Global Regulatory Update for August 2022
Recording Available For “TSCA New Approach Methodologies” Webinar: The Acta Group (Acta®) affiliate Bergeson & Campbell, P.C.’s (B&C®) August 3, 2022, webinar “TSCA New Approach Methodologies” is now available for on-demand viewing at https://attendee.gotowebinar.com/recording/8166994675079284995. During this one-hour webinar, panelists shared a comprehensive review of the U.S. Environmental Protection Agency’s (EPA) use of New Approach Methodologies (NAM) in evaluating chemicals under the Toxic Substances Control Act (TSCA). Kristie Sullivan, MPH, Vice President of Research Policy with the Physicians Committee for Responsible Medicine (PCRM), Richard E. Engler, Ph.D., Director of Chemistry, Acta, and James W. Cox, M.S., Senior Scientist, Acta, discussed examples of EPA’s use and development of non-vertebrate testing strategies, successful collaborations between EPA and external partners to advance understanding and use of NAMs, and the need for EPA and stakeholders to approach implementation of NAMs with an “innovation mindset” that fulfills the requirements under TSCA. Lynn L. Bergeson, President, Acta, moderated.
The National Tribal Toxics Council — A Conversation With Dianne Barton, Ph.D.: On this episode of All Things Chemical®, Lynn L. Bergeson and Dianne Barton, Ph.D., Water Quality Coordinator at the Columbia River Inter-Tribal Fish Commission in Portland, Oregon, and Chair of the National Tribal Toxics Council (NTTC), discuss toxics issues and how the NTTC is engaged with EPA on a wide variety of Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) implementation issues, particularly those affecting tribal communities. Listen now.
Tips For Working With Foreign Regulators In China — A Conversation With David Cragin, Ph.D.: Lynn L. Bergeson was joined by David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director with a large multinational pharmaceutical company, for this episode of All Things Chemical. Dr. Cragin shares his experience living and working in China and provides advice for working with foreign regulators with the additional challenge of language barriers, cultural differences, and differing regulatory standards. Listen now.
How Does A Recent Supreme Court Ruling Apply To EPA’s Implementation Of TSCA?: Since the U.S. Supreme Court issued its blockbuster ruling in West Virginia v. EPA, 597 US _ 2022 WL 2347278 (June 30, 2022), many are asking whether the Court’s amplification of the “major questions doctrine” (MQD) might be used to seek to limit EPA authority in implementing Congress’s 2016 amendments to TSCA, the Lautenberg Act.
The answer is yes. West Virginia will henceforth be cited with predictable regularity in claiming that EPA, or any federal agency for that matter, has taken final agency action in what detractors will claim is an “extraordinary case” with outsized “economic and political significance” that, as Chief Justice John Roberts somewhat glibly noted, “raise[s] an eyebrow.” The full text of this article, written by Lynn L. Bergeson, President, Acta, for Chemical Watch, is available here.
Lynn L. Bergeson Authors “EPA Seeks Input From Small Businesses,” Chemical Processing: EPA invited on July 6, 2022, small businesses to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) panel. EPA seeks self-nominations directly from entities that may be subject to the rule requirements; self-nominations were due July 20, 2022. The panel focuses on the Agency’s proposed rule to collect data to inform each step of the TSCA risk evaluation and risk management process. Participating in the SBAR, or at least tracking its activities and engaging as much as possible, is encouraged. The reasons for engagement are discussed in this article.
Submission Opens For Annual Declarations Of Chemical Introductions During The 2021-22 Registration Year: Companies registered with the Australian Industrial Chemicals Introduction Scheme (AICIS) that introduced industrial chemicals or products containing industrial chemicals during the 2021-22 registration year must submit an annual declaration by November 30, 2022. This applies to all chemical introductions, regardless of the category, the amount, or the number of chemicals. According to AICIS, companies need only one form to select the introduction categories that apply to the chemicals imported or manufactured during the 2021-22 registration year.
If companies introduced certain types of chemicals that were categorized as exempted during the 2021-22 registration year, separate post-introduction declarations for these chemicals must be submitted. The once-off declarations apply only after introduction of the following exempted introductions for the first time: polymers of low concern; low-concern biopolymers; and chemicals categorized as very low risk for human health and the environment.
