Toxic Substances Control Act (TSCA)

TOXIC SUBSTANCES CONTROL ACT
15 U.S.C. 2601 et seq.

Recent Posts regarding TSCA:

  1. “GAO Adds EPA’s Processes for Assessing and Controlling Toxic Chemicals to Its 2009 High-Risk List.” Posted 01/22/2009
  1. Introduction
    1. TSCA became effective on January 1, 1977 and unlike most environmental statutes, TSCA deals with much more than waste materials or materials released into the environment. TSCA regulates the manufacture, processing, distribution, use and disposal of many chemical substances.Section 2(c) of TSCA provides that:

      “It is the intent of Congress that the Administrator shall carry out this Act in a reasonably and prudent manner, and that the Administrator shall consider the environmental, economic and social impact of any action the Administrator takes or proposes to take under this Act.”

    2. One of the key criteria that Congress had in adopting this statute was to require USEPA to review chemicals in light of unreasonable risk, although that term is not used in the statute itself.
    3. The statute provides certain mechanisms, discussed in more detail below, to control chemical risks to health and to the environment. Under Section 5, no person may manufacture or import a new chemical substance, or manufacture, import or process an existing chemical substance for a significant new use unless that person submits to EPA a notice of intent to do so at least 90 days prior to commencing such importation, manufacture or process. USEPA reviews these notifications, which must address potential health or environmental risks and can issue orders which prohibit or restrict the chemical’s use.
    4. USEPA has also promulgated regulations controlling risk to employees presented by certain chemicals.
    5. In addition, Section 4 of TSCA allows EPA to require testing of chemicals to determine potential health and environmental effects. Section 8 of the statute sets forth detailed record keeping and recording requirements concerning health and environmental information of chemicals.
    6. Additionally, TSCA provides broad powers for citizens to bring lawsuits to enforce the provisions of TSCA and for citizens to petition USEPA to take action under TSCA.
    7. Certain of the major provisions of TSCA are discussed below.
  2. INVENTORY OF CHEMICAL SUBSTANCES
    1. Section 8(b) of TSCA requires EPA to compile, keep current, and publish a list of all chemical substances manufactured, imported or processed for commercial purposes in the United States. This list as known as TSCA Inventory of Chemical Substances.
    2. Requirements are found at 40 C.F.R. Part 710.
    3. Periodic updates are required from chemical manufacturers and importers.
  3. MANUFACTURERS’ PRELIMINARY ASSESSMENT INFORMATION REPORT (“PAIR”)
    1. Manufacturers and importers in bulk of chemical substances or mixtures are subject to these requirements.
    2. Specific requirements are set out in 40 C.F.R. Section 712.30.
    3. Procedures are set forth for chemical manufacturers and processors to report production, use and exposure-related information for certain chemical substances.
  4. ADVERSE HEALTH OR ENVIRONMENTAL EFFECTS
    1. Section 8(c) requires manufacturers, importers and some processors of chemicals, substances or mixtures to keep records of significant adverse reactions to health or to the environment which were allegedly caused by the chemicals in question or which are alleged to be associated with the manufacturer, processing or distributing.
    2. This requirement is limited to chemical processors classified in the Standard Industrial Classification (“SIC”) Codes 28 (chemical and allied products) and 2911 (petroleum refine)
    3. Records must be maintained, and must be available for EPA inspection. Records must be also be submitted upon request to EPA.
    4. The regulations governing this requirement are found at 40 C.F.R. Part 717. See also EPA publication “Questions and Answers Concerning the TSCA Section 8(c) Rule,” July 1984.
  5. HEALTH AND SAFETY DATA REPORTING
    1. Section 8(d) of TSCA requires that persons who manufacture, import or process for commercial purposes certain listed chemicals must report the existence of health and safety studies to EPA. This does not require new studies to be conducted.
    2. Specific chemicals are set out in 40 C.F.R. Section 716.120. Distributors and retailers who do not manufacture, import or process are exempt.
    3. Implementing regulations are found at 40 C.F.R. Part 716.
  6. REQUIREMENT TO REPORT SUBSTANTIAL RISKS TO HEALTH OR ENVIRONMENT
