Global Regulatory Update for October 2022


WEBINAR -- Register Now For “Environmental, Social, And Governance Issues: A Business Imperative,” October 11, 2022, 12:00 p.m. - 1:00 p.m. (EDT): Environmental, Social, and Governance (ESG) performance is more than an aspiration, and realizing it in real time is not easy. A well-designed ESG strategy can achieve meaningful improvements in corporate performance and provide real value to stakeholders through specific commitments to corporate responsibility. Any such approach, however, must be measurable, transparent, and accountable. Christine DiBartolo, Senior Managing Director of FTI Consulting’s Strategic Communications segment; Ken Ditzel, Senior Managing Director at FTI Consulting and leader of the firm’s North American energy and environmental market advisory team; and Lynn L. Bergeson, President, The Acta Group (Acta®), will discuss how to undertake an ESG assessment, build an effective ESG program, and create credible sustainability reporting systems. Register now!

SEMINAR -- IBA Annual Conference, October 30-November 4, 2022, Miami, FL: The International Bar Association (IBA) Annual Conference is open to both members and non-members of the IBA, with lawyers from over 130 jurisdictions and all parts of the legal profession attending. The conference will cover law firm management and international relationships; ethics; the future of the legal profession; and the rule of law and human rights. The IBA’s Agricultural Law Section, co-chaired by Lynn L. Bergeson, will present the Sustainability Focus session titled “Sustainable Investment In Agriculture – The Role Lawyers Play.”

PODCAST -- The New Era Of Smarter Food Safety — A Conversation With Karin Baron: Lynn L. Bergesonand Karin F. Baron, Senior Regulatory Consultant at Acta, discuss the U.S. Food and Drug Administration’s (FDA) initiative called the New Era of Smarter Food Safety. The goal of this initiative is to diminish the number of foodborne illness, which, surprisingly, has not diminished since the Food Safety Modernization Act was enacted 11 years ago. They cover FDA’s “blueprint for the future” as the initiative has come to be called, the use of emerging technologies to achieve FDA’s goal, and how FDA is trying to change the culture of food safety in the United States. Listen now.

PODCAST -- Is There A New Chemical Bias? — A Conversation With Richard E. Engler, Ph.D.: Lynn L. Bergeson and Richard E. Engler, Ph.D., Director of Chemistry at Acta, discuss one thing that did not change when the Toxic Substances Control Act (TSCA) was revised: the new chemical bias, explaining why it continues to confound chemical innovators, and what is being done to eliminate the bias and level the playing field. Listen now.

ARTICLE -- Lynn L. Bergeson Authors “Due Diligence In Mergers And Acquisitions Involving Chemical Products,” For Financier Worldwide: The scope of what diligence is due in any corporate transaction has evolved greatly over the past decade, particularly with respect to transactions involving chemical products. Once upon a time, transactional due diligence involving chemical products, whether “neat” (pure) chemicals, formulations, or end-use products, typically consisted of a phase I or phase II environmental site assessment (ESA) focusing on identifying contamination derivative of chemical releases into environmental media as effluent, emissions, fugitive releases, or waste, as well as quantifying the potential for such releases to pose litigation risks or regulatory enforcement, or require costly remediation. Increasingly, parties to corporate transactions now continue to focus on these liabilities and on the compositional elements of chemical products themselves as potential sources of liability and commercial disruption. This article explains why the transition to chemical product due diligence has been slow and offers a few tips to help assess what diligence is due in corporate transactions involving chemical products.

AUSTRALIA

AICIS Clarifies What “Significant” Or “Significantly” Mean In A Specific Information Requirement: An Australian Inventory of Industrial Chemicals (Inventory) listing for a chemical may include a “specific information requirement,” meaning that the Australian Industrial Chemicals Introduction Scheme (AICIS) has assessed the chemical and submitters are obligated to tell AICIS about their introduction in certain situations. AICIS posted a news item on September 19, 2022, announcing that it has added more details to its page on “what is a specific information requirement.” The information includes:

  • An example of a “specific information requirement” that may be seen on an Inventory listing;
     
  • Examples of when AICIS uses the words “significant” or “significantly” to describe situations where the submitter proposes to use the chemical in a way that is different to what AICIS originally assessed;
     
  • Various scenarios to help submitters understand how specific information requirements could work and how to meet their obligations, if required; and
     
  • What to do if the submitter cannot find AICIS’s assessment report.
     

