Distribution in commerce

There are very few activities in the United States that do not affect commerce and therefore TSCA covers many activities. TSCA states  

The terms distribute in commerce and distribution in commerce when used to describe an action taken with respect to a chemical substance or mixture or article containing a substance or mixture mean to sell, or the sale of, the substance, mixture, or article in commerce to introduce or deliver for introduction into commerce, or the introduction or delivery for introduction into commerce 

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The term manufacture also includes coincidental production of a toxic chemical (e.g., as a byproduct or impurity) as a result of the manufacture, processing, use, or treatment of other chemical substances. In the case of coincidental production of an impurity (i.e., a chemical that remains in the product that is distributed in commerce), the de minimis limitation, discussed on page 11, applies. The de minimis limitation does not apply to byproducts (e.g., a chemical that is separated from a process stream and further processed or disposed). Certain listed toxic chemicals may be manufactured as a result of wastewater treatment or other treatment processes. For example, neutralization of acid wastewater can result in the coincidental manufacture of ammonium nitrate (solution). 

Otherwise Use The term otherwise use encompasses any use of a listed chemical at a facility that does not fall under the definitions of manufacture" or process." A chemical that is otherwise used by a facility is not intentionally incorporated into a product distributed in commerce. 

In this part of the form, you ara required to list all off-sIte locations to which you transfer wastes containing toxic chemicals. Do not list locations to which products containing toxic chemicals are shipped for sale or distribution in commerce or for further use. Also, do not list locations to which wastes containing chemicals are sold or sent for recovery, recycling, or reuse of the toxic chemicals. The information that you enter in this section relates to data you will report in Part III, Section 6. 

Only on-site releases of the toxic chemical to the environment for the calendar year are to be reported in this section of the form. The total releases from your facility do not include transfers or shipments of the chemical from your facility for sale or distribution in commerce, or of wastes to other facilities fortreatment ordisposal (see Pari III, Section 6). Both routine releases, such as fugitive air emissions, and accidental or nonroutine releases, such as chemical spills, must be included in your estimate of the quantity released. EPA requires no more than two significant digits when reporting releases (e.g., 7521 pounds would be reported as 7500 pounds). 

Section 8(d) governs EPA acquisition of health and safety studies. It authorizes EPA to promulgate rules requiring any person who manufactures, processes or distributes in commerce any chemical substance or mixture, or proposes to do so, to submit lists and/or copies of health and safety studies. EPA may exclude... 

A former Assistant Administrator for Toxic Substances observed that such analyses are "based upon a fundamental lack of information and data. This in turn means that our information will be highly uncertain."(6) On the other hand, prior to the establishment of the PMN system, those chemicals for which EPA requested better data might otherwise have been produced or distributed in commerce with little or no testing whatever. 

Toxic Substances Control Act (TSCA) of 1976 gives the Environmental Protection Agency (EPA) comprehensive authority to regulate any chemical substance whose manufacture, processing, distribution in commerce, use, or disposal may present an unreasonable risk of injury to health or the environment. 

Toxic Substances Control Act (TSCA) Law passed in 1976 that governs the regulation of toxic substances in commerce, with the objective of preventing human health and environmental problems before they occur. The manufacturing, processing, or distribution in commerce of toxic substances may be limited or banned if EPA finds, based on results of toxicity testing and exposure assessments, that there is an unreasonable risk of injury to human health or the environment. Important hazardous chemicals regulated under TSCA include, for example, dioxins, PCBs, and asbestos. 

U.S. EPA (Environmental Protection Agency). 2008. Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions CFR 40 Part 761. 

Land disposal of CDD-containing wastes is currently prohibited (EPA 1986f, 1988f). The Toxic Substances Control Act (TSCA) regulates the use, disposal, and distribution in commerce of process... 

TSCA was first enacted in 1976 and has been amended significantly three times. It is a federally managed law and is not delegated to states.30 TSCA gives EPA broad authority to regulate the manufacture, use, distribution in commerce, and disposal of chemical substances. The law is overseen by the EPA Office of Pollution Prevention and Toxics (OPPT).31... 

Process The term process means the preparation ol a listed toxic chemical, after its manulacture, tor distribution in commerce. Processing is usually the intentional incorporation r f a toxic chemical into a product (see page 19 lor further clan... 

