Global Regulatory Update for May 2021
Prominent Industry And Agency Veterans Join Bergeson & Campbell, P.C. And The Acta Group: Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are pleased to announce that Dennis R. Deziel, former Regional Administrator, Region 1 (New England), U.S. Environmental Protection Agency (EPA), Todd J. Stedeford, Ph.D., DABT®, ERT, ATS, former Senior Science Advisor in EPA’s Office of Pollution Prevention and Toxics (OPPT), and Amy L. Babcock, MPH, DABT®, ERT, MRSB, former Supervisory Toxicologist and Branch Chief of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), have joined our firms. Mr. Deziel, Dr. Stedeford, and Ms. Babcock join a powerful team of EPA alumni at B&C and Acta, offering clients an unmatched wealth of experience and an unparalleled record of scientific, legislative, and business accomplishment for substances and products regulated by the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and global chemical analogs.
Registration Opens For TSCA Reform: Five Years Later, June 30, 2021: The Environmental Law Institute (ELI), the George Washington University Milken Institute School of Public Health, and B&C present the fifth annual conference, providing updates and insights regarding the current state of TSCA implementation, ongoing and emerging issues, and related developments. Topics will include how EPA is implementing Section 6 risk evaluation provisions, changes in TSCA Section 5’s new chemical review, existing chemical risk management provisions, a TSCA litigation update, and TSCA’s role in achieving environmental justice, among other topics. The full faculty of speakers from government, non-governmental organizations (NGO), industry, and academia is available online and includes Lynn L. Bergeson, President, Acta; Richard E. Engler, Ph.D., Director of Chemistry, Acta; and Dennis R. Deziel, Senior Government Affairs Advisor, Acta. Register now at https://www.eli.org/events/tsca-reform-five-years-later.
Registration Opens For Free Webinar On “TSCA: It Is Not What You May Think”: Lynn L. Bergeson will join the Retail Industry Leaders Association’s (RILA) Retail Compliance Center (RCC) on June 10, 2021, at 2:00 p.m. (EDT) to present a webinar entitled “TSCA: It Is Not What You May Think. For decades, TSCA has been regarded as a “chemical producer” law that retailers, product manufacturers, and other “article” manufacturers could, for the most part, comfortably ignore. Not anymore. TSCA was significantly amended in 2016, and EPA implementation of “new TSCA” has drawn many, often unsuspecting, entities in the value chain — including retailers — squarely into TSCA’s broad reach. The “new normal” may not be what you want, but this webinar tells you what you need to know!
Richard E. Engler, Ph.D., Will Present On U.S. Regulatory Trends At ACS’s GC&E Conference And Chemical Watch’s PFAS Updates Conference In June: Regulatory approval of new chemicals is critical for companies going to market. Richard E. Engler, Ph.D., will present “Getting to Market: Planning for Regulatory Approval” during the Green and Sustainable Chemistry in Manufacturing for More Sustainable Household and Personal Care Products session of the American Chemical Society’s (ACS) 25th Annual Green Chemistry & Engineering Conference on June 14-18, 2021. Dr. Engler will also present “Chemical Identity and the EPA Process for Approving New PFAS Chemicals” during Chemical Watch’s PFAS Updates Conference on June 23, 2021. Registration for both events is open now.
Lynn L. Bergeson Authors “Don’t Ignore Game-Changing EU Environmental Initiatives,” In Bloomberg Law Insights: EU chemical regulatory and policy initiatives are often influential far beyond their jurisdictional limits. Two such initiatives are noteworthy, and U.S. chemical stakeholders can expect to experience the tremors of these explosive initiatives soon. One initiative restricts certain chemicals to comply with the European Green Deal, while the other amends chemical disclosure requirements. The full article is available here.
AICIS Issues Infringement Notice To Unregistered Importer Of Industrial Chemical: The Australian Industrial Chemicals Introduction Scheme (AICIS) announced on April 14, 2021, that it recently issued an infringement notice to a person or business for importing an industrial chemical without being registered. AICIS states that “[o]f particular concern was the fact that the imported chemical is known to cause a range of harmful human health effects.” According to the announcement, AICIS inspectors, with the assistance of the Australian Border Force, seized and destroyed the chemical. The importer was fined for the breach. AICIS notes that companies that import or manufacture (introduce) industrial chemicals without a valid AICIS registration are in breach of the Industrial Chemicals Act 2019 and can face fines of up to 60 penalty units (A$13,320).
