By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced on October 14, 2021, several actions intended to enhance scientific integrity, including establishing two internal science policy advisory councils, creating a new senior-level career position to serve as a science policy advisor to the Assistant Administrator, and making further improvements to policies and procedures. The announcement includes the following actions:

• New OCSPP Science Policy Council and New Science Policy Advisor Position: OCSPP is forming a new internal advisory group, the OCSPP Science Policy Council, to provide advisory support and recommendations on science policy and scientific integrity issues that arise within its Office of Pollution Prevention and Toxics (OPPT) and Office of Pesticide Programs (OPP). The OCSPP Science Policy Council will be chaired by a science policy advisor, a newly created position. The science policy advisor will report to the OCSPP Assistant Administrator, provide guidance on emerging science policy and scientific integrity matters, and serve as the deputy scientific integrity official for OCSPP. OCSPP states that the OCSPP Science Policy Council will provide an advisory perspective on matters related to scientific integrity; identify scientific questions that are of broad interest within OCSPP for informal review and, as appropriate, recommend a process for further addressing them; and foster informal opportunities for scientific collaboration within OCSPP. Members chosen to address specific issues or questions will be selected based on their expertise and impartiality on the issue or question, and they may include EPA experts outside of OCSPP. OCSPP notes that the group is not intended to replace or otherwise interfere with EPA’s Scientific Integrity Policy, the Scientific Integrity Official’s role, or the Inspector General’s role.
• Strengthening New Chemical Safety Reviews: According to OCSPP, as part of its broader review of policies and procedures to ensure the program effectively implements the Biden Administration’s executive orders, other directives, and principles of scientific integrity, OCSPP’s New Chemicals Division (NCD) engaged in a top-to-bottom effort to catalogue, prioritize, and improve its standard operating procedures (SOP), decision making, and recordkeeping practices related to review and management of new chemicals under the Toxic Substances Control Act (TSCA). OCSPP states that to date, NCD has inventoried and reviewed over 100 different SOPs, guidances, and science policies, and prioritized those that NCD expects to be updated over the next year. Several policy changes have already been implemented, including stopping harmful new per- and polyfluoroalkyl substances (PFAS) from entering the market and procedures to strengthen the review of new chemicals and ensure worker safety.
  • New Chemicals Advisory Committee: According to OCSPP, NCD has formed the New Chemicals Advisory Committee (NCAC) that, similar to other long-standing internal advisory bodies within OCSPP, will serve as an advisory body to review both scientific and science policy issues related to new chemical submissions subject to TSCA. If differing opinions cannot be resolved through the human health risk assessment process improvements described below, the NCAC and OCSPP Science Policy Council could provide additional opportunities for further consideration.
  • Human Health Risk Assessment Process Improvements: According to OCSPP, NCD solicited feedback from staff and implemented important changes to its process for reviewing and issuing final human health risk assessments. The new process provides additional opportunities for resolution of differing scientific opinions and invites input to the decision-making process to be provided by EPA subject matter experts outside of NCD.
  • Enhanced Recordkeeping Requirements: Proper documentation of decisions and of any differing scientific opinions of those decisions is a significant component of EPA’s Scientific Integrity Policy. OCSPP states that it has implemented some changes to its procedures to ensure improved documentation of decisions and is in the process of further review to identify additional improvements, if any, including for new chemicals human health risk assessments.
• Workplace Climate Assessment: In September 2021, with the support of an independent contractor, OCSPP launched a workplace climate assessment of the NCD to obtain feedback from employees and management about any potential workplace barriers and opportunities for organizational improvement. OCSPP states that this effort will expand to other parts of OCSPP over the coming months. OCSPP leadership will use the feedback collected to understand, evaluate, and, if necessary, make changes in its work practices and culture to promote collaboration and enhance the science used in its program decision making.

