Consumers Union of United States, Inc., Petitioner, v. Consumer Product Safety Commission, Respondent, 491 F.2d 810 (2d Cir. 1974)

The sole issue before us on this petition to review portions of regulations of the Food and Drug Administration, 21 C.F.R. 191b.5(e), 191b. 3(e) (2) and 191b.7 (1973), establishing standards for electrically operated toys and other electrically operated articles intended for use by children is whether the determination by the Commissioner of Food and Drugs in promulgating the regulations was 'arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law'. 5 U.S.C. 706(2) (A) (1970). We hold it was not. We deny the petition to review.

On January 13, 1972, the Commissioner proposed, and later published in the Federal Register, certain regulations of the FDA designed to ban electrically operated toys or other electrically operated articles intended for use by children which failed to meet certain prescribed labeling, design, construction and performance standards. 37 Fed.Reg. 1020-27 (January 21, 1972). The regulations were proposed to implement the Federal Hazardous Substances Act of 1960, as amended by the Child Protection and Toy Safety Act of 1969, 15 U.S.C. 1261-74 (1970), and pursuant to powers delegated by the Secretary of HEW to the Commissioner by 21 C.F.R. 2.120(a) (1) (1973).¹ 

Consideration of the proposed regulations followed standard rule making procedure prescribed by the Administrative Procedure Act, 5 U.S.C. 553 (1970), including requirements as to notice and public participation. Among the forty-five comments received in response to the Commissioner's invitation was a two page letter of comment submitted by the petitioner herein on February 24, 1972. After due consideration, the Commissioner concluded that the regulations should be adopted. Accordingly, they were promulgated on March 2, 1973, to become effective September 3, 1973. 38 Fed.Reg. 6141-48 (March 7, 1973).

Having failed to persuade the Commissioner to incorporate in the regulations as promulgated those modifications suggested in its letter of comment, petitioner filed its petition to review in our Court on April 27, 1973. Essentially petitioner claims that the agency action here under review, 21 C.F.R. 191b.5(e), 191b.3(e) (2) and 191b.7 (1973), was arbitrary and capricious within the meaning of 5 U.S.C. 706(2) (A) (1970) because the Commissioner (1) failed to require double insulation or grounding on toys with high shock risk, (2) chose maximum acceptable surface temperatures for electrically operated toys, and (3) relied upon cautionary labeling to protect children from thermal hazards-- all without full consideration of crucial safety issues and without any apparent rational basis for his determination. We disagree.

Here, under the 'arbitrary, capricious' standard, our scope of review is even narrower than it was in Scenic Hudson Preservation Conference v. FPC (Scenic Hudson II), 453 F.2d 463 (2 Cir. 1971), cert. denied, 407 U.S. 926 (1972), where the statutory standard was 'substantial evidence'. Under either standard, at a minimum, an agency must exercise its jurisdiction where it properly lies. It must not ignore evidence placed before it by interested parties. See Scenic Hudson II, supra, 453 F.2d at 467-68.

Petitioner here does not claim that respondent failed to exercise its jurisdiction. It does claim that the FDA failed even to consider its position-- especially its position with regard to grounding. This claim is belied by petitioner's letter of comment, by the fact that the Commissioner specifically rejected other suggestions of petitioner, and by the fact that the Commissioner incorporated in the final regulations suggestions of ten others who submitted comments.

Scenic Hudson II also held that there must be a reasoned basis for agency action. However, a formal opinion specifically covering all rejected alternatives is not required in an informal rule making proceeding.

Petitioners challenge the sufficiency of the factual record. The record need not be as complete under the 'arbitrary, capricious' standard as under the 'substantial evidence' standard. Thus, in the present case, it is sufficient that the regulations be supported by evidence in the Commission's files, or even by its experience. The record clearly establishes that there was sufficient evidence to support the regulations in the three respects challenged by petitioner:

(1) The record supports the Commission's choice of a generalized electric shock standard, rather than one of the two shock-minimization strategies favored by petitioner. There was evidence that grounding is not effective because of the small number of households wired for three-prong plugs. The evidence in favor of rejecting double insulation was more tenuous, but the FDA could have concluded that the general standard is more desirable because it gives the manufacturer a wider choice of cost options.

(2) There was a wealth of evidence supporting the chosen maximum surface temperature levels, assuming an 'irreversible tissue damage' standard. From the relatively small number of pain-related injuries, and from its own experience, the FDA could have concluded that tissue damage was the appropriate standard.

(3) The child developmental information, and the letter from the Director of the Poison Control Center, provided a sufficient basis for the decision to rely on labeling for toys used by children older than eight years of age.

In short, our careful examination of the record satisfies us that the regulations were promulgated on the basis of an adequate administrative record indicating that the Commissioner fairly considered, among other things, pertinent aspects of electrical shock hazards, thermal injury hazards and cautionary labeling. The claims asserted by petitioner do not warrant our interfering with a presumably expert agency's exercise of its rule making discretion. Congress gave the job of regulating toy manufacturers to the Secretary of HEW and more recently to the Consumer Products Safety Commission, not to us. We have no special expertise in the complexities of child development.

Petition denied.