Canada Issues Revised Draft Guidance For NSN Submissions: Environment and Climate Change Canada (ECCC), in March 2021, issued a draft document entitled “Guidance Document for the Notification and Testing of New Chemicals and Polymers.” ECCC states that the new Guidance Document:
- Helps the user to determine whether a substance is subject to notification and the applicable timelines;
- Outlines the treatment of confidential information;
- Provides guidance on acceptable test methods, alternative information, and waiver requests;
- Explains how the New Substances program assesses the submitted information; and
- Describes the possible decisions following the assessment of a new substance.
When issued in final, it will replace the current guidance for submitting New Substance Notifications (NSN) in Canada. Interested parties are encouraged to review the draft guidance and submit comments to ECCC by June 30, 2021.
Government Announces Bill Intended To Modernize CEPA: On April 13, 2021, the government of Canada announced that it will take steps to amend the Canadian Environmental Protection Act, 1999 (CEPA) through the Strengthening Environmental Protection for a Healthier Canada Act (Bill C-28). The press release states that the changes will strengthen protections for Canadians and the environment by:
- Recognizing a right to a healthy environment for every individual in Canada as provided for under CEPA;
- Assessing real-life exposure based on the cumulative effects of a substance in combination with exposure to other substances, and better protecting populations most at risk due to greater susceptibility or potential exposure to harmful substances;
- Implementing a new regime for toxic substances that pose the highest risk;
- Supporting the shift to less harmful chemicals through the establishment of a Watch List of substances capable of meeting the criteria in CEPA to be considered at risk if, for example, there should be an increase in exposure. The amendments would require the Ministers to publish and maintain a list of substances that are capable of becoming toxic;
- Creating a new Plan of Chemicals Management Priorities that will set out an integrated plan for the assessment and management of substances, as well as supporting activities such as research, monitoring, information gathering, and risk communication; and
- Amending the Food and Drugs Act to provide the ability to develop a regulatory framework to assess and manage the environmental risks of new drugs. This would remove the requirement to notify and assess new drugs under both the Food and Drugs Act and CEPA, providing a more efficient and effective approach to managing the risks of drugs in Canada.
Canada published a summary of the amendments in Bill C-28.
Canada Publishes Notice Of Intent To Address Broad Class Of PFAS: Canada published a Canada Gazette notice on April 24, 2021, announcing that it is considering activities that would address PFAS as a class. In 2021, Canada will:
- Continue to invest in research and monitoring on per- and polyfluoroalkyl substances (PFAS);
- Collect and examine information on PFAS to inform a class-based approach; and
- Review policy developments in other jurisdictions.
In addition, within the next two years, Canada will publish a State of PFAS Report that will summarize relevant information on the class of PFAS. Canada invites stakeholders to provide initial feedback on the intent to address PFAS as a class, including any challenges or opportunities they foresee.
Canada Adds Plastic Manufactured Items To CEPA Schedule 1: On May 12, 2021, Canada published an order in the Canada Gazette adding plastic manufactured items to CEPA Schedule 1. Adding a substance to Schedule 1 enables the Ministers of the Environment and of Health to propose risk management measures. A substance may be added to Schedule 1 under CEPA Section 64 if it is entering or may enter the environment in a quantity or concentration or under conditions that:
- Have or may have an immediate or long-term harmful effect on the environment or its biological diversity;
- Constitute or may constitute a danger to the environment on which life depends; or
- Constitute or may constitute a danger in Canada to human life or health.
The order states that based on the information provided in the science assessment, the Ministers are satisfied that “plastic manufactured items” meet the criteria set out in CEPA Section 64(a). Accordingly, the Ministers recommended that plastic manufactured items be added to Schedule 1, enabling them to propose risk management measures under CEPA on certain plastic manufactured items to manage the potential ecological risks associated with those items becoming plastic pollution. Using CEPA allows the Ministers to access the full range of authorities needed to manage plastic manufactured items along their entire life cycle. The order states that any risk management measures developed under CEPA will be guided by the precautionary principle as set out in Section 2(1)(a).
China Launches National Database Of Laws And Regulations: China’s National People’s Congress (NPC) announced on February 24, 2021, the National Database of Laws and Regulations. The Database includes 275 constitutions and currently valid laws, 25 legal interpretations, 147 decisions on legal and major issues, and 609 administrative, local, autonomous, separate, and special economic zone regulations. The Database, which is in Chinese only, is available at https://flk.npc.gov.cn.
