The European Chemicals Agency (ECHA) has announced that it will support the European Commission and Member States to develop risk profiles for methoxychlor and Dechlorane Plus®. This contributes to global work to eliminate or limit the use of the most hazardous persistent organic pollutants.

In early October 2019, the Organic Pollutants Review Committee (POPRC) agreed that methoxychlor (EC 200-779-9, CAS 72-43-5) and Dechlorane Plus® (EC 236-948-9, CAS 13560-89-9) fulfill the screening criteria as persistent organic pollutants (POPs). Together with the Commission, ECHA will support the committee in the preparation of risk profiles for these two substances and will launch a public consultation on the drafts in early 2020.

If the POPRC adopts the risk profiles, it will conduct risk management evaluations and then eventually recommend lisitng these substances as persistent organic pollutants in the Stockholm Convention. Listing under this convention would either result in their worldwide elimination or in the strict restriction of their production and use.

Dechlorane Plus® is mainly used as a flame retardant and has been identified as a substance of very high concern (SVHC) under REACH. Methoxychlor is a pesticide and its use in the EU has already been banned since 2002. Both substances have adverse effects to humans and the environment.

As of July 2019, ECHA supports the Commission and the Member States to identify and propose new POPs from the EU to the Stockholm Convention.

The Persistent Organic Pollutants Review Committee (POPRC) is a subsidiary body to the Stockholm Convention under the United Nations.

For details, visit echa.europa.eu.

The U.S. Environmental Protection Agency (EPA) sent two actions that address per- and polyfluoroalkyl substances (PFAS) to the Office of Management and Budget for interagency review. The agency’s first action is an advanced notice of proposed rulemaking that would allow the public to provide input on adding PFAS to the Toxics Release Inventory toxic chemical list. The second action is a supplemental proposal to ensure that certain persistent long-chain PFAS chemicals cannot be imported into the United States without notification and review by EPA under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016.  EPA has the authority to deny such “significant new use requests” under TSCA.

“Today’s announcement is just one of the many ways we are delivering on the PFAS Action Plan – the most comprehensive, multi-media research and risk communication plan ever issued by the agency to address an emerging chemical of concern,” said EPA Administrator Andrew Wheeler. “These actions are intended to provide the public with more information on PFAS in the environment and to ensure that EPA receives notice of any plan to import certain persistent long-chain PFAS into the country, further protecting all Americans.”

Both actions are critical steps in EPA’s efforts to help provide communities with additional information about PFAS chemicals. EPA looks forward to working with its federal partners throughout the interagency review process and will issue the proposals after that process is complete.

For more information: www.epa.gov/pfas

The U.S. Environmental Protection Agency (EPA) has awarded $849,811 to University of California Riverside as part of a total of $4.25 million in funding to five universities to research the development and use of alternative test methods and strategies that reduce, refine and/or replace vertebrate animal testing. Furthering these efforts, EPA Administrator Andrew Wheeler signed a memo titled, “Directive to Prioritize Efforts to Reduce Animal Testing.”

“Today’s memo directs the agency to aggressively reduce animal testing, including reducing mammal study requests and funding 30% by 2025 and completely eliminating them by 2035,” said EPA Administrator Andrew Wheeler. “We are also awarding $4.25 million to advance the research and development of alternative test methods for evaluating the safety of chemicals that will minimize, and hopefully eliminate, the need for animal testing.”

“We are excited to support U.C. Riverside’s work in helping reduce the use of animal testing and improve our understanding of chemical safety,” said Pacific Southwest Regional Administrator Mike Stoker.

University of California Riverside will use the grant to use human cells to develop a cost-effective endpoint to characterize potential skeletal embryotoxicants.

In addition, Administrator Wheeler called for the agency to aggressively pursue a reduction in animal testing. The memo states, EPA will reduce its requests for, and funding of, mammal studies by 30% by 2025 and eliminate all mammal study requests and funding by 2035. Any mammal studies requested or funded by EPA after 2035 will require administrator approval on a case by case basis. It directs leadership and staff in the Office of Chemical Safety and Pollution Prevention and the Office of Research and Development to prioritize ongoing efforts and to direct existing resources toward additional activities that will demonstrate measurable impacts in the reduction of animal testing while ensuring protection of human health and the environment.

