Full opinion text
ROBB, Circuit Judge: Independent Cosmetic Manufacturers and Distributors, Incorporated (ICMAD) challenges a regulation promulgated by the Food and Drug Administration. The regulation requires that all packaged cosmetics be identified by labels listing their ingredients. ICMAD challenged the regulation on two fronts. First, ICMAD sought declaratory and injunctive relief in the District Court. The District Court dismissed the suit for want of jurisdiction and ICMAD appeals. ICMAD’s second front is a petition in this court for direct review of the regulation. We affirm the District Court’s holding that it lacked jurisdiction, for jurisdiction lies exclusively in the court of appeals. In exercising our jurisdiction, however, we decline to set aside the regulation. We turn first to the jurisdictional issue. JURISDICTION OF THE DISTRICT COURT The regulation may be challenged by petition to an appropriate United States Court of Appeals. 15 U.S.C. § 1455(a); 21 U.S.C. § 371(f). The statute does not specify whether district courts may exercise concurrent jurisdiction when an independent source of jurisdiction can be found. IC-MAD asserts, however, that the trial court had concurrent jurisdiction by virtue of a savings clause in the statute, 21 U.S.C. § 371(f)(6). That clause provides: The remedies provided for in this subsection [review in the court of appeals] shall be in addition to and not in substitution for any other remedies provided by law. We think jurisdiction in this case is governed by our decision in Nader v. Volpe, 151 U.S.App.D.C. 90, 466 F.2d 261 (1972). In that case we considered a similar review provision of the National Traffic Motor Vehicle Safety Act, with an almost identical savings clause. See 15 U.S.C. § 1394(a). We concluded that when Congress has specified a procedure for judicial review of administrative action, that procedure is the exclusive means of review unless, because of some extraordinary circumstances, the procedure fails to provide an adequate remedy. 151 U.S.App.D.C. at 100, 466 F.2d at 271. Those extraordinary circumstances, we noted, were “instances of agency action which is ultra vires or damaging beyond the capability of the statutory procedure to repair.” Id. Although ICMAD contends that the Commissioner’s action in this case is ultra vires, we disagree. As our opinion in Nader v. Volpe makes clear, a party urging jurisdiction based on ultra vires action must show a patent violation of agency authority. Compare 151 U.S.App.D.C. at 100 & n. 66, 466 F.2d at 271 & n. 66, with 151 U.S.App.D.C. at 95 & n. 30, 466 F.2d at 266 & n. 30. ICMAD argues that the agency disregarded 21 U.S.C. § 371(e)(3) in failing to hold a hearing “as soon as practicable” after objections were filed regarding certain parts of the regulation promulgated on October 17, 1973. The objections — none of which came from ICMAD — asserted that exemptions to labeling and alternative means of compliance should be permitted. Instead of immediately convening a hearing the Commissioner began negotiations with the objectors. This informal procedure was, at least in part, invited by the objectors. The negotiations resulted in the amendment of the regulation on March 3, 1975 (40 Fed.Reg. 8918), after which the objections were withdrawn and the need for a hearing obviated. 40 Fed.Reg. 23460 (1975). We need not determine whether upon closer scrutiny this informal procedure fully comported with the statute; it is sufficient that we decide that in these circumstances the failure to hold a hearing was not a patent violation of agency authority. Nor are any of the lesser irregularities alleged by ICMAD so patently defective as to warrant district court jurisdiction. Our conclusion is consistent with settled principles of law and the legislative history of the Food and Drug Act. ICMAD contends, however, that the legislative history as set out in Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967), is contrary to our conclusion and that the Court’s holding there controls this case. We disagree. The Supreme Court in the Abbott Laboratories case noted that Congress intended in enacting the savings clause to preserve, not concurrent jurisdiction, but equitable remedies available when no adequate remedy at law exists. See id. at 142-43, 87 S.Ct. 1507. The Supreme Court did uphold district court jurisdiction in that case, for no special statutory review provisions applied to the challenged regulations, id. at 141, 87 S.Ct. 1507, and hence there was no adequate remedy at law. Nader v. Volpe, 151 U.S.App.D.C. at 100 n. 68, 466 F.2d at 271 n. 68 (distinguishing Abbott Laboratories v. Gardner on this basis). Indeed, the Supreme Court said in the Abbott Laboratories opinion, “when the special provisions [for review] apply, presumably they must be used and a court would not grant injunctive or declaratory judgment relief unless the appropriate administrative procedure is exhausted.” Id. at 146, 87 S.Ct. at 1514; see Katzenbach v. McClung, 379 U.S. 294, 296, 85 S.Ct. 377, 13 L.Ed.2d 290 (1964). Here those special procedures for review do apply and as we noted in Nader v. Volpe: The District Court had but limited jurisdiction of the case at the outset — for the purpose of taking a peek to see whether it had jurisdiction of the subject matter by virtue of exceptional circumstances. When it found no such circumstances it rightly dismissed the action for lack of subject-matter jurisdiction. 