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In summary, the evidence at hand appears to represent only the tip of the iceberg of the hazards of 2,4,5-T.5
FACTORS INCREASING THE DANGERS OF 2,4,5-T Drift.—The Mrak Commission has reported that, depending upon meteorological conditions, pesticides applied by airplane and by commercial spraying or fogging equipment have drifted as far as 100 miles (Exhibit 10, p. 2). In one example cited by the Commission, a dust storm originating in southern Texas carried pesticides, including 2,4,5-T, all the way to Cincinnati, Ohio (Id., p. 1). But normal weather conditions and common household spraying or dusting techniques also carry a significant threat 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 one mile when released at a height of ten feet with a 3 mile per hour wind.'
The Department of Agriculture, in its caution suggested for use on weedkillers 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. 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.” Hearings, testimony of Harrison Wellford (Exhibit 9, p. 13).
Persistence.—The hazards of 2,4,5-T persist after application because a long period of time may elapse before 2,4,5-T breaks down chemically and loses it potential for harm. In wet and warm conditions, 2,4,5-T generally takes six to eight weeks to break down and in dry and cool conditions it may take well over a year. Hearings, testimony of Dr. Westing (Exhibit 8, pp. 9–10). The Mark Commission cites three studies reporting that total degradation of 2,4,5-T required 103, 205, and 270 days, respectively (Exhibit 10, pp. 203–204).
No safe method of use. The dangers of 2,4,5-T are increased by improper application. Even the United States Forest Service, a part of ihe Department of Agriculture, has been negligent in carrying out 2,4,5-T spraying programs. The Forest Service has contaminated bodies of water and private property by spraying methods that violated the Department's own restrictions. Hearings, testimony of Congressman McCarthy (Exhibit 13, p. 3).
If professionals are negligent, it is likely that non-professionals will also be negligent. The Mark Report observes :
"Homeowners are seldom acquainted with the scientific rationale of safe application and frequently fail to read and understand the instructions contained in the label. Thus, problems of over-use and misapplication have reached the point where contamination by household pesticides may constitute a significant proportion of the total population exposure.” (Exhibit 3, pp. 3-4).
A survey in Charleston, South Carolina found:
"Both white and nonwhite families commonly ignored safety precautions in the use of household chemicals. Locked storage was not employed by 88 per cent of all families; 66 per cent stored the pesticides within easy reach of small children ; 54 per cent stored the chemicals near food or medicine; andl 66 per cent never wore protective gloves during use or washed their hands after the application." Mark Report (Id., p. 6).
So it is likely that no labeling will provide sufficient protection against improper and potentially dangerous use of 2,4,5-T. Hearings, testimony of Harrison Wellford (Exhibit 9, pp. 14-15).
Impurities.-Commercially available 2,4,5-T contains a number of impurities, One of which is 2,3,7,8-tetrachlorodibenzo-p-dioxin. Dioxin is one of the most potent teratogens and toxic substances ever discovered. Amounts as little as 2.5 parts per trillion have caused birth defects in chicks (Exhibit 23) while 9 parts per trillion were fatal to 98% of hamster fetuses. (Exhibit 13).
5 Scientific opinion against many or all uses of 2,4,5-T as well as other public and private expressions of concern over the use of 2,4,5-T are acumulating. Exhibit 24 includes a few such statements not specifically referred to in this petition. More pvidence would be available if doctors and scientists had been alerted to the hazards of 2,4,5-T at an earlier date, and if pesticide control centers compiled information identifying specific pesticides with particular accidents reported. Unfortunately, statistics on pesticide accidents, and on birth defects in general, are totally nadequate. Hearings, testimony of Harrison Wellford (Exhibit 9, pp. 17 and 6-7, respectively).
Compounding the hazards of dioxin is the fact that it, even more than 2,4,5-T, may be persistent in the environment. There is no "data on the stability of dioxin in soil, water, crops, milk and human or animal tissue." (Exhibit 12). However, the facts that dioxin is heat stable up to 800°C, has a DDT-like solubility in fats and has a cumulative toxicity in experimental animals, suggests that it may be quite persistent and may accumulate in the food chain, with extreme hazards to man. (Exhibit 12).