In accordance with the memo, EPA will hold an annual conference on new approach methods beginning in 2019.

To read the full memo, visit https://www.epa.gov/environmental-topics/administrator-memo-prioritizing-efforts-reduce-animal-testing-september-20-2019

Several chemical regulatory conferences are scheduled at key sites around the world this Fall. These include conferences in Europe, Asia and the USA. The conferences focus on developments in global chemical regulations, and include:

Regulatory Summit Europe to be held in Brussels, Belgium from 14-15 October, 2019

Regulatory Summit USA to be held in Washington DC, USA from 4-5 November 2019

Regulatory Summit Asia to be held in Kuala Lumpur, Malazia from 19-21 November 2019.

Key topics include hazardous chemicals management, REACH and K-REACH, the ECHA database for SVHCs, Proposition 65, ASEAN developments, RoHS and the new TSCA, OSHA harmonization, and more. More than thirty experts from a variety of organizations — including ECHA, the European Commission, Cefic, US EPA, and more — provided in-depth information about regulatory challenges and solutions.

For details, click on the links to the specific conferences above.

The U.S. Environmental Protection Agency (EPA) is proposing to designate 20 chemical substances as Low-Priority Substances under the Toxic Substances Control Act (TSCA). This proposal marks EPA’s meeting another major milestone under the Frank R. Lautenberg Chemical Safety Act for the 21st Century amendments to TSCA – which require EPA through a variety of transparent processes to prioritize existing chemical substances for high- or low-priority designations. A final designation of “low-priority” means that the risks associated with the chemical substances are low, and risk evaluation for that chemical substance is not warranted at this time.

“Today’s action demonstrates EPA’s diligence in meeting its obligations under the Frank R. Lautenberg Chemical Safety Act for the 21st Century,” said EPA Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention Alexandra Dunn. “The agency’s proposed designation of 20 Low-Priority Substances is part of a rigorous, transparent, and scientifically sound process to ensure that the chemical substances in American commerce do not pose unreasonable risks of injury to human health or the environment.”

To support a proposed priority designation, EPA considered reasonably available information for each chemical substance under its conditions of use as specified in TSCA section 6(b)(1).

For each chemical substance, EPA is making a docket available that contains the screening review and rationale for the proposed Low-Priority Substance designation. The dockets are available on www.regulations.gov. A 90-day public comment period will start after the proposal is published in the Federal Register. During this period, the public may submit relevant information and comments on the proposed designations. EPA has also published the Approach Document for Screening Hazard Information for Low-Priority Substances Under TSCA that describes the literature review process that will be used for each chemical’s hazard information.

EPA published a list of 40 chemical substances on March 20, 2019, that initiated the prioritization process to designate 20 chemical substances as “high-priority” for subsequent risk evaluation and 20 as “low-priority.” EPA will make the supporting information for the proposed high-priority substances available in the coming weeks and remains on track to finalize the designations for 20 high-priority chemical substances and 20 low-priority chemical substances by December 2019 – the TSCA deadline.

More information on the Low-Priority Substances can be found at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-undergoing-prioritization-low

More information on TSCA and the prioritization process can be found at: www.epa.gov/assessing-and-managing-chemicals-under-tsca/prioritizing-existing-chemicals-risk-evaluation

Several new features and improvements are now publicly available in the European Chemical Agency (ECHA) chemicals database. These include new information in substance Infocards, quick links to deeper datasets for each substance, and more visibility on nanomaterials.

The properties of concern section in the Infocards have been extended and the search possibilities for substances based on these properties has been likewise extended.

The current regulations and regulatory activities section have been restructured and the different regulatory lists are now laid out by legislation in expandable blocks, with explanations why the substances are on key lists.

The other identifiers section has also been improved and restructured to include all public identifiers, including translated names and where available allowing to search them in different EU languages.

For all of these improvements and new features, the Infocard integrated help system has been updated with extensive explanations and links to more information.

There are also new quick links to key datasets for each substance, giving users a faster way to browse through more data-rich datasets, such as the Brief Profiles, REACH registered substance factsheets, the Classification and Labeling (C&L) Inventory, biocides data and the public activities coordination tool (PACT).

The advanced search has also been extended and restructured, allowing new search possibilities. For instance, the advanced classification and labeling search now also covers Seveso Directive data.

