By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) published on August 11, 2020, its quarterly update of the Toxic Substances Control Act (TSCA) confidential business information (CBI) review statistics. These data summarize the number of CBI cases under review and results of completed reviews through June 15, 2020:
|CBI Review Statistics (cases received between June 22, 2016 and June 15, 2020)
|Cases in which the specific chemical identity is subject to CBI review
|Cases in which information other than the specific chemical identity is subject to CBI review
|Cases in which both the specific chemical identity and information other than the specific chemical identity is subject to CBI review
|Total cases subject to CBI review
|Cases resulting in final CBI determinations
|Cases with all CBI claims subject to review, approved
|Cases with all CBI claims subject to review, denied
|Cases with CBI claims subject to review, approved-in-part/denied-in-part
|Total cases resulting in final CBI determinations
|Cases reviewed with no final CBI determination necessary
|Cases with all CBI claims screened and found to be exempt from review
|Cases with all CBI claims withdrawn by submitter
|Cases identified for CBI review, for which no determination required (e.g., in some instances, older EPA information systems do not specifically identify which information is claimed as CBI and upon review, it is determined that no claims require review)
|Total cases reviewed/screened with no final CBI determination necessary
|Cases currently undergoing CBI review
|Cases currently undergoing CBI review
In August 2020, EPA published an updated list of cases with completed CBI reviews under TSCA Section 14. The spreadsheet includes the results of completed CBI determinations and cases with approved claims for specific chemical identity for which unique identifiers have been assigned.
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on December 9, 2019, that in advance of the 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.
By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts
The cost of generating health and safety studies is considerable and data owners have every right to expect some protection from disclosure to preserve the value of their intellectual property. This is no longer guaranteed as Lynn L. Bergeson, Richard E. Engler, Ph.D., and Kathleen M. Roberts wrote in a two-part article in Bloomberg Environment Insights. The authors propose that the U.S. Environmental Protection Agency’s (EPA) practice of disclosing entire health and safety studies voluntarily submitted under Toxic Substances Control Act (TSCA) Section 6 is based upon a misinterpretation of TSCA Section 14(b)(2)(A)(i) and should be reconsidered in light of a recent judicial decision and the pressing need to acknowledge the global relevance of health and safety studies.
Many of the studies that will be relevant to EPA’s risk evaluations under TSCA Section 6 have significant monetary and competitive value, and data owners have every right to expect some protection from the disclosure of the study reports to preserve their value. If EPA as a matter of practice routinely posts entire study reports publicly, the reports would be rendered valueless for data compensation purposes. Some organizations have considered approaches that include the selective claiming of certain information elements in the study report as confidential to protect the value of the research while providing relevant information on the general findings and health and safety effects observed in the study. It is unclear, however, if this practice provides other stakeholders with sufficient information or if this practice is entirely effective in preserving the monetary and competitive value of the study report. EPA’s insistence that those who send in study reports accept the fact that the entire submission will be posted publicly also ignores the reality that many of these reports are jointly owned. Multiple entities often have title to the study as joint owners and its disclosure is generally subject to data sharing agreements that expressly prohibit its publication unless required by law.
Despite these concerns with the interpretation of TSCA Section 14(b)(2)(A)(i), submitters need to up their game, as it were, in identifying confidential business information (CBI) and certifying that release of such information would pose “substantial commercial harm.” For more information on the greater burden being placed on submitters, and for possible options to protect CBI, read the full article “Protecting the Value of Health, Safety Studies—Emerging TSCA Issues” online.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
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)
- 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.
- Section 8 Reporting and Retention of Information
- Small Manufacturer Definition
- Reporting by Processors
- Byproduct Rulemaking and Reporting
- Toxic Substances Control Act (TSCA) Inventory
- 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
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.