V. WHY THE RELIEF PETITIONED FOR IS IMPERATIVE
Immediate suspension for use on food crops
The Food and Drug Administration has ruled that a food contaminated with any detectable 2,4,5-T is “illegal and subject to seizure if found in the channels of interstate commerce.” (Exhibit 2, p. 2). But the FDA cannot sample all food in interstate commerce. The use of 2,4,5-T on food crops must necessarily leave some residues in food marketed and eaten by human beings. The only way of ensuring against such residues is to ban the use of 2,4,5-T on the crops themselves
Apples, blueberries and sugarcane were among the crops included in Dow Chemical Company's petition to FDA to establish tolerances for 2,4,5-T. These and other crops on hich 2,4,5-T is sprayed are harvested by migrant workers. Migrant families, including children and women in the early months of pregnancy, all work in the fields together. They are employed in spraying pesticides and herbicides, in harvesting the treated crops and in cleaning the fields after harvest. Given the slow breakdown of 2,4,5-T during their entire working season. Immediate suspension of use on food crops is imperative to protect their health. Nonliquid formulations
Without explanation-and without any factual basis for differentiation—the Department has exempted non-liquid formulations of 2,4,5-T for home and recreation area use from the suspension and recall order. The dangers from 2,4,5-T exist whatever its form. 2,4,5-T in dust form is easily carried for long distances by the wind. Unlike liquids, it does not soak into the ground but, in the absence of rain, remains on the ground and on plants for long periods. Suspension and recall should apply to all formulations of 2,4,5-T. No relabelling
The Department has ordered recall of the suspended products; but has left a hoophole for relabelling (Exhibit 7). That loophole should be plugged ; no product available for home or recreational area use, use on waters or use on food crops should be allowed to be sold. As this petition shows, label directions are simply inadequate to protect users and the public.
Recall is the common remedy employed to prevent substances that are found to be hazardous to human health from causing disease or injury. Recall requires the manufacturer to issue an immediate recall of the product in the distribution pipeline, down to the retail level. This remedy has been used many times by the Food and Drug Administration. It is the only effective way of making sure that no more of the dangerous substance is sold. The sanction of libel and seizure and consequent unfavorable publicity is the unpleasant alternative. Manufacturers generally cooperate with alacrity with a recall order; although now and then an exemplary seizure is required to speed cooperation. Proceedings for cancellation for all uses
According to Dr. Steinfeld's announcement (Exhibit 5), the Department proposes to begin proceedings to cancel the registration of 2,4,5-T in non-liquid formulations for home use and for use on food crops. We have petitioned for immediate suspension of 2,4,5-T for use on food crops. But we also petition for issuance of notices of cancellation of 2,4,5-T for all uses in all formulations.
The accumulating evidence of the dangers of 2,4,5-T casts serious doubt about whether it can be used safely in any circumstances. In any event, the burden of proving safety must be placed on the registrants. 2,4,5-T may be safe for certain uses if applied with proper precautions in areas where there is no chance of human contact. But the registrants should bring in evidence so proving. The only way to effect this is by issuing a blanket notice of cancellation; in advisory committee proceedings and hearings registrants can argue for and produce evidence supporting the safety of certain uses. And these petitioners should have the opportunity to participate in those proceedings.
Publication in the Federal Register
The Department has sent notices, by letter, to manufacturers and formulators of 2,4,5-T, notifying them of the partial suspension of registration. That notice is inadequate because no publication in the Federal Register is contemplated.
The Administrative Procedure Act provides that "substantive rules of general applicability adopted as authorized by law" shall be published in the Federal Register. 5 U.S.C. 552 (a). Suspension of registration of an economic poison used as widely as is 2,4,5-T is such a rule. It affects major corporations that manufacture the substance, more than 100 "formulators"—i.e., producers of mixed herbicides containing 2,4,5-T—thousands of wholesalers and jobbers of mixed thousands of retailers and millions of consumers. It affects sales of products of tens of millions of dollars. It is, therefore, a substantive rule of general applicability within the meaning of the Administrative Procedure Act.
Since actual notice of suspension has been given only to manufacturers and formulators, only they are bound by the notice. 5 U.S.C. 552(a) (1). The thousands of wholesalers and jobbers and the tens of thousands of retailers are unaffected by the notice until they receive a recall notice from their suppliers. They may therefore, in violation of FIFRA section 3a, unknowingly continue to sell 2,4,5-T to an unsuspecting public, perpetuating the dangers that the suspension has recognized.