Colombia Publishes Regulation Implementing GHS In The Workplace: The Ministry of Labor published Resolution 0773/2021 in April 2021, adopting the sixth revised edition (Rev 6) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) for chemicals in the workplace. The regulation addresses employer and employee responsibilities and provides instructions for preparing labels, safety data sheets (SDS), and pictograms. Labels must include the identity of the product and of the suppliers (manufacturers, importers, or distributors); the appropriate hazard communication elements; and precautionary statements. The regulation includes tables with cut-off values/concentration limits for classifying mixtures as carcinogens; toxic for reproduction or with effects on or through lactation; or specific target organ toxicants. The regulation provides a transition of 24 months for substances and 36 months for mixtures.
ECHA Enforcement Forum Agrees On Scopes Of Checks For Consumer Products And Biocides In 2022: The European Chemicals Agency (ECHA) announced on March 24, 2021, that the Enforcement Forum’s Tenth Coordinated Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Enforcement Project (REF-10) will focus on integrated controls of consumer products. The Enforcement Forum agreed that inspectors will be able to check that products comply with the different restrictions for hazardous substances under REACH. Inspectors could check restrictions for carcinogenic, mutagenic, and reprotoxic (CMR) substances in textiles, the siloxanes octamethylcyclotetrasiloxane (D4)/decamethylcyclopentasiloxane (D5) in wash-off cosmetic products, or bisphenol A in thermal paper. Enforcers will also check REACH duties for substances in articles requiring that information on substances of very high concern (SVHC) in products is being communicated in the supply chain.
The Biocidal Products Regulation (BPR) Subgroup of the Enforcement Forum agreed that inspections in its Second Coordinated Enforcement Project on Biocides (BEF-2) project will focus on controls of biocidal products for the presence of approved and non-approved active substances. The controls will be wide, covering all types of biocidal product types, and include both products already authorized under BPR and products covered by pieces of national biocides legislation (i.e., transitional measures under Article 89 of BPR).
ECHA states that REF-10 and BEF-2 will both be prepared in 2021, with inspections carried out in 2022 and reports to be published in 2023.
JRC Publishes 2021 Edition Of Export Control Handbook For Chemicals: The European Commission (EC) Joint Research Center (JRC) published its 2021 edition of the Export Control Handbook for Chemicals. The Handbook is intended to enable exporters and customs officers to verify quickly those chemicals that require an export authorization and to check exported products’ compliance with the EU export control legislation. The Handbook lists approximately 1,800 chemicals subject to export controls.
ECHA Recommends EC Add Seven Substances To Authorization List: ECHA announced on April 14, 2021, that it recommends that the EC add seven substances to the Authorization List. ECHA states that the cyclosiloxanes D4, D5, and dodecamethylcyclohexasiloxane (D6) are considered harmful to the environment and human health. ECHA prioritized these chemicals from the Candidate List because they are hazardous, produced in high volumes, and widely used. Terphenyl, hydrogenated is considered to be harmful for the environment. The three other substances — dicyclohexyl phthalate (DCHP), disodium octaborate, and trimellitic anhydride (TMA) — are considered harmful to human health. ECHA states that they may be used to replace substances with similar chemical structures and uses that have already been recommended or included in the Authorization List.
ECHA Identifies 290 Chemicals As Candidates For Regulatory Action: ECHA announced on April 21, 2021, the availability of its third report on its Integrated Regulatory Strategy, which provides the latest on ECHA’s work to identify and manage chemicals that may pose risks to people and the environment, as well as recommendations to authorities and industry on managing the risks. According to ECHA, from the group assessments concluded in 2020, it identified 290 chemicals as candidates for further EU regulatory risk management. ECHA states that most of these will require more data to be generated and confirmation of hazard before any actions can start, however. ECHA identified over 100 substances that, based on currently available information, would warrant harmonized classification, but which have so far not been picked up by authorities. ECHA notes that a lack of harmonized classification may delay risk management actions by companies or authorities. ECHA recommends that:
- Member states ensure adequate resources and initiate regulatory risk management for substances that require further action without delay;
- Member states intensify collaboration with each other to maximize the outcome of their work; and
- Industry make use of programs developed to help them to review and update data in their REACH registration dossiers. The updates must be done proactively and not only after authorities take regulatory action.
