By Lynn L. Bergeson and Carla N. Hutton
On February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents. According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance. On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public. The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents. EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant. The guidance portal provides a mechanism for the public to request modification or withdrawal of any documents. EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.” According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.
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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, Richard E. Engler, Ph.D., and Molly R. Blessing
Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018. Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online. This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.
On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.” EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance. The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”). EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance. EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity. More information on this guidance is available in our full memorandum.
By Lynn L. Bergeson and Carla N. Hutton
On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule. As noted in our June 29, 2016, memorandum, “TSCA Reform: EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA). EPA lists the following milestones that it has completed at the two-year anniversary:
In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.” Speakers will include:
- Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
- Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
- Michael Gould, EH&S Committee Chairman, RadTech North America; and
- Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.
More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.
By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).” EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.” EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document into its guidance. EPA also issued a “Response to Comments Received on Points to Consider Posted for Comment November 2017.” EPA states that it expects that use of the guidance will result in “more robust submissions.” EPA encourages companies to contact its new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their premanufacture notices (PMN). According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process.
More information will be available in our detailed analysis to be issued in a memorandum later today and posted to our Recent Regulatory Developments web page.
By Lynn L. Bergeson, Charles M. Auer, and Margaret R. Graham
On March 13, 2018, the U.S. Environmental Protection Agency (EPA) released three draft guidance documents for public comment clarifying the circumstances under which EPA may disclose Toxic Substances Control Act (TSCA) confidential business information (CBI) with an expanded set of people. Amended TSCA Section 14(d) expanded the categories of people to whom EPA may disclose TSCA CBI by specifically authorizing EPA to disclose TSCA CBI to state, tribal, and local governments; environmental, health, and medical professionals; and emergency responders, under certain conditions, including consistency with guidance that EPA is required to develop. The draft guidance documents are:
EPA’s prepublication version of the notice of availability of the draft guidance states the conditions for access vary under each of the new provisions, but generally include the following: requesters must show that they have a need for the information related to their employment, professional, or legal duties; recipients of TSCA CBI are prohibited from disclosing or permitting further disclosure of the information to individuals not authorized to receive it (physicians/nurses may disclose the information to their patient); and, except in emergency situations, EPA must notify the entity that made the CBI claim at least 15 days prior to disclosing the CBI. In addition, under these new provisions, requesters (except in some emergency situations) are required to sign an agreement and may be required to submit a statement of need to EPA. In accordance with the requirements of TSCA section 14(c)(4)(B), each guidance document covers the content and form of the agreements and statements required under each provision and include information on where and how to submit requests to EPA. A 30-day comment period for the draft guidance documents will open upon the notice’s publication in the Federal Register; comments can be submitted to docket EPA-HQ-OPPT-2017-0652 via www.regulations.gov.
On March 12, 2018, EPA also announced that it collecting comments on burden and other information required by the Paperwork Reduction Act related to these documents in the form of an Information Collection Request (ICR), as detailed in a separate notice. 83 Fed. Reg. 10719. Comments on the ICR are due May 11, 2018. EPA states that it anticipates using comments received in response to the guidance document notice and the ICR notice to inform the development of final guidance documents, which it anticipates to be released in June 2018.
By Lynn L. Bergeson and Carla N. Hutton
As reported in our January 11, 2017, blog item, the January 12, 2017, final rule establishes reporting and recordkeeping requirements for certain discrete forms of chemical substances that are manufactured or processed at the nanoscale. Under the rule, manufacturers and processers, or persons who intend to manufacture or process these chemical substances must report certain information to EPA. The information to be reported includes, insofar as known to or reasonably ascertainable by the person making the report, the specific chemical identity, production volume, methods of manufacture and processing, exposure and release information, and existing information concerning environmental and health effects. Persons who manufacture or process a discrete form of a reportable chemical substance at any time during the three years prior to August 14, 2017, the effective date of the final rule, must report to EPA one year after the effective date of the final rule. There is also a standing one-time reporting requirement for persons who intend to manufacture or process a discrete form of a reportable chemical substance on or after the effective date of the rule. These persons must report to EPA at least 135 days before manufacture or processing of that discrete form. More information regarding the final rule is available in our January 12, 2017, memorandum EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.
By Lynn L. Bergeson and Margaret R. Graham
On July 20, 2017, the U.S. Environmental Protection Agency (EPA) published two of the three Toxic Substances Control Act (TSCA) framework final rules in the Federal Register:
These rules will become effective on September 18, 2017. The TSCA Inventory Notification (Active-Inactive) Reporting Requirements final rule has not yet been published. EPA also published the notice of availability of its guidance to assist in developing and submitting draft risk evaluations:
More information on these final rules and the guidance are available in our memorandum EPA Issues Final TSCA Framework Rules.
By Lynn L. Bergeson and Margaret R. Graham
On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval. Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.” While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations. EPA must publish the final rule in the Federal Register by June 22, 2017.
More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.
Bergeson & Campbell, P.C. (B&C®) is pleased to announce the publication of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation, released today by the American Bar Association (ABA). This new book is a comprehensive guide to the substantial revisions to the Toxic Substances Control Act (TSCA) occasioned by enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, to produce “new TSCA,” amending and replacing “old TSCA” as of that date. B&C Managing Partner Lynn L. Bergeson and Senior Regulatory and Policy Advisor Charles M. Auer are editors and co-authors, with contributions from B&C’s outstanding TSCA practice group, including Timothy D. Backstrom, Lisa R. Burchi, Lisa M. Campbell, Sheryl L. Dolan, Richard E. Engler, Ph.D., Margaret R. Graham, Oscar Hernandez, Ph.D., Carla N. Hutton, and Kathleen M. Roberts.
Readers of New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation will gain an appreciation of the fundamental shifts in the requirements and approach to chemical management under new TSCA, and will benefit from thorough analysis of a number of the provisions, including those relating to definitions, testing, review and regulation of new and existing chemicals, information reporting, confidential business information (CBI), preemption, fees, and others. A 15-page Executive Summary of the book is available on the ABA website.
Reflecting on the book, Ms. Bergeson stated: “New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation reflects the expert counsel and advice of seasoned scientific and regulatory professionals and, of course, the essential views of former U.S. Environmental Protection Agency regulators and scientists, each of whom knows intimately the law, policy, and science of TSCA. Collectively, there is no stronger, more experienced TSCA team in the country to assist the regulated community tackle the challenges posed and seize the opportunities presented by the new law."
New TSCA: A Guide to the Lautenberg Chemical Safety Act and Its Implementation is available for purchase via the ABA online bookstore.