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Key Federal Laws

Toxic Substances Control Act (TSCA)

Background

(as amended)

TSCA was first enacted in 1976 and has been amended significantly three times. TSCA gives EPA broad authority to regulate the manufacture, use, distribution in commerce, and disposal of chemical substances.  TSCA is a federally-managed law and is not delegated to states.  The law is overseen by the EPA Office of Pollution Prevention and Toxics (OPPT), which has assembled an important set of on-line information resources on TSCA.

A major objective of TSCA is to characterize and evaluate the risks posed by a chemical to humans and the environment before the chemical is introduced into commerce.  TSCA accomplishes this through the requirement that manufacturers perform various kinds of health and environmental testing, use quality control in their production processes, and notify EPA of information they gain on possible adverse health effects from use of their products.  Under TSCA, "manufacturing" is defined to include "importing", and thus all requirements applicable to manufacturers apply to importers as well.

EPA has authority to ban the manufacture or distribution in commerce, limit the use, require labeling, or place other restrictions on chemicals that pose unreasonable risks.  Among the chemicals EPA regulates under TSCA are asbestos, chlorofluorocarbons (CFCs), and polychlorinated biphenyls (PCBs).

Under TSCA, EPA classifies chemical substances as either "existing" chemicals or "new" chemicals. To determine how a substance is classified, consult the TSCA Chemical Substance Inventory (commonly referred to as the Inventory), which lists "existing" substances. Searches of the nonconfidential, public Inventory, are available at: Cornell University's TSCA Inventory. Searches of the confidential Inventory require an "EPA Bona Fide Search."

Premanufacture Notice: TSCA Section 5

Section 5 of TSCA regulates anyone who plans to manufacture or import a "new" chemical substance for commercial purposes. Under section 5, EPA requires notice before manufacture or importation sof non-exempt substances so that EPA can evaluate whether the chemical substance poses a threat to human health or the environment. This notice is called a premanufacture notice (PMN) and must be submitted at least 90 days prior to the activity. New chemicals include certain genetically modified microorganisms.  (See the TSCA Biotechnology Program webpage.)   Manufacturers must also submit information on "significant new uses" of existing chemicals to EPA for its review.  Again, the TSCA Inventory establishes what are existing uses.

Submittals are to include information on the manufacturing process, disposal method, and health and environmental effects of the substance.  EPA assesses whether the chemical substance presents an unreasonable risk of injury to health or the environment by weighing the risks versus the social and economic benefits of introducing the chemical into commerce.  After its review of the PMN or Significant New Use information, EPA may choose among a broad range of options that may limit, restrict, or prohibit the manufacture, use, distribution, and/or disposal of the chemical substance.

There are some exclusions and exemptions to the PMN requirements.  For example, drugs and pesticides are excluded since they are otherwise covered under separate laws (FDDCA and FIFRA).  In addition, there are about 15 different exemptions, including exemptions for R&D activities; test marketing; low-volume and low-release/low-exposure chemicals; certain polymers; impurities, by-products, and non-isolated intermediaries; and so forth.  It is therefore important to check with the applicable regulations to insure coverage.

Requirements related to TSCA Section 5 can be found in 40 CFR Parts 700, 720, 723, 725 and 747.  The OPPT New Chemicals webpage also provides extensive information on PMN requirements. 

Testing Requirements:TSCA Section 4

TSCA Section 4 requires manufacturers, importers, and processors of certain chemical substances and mixtures to conduct testing on the health and environmental effects of chemical substances and mixtures, unless they qualify for an exemption. Testing requirements cover existing chemicals (but not new chemicals, since these are addressed in the PMN process), and also cover mixtures as well as individual substances.  EPA has established a "Master Testing List" that lays out testing priorities, based on risk and exposure potential.

For example, EPA is currently working with manufacturers to encourage testing on chemicals that are produced and used in large volumes (High Production Volume Testing).  At the present these test are voluntary, but EPA has authority to develop a testing rule if it determines such a rule to be necessary.

Requirements related to TSCA Section 4 can be found in 40 CFR Parts 790, 791, 792, 799, and 766.  The OPPT TSCA Testing webpage also provides extensive information on testing requirements.

Protection Against Unreasonable Risk: TSCA Section 6

TSCA Section 6 regulates certain hazardous chemical substances and mixtures and authorizes EPA to take regulatory action to protect against unreasonable risk of injury to human health or the environment due to the manufacture, import, processing, distribution in commerce, use or disposal of a chemical substance or mixture. For example, EPA has promulgated regulations under section 6 of TSCA applicable to polychlorinated biphenyls (PCBs) and asbestos.  Various guidance materials on these chemicals can be found at the TSCA publications webpage. Specific requirements can be found in 40 CFR Parts 745, 747, 749, 750, 761, and 763.

