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Multiple federal and state statutes, as well as foreign regulations and international treaties, regulate toxic substances in order to protect the environment and human health. The Toxic Substances Control Act (TSCA) regulates chemical substances that are manufactured, distributed, used, or disposed of in the United States. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires registration and licensing of pesticides before they can be manufactured, sold, or used. Most of the fifty states in the U.S. have enacted laws regulating one or more toxic substances, although they differ tremendously in how and what they regulate. Additionally, there are international conventions and treaties that focus on the regulation of toxic substances. The European Union has enacted a statute entitled the Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) to regulate chemicals.
Watch and download materials from the ELI Summer School Seminar Law and Policy of Products Regulation
Congress passed the Toxic Substances Control Act in 1976 in response to evidence and concerns that toxic chemicals endanger public health and the environment. It was enacted “to prevent unreasonable risks of injury to health or the environment associated with the manufacture, processing, distribution in commerce, use, or disposal of chemical substances.”
TSCA regulates both chemical substances and combinations of chemical substances (mixtures). It defines “chemical substance” as “any organic or inorganic substance of a particular molecular identity.” This does not include mixtures and six substances that are regulated by other statutes including pesticides, tobacco, and food.
Many of TSCA’s requirements apply to persons who “manufacture” or “process” chemical substances. TSCA defines “manufacture” as “to import into the customs territory of the United States . . . , produce, or manufacture” and defines “process” as “the preparation of a chemical substance or mixture, after its manufacture, for distribution in commerce . . . .”
For an in-depth explanation of TSCA, see Carolyn Hathaway, TSCA Deskbook, 2d ed. Listen to and download materials from the ELI Seminar series: Key Issues for Reform of TSCA to learn about the major issues to be addressed in updating TSCA, which has not been significantly reworked since 1976. Read about TSCA reform efforts at Lynn Bergeson, EPA's Action Plans Signal a New Chapter for TSCA While Informing the Future Legislative Debate on Chemicals, Brett Oberst, Obama and EPA Take on TSCA Reform,” and Richard Denison, Ten Essential Elements in TSCA Reform.
Under TSCA, the Environmental Protection Agency (EPA) was required to establish an initial Inventory of all chemical substances manufactured or processed in the United States within three years before the effective date of the statute. EPA updates this Inventory periodically to include additional chemicals and maintains both a public Inventory and a confidential Inventory. EPA will not disclose substances on the confidential Inventory unless someone has demonstrated a bona fide intent to manufacture the substance. Any chemical that is not listed on the Inventory is considered a “new chemical substance.”
TSCA prohibits the manufacture of a “new chemical substance” or the manufacture or processing of an existing chemical substance for a “significant new use” unless a premanufacture notice (PMN) or significant new use notice (SNUN) is submitted to the EPA at least 90 days before the commencement of such manufacture or processing. If the substance in listed on the Inventory and there is not a regulation identifying its uses, then the manufacturer or processor is not required to submit a SNUN for a chemical with a significant new use. If EPA does not object or request additional information, then the person submitting the notice is free to manufacture or process the chemical substance 90 days after the EPA has received PMN or SNUN. EPA describes this process in detail.
The persons submitting the PMN or SNUN must also submit all relevant test data in their possession and describe any other data they know about the chemical substance. They are not required to submit a specified, minimum data set. They may, however, be required to develop additional mandatory test data if the substance is subject to TSCA’s test rules or if the substance is included on the list of substances that EPA determined may present an unreasonable risk or injury to health or the environment.
There are three methods by which EPA may extend the premanufacture review period and postpone manufacture or processing beyond the 90-day review period. EPA may, for “good cause,” extend the initial review period for an additional 90 days, but the extensions and reasons for the extension must be published in the Federal Register. Next, EPA may issue a “proposed order” prohibiting or limiting the manufacturing, processing, distribution, use, or disposal of the substance when EPA determines that there is insufficient data to permit a “reasoned evaluation” of the substance’s health and environmental effects or when the substance may present a substantial risk of injury to health or the environment or there will or may be substantial human health or environmental exposure to the substance. EPA would likely then issue a SNUR that applies to all other regulated parties. Finally, EPA can prohibit or restrict a substance’s manufacture, distribution, processing, use or disposal if it has a “reasonable basis to conclude” that the substance is unsafe.
Nanotechnology, the creation and alternation of substances at the nanometer scale, offers significant challenges to the traditional chemical regulatory scheme. How should consumers, companies, and agencies treat traditional chemicals that have been modified on a nanoscale? See ELI’s Nanotechnology Program for resources on this important topic.
