Federal Law

Congress establishes federal laws (legislation or acts) and the President of the United States signs them into law. These laws often require that regulations (standards) be developed by federal agencies that are responsible for the intent of the law. 

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Federal regulations (40 CFR 261) classify acrylonitrile as a hazardous waste and it is Hsted as Hazardous Waste Number U009. Disposal must be in accordance with federal (40 CFR 262, 263, 264), state, and local regulations only at properly permitted faciUties. It is Hsted as a toxic pollutant (40 CFR 122.21) and introduction into process streams, storm water, or waste water systems is in violation of federal law. Strict guidelines exist for clean-up and notification of leaks and spills. Federal notification regulations require that spills or leaks in excess of 100 lb (45.5 kg) be reported to the National Response Center. Substantial criminal and civil penalties can result from failure to report such discharges into the environment. 

Rotenoids. The use of rotenone-bearing roots as insecticides in the United States was developed as a result of federal laws against residues of lead, arsenic, and fluorine upon edible produce. Rotenone [83-79-4] (5) is harmless to plants, highly toxic to many insects, and relatively innocuous to... 

Mica mining is subjected to local, state, and federal laws. The Mining, Safety and Health Administration (MSHA) regularly monitors mica mining operations for safety violations. 

Because there is no "federal law of trade secrets," protection of trade secrets is often left to the variabHity of the criminal and civil laws of the 50 states. To the extent that a trade secret is property, violation, theft, or misappropriation of the trade secret may be the subject of criminal penalty. To the extent that a trade secret is bound to rights, violation or misappropriation of the trade secret may be the subject of civil penalty. Significant effort, however, has been made in developing a uniform body of law to apply to ideas and innovations which may be the subject of this form of protection. 

Labeling. Labeling, controUed by FDA regulations, includes not only the affixed labels, but also the package inserts that provide mote detailed information. Trade, generic, or common name, dose, number of dose units present, and name and address of manufacturer and distributor ate requited. For nonptescription products, adequate directions for use ate requited. Prescription products must beat the phrase, "Caution Federal law prohibits use without a prescription" on theit labels. 

Interstate Commerce Acts Annotated, Interstate Commerce Commission, Washiagton, D.C. 22 Vols. plus Advance bulletins (last pubHshed Aug. 1981). Compilation of Interstate Commerce Act and related U.S. federal laws, with digests of decisions of federal courts and ICC relating to each section of such Acts. 

Manufacturers of benzene are requited by federal law to pubHsh Material Safety Data Sheets (MSDS) that describe in detail the procedures for its safe handling. Benzene is classified as a flammable Hquid and should be stored away from any potential source of ignition. Fine and explosion hazard data for benzene are shown (91). 

EinaHy, the work must be fixed in a tangible medium of expression. To a very limited extent, there are some works that are not so fixed, such as purely improvised and unrecorded pieces of music or choreography extemporaneous speeches or five, unrecorded, and ephemeral broadcasts. Unfixed works are protected by state common law copyright, and not the federal statute. Under the federal law, however, all works that are so fixed are governed exclusively by the federal statute. 

Besides the above federal laws, all 50 U.S. states have also passed environmental laws. As previously mentioned, both the United States and the state of New Jersey have passed Pollution Prevention Acts (295). 

Prevention of Significant Deterioration (PSD) Of aU the federal laws placing environmental controls on industiy (and, in particular, on new plants), perhaps the most confusing and restrictive are the limits imposed for the prevention of significant deterioration (PSD) of air quahty. These limits apply to areas of the countiy that are already cleaner than required by ambient air-quality standards. This regula-toiy framework evolved from judicial and administrative ac tion under the 1970 Clean Air Act and subsequently was given full statutoiy foundation by the 1977 Clean Air Act Amendments. 

The validity, interpretation and performance of these terms and conditions will he governed hy [insert appropriate state and federal laws]. 

The Clean Air Act is the comprehensive Federal law that regulates air en stationary, and mobile sources. This law authorizes the U.S. Environmental Protection Agency (EPA) to establish National Ambient Air Quality Standards (NAAQS) to protect public health and the environment. The goal of the Act was to set and achieve NAAQS in every state by 1975. This ng of maximum pollutant standards was coupled with directing the states to develop state... 

Federal law requires that States act to review and upgrade their codes. 

Under federal law, limited quantities of certain schedule V drugs may be purchased without a prescription directly from a pharmacist if allowed under state law. The purchaser must be at least 18 years of age and must furnish identification. All such transactions must be recorded by the dispensing pharmacist. 

In the U.S., there are local, state, and federal laws regulating health, safety, and the environment. The laws that address the area of pollution control also cover health and safety, toxic substances, noise, transportation, and building site approval. 

CFR - Part 77 is a federal law that regulates the submission of electronic records and electronic signatures to the FDA. Of particular interest to the statistical programmer are the following requirements of Part 11 ... 

Labeling Requirements for Insecticides and Other Economic Poisons under Federal Law... 

Because the protection afforded users of economic poisons under the federal law applies only to materials shipped in interstate commerce, state laws must provide adequate protection to users of economic poisons shipped solely within the state, and provide cooperative enforcement of the federal law. 

The attitude of the Federal Food and Drug Administration revolves basically upon two sections of the federal law Section 402(a), A food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance... or if it bears or contains any added poisonous or added deleterious substance which is unsafe within the meaning of Section 406. The applicable portion of Section 406 is Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice, shall be deemed to be unsafe for the purposes of the application of Clause 2 of Section 402(a) but when such substance is so required or cannot be so avoided, the administrator shall promulgate regulations.. .. ... 

Legal Controls. These include a labeling law requiring all economic poisons to be clearly labeled according to content and amount of each ingredient, with appropriate statements on first aid measures and precautions and an adequate system of inspection for the presence of poisonous residues on the surface of, or within, the foods placed on the market. It is recommended also that the states adopt legislation consistent with the federal laws. 

In 1980, the U.S. Congress enacted the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the first comprehensive federal law addressing the protection of the environment from the threat of hazardous substances. The primary goal of CERCLA is to establish an organized cost-effective mechanism for response to abandoned or uncontrolled hazardous waste sites that pose a serious threat to human health and the environment.8 9 To accomplish this goal, two types of response capabilities are mandated by CERCLA13 ... 

API publications necessarily address problems of a general nature. With respect to particular circumstances, local, state, and federal laws and regulations should be reviewed. 

API is not undertaking to meet the duties of employers, manufacturers, or suppliers to warn and properly train and equip their employees, and others exposed, concerning health and safety risks and precautions, nor undertaking their obligations under local, state, or federal laws. 

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