Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C., law firm providing biobased and renewable chemical product stakeholders unparalleled experience, judgment, and excellence in bringing innovative products to market.

By Lynn L. Bergeson
 
On May 5, 2021, the U.S. Environmental Protection Agency (EPA) published a notice of disclosure to all obligated parties under the Renewable Fuel Standard (RFS) program that have submitted small refinery exemption (SRE) petitions and to all parties whose RFS information otherwise resides in EPA’s Moderated Transaction System (EMTS).  EPA’s action is in response to a U.S. Government of Accountability Office (GAO) request to disclose such information that has been submitted to EPA that claims to be, or is determined to be, confidential business information (CBI).  The information to be disclosed includes documents and data related to SRE petitions received by EPA since the beginning of the RFS program through the present. Such records include:

  • All materials submitted by small refineries as part of its SRE petition;
  • Any documentation sent by the U.S. Department of Energy (DOE) to EPA summarizing DOE’s findings and score(s) associated with the petition(s) and any EPA responses to such petitions;
  • Any EPA record that addresses the subject of the exemption petition(s), including EPA analysis done in addition to DOE’s findings;
  • EPA’s final exemption decision sent to the refinery; and
  • RFS related transaction-level data contained in EMTS, including Renewable Identification Number (RIN) transactions under RFS.

These records and information will be shared with GAO no later than 16 days after the publication of the notice.  All CBI-claimed documents will be destroyed, deleted, or returned to EPA at the conclusion of GAO's review.

Tags: RFS, SRE, CBI, Biofuel, DOE

 

By Lynn L. Bergeson 

EPA published on February 8, 2021, a periodic update of the TSCA confidential business information (CBI) review statistics. TSCA Section 14(g)(1) requires that EPA, within 90 days of receipt of a CBI claim:

  • Review and make determinations on CBI claims for chemical identity after the chemical substance has been offered for commercial distribution; and
     
  • Review and make determinations on a representative subset of at least 25 percent of other CBI claims that are not exempt from substantiation and review.

The updated data summarize the number of CBI cases under review and results of completed reviews through December 28, 2020. In addition, a spreadsheet is available showing the details of completed TSCA CBI determinations through December 28, 2020.

EPA states that making this information publicly available continues to demonstrate its commitment to transparency while fulfilling its responsibilities under TSCA. EPA notes that it has established numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.

Tags: TSCA, CBI

 

By  Lynn L. Bergeson 

EPA announced on January 5, 2021, that it is reopening the reporting period under the TSCA Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016. As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors. From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years. The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI). In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory. In its January 5, 2021, announcement, EPA states that it has since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period. EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity. The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 

By Lynn L. Bergeson

EPA will host a webinar on May 19, 2020, from 1:00 p.m. to 3:00 p.m. (EDT) to provide an overview of the 2020 CDR requirements. The webinar will include information about the revised reporting requirements, including:

  • New requirements for making confidential business information (CBI) claims;
  • Reporting refinements related to byproducts, including exemptions;
  • Phasing in certain processing and use data codes; and
  • Process improvements for reporting co-manufacturing.

The webinar will also introduce the updated e-CDRweb reporting tool. EPA notes that the presentation will be similar to the webinars EPA hosted on March 31, and April 9, 2020.

EPA states that although registration is not required, it is preferred. Details on how to access the webinar and slides will be sent to participants after registering. Participants should follow along with the webinar slides and use the following call-in number to access the audio: (866) 609-6049; Conference ID: 2499985. EPA will provide webinar materials, including transcripts and recordings, on its CDR website following the webinar.

Tags: CDR, CBI, TSCA

 

By Lynn L. Bergeson

On April 10, 2020, the U.S. Environmental Protection Agency (EPA) published a quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. The data summarize the number of CBI cases under review and results of completed reviews through March 1, 2020. In addition, a spreadsheet showing the details of completed TSCA CBI determinations through March 1, 2020, is available. EPA states that making this information publicly available “continues to demonstrate the agency’s commitment to transparency while fulfilling its responsibilities under the Lautenberg Act amendments to TSCA.” According to EPA, it has established “numerous new processes, systems, and procedures to enable submitters to provide the information required when making confidentiality claims and to facilitate EPA’s review, and where applicable, determinations on these claims.” The updated statistics show EPA’s progress toward meeting these requirements.

Tags: EPA, TSCA, CBI

 

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.


 
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