Before Kiley, Fairchild and Stevens, Circuit Judges.
The labeling of economic poisons is regulated by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).*fn1 All such poisons distributed in interstate commerce must be registered with the Administrator of the Environmental Protection Agency.*fn2 The Administrator is authorized by FIFRA to refuse, or to cancel, the registration of any poison that is misbranded.*fn3
Since 1878 petitioner has been selling phosphorous paste for home use as a rat and roach poison. Its English and Spanish language labels, as modified from time to time, have been registered since shortly after the registration requirement became effective in 1947. On January 4, 1971, the Administrator cancelled these registrations on the ground that phosphorous paste is too poisonous for use in the home except by commercial pest control operators.
The cancellations were precipitated by a review of petitioner's labels, but it is fair to state that the contents of the labels were irrelevant to the determination that the product was too dangerous to be permitted in the home. The evidence plainly showed that phosphorous paste is extremely toxic, that it possesses "great potential for harm," as the Hearing Examiner found, and that both adults and children have been killed or hospitalized by misuse of the product. On the other hand, there is no finding, and little or no evidence, of mortality or morbidity resulting from the use of the product in compliance with the directions on the label.*fn4 The theory of the cancellation order was succinctly explained by the Government's principal witness who testified "that the general public is incapable of handling these things and following directions."*fn5
Petitioner's challenge to the cancellations raises both procedural and substantive questions of first impression.*fn6 At the heart of the controversy is the question whether FIFRA includes a "substantive standard of product safety*fn7," and if so, what that standard is. Because of the novelty and importance of the issues, we shall state the facts in some detail, then review the statute, and finally test the findings against it.
Stearns Electric Brand Paste is an inexpensive and effective killer of rodents, roaches, water bugs and similar pests. The active ingredient in Stearns Paste is white phosphorus, a highly toxic substance, for which-as is true of most poisons-there is no known antidote.*fn8 Phosphorous paste is the only kind of poison which is sold as both a rodenticide and roach killer. It is also the only product sold by petitioner. If an adult swallows over half a tube, "the odds are" that the ingestion will be fatal. Ingestion of much smaller quantities may prove fatal to children. The record plainly supports the finding that the product possesses "great potential for harm." (A. 269, Judicial Officer's decision.)
Petitioner markets its product through distributors and by direct mail. About 300,000 tubes are sold annually at a retail price of about 69 cents per tube. Since each tube contains enough paste for about 50 baits, it is estimated that 72 million baits of Stearns Paste have been used in the past five years. The Company receives about 1500 letters a year from customers who have moved and cannot find a local source of the product; many of these letters state that Stearns Paste is the best rat or roach killer the writer has used. The effectiveness of the product is not disputed; indeed, the question is whether it is too poisonous to be permitted in homes.
The tube is plainly labeled in black and red print as "POISON," with the skull and crossbones symbol and instructions for use printed in black and red letters. The tube is sold in a paper carton, which also contains an explanatory insert. The insert and carton, like the tube, prominently display the poison warnings.*fn9
The record indicates that other products which will kill rats, and other products which will kill roaches, are available. Petitioner's evidence tended to show that the alternatives were less effective and more expensive. The evidence also indicated that rats and roaches pose a significant health problem, particularly in low income areas. Apparently the services of a commercial pest control operator cost at least $35 per visit. The findings do not specifically consider the magnitude of the danger from rats or roaches. Although the findings recognize the availability of various other rodenticides and pesticides, the record contains no square finding that any other product is as effective as phosphorous paste,*fn10 or, assuming that cost is relevant, that any other product performing the same function is equally available.*fn11
As a result of an interagency agreement negotiated in 1964,*fn12 the Department of Agriculture began to refer economic poison labels to the Food and Drug Administration for toxicological review. In making such review, the FDA applied a "general policy that a product that can produce serious injury or death in a small child from an average swallow of about 4 1/2 to 5 cubic centimeters should not be used around the home particularly if there are safer equally effective alternate materials."*fn13
On March 8, 1968, in response to a request from Agriculture for a comment on a proposed label revision, FDA objected to the reregistration of petitioner's product pursuant to its general policy against the home use of products that can produce serious injury or death in a small child from an average swallow. Petitioner was then advised by respondent*fn14 that it would reevaluate its "registration policy with respect to products containing phosphorus paste for use in the home."
On October 7, 1968, respondent issued a notice of proposed interpretation "with respect to labeling of phosphorus paste products," and invited comments thereon.*fn15 The interpretation stated that home use would be unacceptable, but use by government agencies and professional pest control operators would be permitted. Petitioner filed written comments and suggestions which were duly considered and rejected, and on March 19, 1969, Interpretation No. 26 was issued effective 60 days after publication in the Federal Register.*fn16
On May 23, 1969, respondent issued notices of cancellation of both of petitioner's registrations.*fn17 Petitioner filed timely objections and on October 6 and 7, 1970, an evidentiary hearing was held. The Hearing Examiner ruled that the burden of proof was on petitioner, who thereafter presented one witness and 21 exhibits. Respondent's case included the testimony of 8 witnesses and 9 exhibits. After considering the record and arguments of counsel, the Hearing Examiner filed a recommended decision including proposed findings of fact and conclusions. His recommendations were adopted by a judicial officer of the Department of Agriculture, who entered the order of cancellation on January 4, 1971. We stayed the operation of the order pending review in this court.
Respondent's evidence consisted primarily of expert opinion as to the toxicity of phosphorous paste and such data as was available concerning the harm which it has actually caused humans. The statistical evidence included data from the National Clearinghouse for Poison Control Centers*fn18 and reports from state agencies.
The witness from the National Clearinghouse estimated that there are approximately one million ingestions of harmful substances each year, of which only about 115,000 are reported to a poison control center. The reported ingestions include a wide variety of substances, such as aspirin, kerosene, detergents, and other household products, as well as economic poisons. When measured strictly by the number of reported fatalities, aspirin is the most lethal substance used in the home environment.*fn19 The National Clearinghouse records placed in evidence in Government Exhibit IV cover the period from January 7, 1962, through August, 1968. Those records describe 207 ingestions of phosphorous paste products, of which 147 were accidental, 51 were suicidal, and 9 were not classified as either accidental or suicidal. A total of 15 deaths resulted, 9 in ...