EPA may promulgate test rules that require manufacturers or processors to test chemicals or mixtures identified by the Agency for the purpose of assessing their potential risks to human health or the environment. EPA must require testing of any chemical substance or mixture if EPA finds that: (1) the manufacture, distribution in commerce, processing, use, or disposal of a chemical substance or mixture, or that any combination of such activities, may present an unreasonable risk of injury to health or the environment, there is insufficient data or experience, and testing is necessary to develop such data or (2) the chemical substance or mixture is or will be produced in substantial quantities and it enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to such substance or mixture, there is insufficient data or experience, and testing is necessary to develop such data.
TSCA also regulates existing chemicals. EPA has the authority to restrict or ban the manufacture, processing, or distribution in commerce of chemical substances or mixtures upon showing that it “presents or will present an unreasonable risk of injury to health or the environment.” EPA has shied away from using this authority after a negative outcome in Corrosion Proof Fittings v. U.S. Environmental Protection Agency, in which the court refused to allow EPA to ban asbestos.
For a discussion of one chemical manufacturer’s management of an existing chemical upon receipt of new data, see Chris Higgins, 3M and the Withdrawal of PFOS: TSCA, Product Liability, and the Precautionary Principle.
TSCA also provides EPA with significant authority to require companies to keep and maintain records and report information regarding chemical substances and their health and environmental effects. This is a key element of TSCA. TSCA requires reporting and recordkeeping concerning chemical use and exposure, allegations of adverse health and environmental effects, unpublished health and safety studies, and information “which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment.”
There are various enforcement mechanisms by which the EPA may regulate TSCA. Civil penalties up to $25,000 (adjusted annually for inflation) per day may be assessed. Civil administrative proceedings before an administrative law judge are available for respondents who want to contest violations alleged by EPA or the amount of the civil penalty. Criminal penalties may be imposed for knowing and willful violations of TSCA.
The Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), originally enacted in 1947, regulates the manufacture, sale, and use of chemical and biological pest controls and substances that control plant growth. The Act includes requirements for labeling, registration, and recordkeeping of pesticides, and also provides for the regulation and enforcement of those requirements. All pesticides sold or distributed in the United States must be licensed by EPA under FIFRA.
For a detailed discussion of FIFRA, see Ken Weinstein, Pesticide Regulation Deskbook. For a discussion of 1998 amendments to FIFRA, see Ken Weinstein, The Food Quality Protection Act: A New Way of Looking at Pesticides.
FIFRA defines a pesticide as “(1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer . . . .” EPA uses three factors to determine whether a substance is intended to be a pesticide: (1) whether the person who sells or distributes the product claims that is has a pesticidal purpose or use or it contains an active ingredient that can be used to manufacture a pesticide; (2) whether the substance contains an active ingredient and has no commercially valuable use other than for a pesticidal purpose or for the manufacture of a pesticide; and (3) whether the person who distributes or sells the substance has actual or constructive knowledge that the substance will be used or is intended for a pesticidal purpose. EPA has created an objective standard for its regulation of FIFRA, meaning that the Agency will not impose penalties on the producer of a non-pesticide product if others make claims that the product has a pesticidal purpose.
FIFRA’s regulatory process is examined in detail in the Law of Environmental Protection, Ch. 18.
Each pesticide sold or distributed in the United States must be registered with EPA. Any sale or distribution of a pesticide that is unregistered is prohibited. Under FIFRA, the Administrator shall register a pesticide if it performs as claimed and “when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonable adverse effects on the environment.” EPA will not register a pesticide unless the registrant has obtained a pesticide residue tolerance or exemption from a tolerance under the Federal Food, Drug and Cosmetic Act as amended by the Food Quality Protection Act.
During the registration process, the Administrator will classify pesticides either as general use or restricted use pesticides. The Administrator will classify a pesticide as restricted use pesticide if it may generally cause “unreasonable adverse effects on the environment” but may be used for specific purposes. In addition to the requirement to register pesticides used or sold in the U.S., producers of pesticides must register the establishments producing pesticides and file annual reports with EPA.
For a discussion of the myriad testing issues that arise under FIFRA, see Lynn Bergeson, FIFRA—Chemical Testing Issues.
FIFRA also sets forth extensive requirements for the labeling and packaging of pesticides. Registered pesticides must have an EPA-approved label, which includes the name of the product, the name of the producer, the net contents, the registration numbers for the product and for the producing establishment, an ingredient statement, warning or precautionary statements, directions for use, and the use classification of the product.
End-users of pesticides are also regulated under FIFRA. First, any person is prohibited from “us[ing] any registered pesticide in a manner inconsistent with its labeling.” States have authority to establish requirements for “maintenance applicators” and service technicians. If a pesticide has been classified as a restricted-use pesticide, usually only certified applicators (those authorized under FIFRA) or those under their supervision may use the pesticide. Finally, there are worker protection requirements under FIFRA that implement worker protection standards and require worker protection information on labels.
