EPA seeks small businesses’ input on development of proposed TSCA Data Reporting Rule

The U.S. Environmental Protection Agency (EPA) is inviting small businesses to participate as Small Entity Representatives (SERs) for a Small Business Advocacy Review (SBAR) Panel. This Panel will focus on EPA’s development of a proposed rule to collect data to inform each step of the Toxic Substances Control Act (TSCA) risk evaluation and risk management process.

The proposed rule would establish a framework of reporting requirements based on a chemical’s status in the TSCA Section 6 Risk Evaluation/Risk Management Lifecycle. Additionally, this new data reporting rule would enhance the exposure-related data collected through the TSCA Chemical Data Reporting (CDR) process. EPA is interested in ensuring its data collection strategies provide information to better meet the agency’s basic chemical data needs, such as information related to exposure, health and eco-toxicity. Collecting data geared specifically towards prioritization, risk evaluation, and risk management would help ensure the agency has relevant and timely data to inform each step of the process for reviewing potential risks from existing chemicals.

The data reporting rule, including changes to CDR, is tiered to specific stages of the TSCA Section 6 existing chemicals program: 

  • Identifying a pre-prioritization pool of substances as potential candidates for prioritization; 
  • Selecting candidate chemicals and completing the prioritization process; and 
  • Assessing high-priority substances through a robust risk evaluation, which may be followed by risk management actions (depending on the outcome of the risk evaluation). 

Tying specific reporting requirements to the activities that make use of reported data will also reduce the burden related to data collection efforts while ensuring that EPA has the information it needs to fulfill its risk evaluation and risk management responsibilities.

The proposed rule is intended to create a framework to obtain information about potential hazards and exposure pathways related to certain chemicals, particularly occupational, environmental, and consumer exposure information. EPA’s ability to collect data under this proposed rule would derive from authorities in TSCA sections 8(a) and 8(d), which give EPA authority to require:

  • Manufacturers and processors to provide known or reasonably ascertainable information, including chemical identity, production volumes, uses, byproducts, and worker exposure; and
  • Manufacturers, processors and distributors to submit health and safety information.

The potentially regulated community consists of entities that manufacture, import or process chemical substances, potentially including when the chemical substance is manufactured as a byproduct or is part of a formulated product or article (including import and processing). Most respondents anticipated to be affected by this collection activity are from the manufacturing sectors, including chemical manufacturing; petroleum and coal product manufacturing; chemical, petroleum and merchant wholesalers; paper, plastics, paint and printing ink manufacturing; electronic product and component manufacturing; or other activities, including utilities and construction. Learn more about potentially regulated entities.

The Panel, convened under the authority of the Small Business Regulatory Enforcement Fairness Act, will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. The Panel members ask a selected group of SERs to provide advice and recommendations on behalf of their company, government, or organization to inform the Panel members about the potential impacts of the proposed rule on small entities.

EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.

Self-nominations may be submitted through the link below and must be received by July 20, 2022.

Nominate yourself as a SER

Wrap-up of federal and state chemical regulatory developments, May 2022

Read the full round-up of actions at JD Supra. The article includes links to podcasts, meeting recordings, and Federal Register notices.

An Approach to Determine Missing Life Cycle Inventory Data for Chemicals (RREM)

Huber, E., Bach, V., Holzapfel, P., Blizniukova, D., & Finkbeiner, M. (2022). “An Approach to Determine Missing Life Cycle Inventory Data for Chemicals (RREM).” Sustainability 14(6), 3161. https://doi.org/10.3390/su14063161

Abstract: Chemicals impact the environment. However, life cycle assessments (LCA) of products containing chemicals are often not possible due to a lack of available datasets. Existing methodologies to address this problem have several shortcomings. Therefore, a new approach to model chemicals is introduced to fill dataset gaps in inventory databases. Further data for 60 chemicals are provided. The approach consists of four steps: (i) general research on the chemical and the synthesis processes, (ii) setting up the reaction equations, (iii) researching the required thermal energy, and (iv) modeling of the dataset (RREM). Depending on the obtained data, calculations are carried out or assumptions are applied. The environmental impact of the chemicals is modeled in the LCA software linking to existing datasets. A case study of the chemical octocrylene illustrates the application of RREM. An overview is given of the environmental profile of 60 chemicals modeled based on RREM. The validity of the assumptions and their influences on the results are examined by a sensitivity analysis. By modeling chemicals with the RREM approach, previously unknown environmental impacts of chemicals and products containing them can be determined.

EPA seeks comment on draft document “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA”

In February 2022, EPA launched a new effort under the Toxic Substances Control Act (TSCA) to modernize the process and bring innovative science to the review of new chemicals before they can enter the marketplace.

Through this effort, the Office of Chemical Safety and Pollution Prevention (OCSPP) is proposing to develop and implement a multi-year collaborative research program in partnership with the Agency’s Office of Research and Development (ORD) and other federal entities focused on approaches for performing risk assessments on new chemical substances under TSCA.

EPA is holding a virtual public meeting on April 20 and 21, 2022, from 1:00 PM to approximately 5:00 PM (EDT) to provide an overview of the TSCA New Chemicals Collaborative Research Program and give individual stakeholders an opportunity to provide input. Written comments on the draft document are due April 26, 2022.