The only appropriate remedy for this impossible situation is immediate publication of the notice in the Federal Register—so that all sellers of 2,4,5-T will be bound and will be subject to the penalties of law if they sell another container of an herbicide containing 2,4,5-T. Publicly naming dangerous products
Full publication in the Federal Register will also alert the public to the dangers of 2,4,5-T found by the Department. Inexplicably, the press release (Exhibit 6) fails to mention recall. There has been no notification to the public to avoid purchasing specific, named products. Nowhere are these products publicly named ; names of products were omitted from the form of letter furnished to petitioners (Exhibit 7). When health is at stake the public interest in being fully informed must overide solicitousness for the public relations image of chemical manufacturers. It is imperative that the Department immediately make public, and warn the public against all products containing 2,4,5-T. Conclusion
The Department of Agriculture's action to date is insufficient to remove the health hazard of 2,4,5-T. The potential teratogenicity and toxicity of 2,4,5-T for humans has been amply documented by scientific studies and clinical reports. Further use of 2,4,5-T around the home, in or near water or on food crops directly contravenes the high standards of safety which the Secretary of Agriculture is bound to enforce.
Biologists Arthur W. Galston, Robert E. Cook and William Haseltine have stated that 2,4,5-T “may represent the ecological equivalent of thalidomide.” (Exhibit 14, p. 2). Professor John T. Edsall of Harvard University has observed that “the use of these compounds [including 2,4,5-T] is much more seriously questionable than the use of cyclamates. If one applies the same criteria, one would consider the risks quite unacceptable.” See Hearings, testimony of Harrison Wellford (Exhibit 9, p. 1).
Where the danger of human contamination by 2,4,5-T is most critical-in its use around the home, on bodies of water and on food-immediate and publicized removal of 2,4,5-T from the channels of commerce is necessary. Respectfully submitted.
1. Announcement by Dr. Lee A. DuBridge from the Executive Office of the
President, Office of Science and Technology, October 29, 1969. 2. FDA Fact Sheet, announcing refusal to authorize residues of 2,4,5-T on
foods. 3. Statement by Ned D. Bayley, Director of Science and Education, Depart
ment of Agriculture, Before the Subcommittee on Energy, Natural Resources, and Environment of the Senate Commerce Committee, April 7,
1970. 4. Thomas Whiteside, Letter to the Editor, The New Yorker, March 14, 1970. 5. Department of Health, Education, and Welfare Press Release, April 15, 1970. 6. Department of Agriculture Press Release, April 23, 1970.
7. Department of Agriculture Notice to Manufacturers, Formulators, Distribu
tors and Registrants of Economic Poisons (PR Notice 70–11). 8. Testimony of Dr. Arthur H. Westing, Chairman, Biology Department of
Windham College, Putney, Vermont, Before the Subcommittee on Energy,
April 7, 1970. 9. Testimony of Harrison Wellford of the Center for Study of Responsive Law,
Before the Subcommittee on Energy, Natural Resources, and Environment
of the Senate Commerce Committee, April 7, 1970. 10. Excerpts from the Department of Health, Education, and Welfare Report
of the Secretary's Commission on Pesticides and Their Relationship to
Environmental Health, December 5, 1969 (the “Mrak Report"). 11. Thomas Whiteside, “Defoliation”, The New Yorker, February 7, 1970. 12. Statement of Dr. Samuel S. Epstein, Children's Cancer Research Founda
tion, Inc., and Harvard Medical School, Before the Subcommittee on Energy, Natural Resources, and Environment of the Senate Commerce
Committee, April 15, 1970. 13. Statement by Dr. Jacqueline Verrett, Division of Toxicology, Food and Drug
Administration, U.S. Department of Health, Education, and Welfare, Before the Subcommittee on Energy, Natural Resources and Environment of the
Senate Commerce Committee, April 15, 1970. 14. "What Have We Done to Vietnam?” by Robert E. Cook, William Haseltine,
and Arthur Galston, reprinted in 116 Cong. Rec. S1983, 91st Cong. 2d sess.