After registration, an applicant is required to report information to EPA if the applicant learns any new information about unreasonable adverse effects of the pesticide or other harmful effects of registered products.
FIFRA provides various enforcement mechanisms for EPA. Similar to other federal environmental statutes, EPA has largely delegated enforcement authority of FIFRA to the states. EPA uses a number of enforcement mechanisms, most notably civil penalties. Registrants, commercial applicators, wholesalers, dealers, retailers, or other distributors who violate any FIFRA provision are subject to administrative civil penalties of not more than $5,500 (adjusted annually for inflation) for each violation. EPA may also issue stop sale, use, or removal orders, or may seize the violating pesticide or device. Finally, FIFRA establishes criminal penalties for those who knowingly violate FIFRA. There is no citizen suit provision found in FIFRA, so citizens have no private cause of action against violators of FIFRA.
States and tribes throughout the U.S. have enacted laws and regulations to control the use of toxic substances. These provisions vary depending on the state or tribe. Many regulations address specific chemicals, while others focus on pollution prevention, reducing the amount of toxic chemicals, or requiring registration or licensing. Because of the vast differences in the toxic substance laws of each state, this summary will focus on two states with multiple regulations that cover a wide range of the types of provisions seen in the states.
For a discussion of tribal pesticide programs, see Jane Kloeckner, Hold On to Tribal Sovereignty: Establishing Tribal Pesticide Programs That Recognize Inherent Tribal Authority and Promote Federal-Tribal Partnerships.
California enacted the Safe Drinking Water and Toxic Enforcement Act in 1986 to promote clean drinking water and protect and inform the public about toxic chemicals. Each year the state publishes a list of chemicals known to cause cancer or birth defects or other reproductive harm. The list now includes about 800 chemicals.
For one perspective on the efficacy of Prop 65, see Clifford Rechtschaffen, The Continued Success of Proposition 65 in Reducing Toxic Exposures.
Once a chemical is listed, businesses must notify Californians about significant amounts of listed chemicals in the products they manufacture or release into the environment. The businesses must also provide warning before knowingly or intentionally exposing people to the chemical, although safe harbor levels have been established for some substances. This warning can be given in a number of ways including labeling products, posting signs, or publishing notices in the newspaper.
California has enacted multiple laws and regulations dealing with specific chemicals. For example, it has set formaldehyde emissions standards for various kinds of wood that is sold, supplied, or offered for sale in California. California also restricts lead in jewelry by requiring testing and submission of technical information. Similarly, the state has prohibited the use of lead in water pipes. The state also restricts or prohibits the use of mercury in thermostats, the amount of lead and arsenic in certain glass beads, and the sale of toys made with bisphenol-A or phthalates.
California’s Green Chemistry Initiative focuses on reducing or eliminating the use of hazardous materials. As part of the Initiative, DTSC has proposed regulations, entitled Safer Consumer Product Alternatives, to identify and prioritize chemicals, require alternative assessments for those chemicals, and impose requirements for those alternatives. The Initiative is also in the process of implementing a Toxics Information Clearinghouse, to be operated by the Office of Environmental Health Hazard Assessment, which will provide information on toxic chemicals to the public.
The California Department of Pesticide Regulation oversees pesticide regulation in California, which requires licensing and registration for those using pesticides. Any person who advertises, solicits, or operates as a pest control business must obtain a valid pest control business license. The person must also register with the department for the current calendar year to advertise, solicit, or operate as a pest control business in any county. The registrant must keep and maintain a record of each property treated that shows all information required by the director or commissioner and shall report that information as required.
California also requires pesticides to be registered before the pesticide is offered for sale. Furthermore, every registrant must label the product with information related to the product’s registration.
Massachusetts enacted the Toxics Use Reduction Act (TURA) in 1989 to require Massachusetts companies that use large quantities of specific toxic chemicals to evaluate and plan for pollution prevention opportunities, implement the opportunities, and measure and report their results annually. The Act aims, in part, to reduce the generation of toxic waste by 50% (which was met by 1998) and establish toxics use reduction as the preferred means for achieving compliance with other federal and state laws and regulations. Massachusetts amended TURA in 2006 by revising the reporting and planning requirements and establishing categorization of chemicals so that low hazard chemicals would have different reporting requirements and fees. Massachusetts also produces an annual report on the use of toxic chemicals in the state.
For a discussion of similar legislation in Oregon, see Larry Edelman, Oregon's Toxics Use Reduction and Hazardous Waste Reduction Act: A Bellwether for Pollution Prevention Regulation.
