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.

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

 

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
 
The U.S. Environmental Protection Agency (EPA) promulgated a final rule on January 13, 2020, to adjust the level of the maximum (and minimum) statutory civil monetary penalty amounts under the statutes it administers, including the Toxic Substances Control Act (TSCA).  85 Fed. Reg. 1751.  EPA states that this action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act).  The 2015 Act prescribes a formula for annually adjusting the statutory maximum (and minimum) amount of civil penalties to reflect inflation, maintain the deterrent effect of statutory civil penalties, and promote compliance with the law.  EPA notes that the rule does not necessarily revise the penalty amounts that it chooses to seek pursuant to its civil penalty policies in a particular case.  EPA’s civil penalty policies, which guide enforcement personnel on how to exercise EPA’s statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator’s good faith efforts to comply, any economic benefit gained by the violator as a result of its noncompliance, and a violator’s ability to pay.  The final rule was effective January 13, 2020.


 

By Lynn L. Bergeson and Carla N. Hutton

Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) published on January 9, 2020, our “Forecast for U.S. Federal and International Chemical Regulatory Policy 2020.”  In this richly detailed and comprehensive document, the legal, scientific, and regulatory professionals of B&C and Acta distill key trends in U.S. and global chemical law and policy, and provide our best informed judgment as to the shape of key developments we are likely to see in the New Year.  The document includes a list of B&C speeches and writings, as well as a list of B&C webinars and podcasts available on demand.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our December 20, 2019, blog item, the U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated document and beginning a 45-day comment period.  85 Fed. Reg. 99.  Comments are due February 18, 2020.
 
The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  More information is available in our December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”


 

By Lynn L. Bergeson and Carla N. Hutton

Kevin L. Bromberg, Assistant Chief Counsel for Environmental Policy for the U.S. Small Business Administration’s (SBA) Office of Advocacy, will retire from federal service on January 3, 2020.  Bromberg served two terms in the Office of Advocacy, from 1979 to 1991 and from 1994 to the present.  Prior to rejoining the Office of Advocacy in 1994, Bromberg represented small business trade associations in regulatory matters dealing with the U.S. Environmental Protection Agency (EPA).  He was counsel for the Small Business Coalition for a Responsible Toxic Release Inventory and executive director of the Industry Coalition for a Workable Clean Air Program.  Bromberg founded the first Advocacy Roundtable, the Environmental Roundtable, in 1990.  He is the primary author of three petitions for regulatory relief to EPA, all of which EPA granted.  Bromberg has also worked for EPA and the U.S. Consumer Product Safety Commission.  Bromberg was instrumental in developing the procedures for implementation of EPA panels under the Small Business Regulatory Enforcement Fairness Act (SBREFA) and has represented the Office of Advocacy in more than 30 EPA SBREFA panels.

Kevin will be sorely missed.  He has been a relentless and exceedingly effective advocate for small business for decades.  Kevin’s zealous pursuit of the facts -- scientific, economic, and otherwise -- and his impressive and creative legal advocacy have served businesses well.  Kevin’s tireless advocacy and efforts to enhance regulatory transparency, most visibly apparent in forming the Environmental Roundtable, have made Kevin one of the most respected, effective, and dedicated attorneys of his time.  Thanks for all you have contributed, Kevin, and our best to you in your new endeavors.

Tags: SBA, SBREFA

 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published on December 20, 2019, the final list of high-priority chemicals.  These chemicals will be the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  According to EPA, issuing the final list of high-priority chemicals for risk evaluation “represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of existing chemicals in the marketplace.”  The 20 chemicals consist of seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer precursor:

  1. p-Dichlorobenzene;
  2. 1,2-Dichloroethane;
  3. trans-1,2- Dichloroethylene;
  4. o-Dichlorobenzene;
  5. 1,1,2-Trichloroethane;
  6. 1,2-Dichloropropane;
  7. 1,1-Dichloroethane;
  8. Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester);
  9. Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester;
  10. Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester);
  11. Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester);
  12. Dicyclohexyl phthalate;
  13. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA);
  14. Tris(2-chloroethyl) phosphate (TCEP);
  15. Phosphoric acid, triphenyl ester (TPP);
  16. Ethylene dibromide;
  17. 1,3-Butadiene;
  18. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
  19. Formaldehyde; and
  20. Phthalic anhydride.

More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) released on December 20, 2019, an updated version of the “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  EPA discussed the updated document, “TSCA New Chemical Determinations:  A Working Approach for Making Determinations under TSCA Section 5,” at a public meeting on December 10, 2019.  EPA states that the updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):

  • The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
  • Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
  • In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
  • The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
  • The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.

EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:

  • Additional clarification and detail throughout;
  • General guiding principles and concepts for making determinations;
  • Decision-making logic and key questions that EPA must address; and
  • Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).

EPA has posted a document summarizing public comments received on the 2017 document and its responses.  Upon publication in the Federal Register, EPA will accept comment on the updated document for 45 days in docket EPA-HQ-OPPT-2019-0684 at https://www.regulations.gov.  More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 18, 2019, that it is extending the public comment period for the draft risk evaluation of N-methylpyrrolidone (NMP) to give stakeholders more time to review and comment on the draft document.  Comments are now due January 21, 2020.  EPA states that it will use feedback received from the public comment process, along with input from the Science Advisory Committee on Chemicals (SACC), to inform the final risk evaluation for NMP.  If the final risk evaluation for NMP finds there are unreasonable risks under any of the specific conditions of use, EPA will propose actions to address those risks within the timeframe required by the Toxic Substances Control Act (TSCA).  EPA notes that these actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical, as applicable.  EPA will publish a Federal Register notice announcing the comment period extension.  More information on the draft risk evaluation is available in our November 5, 2019, memorandum, “EPA Releases Draft Risk Evaluation for NMP, Schedules SACC Review for December.”


 
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