This multi-year research program will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations. Key areas proposed in the TSCA New Chemicals Collaborative Research Program include:

  • Updating OCSPP’s approach using data from structurally-similar chemicals to determine potential risks from new chemicals, also known as read-across. This will increase the efficiency of new chemical reviews promoting the use of the best available data to protect human health and the environment.
  • Digitizing and consolidating information on chemicals to include data and studies that currently only exist in hard copy or in disparate TSCA databases. The information will be combined with publicly available sources to expand the amount of information available, enhancing chemical reviews and enabling efficient sharing of chemical information across EPA. Safeguards for confidential business information will be maintained as appropriate in this process.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics to provide a suite of models to be used for new chemicals assessments. The goal of this effort is to update the models to reflect the best available science, increase transparency, and establish a process for updating these models as science evolves.
  • Exploring ways to integrate and apply NAMs in new chemicals assessments, reducing the use of animal testing. As this effort evolves, the goal is to develop a suite of accepted, fit-for-purpose NAMs that could be used by external stakeholders for data submissions under TSCA as well as informing and expanding new chemical categories.
  • Developing a decision support tool that integrates the various information streams specifically used for new chemical risk assessments. The decision support tool will more efficiently integrate all the data streams (e.g., chemistry, fate, exposures, hazards) into a final risk assessment and transparently document the decisions and assumptions made. Simply put, this will facilitate the new chemicals program tracking decisions over time and evaluating consistency within and across chemistries.

EPA stops posting ‘critically important’ chemical risk data

Read the full story from Bloomberg Law. See also the story in The Intercept.

The EPA has all but stopped posting online data about new types of problems commercial chemicals may cause, frustrating public interest groups and businesses that use the information to make health and safety decisions.

The Environmental Protection Agency says it went from posting substantial risk notices for hundreds of chemicals every year in its ChemView database—to posting just two notices since 2019—because the employee who updated the website retired, and because it’s not legally required to keep the website up to date.

The only way to view the data immediately is to visit the EPA headquarters in Washington, D.C. That leaves the public “completely blind to critical health and safety information for hundreds of chemicals,” said Jennifer McPartland, a health scientist at the Environmental Defense Fund.

New EU rules would permit use of most polymers without checks, experts warn

Read the full story in The Guardian.

New rules on chemicals to be debated by the EU this week would allow most polymers to be used without further checks, according to a group of scientists.

Only about 6% out of about 200,000 polymers would require extensive safety checks under proposals being discussed as part of Europe’s Reach chemicals regulations.

EPA announces changes to prevent unsafe new PFAS from entering the market

Today, in support of the Biden-Harris Administration’s commitment to tackling pollution from Per-and Polyfluoroalkyl Substances (PFAS) and protecting human health and the environment, the U.S. Environmental Protection Agency (EPA) is announcing important policy shifts in its review of new PFAS before they can enter the market.

Historically, some new PFAS have been allowed to enter the market through low volume exemptions (LVEs). EPA’s New Chemicals Program is implementing a new strategy for reviewing and managing LVE requests for PFAS to protect all Americans and the environment from the potentially harmful effects of these chemicals.

Due to the scientific complexities associated with assessing PFAS, and the hazard potential associated with various sub-classes of PFAS, it is challenging to conduct an appropriately robust review of LVE requests for PFAS in the 30 days the regulations allow. The regulations provide for the denial of LVE requests when EPA finds the chemical in question may cause serious human health effects or significant environmental effects, or when issues concerning toxicity or exposure require review that can’t be completed in 30 days.

Given the complexity of PFAS chemistry, potential health effects, and their longevity and persistence in the environment, an LVE submission for a PFAS is unlikely to be eligible for this kind of exemption under the regulations. While EPA will consider each LVE application individually, the agency generally expects that pending and new LVE submissions for PFAS would be denied. Doing this will allow the agency additional time to conduct a more thorough review through the pre-manufacture notice review process and, as appropriate, put measures in place to mitigate the potential risk of these chemicals as the agency determines whether to allow them to enter commerce.

Additionally, EPA is exploring ways to work cooperatively with companies to voluntarily withdraw previously granted LVEs. This would build upon a 2016 outreach effort that resulted in companies withdrawing more than half of the 82 long-chain PFAS LVEs that existed at the time.

Last month, EPA also announced important changes in the way the agency reviews and make determinations on new chemicals submissions to better align with TSCA, including using consent orders, when appropriate, to address any unreasonable risks. These policy shifts apply to all pending and new PMNs and significant new use notices, including those that involve PFAS.

These policy changes will ensure that if new PFAS are allowed to enter commerce, EPA will have reviewed all intended, known, and reasonably foreseen conditions of use and that these chemicals will not enter commerce absent appropriate and enforceable protections for human health, including that of workers, and the environment.

Learn more about EPA’s review of new chemicals.

Changes on the Horizon for Toxic Substance Control Regulation

Read the full post at JD Supra.

