Toxic Substances Control Act (TSCA)

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Presentation transcript:

Toxic Substances Control Act (TSCA) Purpose To control the manufacture, use, and distribution and disposal of chemical substances to protect human health and the environment Scope Manufacturers have the burden of supplying the EPA with information on environmental and health effects of chemical substances and mixtures The EPA then has broad power to regulate the manufacture, use, distribution, and disposal of chemical substances and mixtures Who implements the EPA? The EPA EPA Authority Review new chemicals and significant new uses of existing chemicals Require testing of chemicals that may present a significant risk to human health or the environment To study the effects of existing chemicals To limit the manufacture, use, distribution and/or disposal of chemicals that present an unreasonable risk

Activities Subject to TSCA Regulation Manufacturing Manufacture is defined as producing, preparing, importing, or compounding a toxic chemical, including the creation of substances produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, such as by-products, coproducts, or impurities Premanufacture Notice (PMN) When a company plans to manufacture, import, or process a substance deemed to be “new,” that company is required to provide the EPA with this notice, which includes detailed information concerning the substance and the proposed manufacturing operation Processing Process is defined as the preparation of a chemical substance after its manufacture for distribution in commerce in the same form or physical state as, or in a different form or physical state from, that in which it was received by the persons so preparing such substance as part of an article containing the chemical substance or mixture Using Disposing

Requirements of Manufacturers Under the TSCA, manufacturers must Conduct tests on chemicals they manufacture and submit data from these tests to the EPA Submit a premanufacture notice (PMN) when they are manufacturing a chemical not already on the TSCA Inventory or prior to manufacturing a chemical for a significant new use Avoid manufacturing PCBs Create and maintain reports as required by the TSCA Respond to subpoenas and allow the EPA to inspect their manufacturing facilities Demonstrate compliance with the TSCA when importing chemicals or chemical mixtures

Requirements of Processors Processors must Provide the EPA with certain data under test rules Notify the EPA before processing a chemical for a significant new use Comply with EPA orders and rules Avoid processing PCBs unless permitted to do so by the EPA Comply with the reporting requirements of the Comprehensive Assessment Information Rule (CAIR), and record keeping and reporting requirements Respond to subpoenas and submit to inspections by the EPA

Requirements of Users Users, however defined, who are not also manufacturers, processors, or distributions must Comply with applicable EPA regulations Refrain from using PCBs except when permitted by the EPA Refrain from using any chemical substance the user knows or has reason to know has been manufactured, produced, or distributed in violation of the TSCA Respond to subpoenas and submit to inspections by the EPA

Requirements of Distributors Distribution The process of selling, introducing, or delivering a chemical substance into commerce or holding the mixture or article after its introduction into commerce Distributors are required under the TSCA to Comply with applicable rules and regulations Refrain from distributing PCBs except as permitted by the EPA Report “substantial risk information” to the EPA Respond to subpoenas and submit to inspections by the EPA

Requirements of Disposers Disposers of chemicals or chemical mixtures are required to Comply with applicable regulations Dispose of PCBs properly Respond to subpoenas and submit to inspections by the EPA

TSCA Inventory Since 1976, the list represents “each chemical substance which is manufactured or processed in the United States” Keeps tracks of existing and new chemicals The number of chemicals on the list presently exceeds 80,000 The Inventory lists reportable chemical substances, defined as Chemical substances which are “. . . any organic or inorganic substance of a particular molecular identity, including (i) any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature and (ii) any element or uncombined radical,” Manufactured, imported, or processed for a commercial purpose in the United States, and Not specifically excluded from the Inventory Delisting Update Rule

TSCA Inventory (cont.) Confidential chemical identity A chemical formula permitted to be kept confidential under most circumstances pursuant to the Emergency Planning and Community Right-to-Know Act (EPCRA) Bona fide intent A bona fide intent, submitted by the requester in writing, includes the following: The specific chemical identity of the chemical the entity intends to manufacture or import A signed statement demonstrating an intent to manufacture or import the chemical for commercial purposes A description of the R&D activities conducted The purpose for which the chemical will be manufactured or imported An analysis of the elements in the chemical An x-ray diffraction pattern (inorganic substances), a mass spectrum, or an infrared spectrum

Premanufacture Notice (PMN) Applies to (i) any new chemical substance, and (ii) significant new use of an existing chemical PMN Requirements The PMN must include The identity of the chemical Its categories of use The amounts to be manufactured or imported By-products from the chemical Exposure of employees to the chemical Methods of disposal Test data related to the chemical’s effect on human health or the environment Any other data regarding the chemical that is “reasonably ascertainable” by the manufacturer or importer Exemptions Types of PMNs The PMN Process Significant New Use Rule (SNUR) Significant New Use Notice (SNUN)

TSCA Testing Interagency Testing Committee (ITC) ITC criteria for identifying new chemicals: The quantities manufactured or introduced into the environment The amount of human exposure Whether the substance is similar to another chemical known to be harmful Any data concerning effects of the chemical Whether testing will assist in determining the possible risk of the chemical Preliminary Assessment Information Rule (PAIR)

Test Rules Test rules can be either Risk-based rules Exposure-based rules Published if the EPA determines that the risk trigger or the exposure trigger has been met for a particular chemical or chemical substance TSCA requires the EPA to follow its usual rulemaking procedures in enacting a test rule Test rules must specify how data is to be collected and explain any testing methodologies Exemptions Reimbursement Order

TSCA Recordkeeping Comprehensive Assessment Information Rule (CAIR) Record of Significant Adverse Reaction A “significant adverse reaction” has been defined as one that “may indicate a substantial impairment of normal activities, or long-lasting or irreversible damage to health or the environment” [40 C.F.R. sec. 710] Types of reactions that must be reported: Gradual or sudden changes in the composition of animal or plant life Abnormal numbers of deaths of organisms Reduction in the reproductive rate of a species Changes in the behavior or location of a species

Enforcement Civil penalties Factors influencing civil penalties Nature of the violation Circumstances surrounding the violation Extent of the violation Seriousness of the violation The violator’s role in the violation The violator’s previous compliance history The violator’s financial situation Other factors “as justice requires” Additional penalties may be imposed for willful violations Credit for good attitude/good faith effort to comply with applicable regulations Settlement agreements

Enforcement (cont.) Criminal liability “Knowing” or “willful” violations may result in imprisonment and/or stiff monetary fines Corporations may be found criminally liable for employees’ actions No “corporate shield” in the TSCA protects corporations from criminal liability Citizen suits May be brought by “any person” believing that there has been a violation of the TSCA, or that the EPA has failed to perform any of its nondiscretionary duties under the TSCA

Bhopal Disaster 12/3/1984 in Bhopal, India 40 metric tons of methyl isocyanate (MIC) gas leaked from tank at a manufacturing plant operated by Union Carbide India Limited (UCIL) The plant manufactured carbyl, a pesticide used in India to help the productivity of the agricultural industry (MIC is part of the production of carbyl) Cause of Leak Why was the leak not contained? UCIL paid more than $470 million in damages to the disaster victims The gas immediately killed approximately 3,800 people and reports indicate 150,000 to 600,000 people were injured, of whom at least 15,000 later died One of the worst industrial and environmental disasters ever to occur primarily because of the great loss of human life and the damage caused to the survivors’ lives