ECHA States Companies Must Review Registrations Transferred From The UK: On April 26, 2021, ECHA published a press release stating that companies “must review registrations transferred from the [United Kingdom (UK)].” ECHA states that all transfers of registrations following the UK’s withdrawal from the EU have been completed and more than 8,000 UK-based registrations have been successfully transferred to companies in the EU, European Economic Area (EEA), or Northern Ireland. According to ECHA, as the transfers have now been completed, safety information may need to be reviewed and updated, and administrative information, such as the company’s role in the supply chain, may also need to be revised by the new registrant. If an update is required, registrants have up to three months to update administrative information or up to six, nine, or 12 months for more complex updates. The obligation to update applies to REACH registrations and previously notified substances under the Dangerous Substances Directive.
Comment Period Begins On Roadmap For Revision Of REACH To Help Achieve Toxic-Free Environment: The EC published a roadmap on May 4, 2021, for a targeted revision of REACH to achieve the objectives of the Chemicals Strategy for Sustainability. The roadmap lists the following preliminary options to address identified issues:
- Revision of the registration requirements;
- Introduction of a Mixture Assessment Factor (MAF);
- Simplifying communication in the supply chains;
- Revision of the provisions for dossier and substance evaluation;
- Reforming the authorization process;
- Reforming the restriction process; and
- Revision of provisions for control and enforcement.
Comments on the roadmap are due June 1, 2021.
Roadmap For Revision Of CLP Available For Comment: On May 4, 2021, the EC published a roadmap for the revision of the Classification, Labeling, and Packaging (CLP) regulation to achieve the objectives of the Chemicals Strategy for Sustainability. The roadmap states that the measures that will be examined could include:
- Introducing new hazard classes (such as endocrine disruptors) and corresponding criteria;
- Introducing an obligation to provide information of some hazards on the label for products currently outside the scope of CLP;
- Clarifying the obligations to classify mixtures and some complex substances;
- Introducing specific rules for online sales;
- Introducing the possibility to submit proposals for and set harmonized environmental and safety values for some substances;
- Requiring importers and downstream users to submit information on substances classified for physical effects or health hazards to poison centers and clarifying obligations for distributors to submit such information through an only representative (OR) or other means;
- Introducing a mandate for the EC to request ECHA to develop new harmonized classification and labeling (CLH) dossiers;
- Allowing multilingual fold-out labels;
- Introducing tailored labeling rules where there is not enough space on packaging;
- Introducing a prioritization mechanism for harmonizing the classification of certain chemicals; and
- Simplifying and reducing unnecessary administrative costs.
Comments on the roadmap are due June 1, 2021.
Safer Chemicals Conference 2021 Will Be Held October 6, 2021: The Safer Chemicals Conference 2021 will be held online on October 6, 2021. Attendees will learn how ECHA and its partners are supporting companies on the path to sustainability. ECHA will review the regulatory expectations in the evolving landscape and how it can help companies meet them. According to ECHA’s website, registration for the conference will begin August 6, 2021.
Egypt Submits Decree Mandating Standard For SDSs For Chemical Products To WTO: On March 30, 2021, Egypt submitted to the World Trade Organization (WTO) Ministerial Decree No. 610/2020 mandating use of Egyptian Standard ES 8398, “Safety data sheet for chemical products — Content and order of sections.” The Ministerial Decree gives producers and importers a six-month transitional period to comply with Standard ES 8398. Egypt’s WTO notification states that the standard defines sections, content, and the general format of SDSs for chemical products. It does not define a fixed format, nor does it include a blank SDS. The notification states that “[w]orth mentioning is that this standard is technically identical with ISO 11014 /2009 (confirmed 2020).”
ANSES Identifies Priority Substances To Be Included In Endocrine Disruptor Assessment Program: The French Agency for Food, Environmental and Occupational Health & Safety (ANSES) announced on April 15, 2021, that as part of France’s Second National Endocrine Disruptor Strategy (SNPE 2), it has drawn up a list of substances of interest and identified a selection of priority substances to be included in its assessment program. ANSES compared the existing lists of endocrine disruptors and the methods used to compile “a rigorous list of the substances of interest for which the data available are sufficient to consider an assessment based on the three points set out by the [World Health Organization (WHO)].” There are 906 substances on the list of interest. ANSES then identified 16 priority substances for which it considers an assessment necessary to establish their level of hazard as endocrine disruptors. ANSES will submit the list of priority substances to the ANSES Thematic Steering Committee on Endocrine Disruptors. Following this consultation, ANSES will formulate its recommendations on the substances to be included in its work program from 2021 to the ministries responsible for SNPE 2. ANSES is also recommending a method to establish whether the substances assessed are known, presumed, or suspected endocrine disruptors.
