By Lynn L. Bergeson and Carla N. Hutton
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”
By Lynn L. Bergeson and Carla N. Hutton
As reported in our June 28, 2021, blog item, on June 28, 2021, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 33926. EPA announced on July 29, 2021, that it is extending the comment deadline to September 27, 2021. EPA will announce the extension of the comment deadline in the Federal Register.
The proposed rule would require certain persons that manufacture (including import) or have manufactured PFAS in any year since January 1, 2011, to report information electronically regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA requests public comment on all aspects of the proposed rule and states that it has also identified the following items “of particular interest for public input”:
- Identifying the chemical substances that would be subject to reporting;
- Considerations for EPA’s economic analysis: EPA is specifically seeking additional information and data that EPA could consider in developing the final economic analysis;
- Submission period: EPA proposes a six-month submission period for reporting entities that would begin six months following the effective date of the final rule;
- Duplicative reporting: EPA requests comment on whether any additional data elements may be duplicative of information collected by EPA under TSCA or other federal statutes;
- Scope of environmental and health effects information collected: EPA requests comment on what existing environmental and health effects information should be within the scope of the rule;
- Additional information or data elements: EPA states that it is interested in comments on whether the final rule should include a data field allowing reporters to provide generic names or descriptions in the event a manufacturer is aware they have produced or imported a PFAS but are not able to ascertain reasonably the specific PFAS identity. EPA is also requesting comments on additional data elements such as composition information if a PFAS has a variable composition, analytical methods, and whether occupational exposure information should distinguish occupational nonusers (i.e., those nearby but not in direct contact with the chemical) from workers (i.e., those who are in direct contact with the chemical);
- EPA’s use and publication of certain non-confidential business information (CBI) data;
- Joint submissions: EPA is requesting public comment on whether it should enable the use of joint submissions in specific circumstances, similar to Chemical Data Reporting (CDR) joint submissions; and
- Small manufacturers: EPA is requesting public comment on how it may assist small manufacturers with compliance with the proposed rule.
More information is available in our June 11, 2021, memorandum, “EPA Announces Three PFAS Actions, Including Proposed TSCA Section 8(a) Reporting Rule.”
A Timely and Essential Complimentary Conference
Wednesday, June 30, 2021
9:00 a.m. - 4:30 p.m. (EDT)
Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health are pleased to present “TSCA Reform - Five Years Later.” This complimentary virtual conference marks the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Leading panelists will reflect on the challenges and accomplishments, while offering unique insights into the decision-making process of top U.S. Environmental Protection Agency (EPA) officials.
Confirmed speakers from government, non-governmental organizations (NGO), industry, and academia include:
- Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean of the Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University
- Michal Ilana Freedhoff, Ph.D., Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA
- Dianne Barton, Council Chair, National Tribal Toxics Council
- Lynn L. Bergeson, Managing Partner, B&C
- Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.
- Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP
- Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund
- Dennis R. Deziel, Senior Government Affairs Advisor, B&C, and former Administrator, Region I, EPA
- Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.
- Richard E. Engler, Ph.D., Director of Chemistry, B&C
- Penny Fenner-Crisp, Ph.D., Environmental Protection Network
- Scott Fulton, President, ELI
- Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice
- Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.
- Liz Hitchcock, Director, Safer Chemicals Healthy Families
- Jon Kalmuss-Katz, Supervising Staff Attorney, Earthjustice
- Marianne Engelman Lado, Deputy General Counsel, Environmental Initiatives, Office of General Counsel, EPA
- Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC
- John Pendergrass, Vice President, Programs & Publications, ELI
- Betsy Southerland, Issue Team, TSCA, Environmental Protection Network
- Robert M. Sussman, Principal, Sussman & Associates
- Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP
Additional speakers will be announced as they are confirmed.
Mark your calendar for June 30, 2021, to join ELI, B&C, the George Washington University Milken Institute School of Public Health, leading experts, and distinguished keynote speakers in this day-long exploration of the issues and regulations surrounding TSCA.
