Medina, Friendly and Feinberg, Circuit Judges.
Petitioner, R. B. Jarts, Inc., is a South Glens Falls, N. Y., manufacturer whose sole business is the production of plastic-finned lawn darts and related equipment, which it promotes and sells throughout the United States and Canada. Late in the afternoon of Friday, December 18, 1970, it sought a stay, pending judicial review, of a portion of a Regulation of the Deputy Commissioner of Food and Drugs, filed that day to become effective on the next, when it was published in the Federal Register, 35 F.R. 19266. As petitioner alleged, the Regulation would have had the effect of immediately prohibiting the sale of its product.*fn1 With the Government's consent the writer stayed the effectiveness of the Regulation as regards petitioner until December 22, 1970, so that the motion could be considered by a panel. After studying the briefs of the parties and hearing argument on the motion, we continued the stay pending determination of the petition to review but directed that this be submitted for decision on further briefs, to be filed on January 5, 1971.
The Deputy Commissioner promulgated the Regulation here at issue, under delegation from the Secretary of Health, Education and Welfare, 21 C.F.R. §§ 2.120(a), 2.121(a), pursuant to the Child Protection and Toy Safety Act of 1969, 83 Stat. 187. This statute constitutes the third and latest development in general federal control of the distribution of "hazardous substances" in interstate commerce. The first step was taken by the Federal Hazardous Substances Labeling Act of July 12, 1960, 74 Stat. 372, 15 U.S.C. §§ 1261-1273. The scheme of that Act was first to define, in 15 U.S.C. § 1261(f) (1), three categories of "hazardous substances,"*fn2 and then to prohibit their receipt and delivery in interstate commerce if "misbranded," 15 U.S.C. § 1263, i. e., if they did not carry an appropriate warning label. 15 U.S.C. § 1261(p). The second step was taken in the Child Protection Act of November 3, 1966, 80 Stat. 1303. This statute introduced the concept of a "banned hazardous substance"*fn3 which could not be introduced into or received from the stream of interstate commerce at all. As will be seen from the definition set forth in the margin, the Act drew a sharp distinction between a "toy, or other article intended for use by children, which is a hazardous substance, or which bears or contains a hazardous substance in such manner as to be susceptible of access by a child to whom such toy or other article is entrusted" and hazardous substances for household use. The former were banned automatically subject to the two exceptions stated in the proviso; the latter were banned only if the Secretary first found that cautionary labelling would not suffice to reduce the danger to acceptable limits.
A year later Congress created a National Commission on Product Safety, 81 Stat. 466 (1967), to "conduct a comprehensive study and investigation of the scope and adequacy of measures now employed to protect consumers against unreasonable risk of injuries which may be caused by hazardous household products" and to report to the President and the Congress thereon. The Commission's Interim Report found the existing laws were inadequate, particularly in respect of toys, some of which were found to be dangerous although they did not contain "hazardous substances" as defined in the 1960 Act, and recommended remedial legislation.*fn4
In response to this report Congress adopted the Child Protection and Toy Safety Act of 1969. The 1969 statute added to 15 U.S.C. § 1261(f) (1) a fourth category of "hazardous substance," to wit:
(D) Any toy or other article intended for use by children which the Secretary by regulation determines, in accordance with section 1262(e) of this title, presents an electrical, mechanical, or thermal hazard.
An article might be "determined to present a mechanical hazard if, in normal use or when subjected to reasonably foreseeable damage or abuse, its design or manufacture presents an unreasonable risk of personal injury or illness * * * (3) from points or other protrusions, surfaces, edges, openings, or closures * * * or (9) because of any other aspect of the article's design or manufacture," 15 U.S.C. § 1261(s). Section 1262(e) provided that the Secretary could formulate regulations under § 1261(f) (1) (D) pursuant to the general rule-making provisions of the Administrative Procedure Act, 5 U.S.C. § 553, with an exception unnecessary here to specify, subject to judicial review, 15 U.S.C. § 1262(e) (3), unless he elected to follow the more cumbersome method of § 701(e) of the Federal Food, Drug and Cosmetic Act, see fn. 2, in which event the review provisions of that section would apply. Finally, a new section, 15 U.S.C. § 1274, which went beyond the title of the Act, provided that manufacturers, distributors or dealers must repurchase any "banned hazardous substance" in accordance with regulations of the Secretary.
