Regulations that work.

REGULATIONS THAT WORK

When Jonas Salk discovered a vaccine for polio, the news was welcomed by The New York Times as "one of the greatest triumphs in the history of medicine.' The serum's widespread use lowered the incidence of polio from 21,000 cases in 1952 to fewer than 900 in 1962. Thanks to Salk, proclaimed the cover of Time magazine, "generations will grow up free.'

Salk's considerable achievement drew praise because it was the work of one easily identifiable hero against a disease that was widely known and feared. We are not so quick to support great potential strides in public health when they are made by the federal government and when they take on not bacterial but man-made killers. In 1984, for example, the Environmental Protection Agency proposed a new rule to reduce the amount of lead in regular gasoline. The rule, which went into effect in March 1985, will protect an estimated 50,000 children from brain damage due to airborne lead. But because those responsible for this regulation were anonymous bureaucrats, and because the hazard being fought was not an identifiable "disease,' there were no brass bands--only a quick blip on the evening news.

Regulators have not always been quick to respond to health and safety hazards, and when they have, the results often have been disappointing. In many cases, however, the federal government has made great strides toward removing or at least reducing dangers that affect us all. These success stories have gone unsung, particularly in the present conservative climate, where it has become fashionable to denounce all regulation as inherently meddlesome. With a president in office who has shown himself unabashedly hostile to regulation and a Congress entering the tightfisted era of Gramm-Rudman, it's worth considering instances where federal regulators, no less than Dr. Salk, have saved American lives. Herewith, we submit ten regulations that have made a difference.

I. Safe Drugs: Pre-Market Testing

There's a reason why you cannot buy "Hamlin's Wizard Oil' or "Warner's Safe Cure for Diabetes' at your corner drug store. Nearly 50 years ago, the Food and Drug Administration determined that these once-popular "medicines' were worthless and banned their sale. Ever since, consumers have been spared costly frauds and, more importantly, serious illness, drug addiction, blindness, and death caused by quack medicines.

In 1938, 100 people, many of them children, experienced slow, agonizing deaths from a special elixir used to treat streptococcal infection. The next year Congress gave the FDA authority to review and approve drugs before they go on the market. The FDA now requires the pharmaceutical companies to perform rigorous tests, the results of which the FDA scientists review. Although drug companies often complain about the lengthy process, the FDA's drug approval system has saved thousands of lives and prevented millions of adverse drug reactions.

Between 1959 and 1961, for example, approximately 10,000 babies in more than 20 countries were born with serious deformities because their mothers had taken a new sedative, thalidomide, during pregnancy. American women who obtained the medicine from Canada and Europe or participated in investigational tests were affected as well. A skeptical FDA medical officer withheld full approval, preventing tens of thousands of birth defects in the U.S. The FDA has screened out other medications that have caused deaths and injuries overseas. For example, it refused to approve isoproterenol inhalers--used to relieve asthma--which caused the death of 3,500 children in England and Wales in the 1960s. It also banned Stalinon, an ineffective treatment for boils that killed more than a hundred patients in a small French town in 1954, and Aminorex, an appetite suppressant marketed in Europe, which caused an epidemic of primary pulmonary hypertension and 26 deaths.

II. Safe Food: Slaughterhouse Inspections

The serious problems with meat slaughterhouses and packinghouses first came to public attention in the early 1900s when Upton Sinclair's muckraking novel, The Jungle, and subsequent congressional hearings revealed revolting conditions: filth on meat, standing water that could breed disease, inadequate toilet facilities for workers, and meat-borne diseases. Much of the burden for preventing such conditions falls on the Department of Agriculture (USDA) slaughterhouse inspection program. First, the department must approve the blueprints of a new plant to ensure that it meets sanitation standards. Water supplies, for example, must be safe from contamination, and slaughterhouses no longer may have wooden floors, which can rot, spawning disease. USDA inspectors check cattle, sheep, swine, goats, and other livestock for diseases that may be difficult to detect after slaughter, like rabies and listeriosis. For the slaughter, the USDA stipulates methods that are both sanitary and humane. Don Houston, administrator of the Food Safety and Inspection Service, notes, "We have very specific procedures that a company must follow to make sure that manure is not released on the carcass. For certain cuts, you have to tie off certain body orifices, etc.' To be sure that the standards are adhered to, USDA inspects carcasses after the slaughter.

Data on diseased carcasses is collected daily and fed into the USDA's Livestock Disease Reporting System, which monitors disease patterns and checks how thoroughly inspections are being performed. With this specific information, inspectors can identify diseases that are confined to certain parts of the country or breeds of livestock.

