FRIENDLY, Circuit Judge:
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.
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,"
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.
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:
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' away. The Jart is a dart, about 13" 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.
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
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),
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:
Section 191.9a of the new Regulations, entitled "Banned toys," recited a determination that various toys or other articles intended for use by children
However, having marched all the way up the hill with respect to lawn darts, the Commissioner then marched a considerable distance down. Section 191.65a, entitled "Exemptions from classification as a banned toy," says that the term "banned hazardous substance" as used in 15 U.S.C. § 1261(q) (1) (A) shall not apply to various articles, among which are:
The controversy stems mainly from the ambiguity in the phrase "toy or other article intended for use by children" as used in 15 U.S.C. § 1261(f) (1) (D) and (q) (1). The House Committee report gives as examples:
H.R.Rep., 91-389, 91st Cong., 1st Sess. 9 (1969), U.S.Code Cong. & Admin. News 1969, p. 1236. However, the Senate report, while noting similar examples, S.Rep. No. 91-237, 91st Cong., 1st Sess. 2 ("roly poly doll," toy blowgun) (1969), also refers to equipment which is to be presented to a child for his "amusement" or to be "used for children in close proximity to them" and contains a statement "In no event, however, were any of these terms so broad as to give the Secretary of Health, Education and Welfare the authority to prescribe design criteria for all products to which children have access." Id. at 5.
It is plain enough that such articles as rattles, dolls, stuffed animals, nursery and playground equipment, and infants' carriages and strollers, which are intended only for use by children, fall within the statutory term. On the other hand, despite the mention of sports equipment in the Committee reports, the mere fact that a child might get hold of an article of that character which is kept in the home but is intended solely for use by adults, such as a regulation size golf-club or rifle, would scarcely make the statute applicable. Between these ends of the spectrum is a case like this where the article is intended primarily for use by adults but also for use by children when playing with them.
The Government argues with what it considers relentless logic that if an article is intended for use by children, even only when under adult supervision, it is
Petitioner responds that so broad a reading would produce results that Congress could never have purposed. For one example, it cites the fish-hook. While these, like Jarts, are intended primarily for use by adults, they often are used by children, initially under the supervision of a parent or older sibling, but later often without. For another, it cites the indoor dart, which has a much sharper point than the Jart. These, too, although intended primarily for adult use, may be used by children who have seen adults playing or have played with them. Could Congress have meant to authorize the Secretary to ban an article that is standard equipment in every British pub? Petitioner caps its argument with the conclusion in the December 17 Regulations, quoted above, that "[t]he large outdoor-type-darts are intended for use by adults as an outdoor sport or game." It contends that by saying this the Commissioner cut the ground out from under himself. The Government naturally denies this.
Both sides want us to decide an issue that does not require determination now. The Government, although recognizing the possibility of a narrower ruling in its favor, would like it best if we were to say the Secretary could ban Jarts altogether; petitioner urges us to hold that under no circumstances could this be done and seems to think such a holding would end the case in its favor. We are not obliged thus to accommodate either party. When the two sections added to the Regulations are read together, as they must be, they do not say that lawn darts are a "toy or other article intended for use by children" semper et ubique. They say lawn darts are such when and only when they do not carry a warning that they are "Not a Toy for Use by Children" and when they are "sold by toy stores or store departments dealing predominantly in toys and other children's articles." A manufacturer,
Although petitioner does not strongly argue the point, it is necessary to consider whether even if Jarts can lawfully be brought within § 1261(f) (1) (D) and thus § 1261(q) (1) (A) to the extent they have been, they are nevertheless entitled to exemption under the first proviso of § 1261(q) (1) which requires the Secretary to exempt from classification as a "banned hazardous substance" under clause (A) articles "which by reason of their functional purpose * * * necessarily present an electrical, mechanical, or thermal hazard, and which bear labeling giving adequate directions and warnings for safe use and are intended for use by children who have attained sufficient maturity and may reasonably be expected, to read and heed such directions and warnings * * *." Assuming arguendo that this provision is applicable, we think the Regulation satisfied it. It did exempt Jarts from classification as a "banned hazardous substance," on two conditions. One of these, cautionary labeling, is permitted, indeed required, by the statute. The other, the prohibition of sale in toy stores or store departments dealing predominantly in toys and other children's articles, is a reasonable method for endeavoring to assure against use by children who are not likely to meet the conditions of the proviso.
It remains only to decide whether petitioner should be allowed a further period in which to effect compliance. It can be argued against this that great weight should be accorded the Deputy Commissioner's determination that "it would be contrary to the public interest to delay the effective date" and that petitioner has already had a stay of several weeks. Against this we are favorably impressed by petitioner's cooperation with the FDA before any proceeding was brought, and this season is not conducive to the playing of lawn darts in most parts of the country. We therefore continue the stay of the Regulation with respect to petitioner for ten days from the filing of this opinion.
The petition for review is denied.
Section 1262(a) provided that in making regulations the Secretary must follow the procedure set forth in § 701(e) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 371(e), which requires an evidentiary hearing if objection is made to a proposed regulation.
The 1966 Act also amended the short title of the 1960 Act by deleting the word "Labeling," 80 Stat. 1305.
Most of the lawn dart injuries of record were in 1970; the earliest was in 1967. The Government suggests that since Jarts have been on the market since the late 1950's, these recently reported injuries are only a small proportion of the total.