By Lynn L. Bergeson and Carla N. Hutton
On November 21, 2022, the U.S. Environmental Protection Agency (EPA) announced that it has improved public access to certain reports submitted by chemical companies in ChemView, EPA’s web application for public access to non-confidential business information (non-CBI) on chemicals regulated under the Toxic Substances Control Act (TSCA), including new chemical notices and notices of substantial risk. EPA has published previously unpublished new chemical notices received under TSCA Section 5 and notices of substantial risk provided by companies under TSCA Section 8(e). EPA states that going forward, it will continue to identify older, previously submitted unpublished information to make available in ChemView and will publish newly received TSCA Section 5 notices and TSCA Section 8(e) reports on a “near real-time basis.” EPA has also published in ChemView chemical health and safety studies received under TSCA Section 8(d).
New Chemical Submissions
TSCA Section 5 requires EPA to publish a list of new chemical submissions it has received, including premanufacture notices (PMN), significant new use notices (SNUN), microbial commercial activity notices (MCAN), test market exemption (TME) applications, notices of commencement of manufacture or import (NOC), and test information submitted under Section 5. According to EPA, in 2022 it made available in ChemView more than 25,000 new chemical notice records received under TSCA Section 5, including notices received between 2014 and 2019 that had not been published previously. In 2019, EPA began publishing non-CBI notices on an ongoing basis, and “new records are now generally published within five days of receipt.” EPA states that it will also continue to identify and make public older, previously unpublished new chemicals notices.
Notices of Substantial Risk
TSCA Section 8(e) requires chemical companies to inform EPA of information that reasonably supports the conclusion that a chemical may present a substantial risk of injury to health or the environment. EPA uses these notices to inform new and existing chemical risk assessment activities. According to EPA, in 2022 it has published 3,900 notices of substantial risk records received under TSCA Section 8(e) in ChemView, including more than 3,300 non-CBI notices submitted between January 1, 2019, and December 20, 2021, that were not previously published due to resource limitations. EPA states that over the next several months, it will publish all non-CBI versions of Section 8(e) notices received from December 20, 2021, to the present. Going forward, “EPA will strive to publish 8(e) notices deemed complete within a week of receiving them from companies.” Additionally, EPA will work to identify and publish Section 8(e) notices received before 2019 as resources allow.
Health and Safety Data Reporting
Regulations promulgated under TSCA Section 8(d) require chemical companies to submit lists and copies of health and safety studies relating to the health and/or environmental effects of specified chemical substances and mixtures. According to EPA, in 2022 it published more than 1,700 health and safety study records received since September 2021 under TSCA Section 8(d) in ChemView. EPA notes that many of these records were in response to EPA’s 2021 Section 8(d) rulemaking, Health and Safety Data Reporting; Addition of 20 High-Priority Substances and 30 Organohalogen Flame Retardants. EPA states that it expects to publish additional Section 8(d) records “in the future.”
By Lynn L. Bergeson and Carla N. Hutton
The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program will host a webinar on October 18, 2022, on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar will cover examples of quantitative and qualitative data unlikely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and clarifications of common misconceptions in EPA’s new chemical assessments.
As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe to stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and worker exposure) provided for new chemical submissions and common issues that cause EPA to have to reconduct risk assessments (“rework”). The goal of this effort is to prevent delays of EPA’s new chemical reviews caused by rework.
This will be the second in a series of webinars intended to increase the efficiency and transparency of EPA’s new chemical determinations. As reported in our July 28, 2022, memorandum, in July 2022, EPA hosted the first webinar, analyzing common issues that cause EPA to have to rework risk assessments. Meeting materials are available for those who missed the first webinar.
By Lynn L. Bergeson
The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended TSCA, “including key reforms to increase EPA’s authority to mandate testing, require EPA to make affirmative decisions about the safety of new chemicals, and require the evaluation, and where merited, the regulation of existing chemicals.”
