EPA Extends Deadline For Chemical Data Reporting Filings Under Toxic Substances Control Act

Effective April 9, 2020, EPA is amending the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations by extending the submission deadline for 2020 reports from September 30, 2020, to November 30, 2020. This is a one-time extension for the 2020 submission period only. The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on the manufacturing, processing, and use of the chemical substances. This extension may potentially affect any entity that manufactures (including imports) chemical substances listed on the TSCA Inventory.

EPA does not indicate that this extension relates to the COVID-19 pandemic. Instead, EPA indicates that the one-time extension is for the purpose of allowing additional time for the regulated community to become familiar with the changes to the CDR reporting requirements as a result of the CDR Revisions Final Rule (FRL–10006–56) and to allow time for reporters to familiarize themselves with an updated public version of the reporting tool. EPA believes it is appropriate to extend the reporting period to allow the regulated community additional time to submit their reports. Although not attributed to COVID-19, this extension could nonetheless provide welcome news to companies already struggling through challenges presented by the pandemic.

For details, visit www.epa.gov.

EPA Will Host April 16 Call on TSCA Fees for EPA-Initiated Risk Evaluations

The U.S. Environmental Protection Agency (EPA) will hold a call on April 16, 2020, from 1:00 p.m. to 2:00 p.m. (EDT) on its recently announced plan to reduce burden for certain stakeholders subject to the Toxic Substances Control Act (TSCA) fees rule requirements for EPA-initiated risk evaluations.  The call will cover:

  • TSCA fees rule requirements and processes associated with EPA-initiated risk evaluations;
  • EPA’s March 25, 2020, rulemaking announcement and “No Action Assurance” and the implications for certain manufacturers who:  (1) import a high-priority chemical in an article; (2) produce a high-priority chemical as a byproduct; or (3) produce or import a high-priority chemical as an impurity; and
  • Reporting obligations during the current comment period for the preliminary lists of fee payers, closing May 27, 2020.

EPA asks stakeholders to submit questions by April 14, 2020, to Ben Dyson, dyson.benjamin@epa.gov, and EPA will address them during the call.  Additional questions from participants will be answered during the call as time permits.  Registration is now open.

EPA Announces Plan to Reduce TSCA Fees Burden for Stakeholders

On March 25, 2020, the U.S. Environmental Protection Agency (EPA) announced its plan to consider a proposed rule that would look at potential exemptions to the TSCA Fees Rule in response to stakeholder concerns about implementation challenges. By considering a proposal to narrow the broad scope of the current requirements, the agency could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments to the Toxic Substances Control Act (TSCA) to protect human health and the environment.

“Stakeholders are important partners in the work we do to ensure the safety of chemicals and seeking feedback from the public is a standard and valuable part of all our processes,” said EPA Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Alexandra Dapolito Dunn. “After reviewing their input and concerns regarding the TSCA Fees Rule, we are taking action to continue evaluating potential risks from chemicals while ensuring our requirements are practical and realistic.”

The agency plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; and
  • Produce or import the chemical substance as an impurity.

The agency may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the Fees Rule every three years.

EPA believes that considering exempting certain entities from self-identification requirements will not impede the ability to fully collect the necessary fees and will still allow the agency to achieve the ultimate objective of the TSCA Fees Rule and the statute – to defray a portion of EPA’s TSCA implementation costs. EPA intends to issue proposed amendments to the current fees rule later this year and with the goal of finalizing the amendments in 2021.

Additionally, in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information under the TSCA Fees Rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time. More specifically, EPA will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers that the agency intends to propose an exemption from certain requirements in the TSCA Fee Rule.

For businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above, see the agency’s FAQs for more information about how to certify as such to EPA and to avoid fee obligations. More information on this announcement, as well as a copy of the no-action assurance, can be found at https://www.epa.gov/tsca-fees/information-plan-reduce-tsca-fees-burden-and-no-action-assurance.

The Helsinki Chemicals Forum Conference of 4-5 June 2020 Postponed till 2021

HCF_logo_webThe Chemicals Forum Association and Messukeskus Helsinki have decided to postpone the 2020 Helsinki Chemicals Forum conference to next year. This decision was taken due to current COVID-19 pandemic, which forces all countries around the world – including Finland – to take emergency measures to avoid human contact which adversely affect international traveling and conferencing.