AICIS Proposes Changes To Industrial Chemicals Rules For Chemical Introductions Of Ten kg Or Less In A Registration Year: AICIS has begun a public consultation on proposed changes to the Industrial Chemicals (General) Rules 2019. According to AICIS, these changes would affect the requirements for certain lower risk chemical introductions, where the introduction volume is ten kilograms (kg) or less in a registration year. The main consultation points include:

  • Under the amended rules, it would be easier for introducers of chemicals at volumes of ten kg or less in a registration year to meet their AICIS obligations;
     
  • Eligibility criteria and exclusions would apply to ensure that:
     
    • Appropriate information is known about chemicals being introduced; and
       
    • Higher concern chemicals could not be categorized as low risk (reported) introductions by accessing these proposed amendments; and
       
  • Instead of holding a written undertaking from the chemical supplier, where the Chemical Abstracts Service Registry Number (CAS RN) (if assigned) and Chemical Abstracts Service (CAS) name of the chemical is confidential, the introducer would need to know information that is more proportionate to the risk of introduction of a chemical at ten kg or less. For example, the International Nomenclature of Cosmetic Ingredients (INCI) name of a chemical would be accepted for the identity of the chemical.

The consultation will close on October 11, 2022. According to AICIS, the consultation period is shorter than usual to address issues identified by companies when transitioning their introductions to AICIS and to provide certainty to introducers of chemicals at ten kg or less in a registration year, in the shortest possible time frame.

SWA Begins Consultation On Model WHS Regulations Relating To MHFs: Safe Work Australia (SWA) began a public consultation on October 6, 2022, on the model Work Health and Safety (WHS) Regulations relating to Major Hazard Facilities (MHF). An MHF is a facility where certain hazardous chemicals are present (or are likely to be present) in a quantity that exceeds a prescribed threshold quantity. Under the model WHS Regulations, a regulator can also determine a facility to be an MHF in certain circumstances. Examples of MHFs include oil refineries, chemical plants, and large fuel or chemical storage sites. According to SWA, the purpose of the consultation is to gather evidence to understand better stakeholder concerns with the model WHS Regulations in relation to MHFs. It will help us determine whether there are issues that need to be addressed through changes to the model WHS laws.

SWA seeks stakeholder suggestions on potential amendments to the model WHS Regulations and non-regulatory options to support improved application of MHF laws and consistency across jurisdictions, as well as ensuring they meet the intended policy objectives of:

  • Protecting workers and other persons against harm to their health, safety, and welfare through the elimination or minimization of risks arising from work;
     
  • Maintaining and strengthening the national harmonization of laws relating to WHS; and
     
  • Facilitating a consistent national approach to WHS.
     

SWA notes that it is also updating guidance material relating to MHFs and welcomes comments on the current versions of the guidance. Comments are due November 3, 2022.

BRAZIL

ABNT Begins Public Consultation On Proposed Technical Standard Concerning GHS Classification And Labeling Of Chemicals: The Association of Technical Standards (ABNT), the body responsible for establishing technical standards in Brazil, has begun a public consultation on proposed revisions to ABNT NBR 14725, “Chemicals -- Information about safety, health and environment -- General aspects of Globally Harmonized System (GHS), classification, SDS and labelling of chemicals.” When approved, the standard will replace ABNT NBR 14725-1:2009, ABNT NBR 14725-2:2019, ABNT NBR 14725-3:2017, and ABNT NBR 14725-4:2014. The standard will establish:

  • Terms adopted on the classification of chemical hazards in labeling and in safety data sheets (SDS);
     
  • The purpose, scope, and application of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS);
     
  • Criteria for the classification of physical hazards, human health, and the environment of a chemical;
     
  • Information on safety, health, and environment related to the chemical to be included on the labels;
     
  • Information on how to prepare an SDS; and
     
  • Confidentiality and comprehensibility of information, and training within GHS.
     

