By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) released on February 19, 2020, a final rule concerning the process companies must follow to make certain confidential business information (CBI) claims and EPA’s plan for reviewing those claims. EPA describes its final rule as creating “an efficient process” for fulfilling the CBI requirements under the Toxic Substances Control Act (TSCA) and providing clarity for affected stakeholders. Following the procedures set forth in the final rule, EPA states that it will review CBI claims made for chemical substance identity for chemicals on the “active” portion of the TSCA Inventory. These procedures and requirements are intended to help ensure that when a company claims the identity of a chemical as CBI, that claim meets the criteria laid out in TSCA.
The final rule is a follow-on to EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule and amends certain substantiation provisions of that rule in response to a recent federal court decision. The final rule applies to manufacturers and processors who made CBI claims for specific chemical identities for chemicals reported as “active” in response to the TSCA Inventory (Active-Inactive) Notification Rule. The final rule describes the procedures and deadlines for substantiating these CBI claims, including provisions for supplementing certain previously filed substantiations.
The final rule also describes EPA’s plan to review these CBI claims for “active” chemicals, including procedures for its publication of annual review goals and results. Manufacturers that amend, update, or file new CBI substantiations consistent with the new requirements must do so electronically via EPA’s Central Data Exchange. According to EPA, providing this information electronically supports more efficient data transmittal, improves data quality, and minimizes respondent burden and EPA administrative costs associated with information submission and recordkeeping.
More information on the final rule will be available in a forthcoming memorandum that will be posted on our website. Information on EPA’s 2017 TSCA Inventory Notification (Active-Inactive) Rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”
Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the release of the complete suite of TSCA Tutor™ regulatory training courses online and on-demand at www.TSCAtutor.com. Professionals seeking expert, efficient, essential training can preview and enroll in on-demand classes to complete at their own pace and timing. In addition to the newly released online e-learning courses, B&C’s TSCA Tutor™ training platform offers live in-person training at a company’s site and customized live webinar training, so companies can mix and match training modules and training approaches to provide the most suitable combination for their work needs.
Toxic Substances Control Act (TSCA) awareness is a critically important element in the 21st century work environment for any business that involves industrial chemicals. The new normal requires awareness of TSCA’s application to a company’s operations to ensure consistent compliance with TSCA regulations and, importantly, to understand and anticipate how the U.S. Environmental Protection Agency’s (EPA) ongoing implementation of new TSCA will impact a company’s industrial chemical selection and use processes.
TSCA Tutor™ online training courses include:
- Video lessons.
- Detailed hand-out materials, including copies of all presentations and relevant course materials from EPA and other sources.
- Customizable, yet detailed and ready-to-use Standard Operating Procedures (SOP) for the regulatory topic covered in the session.
The courses were developed and are presented by members of B&C’s renowned TSCA practice group, which includes five former senior EPA officials; an extensive scientific staff, including seven Ph.D.s; and a robust and highly experienced team of lawyers and non-lawyer professionals extremely well versed in all aspects of TSCA law, regulation, policy, compliance, and litigation.