The Infocards now have a new nanomaterial form section, which shows whether the substance is placed on the EEA market in nanoform and provides links to the EU Observatory for Nanomaterials (EUON). Through the EUON’s search for nanomaterials, information on over 300 nanomaterials on the EU market can be found and linked to hazard data. The search uses data from REACH registrations, the cosmetic ingredients notification portal as well as the French and Belgian national inventories.

Finally, disseminated REACH registration data will now start to be automatically linked to the OECD’s eChemPortal.

For details, visit echa.europa.eu.

On the third anniversary of the Frank R. Lautenberg Chemical Safety for the 21^st Century Act (Lautenberg) which amended the Toxic Substances Control Act (TSCA), the EPA is proposing for public comment a rule to reduce exposures to certain chemicals that are persistent, bioaccumulative and toxic (PBT).  These chemicals build up in the environment over time and can therefore have potential risks for exposed populations including the general population, consumers and commercial uses, susceptible subpopulations (such as workers, subsistence fishers, tribes and children).

“We are proud to meet another statutory deadline under Lautenberg today,” said Assistant Administrator Alexandra Dunn of EPA’s Office of Chemical Safety and Pollution Prevention.  “Today’s proposal offers a tangible example of the wide range of management tools available to EPA under Lautenberg. EPA worked diligently to propose a rule that reflects consideration of a wide range of perspectives and extensive research on whether, and if so how, these chemicals are used in commerce.”

TSCA section 6(h) requires EPA to propose a rule “to address the risks of injuries to health or the environment that the Administrator determines are presented by the chemical substance and to reduce exposures to the substance to the extent practicable,” no later than June 22, 2019, with a final rule to follow no more than 18 months later.

This section of TSCA prescribes the criteria for how the specific PBTs were to be selected from the 2014 Update of the TSCA Work Plan for Chemical Assessments list, with the resulting list of chemicals identified for action by EPA in 2016, as follows:

• Decabromodiphenyl ether (DecaBDE);
• Phenol, isopropylated phosphate (3:1) or PIP (3:1);
• 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP);
• Hexachlorobutadiene (HCBD); and
• Pentachlorothiophenol (PCTP).

Each of the five chemicals has different hazards and uses. To reduce exposure to these chemicals, the proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses for four of the five chemicals. For one chemical, hexachlorobutadiene, EPA has evaluated the conditions of use and is proposing no action as the agency did not identify any practicable ways of further reducing human or environmental exposure to the chemical substance.  HBCD is, notably, regulated as a hazardous air pollutant under the Clean Air Act. The proposed rule also includes recordkeeping requirements for several of the chemicals and downstream notification requirements for one chemical.

The Agency conducted extensive outreach and established public dockets to gather information for this proposal, including holding a webinar on chemical use information, carrying out a consultation with Tribes, and organizing dozens of individual meetings with the members of the chemical industry, environmental organizations, Federal partners, State agencies, and others. EPA incorporated public comments on and received scientific peer review of two documents – a Hazard Information document, which identifies current uses of PBT chemicals, and a Use and Exposure Assessment, which supports the finding that exposure to these five substances is likely under the conditions of use.

Upon publication in the Federal Register, EPA is asking for public comment for 60 days on the proposal. Comments should be submitted through regulations.gov to docket EPA-HQ-OPPT-2019-0080.

For details, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/persistent-bioaccumulative-and-toxic-pbt-chemicals-under.

A stunning 8.3 billion tonnes of plastics produced since early 1950s. A miniscule amount of this plastic — created with non-renewable resources — is recycled or burned, and mostly ends up in dump sites. One million plastic bottles purchased every minute around the world. Jacob Duer, chief of the Chemicals and Health Branch with UN Environment Programme opened a session on plastics and the circular economy at the 2019 Helsinki Chemicals Forum on May 24 with these grim facts.

The session covered efforts to address the issue from industry, retailers, investors, civil society, what they are doing to promote action.

Ingeborg Mork Knutsen, senior advisor with Norway’s Ministry of Climate Change and Environment spoke about marine litter and microplastics and described how her country is tackling the problem of marine litter and reducing single-use plastics. For example, Norway has had a recycling tax on plastic bottles for many years, and as a result has achieved a return rate of about 90% for all plastic bottles. Now the country is turning its attention to the challenge of marine litter and is in the process of developing an app for tracking and retrieving lost fishing gear which is receiving a lot of international attention.

