Category: Chemicals

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.

Perchloroethylene Draft Risk Evaluation Available for Public and Scientific Review

EPA is asking for public input on the draft risk evaluation of perchloroethylene. Seeking public input on the draft risk evaluation is the next step in the process outlined by the amended Toxic Substances Control Act (TSCA).

The draft risk evaluation is not a final agency action. Rather, it represents the agency’s initial review of the scientific data on this chemical and will be peer reviewed by independent, scientific experts as well as open for public comment. EPA will use feedback received from the peer review and public comment process to inform the final risk evaluation and will provide frequent updates on the agency’s progress throughout this process. If EPA’s final risk evaluation finds there are unreasonable risks associated with this chemical under the specific conditions of use, the agency will propose actions to address those risks within the timeframe required by TSCA. EPA’s actions could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemical substance, as applicable.

The document discusses how workers, occupational non-users, consumers, bystanders, and the environment could be adversely affected by perchloroethylene under certain conditions of use. Any unreasonable risks found in the draft risk evaluation, including those associated with this chemical’s use in dry cleaning, are preliminary and do not require any action at this time. It is important to note that use of perchloroethylene in dry cleaning has decreased over time as companies shift to alternative chemicals and new technologies. As with any chemical product, EPA strongly recommends that users carefully follow all instructions on the product’s label/safety data sheet. Consumers wishing to avoid exposure can ask retailers if products used contain perchloroethylene and consider not using products containing this chemical.

Upon publication of the Federal Register notice, EPA will accept comments on the draft risk evaluation for perchloroethylene for 60 days in docket EPA-HQ-OPPT-2019-0502 on regulations.gov. EPA will also hold a virtual peer review meeting of EPA’s Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation on May 26-29, 2020. The virtual peer review meeting is open to the public to attend and provide comments.

Additional Information

View the perchloroethylene draft risk evaluation and supporting documents: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/draft-risk-evaluation-perchloroethylene

Learn more about the peer review meeting: https://www.epa.gov/tsca-peer-review/peer-review-draft-risk-evaluation-perchloroethylene

Background

Perchloroethylene is a colorless liquid used primarily in industrial settings for dry cleaning and degreasing metals. This chemical is also used in the production of fluorinated compounds, as a solvent for cleaning and degreasing, and in lubricants, adhesives, and sealants. Perchloroethylene has a limited number of consumer uses in products like adhesives for arts and crafts and stainless steel polish. The yearly aggregate production volume ranged from 388 to 324 million pounds between 2012 and 2015.

CompTox Chemicals Dashboard

The CompTox Chemicals Dashboard. developed by U.S. EPA, is a one-stop-shop for chemistry, toxicity and exposure information for over 875,000 chemicals. Data and models within the Dashboard also help with efforts to identify chemicals of most need of further testing and reducing the use of animals in chemical testing. 

The dashboard includes several chemical lists that will be of particular interest:

Draft Risk Evaluation for Carbon Tetrachloride

Download the document.

In the draft carbon tetrachloride risk evaluation, EPA reviewed 15 potential uses, all of which are associated with industrial and commercial work and are primarily associated with the manufacturing process of other chemicals. There are no consumer uses of this chemical.

Upon publication of the Federal Register notice, the agency will accept comments on the draft risk evaluation for 60 days in docket EPA-HQ-OPPT-2019-0499. EPA also will hold a peer review meeting of EPA’s Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for this chemical’s conditions of use on February 25-26, 2020.

Hazardous substances: ECHA to launch first version of new database

Read the full story from ENDS Report.

The European Chemicals Agency (ECHA) has set October 2020 as the provisional date for rolling out the first version of a database listing substances of concern in articles or complex products.

EPA Tools and Resources Webinar: CompTox Chemicals Dashboard

Wednesday 09/11/2019 2:00PM to 2:00PM CDT
Register here.

The Computational Toxicology (CompTox) Chemicals Dashboard is a “first-stop-shop” for chemistry, toxicity and exposure for over 875,000 chemicals. This information is available to support federal agencies, state environmental and health agencies, international governmental agencies and industries make decisions about chemicals related to human health and the environment. Data are added on an ongoing basis and new releases of the dashboard occur a minimum of twice per year releasing new data and ongoing enhancements to functionality. EPA ORD’s Maureen Gwinn will present an overview of the CompTox Chemicals Dashboard and how it can be used, with an emphasis on updates released with the dashboard version 3.0.

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