The year ahead promises to be a busy one for regulation of new and existing chemicals under the 2016 reforms to the Toxic Substances Control Act (TSCA). TSCA gives EPA expanded authority to regulate both new and existing chemicals, as the agency must make findings on the risks presented by new chemicals, as well as review all active existing chemicals to identify “high priority” chemicals that must undergo risk evaluations and risk management plans as needed. The law applies broadly to any “person” who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, including companies that have manufactured chemical products or importing retailers, regardless of industry sector.

These entities are subject to TSCA requirements and should be aware of the business and legal implications, including upcoming chemical data reporting, evolving rules on risk evaluations and management, changes in fees, and rising enforcement penalties. A number of TSCA regulations are on the Biden Administration’s list of agency actions slated for review, consistent with an Executive Order. This alert provides a summary of these recent TSCA developments and expected changes in the new year for the regulated community.

Chemicals Strategy for Sustainability: Towards a Toxic-Free Environment

Download the document.

…in order to develop and deploy the sustainable chemicals that enable the green and digital transitions and to protect environment and human health, in particular that of vulnerable groups, innovation for the green transition of the chemical industry and its value chains must be stepped up and the existing EU chemicals policy must evolve and respond more rapidly and effectively to the challenges posed by hazardous chemicals. This includes ensuring that all chemicals are used more safely and sustainably, promoting that chemicals having a chronic effect for human health and the environment – substances of concern – are minimised and substituted as far as possible, and phasing out the most harmful ones for non-essential societal use, in particular in consumer products.

A more coherent, predictable and stronger regulatory framework, combined with nonregulatory incentives, will drive the necessary innovation, deliver increased protection, while enhancing the competitiveness of the European chemical industry and its value chains. To ensure a level playing field between EU and non-EU players, the EU must ensure full enforcement of its rules on chemicals both internally and at its borders, and promote them as a gold standard worldwide, in line with our international commitments.

The COVID-19 pandemic has not only added to the urgency to protect human and planetary health but it has also made us aware that manufacturing and supply chains have become increasingly complex and globalised for some critical chemicals, such as those to produce pharmaceuticals. The EU must strengthen its open strategic autonomy with resilient value chains and diversify sustainable sourcing for those chemicals that have essential uses for our health and for achieving a climate-neutral and circular economy.

This strategy highlights the areas where the Commission wants to make greater progress, in close concertation with stakeholders to fine-tune these objectives as part of rigorous impact assessment processes building on the ample evidence already gathered on the performance of existing legislation. The Commission will establish a high-level roundtable with representatives from industry including SMEs, science and the civil society to realise the strategy’s objectives in dialogue with the stakeholders concerned. Discussions of the
roundtable are envisaged to focus in particular on how to make the chemicals legislation
work more efficiently and effectively and how to boost the development and uptake of innovative safe and sustainable chemicals across sectors.

EPA Announces Opportunities for Public Engagement and Outreach on Risk Management Under TSCA

Today, the U.S. Environmental Protection Agency (EPA) is announcing a broad public engagement and outreach effort to discuss how the agency will approach the rulemaking process to address unreasonable risks found in the final Toxic Substances Control Act (TSCA) chemical risk evaluations. After issuing the first two final risk evaluations, methylene chloride and 1-bromopropane, EPA is moving into the risk management phase and is hosting a robust process to gain important feedback from stakeholders on the options for managing those risks.

“All stakeholders can expect transparent, proactive and meaningful outreach and engagement as we move through the risk management rulemaking process,” said EPA Office of Chemical Safety and Pollution Prevention Assistant Administrator Alexandra Dapolito Dunn.

EPA is holding two public webinars in September 2020 to kick off this outreach effort. Each will provide an overview of the TSCA risk management process and the tools available to manage the unreasonable risks. The first webinar, scheduled for September 16, 2020, will feature a discussion of the findings from the final risk evaluation for methylene chloride. The second webinar, scheduled for September 30, 2020, will include a discussion of the findings from the final risk evaluation for 1-bromopropane. Additional public webinars will be scheduled as EPA begins the risk management process for chemicals with unreasonable risks.

Additionally, EPA will begin one-on-one meetings with stakeholders and formal consultations with state and local governments, tribes, environmental justice communities, and small businesses. There will also be an open public comment period on any draft risk management regulation.

Under TSCA, there are several actions EPA can take to address unreasonable risks including banning a chemical, restricting the manufacturing, processing, distribution or use, warning labels /testing, and requiring manufacturers to notify distributors of any unreasonable risks. EPA has up to one year after issuing a final risk evaluation to propose and take public comments on any risk management actions.

Find registration information for the September webinars and more information on EPA’s risk management outreach https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca

Background

Under TSCA, EPA is required to evaluate the risks associated with existing chemicals in commerce using the best available science before taking action to address any unreasonable risks. The agency has issued two final risk evaluations, methylene chloride in June 2020 and 1-bromopropane in August 2020, both showing unreasonable risks to workers and consumers under certain conditions of use. EPA is now moving to risk managment for these chemicals, the next step in the process required by TSCA. EPA plans to issue final risk evaluations for the remaining eight of the first 10 chemicals by the end of 2020.

Learn more about the risk evaluation process required by TSCA.