Comments are due October 27, 2022.

EUROPEAN UNION (EU)

ECHA Announces Call For Evidence On Skin Sensitizing Substances In Consumer Mixtures: According to an item in the August 10, 2022, ECHA Weekly, France, Ireland, and Germany are requesting interested parties to submit information related to skin sensitizing substances in consumer mixtures. The European Chemicals Agency (ECHA) website states that this is an opportunity for all sectors to provide information on the presence of skin sensitizing substances in mixtures with consumer uses, including information on known safe uses. The call for evidence is issued to assess whether there are risks that are adequately controlled under specific conditions and what impact additional regulatory risk management would have on society. The scope of the investigation comprises substances fulfilling the criteria for classification as skin sensitizers as defined by Regulation (EC) No 1272/2008 on the classification, labeling, and packaging of substances and mixtures (CLP) in mixtures marketed or available for consumers in the EU/European Economic Area (EEA). Uses of substances in cosmetic products are outside the scope of the investigation. The deadline for comments has been extended to October 31, 2022. More information is available in our August 17, 2022, blog item.

ECHA Modifies Recommendations To Registrants On How To Cover Mutagenicity Information Requirements: During its June 2022 meeting, ECHA’s Member State Committee (MSC) agreed to modify the approach for investigating chromosomal aberration under Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) dossier evaluation. The main changes include:

  • To fulfill REACH Annex VIII 8.4.2 requirements, an in vitro micronucleus study (Organization for Economic Cooperation and Development (OECD) Test Guideline 487) is the default test as it allows the mode of action (clastogenicity and/or aneugenicity) to be identified; and
     
  • If a concern for chromosomal aberration is identified in vitro, a follow-up study combining an in vivo comet assay (OECD Test Guideline 489) and an in vivo micronucleus test (OECD Test Guideline 474) will be needed in most cases.
     

ECHA has modified its recommendations to reflect these changes, which have applied since September 1, 2022. Exceptions to this general approach may apply.

EC Opens Call For Evidence On A Proposal For A Basic Regulation For ECHA: On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for ECHA. According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023.

During the 15 years since ECHA was created in 2007, its structure, authority, and funding have not kept pace with the increasing breadth and complexity of its mission. The need for this initiative to strengthen ECHA governance, adapt it to its present and future roles, and streamline the working methods of ECHA bodies has been recognized for many years by the regulators and the regulated community. The ambitious goals of the Chemicals Strategy for Sustainability (CSS) require improved alignment of ECHA’s scientifically rigorous safety assessments with implementation and enforcement of risk management decisions more quickly, and in a manner that is not only comprehensive and efficient, but consistent and coherent across various EU chemicals regulations. More information is available in our September 28, 2022, memorandum.

EC Adopts New Rules Allowing Use Of Recycled Plastics In Food Packaging: The EC announced on September 15, 2022, that it adopted a new regulation on the safety of recycled plastic materials and articles intended to come into contact with food. According to the EC, this regulation will set clear rules to ensure that recycled plastic can be safely used in food packaging in the EU. The EC states that the regulation will help the recycling industry establish suitable ways for recycling plastics that presently cannot be recycled into food packaging. The European Food Safety Authority (EFSA) will have a clearer basis to evaluate the suitability of recycling technologies and the safety of the recycled plastic in food packaging manufactured with processes using these technologies. The regulation will establish a public register of recycling processes, recyclers, and recycling installations under its scope, providing an increased level of transparency.

ECHA Proposes To Identify Nine Substances As SVHCs: ECHA has begun public consultations on nine proposals to identify new substances of very high concern (SVHC). The substances and examples of their uses are:

  • 4,4′-sulphonyldiphenol (bisphenol S; BPS): The substance is used for the manufacture of pulp, paper, and paper products; textile, leather, or fur; and chemicals.
     
  • Perfluoroheptanoic acid and its salts: The substances are not registered under REACH.
     
  • Melamine: The substance is used in polymers and resins, coating products, adhesives and sealants, leather treatment products, and laboratory chemicals.
     