New Zealand Now Using Rev 7 Of The GHS: The New Zealand Environmental Protection Authority (New Zealand EPA) announced on April 30, 2021, that it is now using the seventh revised edition (Rev 7) of the GHS. According to New Zealand EPA, the changes primarily require importers and manufacturers to update their hazard classification, labeling, and SDSs. New Zealand EPA states that consumers should start to see the GHS pictograms appearing on product labels as New Zealand’s chemical labeling “aligns with the rest of the world.” Substances with an individual approval issued after April 30, 2021, must comply with the labeling, SDS, and packaging notices immediately. Individual approvals issued before April 30, 2021, have a four-year transitional period, until April 30, 2025, to comply with the updated notices. Substances managed under a group standard must also comply with the labeling, SDS, and packaging notices by April 30, 2025, regardless of when the substance was imported into or manufactured in New Zealand. New Zealand EPA states that the next phase of the project is to complete a move to the International Uniform Chemical Information Database (IUCLID) later in 2021. More information is available on the New Zealand EPA website.
Biocide Article Suppliers Must Meet December 31, 2022, Deadline To Remain On GB Article 95 List: The March 26, 2021, issue of the HSE Biocides eBulletin provides information for active substance and product suppliers that were on the EU Article 95 List on December 31, 2020. The Health and Safety Executive (HSE) has included these suppliers on the GB Article 95 List. To remain on the GB Article 95 list after December 31, 2022, suppliers must:
- Resubmit active substance dossiers/data or letters of access to HSE; and
- Confirm they are established in the UK.
Suppliers can complete both actions at the same time or independently, but both actions must be completed by December 31, 2022.
HSE states that if a supplier submits its active substance dossier by either the March 2021 or June 2021 deadlines for pending applications for active substance approval, it does not need to resubmit the dossier for the Article 95 deadline. It still must complete the UK establishment action.
If a supplier submits an active substance dossier in advance of the Article 95 deadline to support Letters of Access (e.g., to product authorization applicants and authorization holders or new Article 95 suppliers), it does not need to resubmit the dossier. The supplier still must complete the UK establishment action.
HSE Postpones Approval Expiration Dates For Renewals Of Eight Active Substances: The March 31, 2021, issue of the HSE Biocides eBulletin announces that HSE has agreed to postpone the approval expiration dates for eight active substances that were due to lapse within the next six months. HSE states that under the GB Biocidal Products Regulation (GB BPR), where for reasons beyond the control of the applicant, the approval of the active substance is likely to expire before a decision has been made on its renewal, the Secretary of State, with the consent of Ministers in Scotland and Wales, can issue a decision postponing the expiration date of approval for a period sufficient to enable the competent authority to examine the application. HSE has postponed the approval expiration dates for the following substances to July 24, 2023: propiconazole, metofluthrin, sulfuryl fluoride, alphachloralose, aluminium phosphide releasing phosphine, boric acid, and disodium tetraborate pentahydrate. HSE will update the GB List of Active Substances to reflect this decision, and there are no further changes in the approvals.
HSE Will Set WELs In GB Following End Of EU Transition Period: HSE published an HSE eBulletin on April 9, 2021, that provides information on setting workplace exposure limits (WEL) in Great Britain (GB) following the end of the EU transition period. According to HSE, it has a “robust and well-established regulatory framework” in place to protect workers from health risks associated with occupational exposure to hazardous substances through the Control of Substances Hazardous to Health Regulations 2002 (COSHH). Under COSHH, WELs are set for specific hazardous substances and must not be exceeded. Exposure to asthmagens, carcinogens, and mutagens must be reduced to as low as is reasonably practicable. HSE states that it will continue to review and introduce new WELs and is currently developing its long-term delivery model for GB. The GB model will continue to include a review of scientific data and evidence and an economic analysis. HSE will seek independent expert advice on any proposals and will continue to consult with stakeholders on any new or revised limits to be introduced in GB. While HSE embeds its GB approach, it will continue to consider, then apply as appropriate, those limits set under the EU regime that are of significance to GB.
UNEP Publishes Legislative Guide For Regulating Single-Use Plastic Products: The UN Environment Program (UNEP) announced on April 6, 2021, the release of a “first-of-its-kind legislative guide that provides four policy and legal approaches that countries can use to reduce their plastic waste permanently, regardless of the pandemic.” UNEP states that the guide outlines the most common regulatory approaches and explains the main elements that legislators should consider when drafting legislation. The guide includes examples of each type of regulatory approach and sample legal provisions. UNEP developed the guide with the World Resources Institute.