More information about “TSCA Reform - Five Years Later” is available at the ELI website and a recording will be made available to all participants after the conference. Details about previous TSCA Reform events can be found at “TSCA Reform – Four Years Later,” “TSCA: Three Years Later,” “TSCA Reform at 2 Years” and “TSCA Reform: One Year Later.”
By Lynn L. Bergeson and Carla N. Hutton
On March 2, 2021, the U.S. Government Accountability Office (GAO) published its latest High Risk List, which includes 36 areas across the federal government vulnerable to waste, fraud, abuse, and mismanagement or needing broad-based transformation. According to GAO, five areas have regressed since 2019, including the U.S. Environmental Protection Agency’s (EPA) process for assessing and controlling toxic chemicals. GAO’s report, High-Risk Series: Dedicated Leadership Needed to Address Limited Progress in Most High-Risk Areas, states that this high-risk area declined in the monitoring criterion from a partially met rating in 2019 to a not met rating in 2021; three criteria in each of the two segments declined to a not met rating in 2021. GAO notes that the Integrated Risk Information System (IRIS) Program did not issue a completed chemical assessment between August 2018 and December 2020, and EPA (1) did not indicate how it was monitoring its assessment nomination process to ensure it was generating quality information about chemical assessment needs; and (2) lacked implementation steps and resource information in its strategic plan and metrics to define progress in the IRIS Program. Additionally, according to GAO, EPA’s programs supporting the Toxic Substances Control Act (TSCA) (1) did not complete workforce or workload planning to ensure the agency can meet TSCA deadlines; and (2) did not meet initial statutory deadlines for releasing its first ten chemical risk evaluations.
By Lynn L. Bergeson and Carla N. Hutton
On October 16, 2020, the U.S. Environmental Protection Agency (EPA) reminded companies that if they filed a retrospective activity notice (Notice of Activity (NOA) Form A) under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Rule and claimed the specific chemical identity as confidential business information (CBI), they have until November 1, 2020, to submit or amend their CBI substantiations. Companies that amend, update, or file new CBI substantiations must do so electronically via EPA’s Central Data Exchange.
On March 6, 2020, EPA promulgated a final rule on procedures for review of CBI claims made under TSCA. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year timeframe set in TSCA. More information is available in our February 28, 2020, memorandum, “EPA Releases Final Rule on Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory.”
By Lynn L. Bergeson and Carla N. Hutton
On August 17, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) published a report entitled Lack of Planning Risks EPA’s Ability to Meet Toxic Substances Control Act Deadlines. OIG conducted the audit to determine whether EPA met the deadlines already imposed by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) in 2016, which amended the Toxic Substances Control Act (TSCA), and has the staff, resources, and management controls in place to meet future statutory deadlines. The Lautenberg Act required EPA to develop new rules for chemical prioritization for risk evaluation and risk evaluation for existing chemicals and to review all new chemical submissions and make a regulatory determination. OIG found that while EPA met several of its TSCA deadlines, it did not complete all ten required existing chemical risk evaluations by the June 19, 2020, deadline. OIG notes that because of statutory requirements, the number of required existing chemical risk evaluations doubled at the end of 2019, “risking the EPA’s ability to meet TSCA deadlines.”
OIG states that EPA’s ability to assess its TSCA workload -- and subsequently estimate the workforce levels necessary to achieve that workload -- “is critically important.” OIG notes that the Office of Pollution Prevention and Toxics (OPPT) has not publicly identified the additional staff and resources it needs to accomplish all mandated TSCA requirements. According to OIG, “OPPT’s resource planning is hindered by not complying with the U.S. Office of Personnel Management regulations, which requires developing a workforce plan to manage current and future workforce needs.”