Dr. Michal Ilana Freedhoff, Assistant Administrator for OCSPP, was the Subcommittee’s only witness. In her testimony, she emphasized several critical building blocks of a sustainable TSCA program:
- Resources: EPA needs meaningful new funding to reflect its new responsibilities under the Lautenberg Act. Freedhoff estimates that EPA has less than 50 percent of the resources necessary to review and approve new chemicals in the way Congress intended;
- Strong science and scientific integrity; and
- Policies and processes that will lead to legally and scientifically defensible and protective chemical safety actions. The previous Administration issued ten final risk evaluations. While some EPA policy changes made under the Biden Administration will require revision to some of these risk evaluations, EPA’s intent is to do only what is necessary. These policy changes include reversing the assumption that all workers always use personal protective equipment (PPE) and reversing the decision to exclude exposures to chemicals from air, drinking water, and disposal.
Freedhoff stated that EPA’s goal is to move to rulemaking as soon as possible. She expects that the proposed rule for asbestos will be the very first of the first ten chemicals assessed under the Lautenberg Act that will be sent to the Office of Management and Budget (OMB) for interagency review later in 2021. According to Freedhoff, the scope for the next part of the asbestos risk evaluation that addresses uses and fiber types that the previous Administration excluded will be ready “roughly” by the end of 2021. EPA expects to complete that risk evaluation by the end of 2024.
Freedhoff described EPA’s work to improve implementation of the new chemicals program. Freedhoff noted that EPA has made policy changes intended to protect workers and ensure that the scope of new chemical reviews aligns with Congress’s expectations. EPA has also revised the process for reviewing and issuing final human health risk assessments and established a new internal advisory body to review and consider scientific policy issues related to new chemical submissions. Freedhoff stressed that she does not believe ensuring that new chemicals be used safely and reviewing new chemicals quickly are mutually exclusive. EPA can do both, and the Lautenberg Act states that EPA should. When questioned about the delay in review of premanufacture notices (PMN) within the allotted 90 days, Freedhoff stated that EPA is operating under the typical workload, as has been the case the past few years. According to Freedhoff, when EPA takes more than 90 days, it is typically because the companies have asked EPA to do so. Sometimes that is because the companies are providing new information late in the process and sometimes, especially in the past few years, it is because they disagree with EPA’s risk assessment and want to change EPA’s mind. Freedhoff reiterated her earlier point about needing resources, noting that EPA is operating with less than 50 percent of the resources that it thinks it needs to operate the NCD in the way that Congress intended.
Freedhoff stated that in April 2021, she and the scientific integrity official found a way to initiate a review of a small number of human health assessments about which concerns were raised, and she shared the information with the Office of the Inspector General (OIG). She learned that sometimes very serious questions were raised about how hazardous a new chemical is found to be, even when there is agreement that hazard exists. She heard that changes to the scientific basis of the assessments is not always well explained or understandable. Freedhoff stated that there are legitimate questions about the process and science associated with reviewing new chemicals and that she takes these concerns seriously. She personally let the OIG know that OCSPP will cooperate fully with its investigation; launched a series of scientific integrity trainings; put into place new ways for scientists who believe that there is disagreement can elevate their concerns and obtain a review; and hired someone to come in and talk about ways to improve recordkeeping practices.
Freedhoff highlighted one of OCSPP’s contributions to the Biden Administration’s multi-agency plan to address PFAS contamination, the national PFAS testing strategy. According to Freedhoff, most of the thousands of PFAS have no toxicity data, and if EPA continues to work on one PFAS at a time, EPA will not get through them. Freedhoff stated that the first TSCA test orders to manufacturers for about 20 different PFAS in 20 different categories will go out in a matter of months. EPA expects to extrapolate the information that it receives to more than 2,000 other PFAS in similar categories. EPA is currently determining what tests to require. The timeline for industry to conduct the testing and provide results to EPA depends on what tests are required.
After Freedhoff completed her opening statement, Committee and Subcommittee members had an opportunity to ask questions. During the question and answer period, Freedhoff agreed that the Lautenberg Act requires that EPA make health and safety studies public, such as those for Colour Index (C.I.) Pigment Violet 29 (PV29) that were initially declared confidential, and EPA is going to do that. EPA has updated the confidential status of almost 400 chemicals and will include those chemicals on the next update of the TSCA Inventory. EPA is also working to provide more information about new chemicals and make it more public as quickly as possible.
