What’s In Your Product? EPA Wants to Know
Until recently, the major focus of EPA under the Toxic Substances Control Act (TSCA) was on the regulation of individual chemical substances or mixtures of those substances. But on September 28, EPA’s new Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, Dr. Michal Ilana Freedhoff, told attendees at an industry conference that a vast number of manufactured goods or finished products, referred to as “articles” under TSCA, would now be fair game for regulation when linked to a chemical substance the Agency views as potentially risky.
Passed by Congress and signed into law by President Ford in 1976, TSCA gave EPA broad authority to regulate chemical substances that were not covered by certain other federal statutes. As a practical matter, that meant that all chemical substances would fall under TSCA unless they were subject to regulation as pesticides, foods and food additives, drugs, cosmetics, tobacco and tobacco products, nuclear materials, or munitions. Since that time the TSCA Chemical Substances Control Inventory (Inventory), the official list of TSCA regulated chemical substances, has grown to over 86,000 substances. Products manufactured or otherwise containing any of these chemicals could fall under EPA’s jurisdiction.
TSCA requires EPA to review all “new” chemical substances, i.e., substances not on the Inventory, prior to their manufacture, processing or importation, and to address any unreasonable risks the chemicals may pose to human health and the environment prior to their listing on the Inventory. EPA can also take action to address risks posed by chemical substances that are already on the Inventory, referred to as “existing” chemical substances. Whether a chemical substance is new or existing, risks to health that are subject to EPA’s jurisdiction under TSCA include those involving workers, consumers, and anyone else who may be exposed at any point in the life cycle of the chemical substance. EPA can also regulate companies that process chemical substances or mixtures that become part of an article (e.g., painting an article prior to distribution).
TSCA does not define “article,” but EPA regulations (40 CFR 704.3) define the term as follows:
Article means a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.
While there are a number of key provisions of TSCA, such as premanufacture review and the Inventory itself, that do not generally apply to articles, there is no question that articles and the chemicals in them are subject to regulation under TSCA. Indeed, the statute contains 53 references to the term “article,” including provisions authorizing EPA to take a variety of actions to mitigate risks to health and the environment. This includes measures deemed necessary to address the identified risks from exposure to a chemical substance or mixture from an article, including chemicals used in the article’s manufacture.
EPA’s concern with articles appears to be based on the fact that when they break down, either in use or on disposal, the chemicals they contain may sometimes get into the environment -- in dust, the air, surface water, and groundwater -- and result in exposures. In other cases, chemicals may not be fully encapsulated within an article.
EPA has already taken actions under TSCA involving articles, including rules applicable to the processing and distribution in commerce of certain persistent, bioaccumulative and toxic (PBT) chemicals, such as articles containing the flame retardant phenol isopropylated phosphate (“PIP (3:1)”) and the PIP (3:1) used to make those articles.
The following examples will illustrate some of the authorities under TSCA that EPA could potentially exercise to address health and environmental concerns involving articles.
Notification for Significant New Use
EPA can require notification prior to the import or processing of a chemical substance for use as part of an article or category of articles based on an affirmative finding in a rule that the reasonable potential for exposure to the chemical substance through the article(s) justifies notification.
Articles containing a chemical substance or mixture covered by certain TSCA rules may be denied entry into the customs territory of the United States.
While exports are generally exempt from most TSCA requirements, that does not apply if EPA finds that any chemical substance, mixture, or article presents an unreasonable risk of injury to health within the U.S. or to the environment of the U.S.
EPA can impose a requirement that any article containing a chemical substance or mixture of concern be marked with clear and adequate minimum warnings and instructions with respect to its use, distribution in commerce, and/or disposal.
EPA can prohibit or otherwise regulate any manner or method of disposal of any article containing a chemical substance or mixture of concern by its manufacturer or processor or by any other person who uses it or disposes of it for commercial purposes.
EPA can assess civil and criminal penalties for violations of TSCA or EPA’s implementing regulations. The agency can also request a federal district court to authorize the seizure of any article containing an imminently hazardous chemical substance or mixture, or such other relief against any person who manufactures, processes, distributes in commerce, uses, or disposes of, any article containing an imminently hazardous chemical substance or mixture.
TSCA also has a citizen suit provision that allows any person seeking to restrain a violation of TSCA or any TSCA rule to commence a civil action in federal court against any other person (or business). The suit can also be brought to force the EPA to take appropriate action under TSCA.
With the expectation of EPA’s increased emphasis on the inclusion of articles in TSCA regulations and enforcement actions, companies may want to look more closely at the chemicals used in manufacturing their finished goods as well as any potential exposure issues associated with the manufacture, processing, use, and disposal of those products.
The chemical regulatory team at Arent Fox, consisting of experienced attorneys and scientists, will continue to follow this development and stands ready to assist clients in proactively addressing these and other TSCA compliance issues.