(2) The hazards to public health which may result from widespread use of 2,4-D and 2,4,5-T in populated areas.

My colleague, Mr. James Turner, will discuss the profound implications which the 2,4,5-T-2,4-D case has for the effectiveness of Government efforts to protect the public from pesticide hazards.

2,4,5-T was developed from research done at the Chemical and Biological Warfare Center at Fort Detrick during the 1940's. It has been massively applied to the human environment for 20 years, but until very recently no studies have been conducted by any Government agency on the possible carcinogenic, mutagenic, or teratogenic properties of this herbicide, or on the ecological consequences of its use. In 1966 the Bionetics Laboratory was commissioned by the National Cancer Institute to begin research into the birth defect properties of a variety of pesticides and herbicides, including 2,4-D and 2,4,5-T. By 1968 these tests had revealed substantial evidence that 2,4,5-T caused birth defects in test animals. In February of 1969, the preliminary results from the Bionetics testing were to be presented to the annual meeting of the American Society of Toxicology. The report included tests results which showed that 2,4-D and 2,4,5-T cause gross abnormalities and birth defects in mice. 2,4-D was termed "potentially dangerous, but needing further study," while 2,4,5-T was labeled "probably dangerous." This report would have provided an early warning on potential hazards from these herbicides, but for reasons still unknown, the Bionetics presentation was canceled at the last minute, although its paper was listed on the printed agenda of the meeting. The Bionetics report thereafter returned to obscurity. Only a few scientists in the Government knew of its existence. Even members of the Mrak Commission Panel on Teratogenicity were initially rebuffed when they asked to see the report. The report, however, had been presented to selected officials in the Food and Drug Administration, the U.S. Department of Agriculture, and the Defense Department. These delays contradict the recommendation of the Mrak report that "any teratogenic pesticide to which the population is exposed should be promptly identified so that appropriate precautions can be taken to prevent risk of human exposure "(p. 657).

On October 29, after the existence of the report finally became public (it has still not been officially released), Dr. Lee Dubridge, the Science Adviser to the President, announced that "a coordinated series of actions" was being undertaken by several Federal agencies to ban the use of 2,4,5-T on food crops and Government use of the herbicide in populated areas. Dr. Dubridge stated that these actions were being taken to "assure the safety of the public while further evidence is sought." The ban on use of 2,4,5-T on crops was to go into effect on January 1, 1970 unless by that time the FDA had found a means to establish safe residue tolerances. Apparently because Dr. Dubridge estimated that "almost none (of 2,4,5-T) is used by home gardeners, or in residential areas," nothing was said about stopping individual consumers from using 2,4,5-T in their own backyards.

The Department of Interior did follow Dr. Dubridge's recommendation and ceased the use of 2,4,5-T in its operations. The deadline

of January 1, 1970, passed without FDA setting a tolerance. By late January, it was clear that the Department of Agriculture and other Federal agencies (with the exception of Interior) had no intention of restricting the use of 2,4,5-T. On February 6, the Department of Agriculture announced that the original 2,4,5-T used in the Bionetics test had been contaminated with a tetradioxin and that further testing with a purer batch of 2,4,5-T had shown no adverse effect. The Department relied on tests conducted by the Dow Chemical Co., a major manufacturer of 2,4,5-T. The Dow evidence was immediately contradicted by tests conducted at several other Federal agencies which clearly showed that even the purest 2,4,5-T, where the dioxin contaminant was present at less than one part per million, still produced birth defects in test animals at significant levels. Recent tests on 2,4-D conducted by the FDA have confirmed that this herbicide, which is very often mixed with 2,4,5-T, is also teratogenic. Many other questions with significance for public health remain to be answered: How persistent are 2,4,5-T and 2,4-D once applied? How persistent is the dioxin contaminant? Is it cumulative in human tissue? How much dioxin is present in herbicides already on the shelves of local hardware stores?

Therefore, Mr. Chairman, 5 months after Dr. Dubridge urged that most uses of 2,4,5-T be banned to "assure the safety of the public while further evidence is sought," these herbicides continue to be teratogenic and are as widely used as ever. The most recent tests provide the "further evidence" Dr. Dubridge asked for. The burden of proof on those who wish to demonstrate the safety of these herbicides has greatly expanded since the first Bionetics test.