Section 6(e) of the Toxic Substances Control Act (TSCA) prohibits the manufacture, processing, and distribution in commerce of PCBs. In addition, the EPAhas set a limit of 0.0005 milligrams of PCBs per liter of drinking water (0.0005 mg/L). Discharges, spills or accidental releases of 1 pound or more of PCBs into the environment must be reported to the EPA. The Food and Drug Administration (FDA) requires that infant foods, eggs, milk and other dairy products, fish and shellfish, poultry and red meat contain no more than 0.2-3 parts of PCBs per million parts (0.2-3 ppm) of food. 

EPA. 1979b. Polychlorinated biphenyls (PCBs) manufacturing, processing, distribution in commerce, and use prohibitions. Subpart D Storage and disposal. Disposal Requirements. U.S. Environmental Protection Agency. Code of Federal Regulations. 40 CFR 761.60. 

From 1929 until 1977, approximately 99% of all PCBs used by U.S. industries were manufactured by the Monsanto Chemical Company at a production facility in Sauget, Illinois (Durfee 1976 lARC 1978). During that period, over 571,000 metric tons (1,250x10 pounds) of PCBs were produced and/or used in the United States (Erickson 1997 Hansen 1999). In 1976, the U.S. Congress banned the manufacture, processing, distribution in commerce, and use of PCBs under the Toxic Substances Control Act (TSCA) and the Resource Conservation and Recovery Act (RCRA). Exemptions may be granted to individual petitioners for use with optical microscopy, and for research and development (see Section 5.3 EPA 1998u). 

Continued reporting requirements are placed on persons that manufacture, process, or distribute in commerce any chemical substance or mixture and include (1) maintaining records of significant adverse reactions to health or the environment, alleged to have been caused by the substance or mixture (Section 8(c) of TSCA) and (2) immediately informing the U.S. ERA of ... information which reasonably snpports the conclnsion that such chemical substance or mixture presents a substantial risk of injnry to health or the environment, nnless the person has actual knowledge that the U.S. ERA has been adeqnately informed (Section 8(e) of TSCA). 

The CWC established a schedule of chemicals that are controlled under the CWC. Several of the agent degradation products are designated under CWC Schedule 2, and their manufacture and distribution in commerce is controlled. If secondary wastes contain Schedule 2 chemicals, additional scrutiny from CWC inspectors may be required during secondary waste treatment or disposal. 

Under Section 6(e)( 1), within six months of the effective date of the Act, EPA is obligated to promulgate rules that prescribe methods for the disposal of PCBs and require PCBs to be marked with clear and adequate weimings, as well as with instructions with respect to their processing, distribution in commerce, use, or disposal. Section 6(e)(2) provides that, one year after the effective date of the Act, no person may manufacture, process, distribute in commerce, or use any PCB other than in a totally enclosed manner. Section 6(e)(3) provides that no person may manufacture any PCB after two years from the effective date of the Act, or process or distribute in commerce any PCB after two and one-half years after such date. The provisions of Sections 6(e)(1) and 6(e)(2) allow the Administrator to promulgate rules granting exemptions from the control measures mandated by Section 6(e). 

Three provisions of the CPSA have a bearing on the labeling responsibilities of chemical manufacturers (1) Section 7, which authorizes the Commission to prescribe safety standards which may include labeling requirements (2) Section 27(e), which the Commission views as an additional source of labeling authority and (3) Section 15, under which an inadequately labeled product already distributed in commerce can be subjected to recall, replacement, notification and other remedies. 

The Act specifies three criteria for determining whether a risk of injury is substantial the pattern of defect, the number of defective products distributed in commerce, and the severity of the risk. These criteria suggest that the overriding inquiry in measuring substantiality must be twofold first, how certain is it that the product will cause injury and, second, how extensive is that injury likely to be Discussing the definition of substantial risk, the CPSA s legislative history states ... 

In addition to substances specifically excluded from the TSCA, the EPA has exempted other types of substances from certain TSCA requirements. For example, certain chemical substances—including certain impurities and byproducts—are excluded from TSCA Section 5 requirements because although they are manufactured for commercial purposes under the Act, they are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part [10]. 

The TSCA may apply to any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance [16]. A person is defined broadly as any natural or juridicial person including any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality, any interstate body and any department, agency, or instrumentality of the Federal Government [17]. Not all persons are subject to all of requirements of the TSCA. Instead, the TSCA subjects different persons to its requirements depending on the type of activity a person is engaged in (i.e., manufacturers, importers, processors). 

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