Budget cuts have reduced the Food Safety and Inspection Service inspector corps by 300 to roughly 7,300, while the number of plants they need to inspect has gone up by 200.

III. Safe Cars: Auto Recalls

Before 1966, auto manufacturers who produced defective cars had nothing to fear from the federal government. Only state product liability laws put pressure on them to warn consumers or to correct defects, and the pressure was minimal. When cars needed to be recalled, a manufacturer simply sent letters to customers suggesting that they take advantage of the company's "customer relations program' to bring their cars to the dealer for a general checkup; no mention was made of a defect that might threaten the car owners' safety.

Since the creation of the National Highway Traffic Safety Administration (NHTSA) in 1966, the industry no longer can leave motorists in the dark. Automakers must now inform each car owner specifically about safety-defect recalls. During the Carter administration, the NHTSA set up a toll-free hotline for car owners to find out if their automobile, or any of its components, has been recalled. They can also use the hotline to report a problem with their car. By compiling defect complaints by year, model, and make of vehicle and combining this data with the hundred thousand or more complaint letters the agency receives each year, the NHTSA can spot previously undetected problems. When a number of similar complaints are lodged, the agency begins an investigation that may lead to a recall.

Recalls have had a direct impact on public safety. Since 1966 more than 100 million vehicles and equipment with potentially dangerous defects have been recalled by manufacturers. For example, NHTSA forced the recall of eight million Firestone 500 tires after it had documented at least 50 deaths and several hundred injuries resulting from a design defect in which the steel belt did not bond to the tire carcass.

Unfortunately, today recalls rarely make the news. Since Reagan took office, NHTSA has made an average of 154 recalls annually for six million automobiles compared to an average of 244 recalls for 7.2 million automobiles in the previous ten years.

IV. Safe Driving: Motorcycle Helmets, Seat Belts, and Air Bags

The probability of a motorcyclist being killed is 10 to 15 times greater per mile than that of a passenger in an automobile, and about 70 percent of motorcycle fatalities are from head injuries. One way to fight these grim odds is to wear a helmet: unhelmeted riders are at least three times more likely to incur a fatal head injury than helmeted riders. In 1966 the NHTSA started leaning on the states to require motorcyclists to wear helmets. States that failed to enact helmet laws could be penalized by reductions in precious federal highway funds. By the end of 1975, all but three states had complied.

The success of this regulation is, sadly, easy to measure. In 1976, Congress struck the helmet law requirement from the books, allowing states to repeal their helmet laws without loss of federal funds. Over the next three years, deaths from motorcycle crashes jumped 48 percent, or 1,832 more fatalities, a disproportionate number occurring in the 27 states that had either repealed or weakened their helmet laws. Only then did states take the message to heart and stop repealing the laws. Libertarians point to motorcycle helmet laws as an example of government intrusion into personal decision-making. The real question, though, is whether it is in society's interest to pass a law that can save 1,832 lives.

In 1974 the Department of Transportation took a major step toward protecting car passengers by requiring air bags or automatic seat belts. But as the federal government retreated from motorcycle helmet laws, it also tried to dump the passive restraint standard. After the U.S. Supreme Court, in 1983, overruled Reagan and ordered the federal standard reissued, Reagan added a new twist. Transportation Secretary Elizabeth Dole announced that the requirement would be rescinded if states comprising two thirds of the population passed by April 1989 seatbelt laws that meet certain criteria. The auto industry has launched a $20 million campaign to enact the laws and avoid the passive restraint requirement.

Twenty states have passed seatbelt laws, but none of the laws meet the minimum criteria. The Insurance Institute for Highway Safety estimates that in New York, the first state to pass a mandatory seatbelt law, motor vehicle fatalities declined by 9 percent in the first nine months after passage (that is 75 lives saved). It is estimated that, if instituted nationally, seatbelt laws could save 4,400 deaths and prevent 73,000 injuries annually. But statistics from the states that have passed the laws show an increase in seatbelt use immediately after passage and then a decline as enforcement slackens. Usage averages below 50 percent.

While seatbelts are better than nothing, air bags offer protection to car occupants who do not use seatbelts (teenagers and drunk drivers are least likely to wear seatbelts and most likely to have an accident) and provide those who do wear seatbelts the head and facial protection needed in a crash over 20 miles per hour. Passive restraints (including air bags) could save 9,000 lives and prevent more than 150,000 injuries annually, twice the estimates for seatbelts alone.