151 U.S.App.D.C. at 101, 466 F.2d at 272. That exclusive jurisdiction lies in the courts of' appeals is further demonstrated by the scheme of the Act. Finding concurrent jurisdiction under some general jurisdictional mandate, such as federal question jurisdiction, would permit ICMAD to bypass the 90-day time limit that Congress imposed on petitions to review challenged regulations. See 21 U.S.C. § 371(f)(1). That is precisely what ICMAD seeks to do here; for as we demonstrate later, a major portion of ICMAD’s petition for direct review in this court is untimely. PETITION FOR REVIEW In its petition to this court ICMAD challenges the Commissioner’s regulation in two respects. First, on several different theories ICMAD argues that the substance of the original regulation contravenes the Fair Packaging and Labeling Act (F.P.L. A.). See Petitioner’s Brief in 75-1845 at p. 3. Second, ICMAD contends that the procedure followed by the Commissioner in promulgating amendments to the regulation was deficient. Id. Because ICMAD’s challenge to the original regulation is untimely and because ICMAD has not been prejudiced by the procedure followed in adopting the amendments, we deny its peti-. tion. ICMAD argues that the cosmetic ingredient labeling regulation violates the F.P.L.A. because: section 1454 of the Act mandates that the Commissioner promulgate labeling regulations on a commodity-by-commodity, not a cosmetic-wide, basis; that the Commissioner, contrary to section 1454(c), made no determination that the regulation was necessary to prevent deception and to facilitate comparisons; that contrary to section 1454(c)(3) the regulation requires divul-gence of trade secrets; and that while section 1454(c)(3) requires labeling of only certain ingredients, the regulation requires labeling of all ingredients. See Petitioner’s Brief at 13-23. ICMAD’s attack challenges the original regulation, which was published in final form in the Federal Register on October 17, 1973 (38 Fed.Reg. 28912). Section 371(f)(1) of the Food and Drug Act requires that petitions for review of an FDA order be filed within 90 days from the date the order issues, and ICMAD’s petition for review in 1975 clearly falls outside that 90-day boundary. Nor can ICMAD’s challenge be deemed timely filed as an attack on the amendments promulgated in 1975. The amendments merely provided narrow exemptions to labeling and alternate means of compliance applicable in limited circumstances. A comparison of the original regulation and the amendments makes clear that the amendments did not change the substance or thrust of the original regulation. See 40 Fed.Reg. 8918-24 (1975); note 6, supra. The attack on the original regulation is therefore untimely. ICMAD’s procedural attack must also fail. ICMAD urges that because of alleged irregularities in amending the regulation, it was foreclosed from challenging the basic regulation. We believe however that if any irregularity occurred, ICMAD was not prejudiced thereby and hence no basis exists for setting aside the original regulation. A brief review of the history of the challenged regulation is helpful in analyzing ICMAD’s procedural contention. The regulation was promulgated on October 17,1973. 38 Fed.Reg. 28912. Within the 30-day period permitted by the statute, several parties objected to certain parts of the regulation and requested a hearing. See 21 U.S.C. § 371(e)(2). ICMAD neither objected nor requested a hearing during this 30-day period; and those parties objecting merely sought narrow exemptions and alternate compliance methods. See 40 Fed.Reg. 8918-21 (1975). The objections stayed the effectiveness of the parts of the regulation objected to, but only those parts. See 21 U.S.C. § 371(e)(2). And, as we have said, any party seeking to challenge the other parts in the courts had only ninety days from the date of the order to file its petition. This ICMAD also failed to do. At the close of the 30-day period for objecting, the Commission began negotiations with the objectors. As a result the objections were withdrawn and no hearing was held. Apparently because of these negotiations, the Commissioner did not publish a notice of what parts of the regulation were stayed until sixteen months after the objections were filed, although the Act requires notice as soon as practicable after the close of the 30-day period for objecting. See id. ICMAD contends that this procedure precluded it from contesting the original regulation. It argues, more specifically, that it was denied a hearing to contest the legality of labeling when the Commissioner failed to hold a hearing on the timely filed objections. As we have pointed out, even if a hearing was required, the purpose of the hearing would only have been to consider and receive evidence on the objections, which raised issues unrelated to ICMAD’s claims here. Thus, the absence of a hearing did not prejudice ICMAD in its challenge to the basic regulation and therefore that cannot be a basis for overturning the regulation. See Braniff Airways, Inc. v. CAB, 126 U.S.App.D.C. 399, 413, 379 F.2d 453, 465 (1967). Similarly, ICMAD’s challenge to labeling could not have been prejudiced by the Commissioner’s failure on July 25, 1974 and March 3, 1975 to publish the proposed amendments. Those amendments, we have noted, provided exemptions and alternate means of compliance, an approach that ICMAD apparently endorses. The amendments had nothing to do with the claims that ICMAD now makes before this court. Moreover, the alleged omissions occurred well after the requirement of labeling had become final and ICMAD had lost its right to object and petition for review. ICMAD’s most forceful procedural argument is that it was prejudiced by the Commissioner’s failure to publish promptly a notice of stay. 21 U.S.C. § 371(e)(2) mandates that “as soon as practicable” a notice shall be published “specifying those parts of the order which have been stayed by the filing of objections . . . .” The Commissioner filed no notice of stay until some 16 months after objections had been filed. 40 Fed.Reg. 8918 (1975). ICMAD contends that had a notice of stay been filed, it would have known that no one had objected to the concept of labeling and accordingly it might have filed a timely petition for review. We cannot agree however that ICMAD was prejudiced. The statute does not make publication of a notice of stay a prerequisite for seeking judicial review. Rather, the statute clearly specifies that a petition for review must follow within ninety days of the order. 