Chemicals Management

Background

The World Coatings Council has developed a Chemical Management Regulatory Toolkit 2.0 to assist countries develop life-cycle-oriented and risk-based regulatory frameworks for chemical management that are based on sound science. The toolkit serves as a resource for national governments as they develop and update their chemicals management regulations. Below is a short overview of the toolkit.

Chemical management systems should consist of four elements:

  • Site and worker safety — Site and process safety standards and systems are the first steps to help reduce risks and incidents at chemical manufacturing facilities for workers, the environment, and the public.
  • Emergency response — Emergency response systems address chemical accidents,
    especially those occurring on plant sites and during transport.
  • National objective for regulatory action on chemicals management — Developing national objectives and a timeline to achieve the objectives is essential to successfully implementing a chemical control law and regulation.
  • Risk-based versus hazard-based regulatory systems — A risk-based approach incorporates an understanding of both hazard (toxicity) and exposure. It considers both the degree of hazard (hazard identification and dose-response characterization of adverse effects) and the extent of exposure (amount of contact).

The tool kit also includes:

  • A list of chemical management system/regulation key elements;
  • Suggestions on implementing a hazard communication system;
  • Identifying chemicals in commerce (inventory and periodic reporting);
  • Prioritization schemes;
  • National chemical inventories;
  • New substance notification requirements; and
  • Insights into industry’s role in promoting sound chemicals management.

Three examples of chemicals management systems:

Example A. Chemicals management in Canada

Canada has developed a risk-based system of evaluating and managing chemicals with implementation of the Canadian Environmental Protection Act, 1999 (CEPA), administered by Health Canada. The Act provides for the assessment and management of chemical substances to prevent, reduce or control environmental and human health impacts of:

  • new and existing substances (including products of biotechnology);
  • marine pollution;
  • emissions from vehicles, engines and equipment;
  • fuels;
  • hazardous wastes; and
  • environmental emergencies, including accidental spills.

Health Canada evaluates chemicals against criteria in Section 64 of CEPA, defining “toxic” as chemicals that enter or could enter the environment that:

  • have or may have a harmful effect on the environment;
  • are or could be dangerous to the environment that life depends on; or
  • are or could be dangerous to human life or health.

Health Canada maintains a List of Toxic Substances, consisting of evaluated chemicals. When listing, Health Canada publishes environment and human health objectives that serve as benchmarks for risk mitigation. These may include quantitative limits or general public health goals.

When proposing a listing on the List of Toxic Substances, Health Canada also proposes a risk management scope providing preliminary issues for management strategies, while accepting comment on both the proposed listing and risk mitigation strategy. Stakeholders have additional opportunities to comment as Health Canada continues to develop risk mitigation. This may include proposed regulations, pollution prevention programs, release guidelines, codes of practice or management practices in a Significant New Activity Notice (SNAN). Health Canada may also select risk management options under other statutes such as the Canada Consumer Product Safety Act, the Pest Control Products Act or the Food and Drugs Act.

Example B. Chemicals management in Europe

REACH is the EU chemicals regulation (EC 1907/2006) establishing requirements for registration, evaluation, authorization, and restriction of chemicals. It entered into force on 1 June 2007.

Registration

REACH requires manufacturers and importers to register substances with ECHA prior to manufacture and import of substances in amounts of 1 tonne or more per year. REACH follows the “one substance, one registration” principle. Under this principle, a consortium of manufacturers and importers support a lead registrant to assure ECHA receives all necessary information to register a chemical and receives payment of the associated registration fee. Registration requires standardized data sets. Data varies by tonnage of manufacture and import, as specified by tonnage bans. A consortium must submit hazard properties, intrinsic properties, risk mitigation methods, etc.

The registration obligation includes registration of individual substances contained in mixtures, isolated intermediates and substances in articles intended for release.

