By Lynn L. Bergeson and Carla N. Hutton
On January 24, 2020, the U.S. Environmental Protection Agency (EPA) released the draft risk evaluation of carbon tetrachloride, “a solvent primarily used in the manufacturing of chlorinated compounds and petrochemicals.” Carbon tetrachloride is the seventh of the first ten chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA). EPA published a Federal Register notice on January 27, 2020, announcing the availability of the draft risk evaluation and beginning a 60-day comment period. 85 Fed. Reg. 4658. The TSCA Science Advisory Committee on Chemicals (SACC) will hold a preparatory virtual meeting on February 4, 2020, to consider the scope and clarity of the draft charge questions for the peer review. On February 25-26, 2020, SACC will hold an in-person public meeting to consider and review the draft risk evaluation. EPA will provide comments submitted on the draft risk evaluation on or before February 19, 2020, to SACC for their consideration before the meeting. Comments received after February 19, 2020, and prior to the oral public comment period during the meeting will be available to the SACC for their consideration during the meeting. Comments on the draft risk evaluation are due March 27, 2020.
EPA states that it “reviewed 15 potential uses, all of which are associated with industrial and commercial work and are primarily associated with the manufacturing process of other chemicals.” According to EPA, there are no consumer uses of carbon tetrachloride. EPA made the following initial determinations on risk:
- EPA did not find risk to the environment or workers. For all the conditions of use included in the draft risk evaluation, EPA states that it has preliminarily found no unreasonable risks to the environment under any of the conditions of use or to workers when appropriate personal protective equipment is used; and
- EPA’s draft risk evaluation preliminarily found unreasonable risks associated with chronic inhalation exposure for occupational non-users (ONU). EPA found that ONUs -- those workers in the vicinity of carbon tetrachloride’s use but not directly working with the chemical -- could be adversely affected by carbon tetrachloride under certain conditions of use.
More information, including an insightful commentary, is available in our January 27, 2020, memorandum, “EPA Releases Draft Risk Evaluation of Carbon Tetrachloride.”
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) announced on January 15, 2020, that it is partnering with People for the Ethical Treatment of Animals (PETA) and Physicians for Responsible Medicine (PCRM) to host public webinars on various topics related to reducing, refining, or replacing vertebrate animal testing. A webinar will be held on January 22, 2020, covering the use and application of the Collaborative Acute Toxicity Modeling Suite (CATMoS), a free resource for screening organic chemicals for acute oral toxicity. Drs. Nicole Kleinstreuer and Kamel Mansouri will discuss the development of and demonstrate CATMoS, which was developed during a project in which the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the EPA National Center for Computational Toxicology (NCCT) collected a large body of rat oral acute toxicity data and made these data available to project participants. Participants built several models that were then used to generate consensus predictions for the acute oral toxicity endpoints of interest to regulatory agencies. The webinar will offer a walk-through of how to use the modeling suite to generate acute oral toxicity predictions for chemicals of interest. EPA notes that it “does not necessarily endorse the views of the speakers.”
By Lynn L. Bergeson and Carla N. Hutton
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.
By Lynn L. Bergeson and Emily A. Scherer
As reported in our June 28, 2019, memorandum, on June 24, 2019, Bergeson & Campbell, P.C.(B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health (GWU) presented “TSCA: Three Years Later,” a day-long conference with leading experts exploring the current impacts of the Toxic Substances Control Act (TSCA) on science policies, challenges faced by industry, and the impacts of TSCA on regulatory policies, especially those concerning ensuring compliance and enforcement. A recording of the full conference is available online. Our memorandum provides details regarding the session topics and presenters, including copies of the presentation where available.
By Lynn L. Bergeson and Margaret R. Graham, M.S.
On April 11, 2019, the U.S. Environmental Protection Agency (EPA) announced that it was partnering with the Physicians Committee for Responsible Medicine (PCRM) and the People for the Ethical Treatment of Animals (PETA) International Science Consortium to host a public webinar related to meeting the goal of reducing, refining, or replacing vertebrate animal testing as stipulated in the Frank R. Lautenberg Chemical Safety for the 21st Century Act that amended the Toxic Substances Control Act (TSCA), specifically New Approaches for Respiratory Sensitization, set for April 24, 2019, at 10:00 a.m. (EDT). Registration is required. The speakers are Steve Enoch, Ph.D., Liverpool John Moores University, who will be presenting “Chemistry-based Approaches for Identifying Respiratory Sensitizers”; and Arno Gutleb, Ph.D., Luxembourg Institute of Science and Technology, who will be presenting “In Vitro Models to Identify Respiratory Sensitizers.”
The two other webinars in this Webinar Series on the Use of New Approach Methodologies (NAM) in Risk Assessment already took place; the first one was Skin Sensitization Testing and the second one was MPPD and CFD Modeling to Predict Dosimetry of Inhaled Substances. EPA states that these webinars on the use of New Approach Methodologies (NAMs) in Risk Assessment are part of EPA meeting commitments identified in EPA’s Strategic Plan to Promote the Development and Implementation of Alternative Test Methods, required by amended TSCA.
B&C is launching a podcast November 1, 2018. It’s called All Things Chemical™ and it will engage listeners in intelligent, insightful conversation about everything related to industrial, pesticidal, and specialty chemicals and the law and business issues surrounding chemicals. B&C’s talented team of lawyers, scientists, and consultants will keep listeners abreast of the changing world of both domestic and international chemical regulation and provide analysis of the many intriguing and complicated issues surrounding this space.
A teaser introduction to the podcast is available now. Full episodes will be available November 1, 2018, on iTunes, Spotify, and Stitcher.
By Lynn L. Bergeson and Carla N. Hutton
On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA). As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.” Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:
- Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
- Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
- Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).
EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs. In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN). Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA. EPA did not propose specific fees for submission of confidential business information (CBI).
By Charles M. Auer, Oscar Hernandez, Ph.D., and Lynn L. Bergeson
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) released its Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program. Development of the Strategic Plan was required under Section 4(h)(2)(A) of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with a deadline of not later than two years after enactment. Release of the final Strategic Plan occurred on the second anniversary of enactment of amendments to the Toxic Substances Control Act (TSCA).
The goal of the strategy is to reduce the level of testing in vertebrates for chemicals regulated under TSCA. EPA describes alternative test methods and strategies as different descriptors that have a common goal. The former is based on reduction, refinement, and replacement of animal test methods (the 3Rs), while strategies incorporate more than just toxicity test methods to characterize hazard. The strategy as proposed relies on a range of applications and testing approaches to characterize human health and environmental endpoints.
Collectively, alternative test methods and strategies combine to define a new term: new approach methodologies (NAM). The NAM designation is used as a broadly descriptive reference to any technology, methodology, approach, or combination thereof that can be used to provide information on chemical hazard and risk assessment that avoids the use of vertebrates. For the purposes of TSCA, EPA recognizes this new term (i.e., NAM) as encompassing any “alternative test methods and strategies to reduce, refine or replace vertebrate animals.”
A much more detailed summary and analysis of this important issue is available in our memorandum.