21 U.S.C. § 371(f)(1). ICMAD does not, and could not, contend that the lack of a notice misled it into believing that its challenge had somehow been mooted by objections. No prejudice is thus apparent. Indeed, what ICMAD actually seeks is to have us amend section 371(f) to extend the time for filing a petition for review until after publication of a notice of stay. This is a legislative task which we decline. CONCLUSION We affirm in No. 76-1007 the District Court’s dismissal for lack of jurisdiction. Jurisdiction in this case lies exclusively in the court of appeals. We deny, in No. 75-1845, ICMAD’s petition for review. The challenge to the substance of the 1973 regulation is untimely; the attack on the procedure followed in amending that regulation fails because no prejudice has been shown. So Ordered. . The Cosmetic, Toiletry and Fragrance Association (CTFA) was the major party objecting to the parts of the regulation. CTFA included with its objection a proposed amendment to the' regulation and stated that if adopted the amendment would remove the basis for its objections and the need for a hearing. Letter from CTFA to the Dept, of HEW, Nov. 16, 1973. In addition, CTFA subsequently wrote the Commissioner reiterating that adoption of the proposed amendments was intended to be an alternative to holding a hearing on CTFA’s objections. Letter from CTFA to the Associate Commissioner for Compliance, FDA, May 15, 1974. . “[I]t is well settled that bifurcated jurisdiction between District Court and Court of Appeals over identical litigation is not favored.” Oljato Chapter of Navajo Tribe v. Train, 169 U.S.App.D.C. 195, 201, 515 F.2d 654, 660 (1975). And, as we noted in Investment Company Institute v. Board of Governors, 551 F.2d 1270, 1279-80 (1977): Indeed, an impressive line of authority supports the . . . proposition that, even where Congress has not expressly conferred exclusive jurisdiction, a special review statute vesting jurisdiction in a particular court cuts off other courts’ original jurisdiction in all cases covered by the special statute. See, e. g., Macauley v. Waterman S. S. Corp., 327 U.S. 540, 543-545 [66 S.Ct. 712, 90 L.Ed. 839] (1946); E. I. duPont de Nemours & Co. v. Train, 528 F.2d 1136, 1137 & n. 1, 1142 (4th Cir. 1975), [aff'd in part 430 U.S. 112, 97 S.Ct. 965, 51 L.Ed.2d 204 (1977)]; UMC Industries, Inc. v. Seaborg, 439 F.2d 953, 955 (9th Cir. 1971); United States v. Southern Ry. Co., 380 F.2d 49, 53-54 (5th Cir. 1967) To this line of authority supporting our position must be added our opinion in the Investment Company case, as well as recent circuit opinions in Virginia Electric and Power Co. v. Costle, 566 F.2d 446 (4th Cir. 1977), and U. S. Steel Corp. v. Train, 556 F.2d 822, 837 (7th Cir. 1977). . See note 4, infra. . Moreover, the comprehensiveness of our review power is evinced by the statutory review provision permitting the administrative record to be supplemented upon petition to the courts of appeals. Section 371(f)(2) of the statute, regarding petitions for review to the courts of appeals, provides: If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence. 21 U.S.C. § 371(f)(2) [emphasis added]. Thus, the Act clearly envisions that the courts of appeals should have jurisdiction of cases in which the administrative record is deficient. The dissent reads the quoted statutory provision, however, to reach the conclusion that when the record is inadequate, trial before the District Court is mandated. Dissent at-- - of 187 U.S.App.D.C., at 569 of 574 F.2d. We disagree. The dissent’s conclusion disregards the clear import of section 371(f)(2). Further, subjecting the Commissioner’s regulations to a trial de novo in the District Court would be inimical to the aim of Congress in enacting section 371(f). Indeed, several congressmen urged that the statute provide for trial de novo in the district courts, but the idea was rejected for fear that harassing suits in that forum would “hamstring” the Commissioner. Abbott Laboratories v. Gardner, 387 U.S. 136, 143, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967); compare 83 Cong.Rec. 7779, 7785-86, 7789 (1938) with H.R.Rep.No.2139, 75th Cong., 3d Sess. 10-13 (1938). Instead, review in the courts of appeals was adopted as “a method of reviewing agency factual determinations.” Abbott Laboratories v. Gardner, 387 U.S. 136, 143, 87 S.Ct. 1507, 1512, 18 L.Ed.2d 681 [emphasis in original]. To order a trial de novo in the District Court would therefore appear to violate Congress’ intent as well as to ignore section 371(f)(2). See Investment Company Institute v. Board of Governors, 179 U.S.App.D.C. 311, 320, 551 F.2d 1270, 1279 (1977). ICMAD’s challenges here appear not to be based on any factual dispute but are premised on the Commissioner’s exceeding his authority under the statutes. See ICMAD’s complaint at 7-9, J.A. at 8-10; Brief of Petitioner ICMAD at 12-21. These challenges are outlined in that portion of our opinion discussing ICMAD’s petition for review. The dissent appears to say that a factual issue was raised by ICMAD’s contention that the Commissioner made no determination that the regulation was necessary to prevent the deception of consumers or to facilitate value comparisons. ICMAD’s argument however is, as stated in its brief, a nonfactual one: It is beyond dispute that the Commissioner failed to make the statutory finding that the ingredient labeling regulation is necessary to prevent deception or to facilitate value comparisons. Instead, he stated in conclusory language that ingredient labeling “can be meaningful” in preventing consumer deception and that ingredient identity “is one important criterion of a product’s value. . . ” (38 Fed.Reg. 28912 (Oct. 17, 1973)). That a regulation “can be meaningful,” or that ingredient identity is an “important criterion of a product’s value” does not demonstrate that uniform cosmetic ingredient labeling is “necessary” to prevent deception or facilitate value comparisons. Since there has been no finding of necessity, the regulation must be held unlawful as contrary to § 1454(c) of the FPLA. Appellant ICMAD’s Brief in No. 76-1007 at 28-29; see Petitioner ICMAD’s Brief in No. 75-1845 at 13-15. Indeed, as the dissent notes, the Commissioner does not contend before this court that he compiled a record in making the necessary determination; rather, the Commissioner argues that the