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
 
According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29, 2021, memorandum, EPA is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation that may be followed by risk management actions (depending on the outcome of the risk evaluation). According to the memorandum posted in the docket, the August 16, 2021, deadline is for EPA’s use in the current stage of its rulemaking development. While EPA will consider later comments as it continues to develop the proposed rule, EPA states that “comments submitted at this point will be especially useful to EPA and stand a greater chance of influencing the rulemaking.” Because there will be other opportunities to comment on the tiered data reporting rule, including during the public comment period following publication of the proposed rule, EPA “do[es] not believe that an extension of the comment period is necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton
 

On July 27, 2021, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) will hold a public meeting to engage with interested stakeholders on the development of a proposed rule for implementing a tiered data collection strategy to help inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures under the Toxic Substances Control Act (TSCA). According to EPA, it currently primarily collects exposure-related data through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring that data collection strategies provide information to meet better its basic chemical data needs, such as information related to exposure, health, and ecotoxicity. To this end, EPA states that it is exploring a data reporting rule that is tiered to specific stages of the TSCA existing chemicals program: identifying a pool of substances as potential candidates for prioritization; selecting candidate chemicals for and completing the prioritization process; and assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). According to EPA, feedback from the public meeting and comments received will help inform its development of a proposed rule. The meeting will be held virtually via WebEx on July 27, 2021, from 1:00 to 3:00 p.m. (EDT). Those who would like to make a comment during the meeting must register by 6:00 p.m. EDT on July 22, 2021. Those who would like to participate in listen-only mode must register by 6:00 p.m. EDT on July 26, 2021. Written comments are due August 15, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency’s (EPA) April 2018 Toxic Substances Control Act (TSCA) Chemical Substance Inventory is now available.  For the first time, the Inventory includes a field designating substances that are “active” in U.S. commerce based on the following:

  • Reporting from the 2012 and 2016 Chemical Data Reporting cycles;
  • Notices of Commencement received by EPA since June 21, 2006; and
  • Notice of Activity Form A’s received by EPA through the February 7, 2018, deadline, per the TSCA Inventory Notification (Active-Inactive) Rule.

EPA states that it “carefully processed and conducted a quality check of the data to ensure duplicate entries and confidential business information were removed” from the large number of notices received under the Active-Inactive Rule.  EPA also posted a list of substances reported in a Notice of Activity Form A from February 8 through March 30, 2018.  According to EPA, this list should assist processors in determining which of their substances on the Inventory have not yet been designated as “active” to date.  Based on our review, the Inventory lists approximately 38,303 total active substances, or about 44.5 percent.  The deadline for voluntary submission of a Notice of Activity Form A by processors is October 5, 2018.

If your company is having trouble reporting through EPA’s Central Data Exchange (CDX), please contact Richard E. Engler, Ph.D. or Lynn L. Bergeson to obtain a copy of our comprehensive Guidance Materials for TSCA Inventory Notification Rulemaking.  Our TSCA experts would be pleased to assist you with the reporting process!

More information on the TSCA Inventory rulemaking and TSCA Inventory issues is available on our blog under the key phrase TSCA Inventory and on our TSCA Reform News & Information web page.  More information on EPA’s Final TSCA Inventory Notification (Active-Inactive) Rule is available in our memorandum, “EPA Issues Final TSCA Framework Rules.”  Specific information on changes in the CDX system is available in our blog item, “EPA Updates eNOA Template in CDX System.”


 

By Lynn L. Bergeson and Carla N. Hutton

On August 22, 2017, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) announced that it plans to begin preliminary research to assess Chemical Data Reporting (CDR) under the Toxic Substances Control Act (TSCA).  According to OIG’s Project Notification, the specific objectives for this evaluation are to determine:  (1) how EPA is ensuring that companies are compliant with CDR requirements under TSCA; and (2) whether EPA is using CDR data to prioritize imported and manufactured chemicals for the purpose of identifying the potential for human health and environmental risks.  The Project Notification asks Wendy Cleland-Hamnett, Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, and Lawrence Starfield, Acting Assistant Administrator for the Office of Enforcement and Compliance Assurance, to provide the following information:

  • Policies, procedures, and guidance on how CDR data are used in the prioritization of chemicals for TSCA risk evaluations and/or other assessments;
  • Policies, procedures, and guidance regarding the quality assurance/quality control of CDR data; and
  • Enforcement response policy and guidance for CDR violations.

The Project Notification states that the anticipated benefits of the project are “reduced risks to human health and the environment from the monitoring and oversight of TSCA chemicals subject to the CDR rule reporting requirements.”


 

Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time

Register Today

With passage by unanimous consent voice vote of the U.S. Senate of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 7, 2016, this bill, that profoundly alters the regulation of industrial chemicals in the U.S. under TSCA, has cleared all hurdles and was signed into law by President Obama on June 22, 2016.

All chemical stakeholders doing business in the U.S., as well as foreign entities with business interests in the U.S., will need to understand the fundamental shifts in requirements, and the new concepts and approaches that are introduced by the law.

Bergeson & Campbell, P.C. has collaborated with Chemical Watch in assembling an impressive faculty of TSCA experts representing the perspectives of industry, environmental organizations, and U.S. federal and state regulatory authorities to present a series of complimentary webinars titled "'The New TSCA' -- What You Need to Know."

Webinar 3: Inventory, CDR, and CBI (Sections 8 & 14)

Speakers:

  • Charles M. Auer, Charles Auer & Associates, LLC, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA)
     
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
     
  • Richard E. Engler, Ph.D., Senior Chemist, Bergeson & Campbell, P.C., former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program
     
  • Kelly Franklin, Chemical Watch
     
  • Kathleen M. Roberts, Vice President, B&C® Consortia Management, L.L.C.

 

Topics Covered:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition
       
    • Reporting by Processors
       
    • Byproduct Rulemaking and Reporting
       
    • Toxic Substances Control Act (TSCA) Inventory
       
    • Nomenclature
       
  • Section 14 Confidential Business Information (CBI)
     
    • Information Not Protected
       
    • Asserting CBI
       
    • Presumptive CBI
       
    • Requirements for CBI Claims
       
    • Exemptions to Protection from Disclosure
       
    • Review and Resubstantiation
       
    • Duties of Administrator
       
    • Criminal Penalties

Register Online

 

Additional Webinars in "The New TSCA" Series:

 

Webinar 1: Overview and Summary of Major Changes: What to Expect and When to Expect It, presented June 13, 2016.
Webinar 2: Impacts on New Chemical Programs, presented July 14, 2016.
Webinar 4: Other Provisions -- PBTs, Preemption, Green/Sustainable Chemistry -- will be presented on September 26, 2016.