The full programme of and registration for the Helsinki Chemicals Forum conference of 4-5 June was published in February. However, over the past month the current health crisis moved from Asia to Europe and the rest of the world, so that the World Health Organisation declared COVID-19 a pandemic and called on all countries to adopt measures that would prevent or slow down viral transmission. All developed countries have in the meantime adopted such measures which are regularly made more stringent and covering a longer time span. There is at this stage no clarity when non-essential traveling for international conferences will again be accepted.

In this very exceptional and uncertain situation, the Chemicals Forum Association and Messukeskus Helsinki have decided to postpone Helsinki Chemicals Forum 2020 to next year, even if there is no obligation at this point in time to do so. Those that already registered will be individually contacted.

“The personal safety of all participants is of primary importance to us. We are sorry for our customers and we thank all our international partners for the work done up to this point for the Helsinki Chemicals Forum 2020 conference and on whom we count for next year conference” says Geert Dancet, Secretary General of Helsinki Chemicals Forum.

The available Helsinki Chemicals Forum 2020 programme will inspire the next conference and its programme will be published before the end of the year on the webpage www.helsinkicf.eu.

ECHA Committees Conclude on Five Restrictions

The Committee for Socio-economic Analysis (SEAC) has adopted its opinion on the restriction proposal for siloxanes (D4, D5, D6) in personal care products while the Committee for Risk Assessment (RAC) has adopted its opinion, among others, on skin sensitising substances used in textile and leather products.

Specifically, SEAC adopted its final opinion supporting ECHA’s proposal to restrict the placing on the market ofD4, D5 and D6 as substances, as contituents of other substances, or in mixtures in a concentration equal to or greater than 0.1 % weight by weight of each substance. This proposal covers both leave-on personal care products (D4, D5 and D6) and other consumer or professional products as well as wash-off personal care products (D6).

SEAC also agreed on its draft opinion on ECHA’s proposal to restrict the placing on the market, manufacture and use of five cobalt salts as substances on their own or in mixtures in a concentration equal or above 0.01 % by weight in industrial and professional applications. RAC adopted its opinion on this restriction proposal by written procedure in February 2020.

RAC adopted its opinion on France and Sweden’s proposal to restrict skin sensitising substances in finished textile, leather, hide and fur articles, placed on the market for the first time. Agreement on the SEAC draft opinion is postponed until June 2020.

RAC and SEAC supported Norway’s proposal to restrict the manufacture or placing on the market of PFHxS (linear or branched), its salts or related substances and as a constituent of another substance, in a mixture or in articles.

Furthermore, SEAC supported ECHA’s proposal to restrict the placing on the market of articles releasing formaldehyde at concentrations greater than 0.124 mg/m3 and that a formaldehyde concentration of 0.1 mg/m3 shall not be exceeded in the interiors of road vehicles and aircraft. RAC’s opinion supported the proposal but included several proposed modifications to its scope and conditions.

Consultations on the agreed SEAC opinions (cobalt salts, PFHxS and formaldehyde) will begin soon and the committee is expected to adopt its opinions at its June 2020 meeting.

The committees did not reach agreement on ECHA’s proposed restriction of intentionally-added microplastics and will continue discussions in June.

Applications for authorisation

RAC and SEAC adopted two opinions on applications for authorisation on one use of chromium trioxide and one use of octylphenol ethoxylates. In addition, RAC agreed on 16 draft opinions on applications for authorisation of uses of octyl- and nonylphenol ethoxylates; pitch, coal tar, high temperature; anthracene oil and chromium trioxide, reaching provisional agreement on 21 further uses, which will now go to written procedure.

SEAC agreed on 27 draft opinions on uses of octyl- and nonylphenol ethoxylates and pitch, coal tar, high temperature. Furthermore, RAC discussed key issues in 10 applications for authorisation, which were received by ECHA in November 2019.

More information about the opinions is available in an annex.

EU Project Determines 44% of Hazardous Mixtures Not Compliant with Classification and Labeling Obligations

The sixth EU-wide Enforcement Forum Project (REF-6) found significant non-compliances in hazardous mixture classification and labeling in 2019. The most common mixtures checked were washing and cleaning products; biocidal products; coatings, paints, thinners and paint removers; adhesives and sealants; room fragrances and air freshener products – these are known to commonly contain hazardous ingredients.

