Unreasonable risk, regulations

Premanufacture Notification - The Toxics Act requires chemical manufacturers to give EPA 90 days notice before commencing commercial production on any new chemical substance. Through premanufacture notification, the Agency is charged with the responsibility of regulating unreasonable risks from these new chemicals before they occur. 

As part of TSCA, EPA can require the testing of any chemical if there is the possibiUty of an unreasonable risk to health or environment or if there is significant human or environmental exposure. If the substance poses an unreasonable risk, EPA can prohibit the manufacture, processing, or distribution of the substance limit the amount of the substance that can be manufactured, processed, or distributed prohibit a particular use for the substance limit the concentration of the substance during manufacture, processing, or distribution regulate disposal methods for the substance and require manufacturers to maintain records of process and to conduct tests to assure compliance with EPA rules. 

Regulation. Dental implants are regulated by the Food and Dmg Administration. AH dental implants faH iato the FDA class III which covers devices that are life sustaioiag, life supportiag, or are implanted iato the body and have the potential to cause unreasonable risk, illness, or iajury. Devices ia class III are requited to have appHcatioas for premarket approval (315). There are 15 to 20 companies that have FDA marketing clearance for specific dental implants, based on substantial equivalency to implants marketed prior to 1976, and approximately one third of these companies are foreign. Marketing clearance is not the same as premarket approval. 

The Toxic Substances Control Act (TSCA) was enacted in 1976 to identify and control toxic chemical ha2ards to human health and the environment. One of the main provisions of TSCA was to estabUsh and maintain an inventory of all chemicals in commerce in the United States for the purpose of regulating any of the chemicals that might pose an unreasonable risk to human health or the environment. An initial inventory of chemicals was estabhshed by requiring companies to report to the United States Environmental Protection Agency (USEPA) all substances that were imported, manufactured, processed, distributed, or disposed of in the United States. Over 50,000 chemical substances were reported. PoUowing this initial inventory, introduction of all new chemical substances requires a Premanufacturing Notification (PMN) process. To be included in the PMN are the identity of the new chemical, the estimated first year and maximum production volume, manufacture and process information, a description of proposed use, potential release to the environment, possible human exposure to the new substance, and any health or environmental test data available at the time of submission. In the 10 years that TSCA has been in effect, the USEPA has received over 10,000 PMNs and up to 10% of the submissions each year are for dyes (382)... 

Most of the provisions of the Toxic Substances Control Act (TSCA) of 1976 (PL 94-469) rely in some way on risk assessment of chemicals. Under the reporting requirements of the statute, any manufacturer, processor, or distributor of a chemical for commercial purposes must inform the EPA immediately after discovering any information which "reasonably supports the conclusion" that a chemical substance or mixture "presents a substantial risk of injury to health or to the environment" unless the EPA Administrator has been adequately informed already. EPA is mandated to establish regulations for testing new or existing substances when it is determined that there is not enough health or environmental information, that testing is necessary to develop such information and that the chemical or mixture "may present an unreasonable risk of injury to health or the environment."... 

TSCA "Unreasonable Risk" Regulations, and Other Restrictions. During the three years that companies have been submitting PMN s to EPA, the Agency has developed a number of means for informally regulating the production and use of certain new chemicals. In addition, 5(f) authorizes EPA to initiate more formal regulatory actions, primarily involving lawsuits. 

In addition to these informal means for regulating, 5(f) authorizes EPA to seek restrictions upon the production, distribution, use, and disposal of new substances that "present or will present an unreasonable risk of injury to health or the environment. To ban a new chemical outright, the Agency must obtain an injunction from a U.S. district court. Any other restrictions... 

Second, EPA could issue rules under S 8(a) to require periodic reports concerning the commercial development of certain new substances once they enter production. Unlike SNUR s, S 8(a) requirements would not prevent companies from continuing their production and marketing activities. Rather, EPA would review information contained in the 8(a) reports, and then could pursue control actions under its other TSCA authorities for regulating existing chemicals (i.e. 4 test rules, or 6(a) "unreasonable risk" regulat ions). 

The goal of the Toxic Substances Control Act (TSCA) is to provide authority to regulate chemical substances which present an unreasonable risk of injury to health or the environment. An important feature of TSCA requires the administrator of the Environmental Protection Agency (EPA) to examine such data on existing chemicals and, when it is insufficient, to direct industry to conduct tests. 

So, after 6 years of debate, TSCA was born. This was an important six years. Many of the environmental laws of our country were enacted during the 1960 s and early 70 s. TSCA was to be the "cap" on all of the laws - filling all the gaps that existed between the previous laws. It was also designed to put in place, a law to regulate all chemicals in commerce which may present an unreasonable risk in any part of the chemical s life cycle. Any part of the life cycle can be regulated from R D through production, distribution and disposal. 

So in TSCA, we have a "balancing-type law" wherein the Administrator is required to consider not just the risks associated with a chemical, but also whether it is an unreasonable risk in light of the benefits associated with the chemical. For the Administrator to regulate a chemical substance or mixture under Section 6 of TSCA, the law requires that "the Administrator shall consider... 

Under the Department of Transportation (DOT) regulations, a hazardous material is any substance or material, including a hazardous substance and hazardous waste that is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. DOT thus has broad authority to regulate the transportation of hazardous materials that, by definition, include hazardous substances as well as hazardous wastes. 

Probably the law that has specifically affected the chemical industry the most is the Toxic Substances Control Act (TSCA). Since it was signed on October 11, 1976 and became effective on January 1, 1977, it has caused many changes in the industry and will create further modifications in the years to come. The basic thrust of the law is threefold (1) to develop data on the effects of chemicals on our health and environment, (2) to grant authority to the EPA to regulate substances presenting an unreasonable risk, and (3) to assure that this authority is exercised so as not to impede technological innovation. 

ORM (Other Regulated Material) Under U.S. Department of Transportation regulations, an Other Regulated Material (ORM) is a material that (a) May pose an unreasonable risk to healdi and safety or property when transported in commerce and (b) Does not meet any of the definitions of the other hazard classes specified in subchapter C of the regulation or (c) Has been reclassified an ORM (specifically or permissively). 

If the Agency feels the chemical presents an "unreasonable risk to health or the environment," it may regulate the chemical in such a way to eliminate the unreasonable risk. 

By 1979, the production of PCBs had been phased out because of the strict regulations of the TSCA. Only totally enclosed products that include PCBs are exempted. Also, a threshold of 50 parts per million (ppm) was established by the USEPA, as concentrations under that level do not cause unreasonable risk. Since the inception of these regulations, high levels of PCB concentrations have dropped from 12% of the American population in 1979 to nearly 0% in the late 1980s (Rosenbaum, 1995). In addition to PCBs, the TSCA has also been used to help reduce the unreasonable risk of asbestos in the environment. In 1986, the TSCA was amended to include the Asbestos Hazard Emergency Response Act. The primary function of this act was to remove asbestos from the nation s schools, and it was passed in response to studies that found asbestos to be an airborne carcinogen. In 1989, the USEPA issued regulations that would phase out all uses of asbestos in commercial products by 1997. 

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. 

Toxic Substances Control Act, 1976 The two major goals of the Toxic Substances Control Act (TSCA), passed by Congress in 1976, are (1) the acquisition of sufficient information to identify and evaluate potential hazards from chemical substances and (2) the regulation of the manufacture, processing, distribution, use, and disposal ofany substance that presents an unreasonable risk of injury to health of the environment. 

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