OIG states that EPA’s program offices have not conducted a systematic workload analysis or identified workforce needs for budget justification purposes since 1987 and that this is also true for OPPT, which is responsible for implementing the TSCA amendments. According to OIG, though OPPT expects to hire more staff members to implement the TSCA amendments in fiscal year (FY) 2020, OPPT “lacks a workforce-and-workload analysis to successfully implement and meet the 2016 TSCA deadlines.” Additionally, OIG states, EPA’s annual plans for risk evaluations “were neither done in a timely manner nor met the statutory requirements to identify the resources needed to initiate or complete the risk evaluations for the year.”
OIG recommends that the assistant administrator for Chemical Safety and Pollution Prevention: (1) publish the annual existing chemical plan including the anticipated implementation efforts and required resources; (2) conduct a workforce analysis to assess OPPT’s capability to implement the TSCA amendments; and (3) specify what skill gaps must be filled in FY 2021 to meet the TSCA requirements. According to OIG, EPA “provided acceptable corrective actions and estimated milestone dates for all recommendations.” OIG “consider[s] these recommendations resolved with corrective actions pending.”
Chemical manufacturers and processors have just over four months to submit Chemical Data Reporting (CDR) data by the November 30, 2020, close of the reporting period. To assist companies in that process, Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) developed CDR Cross-Check™, an ingenious and cost-efficient tool to identify whether a company’s chemicals are subject to CDR reporting and if so, at what reporting threshold.
CDR Cross-Check will identify:
- Whether the chemical is listed as active or inactive;
- Whether the chemical was subject to specific TSCA regulatory actions in 2016;
- Whether the chemical is exempt; and
- What the reporting thresholds are based on the updated data released by the U.S. Environmental Protection Agency (EPA) on May 29, 2020.
Visit the CDR Cross-Check page on the Acta website for a sample report and information on how to use CDR Cross-Check.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
TSCA Tutor™ online training courses include:
- Video lessons.
- Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
- Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
Online courses are offered at $100 for one-hour modules and $200 for 2-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com
, or read our full course descriptions here
TSCA Tutor -- Curriculum
- An Overview of TSCA (Course number T101)
- New TSCA at a Glance (Course number T102)
- Import Requirements, TSCA Section 13 (Course number T103)
- Export Requirements, TSCA Section 12 (Course number T104)
- Confidential Business Information (CBI) (Course number T105)
- Reporting and Retention of Information, TSCA Section 8 (Course number T106)
- Inspections and Audits (Course number T201)
- Preparing for a TSCA Audit
- TSCA Penalties/Overview of Self-Confession Policy
- TSCA Section 5, Part 1: TSCA Chemical Inventory, Exemptions (Course number T202)
- TSCA Inventory
- TSCA Section 5, Part 2: New Chemicals/New Use (Course number T203)
- New Chemicals/New Use
- Chemical Data Reporting (CDR) (Course number T204)
- CDR Overview
- Byproduct Reporting under CDR
- Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
- Chemical Testing
- How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
- Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
- Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
- How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold its next Enforcement and Compliance History Online (ECHO) webinar on February 18, 2020, at 1:30-2:30 PM (EST). The webinar will provide an overview of the data in ECHO and guide users through using the site to answer environmental compliance and enforcement questions. EPA states that the focus of this session will be a collection of short, step-by-step demonstrations geared toward new and infrequent users. EPA will demonstrate the capabilities of the ECHO Facility Search to answer questions such as:
- How to search for a specific facility;
- How to search for facilities in a community; and
- How to search for facilities releasing a pollutant.
Registration is now open. ECHO video tutorials and recorded webinars are available at any time.
Bergeson & Campbell, P.C. (B&C®) is pleased to present the complimentary webinar “New TSCA at 3: Key Implementation Issues.” The webinar will drill down on key implementation challenges facing industry and the U.S. Environmental Protection Agency (EPA) three years into navigating the legal, regulatory, and science policy issues arising under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention (OCSPP); Lynn L. Bergeson, Managing Partner, B&C; and Richard E. Engler, Ph.D., Director of Chemistry, B&C, will present. Register online now.