Imminent Hazards: TSCA Section 7

TSCA Section 7 authorizes EPA to commence a judicial action for seizure of a chemical substance, mixture, or article containing such a chemical substance or mixture which EPA has determined is imminently hazardous, and/or for other relief against any person who manufactures, imports, processes, distributes in commerce, uses, or disposes of an imminently hazardous chemical substance or mixture.

Data Gathering and Reporting: TSCA Sections 8, 12(b), & 13

TSCA Sections 8, 12(b), and 13 mandate data gathering activities to provide data that EPA and others can utilize to identify, assess, manage, and reduce actual or potential risks posed by exposure to existing chemical substances and include import and export reporting requirements.  The OPPT Data Gathering website provides extensive information on these requirements.

Section 8 of TSCA authorizes EPA to require persons engaged in the manufacture (including importing), processing, and distribution of TSCA-covered chemical substances and mixtures to perform certain record-keeping and reporting activities. This includes, among other things:
  • Chemical Data Reporting (CDR) Rule (formerly known as the Inventory Update Reporting (IUR) Rule) - TSCA Sec. 8(a): Companies that manufacture or import certain chemicals that are included on the TSCA Chemical Substance Inventory are required to report production volume for 2010 and processing and use information for 2011, if volumes hit the new 100,000lb. threshold.  Reporting under the IUR originally took place at four-year intervals which began in 1986.  It then became every 5 years, but is now back to every 4 years.  Certain small businesses as defined by 40 CFR 704.3 are generally exempt. The next round of reports will be due in 2012.  The CDR rule contains some modifications from the 2006 IUR and a slew of subsequent ones are planned to be phased-in for the 2016 CDR.
  • Preliminary Assessment Information Rule (PAIR) - TSCA Sec. 8(a):  Companies must report site-specific information on the manufacture or importing for commercial purposes of any chemicals listed at 40 CFR 712.30.  The information includes: quantity of chemical, amount lost to the environment during production or importation, quantity of releases (controlled and non-controlled) of the chemical, and per release worker exposure information.
  • Allegations of Significant Adverse Reactions Rule - TSCA Sec. 8(c): Companies are required to keep a file of allegations of significant adverse reactions (to human health or the environment) of any chemical they manufacture, import, process or distribute.  Companies must also provide this information to EPA upon request.
  • Unpublished Health and Safety Studies Rule - TSCA Sec. 8(d): Companies may be required to submit to EPA a list and/or copies of unpublished studies that address the health or safety issues of certain listed chemicals.
  • Substantial Risk Information Requirement - Section 8(e): Companies are under a duty to report to EPA within 30 days any new information they have which reasonably supports the conclusions that a substance or mixture they manufacture, import, process or distribute presents a substantial risk of injury to health or the environment.

EPA’s TSCA Section 12(b) "Export Notification" Rule requirements (see 40 CFR Part 707 Subpart D) apply to chemical substances or mixtures covered by various proposed or final actions under TSCA Sections 4, 5, 6, or 7.   Notification of export is generally not required for articles, as provided by 40 CFR section 707.60(b).
  • With regard to Sections 5, 6, and 7,  the 12(b) export notice requirements apply to chemical substances or mixtures for which data are required under TSCA Section 5(b), an order has been issued under TSCA Section 5, a proposed or final rule has been issued under TSCA Sections 5 or 6, or an action is pending or relief has been granted under TSCA Sections 5 or 7.  If a chemical substance or mixture is covered by any of these circumstances, an exporter must notify EPA of the country of destination the first time a chemical is shipped to the country during a calendar year.
  • With regard to Section 4 of TSCA, only those chemical substances or mixtures listed in final TSCA Section 4 test rules and TSCA Section 4 Enforceable Consent Agreements (ECAs) are subject to the 12(b) export notice requirements.  In this case, an exporter must notify EPA of the country of destination the first time a chemical is shipped to the country.

TSCA Section 13 requires that any chemical substance, mixture, or article containing a chemical substance or mixture be in compliance with TSCA and, in addition, EPA requires import certification. Additional information regarding import requirements can be found in the Introduction to the Chemical Import Requirements of the Toxic Substances Control Act.

Exemptions

There are certain exemptions for many of the TSCA requirements reviewed above. It is important to review the regulations to determine applicability to any particular circumstances.


Program office links
EPA Office of Pollution Prevention and Toxics

Regulations:
40 CFR 700-799

Related sites:
Current TSCA legal issues



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