When tests indicate that a pesticide is teratogenic in animals, the burden of proving that it is safe should be placed on the manufacturers of the pesticide, not on its possible victims in the general population. If the manufacturers do not cooperate, the Federal Government has a statutory responsibility to minimize human exposure to teratogenic pesticides by appropriate regulatory preventive action. The Government must not fail in its trust, for nationwide statistics on birth defects are so inadequate that even an increase of several thousand deformities could probably go undetected. Therefore, if Government and industry act irresponsibly, there will probably be few complaints from the medical profession or the general public to call them to task.

Present population monitoring techniques do not provide adequate gages of the incidence of birth defects in the population. Federal regulators charged with protecting the public from pesticide hazards are being very irresponsible if they assume, as did Dr. Lindsey of the Food and Drug Administration in a recent interview that, "the National Institute of Neurological Disease and Stroke has recorded birth defects for some 15 years and would be telling us if they were on the rise." Dr. Hines Berendes, Chief of NINDS Perinatal Research Branch, has unhappily conceded that, "no nationwide data are available on the frequency or incidence of malformation.” 1 Even in States where birth certificates request that doctors record birth defects, the completeness and accuracy of the reporting depends on

1

* Medical World News, Feb 27, 1970

the interest and diligence of the physician and on the conspicuousness of the abnormality. Nationally, no attempt has been made to collect and evaluate all the data on birth defects that are presently available on birth certificates. After careful study of this problem, the writers of the Mrak report concluded that "epidemiologic data on possible effects of pesticides on human reproduction and teratologf are grossly inadequate." 2

The Mrak Commission report states that when animal experiments indicate that a pesticide is teratogenic, the effect should be retrospectively evaluated when possible by a study of pregnancies during which the mothers were inadvertently exposed to the pesticide, such as in farmwork and industrial exposure and through accidental ingestion. As far as we know, this has not been done for 2,4,5-T and other weedkillers. Because of the need to minimize human exposure, it is not possible to test on human populations pesticides previously shown to be teratogenic by experimental animal studies.

The Mrak report states unequivocally that there is little comfort to be gained from the expectation that present epidemiological surveys of pesticides in current use will discover in time chemical compounds causing birth defects. It states that no major teratogen (term for substance causing birth defects) has been discovered in this way. The malformations induced by X-rays, german measles, thalidomide, and mercury were each recognized by "an alert medical practitioner who observed a cluster of cases and then traced the cause to its source."3 Tracing observed defects to a specified cause is much more difficult when the defect commonly occurs. In the case of 2,4,5-T, the most common defects produced in test animals are kidney abnormalities and cleft palates, neither of which is unusual in humans. Had thalidomide produced such ordinary malformations instead of bizarre and unusual ones, it probably would never have been discovered. Thus any birth defects produced by human exposure to 2,4,5-T are unlikely to be traced to the weedkiller because they are already common in the population.

If 2,4,5-T and 2,4-D, as commonly used in populated areas, do produce birth defects in humans, the birth defects will remain a very private family tragedy. Because 2,4,5-T leaves no unique fingerprints on the fetus to indicate its specific role as the teratogen, the parents of the deformed child would probably remain silent, with no knowledge of the cause of their distress, They would probably never know that they belong to a class of victims of a preventable tragedy. There is another reason why Government has a special responsibility here to protect the public. Because a 2,4,5-T or 2,4-D induced birth defect is not unique, the parents of deformed children will have great difficulty in using the courts to discipline the manufacturers of dangerous herbicides. The parents will gain no compensation for their loss. Moreover, there will be no lawsuits to force the chemical companies to test more thoroughly their products for teratogenic effects before they are released on the market or to maintain strict quality control standards which will keep the level of contami

= Report of the Secretary's Commission on Pesticides (the Mrak report, U.S. Department of Health, Education, and Welfare. December 1969, p. 674. Mrak report, p. 661.

nation of dangerous dioxins as low as possible. In the absence of legal remedies for private citizens, protection must come from the Federal Government.

As a first step, we suggest that the committee consider the recommendation of the Mrak Commission that efforts must be made to improve and use information on congenital malformations recorded on birth certificates and that new systems of collecting birth defect data be established.

POTENTIAL HAZARDS FROM CONSUMER USE OF TERATOGENIC
HERBICIDES IN RESIDENTIAL AREAS

Weed-killers containing 2,4,5-T are readily available to the home gardener. These products come both as premixed, ready-to-use liquid, spray or dust, and as liquid preparations which the user dilutes at home, or uses with the garden hose atomizer. The concentrated liquids are obviously the most dangerous.

