The solution of an environmental problem frequently involves trade-offs that were not apparent when consumers first took up the issue and demanded action. Household detergents are a case in point. When environmental groups charged that the phosphates in detergents were killing our lakes and streams, many consumers demanded that phosphates be eliminated. But the substitutes for phosphate turned out to present a potential danger to the consumers themselves, and FDA's Bureau of Product Safety had to move in under the provisions of the Federal Hazardous Substances Act.

FDA was able to minimize the hazards by assessing the products and requiring that their labeling warn the householder to exercise caution in their use and storage. Some judged too dangerous were seized, and FDA stands ready to ban any for which no warning label would be adequate.

The original popularity of detergents containing phosphates was based on their superiority over conventional soaps in cleaning ability; they quickly supplanted soaps as the primary home laundry and cleaning product. Another positive aspect of these detergents, less widely known,

is that with few exceptions theylike soaps-constitute only a minor threat to human health if accidentally ingested.

Approximately 5,200 cases of human ingestion of detergents and household cleaners are reported annually on a nationwide basis by the network of Poison Control Centers coordinated by the Food and Drug Administration. These reports are estimated to represent a ninth to a seventh of the actual number of ingestions. Few of these reports have noted illness or injury; and of the one or two reported deaths that were attributed to detergents, phosphate was not considered the ingredient responsible.

In early 1970, however, widely publicized reports charged that phosphates from detergents, as well as from other sources, were causing extensive damage to the Nation's water

resources.

When it ends up in a lake, for example, the phosphorus in detergents adds to the naturally existing supply of this key nutrient necessary for the growth of algae. Lavish proliferation of algae is the most visible sign of the first phase of eutrophication, a process in which a lake is gradually transformed, first into a slime-cov

of phosphate detergents were nullified by the pollution charges. Environmentalists and consumer groups demanded the immediate removal of phosphates from detergent formulations. Several State governments prohibited the sale of highphosphate detergents, and a few local governments banned the sale of detergents containing any phosphate.

Manufacturers, responding to this public demand, have offered newly formulated detergents with silicates, carbonates, borates, and citrates substituted for all or part of the phosphorus in the product. The new nonphosphate or low-phosphate detergents, in that they seem to reduce the environmental hazard, provide one possible solution to an understandably worrisome problem.

problem, it a responsibility for consumer protection under the Federal Hazardous Substances Act, to which home laundry, washing, and cleaning products are subject. Toxicologists at the FDA's Bureau of Product Safety learned that some of the new formulations containing certain of the highly alkaline carbonates and silicates were corrosive to the skin, eyes, and mucous membranes, and were toxic in their corrosive effect on the esophagus and stomach.

The Federal Hazardous Substances Act requires products that are toxic, corrosive, irritating, sensitizing, flammable, radioactive, or stored under pressure to carry suitable and prominently displayed warnings on their labels describing the hazard and providing first-aid information.

The law also provides authority to ban any product from sale for use in the home if it is found to be so hazardous that cautionary labeling is inadequate to prevent serious illness or injury.

Under the provisions of the Poison Prevention Packaging Act of 1970, the FDA also can require special packaging, such as safety closures, for substances that present a potential hazard to young children because of the way the product is packaged.

The Bureau of Product Safety felt that the wide availability of some of these new detergent formulations might sharply increase the number and severity of illnesses and injuries attributable to accidental exposure to household detergents. Of particular concern was the danger of accidental ingestion of detergent products by small children.

Consequently, since early 1971, the Bureau has examined over 100 of the estimated 200 detergent products currently on the market to assure that, if they are hazardous, their

labels will bear appropriate warnings for safe use. Limited Bureau facilities and resources and the numerous tests required for each product (an average of 15 separate tests per product) make this an extended project, and one that will continue as long as manufacturers keep changing detergent formulations.

If a marketed detergent product is found to violate the Federal Hazardous Substances Act, the Bureau has a number of alternatives available. The manufacturer or distributor can be directed to adequately label future production, a procedure

In 1971, three detergents were removed from the market by seizure after testing showed them to be toxic, corrosive to the skin, and irritating to the eyes.

In addition, persons violating any of the requirements of the Act may be subject to injunction or prosecution.

To this date, it has not been necessary for FDA to ban any household detergent. This sanction, however, will be invoked if a detergent proves so toxic or corrosive that it constitutes a serious hazard despite any warning labeling that could be devised.

continuing detergent survey. Occasionally a manufacturer will be asked to voluntarily recall his product or remove it from sale until it is relabeled to meet the requirements. FDA can also warn the public directly of a potential hazard through the news media.

Products can be seized when a serious hazard exists or when other compliance actions are unsuccessful.

Product Safety have met frequently with manufacturers throughout the country, advising them of the requirements of the law. As a result, some products have been reformulated and others relabeled.

FDA has not recommended any particular class of detergents to consumers. It has left the choice of purchasing phosphate or nonphosphate

detergents to the individual buyer. Some State and local jurisdictions are maintaining a ban on phosphate formulations, however.

The choice is becoming more academic. Most of today's reformulated detergents consist of a reduced percentage of the highly alkaline silicates and carbonates combined with phosphate used at lower concentrations.

As long as formulations that may be toxic or corrosive are used, the Bureau of Product Safety will continue its testing to insure that any detergent marketed will be labeled properly for safe use.

But a warning label, no matter how strongly worded, cannot be effective if it's ignored. The final responsibility for the safe use of detergents rests with consumers. Parents of small children are especially responsible for reading and heeding warning labels to protect those who can't understand them.

Robert Burke is a writer-editor in FDA's Bureau of Product Safety.

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We are responsible for making sure that the vaccines available to the American public are safe, effective, and properly labeled. Our control is over the manufacturer. We begin by monitoring his work during the experimental phase. Then he must apply for a license for his establishment and a separate license for each product that he proposes to manufacture.

To obtain the licenses, he must be inspected and must have demonstrated his capability to make a product that will meet all standards. His staff, buildings, equipment, and methods are all evaluated. Even after the licenses have been issued, he must submit complete records and samples to us from each batch of vaccine prepared. To maintain his licenses to manufacture, he must be reinspected one or more times annually.

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In past years our control was exercised by the same licensing mechanism applied to vaccines, but was limited to those products involved in interstate shipment. This covered establishments processing 60 to 70 percent of the blood collected each year.

Since becoming a part of the FDA, we have begun the process of extending our control to the smaller intrastate blood banks as well. The mechanism here is a little different, since it is based on the provisions of the Federal Food, Drug, and Cosmetic Act rather than the licensing authority of the Public Health Service Act.

our big projects and one that we're very enthusiastic about. To explain it briefly, biologicals were regulated under the Public Health Service Act, which did not give the Division of Biologics Standards specific authority to assure that these products would be effective. They could only require safety, purity, and potency—and a potent product is not necessarily effective.

Obviously, the effectiveness of any product is fundamental, both to the physician and, more importantly, to the patient. After we transferred to FDA, biologicals also came under the umbrella of the Federal Food, Drug, and Cosmetic Act, which requires that each drug sold in the United States be effective. The same requirements for effectiveness could be required of biologicals, since they are legally defined as drugs. So, under the provisions of the Food, Drug, and Cosmetic Act, we are now proceeding with a systematic review of all previously licensed biological products.