V. Clean Air: Industrial Pollution

Before the 1970 Clean Air Act, American industry dismissed air pollution as either negligible or the inevitable price of progress. "Particulates' --better known as smoke, soot, and invisible dust --poured into the air, aggravating asthma and heart disease and carrying carcinogens, toxic gases, and heavy metals into people's respiratory systems. Electric utilities burned high-sulfur coal and oil; owners of apartment buildings vented incinerator smoke into the open skies; factories, refineries, printing plants, and other industrial enterprises had become so accustomed to pollution-prone production methods that the prospect of cleaning up the air seemed unlikely.

In barely a decade, though, the EPA has made dramatic progress in cleaning up the air. The particulate levels in Birmingham, Alabama, for example, were more than double the primary health standard in 1972. By mid-1976, annual emissions from stationary sources had dropped 83 percent, from 155,000 tons to 26,000 tons. Sulfur dioxide levels in Washington, D.C. are now half their 1960 levels and the pulp and paper mills of New Hampshire and Maine pour less than one-tenth of the particulates into the air than they did prior to 1970.

The EPA has three tools for reducing air polution. The "new source performance standards' require that a new factory have the most modern pollution control devices. As new plants with stricter controls gradually replace old ones with less effective, obsolete controls, a region's air quality improves over time. The EPA established industry-by-industry standards, but in 1982 the Reagan administration removed 12 types of industries from the list of those needing regulation.

The "emissions offsets' require that if a company in an already highly polluted area is opening a new facility that will increase the pollution, it has to reduce pollution within its existing facility or convince another polluter to reduce its output. Thus, when General Motors proposed a new assembly plant in Oklahoma City, it, with the help of local officials, paid local oil companies to reduce their pollution emissions. The offset policy successfully allows polluters to establish a market price for "pollution rights.' Air pollution has become a commodity that companies can buy, sell, trade, and even bank, and businesses have an incentive to efficiently meet the EPA's pollution standards. The Reagan administration, however, has drastically weakened the offset program. By making some changes within the regulations, the administration has enabled companies to get away with increasing the pollution level a certain amount and not having to use state-of-the-art pollution control technology.

The third tool is the EPA's "prevention of significant deterioration' program, which keeps industries that dislike strict cleanup requirements in one state from relocating to cleaner regions of the country and start polluting there. The EPA requires industries to abide by especially tough pollution standards in areas without major pollution problems.

VI. Clean Air: Lead Standards

Lead can cause irreversible brain damage, kidney problems, anemia, mental retardation, seizures, and even death. Children are especially vulnerable, particularly those from poor families, who are more exposed to peeling paint and automobile pollution. (They are also likelier to suffer from poor nutrition, which aggravates the effects of lead poisoning.) Lead poisoning kills several hundred children each year and causes learning deficiencies in thousands more.

Because lead is a multi-source pollutant--it is transmitted through the air and in food, paint, and soil--the federal government's response has had to take several forms. With prodding by the FDA, food manufacturers voluntarily have reduced the amount of lead in metal containers or have switched to glass containers when possible. The FDA has put special emphasis on packaging foods for babies and young children in lead-free containers. As a result, there was an approximately 40 percent decrease in the amount of lead in canned foods from 1977 through 1982.

The fight against lead in paint has been a mixed success. On the one hand, the Lead-Based Paint Poisoning Prevention Act of 1971 has reduced the lead content of new paint products to .06 percent. (During the 1950s the lead content of house paint was as high as 60 percent.) On the other hand, 28 million buildings remain with walls covered by lead-based paint. The act directed a federal effort to reduce lead hazards in existing buildings, but this has been hampered by scientific uncertainties, limited funding, and the magnitude of the problem. Environmental Action reports that more than one half of the 61 cities that had lead testing programs in 1981 have had their funding reduced and 14 cities have eliminated their programs.

It is in the battle against airborne lead that regulators have been most successful. Airborne lead has been the easiest to control because 80 percent originates from one source--motor vehicle exhaust. For decades, auto emissions contained lead because gasoline refiners found it a cheap, simple way to boost the octane of low-grade fuels to prevent engine knocking. Lead probably would have remained the octane-booster of choice if Congress hadn't decided to clean up the nation's air. When it was discovered that only a few tankfuls of leaded gasoline could ruin the most promising emission-control device --the catalytic converter--it was clear that lead would have to be controlled. So, starting in 1975, when new cars were required to be equipped with catalytic converters, refiners were forced to invest in technology to produce high-octane gasoline without lead. By 1984 only 45 percent of the gasoline sold in the nation was leaded. Under current law, this figure is expected to drop to 18 percent by 1990, as pre-1975 cars are retired from use.