To address risks to communities that live near industrial facilities, EPA is creating a fenceline screening methodology to ensure that communities are not inadvertently left out of the risk evaluation process. According to Freedhoff, EPA will release the methodology for public comment and peer review in fall 2021. EPA also expects to release a new draft systematic review methodology for both public comment and peer review later in 2021.
When asked about the final rules for five persistent, bioaccumulative, and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), decabromodiphenyl ether (decaBDE), hexachlorobutadiene (HCBD), pentachlorothiophenol (PCTP), and phenol, isopropylated phosphate (3:1) (PIP (3:1)) -- that have caused concerns about the supply chain, Freedhoff noted that these final rules were issued under the Trump Administration. She stated that she believes that the former Administration made every effort to reach out to industry, but industry realized what the implications would be on their supply chains only after the final rules were issued. The Biden EPA immediately took action to extend the PIP (3:1) compliance date and is still working to address industry’s concerns and will continue to do so.
Under the previous Administration, EPA completed the risk evaluation of methylene chloride and banned it in all paint removers for consumer use. According to Freedhoff, EPA is now considering its commercial uses and working to ensure that the rule will not leave fenceline communities with additional exposures. EPA expects to send a proposed rule addressing these uses for interagency review sometime in 2022.
There were not many surprises in the hearing. Freedhoff largely reiterated statements EPA has made in the past, rather than providing new information or additional clarity. Criticism from members followed fairly well-trodden lines of critique that have been raised since 2016, and Freedhoff responded predictably, asserting that EPA would follow the law and the science and urging repeatedly that EPA needs additional resources to fulfill its mission.
For critics on both sides, there was little assurance that OCSPP will take action timely on the many issues that have been delayed, including the Section 6 risk evaluations, new chemicals notices, and PBT regulations.
By Lynn L. Bergeson
On May 18, 2020, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) issued the much-anticipated final Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient (SECURE) rule. 85 Fed. Reg. 29790. The rule is intended to update and modernize USDA’s biotechnology regulations under the Plant Protection Act. The final rule amends the regulations regarding the movement (importation, interstate movement, and environmental release) of certain genetically engineered (GE) organisms in response to advances in genetic engineering and APHIS’s understanding of the plant pest risk posed by GE organisms, thereby reducing the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. For more information, please read the full memorandum here.
By Lynn L. Bergeson
On January 2, 2020, EPA published a Federal Register notice announcing the availability of the updated “Working Approach” document for a 45-day comment period. As reported in the Bergeson & Campbell, P.C. (B&C®) December 20, 2019, blog item, EPA released an updated version of the “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.” Comments are due on or prior to February 18, 2020. The updated document explains its approach for making one of the five affirmative determinations on new chemical notices under the Toxic Substances Control Act (TSCA):
- The chemical or significant new use presents an unreasonable risk of injury to health or the environment;
- Available information is insufficient to allow EPA to make a reasoned evaluation of the health and environmental effects associated with the chemical or significant new use;
- In the absence of sufficient information, the chemical or significant new use may present an unreasonable risk of injury to health or the environment;
- The chemical is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the chemical; or
- The chemical or significant new use is not likely to present an unreasonable risk of injury to health or the environment.
EPA notes that the updated document reflects feedback from a 2017 public meeting and comment period and EPA’s additional experience implementing the 2016 amendments to TSCA Section 5, and includes:
- Additional clarification and detail throughout;
- General guiding principles and concepts for making determinations;
- Decision-making logic and key questions that EPA must address; and
- Example applications of the Working Approach to reach each of the affirmative determinations under TSCA Section 5(a)(3).
EPA has posted a document summarizing public comments received on the 2017 document and its responses. More information is available in B&C’s December 20, 2019, memorandum, “EPA Releases Updated Version of ‘Working Approach’ Document for New Chemicals Review.”