determination was made and that the Act does not require a completed administrative record unless a party timely objects to the determination, which no party did. Respondents’ Brief at 9-11. Thus, the only question regarding the record is the purely legal one of whether the Commissioner was correct in not compiling a record. We note for clarification that the statute supports the Commissioner’s reasoning. The Act requires that the Commissioner make findings of fact, which are to be based on substantial evidence, only after a public hearing has been held, 21 U.S.C. § 371(e)(3), and the Act mandates a public hearing only after a party objects to an order and requests a hearing, id. (2), (3). Moreover, the scope of the hearing is to consider only issues raised by the objections, id. (3), and thus the record and findings must relate to only those issues. ICMAD made no timely request, and the requests by others for a hearing on matters unrelated to ICMAD’s claims here were withdrawn. Nor does the absence of an administrative record imply that this court is an improper forum for review; were the issue properly presented, we could review the Commissioner’s basis for determining that the regulation was necessary. See Mobil Oil Corp. v. FPC, 152 U.S.App.D.C. 119, 469 F.2d 130 (1972); Kennecott Copper Corp. v. EPA, 149 U.S.App.D.C. 231, 462 F.2d 846 (1972); see also City of Chicago v. FPC, 147 U.S.App.D.C. 312, 322 n. 45, 458 F.2d 731, 741 n. 45 (1971). . See note 4, supra. . The dissent poses the questions, “Where, When, and from What judicial review should take place.” We decide in the first part of this opinion that as to “Where”, the proper forum is the courts of appeals. With respect to “When”, the statute compels that the request for review be within 90 days of the date of the order that adversely affects the petitioning party. The “What” in this case is the October 17, 1973 order, which promulgated the basic regulation. The dissent asserts, however, that the order of October 17, 1973 served primarily only as an expression of the Commissioner’s view on comments received regarding the regulation and as an opportunity to invite formal objections and requests for hearing. Dissent at of 187 U.S.App.D.C., at 563 of 574 F.2d. Because the order invited formal objections and hearing requests, the dissent surmises that “the form and content of the regulation were still very much open to discussion and debate.” The dissent in elaborating the effect of the October 17, 1973 order, however, ignores its principal function: to promulgate in final form the earlier proposed regulation. Thus, after discussing the comments received on the proposal, the Commissioner announced: The Commissioner concludes that all cosmetic labeling ordered after March 31, 1974, and all cosmetic products labeled after March 31, 1975, shall comply with this regulation. This will, within reasonable limits, allow industry time to exhaust current inventories, redesign labeling, and obtain new labeling. Therefore, pursuant to provisions of the Fair Packaging and Labeling Act (secs. 5(c), 6(a), 80 Stat. 1298, 1299; 15 U.S.C. 1454, 1455) and the Federal Food, Drug, and Cosmetic Act (sec. 701(e), 52 Stat. 1055-1056, as amended; 21 U.S.C. 371(e)), and under authority delegated to the Commissioner (21 CFR 2.120), Part 1 is amended by adding the following new section: * * * * * * 38 Fed.Reg. 28913. This pronouncement was followed by a statement of the regulation in the form customarily used by agencies when promulgating regulations in the Federal Register. Furthermore, the Commissioner’s inclusion in the order of a statement of the parties’ rights to object and request a hearing does not suggest that the order was not appealable. The Act permits review of an order acting upon a proposed regulation that has been publicized and commented on. 21 U.S.C. § 371(f)(1). The October 17, 1973 order was such an order. ICMAD could therefore petition for review of this order, or alternatively, it could object to the order and seek a hearing. 21 U.S.C. § 371(e)(2). Therefore, inclusion of a statement of this right, granted by statute, should not make an otherwise appealable final order something else. Nor do we believe that the subsequent amendments so altered the character of the original regulation that the regulation must be deemed not to have been in final form until after promulgation of the amendments. While the dissent appears to measure the effect of the amendments on the regulation spatially, we believe a less quantitative gauge is required. Our reading of the two sections shows that the amendments only granted limited exemptions and alternate means of compliance and thus they did not alter the fundamental character of the original regulation, which went into effect October 17, 1973. For example, the first section of the amendments permits manufacturers a slight variance from the requirement in the basic regulation that ingredients be listed in descending order of predominance. It permits grouping without respect to predominance of color additives and of ingredients, other than color additives, which are present at a concentration of not more than one percent. 40 Fed. Reg. 8922 (1975). . See note 6, supra. . Therefore, contrary to the implication of the dissent, ICMAD was not denied the opportunity for a hearing on its challenge to the basic regulation; rather, ICMAD waived its statutory right to such a hearing by failing to make a timely request. . On July 25, 1974 the Commissioner, instead of publishing the proposed amendments, gave public notice that a tentative revised final order reflecting the proposal was available. 39 Fed. Reg. 27181. The notice also invited comment by interested parties. On March 3, 1975 the Commissioner published the amendments in final form. 40 Fed.Reg. 8918. . By letter of April 1, 1975 ICMAD commented on the amendments. Except for contesting the original regulation, an attack the Commissioner found untimely (40 Fed.Reg. 23158, 23159 (1975)), ICMAD principally argued for additional exemptions and alternate means of compliance. As the Commissioner concluded, this argument properly should be styled a request for further amendments and not an objection to the present amendments. 40 Fed.Reg. 23159. . In fact, the Commissioner adopted many of the proposals advanced by the objectors, see 40 Fed.Reg. 8918-21 (1975), and had the Commissioner adopted all the objectors’ proposals, see id, it is difficult to understand how that would have mooted any of ICMAD’s contentions.