  • Isobutyl 4-hydroxybenzoate: The substance is used in the manufacture of substances and in coating products, fillers, putties, plasters, modeling clay, and inks and toners.
     
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof: The substance is used as a flame retardant and as a plasticizer for flexible polyvinylchloride and for use in wire and cable insulation, film and sheeting, carpet backing, coated fabrics, wall coverings, and adhesives.
     
  • Barium diboron tetraoxide: The substance is used in paints and coatings.
     
  • Reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl)morpholine (FC-770): The substance is used in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites, and in manufacturing.
     
  • 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol (tetrabromobisphenol-A; TBBPA): The substance is used as a reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards, and paper and textiles.
     
  • 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]: The substance is not registered under REACH.
     

The deadline for comments is October 17, 2022.

ORs Must Declare Non-EU Manufacturers In REACH-IT By October 14, 2022: ECHA recently reminded only representatives (OR) that they must identify the non-EU manufacturers that they represent and provide their contact information in REACH-IT by October 14, 2022. According to an April 25, 2022, news item, ORs must have a separate REACH-IT account for each non-EU manufacturer they represent and have the necessary registrations for each. The contact information that must be provided includes:

  • Name, address, telephone number, and e-mail address;
     
  • Contact person;
     
  • Location of any production or formulation sites;
     
  • Company website; and
     
  • National company identification numbers.
     

ECHA states that ORs may need to reorganize their REACH-IT accounts to ensure that there are separate accounts for each non-EU manufacturer represented. Similarly, if an entity is an OR but also a manufacturer/importer under REACH, it will need separate REACH-IT accounts for the OR and for the manufacturer/importer roles. According to ECHA, if the REACH-IT accounts must be rearranged due to these new requirements, the fee for transferring registrations in REACH-IT accounts can be waived until October 14, 2022.

EC Begins Survey On Use Of Health-Based Limit Values: The EC is conducting a survey on the use of health-based limit values that are used in a regulatory context to protect people and the environment from negative effects after exposure to different chemical substances or mixtures. As part of the “One substance, one assessment” approach, the EC aims to develop a centralized and structured repository in the form of an online platform that would make all relevant health-based limit values easily available and accessible at one place. The survey will be open until October 10, 2022.

EC Calls For Comment On Adding New Hazard Classes To CLP: On September 20, 2022, the EC began a public consultation on a draft act that would introduce new hazard classes as part of its revision to CLP. Hazard classes and criteria would be added for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile, and toxic (PMT), or very persistent and very mobile (vPvM). The inclusion of the new hazard classes is meant to address commitments under the CSS, which is noted as a building block for the European Green Deal, and to ensure a high level of protection for human health and the environment. The EC notes that comments will be taken into account for preparing in final the initiative. Responses are due October 18, 2022.

The EU United Nations (UN) GHS adaptation into its CLP regulation is one of the most complex aspects of GHS implementation. CLP contains many variations to UN GHS that result in a hazard communication process that is consistently misaligned with other countries’ approaches. The proposed revisions, which include entirely new hazard classes that lack clarity, add layers of confusion to an already complex approach to hazard classification. Previous responses to comments agreed the criteria are important, but most expressed the view that introduction of PBT, vPvB, PMT, and vPvM was not necessary. More information is available in our September 29, 2022, memorandum.

ECHA Announces QSAR Toolbox Extension That Broadens Possibilities For Animal-Free Chemicals Assessment: ECHA announced on September 27, 2022, a new add-on to the OECD Quantitative Structure-Activity Relationship (QSAR) Toolbox that is intended to help users predict chemical properties, including endocrine activity, while avoiding testing on animals. The Open (Quantitative) Structure-activity/property Relationship App (OPERA) extension contains models for predicting properties that are important for assessing chemical hazards. According to ECHA, the extension can be used to screen chemical databases to identify substances that may cause endocrine disruption. It also helps users to estimate acute oral toxicity and other regulatory relevant properties. Developed by the U.S. National Institute of Environmental Health Sciences (NIEHS), OPERA can predict properties related to the absorption, distribution, and metabolism of substances that can strengthen read-across justifications and facilitate the regulatory use of in vitro test results. The extension can be downloaded for free from the QSAR Toolbox Repository.

