Regulatory Library

TSCA

TSCA gives EPA broad authority to regulate the manufacture, importation, use, distribution in commerce, and disposal of chemical substances.   TSCA and its regulations are very complicated and hard to simplify; thus the following points should be taken only as an introductory guide.

TSCA classifies chemicals as either "existing" or "new."  Existing chemicals are listed in the TSCA Chemical Substances Inventory (the "Inventory").  Both existing and new chemicals can be covered by TSCA requirements.

There are 6 main regulatory areas under TSCA:

  1. New Chemicals
  2. Test Rules
  3. Recordkeeping and Reporting under TSCA
  4. TSCA Export Requirements
  5. TSCA Import Certification
  6. Existing Chemicals Regulation



1.  New Chemicals

Law: TSCA Section 5
Regulations: 40 CFR 700,720-725,747

Companies that manufacture or import new chemicals must submit notice to EPA 90 days prior to manufacturing or importing almost all chemicals.    Manufacturers/ importers must also submit notice of significant new uses of certain existing chemicals to EPA for its review. To determine if a substance is "new" or if a use is a "significant new use", consult the TSCA Inventory.

These "Premanufacture Notices" must include information on the manufacturing process, disposal method, and health and environmental effects of the substance. After its review of the premanufacture notice, 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 exemptions to the PMN requirement, including chemicals such as drugs and pesticides that are regulated by other statutes, as well as chemicals developed under certain special circumstances (e.g., for R&D).

Meanwhile, it should be noted that certain genetically modified microorganisms are also considered "new" chemicals and are therefore covered by the PMN requirements. 


2.  Test Rules


Law: TSCA Section 4
Regulations: 40 CFR 766, 790-799

In addition to the PMN process, chemical manufacturers and importers may be required by rule to perform testing on human health and environmental effects of their substances under TSCA.  Testing requirements cover existing chemicals, 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.


3.  Recordkeeping and Reporting under TSCA


Law: TSCA Sections 8(a), 8(c), 8(d), 8(e)
Regulations: 40 CFR 710, 711, 712, 717, 716

There are several important recordkeeping and reporting requirements under TSCA.  These requirements apply generally to chemical manufacturers, importers, processors, and distributors. 

  • 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.


4.  TSCA Export Requirements

Law: TSCA Section 12
Regulations: 40 CFR 707

Exporters of chemicals that are subject to final or proposed rules and orders under Sections 5, 6 and 7 of TSCA must notify EPA of the country of destination the first time a chemical is shipped to the country during a calendar year.  In addition, exporters of chemicals subjet to final rules or orders under Section 4 of TSCA must notify EPA of the country of destination the first time a chemical is shipped to the country.


5.  TSCA Import Certification


Law: TSCA Section 13
Regulations: 40 CFR 707 and 19 CFR 12.118 - 12.128

Under EPA and Customs regulations, the importer of a chemical substance or mixture must certify at the port of entry that each shipment is either subject to and in compliance with TSCA (a positive certification); or the shipment is not subject to TSCA   (a negative certification).


6.  Existing Chemicals Regulation


Law: TSCA Section 6
Regulations: 40 CFR 747,749,761, 763

Substances or mixtures that EPA finds "presents or will present an unreasonable risk of injury to health or the environment" can be controlled through Section 6 rulemaking.  EPA has issued Section 6 regulations for only a few substances, including chlorofluoroalkanes, hexavalent chromium-based water treatment chemicals, and metalworking fluids.  A separate set of requirements strictly regulate polychlorinated biphenyls (PCBs).

While PCBs have not been manufactured in the U.S. since the late 1970's, older transformers and electrical equipment may still have PCB contamination.  Any such equipment must be managed to stringent TSCA requirements.  These requirements include registering all PCB transformers with EPA using Form 7720-12, and notifying the National Response Center if a PCB transformer is involved in a fire (1-800-424-8802).

Management of asbestos-containing materials also may be subject to EPA and state regulations.  These requirements are sometimes triggered by renovation activities.







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