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 and Carla N. Hutton
 
On March 3, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a supplemental notice of proposed rulemaking (SNPRM) to the Strengthening Transparency in Regulatory Science proposed rule.  EPA notes that the SNPRM “is not a new rulemaking; rather, it provides clarifications on certain terms and aspects of the 2018 proposed rule.”  The SNPRM:

  • Proposes that the scope of the rulemaking applies to influential scientific information, as well as significant regulatory decisions;
     
  • Defines and clarifies that the proposed rule applies to data and models underlying both pivotal science and pivotal regulatory science;
     
  • Proposes a modified approach to the availability provisions for data and models that would underlie influential scientific information and significant regulatory decisions, as well as an alternate approach; and
     
  • Clarifies the ability of the Administrator to grant exemptions.

EPA published the SNPRM in the Federal Register on March 18, 2020.  85 Fed. Reg. 15396.  EPA states that it “is taking comment on whether to use its housekeeping authority independently or in conjunction with appropriate environmental statutory provisions as authority for taking this action.”  On April 2, 2020, EPA announced that it would extend the comment period to May 18, 2020.  EPA anticipates promulgating a final rule later in 2020.  More information is available in our March 9, 2020, memorandum, “EPA Releases Supplemental Proposed Rule to the Proposed Rule on Strengthening Transparency in Regulatory Science.”


 

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.

Tags: OPPT, Collazo

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on March 20, 2020, inviting the public to nominate scientific experts from a diverse range of disciplines to be considered for appointment to the Toxic Substances Control Act (TSCA) Science Advisory Committee on Chemicals (SACC).  85 Fed. Reg. 16094.  EPA is seeking nominations of individuals who have demonstrated high levels of expertise in scientific and/or technical fields relevant to chemical safety and risk assessment, including, but not limited to:  human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically based pharmacokinetics, toxicology and pathology, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.  In addition, nominees should have backgrounds and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable (e.g., geographic location, social and cultural backgrounds, and professional affiliations).  Any interested person or organization may nominate qualified persons to be considered for appointment to SACC.  Individuals also may self-nominate.  The preferred method for submitting nominations is via e-mail to Steven Knott, the SACC’s Designated Federal Officer (.(JavaScript must be enabled to view this email address)).  Nominations are due no later than April 20, 2020.

Background
 
SACC serves as a primary scientific peer review mechanism of EPA’s Office of Chemical Safety and Pollution Prevention and is structured to provide independent scientific advice and recommendations to EPA on the scientific basis for risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA.

 

Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), sat down with Dr. Richard Engler, Director of Chemistry at B&C, to bring everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle.  As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical space.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2020 Bergeson & Campbell, P.C.  All Rights Reserved


 

On March 2, 2020, at ChemCon The Americas 2020 in Philadelphia, Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), and Alexandra Dapolito Dunn, Assistant Administrator, EPA Office of Chemical Safety and Pollution Prevention, sat down with Tjeerd Bokhout to discuss the implementation of Lautenberg and what can be expected through 2020.  Ms. Dunn started off the discussion, noting that EPA is “getting our sea legs under us; we spent the first two or three years after enactment, really through 2019, setting up the bones of the program, the regulations, the structure, the fees rule, and now we’ve begun the deep process of looking at each chemical [for risk evaluation].” The conversation continued with discussion regarding how chemicals are selected for evaluation, surprises EPA encountered while making low-priority determinations, and what can be expected through the remainder of 2020.  Ms. Dunn and Ms. Bergeson agreed that as more chemicals go through this review process, the quantity and type of information needed will standardize, leading to more predictability for all stakeholders.  Now that a system is evolving, EPA plans to identify data gaps early to provide time to strategize how to acquire as much information as is required to evaluate properly a chemical on schedule and with minimal additional costs.

A full video of this informative interview, drawing back the curtain on both EPA and industry’s experience with the implementation of TSCA and details on what to prepare for in the near future, is available to stream now.


 

By Lynn L. Bergeson and Carla N. Hutton
 
Effective March 15, 2020, Madison Le will join the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) as Director of the Chemical Control Division (CCD).  Ms. Le will replace Acting Director Lynn Vendinello.  Ms. Le is currently Director of the Fuels Compliance Policy Center within the Office of Air and Radiation.  In that capacity, Ms. Le manages the implementation of EPA’s national fuels programs, including the Renewable Fuel Standard Program, Tier 3 Gasoline, Ultra-Low Sulfur Diesel, and Fuels and Fuel Additives Registration.  Prior to working for EPA, Ms. Le worked for California’s Los Angeles County on engineering design projects for municipal solid waste landfills and wastewater treatment plants, including air quality modeling and permitting for stationary and mobile sources.  Ms. Le holds an M.S. and B.S. in Environmental Engineering from the University of Southern California.


 

By Lynn L. Bergeson and Carla N. Hutton

On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents.  According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance.  On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public.  The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents.  EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant.  The guidance portal provides a mechanism for the public to request modification or withdrawal of any documents.  EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.”  According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) announced on February 27, 2020, that it plans to begin its audit of the EPA’s Toxic Substances Control Act (TSCA) Service Fee Fund financial statements for the period from inception, June 22, 2016, to September 30, 2018.  According to the Project Notification, the audit objectives are to determine whether:

  1. The financial statements are fairly presented in all material respects in accordance with generally accepted accounting principles;
  2. EPA’s internal control structure over financial reporting related to the financial statements is in place and provides reasonable assurance that:
    • Financial transactions are executed in compliance with applicable laws, regulations, contracts, and grant agreements;
    • Assets are safeguarded against loss from unauthorized acquisition, use, or disposition; and
    • Transactions are properly recorded, processed, and summarized to permit the preparation of reliable financial statements;
  3. EPA has complied with laws and regulations that would have a direct and material effect on the financial statements; and
  4. The information and manner of presentation contained in the Management’s Discussion and Analysis, and any other accompanying information, are materially consistent with the information contained in the principal statements.

OIG states that the Frank R. Lautenberg Chemical Safety for the 21st Century Act requires that the annual audit of the financial statements also include:

  1. An analysis of the fees collected and amounts disbursed;
  2. The reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the law; and
  3. The number of requests for a risk evaluation made by manufacturers.

OIG notes that since fees have not been collected, however, it does not anticipate work in this area for the financial statements for the period from inception, June 22, 2016, to September 30, 2018.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.

Tags: Fees, Audit, OIG

 

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 to view sample course segments and purchase modules.  Volume discounts are available for companies wishing to purchase courses for multiple employees.  Companies interested in live in-person or customized live webinar training should contact .(JavaScript must be enabled to view this email address) to schedule.
 
For more information about TSCA Tutor™, contact Heidi Lewis at .(JavaScript must be enabled to view this email address), or read our full course descriptions here.
 
TSCA Tutor -- Curriculum


ONE-HOUR SESSIONS:

  • 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)

TWO-HOUR SESSIONS:

  • 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
    • Exemptions
  • TSCA Section 5, Part 2:  New Chemicals/New Use (Course number T203)
    • New Chemicals/New Use
    • SNURs
  • 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.

Tags: ECHO, Webinar

 
 1 2 3 >  Last ›