Online courses are offered at $100 for one-hour modules and $200 for 2-hour modules, or $1,400 for the full 12-module training. Courses can be completed at the learner’s own pace, and enrollment is valid for one full year. Interested professionals should visit www.TSCAtutor.com
, or read our full course descriptions here
TSCA Tutor -- Curriculum
- An Overview of TSCA (Course number T101)
- New TSCA at a Glance (Course number T102)
- Import Requirements, TSCA Section 13 (Course number T103)
- Export Requirements, TSCA Section 12 (Course number T104)
- Confidential Business Information (CBI) (Course number T105)
- Reporting and Retention of Information, TSCA Section 8 (Course number T106)
- Inspections and Audits (Course number T201)
- Preparing for a TSCA Audit
- TSCA Penalties/Overview of Self-Confession Policy
- TSCA Section 5, Part 1: TSCA Chemical Inventory, Exemptions (Course number T202)
- TSCA Inventory
- TSCA Section 5, Part 2: New Chemicals/New Use (Course number T203)
- New Chemicals/New Use
- Chemical Data Reporting (CDR) (Course number T204)
- CDR Overview
- Byproduct Reporting under CDR
- Chemical Testing (Regulatory)/Animal Welfare, TSCA Section 4 (Course number T205):
- Chemical Testing
- How to Prepare/Engage If a Chemical of Interest Is Listed under TSCA Section 4
- Prioritization and Risk Evaluation, TSCA Section 6 (Course number T206)
- Overview of Section 6 Risk Framework -- Prioritization, Evaluation, and Management
- How to Prepare/Engage If a Chemical of Interest Is Listed under Section 6
Bergeson & Campbell, P.C. is a Washington, D.C., law firm focusing on conventional, biobased, and nanoscale industrial, agricultural, and specialty chemical product approval and regulation, and associated business issues. B&C represents clients in many businesses, including basic, specialty, and agricultural and antimicrobial chemicals; biotechnology, nanotechnology, and emerging transformative technologies; paints and coatings; plastic products; and chemical manufacturing, formulation, distribution, and consumer product sectors. Visit www.lawbc.com for more information.
By Lynn L. Bergeson and Carla N. Hutton
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 and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) will hold a public meeting on December 10, 2019, to engage with interested stakeholders on the implementation of EPA’s Toxic Substances Control Act (TSCA) New Chemicals program. At the meeting, EPA will:
- Provide an overview of EPA’s updated “Working Approach” document that builds upon EPA’s November 2017 “New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA”;
- Demonstrate how EPA has used concepts in the “Working Approach” document to reach conclusions and make determinations under TSCA Section 5(a)(3) using specific case examples;
- Provide an update on confidential business information (CBI) process improvements and clarifications; and
- Discuss its progress on transparency in the TSCA New Chemicals program.
By the end of 2019, EPA intends to announce the availability of the updated “Working Approach” document and provide an opportunity for written public comment. EPA states that feedback from the public meeting and comments received will help inform its ongoing efforts to improve the way EPA reviews new chemicals under TSCA. Details regarding the meeting are available in the prepublication version of the Federal Register notice announcing the meeting.
EPA states in the prepublication version of the Federal Register notice that after considering comments received on the 2017 version of the “Working Approach” document and based on additional implementation experience, EPA is updating the “Working Approach” document. Later in December 2019, EPA will announce the availability of the updated document after the public meeting and will hold a public comment period. According to the notice, EPA expects the updated document to provide further clarity and detail on EPA’s approach and practices, including: (1) EPA’s general guiding principles and concepts for making determinations on new chemical notices submitted to EPA under TSCA Section 5; (2) the decision-making logic and the key questions that EPA must address; and (3) a discussion of how EPA might apply the working approach to reach one of the five new chemical determinations allowable under the statute.
By Lynn L. Bergeson and Carla N. Hutton
On November 8, 2019, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a supplemental notice of proposed rulemaking regarding revisions to the confidential business information (CBI) substantiation requirements under the Toxic Substances Control Act (TSCA). 84 Fed. Reg. 60363. EPA states that in response to a recent federal circuit court decision, it is proposing revisions to existing and proposed substantiation requirements for certain CBI claims. Specifically, EPA is proposing two additional questions that manufacturers and processors would be required to answer to substantiate certain CBI claims for specific chemical identities and is proposing procedures for manufacturers and processors to use in amending certain previously submitted substantiations to include responses to the additional questions. Comments on the supplemental notice are due December 9, 2019.
EPA notes that these proposed revisions supplement the proposed rule issued in the April 23, 2019, Federal Register and would amend the TSCA Inventory Notification (Active-Inactive) Requirements rule promulgated on August 11, 2017. More information on the proposed rule is available in our April 11, 2019, memorandum, “EPA Announces Proposed Procedures for Review of CBI Claims for the Identity of Chemicals on the TSCA Inventory,” and more information on the final rule is available in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules.”