But the EPA wasn't interested just in protecting its catalytic converters; it also was concerned about reducing the amount of lead in the air. So in 1973 the agency initiated regulations requiring a progressive reduction in the lead content of "regular' (leaded) gasoline as well. By March 1985 the EPA had set the acceptable level of lead in regular gasoline at 0.1 gram per gallon--down from 2.2 grams per gallon prior to 1973. The agency has proposed regulations banning all lead in gasoline in 1988; the true test of its commitment to reducing lead content is whether it issues the final regulation. This would help prevent more than 1,000 strokes and 5,000 heart attacks among those who suffer from high blood pressure.

While lead exposure remains a serious health problem, the switch to unleaded gasoline and the reduction of lead content in regular gasoline have made the air safer to breathe, especially in urban areas. In a study conducted between 1976 and 1980, the Centers for Disease Control found a remarkable 36.7 percent decline in the overall mean blood-lead level in the U.S. population.

One other benefit: cars that run on unleaded gasoline can run three to five times longer without an oil change. A 1984 EPA study estimated that reduction of lead to 0.1 gram per gallon could save car owners as much as $660 million annually in auto maintenance costs.

VII. Clean Water: Technology Standards

By the late 1960s it had become apparent that existing environmental laws had not prevented rampant abuse of the nation's waters. The food, textile, paper, chemical, coal, oil, rubber, metals, machinery, and transportation industries were spewing out an estimated 25 trillion gallons of waste water each year. In one notorious case, the Reserve Mining Company of northern Minnesota was dumping an average of 67,000 tons of iron ore tailings into Lake Superior daily.

Galvanized by the glare of public attention and concern, Congress in 1972 approved amendments to the Federal Water Pollution Control Act that fundamentally changed the way the government regulates water pollution. Previously, states had set water quality standards for individual bodies of water. Although logical in theory, in practice that approach resulted only in protracted battles over the definition of standards and little progress. The 1972 amendments cut through this regulatory Gordian knot by establishing uniform, technology-based standards. The amendments authorized construction of sewage treatment plants and required industry to use the "best practicable technology' to control pollution and to apply to local environmental agencies for dumping permits.

Less than a decade later, dramatic improvements were visible throughout the country. Lake Erie, once considered dead, now attracts hundreds of thousands of fishermen each year. The Detroit River also had been considered a dead river after years of absorbing sewage, chemicals, oil, acid, garbage, and paper sludge. A quarter-inch film of oil covered much of the shoreline and large greaseballs frequently washed ashore. By 1975, the discharge of oil and grease into the river was reduced an estimated 82 percent from 1963 levels. In all, from 1972 to 1977 the regulations reduced industrial discharge of six major pollutants by 69 percent or more. The Clean Water Act reauthorization is now before a House-Senate conference committee; the Reagan administration has threatened to veto the bill unless it phases out the program to build sewage treatment facilities.

VIII. Workplace Safety: Asbestos

Prior to the 1970 creation of the Occupational Safety and Health Administration (OSHA), government and industry contended that they held little responsibility for the 14,000 workers who were killed and the two million who were disabled in industrial accidents every year. OSHA changed that, issuing regulations under the belief that companies have a responsibility to remove unreasonable workplace hazards.

Among the most significant OSHA regulations are those limiting worker exposure to asbestos. Airborne asbestos fibers can cause cancer and asbestosis, a lung disease that resembles emphysema. Because asbestos was unregulated until 1972, an estimated 8,200 to 9,700 workers will die each year during the rest of this century from asbestos-related cancers.

In 1972, in response to overwhelming medical evidence and a petition from the AFL-CIO, OSHA limited asbestos dust levels in the workplace to two million fibers per cubic meter. A study issued in 1975 showed that the regulation was saving hundreds, and perhaps thousands, of lives each year. Unfortunately another study showed that a cancer risk continued at levels as low as 100,000 fibers per cubic meter.

The Reagan administration was uninterested in toughening the asbestos standards until the EPA scandals of 1983 focused attention on its environmental record. In 1984, one standard was proposed but then struck down in court. OSHA has since proposed a new, permanent standard of 200,000 fibers per cubic meter. If this limit goes into effect and is properly enforced, thousands of workers will be spared an unnecessary cancer risk. Even the weak asbestos standards in effect, however, probably will not be well enforced if the administration's past OSHA record is any indication. A 1984 study showed that OSHA's inspection record had improved since the early days of the administration, but there are still serious gaps. Follow-up inspections, for example, were down 87 percent from the Carter administration and penalties for serious health and safety violations had declined 33 percent.