EC Calls For Evidence On Future European Critical Raw Materials Act: On September 30, 2022, the EC announced that it launched a call for evidence in preparation of the European Critical Raw Materials Act, which was announced by President von der Leyen during her 2022 State of the Union Speech. The EC seeks comments and responses to targeted questions on the current problems faced along the critical raw materials supply chain within and outside of the EU and how to address them. The EC states that the Critical Raw Materials Act “will notably aim to identify policy actions necessary for developing strategic projects to strengthen the EU supply chains while maintaining a sustainable level playing field.” The act will be complemented with a Communication presenting other initiatives intended to facilitate the supply diversification through actions with third countries, including trade, cooperation, and industrial strategic agreements, which could take the form of partnerships, sectoral agreements, or multilateral initiatives. The EC notes that critical raw materials are essential for the deployment of the technologies that enable the green and digital transitions. The call for evidence will close November 25, 2022.

INDIA

MEFCC Publishes Battery Waste Management Rules: On August 24, 2022, the Ministry of Environment, Forest and Climate Change (MEFCC) published the Battery Waste Management Rules, 2022. The rules apply to:

  • Producers, dealers, consumers, and entities involved in the collection, segregation, transportation, refurbishment, and recycling of waste batteries; and
     
  • All types of batteries regardless of chemistry, shape, volume, weight, material composition, and use.
     

According to the MEFCC’s August 25, 2022, press release, the rules are based on the concept of extended producer responsibility (EPR) where the producers (including importers) of batteries are responsible for the collection and recycling/refurbishment of waste batteries and use of recovered materials from wastes into new batteries. To meet the EPR obligations, producers may engage themselves or authorize another entity for collection, recycling, or refurbishment of waste batteries. MEFCC states that mandating a minimum percentage of recovery of materials from waste batteries under the rules will bring new technologies and investment in recycling and refurbishment industry and create new business opportunities.

INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)

IARC Announces IARC Monographs Meeting On PFOA And PFOS, Announces Call For Data: On November 7-14, 2023, IARC will hold an IARC Monographs meeting on perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS). IARC has posted a call for experts, closing on November 28, 2022. IARC seeks scientists who wish to be considered for membership in the Working Group that will develop Monographs on PFOA and PFOS. Working Group Members will ascertain that all appropriate studies in their area of expertise have been identified; prepare, review, and revise preliminary working papers that critically review the pertinent scientific literature; and participate in a meeting to discuss and revise the pre-meeting texts, and to reach consensus evaluations of the strength of evidence of carcinogenicity. IARC has also posted a call for data to obtain studies that are relevant to the carcinogenicity of PFOA and PFOS. This includes “all pertinent epidemiological studies and cancer bioassays, plus important mechanistic and other relevant data.” Eligible studies should be published or accepted for publication in the openly available scientific literature. The call for data closes on October 7, 2023.

WORLD HEALTH ORGANIZATION (WHO)

WHO Publishes Draft Background Document For Development Of Guidelines For Drinking Water Quality For PFOS And PFOA: WHO has published a draft document entitled PFOS and PFOA in Drinking-water: Background document for development of WHO Guidelines for Drinking-water Quality. The scope of the draft document includes PFOA and PFOS, with more limited consideration and information provided on other per- and polyfluoroalkyl substances (PFAS). The draft document states that the evidence presented is primarily drawn from existing authoritative reviews, including those from the Agency for Toxic Substances and Disease Registry (ATSDR), EFSA, Health Canada, and the U.S. Environmental Protection Agency (EPA). The draft document describes examples of robust studies from the primary literature to provide an overview of health effects in humans and animals. The draft document is not intended as a comprehensive summary of the primary literature, however, and not all studies are cited. The draft document proposes individual provisional guideline values (pGV) of 0.1 µg/L for PFOS and PFOA and a combined pGV of 0.5 µg/L for total PFAS. Comments on the draft document are due November 11, 2022.


 
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