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) issued a press release on November 22, 2019, reminding stakeholders that its regulations to prohibit the manufacture (including import), processing, and distribution of methylene chloride in all paint removers for consumer use will go into effect after November 22, 2019.  Beginning November 23, 2019, it will be unlawful for any person or retailer to sell or distribute paint removal products containing methylene chloride for consumer use, including e-commerce sales.  EPA states that it “is encouraging all consumers to stop using methylene chloride products that they may have already purchased for paint and coating removal.”  EPA also reminds all retailers that sales of these products to consumers are prohibited by EPA regulations under the authority of Section 6 of the Toxic Substances Control Act (TSCA).  EPA promulgated the final regulation on methylene chloride for consumer paint and coating removal use on March 27, 2019, and the prohibition related to manufacturing, processing and distribution of methylene chloride for consumer paint and coating removal use is now in effect.  According to EPA, “[a] variety of effective, less harmful substitutes are readily available for paint removal.”  EPA notes that it “is continuing to work through the process outlined in TSCA to review the risks associated with other uses of methylene chloride.  This process is designed to thoroughly evaluate available science before taking action to manage the risk associated with the other uses of the chemical.”

More information on EPA’s actions concerning methylene chloride are available in the following memoranda:


 

By Lynn L. Bergeson and Carla N. Hutton

On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 60363.  EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for certain CBI claims.  Specifically, EPA is proposing two additional questions that manufacturers and processors would be required to answer to substantiate certain CBI claims for specific chemical identities and is proposing procedures for manufacturers and processors to use in amending certain previously submitted substantiations to include responses to the additional questions.  Comments on the supplemental notice are due December 9, 2019.

EPA notes that these proposed revisions supplement the proposed rule issued in the April 23, 2019, Federal Register and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated on August 11, 2017.  More information on the proposed rule is available in our April 11, 2019, memorandum, “EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory,” and more information on the final rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) posted an August 7, 2019, petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER) under Section 21 of the Toxic Substances Control Act (TSCA).  PEER asks that oil refineries be prohibited from using hydrofluoric acid in their manufacturing processes and that oil refineries be required to phase out the use of hydrofluoric acid within two years.  According to PEER, TSCA and the Clean Air Act (CAA) regulate hydrofluoric acid and provide the statutory authority for EPA to issue a regulation prohibiting the use of hydrofluoric acid in oil refineries.  PEER states that under TSCA, EPA “possesses the power to promulgate rules banning chemicals that pose an unreasonable risk to human health.”  If the EPA Administrator determines that the “manufacture, processing, distribution in commerce, use, or disposal of a chemical substance . . . presents an unreasonable risk of injury to health or the environment,” TSCA Section 6(a) provides EPA the authority to prohibit or otherwise restrict “the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use.”  PEER argues that the EPA Administrator could ban the use of hydrofluoric acid in refineries if the Administrator found that its use in that context presented an unreasonable risk to health or the environment.  PEER maintains that the use of hydrofluoric acid presents such a risk.

EPA sent a letter to PEER on August 16, 2019, confirming receipt of its petition and noting that Section 21 provides the Administrator 90 days to grant or deny the petition.  If the EPA Administrator grants the petition, the Administrator will “promptly commence an appropriate preceding [sic].”  If the Administrator denies the petition, the Administrator will publish the reasons for the denial in the Federal Register.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on August 1, 2019, that it is making additional information about new chemical notices available on its website.  The new web page, “Statistics for the New Chemicals Review Program under TSCA,” allows users to view and search monthly updates for any active Premanufacture Notice (PMN), Significant New Use Notice (SNUN) and Microbial Commercial Activity Notice (MCAN) of interest by case number.  Users can also download a spreadsheet with a list of all active cases and each case’s status.  More information and commentary is available in our August 5, 2019, memorandum, "EPA Improves Transparency for New Chemicals Review Program under TSCA."