She called for international cooperation in dealing with marine plastic litter and said secondary markets need to be found for recycled plastic material.

Mark Blainey, head of risk management, Unit I with the European Chemicals Agency (ECHA), discussed the EU’s Single Use Plastics Directive which was issued in March this year. He also outlined a restriction proposal for intentionally added microplastics — the small microbeads found in cosmetic products as well as in detergents, printing inks and paints, makeup, in agriculture for seed coatings and other products, and small rubber balls on sports fields.

The proposed restriction is currently going through the scientific group at ECHA which will issue an opinion next year. A definition has already been developed, based on definitions in REACH.

Lorraine Francourt, director, Chemicals Management Policy and Circular Economy, Dow Chemicals, told participants about the Alliance to End Plastic Waste. A CEO-led initiative to keep plastics out of the environment, the alliance is focussed on developing the actual infrastructure for recycling and waste management in developing countries.

Eva Karlsson, CEO, Houdini Sportwear, described how her company is working with suppliers to develop biodegradable polymers for the clothing lines it manufactures, and to eliminate microplastics, and plans to achieve circularity by 2022.

Jacob Huer summed up the session by pointing out that to make restrictions work, developing biodegradable polymers is the only feasible option. The EU has created a tiered structure within the microplastics restriction so if it is shown that the polymer truly is biodegradable, then the product will no longer be defined as a microplastic.

Reported by Leslie Burt, Chemical Matters

The executive director of the European Chemicals Agency (ECHA), Bjorn Hansen, spoke at two key conferences in Helsinki this week and provided participants with an update on the agency’s activities and chemicals regulations. He was keynote speaker both at the ECHA Conference on May 22, and the Helsinki Chemicals Conference (HCF) the following day.

At this year’s ECHA Conference, subtitled Safer Chemicals, he outlined new tasks and priorities facing the organization. These tasks are the agency’s priorities from now until 2023, and include developing a portal for notifications of hazardous mixtures to national poison centres (CLP); a focus on occupations exposure limits (DELs) as well as persistent organic pollutants (POPs); developing a database to track chemicals of concern (waste framework directive) and the EU chemicals legislation FINDER; and the EU Nano Observatory website which collects existing information from databases, registries and studies and generates new data through additional studies and surveys on nanomaterials on the EU market.

At the HCF conference on May 23, Hansen provided an update on REACH/CLP regulations. He commented that the interface is running better and better, and the classification of pesticides, biocides and pthalates is going well. More harmonization with other legislation and sister agencies is a high priority.

The REACH regulations were implemented by the European Union in 2007, and govern the production and use of chemical substances in the EU, putting the burden of proof on companies that manufacture or use the substances. REACH establishes procedures for collecting and assessing information on the properties and hazards of substances.

Companies must register their substances and can work together with other companies who are registering the same substance. ECHA receives and evaluates individual registrations, and the EU member states evaluate selected substances to identify any concerns for human health or for the environment. Authorities and ECHA’s scientific committees then assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorization.

To date, 14,000 companies have registered substances, while 94,000 registration dossiers have been opened with 22,000 substances registered. A total of 197 substances have been placed on the substances of very high concern (SVHC) list, 43 on the authorization list and 69 restrictions have been issued on substances or groups.

Reported by Leslie Burt, Chemical Matters

Finnish companies Neste and VTT have signed cooperation agreements aimed at strengthening expertise in the bio and circular economies as well as developing cleaner fuel solutions. The agreements relate to two separate research projects in Finland — the first to a testing facility being built by Neste in Kilpilahti, Porvoo, Finland and the second to a catalytic processes project at VTT’s Bioruukki pilot centre in Espoo, Finland. The agreements will allow Neste and VTT to use these research infrastructures in their future projects.

“Neste and VTT have long been partners, and the agreements will enable a more extensive research collaboration”, said Peter Vanacker, president and CEO of Neste.

“This partnership is very important to us, and an excellent example of how we are looking for concrete solutions to climate change and resource sufficiency with our partners. The cooperation between Neste and VTT brings up new opportunities to make the best possible use of the research infrastructures,” said Antti Vasara, VTT’s president and CEO.

Reported by Leslie Burt, Chemical-Matters.com