The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.

By Lynn L. Bergeson

EPA announced on June 1, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA notes that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for early 2021. According to EPA, the Inventory contains 86,405 chemicals, of which 41,587 are active in the United States commerce. Other updates to the TSCA Inventory include updates to commercial activity data and regulatory flags, such as consent orders and significant new use rules (SNUR).


 

The Acta Group (Acta®) announced today the launch of CDR Cross-Check™, an ingenious yet simple tool developed and offered by Acta to assist companies in preparing for the 2020 Chemical Data Reporting (CDR) required by the U.S. Environmental Protection Agency (EPA). CDR Cross-Check utilizes the most recent CDR listing information publicly available provided by EPA (currently, 2016 lists) to identify whether all or some of a company’s inventory of chemical substances are subject to CDR under the Toxic Substances Control Act (TSCA) and, if so, at what reporting threshold. CDR Cross-Check will make CDR reporting easier.

CDR Cross-Check will identify whether chemicals are listed on the TSCA Inventory and, if so,

  • whether they are listed as active or inactive;
     
  • whether they were subject to specific TSCA regulatory actions in 2016;
     
  • whether they are exempt; and
     
  • what the 2020 reporting thresholds would be based on the 2016 data.

Sample CDR Cross-Check™ Report:

(Click image to enlarge.)

A CDR Cross-Check report prepared at this time will be extremely useful as a preliminary check in preparation for the 2020 CDR reporting. It will confirm regulatory statuses from the 2016 reporting cycle, so for those chemicals, users will know what the reporting threshold will be for 2020 and can determine now whether reporting is needed. It will also give users time to address potential issues well before the 2020 reports are due.

To access CDR Cross-Check, a customer will upload the list of chemicals to be evaluated by the CDR Cross-Check tool and pay the appropriate fee based on the number of chemicals to be evaluated. Fees are $3.00 (USD) per chemical for the first 750 chemicals plus $2.00 (USD) per chemical for additional chemicals over 750. The minimum fee is $400 (USD).

Acta anticipates that additional chemicals will be added to the regulatory lists in June 2020 that may result in lower reporting thresholds. The CDR Cross-Check will be updated at that time to include the new lists. Customers that have already used the CDR Cross-Check prior to the 2020 updates will receive a 50% discount for an updated list.

Visit the CDR Cross-Check website, https://cdr-cross-check.actagroup.com/, for more information and to order a CDR Cross-Check report.

More information on recent CDR developments is available in Acta’s March 19, 2020, memorandum “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”

The Acta Group is a global scientific and regulatory consulting firm that assists companies with strategic commercialization planning and complex product registration and compliance matters in North America, South America, Europe, the Middle East, and Asia. Acta is the consulting affiliate of Washington, D.C., law firm Bergeson & Campbell, P.C.


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on March 11, 2020, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
     
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
     
  • Additional unique identifiers.
     

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On March 11, 2020, EPA announced the availability of the latest TSCA Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. According to EPA, this update adds 81 new chemicals, and the Inventory as a whole now contains 86,405 chemicals, of which 41,484 are active in U.S. commerce. Other updates to the TSCA Inventory include:

  • Updates to commercial activity data, or active/inactive status;
  • Updated regulatory flags, such as consent orders and significant new use rules (SNUR); and
  • Additional unique identifiers.

EPA notes that the TSCA inventory is a list of all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for exemption or exclusion under TSCA. More information on the TSCA Inventory is available on EPA’s website.


 

By Lynn L. Bergeson

On October 30, 2019, EPA announced that in response to an April 2019 court decision on the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Requirements Final Rule, EPA will publish a supplemental notice of proposed rulemaking that includes two additional questions about “reverse engineering” that manufacturers and processors would be required to answer when making confidential business information (CBI) claims. According to EPA, these questions would help provide additional information on CBI claims for specific chemical identities and would ensure that chemical companies are fully supporting their CBI claims. EPA is also proposing a process for manufacturers and processors to use to amend and update certain previously submitted claims to include responses to these additional questions, as required to be addressed by federal circuit court decision. EPA notes that the supplemental notice is limited in scope and that “it impacts only the universe of CBI claims made for specific chemical identities for chemicals reported as ‘active’ in response to the Active-Inactive Rule.” Publication of the supplemental notice in the Federal Register will begin a 30-day comment period.


 

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

Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®) and Chemical Watch have collaborated to present a series of complimentary webinars on the reformed Toxic Substances Control Act (TSCA). Webinar 3 -- Inventory, CDR, and CBI will cover:

  • Section 8 Reporting and Retention of Information
     
    • Small Manufacturer Definition;
       
    • Reporting by Processors;
       
    • Byproduct Rulemaking and Reporting;
       
    • TSCA Inventory; and
       
    • 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; and
       
    • Criminal Penalties.

Previous webinars in the series:

Webinar 1 -- The New TSCA -- Overview and Summary of Major Changes: What to Expect and When to Expect It, June 13, 2016; and

Webinar 2 -- Impacts on New and Existing Chemicals Programs (TSCA Sections 4, 5, and 6), July 14, 2016.

To request materials from previous webinars, please contact .(JavaScript must be enabled to view this email address).


 

Biofuels Digest is running a "Thought Leadership" series of articles highlighting some of the ways the Toxic Substances Control Act (TSCA) applies to biobased products. The articles, written by Biobased and Renewable Products Advocacy Group (BRAG®) Senior Policy Advisor and former head of the U.S. Environmental Protection Agency's (EPA) Green Chemistry program, Richard E. Engler, Ph.D., cover key points throughout the manufacturing and commercialization process at which biobased companies need to be aware of TSCA requirements.

"The Toxic Substances Control Act and the Bioeconomy: Part 1, The Impact of Nomenclature on the Commercialization of Biobased Chemicals," published April 26, 2015, begins with some common misconceptions about TSCA:

When I meet people from bioeconomy companies, I ask them about their products' status under the Toxic Substances Control Act (TSCA). The most common answers I receive are: "TSCA doesn't apply because our product is not toxic," "TSCA doesn't apply because our product is naturally occurring," and "We are compliant with TSCA because we're making something that's already in commerce." This usually leads to a more in-depth discussion of how TSCA works and its idiosyncrasies with respect to biobased products. I do not ask this to be accusatory, rather I want to be sure that companies understand their obligations so that they do not run afoul of the law. TSCA penalties can add up quickly (maximum $37,500 per violation per day) and can threaten nascent companies if they are not diligent.

The article continues by detailing how the Chemical Abstracts Index name and identity of a substance is determined, how feedstock and production processes can affect identity, and the impact the name has on commercialization prospects since all chemicals in production must be listed on the TSCA Inventory.

"The Toxic Substances Control Act and the Bioeconomy: Part 2, Reportable Substances across the Manufacturing Process," published May 3, 2015, details when feedstocks, intermediates, and catalysts may be reportable under TSCA.

Importantly, in addition to final chemical products, TSCA also applies to the other chemicals used in the manufacturing process. Looking at the various stages of a typical manufacturing process allows us to examine how TSCA applies at each stage.

The article then discusses feedstocks, such as plants, sugars, and municipal wastes; isolated and non-isolated intermediates; and catalysts, such as metals, enzymes, and microoganisms; and how each of those is treated under TSCA.

The final article in the series will be published in Biofuels Digest on May 10, 2015, and we will feature excerpts in next week's BRAG Report.