Evaluation

REACH authorizes ECHA and its scientific committees to evaluate submitted information to determine an appropriate regulatory approach. Evaluation process addresses three issues:

  • Evaluation of proposed testing submitted by registrants.
  • Compliance checks of dossiers submitted by registrants.
  • Evaluation of substances.

ECHA uses a combination of hazard and exposure related information to priorities chemicals for evaluation by listing on the Community Rolling Action Plan (CoRAP), which is updated annually. The selection criteria includes hazard information: potential persistency, bioaccumulation and toxicity (PBT), endocrine disruption, or carcinogenicity, mutagenicity and toxicity to reproduction (CMR). ECHA also considers exposure information including exposure potential based on uses, and total registered volumes and Member States can also submit proposals for substances of interest to be evaluated.

Whilst evaluation of these substances is distributed throughout the EU, with different Member states conducting the evaluation of an assigned chemical, there are concerns surrounding the ability to evaluate broad data sets of substances, with some Member States having greater capacity than others.

Upon publication of the annual CoRAP, a Member State has one year to conduct a preliminary evaluation and publish a draft decision, seeking additional information, as necessary. The evaluation process takes up to three years.

A Member State can propose one of four options as an outcome of evaluation:

  • A proposal for harmonized classification and labelling for carcinogenic, mutagenic or toxic to reproduction, respiratory sensitizer or other effects.
  • A proposal to identify the substance as a substance of very high concern (SVHC).
  • A proposal to restrict the substance.
  • Actions outside the scope of REACH such as a proposal for EU-wide occupational exposure limits, national measures, or voluntary industry actions.

Authorization and Restriction

REACH provides a framework for restriction of chemicals with authorized use, with initiation of the authorization process initiated by listing as a “Substances of Very High Concern” or an SVHC. SVHCs are listed in Annex XV, known as the candidate list for authorization. After listing on Annex XV, ECHA further considers risks associated with use and if necessary, will require an authorization for use. Chemicals requiring authorization are then moved from Annex XV to Annex XIV, the authorization list. Another relevant list is in Annex XVII, listing certain chemicals that are restricted for manufacture or use.

The process for listing on the Annex XV list of SVHCs (candidates for authorization) begins when a member state or ECHA proposes listing, based on a chemical’s hazards. ECHA will accept comments on the proposal for a 45-day period. REACH defines SVHCs as having one or more of the following hazard characteristics:

  • Substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
  • Substances which are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to REACH Annex XIII.
  • on a case-by-case basis, that cause an equivalent level of concern as CMR or PBT/vPvB substances.

Listing on the Annex XV candidate list for authorization triggers the following requirements:

  • supplying a safety data sheet
  • communicating instructions about safe use
  • responding to consumer requests within 45 days and
  • notifying ECHA if the article they produce contains an SVHC in quantities above one tonne per producer/importer per year and if the substance is present in those articles above a concentration of 0.1% (w/w).

For additional details regarding REACH generally and process and requirements for registration, evaluation, authorization and restriction, see the ECHA website at: https://echa.europa.eu/regulations/reach/understanding-reach

In October of 2020, the European Commission finalized published the EU Chemicals Strategy for Sustainability. The policy recommends several changes to European Chemicals management requirements, with changes to chemicals management laws, some of which have been finalized and several others being negotiated with ECHA, the Commission and stakeholders. Note that there is an emphasis on responding to an identified hazard, rather than the risk of exposure. These policy changes clearly embrace the “Precautionary Principle.” The commission also plans to implement a hazard-based approach at the global scale, by introducing new hazard classes into the GHS and seeking to phase-out chemical groups and hazard classes through international conventions and agreements.

Example C. Chemicals management in the United States

The U.S. legislature substantially updated the framework for chemicals management with the Lautenberg Chemical Safety for the 21st Century Act, updating the Toxic Substances Control Act (TSCA). TSCA amendments took effect in June 2016, implementing changes around three basic issues: 1) Updating the inventory of chemicals active in commerce; 2) Providing a framework to conduct risk evaluations of chemicals on the TSCA inventory; and 3) Requiring evaluation of any new chemicals prior to allowing commercialization.