Senate Passes Bill Intended To Modernize CEPA: On June 22, 2022, the Senate passed the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act. According to the third reading, as amended by the Senate Energy, Environment and Natural Resources Committee, the bill would:
- Elaborate on principles such as environmental justice, intergenerational equity, and non-regression;
- Modernize Canada’s approach to chemicals management by requiring a new plan of chemicals-management priorities to give Canadians a predictable, multi‑year, integrated plan for the assessment of substances, as well as the activities and initiatives that support substances management;
- Set out a workable regime for substances of the highest risk. The bill requires that, when considering how to manage such substances, priority be given to prohibiting them;
- Include several provisions intended to avoid regrettable substitution; and
- Increase transparency with changes to the confidential business information (CBI) regime and include substantive requirements to accelerate efforts to replace, reduce, and refine animal testing.
The House of Commons will review the bill in September 2022.
Canada Intends To Renew Federal Agenda On The Reduction Of VOC Emissions From Consumer And Commercial Products: According to a July 9, 2022, Canada Gazette notice, Canada intends to take action between 2022 and 2030 to protect further the health of Canadians and their environment from the impacts of air pollution by renewing the federal agenda on the reduction of emissions of volatile organic compounds (VOC) from consumer and commercial products. The planned actions include:
- Reducing VOC emissions released by portable fuel containers.
- Amending current regulations:
- Architectural coatings; and
- Automotive refinishing products.
- Architectural coatings; and
- Developing new risk management instruments:
- Industrial and commercial adhesives and sealants;
- Printing; and
- Other activities: In recognition of an integrated North America market place and to allow for innovative reformulation of products, Canada will update, on an as-needed basis, the VOC definition found in CEPA Schedule I to align with the U.S. Environmental Protection Agency (EPA) definition published in 40 C.F.R. Section 51.100. The federal government will also conduct studies and gather additional information to evaluate potential emission reduction opportunities for the following sectors:
- Solvent degreasing;
- Cars, vans, light trucks assembly, and auto parts coatings; and
- Plastic, rubber, leather, and glass coatings.
- Industrial and commercial adhesives and sealants;
The notice states that stakeholders and interested parties will have multiple opportunities to provide input to help inform the federal government’s actions towards further reducing VOC emissions related to consumer and commercial products. Stakeholders and interested parties are invited to submit relevant information or indicate their interest in being engaged in future discussions by e-mailing Produits-Products@ec.gc.ca.
Canada Publishes Consultation Papers On Labeling Rules To Strengthen Recycling And Composting Of Plastics And Federal Plastics Registry: In July 2022, Environment and Climate Change Canada (ECCC) published two consultation papers for public comments:
- Consultation paper: Towards Canada-wide rules to strengthen recycling and composting of plastics through accurate labelling: The paper provides stakeholders with the opportunity to provide input on how Canada could introduce rules to improve the accuracy of recyclability and compostability labeling for plastics. The rules would require producers to assess their packaging or single-use plastic item to determine whether it is recyclable. Recyclability would be measured in terms of whether the item is accepted in public recycling systems accessible to at least 80 percent of the population in one or more of five regions across Canada and can be sorted into bales that attract a reliable, positive price on a North American end market.
- Consultation paper: a proposed federal plastics registry for producers of plastic products: According to the consultation paper, a federal plastics registry will support adoption of extended producer responsibility (EPR) rules in Canada that are consistent, comprehensive, and transparent. The registry will also support the implementation and monitoring of other measures that are part of the government’s zero plastic waste agenda, including recycled content requirements for plastic products. A plastic registry would improve the efficiency and effectiveness of EPR as it is practiced in Canada and increase value recovery rates, keeping plastics in the economy and out of the environment. The purpose of the consultation paper is to seek stakeholder input as the government develops this registry.
Comments on the consultation papers are due October 7, 2022.
EP Announces Agreement On New Social And Environmental Reporting Rules For Large Companies: The European Parliament (EP) announced on June 21, 2022, that the EP and EU governments reached a provisional agreement on new reporting rules for large companies. The EP’s June 21, 2022, press release states that the Corporate Sustainability Reporting Directive (CSRD) will make businesses more accountable by obliging them to disclose their impact on people and the planet. The goal is to end greenwashing and lay the groundwork for sustainability reporting standards at the global level. The CSRD will include the following provisions:
- New EU sustainability standards: The new EU sustainability reporting requirements will apply to all large companies (with over 250 employees and a 40 million euro turnover), whether listed or not. Companies will have to report on their impact on the environment, human rights, social standards and work ethics, based on common standards;
- Reliable information and compulsory audits: The information companies provide on their impact on the climate or human rights will be independently audited and certified; and
- Non-EU companies to follow the rules too, subcontractors protected: The EP “successfully insisted” that non-EU companies with substantial activity in the EU market (150 million euro in annual turnover in the EU) will have to follow equivalent reporting rules. EU member states will supervise compliance with the help of the EC. A handful of small- and medium-size enterprises (SME) listed on public markets will be subject to lighter reporting standards.
