Safety amendments

Consumer Protection. The Upholstered Furniture (Safety) (Amendment Regulations) 1983. HMSO, London. 

Under Section 7(a)(1) of the CPSA, the Commission may promulgate consumer product safety standards that enhance product safety by prescribing (1) requirements concerning product performance, or (2) requirements that a consumer product be marked with or accompanied by clear and adequate warnings or instructions. The Consumer Product Safety Amendments of 1981 stress Congress preference for the adoption of voluntary safety standards in lieu of mandatory federal requirements. In its amended form. Section 7(b) provides that the Commission shall rely upon voluntary consumer product safety standards. . . whenever compliance with such voluntary standards would eliminate or adequately reduce the risk of injury addressed and it is likely there will be substantial compliance with such voluntary standards. ... 

The Supply of Machinery (Safety) (Amendment) Regulations 1994 made a number of changes to the 1992 Regulations, in particular, to widen the scope to include machinery for lifting persons and safety components for machinery. The main provisions of the amending Regulations entered into force on 1 January 1995. Therefore from 1 January 1995 ... 

Safety amendments added to Longshoremen s and Harbor Workers Compensation Act. 

A series of eharter bus accidents culminating in a dramatic May 1999 New Orleans erash put the obscure OMC in the public spotlight. Congress responded with the Federal Motor Carrier Safety Amendments of 1999, whieh ereated FMCSA, assigned it all of OMC s employees and responsibilities, and provided some additional regulatory authorities, ineluding the power to require operators to install black box event recorders to monitor vehicle speeds and hours of operation. ... 

Federal Motor Carrier Safety Amendments of 1999, Pub. L 106—159 113 Stat. 1748... 

Consumer Product Safety Amendments of 1981, Pub. L. 97-35, 95 Stat. 703 (1981) Elliott Klayman, Comment, Standard Setting Under the Consumer Produet Safety Amendments of igSi—A Shift in Regulatory Philosophy, 51 Geo. Wash. L. Rev. 96, 101-02, 104, n. 39 (1982) Teresa M. Schwartz, The Role of Federal Safety Regulations in Products Liability Actions, 41 Vand. L. Rev. 1121,1159 (1988) (regulatory output, data collection). 

Occupational Safety and Health Act. The Occupational Safety and Health Act (OSHA), as amended in 1990, encourages reduction of occupation safety and health ha2ards and promotes safe and healthful conditions. 

In 1962, amendments to the U.S. Federal Food, Dmg and Cosmetic Act (Kefauver-Harris amendments) promulgated regulations concerning the requirements for premarketing approval by the FDA. This legislation estabUshed requirements of proof of both safety and therapeutic efficacy and strict control of human clinical testing, for example, which have extended the time and cost to market a new dmg. Thus, whereas approximately 40 new dmgs were marketed annually from 1948 to 1962, this number had fallen to 12 by 1966. 

Clean Air Act and its amendments ia 1970, 1977, and 1990 1967 Air Quahty Standards and National Air Pollution Acts and 1970 National Environmental PoHcy Act) (2) better waste disposal practices (1965 SoHd Waste Disposal Act 1976 Resource Conservation and Recovery Act) (see Wastes, industrial Waste treatment, hazardous wastes) (i) reduced noise levels (1972 Noise Control Act) (4) improved control of the manufacture and use of toxic materials (1976 Toxic Substances Control Act) and (5) assignment of responsibiUty to manufacturers for product safety (1972 Consumer Product Safety Act) (15,16). 

The state of Louisiana amended its air quaUty regulations (26) to incorporate requirements for chemical accident prevention, and several other states, including Michigan and New York, are considering process safety regulations. 

Two statutory provisions of Tide 21 govern the introduction of new medical devices into the marketplace. Section 515 estabHshes a premarket approval appHcation (PMA) containing data and information demonstrating the safety and effectiveness of a device. Section 510(k) estabHshes a premarket notification process. Under this process, a manufacturer is required to file with the EDA, 90 days before a new device is to be marketed, a premarket notification demonstrating that the device in question is substantially equivalent to a device that was on the market before enactment of the 1976 Amendment and therefore marketable without formal EDA approval. 