WILKEY, Circuit Judge, dissenting: The majority here achieves a remarkable result: the petitioner is denied relief in the District Court because the Court of Appeals has exclusive jurisdiction; the petitioner is denied relief in this Court of Appeals because petitioner’s challenge is “untimely”; even though it was precisely the weird procedure in the FDA which left the petitioner with neither clear reason nor opportunity to challenge the regulations, “the attack on the procedure . . . fails because no prejudice has been shown”; and, by lifting of the protective stay on 14 March 1977 with the reasons for decision following eleven months later, the petitioner has been denied any realistic chance of relief by seeking en banc consideration or certiorari. How did Justice assume this shape? It is significant that there is not a Statement of Facts as such in the majority opinion; rather, highlights of the procedural history are interspersed through a discussion of legal precedents. The procedural facts here are detailed and all important to a correct appreciation and resolution of a jurisdictional conundrum which is being posed with increasing frequency to this court. In this particular matter the procedural history is embarrassing to the FDA and to the disposition the majority make of this case. If the reader receives the impression that the Commissioner was operating without legal counsel, or with lawyers who preferred to ignore the agency’s basic statute and the Administrative Procedure Act, while devising ad hoc procedure en route to final regulations, that impression is an accurate reflection of the record. For any effective analysis of both the specific errors here and the recurring legal problem, no giant slalom through the facts, touching a pole here and there, will suffice. We must first look very carefully at the procedural steps taken by the Commissioner and the appropriateness of the responsive action (or non-action) taken by the petitioner, before proceeding to an analysis of Where, When and from What judicial review should take place. The Where, When, and What of judicial review under these circumstances has, in my opinion, an importance far beyond its impact on this case; the ad hoc procedure blithely employed by the FDA here serves only as a glaring illustration of why careful, thorough consideration by this court is necessary. In these two cases the Independent Cosmetic Manufacturers and Distributors, Inc. (ICMAD), a trade association comprised of small-to-medium sized manufacturers and distributors of cosmetic, skin care, and fragrance products, seeks to challenge a cosmetic ingredient labeling regulation promulgated by the Commissioner of the Food and Drug Administration pursuant to § 1454 of the Fair Packaging and Labeling Act (FPLA). Recognizing confusion in the law regarding the proper forum for judicial review, ICMAD filed suit in the District Court for declaratory and injunctive relief on 27 August 1975; on the same day, IC-MAD filed a petition for review of the regulation in this court. The result of the majority’s decision on both of petitioner’s pleas is to deny ICMAD any opportunity to obtain judicial review of the Commissioner’s cosmetic labeling regulation anywhere. I dissent from the majority’s position on the grounds that the District Court has subject matter jurisdiction over ICMAD's action and that, in the context of this case, the District Court was the proper forum for ICMAD’s challenge. Most emphatically, I also dissent from the majority’s conclusion that ICMAD’s petition in this court was not timely filed. These cases present a significant and recurring issue related to the choice of the proper federal forum in which to mount a challenge to federal administrative agency action; the result here is that federal agency action is totally insulated from judicial review. 1. THE AGENCY PROCEEDINGS The thesis of this dissent is that the nature of the administrative record is central to a determination as to the proper forum in this and similar cases; the procedural history of the labeling regulation emphasizes this critical point as to the nature of the record which has been developed. In addition, the precise chronology of. events is crucial to making an informed decision on the question of the timeliness of ICMAD’s petition in this court. In this part, I shall first outline the statutory authority under which the Commissioner proceeded in promulgating the regulation, and then proceed to examine in detail the various stages in the evolution of the cosmetic labeling regulation. A. Statutory Authority. Section 1454(c) of the FPLA grants the Secretary of Health, Education and Welfare the discretionary authority to promulgate labeling and packaging regulations whenever he determines such regulations “are necessary to prevent the deception of consumers or to facilitate value comparisons.” This authority may be exercised to require, among other things, “that the label on each package of a consumer commodity bear (A) the common or usual name of such consumer commodity, if any, and (B) in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance,” so long as trade secrets are not required to be divulged. The labeling regulation at issue in these cases seeks to prescribe the precise method to govern such a listing of cosmetic ingredients in order of decreasing predominance. In promulgating labeling regulations, the Secretary is required by § 1455 of the FPLA to observe the procedural requirements of section 701(e) of the Federal Food, Drug and Cosmetic Act. Also, the judicial review of these regulations is governed by the provisions of section 701(f) of the Food and Drug Act. Therefore, in analyzing the issues presented in this case, the provisions of the Food and Drug Act, not the FPLA, will be the primary focus of concern. B. Procedural Background. The central point to be kept in mind is that the cosmetic ingredient labeling regulation was promulgated in an amazingly piecemeal fashion during the period beginning 7 February 1973 and ending 30 May 1975. During this period the Commissioner published notices and other material concerning the regulation on five separate occasions in the Federal Register, and took other action not so noticed. The undeniable result was, contrary to the majority opinion, that the petitioner had not clear designation as to from What it should appeal, When, and eventually, Where! For purposes of organizing this discussion of the procedural background, these five communications from the Commissioner will be examined seriatim. 