    1. Section 8(e) of TSCA requires that a person who manufactures, imports or processes or distributors in commerce a chemical substance or mixture who obtains information which supports the conclusion that there may be a substantial risk of injury or health or to the environment must inform EPA, unless the person knows that EPA has already adequately been informed.
    2. Information must be submitted no later than the 15th working day after the date the information is obtained.
    3. Also included are emergency incidents of environmental contamination which seriously threatened humans with cancer, birth defects, mutation, death or serious or prolonged incapacitation or seriously threatened non-human organisms with significant population destruction.
    4. See USEPA publication “TSCA Section 8(e) Reporting Guide” June 1991.
  7. IMPORTATION OF CHEMICALS
    1. A person who imports any chemical substance or mixture into the United States must certify either that all the chemical substances in the shipment comply with all applicable TSCA rules and that the chemical is not being offered in the United States in violation of TSCA, or that the chemical substances are not subject to TSCA (pesticides, tobacco and tobacco products, food, food additives, drugs and cosmetics). This does not apply to manufactured articles as defined in TSCA unless otherwise specified.
    2. U.S. Customs Service has the authority to detain shipments which have not been certified.
    3. Only importers are subject to this requirement. The definition of importer is found in the Customs Regulations at 19 C.F.R. Section 101.1(k).
    4. The certification must be filed with Customs Service at the port of entry before release of the shipment.
    5. Specific customs regulations are found at 19 C.F.R. Section 12.118 et seq.
  8. EXPORT NOTIFICATION REQUIREMENTS
    1. TSCA also requires that exporters of certain chemical substances or mixtures are required to notify EPA concerning their first annual report of those chemicals for every foreign country.
    2. Only exporters are subject to this requirement.
    3. See EPA publication, “A Guide for Chemical Importers/Exporters” April 1991.
  9. COMPREHENSIVE ASSESSMENT INFORMATION RULE
    1. Section 8(a) of TSCA requires that USEPA may ask certain specified questions concerning manufacture of particular chemicals.
    2. These requirements are applicable to manufacturers, importers and processors of chemicals listed in 40 C.F.R. Section 704.225.
  10. PRE-MANUFACTURE NOTIFICATION
    1. As noted above, chemicals must be listed in the TSCA inventory of chemical substances. Substances not listed on the inventory are considered new and in order to legally manufacture or import them for commercial purposes a pre-manufacture notification must be submitted to EPA at least 90 days before manufacture or import.
    2. These requirements are set out in 40 C.F.R. Part 720.
    3. There are certain other requirements for chemical substances which are produced in small quantity.
    4. Those regulations are set out at 40 C.F.R. 723.50.
    5. In addition, there are certain other pre-manufacture notification requirements for particular chemicals.
  11. METAL WORKING FLUIDS
    1. 40 C.F.R. Section 747.115 through 747.200 regulates the use of certain metal working fluids.
  12. POLYCHLORINATED BIPHENYLS (PCBs)
    1. In the original version of TSCA, PCBs were the only chemical that was particularly specified for control and regulations. PCBs have low flammability and high chemical stability and they were used throughout the country for many years for fluids in capacitors and transformers, in hydraulic systems, and in consumer products such as fluorescent starters and “carbonless” carbon paper. PCBs have been referred to as a “political pollutant,” and were involved many of the early infamous environmental cases such as Love Canal and Times Beach.
    2. The regulations dealing specifically with PCBs are found at 40 C.F.R. Part 761. These regulations cover manufacturer, use, storage, disposal and clean-up of PCBs. Please note that storage and disposal of PCBs are not covered by RCRA but by TSCA. However, PCBs are a “hazardous substance” under CERCLA.
    3. Generally, TSCA prohibits the manufacturing processing, distribution in commerce and use of PCBs and PCB items. There are some exceptions for use of PCBs in a “totally enclosed manner” such as non- leaking electrical equipment.
    4. There is a schedule for replacement and retirement of PCB containing transformers. (40 C.F.R. Section 761.30.)
    5. Marking of PCBs and PCB items. PCB containers, transporters, capacitors, etc., with some exceptions, must contain PCB markings which are illustrated in the regulations. (40 C.F.R. Section 761.45.)
