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

On March 6, 2020, EPA published its final rule on procedures for review of confidential business information (CBI) claims made under TSCA. 85 Fed. Reg. 13062. The final rule includes the requirements for regulated entities to substantiate certain CBI claims made under TSCA to protect the specific chemical identities of chemical substances on the confidential portion of the TSCA Inventory, and EPA’s plan for reviewing certain CBI claims for specific chemical identities. EPA sets out the review criteria and related procedures that it will use to complete the reviews within the five-year time frame set in TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities. The final rule is effective on May 5, 2020. For more information, please read the full B&C memorandum.

Tags: CBI, TSCA

 

By Lynn L. Bergeson

On March 6, 2020, EPA announced via the Federal Register its final rule on requirements for regulated entities to substantiate certain confidential business information (CBI) made under TSCA. The substantiation requirements describe the applicable procedures and provide instructions for regulated entities, providing the review criteria and related procedures that EPA will use to complete the reviews within the five-year time frame set in TSCA. The final rule will be effective on May 5, 2020.

Tags: TSCA, CBI

 

By Lynn L. Bergeson

On February 19, 2020, the U.S. Environmental Protection Agency (EPA) released its review plan for certain confidential business information (CBI) claims under the Toxic Substances Control Act (TSCA). Aiming to provide clarity for affected stakeholders and efficiently fulfill CBI requirements under TSCA, EPA will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. The final rule is a follow-on to the 2017 TSCA Inventory Notification (Active-Inactive) Rule, amending certain substantiation provisions in response to a federal court decision. Chemical manufacturers and/or processors who have made CBI claims for specific chemical identities listed as “active” substances must follow the final process released by EPA. The final review plan describes the procedures and deadlines for substantiating CBI claims, including provisions for supplementing certain previously filed substantiations. It is important to note that manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange (CDX) system.

Tags: CBI, TSCA

 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of its December 10, 2019, public meeting on new chemicals, it is providing the meeting materials and announcing the availability of a new web page detailing cases with completed confidential business information (CBI) determinations under the Toxic Substances Control Act (TSCA). Materials for the December 10, 2019, meeting include:

The new CBI web page includes a table of all the final CBI determinations under TSCA Section 14(g). The table contains information from CBI reviews including:

  • Case Number;
     
  • Submission Type;
     
  • CBI Review Category (specific chemical identity, other information, or both);
     
  • Final Determination;
     
  • Determination Rationale Summary;
     
  • For CBI Claims for Specific Chemical Identity:
     
    • EPA Unique Identifier (UID);
       
    • Accession Number;
       
    • Generic Name; and
  • Expiration Date for Chemical Identity and Non-Chemical Identity CBI Claims.

EPA states that it plans to update this information on a quarterly basis.

Tags: TSCA, CBI

 

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.


 

By Lynn L. Bergeson

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019. See Bergeson & Campbell, P.C.’s (B&C®) full memorandum for more information on the proposed rule.

Tags: TSCA, CBI

 

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).


 

On August 21, 2014, a coalition of environmental, health, and labor groups filed a 23-page petition with EPA requesting that the Agency "establish time limits for confidentiality claims for chemical information submitted by industry under the Toxic Substances Control Act (TSCA)." According to Earthjustice's press release, change is needed because currently "nder TSCA, industry is given wide latitude to claim such information confidential, making it unavailable to state and local governments, medical professionals, health organizations, research institutions and the general public. EPA currently sets no end date for the protection from disclosure of this information, essentially allowing it to be shrouded in secrecy indefinitely." A copy of the press release, with a link to the petition, is available online.

Tags: CBI, TSCA, EPA