The EP and Council of the EU will have to approve the agreement formally before it is published in the Official Journal of the European Union. It will enter into force 20 days after publication and its provisions will have to be integrated into member states’ national laws after 18 months.
EC Intends To Reduce Pesticide Use By 50 Percent By 2030: On June 22, 2022, the European Commission (EC) adopted proposals for a new Regulation on the Sustainable Use of Plant Protection Products, including EU-wide targets to reduce by 50 percent the use and risk of chemical pesticides by 2030, in line with the EU’s farm-to-fork and biodiversity strategies. According to the EC’s website, the main measures include:
- Legally binding targets at EU level to reduce by 50 percent the use and the risk of chemical pesticides, as well as the use of the more hazardous pesticides by 2030. EU member states would set their own national reduction targets within defined parameters to ensure that the EU-wide targets are achieved;
- Environmentally friendly pest control: New measures would ensure that all farmers and other professional pesticide users practice Integrated Pest Management (IPM); and
- A ban on all pesticides in sensitive areas: The use of all pesticides would be prohibited in places such as urban green areas, including public parks or gardens, playgrounds, recreation or sports grounds, and public paths, as well as protected areas in accordance with Natura 2000 and any ecologically sensitive area to be preserved for threatened pollinators.
The proposals must be approved by EU member states in the Council and the EP under the normal legislative procedure.
EC Begins Consultation On Proposal For A Regulation On The Sustainable Use Of PPPs: On June 24, 2022, the EC began a public consultation on a proposal for a regulation on the sustainable use of plant protection products (PPP). The proposal aims to:
- Replace the Sustainable Use of Pesticides Directive (SUD) in regulating the use of pesticides; and
- Align better with the objectives of the European Green Deal and farm-to-fork strategy.
The proposal is intended to reduce the risks from, and impacts of, pesticide use on human health and the environment by:
- Achieving pesticide-reduction targets contained in the farm-to-fork strategy; and
- Promoting the use of IPM and alternatives to chemical pesticides.
The proposal states that a regulation “is appropriate to both ensure that the level of ambition in the farm-to-fork strategy is met and remedy the problems identified with the implementation of the SUD by providing clear and uniform rules.” Comments are due September 19, 2022.
ECHA Reminds Registrants Of Substances With A Harmonized Classification To Update Their Dossiers: The European Chemicals Agency (ECHA) recently reminded registrants of substances with a harmonized classification to update their dossiers. According to an item in the July 13, 2022, ECHA Weekly, ECHA will soon begin a second screening project to check that companies are keeping their registrations updated. The project will focus on substances with a harmonized classification and labeling and will examine registrations where this information is not used correctly. ECHA will pass cases where incompliance is suspected to national enforcement authorities. ECHA will publish the results of its first screening project, which focused on registrations of substances that are on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Authorization List, “next autumn.” ECHA states that these projects “remind registrants of their obligation to keep their registrations up to date.” ECHA provides information on keeping registration dossiers up to date.
ECHA Submits Restriction Dossier For MCCP: On July 15, 2022, ECHA submitted a proposal to restrict the manufacture, use, and placing on the market of substances, mixtures, and articles containing medium-chain chlorinated paraffins (MCCP) and other substances that contain chloroalkanes with carbon chain lengths ranging from C14 to C17. ECHA’s scientific committees for risk assessment (RAC) and socio-economic analysis (SEAC) will evaluate the proposal, and there will be a public consultation period. The consultation will begin after RAC and SEAC agree that the report is in conformity.
EC Begins Consultation On Initiative To Improve Access To Chemical Data For Safety Assessments: The EC began a public consultation on July 19, 2022, on an initiative that will consider amending in a targeted manner existing pieces of chemicals legislation (EU regulations and directives) to include provisions necessary to:
- Streamline data flows on chemicals;
- Increase interoperability of data, dissemination of data, and data re-use; and
- Better implement the requirement to consider all available data in a chemical safety assessment.