1. 7 February 1978. On this date the Commissioner first issued the proposal for the labeling of cosmetics. There were actually two proposals put forth in this notice— one proposal consisted of a petition presented by a private party, while the other was the Commissioner’s proposal. The Commissioner’s proposal is the one which was subsequently discussed, amended, and adopted, and any further mention of the labeling regulation will refer to this proposal. The Commissioner’s proposal sought to add § 1.205 to Chapter I of 21 C.F.R. and, at this time, consisted of four subsections. In the notice of 7 February 1973 the Commissioner stated that written comments on the proposal to require ingredient labeling would be received until 9 April 1973. 2. 17 October 1973. In this notice the Commissioner announced that 291 comments had been received in response to the proposals published on 7 February 1973. Several comments received during this period questioned (1) the Commissioner’s legal authority to promulgate the regulation and also questioned (2) whether the Commissioner had met the statutory standard of determining that the regulation was necessary to prevent consumer deception or to facilitate value comparison. These objections are of great importance in this ease because they later formed the basis for ICMAD’s judicial challenge to the regulation. The Commissioner undertook to answer these two objections in the notice of 17 October 1973. With respect to the statutory authority issue, the Commissioner stated: The Commissioner concludes that Section 5 of the Fair Packaging and Labeling Act contains ample authority for the promulgation of this regulation. For the purposes of ingredient labeling, the Commissioner concludes that all cosmetics are appropriately considered a single “commodity”. However, even if the term “cosmetic” is considered to encompass several separable cosmetic “commodities”, nevertheless the Commissioner concludes that ingredient labeling is needed for all such commodities and that a .comprehensive order governing all such commodities in this respect is most efficient. As the United States Supreme Court has recently observed in upholding other regulations of the Food and Drug Administration, “[t]he comprehensive rather than the individual treatment may indeed be necessary for quick effective relief.” Weinberger v. Hynson, Westcott & Dun ning, 412 U.S. 609, 93 S.Ct. 2469, 2481 [37 L.Ed.2d 207] (June 18, 1973). With respect to the statutorily mandated finding of necessity, the following justification was put forth: The Commissioner also concludes that cosmetic ingredient labeling is necessary to prevent the deception of consumers and to facilitate value comparisons. Ingredient labeling can be meaningful in preventing consumer deception by precluding product claims that are unreasonable in relation to the ingredients present and by providing consumers with additional information that can contribute to a knowledgeable judgment regarding the reasonableness of the price of the product. Furthermore, while ingredient identity may not be the sole determinant of a product’s value to a consumer, it is one important criterion of a product’s value in comparison with others. The presence of a substance to which a consumer is allergic or sensitive, for example, may render the product worthless to that consumer. In the entire record of the proceedings before the FDA, the issues of statutory authority and adherence to the statutory standard were faced only in this 17 October 1973 notice and only in the above quoted passages. In the 17 October notice the Commissioner set a deadline of 16 November 1973 for the filing of objections and requests for hearings on the provisions of the ingredient labeling regulation. Also, the Commission for the first time set effective dates for the regulation to be put into operation; the regulation was to apply to all cosmetic labeling ordered after 31 March 1974 and to all cosmetic products labeled after 31 March 1975. Finally, in the 17 October 1973 notice, the Commissioner invited petitions for the amendment of the regulation to deal with exemptions for incidental ingredients present in cosmetic products in insignificant amounts. This action was taken in response to comments received on this issue. In summary, the notice of 17 October 1973 sought to accomplish three goals. First, the Commissioner undertook to express his opinion on the substantive issues raised in the written comments that had been received. Second, the Commissioner added a fifth subsection to his original proposal which invited petitions from interested parties to establish specific uniform names for cosmetic ingredients. In announcing this fifth subsection, the Commissioner stated that each such petition would be subject to notice and comment procedures prescribed in the FDA regulations. Third, the Commissioner for the first time invited formal objections and requests for hearing to the regulation as it then stood. This point bears repeating: it was at this stage (17 October 1973) that interested parties were first given the opportunity to exercise the procedural rights to object specified in section 701(e) of the Food and Drug Act. The point to be made is that the form and content of the regulation were still very much open to discussion and debate as of 17 October 1973; the Commissioner on this date envisioned that the process of informal rulemaking would proceed at least until all objections had been dealt with. The majority opinion is thus totally in error on the critical point in its own rationale when it states: “[T]he original regulation . . . was published in final form in the Federal Register on October 17, 1973 (38 Fed.Reg. 28912) ... and ICMAD’s petition for review in 1975 clearly falls outside the 90-day boundary.” The Commissioner himself prescribed a thirty day limit on the filing of objections and requests for hearings in his continuation of informal rulemaking. (38 Fed.Reg. 28912) There was no administration action at this date from which anyone could have sought judicial review within 90 days, and no one did. 3. 