Screen Shot 2020-01-08 at 11.18.03 AM
Altogether, inspectors in 29 countries checked 3 391 mixtures and inspected 1 620 companies (manufacturers, importers, downstream users and distributors).

The project also looked at exemptions from labeling and packaging requirements, harmonized classification, biocides obligations and specific rules for liquid laundry detergent capsules.

REF-6 Emphasizes CLP Regulation

The REF-6 project is chartered with checking compliance with and raising awareness of a variety of legal provisions under the CLP Regulation, the most relevant of which were Articles 4, 17, 29, 35 and 37 of CLP, as well as Article 31 of REACH and Articles 17 and 69 of BPR.

Chemical products used by consumers are mixtures of different substances. To make sure that consumers can use them safely, information on safe use is passed onto them on labels on products that communicate the hazards and inform how to use them safely. Thus the main scope of the REF-6 project is to ensure compliance of the classification and labeling of chemical mixtures.

To prepare the correct information on safe use, the mixture must first be classified to identify hazardous properties and on the basis of such hazard classification an appropriate CLP label is prepared.

Main Findings Highlight Non-Compliances

The main findings of the project were:

  • 43 %of all reported companies were found to have at least one non-compliance and 44 % of reported mixtures were non-compliant in some way.
  • 17 %of reported mixtures were using an incorrect classification, which may result in incorrect labeling on the mixtures, and thereby incorrect safe use advice.
  • For certain substances that have hazards of highest concern (carcinogenicity, mutagenicity, reproductive toxicity and respiratory sensitizers), classification and labeling is harmonized throughout the EU to ensure adequate risk management. For 9 %of those substances checked in the project, the required harmonized classification and labeling were not applied.
  • 33 %of reported mixtures had incorrect labeling.
  • 33 %of the checked safety data sheets were non-compliant with the requirements checked in the project.
  • Inspectors checked the requirements for packaging and labeling liquid laundry detergent capsules (LLDCs). The most significant finding is that for 22 %of the checked LLDCs, the closure of the outer packaging did not maintain its functionality when repeatedly opened and closed during the life span of the packaging.
  • For checked biocidal products, around 7 %of them lacked either valid authorization according to the Biocidal Products Regulation (BPR) or to national legislation during the transitional period. For 17 % of the biocides, labels were non-compliant.

Manufacturers, importers and downstream users have to put more effort into deriving the right classification for mixtures and communicating it down the supply chain. This will prevent incorrect information being disseminated in safety data sheets and on labels. Industry should also work on improving the quality of safety data sheets, which will in turn lead to improved information flowing through the supply chain.

For details, visit https://www.youtube.com/watch?v=CUGEUmDZWiw&feature=youtu.be

American Chemistry Council’s 2020 GlobalChem Conference Registration Now Open

GC2020 Event Banner 215x70 2020Registration for the 2020 GlobalChem Conference and Exhibition, which will take place April 6-8, 2020 in Washington, D.C. at the Grand Hyatt, is now open at http://www.globalchem.org.

Hosted by the American Chemistry Council, GlobalChem is an annual gathering of industry professionals that offers a valuable opportunity to review recent developments in global chemicals management as well as meet industry peers and key government representatives. The 2020 agenda includes sessions about expectations for TSCA implementation in the next five to ten years; 2020 priorities for EPA’s Office of Chemical Safety and Pollution Prevention; international trade policy; emerging contaminants (e.g., PFAS and microplastics); challenges and opportunities raised in SAICM/ICCM5; global data sharing and much more.

Before the official conference opens, there will be an optional workshop day on Monday, April 6, for attendees to explore the fundamentals of the amendments to TSCA, including:

  • The TSCA Framework for Existing Chemicals at Year 3
  • What to Submit and How to Work with Your PMN Manager
  • Manufacturer Requested Risk Evaluations
  • Data Sharing Considerations
  • Understanding Confidential Business Information
  • Hazard Characterization 101

For details, visit http://www.globalchem.org.

EPA Finalizes List of Next 20 Chemicals to Undergo Risk Evaluation under TSCA

After reviewing input from stakeholders and the public, the U.S. Environmental Protection Agency (EPA) has announced the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA). Finalizing this list of high-priority chemicals for risk evaluation represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of existing chemicals in the marketplace.