The TSCA Inventory

U.S. EPA lists chemicals approved for commercialization on the TSCA Inventory. Although listed chemicals are generally approved for manufacture, import and some level of use, EPA may restrict handling and use of any listed chemical with a Significant New Use Rule (SNUR), a consent order with the manufacturer or other regulatory measures. State legislation may also restrict any given chemical. At a broader level, EPA would like to group chemicals on the TSCA Inventory to inform the risk evaluation process. EPA has not yet taken definite steps towards this goal, but it has published a policy document describing a general approach.

As required by the 2016 amendments to TSCA, EPA required manufacturers and importers to notify EPA of chemicals that are or have been active in commerce over the 10-year period prior to the rule. Based on this initial reporting and subsequent notifications, EPA updates the TSCA Inventory every six months. The inventory of active chemicals lists around 42,000 chemicals. It is available online at https://www.epa.gov/tsca-inventory/how-access-tsca-inventory.

To encourage transparency and public access to information, TSCA amendments require EPA to make common chemical names as listed on the TSCA inventory available to the public. Prior to the TSCA amendments, EPA would list chemicals while keeping chemical names and other identifying information confidential when requested by a manufacturer. The amendments still allow for confidentiality of chemical identity, where substantiated by the manufacturer.

As part of revisions to the TSCA Inventory, EPA collected substantiating data for claims of confidentiality from manufacturers and is currently reviewing data. Reviews will result in disclosure of some identities within five years. Data required to substantiate claims of confidentiality are provided in Section 14 of TSCA and include measures a company has taken to protect identity, including information describing how a confidential chemical cannot be reverse engineered.

Risk Evaluations Under TSCA

Under the 2016 amendments, EPA is required to have at least 20 ongoing risk evaluations of chemicals listed on the inventory, at any given time. Companies can also request an evaluation. EPA must ensure that 25-50% of its risk evaluations are based on a manufacturer’s request. Once a chemical is selected as a “high priority chemical” for evaluation, through a prioritization process, EPA initiates a 3-year risk evaluation by publishing a draft scope, open to a 45-day comment period. The designation as “high priority” is not a statement of risk. Rather it merely determines EPA is giving priority to evaluating the chemical.

The scoping document includes a set of “conditions of use” that define the scope of a risk evaluation. “Condition of use” is a defined term commonly used in TSCA and indicates considerations associated with a chemical at any stage of its life cycle. EPA typically defines a range of industrial, commercial and consumer uses of a chemical within scope. EPA considers legacy uses and effects on the general population. EPA’s methods and understanding of these issues continues to evolve. EPA must also consider potentially exposed and susceptible subpopulations including workers.

EPA conducts its risk evaluation for 3 years, with two public comment periods. EPA allows 45 days for comment on the draft scope. It then proceeds with data collection and evaluation for about two years, resulting in a draft risk evaluation. Stakeholders then have 60 days to comment on the draft evaluation. Once evaluation is finalized, EPA initiates a two-year process to finalize a risk mitigation rule.

The goal of the risk evaluation is to reach a determination of “unreasonable risk” or “no unreasonable risk.” Currently, EPA makes this determination for the chemical in its entirety. With the first set of risk evaluations, EPA tried a different approach. EPA would make a separate risk determination for each condition of use. With the current approach, EPA delays a determination on conditions of use to the risk mitigation phase, although it will review associated risk during risk evaluation. The process is controversial as it is unclear how and when EPA will consider typical workplace practices, PPE, and other risk mitigation practices.

The TSCA amendments also do not require industry data submission. Data submission is largely voluntary, although EPA has authority to require data submission by rule. It is in industry’s interest to provide EPA with any data relevant to a condition of use. Since the scope of evaluations encompass a variety of uses, data quality and specificity remain an important issue. EPA is considering approaches to require manufacturer data submission. The paint and coatings industry remains concerned about accuracy of data related to formulating products and downstream uses.