 

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 June 14, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 24, 2019, EPA received manufacturer requests for EPA to conduct risk evaluations of diisodecyl phthalate (DIDP) from ExxonMobil Chemical Company and diisononyl phthalate (DINP) from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, both through the American Chemistry Council’s High Phthalates Panel.  EPA states that both DIDP and DINP belong to a family of chemicals commonly referred to as phthalates, which are used as plasticizers in the production of plastic and plastic coatings to increase flexibility and were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.

Within 15 business days of receiving a facially complete request (i.e., submission appears to be consistent with rule requirements), EPA states that it must notify the public of receipt of this request under 40 C.F.R. Section 702.37(e)(2); and within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).  More information on Manufacturer Requests is available on EPA’s website.


 

Please check out Bergeson & Campbell, P.C.'s (B&C®) new podcast "Inside OCSPP with EPA Assistant Administrator Alexandra Dapolito Dunn" on its All Things Chemical™ webpage.  In this podcast, Lynn L. Bergeson, Managing Partner of B&C, presents a very special guest, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP):  Alexandra Dapolito Dunn. 

As Assistant Administrator Dunn has spent just over five months in office, she and Lynn sit down and talk about what it’s been like to take over OCSPP at this crucial time when the amended Toxic Substances Control Act (TSCA), post-Lautenberg, is just coming into its maturity.  They discuss the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far.  

This is a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months.  


 

By Lynn L. Bergeson and Richard E. Engler, Ph.D.

On May 20, 2019, the U.S. Environmental Protection Agency (EPA) announced that on May 30, 2019, it will begin publishing Toxic Substances Control Act (TSCA) Section 5 notices including premanufacture notices (PMN), microbial commercial activity notices (MCAN), and significant new use notices (SNUN), their attachments, including any health and safety studies, any modifications thereto, and all other associated information in ChemView -- in the form they are received by EPA, without review by EPA.  EPA states that it will not be reviewing confidential business information (CBI)-sanitized filings before publishing.  EPA states that this announcement will be the first of several reminders that EPA sends and, in addition, EPA has incorporated a reminder to check accompanying sanitized submissions as part of the Central Data Exchange (CDX) reporting module for TSCA Section 5 notices.

EPA’s announcement states the following as guidance for submitters to take heed of before submitting their TSCA Section 5 notices:

  1. Verify the asserted CBI claims are correct and consistent; and
  2. Verify the sanitized versions of the form, attachments, and file names are checked for proper and consistent CBI redactions and that watermarks or stamps indicating CBI are removed.  

Commentary

EPA does not specify how long after submission the documents may be posted, but submitters should expect a very short turn-around.  Bergeson & Campbell, P.C. (B&C®) has addressed the topic of CBI before, most recently on our podcast, All Things Chemical™.  When completing a PMN, a submitter must take care to ensure that all information that must be protected as CBI is marked as such.  A submitter cannot expect EPA to extrapolate a claim for CBI in one part of a form to the rest of the document and its attachments.  B&C strongly suggests that a submitter review the sanitized form of an entire document (e.g., a PMN and its attachments) to ensure that all sensitive information is redacted before submitting the document to EPA.

Do not wait until May 30.  Begin developing and practicing good CBI practices today.


 

By Lynn L. Bergeson and Margaret R. Graham, M.S.

On May 16, 2019, the U.S. Environmental Protection Agency (EPA) announced that it has updated its Statistics for the New Chemicals Review Program under TSCA web page, which is under EPA’s Reviewing New Chemicals under the Toxic Substances Control Act (TSCA) section, to make it easier to find and understand how many chemicals are in each stage of the new chemicals review process.  The revised web page now includes a flow chart showing the number of new chemicals cases (premanufacture notices (PMN), significant new use notices (SNUN), and microbial commercial activity notices (MCAN)) at each stage of review and detailed descriptions of each step in the process.

EPA states that these changes “are the first step in a larger effort to increase the transparency of the new chemicals program and ensure stakeholders and the public can quickly and easily view EPA’s progress in reviewing new chemicals submissions as the Agency receives them.”  EPA Assistant Administrator Alexandra Dunn has repeatedly expressed her and EPA’s commitment to enhance the transparency of EPA’s operations, and this latest development reflects that commitment.


 
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