Last week two of my assistants made a survey of herbicide products in 10 Washington area stores: Eight hardware stores, including Meenehans, Sears, Hechingers, McIntyre, Community Paint and Hardware, Kresge's at 7th and Pennsylvania, Chevy Chase Hardware; one grocery store, the Giant at Western Ave. and Wisconsin; and one gardening store, Sheridan Garden Store on Old Georgetown Road.

My assistants found the following:

(1) Eight of the stores carried lawn and garden weedkillers containing 2,4,5-T, nine of the stores carried product lines which included 2,4,5-T products. All of the stores carried weed-killers containing 2,4-D. They found nine product lines containing 2,4-D; six with 2,4,5-T.

(2) In addition to 2,4-D and 2,4,5-T, at least seven of these stores carried all but one of the other products cited in the Bionetics Report as at least potentially causes of birth defects: Captan, Folpet, Sevin; as well as organo-mercurial products which have been known to produce birth defects in humans since an epidemic in Japan led to their being banned in that country.*

(3) Some of the products, the Scotts line in particular, were very badly packaged. Most Scotts products and some others are packaged in flimsy paper bags; a number of the bags which my assistants examined were in such bad repair that they could not be handled without spilling dust on the handler. As a result, there was frequently a coating of chemical dust on products nearby. In an unintended irony, most of the packages bore warnings to the user to "avoid contact with skin, eyes or clothing."

(4) A number of products and again the Scotts line in particular, were fertilizers with various herbicides added, including 2,4-D, and 2,4,5 T (in Greenfield products.) Since the contents were not very conspicuously displayed, many users might well assume that these were only "super fertilizers," and therefore not handle them with the care that their contents warranted. These products, containing a mixture of fertilizer and herbicide are heavily promoted on radio and television, with no warning of potential danger. Their names,

Mrak report, p. 661.

for example, Scotts Turf Builder Plus-1, which contains a mercurial compound, often disguise or play down the herbicide content. Mixing herbicides with fertilizer tends to identify potentially dangerous chemicals with innocuous fertilizers and promotes unnecessary, as well as careless use.

(5) The manner in which these herbicides are used magnifies their potential risk. Their labels all read: "Avoid contact with skin, eyes or clothes. Avoid inhaling dust." Yet these products are dispensed in a manner which makes contamination of the user with either dust or spray inevitable. Herbicides in dust or powder form are often applied by dumping them into a wheelbarrow with a hole in the bottom and a propeller underneath which the user pushes across his lawn raising a cloud of dust. Liquid herbicides are applied through attachments to a garden hose or through hand applicators. In both cases, contact with the spray is unavoidable. Many of these products on their packages depict homeowners spraying with bare hands and bare arms. On no products, even the most poisonous, was there any suggestion that the user wear rubber gloves. Several of the herbicides did contain the difficult instruction that children and pets be kept off the treated areas, sometimes for an unspecified amount of time, until after the area had been watered and dried or it had rained.

Whether applied in spray or dust form, the application of herbicides containing 2,4,5-T presents serious problems of drift. The report of the Subcommittee on Weeds of the National Research Council stated in 1968 that spray with "droplets of 10 microns in diameter can drift up to 1 mile when released at a height of 10 feet with a 3-mile per-hour wind." (p. 248). Even when kept in perfect condition, few nozzles used for spray application would produce uniform droplets large enough to minimize drift and yet small enough to provide even coverage. The hazards of drift, even when the herbicide is applied in dust or powder form is also great. The Department of Agriculture, in its caution suggested for use on weed-killers containing 2,4,5-T and 2,4-D, warns that "this dust may drift for miles even on quiet days." (Federal Register, May 21, 1969).

It is a conservative estimate that even on a relatively calm day children playing within 100 yards of an area where a yard is being sprayed or dusted with 2,4,5-T are probably going to be exposed to the chemical. Droplets and dust particles of 2,4,5-T can be carried by the wind into open windows and onto screen porches. In heavily populated residential areas, one simply cannot defoliate his backyard of chickweed and dandelions without running the risk of contaminating his neighbors or their children. The economic and horticultural benefits of these herbicides in residential areas do not outweigh their risks to those who wish to enjoy the outdoors without being contaminated by teratogenic spray.

(6) A few products did not bear even the minimum federally required warning, "Caution, Keep out of reach of children," which must be displayed prominently on the front. For example, Scotts Kansel Weed Killer, in a salt-shaker like container, had no warnings at all on the front, and only "Avoid contact with skin, eyes, clothing, etc." written very inconspicuously on the back. The same was true of an identically packaged Amchem Garden Weeder.

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