“Today we are continuing to deliver on the promise of the Frank R. Lautenberg Chemical Safety for the 21st Century Act to assess and review existing chemicals in the marketplace,” said EPA Administrator Andrew Wheeler. “EPA is committed to transparency and being open with the public as these chemicals move through this TSCA process to evaluate the risks these chemicals may pose to public health and the environment.”

The 20 chemicals that will undergo risk evaluation consist of seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer precursor. It is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.

The next steps for these chemicals are outlined in TSCA’s process for risk evaluation. This first includes taking public comment on scoping documents for each of these 20 chemicals. By June 2020, EPA will finalize these scoping documents which will include the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations EPA expects to consider during each chemical’s risk evaluation. The agency will also take public comments on the draft risk evaluations for these chemicals and will finalize them after considering the public input the agency receives.

EPA is still carefully reviewing public comments on the 20 low-priority chemicals proposed in August 2019. The agency will finalize the list of low-priority chemicals in early 2020. Additionally, EPA will soon release and take public comments on a draft list of manufacturers and importers of these chemicals to help determine the appropriate division of fees as required under the TSCA fees rule.

List of Next 20 Chemicals

  1. p-Dichlorobenzene
  2. 1,2-Dichloroethane
  3. trans-1,2- Dichloroethylene
  4. o-Dichlorobenzene
  5. 1,1,2-Trichloroethane
  6. 1,2-Dichloropropane
  7. 1,1-Dichloroethane
  8. Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester)
  9. Butyl benzyl phthalate (BBP) – 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester
  10. Di-ethylhexyl phthalate (DEHP) – (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester)
  11. Di-isobutyl phthalate (DIBP) – (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester)
  12. Dicyclohexyl phthalate
  13. 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)
  14. Tris(2-chloroethyl) phosphate (TCEP)
  15. Phosphoric acid, triphenyl ester (TPP)
  16. Ethylene dibromide
  17. 1,3-Butadiene
  18. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)
  19. Formaldehyde
  20. Phthalic anhydride

For more information visit www.epa.gov/assessing-and-managing-chemicals-under-tsca/chemical-substances-undergoing-prioritization.



Helsinki Chemicals Forum Selects Five Chemicals Safety Themes for Debate in the 2020 Conference

HCF_logo_webThe discussion topics of the 2020 Helsinki Chemicals Forum conference have been proposed by its international Programme Committee and validated by the Advisory Board. The twelfth Helsinki Chemicals Forum will be held at the Messukeskus Convention Centre in Helsinki, Finland on 4 and 5 June 2020. Its partner, the European Chemicals Agency (ECHA), also offers chemical safety experts and journalists access to its own Conference in the same week, on 2 and 3 June.

Helsinki Chemicals Forum is a two-day event and consists of five panel discussions and keynote speeches. The European Commission will be invited to open the keynotes explaining how the Green Deal is an integral part of this Commission’s strategy to implement the United Nation’s 2030 Agenda and the sustainable development goals. The Mayor of Helsinki and the Executive Director of ECHA will then explain how his city and the EU agency are implementing these 2030 goals.

The first panel, on Thursday 4 June, focuses on green chemical policy. How can the future chemicals policy in the EU create the necessary framework to achieve carbon neutrality, promote the circular economy and contribute to the ambitions for zero pollution? What will be the role of the EU chemicals policy under “the Green Deal”, and how do other world regions achieve these objectives simultaneously? The European Commission will moderate this panel.

The second panel of the opening day focuses on safer substitution. Although there is increasing awareness of the need for safer and sustainable substitution, a panel of stakeholders including regulators, and representatives of industry and civil society will discuss what could help to increase the pace towards the implementation of safer alternatives under the lead of the OECD. The shift towards safer substitution could be incentivized more effectively by various means, such as the support of research and development, regulatory and financial incentives, and by increasing education and awareness of needs.

The third and final session of the first day will be a panel debate on new United Nations agreement for the Strategic Approach to International Chemicals Management (SAICM), a policy framework to promote chemical safety around the world. This panel will feature discussion of targets and indicators, to encourage countries to improve their chemicals legislation and implementation. This topic also gives an opportunity to reflect on custodians and timeframes, as opposed to the current state of affairs where there are no time-bounded indicators. UNEP will animate this panel.