(February 19, 1970, daily edition). 15. ^ “Leaf Abscission’?” Thời-Báo Gà, November 1969. 16. Ralph Blumenthal, “U.S. Shows Signs of Concern Over Effect in Vietnam
of 9-Year Defoliation Program", The New York Times, March 15, 1970. 17. Bulletin, March-April, 1968, HEW National Clearinghouse for Poison Con
trol Centers. 18. Affidavit of Mrs. Lorraine Huber. 19. Westing, Pfeiffer, Lavorel, and Matarasso, Report on Herbicidal Damage by
the United States in South-Eastern Cambodia, December 31, 1969. 20. Statement of Dr. Arthur W. Galston Before the Subcommittee on National
Security Policy and Scientific Developments of the House Committee on
tion, pp. 107–116, 1970. 21. Testimony of Congressman Richard D. McCarthy Before the Subcommittee
on Energy, Natural Resources and the Environment of the Senate Com
merce Committee, April 7, 1970. 22. Letter to Ralph Nader from the National Health Federation, January 26,
1970. 23. "Defoliants, Deformities: What Risk ?" Medical World News, February 27,
1970. 24. Supplementary compilation of Scientific, Eye-Witness and Other Statements
of Concern Over the Use of 2,4,5-T. Mr. WELLFORD. The Secretary of Agriculture has authority under the Federal Insecticide, Fungicide, and Rodenticide Act to take all the steps specified in this petition.
Now, let me expand on the reasons why cancellation of registration rather than immediate suspension for most uses of 2.4,5-T erodes the significance of the ban. I do not need to remind this committee that there is considerable evidence that 2,4,5-T may be dangerous to human beings. The Surgeon General has branded it an imminent and immediate hazard to the public. There is no evidence that human beings and animals can safely be exposed to 2.4.5-T.
To move against some uses of 2.4.5-T with only a notice of cancellation, to take no action against certain other uses, and to take no action against Silvex, seems a very inadequate response to the situation. Indeed, the manufacturers of 2.4,5-T have reacted to the ban almost complacently. Mr. Horace D. Doan, president of Dow Chemical Co., estimates that the ban as presently conceived will affect only 10 percent of Dow's 2,4,5-T sales.
As far as protection of the public is concerned, there is a critical difference between suspension and cancellation of a product's registration. Suspension removes the product from the marketplace, if not immediately, at least within a couple of months in most cases. Cancellation allows the accused product to be sold as before while administrative and legal proceedings take place. Cancellation in effect is often no ban at all.
The DDT case demonstrates this point. The Pesticide Regulation Division cancelled the registration of DDT last November. The DDT manufacturers then had 30 days to appeal and request appointment of an advisory committee of scientists.
After the appeal was made, there has been to date a 6-month delay in naming the advisory committee of scientists. Here is the loophole in the act, and the Department apparently is taking full advantage of it.
While there is a 30-day deadline for the companies to request the formation of a committee and a 60-day deadline for the committee to report once it has convened, there is no deadline compelling the Government to name the committee members within a specified time. The members have still not been named as of yesterday.
Senator Hart. This is how many weeks after the cancellation? Mr. WELLFORD. It is about 6 months, Senator.
The DDT ban proceedings have not yet gone past this stage, but in any case, its journey has just begun. Once the advisory committee has reported within its allotted 60 days, USDA has 90 days within which to issue an order. After the order is made, the companies have 60 days in which to file an objection and to request a public hearing. Here, this stately procession of deadlines, pauses, and another hiatus occurs. There is no deadline within which USDA must call the public hearing. Again, a delay of several months could occur.
It is also not clear who has standing to appear at this public hearing. After the hearing is held, USDA has 90 days in which to issue a final order.
At this point, administrative due process has consumed 310 days ---by the way, it actually could be longer than that because there are various points where you can get extensions of deadlines-of deadlines and an indeterminate additional period of discretionary delays permitted the Government under a loophole in the law. All of this time, of course, the product accused of causing the harm continues to be marketed in “business as usual” fashion.
This elaborate process may be only a skirmish, however, along the way to the ultimate outcome. Having failed in two hearings and three agency decisions to win its case, the companies may simply shift the fight to another arena. They can challenge USDA's final ruling in the courts where the wheels of due process, of course, also grind wondrous slow.
Of course, I am not suggesting that 2,4,5-T or other pesticides are undeserving of their day in court; what I am saying is that when a company can take advantage of a system of due process which allows perhaps years of delays, products as potentially dangerous as 2,4,5-T and Silvex should at least be held in "preventive detention.”
Here, where the potential social threat of a detainee can be tested in a laboratory, this procedure actually makes sense. Suspension as opposed to cancellation is a form of "preventive detention.” It allows