25 July 1974. The Commissioner reported on this date that thirteen objections and four requests for hearing had been received as the result of his notice of 17 October 1973. In response to these filings, the Commissioner prepared what he termed a “Tentative Revised Final Order.” The Commissioner stated his belief that this tentative revised order adequately dealt with the objections and eliminated the need for a public hearing. The Tentative Revised Final Order was not published in the Federal Register and, therefore, one who depended on public notices as required by the Food and Drug Act would be unable to gauge the magnitude of the changes which the Commissioner made in response to the objections. Rather, the order was sent to all parties who had filed objections and was placed on display with the Hearing Clerk of the FDA for a period of thirty days. The Commissioner also announced that he would meet privately with any parties during the period from 25 July 1974 to 23 August 1974 to discuss the proposed ingredient labeling regulation. The informal rule making, albeit with some unusual variations, was thus continuing; there was still no final administrative action from which an appeal could be taken, and none was. 4. 3 March 1975. This is the key date with respect to understanding the procedural history of the cosmetic ingredient labeling regulation. On this date the Commissioner divided his communications on the subject of cosmetic ingredient labeling into two notices. Although the Commissioner termed the communications as two separate notices, they dealt with the same subject matter, were filed with the Registrar of federal documents at exactly the same time, and were separated in the Federal Register by only a short black horizontal line. As will be seen, there is no doubt the Commissioner wanted the notices thought of as being separate; the question of whether this technique exalts form over substance in an unacceptable manner will be discussed at a later point. In the first notice the Commissioner explained his reason for not holding public hearings in response to the filed objections: The Commissioner believes that the factual circumstances involved are well known to the Food and Drug Administration and that a hearing could not provide additional information. The Commissioner asserted that the private discussions he had been holding pursuant to his 25 July 1974 notice were justified by this assumed inability of a public hearing to provide additional information. The primary purpose of this first notice of 3 March 1975 was to promulgate significant additions to the ingredient labeling regulation which had been the focus of attention since 7 February 1973. In this notice the Commissioner proposed the addition of twelve subsections to the five subsections which had already been proposed. According to the Commissioner, these proposed additions contained “refinements of and alternatives to the original regulations for ingredient labeling . . .. [T]he new provisions offer alternative methods for ingredient declaration.” The Commissioner began the first 3 March 1975 notice by referring to the 17 October 1973 notice as “the first final order” for cosmetic labeling. This terminology at first appears puzzling to one who reads this 3 March notice; the significance of this statement becomes apparent only when the overall purpose of the Commissioner’s 3 March notices is considered. The Commissioner’s intention is to have the 12 new subsections considered as a separate unit, apart from the original five subsections discussed in all previous public notices. Even though the Commissioner has stated that the proposed additions represent “refinements of and alternatives to the original regulations,” as of 3 March 1975 he began to consider the two sets of subsections (a-e, f-q) as separate entities. .The majority opinion accepts without question this post hoc description, ignoring the call in the 17 October 1973 order for further informal rulemaking, ignoring the Commissioner’s own actions over the intervening 17 months, and never deigning to explain from What the petitioner could have sought relief after the 17 October 1973 order which plainly contemplated further administrative proceedings on the proposed regulations. The validity of the Commissioner’s characterization is central to the question of the timeliness of ICMAD’s petition in this court. As a conclusion to the first notice of 3 March 1975, the Commissioner set a deadline of 2 April 1975 for the filing of objections to the twelve proposed subsections. The Commissioner also set new effective dates of 3 March 1976 for ordering labels and 3 September 1976 for labeling of products. The new effective dates were to apply to the entire regulation (the original five plus the twelve new subsections); no attempt was made to separate the regulations for this purpose. In the second notice published on 3 March 1975, the Commissioner dealt with the objections filed in response to the first five subsections discussed in the 17 October 1973 notice. The Commissioner found substance in only two of the objections and ordered that these provisions be stayed pending a public hearing. With respect to the effect of the stayed provisions on the original 17 October 1973 provisions, the Commissioner stated that “the unstayed portions of the October 1973 order are distinct and unaffected. The Commissioner concludes that these separable parts of the October 1973 order should be placed into effect without further delay.” Thus, as a result of the two notices published on 3 March 1975, the Commissioner had divided the cosmetic ingredient labeling regulation into three separate entities: 1) the unstayed portions of the 17 October 1973 notice (three subsections); 2) the stayed portions of the 17 October 1973 notice (two subsections); and 3) the twelve new subsections promulgated first in the notice of 3 March 1975. The logic and appropriateness of this division will be examined in a later section. 