The two main federal agencies involved in the protection of human health and the environment are the Environmental Protection Agency (EPA) and the Occupational Safety and Health Administration (OSHA). EPA s principal concern is the protection of the environment, in most cases, the area outside of an industrial faciUty. There are 10 regional offices that carry out the regulatory functions of the agency (Table 1). Primary laws covered by EPA are the Clean Air Act Amendments (CAAA), the Clean Water Act (CWA), Resource Conservation and Recovery Act (RCRA), Comprehensive Environmental Response, Compensation, and LiabiUty Act (CERCLA), Toxic Substances Control Act (TSCA), and Eederal Insecticide, Eungicide, and Rodenticide Act (FIFRA). 

To further improve the general safety standards, the Delaney Clause was included in the Pood Additives Amendment of 1958. The Delaney Clause states that no food additive or color additive can be deemed safe if it has been found to induce cancer when ingested by humans or animals (23). The Clause acts as an absolute prohibition on the use of any additive found to cause cancer without any regard for whether, or to what extent, the substance is hazardous to human health. As scientific advances continue, both in the realm of food technology and analysis of previously undetected contaminants, the... 

A distinct concern arises in the area of veterinary dmgs because of the possibiUty that dmg residues may be conveyed to humans by the food-producing animals. Therefore, dmg residues and their safety in human food remain a central issue for the Center for Veterinary Medicine (CVM). Animal dmgs also include those products which promotional Hterature claims to improve feed efficiency and increase milk production. An animal food product is regulated under the 1968 Animal Dmg Amendments if it contains a dmg used in feed or premixes (25). 

Class III Premarket Approval. Similar to a new dmg approval, a premarket approval grants the appHcant a Hcense to market a specific weU-characterized device. These devices are subject to the requirements of Section 515 of the Eood, Dmg, and Cosmetic Act. A post-amendment device is a device put ia commercial distribution after May 28, 1976. If it is not substantially equivalent to a preamendment device it is automatically ia Class 111, and a premarket approval appHcation (PMA) is required. The appHcation must iaclude reports of preclinical and clinical studies done ia support of claims of safety and efficacy as well as any labeling claims made for the device. Once the PMA is submitted, the PDA determines whether the appHcation iacludes the required information. If the PMA is suitable for scientific review, the PDA has 180 days from the filing date to approve or deny the appHcation. Polybutester, polydioxanone, polyglyconate, and ePTPE sutures are all regulated as Class 111 devices. 

Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Superfund Amendment and Reauthorization Act Title III (STkRA Title III) Occupational Safety and Health Act (OSHA)... 

The demand for trichloroethylene grew steadily until 1970. Since that time trichloroethylene has been a less desirable solvent because of restrictions on emissions under air pollution legislation and the passage of the Occupational Safety and Health Act. Whereas previously the principal use of trichloroethylene was for vapor degreasing, currentiy 1,1,1-trichloroethane is the most used solvent for vapor degreasing. The restrictions on production of 1,1,1-trichloroethane [71-55-6] from the 1990 Amendments to the Montreal Protocol on substances that deplete the stratospheric ozone and the U.S. 

A primary responsibility of the Food and Drug Administration (FDA) is the enforcement of the Federal Food, Dmg, and Cosmetic Act of 1938 and its various amendments, eg. May, 1976, in which dental materials, instmments, and equipment are included. Premarketing clearance requirements apply for estabhshing the safety and effectiveness of new products. There is a close Haison between the FDA and the ADA standards and certification programs. 

The United States has the most laws regarding environmental safety and health. The National Environmental PoHcy Act (NEPA) of 1969 has resulted in the following acts Eederal Insecticides, Eungicide and Rodenticide (EIERA), Resource Conservation and Recovery (RCRA), Superfund (CERCLA), Superfund Amendments and Reauthori2ation Act (SARA) Plus Tide III, Toxic Substance Control Act (TSCA), Clean Water (CWA), Water Quahty, Safe Drinking Water (SDWA), and Waste Minimi2ation and Control. 

Onboard Refueling Vapor Recovery (OR ) regulations were fust proposed m 1987 but were met with a litany of technical and safety issues that delayed the requirement. The 1990 CAA amendments required the implementation of ORVR and the EPA regulation requires passenger cars to first have the systems starting in 1998. The ORVR test will be performed in a SHED and will require that not more than 0.2 grams of hydrocarbon vapor per gallon of dispensed fuel be released from the vehicle. 

The Health and Safety at Work etc. Act 1974 (Application to Environmentally Hazardous Substances) Regulations 1996 as amended... 

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