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By Lynn L. Bergeson and Carla N. Hutton
 
Effective May 21, 2021, Yvette T. Collazo has resigned as the Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT). Collazo began as OPPT Director in March 2020. During her tenure, OPPT’s accomplishments include:

• Publishing final risk evaluations for the first ten chemicals reviewed under the amended Toxic Substances Control Act (TSCA) and initiating the risk evaluation process for the next 20 high-priority chemicals;
• Beginning risk management activities for the first ten chemicals, including public engagement and consultations with tribal and environmental justice communities;
• Issuing final rules to reduce exposures to five persistent, bioaccumulative, and toxic (PBT) chemicals;
• Proposing revisions to the TSCA fees rule;
• Increasing transparency by conducting and updating data on TSCA Confidential Business Information reviews, publishing updated 2016 Chemical Data Reporting (CDR) information, updating the TSCA Inventory, and making additional information on new chemical submissions available in ChemView;
• Recognizing significant stakeholder achievements through the 2020 Safer Choice and Green Chemistry Awards;
• Re-organizing OPPT to align new chemicals, existing chemicals, confidential information/transparency, and “forward-looking” data collection functions structurally; and
• Establishing an Office for Project Management and Operations that is intended to manage effectively and efficiently the TSCA Program.

More information on these developments is available on our website in our TSCA memoranda.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) has prepared a strategic plan for the Office of Pollution Prevention and Toxics (OPPT) for fiscal years (FY) 2021-2023. The strategic plan outlines how OPPT intends to fulfill its obligations under the Toxic Substances Control Act (TSCA), the Emergency Planning and Community Right-to-Know Act (EPCRA), the Pollution Prevention Act (PPA), and related EPA policies and procedures “in ways that value science, protect people and the environment, and increase transparency for stakeholders and the general public.” The strategic plan includes new vision, mission, and values statements for OPPT. Priority areas include:

• New Chemicals: The New Chemicals Program manages potential risks to human health and the environment from chemicals new to the marketplace. The program identifies conditions to be placed on the use of new chemicals before they enter into commerce;
• Existing Chemicals: TSCA requires EPA to evaluate the safety of existing chemicals through prioritization, risk evaluation, and risk management. Ensuring the safety of existing chemicals requires collecting and analyzing information about the chemicals, developing additional information, conducting analyses to evaluate risk, and taking regulatory action on proper conditions of use for each chemical;
• Pollution Prevention/Safer Choice/Toxics Release Inventory (TRI): OPPT supports a suite of programs that are intended to reduce, eliminate, or prevent pollution at its source as an alternative to pollution control and waste disposal. Safer Choice helps consumers, businesses, and purchasers find products that contain ingredients that are safer for human health and the environment. The TRI Program collects information to track industry progress in reducing waste generation and moving toward safer waste management alternatives;
• Transparency and Stakeholder Engagement: OPPT is committed to providing the public with the information needed to understand EPA’s chemical evaluations. It continually seeks more productive means of engaging with interested stakeholders through public comment during rulemaking, Federal Advisory Committee Act (FACA) workgroups, and other means;
• Human Capital: OPPT strives to provide a healthy and supportive working environment, support for career development, and communication on issues that are important to its colleagues. It closely collaborates with its partners in the Office of Chemical Safety and Pollution Prevention’s (OCSPP) Office of Program Support to ensure that the basics of being an OPPT employee, such as timekeeping, personnel actions, and equipment, are easy to manage; and
• Efficiency and Enabling Tools: OPPT’s priority areas depend on a wide range of data from manufacturers, researchers, and the public. Its employees need to know how to work with these data and to have access to tools that facilitate access to and analysis of these data. OPPT is committed to increasing its ability to manage projects effectively through a unified approach that ensures timely deliverables, increases its ability to track its work, and simplifies its processes.

