she served in a variety of positions with the Committee on Energy and Commerce in the U.S. House of Representatives, including Deputy Chief Counsel, energy and environment in 2017; Senior Energy Counsel from 2011 to 2017; and Counsel from 2009 to 2010. Ms. Neumayr also served as Deputy Counsel for environment and nuclear programs at the U.S. Department of Energy from 2006 to 2009, and Counsel to the Assistant Attorney General for the environment and natural resources division at the U.S. Department of Justice from 2003 to 2006. Prior to her government service, Ms. Neumayr was in private legal practice from 1989 to 2003. She received her B.A. from Thomas Aquinas College and her J.D. from the University of California, Hastings College of the Law.
- Kelvin Droegemeier -- OSTP: Finally, the Senate also approved Kelvin Droegemeier to serve as the director of the White House Office of Science and Technology Policy (OSTP). A meteorologist from the University of Oklahoma, Mr. Droegemeier previously served as Oklahoma Governor Mary Fallin’s secretary of science and technology. He was also previously on the National Science Board for 12 years during the George W. Bush and Barack Obama administrations.
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.