By Lynn L. Bergeson and Carla N. Hutton
On October 30, 2019, the U.S. Environmental Protection Agency (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 “[i]t 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, Richard E. Engler, Ph.D., and Carla N. Hutton
The U.S. Environmental Protection Agency (EPA) announced on September 19, 2019, that it posted the first public Toxic Substances Control Act (TSCA) Inventory to include unique identifier (UID) information. EPA states that the UID is a numerical identifier assigned to a chemical substance when EPA approves a confidential business information (CBI) claim for specific chemical identity. When EPA approves such a claim, it assigns a UID to that chemical identity; applies the UID to other information or submissions concerning the same substance; and ensures that any non-confidential information received by EPA identifies the chemical substance using the UID while the specific chemical identity of the chemical substance is protected from disclosure.
EPA notes that this is the first time that the public version of the TSCA Inventory includes both a field containing a UID for those chemical substances with approved confidentiality claims for specific chemical identity and a field containing the ten-year expiration date from the assertion of such approved claims. EPA states that the UIDs provide the public with a way to connect the specific chemical identity previously listed on the confidential portion of the TSCA Inventory with other relevant information in EPA’s holdings.
EPA’s goal is to publish an up-to-date version of the TSCA Inventory about every six months. With the version published on September 19, 2019, EPA has taken another positive step in implementing its obligations under TSCA. The Inventory now includes two new fields: UI (for the unique identifier or UID) and EX (indicating the expiration date of the CBI claim). EPA continues to work through CBI identities, so only a few of the CBI substances have a UID. We expect that EPA will begin to assign UIDs to CBI substances that are newly added to the Inventory (e.g., through a Notice of Commencement submitted going forward). We also expect that EPA will assign UIDs to substances that were claimed as CBI on a Form A as EPA works through reviewing the almost 8,000 substances listed as active on the confidential portion of the Inventory. A more detailed commentary is available in our September 20, 2019, memorandum, “EPA Includes Unique Identifier Information on Updated TSCA Inventory.”
By Lynn L. Bergeson and Lisa R. Burchi
In a significant victory for industry, on August 27, 2019, the State of New York Supreme Court invalidated the New York Department of Environmental Conservation (NYDEC) Household Cleansing Product Information Disclosure Program (Disclosure Program). Information related to NYDEC’s prior delay of its enforcement of its Disclosure Program is available here, and general information regarding the Program and its extensive requirements for manufacturers of certain consumer cleaning products to disclose information regarding the ingredients in those products is available here.
Two trade associations, the Household and Commercial Cleaning Products Association (HCPA) and the American Cleaning Institute (ACI) (Petitioners), filed the lawsuit last October. Petitioners sought declaratory relief and a judgment invalidating the Disclosure Program on the basis that the Program was a “rule” for which NYDEC did not comply with its State Administrative Procedure Act (SAPA) rulemaking procedures. Petitioners also argued that the Program was established in violation of Article IV Section 8 of the New York State Constitution, was issued in excess of NYDEC’s statutory authority, and was arbitrary and irrational.
The court found that the Disclosure Program was established in violation of SAPA and the New York State Constitution. In making this finding, the court held that the Program was a “rule” as argued by Petitioners and not “guidance” for which adherence to SAPA was not required, as argued by NYDEC. The court also found that “since there is no opt out provision whereby petitioners may choose to deviate from the program, the Disclosure Program is not mere guidance.” The Disclosure Program is thus “null and void and the matter is remitted back to DEC with the directive to comply with SAPA.” Since the decision was reached based on violations of SAPA, the court did not address the other bases upon which Petitioners sought to invalidate the Program. A more detailed analysis and commentary are available in our August 30, 2019, memorandum, “NY Department of Environmental Conservation Household Cleansing Product Information Disclosure Program Ruled ‘Null and Void.’”
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.