Chemicals and products containing potentially toxic substances are international commodities. As a result, at least two important treaties regulate certain chemicals—the POPs and PIC treaties, while other treaties govern wastes, air pollution or specific chemical compounds, such as ozone depleting substances. In addition, the Organization for Economic Cooperation and Development plays an important role in standardizing chemical testing internationally. The European Union’s REACH chemical regulation program and may be setting the standard for chemical regulatory systems internationally.
The Stockholm Convention on Persistent Organic Pollutants (POPs), administered by the United Nations Environment Program (UNEP), is a global treaty to protect human health and the environment from chemicals that: (1) remain intact in the environment for long periods of time; (2) become widely distributed; (3) accumulate in the fatty tissue of humans and wildlife; and (4) have adverse effects to human health and the environment. The treaty entered into force in 2004 and requires parties to take measures to eliminate or reduce the release of POPs. By April 2011, there were 173 parties to the convention. The United States has signed but not ratified the treaty. Initially there were twelve POPs (the “dirty dozen”) recognized by the treaty, but nine additional POPs were recognized at the fourth meeting of the parties.
Parties must take measures to reduce or eliminate POPs releases into the environment from intentional production and use. These measures include prohibiting or taking other steps to eliminate production and use of those chemicals in Annex A. They also include requirements for importing and exporting chemicals listed in both Annex A and B. Annex A includes chemicals that the Convention aims to eliminate while Annex B includes chemicals that should be restricted. Next, the Convention requires parties to develop an action plan to identify, characterize, and address the release of chemicals listed in Annex C, which lists chemicals that are unintentionally produced. Similarly, the Convention requires measures to be taken to reduce or eliminate releases from stockpiles and wastes. Parties can make proposals to add chemicals to the Annexes A, B, and C, through the process laid out in Annex D. The convention also contains various provisions relating to information sharing, education and public awareness.
The Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, administered by the United Nations Environment Program, intends to (1) promote shared responsibility and cooperative efforts among parties in the international trade of certain hazard chemicals in order to protect human health and the environment from human harm; and (2) contribute to the environmentally sound use of those hazardous chemicals, by facilitating information exchange about their characteristics, by providing for a national decision-making process on their import and export and by disseminating these decisions to parties.
The Convention covers pesticides and industrial chemicals that have been banned or severely restricted due to health or environmental concerns. If a party has taken final regulatory action regarding a specific chemical, the party must notify the Secretariat of that action. Once the Secretariat has received at least one notification from two Prior Informed Consent regions regarding a specific chemical, it forwards the notifications to the Chemical Review Committee. The Chemical Review Committee reviews the information provided, then recommends to the Conference of the Parties whether the chemical should be subject to the Prior Informed Consent (PIC) procedure and listed in Annex III.
Once a chemical is listed in Annex III, it is subject to the PIC procedure, meaning there are certain obligations on the parties when they import and export the chemical. Each party must implement legislative or administrative measures with respect to the import of the chemicals listed, deciding whether or not to allow imports or whether to allow them under specified conditions, and must provide a response to the Secretariat concerning the future import of the chemical. Parties that are exporting the chemical must provide export notification to the importing party. Furthermore, the Convention promotes an exchange of information among the parties.
The Registration, Evaluation, Authorisation and Restriction of Chemical Substances (REACH) is the European Union’s chemical regulatory system. The aim of the regulation is “to improve the protection of human health and the environment through better and earlier identification of intrinsic property of chemical substances.” It places greater responsibility upon industry to manage the risks from chemicals and provide a minimum data set of safety information.
For a discussion of REACH and its lessons for the United States, see the November 2012 issue of ELR.
REACH requires registration for most chemical substances that are manufactured or imported in quantities of one ton or greater each year. Manufacturers and importers must submit a registration dossier to the European Chemicals Agency (ECHA) providing information and data on how the substances can be used safely. A registrant may start or continue the manufacture or import of a substance if there is no indication to the contrary in the three weeks following the submission. ECHA may choose to further evaluate a substance if necessary and may place restrictions on the substance. If a company fails to register its substance with ECHA, it will not be allowed to manufacture or import, or continue to manufacture and import, the substance. Registrants must update his or her registration without undue delay with any relevant new information and submit it to the Agency.
REACH also regulates downstream users of chemical substances. Downstream users include formulators of preparations, users of chemicals in industrial processes, professional users or producers of articles, but do not include distributors and consumers. Downstream users must notify ECHA if they use the substance outside the conditions laid out by the manufacturer or importer, if they conclude that their classification and labeling is different from that of the manufacturer or importer, or within three months of the first supply received of the authorized substances.