By Kathleen M. Roberts
On May 9, 2017, Senator Elizabeth Warren (D-MA), along with seven additional Democratic Senators, sent a letter to the Securities and Exchange Commission (SEC), the U.S. Environmental Protection Agency (EPA), and the Commodities Futures Trading Commission (CFTC) requesting an investigation into the activities of Carl Icahn for potential insider trading, market manipulation, and other securities and commodities law violations in the renewable fuel credit market. The letter states that the actions of and the massive profit earned by Icahn raise questions related to conflict-of-interest rules that apply to government officials, and questions regarding insider trading and market manipulation of renewable fuel credits, known as Renewable Identification Numbers (RIN) -- which SEC, EPA, and CFTC have jurisdiction over. EPA oversees the issuance and trading of RINs. CFTC works with EPA to ensure integrity in the RIN market since it has broad authority to prevent insider trading and other market manipulation in commodities markets and futures markets. SEC has jurisdiction to investigate whether Icahn’s actions as a senior adviser to President Trump affected CVR Energy's stock value or the accuracy of the company's annual and quarterly financial reporting and disclosure.
The Senators maintained that RIN insider trading and market manipulation hurts all parties, including biofuel producers and refineries, and requested an investigation by the three agencies based on the publically available information detailed in the letter. The Senators also requested information on whether EPA Administrator Scott Pruitt and SEC Chairman Jay Clayton would recuse themselves from the investigation.
Tuesday, September 27, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted, and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and B&C.
Webinar 4 will cover:
- Section 6(h) -- Chemicals That Are Persistent, Bioaccumulative, and Toxic (PBT);
- Section 18 -- State-Federal Relationship and Preemption;
- Section 19 -- Judicial Review; and
- Section 26 -- Fees.
- Moderator -- Lynn L. Bergeson, Managing Partner, B&C;
- Charles M. Auer, Senior Regulatory and Policy Advisor, B&C, former Director of the Office of Pollution Prevention and Toxics (OPPT), U.S. Environmental Protection Agency (EPA);
- Richard E. Engler, Ph.D., Senior Chemist, B&C, former senior staff scientist in OPPT and leader of EPA's Green Chemistry Program;
- Lisa R. Burchi, Of Counsel, B&C; and
- Sheryl Lindros Dolan, Senior Regulatory Consultant, B&C.
Additional Webinars in "The New TSCA: What You Need To Know" 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 3: Inventory, CDR, and CBI (Sections 8 & 14), presented September 12, 2016.
- For a copy of any of these webinar recordings, click here.
Read B&C's TSCA blog for the latest news and analysis regarding TSCA reform, implementation, and related legal and administrative developments.
Monday, September 12, 2016
8:00 a.m. Pacific Daylight Time/11:00 a.m. Eastern Daylight Time/16:00 British Summer Time
Three months have passed since Toxic Substances Control Act (TSCA) reform was enacted and now implementation trends are starting to take shape. Rather than waiting to see what TSCA reform's impact on your business might be, take control of your approach to "new" TSCA with the information and insight shared in the "The New TSCA: What You Need To Know" webinar series presented by Chemical Watch and Bergeson & Campbell, P.C. (B&C®).
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
- 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.
On September 12, 2016, Lynn L. Bergeson, Managing Partner of Biobased and Renewable Products Advocacy Group (BRAG®) affiliate Bergeson & Campbell, P.C. (B&C®); Richard E. Engler, Ph.D., B&C Senior Chemist; and Kathleen M. Roberts, Vice President of B&C Consortia Management, L.L.C. (BCCM), will present "The New TSCA: Information and Reporting (Sections 8 & 14)" in conjunction with Chemical Watch. This free webinar is the third in Chemical Watch's Toxic Substances Control Act (TSCA) reform series, and will focus on reporting and recordkeeping obligations, confidential business information (CBI) considerations, nomenclature, the "reset" of the TSCA inventory, and obligations for processors. The first two webinars in this series, "Summary of major changes: what to expect and when to expect it" and "Impacts on new and existing chemicals programs" are available on the Chemical Watch website.
On June 14, 2016, DOE's Oak Ridge National Laboratory (ORNL), through UT-Battelle, LLC, published a report determining that bioenergy crops do not impact food security. The report, "Reconciling food security and bioenergy: priorities for action," was put together by experts from ten institutions, including ORNL, the International Food Policy Research Institute, the World Bank, and Imperial College London. The report determined that previous studies finding bioenergy crops to blame for food shortages had underlying assumptions that lead to incorrect conclusions. The authors additionally recommended using flex-crop schemes utilizing crops that may be used as either fuel or food depending on economic and environmental changes.