Federal regulatory statutes

A relatively early, and highly influential work, Of Acceptable Risk Science and The Determination of Safety, by William Lowrance (William Kaufman, Los Altos, CA, 1979) sets forth the basic issues in the determination of safety. Also widely-cited is Peter Barton Hutt s Legal considerations in risk assessment under federal regulatory statutes in Assessment and Management of Chemical Risks, (J.V. Rodricks and R.G. Tardiff, Editors, ACS Symposium Series 239, American Chemical Society, Washington, D.C. 1984). Fred Hoerger offers an excellent perspective on the role of risk assessment in corporate decision-making in this same volume (Chapter 10). 

Legal Considerations in Risk Assessment Under Federal Regulatory Statutes... 

Both the early Federal regulatory statutes and the more recent ones employ a wide variety of control mechanisms. These include private enforcement, government policing of the marketplace, development of voluntary and mandatory standards, and various forms of premarket notification, testing, and approval. 

Federal health and safety regulatory statutes have been interpreted and applied in highly flexible and common sense ways largely because of the existence of a number of important rules of statutory construction. These rules have been created by the judiciary over many decades, and in some instances centuries, as part of our unwritten common law. They do not depend on the words of a particular statute, or the intent of... 

Although the Federal patent statute provides for 17 years of exclusive rights to an invention, the actual amount of time a dmg manufacturer is usually able to market its dmg without competition is substantially less. Because firms usually seek patent protection once a potential dmg compound is identified (284), a large portion of the patent period can be taken up by the sponsor s research and development (R D) activities and the U.S. Food and Dmg Administration s review of the marketing application (507). In 1984, Congress passed the Dmg Price Competition and Patent Term Restoration (DPCPTR) Act (Public Law 98-417), which allowed PTO to add up to five years to the patent term of dmgs when the patent term was eroded by regulatory review.8 As of May 1992, the PTO had issued 142 patent extensions most often for a period of... 

In the United States, the federal regulatory process starts when both Houses of Congress develop a law or statute. Generally, each House develops its own version. These are then sent to committee, where a compromise bill is agreed upon. This, in turn, goes to the President, who signs it (imless he chooses to use his power of veto). 

There are two classes of color additives, those that must be certified and those that are exempt from certification. Both are strictly controlled in the United States by regulatory statutes (Food Color Additives Amendments), but an official certificate is required for each commercial batch of color of the first group, while no such certificate is necessary for the second group. For certification the manufacturer must submit a sample of the batch to the Food Drug Administration for chemical analysis. The results of the analysis are compared with the specifications for certified colors published in the Code of Federal Regulations. If the compliance is complete, a certificate is issued for that particular batch of color. 

At the federal level. Congress passed the National Energy Act of 1978, which was composed of five different statutes (1) the Public Utilities Regulatory Policy Act (PURPA), (2) the National Energy Tax Act, (3) the National Energy Conseiwation Policy... 

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