The second day of the forum opens with the theme of transparency and risk communication. The traceability of chemicals of concern is an important element in creating market trust while complying with existing legal requirements. NGOs argue that traceability of all chemicals in materials, products and waste should become mandatory by 2030, which would be a difficult task. The panel discusses the current best practices for tracking chemicals to inform decisions relating to risk management measures, prevention of exposure and instructions for safe and sustainable recycling. Risk communication and transparency are topics that matter not only to regulators but are also an intrinsic part of supply chain communication, all the way to end consumers. ECHA will moderate this panel.

The closing theme of the forum is textiles. The panel will look at the progress on chemicals management within one specific industrial sector. In the textile and apparel industry there have been formidable challenges and exciting progress with innovative initiatives to achieve real improvements in the way textiles are manufactured, distributed, sold, used and managed at the end of their lifespan. This panel will bring together stakeholders across the supply chain to debate what has been achieved and the persistent barriers and useful incentives for further progress. A Chemical Watch journalist will moderate this panel.

Helsinki Chemicals Forum is an independent non-profit convention organiser. Its mission is to promote chemical safety and management internationally. Helsinki Chemicals Forum’s activities are directed by its advisory board, the members of which include the European Commission, ECHA, the Organisation for Economic Co-operation and Development (OECD), the United Nations Environment Programme (UNEP), the European Environmental Bureau (EEB), the Finnish Ministry of the Environment, the Ministry of Social Affairs and Health, the University of Helsinki, the City of Helsinki, and representatives of Suomen Messut. The chemical industry is represented by the European Chemical Industry Council (CEFIC), which is the main European trade association for the chemical industry, and by Eurometaux, the umbrella association of the non-ferrous metals industry in Europe. Non-governmental organisations are represented by the European Environmental Bureau. Its Director Jeremy Wates has agreed to be the main speaker at the Dinner, which is a traditional highlight of the annual conference.

The programme and themes of the Helsinki Chemicals Forum are selected by a broad and knowledgeable international programme committee. The committee consists of representatives of the aforementioned international organisations, and by representatives of, amongst others, the Canadian Ministry of the Environment, the Australian chemical authorities, the German Chemical Industry Association (VCI), the American Chemistry Council (ACC), and Chemical Watch, the media partner for the event.

For details, visit http://www.helsinkicf.eu

ECHA States Companies Need to Improve Communication of Hazardous Substances in Products

echa_305A Forum pilot enforcement project in 15 participating countries has found that 12% of inspected products contain substances of very high concern (SVHCs). The majority (88%) of suppliers of these products are failing to communicate sufficient information to their customers about SVHCs in products they supply.

According to the Forum for Exchange of Information on Enforcement (Forum), the results of the pilot project show that companies need to improve their knowledge on the products they supply to their customers and to better communicate information so that products containing substances of very high concern can be used safely. The Forum is a network of authorities responsible for the enforcement of the REACH, CLP, BPR, PIC and POP regulations in the EU, Norway, Iceland and Liechtenstein.

In this project, 405 companies across 15 countries were inspected and 682 articles were checked. 84 (12%) of the 682 articles were found to contain substances listed as being of high concern to human health or the environment (Candidate List substances) in concentrations above 0.1% weight by weight.

The products checked by inspectors were selected especially as they were highly likely to contain targeted Candidate List substances. Such products included clothing, footwear and home textiles; wires, cables and electronic accessories; plastic or textile floorings; wall coverings; and other plastic and rubber products.

“While nearly 90% of the products do not contain substances of very high concern above 0.1 %, the report clearly shows a failure of communication in the supply chain. Improvement is needed if we want to make REACH work in all aspects, contribute to the objectives of the circular economy and to have a good database as required under the Waste Framework Directive,” says Erwin Annys, Head of ECHA’s Support and Enforcement Unit.

The duty to communicate information down the supply chain about the presence of Candidate List substances in articles was applicable to 45 articles containing those substances. Suppliers did not do so for 40 (89%) of them, and 37 out of 42 companies (88%) failed to provide the name of the substance to recipients of their articles.

For companies supplying articles directly to consumers only, 22 suppliers (51%) out of 43 were considered to have insufficient information available to fulfill their obligation to provide required information to consumers, when requested. The results show that, in almost all cases, only the name of the Candidate List substance was communicated in the supply chain, and this may not be sufficient to allow safe handling.

For the 12% of articles placed on the EU market containing Candidate List substances, the results of the project show a high rate of non-compliance. This situation hinders the safe use of Candidate List substances in produced and imported articles, in particular those used by consumers.

For details, visit echa.europa.eu.