EPA provides additional information about the risk evaluation process with information about ongoing evaluations online at: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca

New Chemical Review

Prior to manufacture and import of any chemical not listed on the TSCA Inventory, EPA must approve the chemical and mitigate any risk from prescribed uses and “reasonably foreseen uses.” The review process begins with a manufacturer or importer filing a Pre-Manufacture Notice (PMN). Upon review, EPA will issue a finding of “no unreasonable risk” with prescribed control measures. EPA also can issue findings that:

  • information is insufficient;
  • may present an unreasonable risk, pending development of additional information; or
  • the chemical either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure due to substantial quantities of production.

EPA also has the option to issue a finding that the chemical presents an unreasonable risk. To date, EPA has not issued such a finding.

By statute, EPA is required to complete PMN review within 90 days. However, EPA rarely, if ever, meets this deadline. Delays of six months to over a year are common, leading to some companies withdrawing PMNs and delaying or cancelling introduction of products in the U.S. Further, the data requirements for the PMN process are determined on a case-by-case basis, through meetings with EPA. EPA is required under TSCA to review “reasonably foreseen uses” in addition to uses identified by the PMN submitter. EPA identifies potential future uses by reviewing patents, chemical analogs, and other sources.

Upon concluding review, EPA has a policy of issuing a Significant New Use Rule (SNUR) for most chemicals. EPA has the option of also issuing a consent order binding the PMN submitter to control measures. Since review includes uses outside of those contemplated by the PMN submitter, EPA typically issues SNURs as a general rule binding all manufacturers and importers, while often affecting downstream users also. SNURs can impose a variety of restrictions including PPE, restrictions on discharge and emissions, hazard communication requirements, use restrictions, etc.

SNUR requirements provide additional measures to those required by other regulatory programs. Companies must implement and document compliance with SNURs in addition to overlapping controls prescribed in other regulatory programs. Companies that plan to vary from the SNUR in handling or using a chemical must notify EPA at least 90 days prior and obtain EPA’s approval.

EPA provides additional information about its new chemical review program at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca

Policy Concerns

The World Coatings Council recommends that the ICCA toolkit be considered when designing and improving national chemical management systems. Leveraging international risk-based best practices promotes the safe use of chemicals and facilitates international trade through harmonization.

Restriction of Substances

A. PFASs

Background

Per- and polyfluoroalkyl substances (PFASs) are a broad class of chemicals. This diverse family of important chemical substances are used across a wide variety of industries, including aerospace, energy, automotive, healthcare, construction, telecommunications, textiles electronics and first responder services. Beneficial products enabled by PFAS technologies include semiconductors, solar panels, high performance electronics, medical devices and garments, and fuel-efficient automobiles, and fluorinated firefighting foams used to suppress chemical fires.

Policy Concerns

The World Coatings Council supports a committed partnership between the coatings industry and key stakeholders to seek pragmatic and effective solutions to PFAS challenges. Such regulation is important to all stakeholders and should be based on the following principles:

  • Regulation Should Be Based on Sound Science. Any regulatory action addressing PFAS chemistries should be based on sound, peer-reviewed science and a transparent, well-informed record. Agencies should identify sources of uncertainty and the research needed to reduce those uncertainties, and regulations should remain flexible to accommodate emerging science.
  • Specific PFASs Should be Regulated Based on Risk to Human Health and the Environment. A risk-based approach focuses resources on the highest priorities based on the environmental, health, and safety risk of particular chemistries, not just the mere presence or persistence of a substance. Chemistries of low concern should be treated accordingly.
  • Regulatory Outcomes Should Not be Predetermined. Regulatory decisions should be made using existing regulatory frameworks within a formal rule making construct, which includes notice and comment, to ensure that all stakeholders are provided an opportunity to comment, and relevant public policy goals are considered.
  • PFAS Chemistries Should Be Regulated Independently, Not as a Single Group. PFAS chemistries have a wide variety of properties and uses. Due to this variation, it is inappropriate to regulate all PFAS chemistries as a single group and broadly restrict PFAS chemistries through wide-reaching bans. Instead, each individual chemistry or “well defined” small groups of chemistries should be regulated based on the specific risks posed, not on broad similarities/chemical properties. Risks associated with one member of the PFAS class should not be attributed to other members of the PFAS class without clear scientific justification. Suitable substitutes for critical-use applications should be identified prior to instituting regulatory restrictions. Wherever possible, the national governments should strive to minimize multi-jurisdictional solutions and develop nationwide standards that limit regulatory uncertainty, reduce confusion, and improve cleanup outcomes for stakeholders and the public.
  • Risk Communication and Regulatory Transparency Are Important. Agencies should ensure that the public can easily understand the actual risks associated with specific PFAS chemicals. This includes candid discussions regarding the processes associated with evaluating those chemicals as well as any scientific uncertainties in those analyses.
  • RegularConsultation with Stakeholders. Since PFAS regulation affects many parties, efforts to address PFAS should include regular consultation with all relevant governmental organizations and the business community prior to regulatory decisions.

The World Coatings Council remains committed to support efforts to achieve safe use of chemicals based on these principles.

B. Biocides

Background

The term “biocides” encompasses a wide range of materials that control the growth of unwanted, deleterious microorganisms in the environment. The paint and coatings industry acknowledges the need to maintain proper safeguards when using biocides and has a long history of effective collaboration with government to protect public health and the environment and ensure effective policies for biocide use that support their continued availability. The participants in this effort include the companies that make biocides, paint manufacturers — who add biocides to their products; users of paints containing biocides — who have come to expect the efficacy of these products to protect the painted surface and maintain desired conditions; and the government agencies charged with protecting public health and the environment — who provide oversight and continued scrutiny of the safety and effectiveness of biocidal product use in paints and coatings.

Microbial attack (i.e., mold and mildew) on painted surfaces is a wide-ranging and universal concern that has resulted in a global, coordinated strategy to combat it. The impact of microbial growth is not limited to degradation of applied paint films, but also occurs during production and storage of paints and coatings. Increasingly, paint products have embraced waterborne technology, using formulations that are low in volatile organic compounds (VOCs). As with most waterborne products, paints require the use of “in-can” preservatives to protect them from spoilage. In extreme cases, microbial decomposition can generate gases that rupture the container.

The importance of the biocides used for in-can preservation and to prevent dry-film microbial attacks cannot be understated. Over the past 75 years, market growth and public acceptance of waterborne paints and coatings has only been possible with the use of biocides. The effort to protect waterborne paints from microbial growth has resulted in enhanced plant hygiene and work practice controls that ensure product integrity throughout the supply chain. These efforts are part of a holistic approach to microbial control that ensures protection and optimizes the use of biocides, only using as much as needed to maintain a high level of efficacy.

Specialized uses of biocides in certain paints and coatings are critical to protect the substrates to which they are applied. Wood preservative materials are used to suspend the growth of microorganisms and other lifeforms that are associated with the destruction of wood and wood structures. Marine and offshore protective coatings are used to reduce the growth of marine microorganisms and associated biofilms that degrade vessels and steel structures and slow their propulsion through the water. Both uses are highly regulated, and face increased, stringent regulatory controls despite the significant contributions of biocides to sustainability efforts in every sector. End users, paint manufacturers, and biocide producers work closely with government agencies to advance consumer protection and reinforce safe use of biocides in paints and coatings.

Policy Concerns

The WCC believes that certain elements should be present in any biocide regulatory framework. For example, biocide registration as well as the definition and consideration for treated articles are concepts generally present in regulations around the world. The World Coatings Council recommends current and emerging regulations strive to offer a harmonized basis for promoting the essential and safe use of biocides in support of increasingly sophisticated, high-performing waterborne paint and coatings technologies as well as international trade.