IX. Workplace Safety: Vinyl Chloride 

Vinyl chloride and a related resin, polyvinyl chloride, both found in plastics, can cause liver cancer. In 1972 about 10,000 workers were routinely exposed to vinyl chloride, while the emissions from the plants endangered those who lived within a five-mile radius. The general public was exposed to vinyl chloride through plastic bottles, plastic wrap, hair spray, insecticides, and disinfectants.

In 1972, again responding to a petition from the AFL-CIO (and one from the United Rubber Workers), OSHA reduced the permissible exposure level of vinyl chloride from 500 parts to one part per million. The affected companies protested that the regulation would cost them $90 billion and that thousands of workers would be thrown out of work. In fact, the changes required ended up costing only $300 million and no jobs were lost. And the technology developed to comply with the standard actually improved productivity. One study predicted that there would be 2,000 fewer cancer dealths in the last quarter of this century as a result of the regulation.

X. Safe Products: Hazards to Children

The most conscientious parent cannot detect every hazard in poorly designed playground equipment, cribs, and infant strollers. And even when parents are not as vigilant as they should be, their children shouldn't be the ones to suffer. That is why, contrary to the antiregulatory cries of the "pro-family' conservatives, few federal agencies can surpass the Consumer Product Safety Commission (CPSC) for serving and protecting children.

In the 1920s only one out of ten childhood dealths was due to accidental injury. By the 1970s the ratio had risen to one in three. While this increase in part reflects a decline in disease-related deaths, it also reflects the proliferation of new products over the past 60 years.

The CPSC requires that drugs, furniture polish, drain cleaners, paint solvents, and vitamins containing iron be sold in containers with child-resistant safety caps. In 1981 one doctor told a congressional committee, "A decade ago, before safety packaging was really efficiently introduced, 500 children under the age of five died annually. In 1977, 51 children died.' According to the CPSC, aspirin deaths alone were down more than 83 percent seven years after the child-proof container regulations were adopted.

Other hazards to children that have been reduced by CPSC regulations:

Crib rails were sometimes so low that babies could fall to the floor; in some cribs the spaces between spindles and slats were just large enough for a baby's head to slip through, creating the danger of strangulation; some cribs had ill-fitting mattresses, which could lead to suffocation. To prevent these dangers, CPSC regulations have saved an estimated 50 lives a year, cutting design-related crib deaths in half.

Playpens have safer folding mechanisms and have been redesigned to reduce the chances of asphyxiation from webbing or padded vinyl top rails. These voluntary regulations are expected to eliminate some 1,190 serious injuries annually.

Strollers are now more stable and have locking devices that are less likely to crush infants' hands. The voluntary standards will prevent approximately 8,000 injuries a year.

Pacifiers used to be extremely hazardous. In 1978, after some infants choked to death, the CPSC issued standards for pacifiers and banned those that failed to meet them. More recently, the CPSC got manufacturers to reduce significantly or eliminate cancer-causing nitrosamines in pacifiers.

Despite the success of this tiny, $36 million commission, in 1981 the Reagan administration, arguing that the market would ensure product safety, unsuccessfully proposed abolishing it and has since moved to cut back its funding. Since Reagan came into office, the CPSC staff has been reduced by 41 percent. From 1981 to 1983 inspections dropped 45 percent, recalls decreased by two-thirds, and investigations of injuries declined 28 percent. The commission also has had to scale back efforts to make upholstery flame-retardant and kerosene heaters safer.

In addition to restoring the inspectors to the CPSC, Congress could take an inexpensive but effective step toward protecting children by requiring toy manufacturers to describe on box labels what hazards a product might pose to children. Currently, manufacturers must list recommended ages, but do not have to explain, for example, that young children may gag on pieces from a rattle.

Ethics Not Dollars

The Reagan administration has launched a full-scale attack on health and safety protections that save lives and prevent injuries. Often the administration's approach has been to revoke these regulations on the grounds that there are less costly solutions. The ascendency of the economic paradigm in assessing federal regulation tends to obliterate the memory of why regulations are needed in the first place. It seeks to substitute a specious economic test for a distinctly moral criterion for regulation--prevention of human and environmental harm.

While conservative critics of regulation might view this notion of regulation as quaint and uninformed, it is the underlying reason why public support for specific regulatory programs remains so strong. A 1982 Louis Harris survey found: "Anti-regulation opinion outnumbers opinion favoring more regulation by a ratio of two to one. However, this indicator of opinion at a general or abstract level does not translate into public disfavor with all concrete forms of regulation. Quite the contrary, consumers strongly support specific types of regulation. . . . Virtually no support is found for rolling back or dismantling consumer protection regulation.'