According to the call for evidence, amendments will be based on Article 114 (and possibly other articles depending on the specific acts being amended) of the Treaty on the Functioning of the European Union (TFEU). The amendments will target the provision of, access to, sharing of, and re-use of data at the EU member state and EU level. The call for evidence states that “[t]his cannot be sufficiently achieved by the Member States alone, by reason of its scale and effects, and can therefore be better achieved at EU level.” The initiative will build on the Data Governance Act, Open Data Directive, and other relevant rules on data, taking into account the specific scope of chemicals, as well as the intention to extend more generally the “open data” policy to privately held data by default. Comments are due August 16, 2022.
ECHA May Consider Tonnage Band Changes During Dossier Evaluation Process: ECHA announced on July 27, 2022, that it may now take changes to registrants’ tonnage band information into account until the date an adopted dossier evaluation decision has been communicated to such registrants. According to ECHA, this change follows a decision by the Board of Appeal. If registrants want ECHA to take a change to their tonnage band into account after they have received a draft dossier evaluation decision, ECHA states that they need to communicate this and update their dossiers. If they downgrade their tonnage band, they will also need to provide evidence showing the volume of their substance that was imported or manufactured over the preceding calendar year. ECHA notes that once it communicates the adopted dossier evaluation decision to registrants, they must fulfil all information requirements as outlined in the decision, regardless of any tonnage band change or cease of manufacture that may occur afterwards.
Annual Forum On Endocrine Disruptors Will Be Held In September 2022: The EC’s Directorate-General for Environment will organize the second part of the Fourth Annual Forum on Endocrine Disruptors on September 21-22, 2022, in collaboration with the French Agency for Food, Environmental and Occupational Health & Safety (ANSES). It follows up on the first part that took place in Paris on May 12, 2022. The venue will be in the EC’s Charlemagne building in Brussels, and it will be an interactive hybrid event. Registration will close on September 13, 2022.
BIS Consults On Draft Revision Standard On Classification Of Dangerous Goods: The Bureau of Indian Standards (BIS) is consulting on a draft standard entitled “Classification of Dangerous Goods Third Revision.” The draft standard covers classification of dangerous goods on the basis of United Nations (UN) number and type of hazards involved. It includes hazard classifications for 2,336 chemicals. It is based on the 22nd revised edition of the model regulations published by the UN Committee of Experts on the Transport of Dangerous Goods. According to the cover letter, issues for comment include:
- The handling of dangerous goods during transportation is regulated to prevent such goods from causing either accident to persons or damage to the means of transport employed or to other goods. Keeping these objectives in view, the draft standard lists dangerous substances and classifies them according to the hazards involved so that appropriate precautions can be taken by concerned agencies; and
- The draft standard classifies chemicals and dangerous goods by the type of hazards involved and lists the corresponding UN number to facilitate national and international transport.
Comments are due September 18, 2022.
DOSH Consults On Proposal To Align CLASS Regulations With GHS 8: The Department of Occupational Safety and Health (DOSH) began a public consultation June 13, 2022, on proposed amendments to the Occupational Safety and Health (Classification, Labelling and Safety Data Sheet of Hazardous Chemicals) Regulations 2013 (CLASS Regulations) that would align the regulations with the eighth edition of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS 8). Comments are due August 15, 2022. More information is available at http://220.127.116.11/index.php/list-of-documents/eparticipation/2022-2.
ORGANIZATION FOR ECONOMIC COOPERATION AND DEVELOPMENT (OECD)
OECD Publishes Six New And Ten Updated Or Corrected Guidelines For The Testing Of Chemicals: OECD published on June 30, 2022, six new, three updated, and seven corrected Test Guidelines (TG) intended to promote chemical testing best practices and keep pace with emerging technologies. The TGs include:
- TG No. 124: Determination of the Volume Specific Surface Area of Manufactured Nanomaterials;
- TG No. 125: Nanomaterial Particle Size and Size Distribution of Nanomaterials;
- TG No. 467: Defined Approaches for Serious Eye Damage and Eye Irritation;
- TG No. 492B: Reconstructed Human Cornea-like Epithelium (RHCE) Test Method for Eye Hazard Identification;
- TG No. 470: Mammalian Erythrocyte Pig-a Gene Mutation Assay;
- TG No. 251: Rapid Androgen Disruption Activity Reporter (RADAR) assay; and
- TG No. 320: Determining Anaerobic Transformation of Chemicals in Liquid Manure.
- TG No. 442C: In Chemico Skin Sensitisation;
- TG No. 442E: In Vitro Skin Sensitisation; and
- TG No. 488: Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays.