The rules for the game manufactured by petitioner call for a "Jart" to be tossed underhand so as to arc and then land upright in a circular plastic ring target on the ground 35 feet away. The Jart is a dart, about 13 inches long and weighing about half a pound, with three plastic fins, an aluminum shaft and a metal nose; as a result of its design and weight distribution, it will tend to land nose-first when thrown in the air. While the point of the nose is somewhat blunted, we do not understand petitioner seriously to question that the Commissioner could permissibly decide that the Jart presented a mechanical hazard as defined in 15 U.S.C. § 1261(s) if it is a "toy or other article intended for use by children." In any event the evidence of injuries referred to below and simple common sense constitute sufficient basis for a determination that it presents a mechanical hazard, at least "when subjected to reasonable foreseeable * * * abuse."
The first official notice to petitioner of the Food and Drug Administration's concern about Jarts was a letter from the Buffalo, N. Y. district office dated October 20, 1970.*fn5 The letter noted that a number of injuries from Jarts had come to the agency's attention, and asked that the labeling "be revised to clearly caution purchasers and users that this game should not be used by children unless supervised by adults." Petitioner answered, on November 3, that, responsive to this request, it had cancelled all orders for boxes, instruction sheets and sales promotional literature, and had discontinued assembly of the game, temporarily laying off production personnel; that it had ordered new boxes and instruction sheets that would clearly state "that our game should be used by children only under supervision of adults"; and that it had ordered stickers to the same effect which would be placed on the outside of existing boxes and on the instruction sheets.
Despite this cooperation, the head office of the FDA advised petitioner on November 12, 1970, that it was contemplating the proposal of a regulation that would classify Jarts as a "banned hazardous substance." Such a proposal was published on November 17, 35 F.R. 17663. At a conference on November 20, attended by top representatives of the company and the FDA, petitioner was given a copy of a petition to the FDA dated November 18, 1970, by Consumers Union and the Children's Foundation concerning Jarts and products of other manufacturers, was promised a letter summary of the results of the FDA's investigations of injuries caused by Jarts, and was urged to file written comments within fifteen days. While the evidence showed that some of the reported injuries were due to the careless conduct of adults,*fn6 the reports of others -- while varying in specificity -- reveal a number of lawn dart injuries, some of which were caused by Jarts, sustained by children in the course of unsupervised activity.*fn7
Petitioner submitted timely comments upon the proposed regulation. Their main thrust was that, as was claimed to be shown by various facts therein set forth, Jarts was a game intended for use by adults and was neither a toy nor an article intended for use by children; that hence it could not be a "hazardous substance" within § 1261(f) (1) (D),*fn8 and that therefore it could not be a "banned hazardous substance" within § 1261(q) (1). The comments noted that petitioner had made further changes in labeling. In addition to the legend, "CAUTION: SHOULD BE USED ONLY UNDER SUPERVISION OF ADULTS," on the box and the instruction sheet, the box now carried in large letters the legend "AN OUTDOOR GAME FOR ADULTS."
The Regulation published on December 17, 1970, 35 F.R. 19266, consists of three parts. The first summarizes the comments received on the proposal of November 17, the second gives the Commissioner's conclusions from them, and the third, the operative part, adds two new sections to the Regulations under the Federal Hazardous Substances Act, 21 C.F.R. Part 191. We can pass over the first part, and also the second except for the conclusion, stressed by petitioner:
2. The large outdoor-type darts are intended for use by adults as an outdoor sport or game. Suitable labeling can be devised to inform parents or other adults of the necessity of carefully supervising children if they are to be permitted to play the game and to give other ...