REGULATION AND REGULATORY AGENCIES

Regulation is a concept that is associated intimately with science, technology, and ethics. In the most general sense regulations control or direct human activities in accordance with a rule that has been promulgated. Neither sciences nor technologies could exist without internal processes of professional self-regulation. Biology includes research on the processes that regulate early embryonic development. The larger societies in which science and technology are embedded are dependent on forms of regulation that run the gamut from social to legal and governmental. Ethics is a form of regulation that often is seen as being more conscious or self-critical than social regulation and more broad than legal regulation.

The modern social construction of regulatory agencies as part of government was one attempt to respond to the complexity of advancing technological societies by "delegating legislation" that established appropriate institutional bodies to create and enforce "administrative laws" in specific areas of need such as water treatment, radio wave frequency allocation, and air traffic control. Reactions to the bureaucratic inefficiencies sometimes introduced by such agencies has led to countermovements for deregulation.

Historical Background and Modern Emergence

Regulations existed from the earliest periods of human history. Heads of tribes established rules that enabled closely related groups to live at peace within defined territories; rules of marriage, divorce, compensation for damage, bequests, and the status of slaves were set out in the Code of Hammurabi, which was carved in stone in Babylon in the 1700s b.c.e. Before that time the definitions of key weights and measures were established; for example, the mina (one-sixtieth of a talent) was a unit of payment that was mentioned specifically in the Code of Hammurabi. A talent, which might have been the weight a man could carry with comfort (about sixty pounds), had superseded the ox or cow as the unit of exchange.

In the era that preceded democratic governments the all-powerful prince was able to promulgate regal (regulatory) powers to modulate the behavior of his subjects according to his wishes. After the emergence of liberal democracies in the 1700s c.e. individuals and organizations within a society often were allowed to behave as they wished as long as they did not violate any of the rules and regulations crafted to ensure social order and the well-being of the society.

Those rules and regulations constitute a subset of the ethics of a society that are formulated and promulgated by those elected to a representative assembly. That assembly or body of lawmakers acts in place of the prince and therefore may be seen as an agent that regulates the affairs of the society. This is an example of the first level of the regulatory agency: the parliament or legislature.

In a democracy this type of regulatory agency involves the full complement of the members of the society who are eligible to vote and provides laws that have to be obeyed on pain of penalty when they are flouted. Those laws are upheld by an enforcement authority consisting of the police and if necessary the army that brings people suspected of lawbreaking before a judiciary where argument is presented with or without lawyers before a judge and a body of peers (the jury). If the guilt of the accused is established, punishment is meted out in the form of a fine, imprisonment, or another type of penalty.

The second level consists of religious authorities. In this case regulations or ethics are based on interpretations of sacred texts by clerics who have been given the authority to make such determinations by the head of the order or by the collective will of the congregants. The matters that are dealt with at this level are subject to compliance with laws of the state that override ecclesiastical regulation if there is a conflict. Thus, the way the church conducts its business and the messages the church promotes in helping members establish a workable relationship with the deity are an area of regulation for which this agency is fully responsible.

A third tier of regulation operates through groups of individuals who are selected by governmental departments and given authority by the issuance of specific laws to regulate the behavior of particular industries or service organizations. The first body of this type was set up in 1852 by the U.S. Congress as the Steamboat Inspection Service. That body was required to establish and maintain standards of design and production for the boilers that were used to power the paddles of steamboats plying the Mississippi River. Before that time explosions of those boilers resulted in the deaths of hundreds of passengers. Eventually that situation led to the establishment of a professional society, the American Society of Mechanical Engineers (ASME), that drew up codes of conduct to govern the education and practical training of the engineers involved in boiler design and construction along with specific codes that governed the construction of boilers that then were incorporated into local and state law.

In 1887 in the United States the Interstate Commerce Commission (ICC) was established to, among its other regulatory activities, prevent destabilizing competition in railway fares and set fare rates that would allow investment in new track and facilities as well as provisions for maintenance and safety measures without preventing the delivery of dividends to encourage further investment.

Other countries and international organizations established their own regulatory agencies. The United Nations (1945) and its subagencies, notably the World Health Organization, the Food and Agricultural Organization, and the World Bank, were set up. In addition to a variety of international laws, those agencies provide regulations that control trade and the sustainable use of resources as well as the financial control of terrorism. The Treaty of Rome in 1957 established the European Union, which may issue directives whose power is binding on its members. There is also an International Organization for Standardization (1947) that has issued 14,000 international standards that enable world trade to proceed with confidence and a World Intellectual Property Organization that deals with regulations involving patents.

U.S. Regulatory Agencies

During the twentieth century some fifty regulatory agencies were established by the U.S. Congress. Some of the tasks undertaken by those bodies can be of major importance, for example, regulation of the quality of food and drugs through U.S. Food and Drug Administration regulations for pharmaceuticals and vaccines that often require manufacturers to test their products for safety, efficacy, and the consistency of their production process over a period of five to fifteen years at a cost of $500 million to $1 billion per product. Other tasks are trivial, including setting the when times a drawbridge may be raised or lowered.

