ACS Position Statement

Chemicals Management and Regulation

PDF version

In the United States, a wide range of stakeholders—EPA, industry, and public interest groups— have called for consideration of and provided principles for chemicals management reform. State laws and legislative proposals to regulate specific chemicals are increasing along with calls to update federal regulatory programs. In particular, the Toxic Substances Control Act (TSCA) needs to be more comprehensive and focused on assuring the safety of all chemicals in commerce.¹ ACS believes the time has arrived for all stakeholders to come together and work with Congress to update chemicals management and regulatory policy.

Over the last few years, various countries and regions have changed their chemical management systems in response to evolving scientific information, testing capabilities, and public concern that chemicals in commerce require more attention. The European Union adopted regulations dealing with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), a system that requires registration of all chemicals in commerce, evaluation of data and information at tiered levels based on production volume, and use authorization for chemicals of highest concern. Canada is implementing a law that requires screening of chemicals in commerce to ensure that the government identifies, evaluates, and takes appropriate action for those chemicals posing the highest risks.

In addition, advances in toxicology (toxicogenomics, bioinformatics, systems biology, epigenetics, computational toxicology) have begun shifting from whole-animal testing to in vitro methods, and more studies are being done outside industry raising public concerns about chemicals.

The Toxic Substances Control Act, enacted in 1976, provides authority to the Environmental Protection Agency (EPA) to collect information from industry, evaluate chemicals in commerce, and regulate those that may pose an unreasonable risk. Risk is a function of exposure and hazards presented by a chemical over its lifetime. Unreasonable risk adds consideration of technical, economic, and societal impacts and has been the source of controversy since TSCA’s inception. The General Accountability Office, a non-partisan arm of Congress, concluded that

• EPA currently lacks adequate information on potential chemical risks.
• TSCA’s regulatory framework impedes EPA’s ability to control chemical risks by placing a high burden on EPA to show unreasonable risk before acting.
• TSCA limits EPA’s ability to share confidential information.²

Over the last several years, there have been discussions among various stakeholders about how the law, which has not been significantly modified since its passage in 1976, could be improved.

Back to Top

Contents

• Chemicals Risk Management Principles
• ACS Policy Recommendations

Chemicals Risk Management Principles

The need to earn the public’s confidence regarding chemical product safety has been a principal theme of recent chemicals management policy discussions. Legislation should be based on the concept that safety is a shared responsibility between government, industry, the value chain, and consumers. This can be accomplished through the modernization of regulation and by a concurrent commitment from the chemical industry to share more scientific data and information about the safety of their products. However, the federal government ultimately must have the authority to ensure public and environmental safety from chemical risks and have the resources to enforce a national chemicals management policy.

The following key principles are fundamental to a national chemicals management statute and are supported by most stakeholders. Each may be elaborated upon or modified during the course of legislative debate but should serve as the basis for the new law.

• Chemicals should be safe for their intended use. Exposure to chemicals remains a key factor in conducting adequate chemical risk management.
• Risk is a function of hazard and exposure. The regulation of chemical substances must be based on the best available scientific evidence in judging the risk posed through transparent, published, and state-of-the-art risk assessments.3-4
• Companies that manufacture, import, process, distribute, or use chemicals must be required to provide the information necessary for EPA to make safe use determinations. Collected health and environmental data should be made readily available to the public, however, legitimate confidential business information should be protected. Companies and EPA working together need to ensure a balance that maximizes public access to chemical health and safety information.
• EPA should systematically prioritize chemicals for safe use determinations and act promptly on those with high risk. Priorities need to reflect risk considerations, including scientific understanding of hazard, volume in commerce, use (i.e., whether the chemical is formulated in children’s products or whether some communities have disproportionately high levels of exposure to it), detection in biomonitoring programs, persistent and bioaccumulative properties, and adequacy of available risk information. Testing resources availability and information collection capabilities should be considered when informing the action pace on priorities chemicals.
• EPA should be empowered to impose a range of controls to ensure chemicals are safe for their intended use(s). Safe use determinations need to integrate hazard, use, and exposure information. They should also incorporate appropriate safety factors, including separate consideration of vulnerable subpopulations that may be exposed keeping in mind that different exposure controls may be appropriate for different uses and users. The following considerations should be part of EPA’s risk management decision-making, but not part of its safe use determinations: benefits of chemicals being evaluated, cost of methods to control risks, and benefits and costs of alternatives.
• EPA should rely on scientifically valid data and information, regardless of source—including data and information reflecting modern advances in science and technology. It should also incorporate evolving science and methodologies and seek to implement recommendations made by National Academy of Science committees regarding new scientifically valid testing methods and improvements to the risk assessment process. In addition, EPA needs to have funding to sponsor continued research for a better understanding of environmental fate and exposure.
• EPA must have the staff, resources, and regulatory tools needed to ensure the safety of chemicals. Working closely with other relevant U.S. agencies (FDA, CPSC, OSHA and others), states, and countries, governmental organizations is necessary to avoid duplication and gaps and to achieve the most efficient and effective risk management.
• A modernized chemicals management and regulatory policy should encourage technological innovation and globally competitive industry in the United States. Technological innovation includes the continual search for safer chemicals and processes and specifically supports research into green and sustainable chemistry and engineering.
• Developing and evaluating greener alternatives to existing chemical products and processes is a long-term process. Government regulatory requirements should factor this in when considering mandates for substitutions or bans where alternatives are not readily available on the market.
• EPA needs to drive innovation toward greener and more sustainable options. This could be done by removing market distortions that favor riskier alternatives and/or impede safer process and product changes, creating incentives such as providing comprehensive information, reducing regulatory time delays, and encouraging voluntary, industry-government collaborations.

Back to Top

ACS Policy Recommendations

ACS supports the passage of a chemicals management statute, either by amending TSCA or by enacting a comprehensive law. The statute should adequately meet safety goals for human health and the environment, encourage the benefits of a continued flow of new useful chemical substances, and recognize the practical issues of using limited testing resources.

ACS has three specific concerns:

1. Green Chemistry – Principles of pollution prevention, environmental sustainability, and green chemistry need to complement traditional regulatory strategies.

• Financial incentives (tax incentives, grants, awards, preferential treatment in government purchasing) should be used to provide incentives for the development and deployment of greener chemicals and processes.
• An expedited regulatory process should be used to incentivize adoption of green and sustainable chemical products and processes. The government should work with industry, academia, scientific organizations, public interest groups, and other stakeholders to develop such standards that would be used in such a regulatory scheme.
• The government should continue to support research and development by universities, industry and other stakeholders to make new alternatives available and encourage their adoption.

2. Data/Testing – Industry has traditionally been responsible for development of data used to assess risk. EPA testing requirements should give due consideration to existing data on closely related compounds and to intended uses of a chemical. Exemptions should include chemicals used solely in R&D and certain polymers.

• Regulatory preferences or a speedier, simplified regulatory process should be used to encourage environmental, health, and safety data sharing that goes beyond routine requirements.

3. Expertise – The training and education of chemical scientists should more uniformly prepare them to understand toxicity and exposures (i.e., risk) associated with chemicals.

Back to Top