    6. Disposal Requirements
      1. Basically PCBs of concentrations of 50 parts per million or greater must be disposed of in an incinerator. Mineral oil dielectric fluid from PCB contaminated electric equipment of between 50 and 500 parts per million must be disposed of in an incinerator, a certain type of chemical waste landfill or high efficiency boiler. Liquids, other than mineral oil di-electric fluid, containing PCBs between 50 and 500 parts per million may also be disposed in an incinerator, chemical waste landfill that meets certain requirements or high efficiency boiler with certain conditions. There are other requirements for disposal of non-liquid PCBs, such as contaminated soil, rags or other debris, dredged materials, PCB transformers, PCB capacitors, etc.
      2. Regulations provide that spills or other uncontrolled discharges of PCBs of concentrations of more than 50 parts per million constitute disposal of PCBs. (40 C.F.R. Section 761.60(d)). PCBs resulting of clean-up of such spills, leaks or other uncontrolled discharges must also be stored and disposed of in accordance with the general requirements of the regulations.
      3. 40 C.F.R. Section 761.65 provides regulation for storage for disposal of PCBs and PCB items with more than 50 parts per million. The regulations require that any PCB articles or containers stored for disposal before January 1, 1983 must be removed and properly disposed of within one year. Any such PCB article or container stored for disposal after January 1, 1983 was required to be properly disposed within one year after the date it was first put in storage.
      4. Requirements are set forth for incinerators, chemical waste landfills and boilers authorized for the disposal of PCBs.
      5. 40 C.F.R. Section 761.79 provides methods for decontaminating PCB containers and other equipment. USEPA has promulgated a PCB spill clean-up policy effective for spills of PCBs of more than 50 parts per million which occur after May 4, 1987. 40 C.F.R. Section 7761(g). These regulations require certain immediate steps after a spill, including notifying EPA, cordoning off the area, recording and documenting areas of visible contamination, initiation of clean-up of all visible traces of fluid on hard surfaces and initiation of removal of all visible traces of the spill on soil or other media. Regulations set forth the clean-up standards to be used in a spill. The regulations also require post clean-up sampling to verify the level of clean- up. Note that even though the policy applies to spills of more 50 parts per million, a person is required to clean-up to below that level under the policy.
      6. There are numerous record keeping, inspection and reporting requirements that apply to persons who store or dispose of PCBs, PCB items, etc. See 40 C.F.R. Section 761.180.
  13. FULLY HALOGENATED CHLOROFLUOROLKANES (CFCs)
    1. In 1978, USEPA determined that use of certain aerosol propellants could have an adverse effect on the ozone layer.
    2. In general, no person is allowed to manufacture, import, process or distribute unprocessed CFCs for any domestic aerosol propellant use after 1978. There are certain exceptions for materials not covered by TSCA and certain specified uses.
    3. The regulations are set out in 40 C.F.R. Part 762.
  14. ASBESTOS
    1. Certain of USEPA’s regulations dealing with asbestos (but not all) were promulgated under TSCA.
    2. Asbestos in schools
      1. Regulations require local education agencies to inspect schools for friable materials and if friable materials are found, have been sampled for asbestos content. If asbestos is found in schools, the local education agency is required to provide information to employees and to notify the Parent Teacher Association or the parents directly. The rule does identify five specific response actions the local education agency can take. There are also inspection and record keeping requirements.
    3. Reporting commercial and industrial uses of asbestos. These requirements were promulgated in 1982 and required persons who mined, milled, imported or processed asbestos during 1981 to report their activities to EPA. The material was used for information for further promulgation of regulations.
    4. Asbestos abatement programs – These regulations were promulgated at 40 C.F.R. Section 763. The general requirements to be followed during asbestos abatement projects, including state and local government employees not covered by OSHA.
  15. ASBESTOS HAZARD EMERGENCY RESPONSE ACT (AHERA)
    1. In 1986 Congress amended TSCA and required EPA to promulgate certain asbestos regulations primarily relating to schools. Those regulations concerned:
      1. Inspection of asbestos-containing materials in schools,
      2. Identification of circumstances requiring response action,
      3. Description of appropriate response actions,
      4. Implementation of response actions,
      5. Implementations of operation maintenance and repair programs,
      6. Periodic surveillance and reinspection,
      7. Asbestos management plan development and implementation, and
      8. Transportation and disposal of asbestos containing waste material.
    2. EPA promulgated regulations as to all of the above, except as to transportation and disposal of asbestos containing waste material. Therefore the Congressional requirements for transportation and disposal established by Congress in Section 204(f) of TSCA became effective.
  16. TESTING REQUIREMENTS FOR CHEMICAL SUBSTANCES AND MIXTURES
    1. USEPA has promulgated test guidelines, standards and other laboratory requirements for testing of chemical substances and mixtures.
  17. RULEMAKING
    1. USEPA was given authority by Congress to promulgate rules and regulations for the regulation of all the matters set forth in TSCA. The regulations are found generally at 40 C.F.R. Part 700, et seq.
  18. CITIZEN PETITIONS
    1. Section 21 of TSCA provides that citizens may petition USEPA to initiate a proceeding for issuance, amendment or repeal of certain rules or orders issued under TSCA. USEPA may hold public hearings or conduct investigations as necessary. USEPA denial of a petition or failure to grant a petition allows the citizen appeal the action in a federal court.
  19. CITIZEN SUITS
    1. Section 20 of TSCA allows citizens to bring actions to enforce the requirements of TSCA or against the USEPA for its failure to comply with TSCA. As with other federal environmental laws, the citizen must first give 60 days notice of his intent to sue.
  20. ENFORCEMENT
    1. The provisions of TSCA are enforceable by USEPA through administrative actions, civil judicial actions or criminal proceedings.
    2. The most common enforcement tool is that of administrative actions. USEPA may issue a complaint against an alleged violator. The person who receives the complaint has an opportunity to contest the allegations in hearing. USEPA may impose a civil penalty of up to $25,000 for each day of violation of TSCA. In determining the amount of the civil penalty, USEPA is required to take in account the nature, circumstances, extent and gravity of the violation, the violator’s ability to pay, the effect on ability to do business, history of prior violations, degree of culpability and other matters of justice may be required. An administrative decisions may be appealed ultimately to the courts.
    3. USEPA also has authority to ask a court to restrain anyone from violating TSCA and the court may impose penalties. TSCA may also be enforced criminally with potential imprisonment and fines.
    4. USEPA also has authority to file an action in a federal court to seize any chemical substance or mixture which was manufactured, processed, or distributed in violation of TSCA and the rules promulgated thereunder.
  21. CONFIDENTIAL BUSINESS INFORMATION
    1. Section 14 of TSCA establishes a procedure whereby a person who submits information to USEPA under TSCA can claim that it is confidential business information. The law forbids government employees from revealing material that is classified as confidential business information with some exceptions. Procedures are established to claim confidential business information and to have a decision made on it.

      Copyright, 1998, Steven M. Taber staber@taberlaw.com

Responses

  1. Elemental Mercury Used in Flow Meters, Natural Gas Manometers, and Pyrometers; Proposed Significant New Use Rule

    AGENCY: Environmental Protection Agency (EPA).

    ACTION: Proposed rule.

    SUMMARY: EPA is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for elemental mercury (CAS No. 7439-97-6) for use in flow meters, natural gas manometers, and pyrometers, except for use in these articles when they are in service as of the effective date of the final rule. This action would require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. Persons subject to the provisions of this proposed rule would not be exempt from significant new use reporting if they import into the United States or process elemental mercury as part of an article. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

    DATES: Comments must be received on or before November 10, 2009.

    Federal Register vol 74 no 175
    EPA-HQ-OPPT-2008-0483; FRL-8432-3
    http://www.FederalRegister.com


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