Those agencies regulate financial operations (the Securities and Exchange Commission, established in 1933) and control the way people use their local environments (the Environmental Protection Agency, established in 1970). All aspects of the work environment are covered by the Occupational Safety and Health Administration (1970), and the Nuclear Regulatory Commission was set up in 1977 to supervise the development of civil nuclear installations. The development of the executive department of the Congress devoted to agricultural matters has spawned numerous regulatory agencies that oversee most aspects of agricultural practice. When it can be demonstrated that there is an overarching social need for regulation, members of Congress seem to be willing to provide the legal powers or instruments that give the agencies they create the tools to do their jobs.

Some of the functions that are served by American regulatory agencies include the following.

REGULATION OF COMPETITION. Although the liberal nature of the American democracy provides for the freedom of individuals and corporations to compete in attracting the attention of customers, corporations sometimes have colluded in setting prices or availabilities that have affected prices in ways that benefit corporations disproportionately. Such conglomerates have been disaggregated by law, and competition has to be active between the disaggregated entities that have been formed. For this reason the Standard Oil Company was broken up in 1911 and the Bell System's telephone monopoly was broken down to the AT&T company and the seven "Baby Bells" in 1982.

CONTROL OF COMPANY ACTIVITIES IN RELATION TO THE ENVIRONMENT. Most manufacturing companies acquire raw materials and convert them to final products, in the process producing solid, liquid, and gaseous wastes. At one time the disposal of that waste was a matter for company determination. Because there have been serious examples of wastes contaminating environments and damaging the health of local people (the Love Canal in New York State was so polluted that it took twenty years to clean up), regulations have been used to protect local residents and workers in the polluting factories.

PROVISION OF INFORMATION ABOUT PRODUCTS. The need to provide composition and calorific data on foods has turned supermarket shopping into an exercise in nutritional virtuosity. Additionally, data in advertisements have to comply with the realities of products and financial deals have to be expressed in ways that provide complete and comprehensible information to those about to take out loans or mortgages.

PROTECTION OF THE WEAK (CHILDREN) AND INFIRM. Regulations also may express the more basic virtues that are considered the hallmarks of a proud and independent society. These virtues include equality of opportunity; nondiscrimination on the basis of racial, ethnic, or religious affiliations; and the need to protect privacy on the street on in a column of data.

Criticisms

Any regulatory regimen is established at a cost. There is a burgeoning bureaucracy to deal with and costs in terms of time and trouble whenever a licence is required to make or do something. This may provide a hurdle for those who are innovating, who may be put off by the specifications they will have to meet to manufacture a product. There is also the consideration that regulations depart from the ideals of a liberal democracy that is premised on the least involvement of the state in the day-to-day activities of its citizens. In the United Kingdom the criticism that is leveled at the government as it seeks to advise and regulate the way people live, eat, and use mind-affecting drugs is that the government has become the "nanny" of the state.

A corollary of this situation is that regulations have to be devised to regulate the regulators. In the United States the Office of Management and Budget (OMB) was set up by a presidential executive order to determine the cost-effectiveness of the activities of the regulatory agencies that have been established by Congress.

People may live in a liberal society that purports to promote freedom of the individual and the corporation, yet they are biological organisms that need to have multiple levels of control to enable them to function. There are at least four levels of biochemical control of cellular function—environmental, enzymatic, energetic, and genetic—in addition to hormonal, neuronal, instinctive, subconscious, and conscious control systems. There are also social control systems, among which regulatory agencies are only one. There is little doubt that the application of a multitiered system of controls provides people with enhanced survival chances: Whether survival is always the only value is another issue.

R. E. SPIER

SEE ALSO Aviation Regulatory Agencies;Environmental Regulatory Agencies;Foucault, Michel;Regulatory Toxicology;Science, Technology, and Law.

BIBLIOGRAPHY

Unger, Stephen H. (1994). Controlling Technology: Ethics and the Responsible Engineer, 2nd edition. New York: Wiley.

INTERNET RESOURCES

Department of the Environment, Heritage, and Local Government. (2004). "Local Agenda 21." Available at http://www.environ.ie/DOEI/DOEIPol.nsf/wvNavView/Local+Agenda+21?OpenDocument&Lang=.

Environmental Protection Agency, Office of Site Remediation Enforcement. (2004). "The Lovel Canal." Cleanup News. Available at http://www.epa.gov/compliance/resourcesnewsletter/cleanup/cleanup~.pdf.

European Union. (2004). Available at http://europa.eu.int/index_en.htm.

International Organization for Standardization. (2004). Available at http://www.iso.org/iso/en/aboutiso/introduction/index.html#four.

Morris, Jane Anne. (1998). "Sheep in Wolf's Clothing." By What Authority 1(1). Available at http://www.poclad.org/bwa/fall98.htm.

Office of Management and Budget. (2003). "Report to Congress on the Costs and Benefits of Federal Regulations" Available at http://www.whitehouse.gov/omb/inforeg/2003_cost-ben_final_rpt.pdf.

Office of Management and Budget, Office of Information and Regulatory Affairs. (2004). Available at http://whitehouse.gov/omb/inforeg/Chap1.htm.

United Nations. (2004). Available at http://www.un.org/english/.

United Nations Suppression of Terrorism Regulations. Available at http://www.fin.gc.ca/news01/01-082e.html.