- TG No. 117: Partition Coefficient (n-octanol/water), HPLC Method;
- TG No. 123: Partition Coefficient (1-Octanol/Water): Slow-Stirring Method;
- TG No. 406: Skin Sensitisation;
- TG No. 425: Acute Oral Toxicity: Up-and-Down Procedure;
- TG No. 442D: In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method; and
- TG No. 456: H295R Steroidogenesis Assay.
TCSB Proposes To Amend Chemical Substance Labeling Requirements: On July 21, 2022, the Taiwan Environmental Protection Agency’s (Taiwan EPA) Toxic and Chemical Substances Bureau (TCSB) began a 30-day public consultation on a draft amendment to the Administrative Measures for Labeling and Safety Data Sheets (SDS) of Toxic Chemical Substances and Chemical Substances of Concern. The draft amendment would add minimum labeling size specifications for containers and packaging. It would also harmonize the Taiwan EPA’s requirements with those of the Ministry of Labor. The draft amendment would provide a one-year transition period for industry.
Defra Publishes Rationale For UK REACH Work Programme Priorities In 2022/23: The Health and Safety Executive (HSE) recently published the UK REACH Work Programme 2022/23. The work programme sets out the activity that HSE, supported by the Environment Agency and other relevant agencies, will carry out to operate UK REACH. To complement the publication of the work programme, the Department for Environment, Food and Rural Affairs (Defra) has published the rationale used for identifying particular substances for potential regulatory action under UK REACH in 2022 to 2023. Defra identified the following five priorities for the 2022 to 2023 UK REACH work programme:
- Per- and polyfluoroalkyl substances (PFAS): Acting on the recommendations of an ongoing Regulatory Management Options Analysis (RMOA), due for publication in summer 2022;
- Intentionally added microplastics: An evidence project on identifying and managing the risks they pose;
- Formaldehyde and formaldehyde releasers in articles: An RMOA to review the evidence base and evaluate a potential restriction;
- Bisphenols in thermal paper: An RMOA to review the evidence base and evaluate a potential restriction; and
- Hazardous flame retardants: Reviewing and updating the existing evidence on potential environmental risks, to feed into wider chemicals policy.
More information is available in our July 12, 2022, blog item.
Suppliers On GB Article 95 List Must Resubmit Data And Confirm UK Presence By December 31, 2022: Biocidal active substance and product suppliers included on the EU Article 95 List at the end of the EU exit transition period on December 31, 2020, were automatically added to the Great Britain (GB) Article 95 List. Companies that wish to remain on the GB Article 95 List after December 31, 2022, must:
- Resubmit their data or letter of access to HSE; and
- Confirm to HSE that the company (or a representative) is established in the UK (GB or Northern Ireland).
If a company has already provided its data or letter of access to comply with earlier GB resubmission deadlines, it does not need to submit this information again. Suppliers that fail to complete both actions by December 31, 2022, will be removed from the GB Article 95 List.
Defra Begins Public Consultation on Extending the UK REACH Transitional Registration Deadlines: Defra has begun a public consultation on extending the UK REACH submission deadlines for transitional registrations — the registrations under UK REACH of substances that were registered in the EU in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. Defra seeks comment on two options to extend the current deadlines for registration, as well as a do-nothing option:
- Baseline — Do Nothing: Do not change the current submission deadlines (October 27, 2023; October 27, 2025; and October 27, 2027);
- Option 1: Extend all the current submission deadlines for each tonnage band by three years to October 2026, October 2028, and October 2030;
- Option 2 (Preferred Option): Extend the first submission deadline by three years to October 2026, the second by two years to October 2027, and the third by one year to October 2028.
Defra also requests comment on extending the dates for HSE to carry out compliance checks on at least 20 percent of the registration dossiers required under UK REACH Article 41, which was carried over from EU REACH. Responses are due September 1, 2022. More information is available in our July 18, 2022, memorandum.
Defra Calls For Evidence On Amending UK REACH Authorization List: Defra has published two calls for evidence on amending Annex 14 of UK REACH to include the following substances:
Defra will use the calls for evidence to inform the appropriate authorities’ consideration of HSE’s recommendation. Defra asks third parties with an interest in these substances to share any relevant information, including evidence about the use of the substance in Great Britain (GB), availability of alternatives, and impacts on the environment, public health, and society, as well as any general comments. Information is due August 12, 2022.