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By Lynn L. Bergeson and Carla N. Hutton
 
Effective March 29, 2020, Yvette T. Collazo will be the new Director of the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT).  Ms. Collazo previously worked for the U.S. Department of Energy (DOE), where she led activities related to federal contracts and agreements of more than $250 million for the cleanup of radiological, industrial, and groundwater hazards resulting from decades of nuclear material production at DOE’s Savannah River facility.  Ms. Collazo also served as Senior Advisor and Director for the Office of Technology Innovation and Development at DOE’s Office of Environmental Management.  In this capacity, she led the identification and advancement of technologies, processes, and technical practices that improved the performance of waste processing, groundwater and soil, facility decontamination and decommissioning, and nuclear materials projects over their life cycles, from planning to disposal.  Starting in 2013, Ms. Collazo served as District Director of the U.S. Small Business Administration (SBA) Puerto Rico and Virgin Islands District Office.  As District Director, she was responsible for the delivery of the SBA’s financial assistance, business counseling, entrepreneurial training, and federal contracting programs throughout the District.  Ms. Collazo has a Master of Science in Environmental Management from the Illinois Institute of Technology and a Bachelor of Science in Mechanical Engineering from the University of Puerto Rico, Mayagüez Campus.

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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

Risk Evaluations:

• 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.

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By Charles M. Auer and Richard E. Engler, Ph.D.

The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT or the Office) has decided to delay its pending reorganization to take and consider staff comments on the revised reorganization.  The new plan proposes a six division structure that has separate new and existing chemical risk management divisions complemented by separate new and existing chemical risk assessment divisions.  OPPT’s other functions are proposed to be distributed into a mission operations division and a division that sweeps together chemical right-to-know, economics, information reporting, and the Safer Choice/Design for the Environment (DfE) program.  In an internal memo, OPPT Director Jeffery Morris, Ph.D., noting the thoughtful and insightful staff comments received on the earlier proposed reorganization, provides a two-week internal commenting period for the new proposal ending on May 9, 2018.

How to organize OPPT has been a perpetual conundrum with shifting “best approaches” over time.  From our perspective, merging the existing chemicals function of the Chemical Control Division (CCD) with those of the National Program Chemicals Division (NPCD) into an Existing Chemicals Management Division makes sense.  The existing NPCD branches that cover legacy chemical issues (e.g., lead, polychlorinated biphenyls (PCB), mercury, and asbestos) will presumably become risk management branches tasked with overseeing risk management activities for those chemicals under the amended Toxic Substances Control Act (TSCA or new TSCA).  The other “first ten” risk evaluation chemicals that are currently being managed by the existing chemicals staff in CCD will become other risk management branches in the new structure.  Creating a separate New Chemicals Management Division also makes sense in light of the challenges encountered by the office in its early implementation of Section 5 under new TSCA.  Such a division will ensure a tight management focus on new chemicals issues without the need to also juggle complex existing chemicals issues.  While this could present concerns regarding divergent decisions and policies between the two divisions, this seems to be less of an issue since the requirements in Sections 5 and 6 differ so much.

More information and commentary on this reorganization is available in our memorandum.

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On April 4, 2018, the U.S. Environmental Protection Agency (EPA) announced the following management changes in its Office of Pollution Prevention and Toxics (OPPT):

• Maria Doa, Ph.D., Director of the Chemical Control Division (CCD) at OPPT since 2011, will move to the Office of Research and Development’s (ORD) Office of Science Policy.  Prior to leading CCD, Dr. Doa was director of the National Program Chemicals Division (NPCD).
• Lynn Vendinello, Deputy Division Director of the CCD since 2014, will serve as the CCD Acting Director on an interim basis.  Ms. Vendinello has held a number of management and supervisory positions in OPPT and EPA’s Office of Compliance.
• Tanya Mottley, Acting Deputy Director of OPPT, will resume her leadership role as Director of NPCD.  Prior to leading NPCD, Ms. Mottley was the Director of OPPT’s Pollution Prevention Division (PPD).
• Bryan Symmes will resume his duties as NPCD Deputy Director.
• Tala Henry, Ph.D., Director of OPPT’s Risk Assessment Division (RAD) since 2013, will be the next Acting Deputy Director for OPPT.  Prior to leading RAD, Dr. Henry led NPCD after serving as a toxicologist in RAD and the Office of Water.
• Cathy Fehrenbacher, now RAD Deputy Director, will serve as RAD Acting Director.   Ms. Fehrenbacher has held exposure assessment-related supervisory positions with OPPT; she began her career at EPA as a senior industrial hygienist.

These are significant leadership changes and are likely intended to maximize OPPT efficiency. We applaud OPPT’s continuing efforts to implement TSCA and the changes occasioned by the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act almost two years ago.

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By  Lynn L. Bergeson and Molly R. Blessing

As noted in our blog posting on November 16, 2016, the U.S. Environmental Protection Agency (EPA) announced on December 1, 2016, that its Office of Pollution Prevention and Toxics (OPPT) will hold a public meeting on December 14, 2016, from 9:00 a.m. to 3:00 p.m. (EST) to update the public on changes to the New Chemicals Review Program under the Toxic Substances Control Act, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (TSCA).  Note the time change from EPA’s previous announcement of this public meeting; the meeting time has been extended to end at 3:00 p.m. instead of the original 12:00 p.m.  Reportedly, the response to EPA’s earlier notice was quite robust so EPA has extended the public meeting by three hours.

EPA states that it will “describe its review process for new chemicals under the amended statute, as well as discuss issues, challenges, and opportunities that the Agency has identified in the first few months of implementation.”  Interested parties will have the opportunity to comment “on their experiences with the New Chemicals Review Program, including submittal of pre-manufacture notices (PMNs), microbial commercial activity notices (MCANs), and significant new use notices (SNUNs) under section 5 of the law.”  Information obtained during this meeting and from submitted written comments will be considered as EPA works to “implement the new requirements and improve the efficiency of its review process under TSCA.”

In-person and webinar registration is available now.  EPA is requesting that interested parties register by December 13, 2016. Written comments will be accepted via www.regulations.gov under Docket EPA-HQ-OPPT-2016-0658 and must be submitted by January 14, 2017.

More information on new chemicals review under amended TSCA is available in our memorandum TSCA Reform: An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA, as well as on the Bergeson & Campbell, P.C. website under Regulatory Developments: TSCA.

Commentary

As noted in our earlier blog, given the considerable impact of new TSCA on EPA’s New Chemicals Program, this public meeting is a must attend for TSCA stakeholders.  Interested parties should come to the meeting with thoughtful questions and clear expectations as to what stakeholders can usefully share with EPA at the meeting.  This could be the first of several such meetings to help interested parties understand the processes OPPT is developing in response to new TSCA, add greater transparency to those processes, and to assist EPA as appropriate with implementing the new law.

One point in particular that we draw attention to is a sentence at the top of page 86714 in the Federal Register notice describing the affirmative determinations that initially are tied to unreasonable risk determinations, then goes on to claim that there is an alternative concerning “insufficient information to allow for a determination.”

Pursuant to the amended law, EPA is now required to make an affirmative determination as to whether or not the new use or new chemical presents, may present, or is not likely to present an unreasonable risk of injury to health or the environment, or, alternatively, if there is insufficient information to allow for a determination.

This reading of the law is plainly at odds with the text that clearly states (Section 5(a)(1)(B))  that EPA has to “make a determination under subparagraphs (A), (B), or (C) of paragraph (3).”  The insufficient information provision appears at Section 5(a)(3)(B)(i). and, thus, “insufficient information” is both included within (B) and is a determination.  We also note that in discussing the affirmative determinations, EPA has omitted discussion of the substantial production/exposure determination at Section 5(a)(3)(ii)(II).  

While this may only represent an error in drafting the notice, it is also possible that it indicates a basic misunderstanding of the new chemicals provisions, a view that may find support in some of the decisions recently communicated to our clients in “action letters” on Section 5 notices.

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