5. 30 May 1975. In this notice the Commission dealt with the objections (which included the first written objections interposed by ICMAD) filed pursuant to the notices issued 3 March 1975. As to those objections which concerned the first five subsections originally published on 17 October 1973, the Commissioner stated that nothing in the regulations published March 3, 1975, requires the declaration of ingredients on cosmetic products. That requirement was issued under § 701.3(a) in the order published in the Federal Register of October 17, 1973, at which time a period of 30 days was provided for the filing of objections and requests for hearing. Consequently, the objections to provisions of § 701.3(a) received in response to the announcement of March 3, 1975, are untimely, and the requests for hearing on those provisions are denied. With respect to ICMAD’s objection that there was no substantial evidence to support the conclusion that the regulation was “necessary” in the statutory sense, the Commissioner stated, The Commissioner notes that the question whether a particular regulation prevents consumer deception or facilitates value comparisons is a question of fact, not a question of law . . . Had objections and a request for hearing been made [pursuant to the 17 October 1973 notice], the Commissioner would have placed any appropriate additional evidence in the record at such a hearing, demonstrating that ingredient declaration prevents consumer deception and facilitates value comparisons. After dealing with the objections to the first five subsections by declaring them untimely, the Commissioner in his 30 May 1975 notice turned to the objections to the additional twelve subsections which had been promulgated on 3 March 1975. The Commissioner dealt with these objections by terming them “petitions for amendment” of the labeling regulation; that is, he denied that they were objections at all. As the Commissioner stated, “each is in fact a request that additional exemptions be granted or alternative methods of labeling be permitted.” After labeling these objections as “petitions”, the Commissioner proceeded to declare that the petitions were defective qua petitions in that they did not meet the statutory standards for petitions. Thus, the objections to the twelve additional subsections were first characterized as being in a different form than the parties intended, and then were denied as not fitting into that newly designated category. This action with respect to objections to the twelve additional subsections was taken eighty-eight days after the subsections were promulgated on 8 March 1975. The Commissioner did find that one objection interposed by ICMAD had merit and ordered that the provision in question be stayed pending the outcome of a public hearing. In addition, the partial stay issued 3 March 1975 was revoked. The Commissioner at this time set a new and final effective date for the labeling regulation; all labeling for cosmetic products ordered after 31 May 1976 and all cosmetic product packages labeled after 30 November 1976 were to comply with all of the requirements of the regulation except the one provision stayed in the 30 May 1975 notice. Again, the effective dates applied to all seventeen subsections and did not distinguish between what the Commissioner termed the two separate regulations. The notice of 30 May 1975 was the final pronouncement by FDA on this matter. There has been no citation by the parties as to the outcome of any proceedings concerning the one provision which was stayed on 30 May 1975. II. ICMAD’S OBJECTIONS ICMAD first interposed written objections on 1 April 1975; these objections were filed within the prescribed 30 days in response to the Commissioner’s notice of 3 March 1975. ICMAD objected “totally to the concept of ingredient labeling on cosmetics” in its letter to the Commissioner on 1 April 1975. This objection was based on the adverse consequences of the regulation which would fall particularly hard on the type of manufacturers and distributors represented by ICMAD. ICMAD chose to mount its frontal challenge to the regulation at this point because, in its view, the twelve new subsections proposed on 3 March 1975 “in fact give no relief from the adverse effects of” the first five subsections promulgated on 17 October 1973. ICMAD also contended in its 1 April 1975 submission that the Commissioner had not made the statutorily required finding of necessity in promulgating the regulation; as ICMAD stated, the conclusion “that cosmetic ingredient labeling is necessary to prevent deception and facilitate value comparison ... is not supported by facts, but by surmises.” ICMAD thus challenged the legal basis on which the regulation was promulgated. After outlining the adverse consequences of the regulation' for its membership and challenging the legal basis for the regulation, ICMAD put forth particularized objections to the twelve additional subsections proposed on 3 March 1975. In each case ICMAD identified what it considered the particular defect in the proposed provisions and offered a precise formulation of the issue on which a public hearing was requested. It is the thoroughness and completeness of ICMAD’s objections which apparently inspired the Commissioner to label the objections as “petitions for amendment” and label them as defective as “petitions”; presumably if ICMAD’s objections had been more cursory and far less specific they would have passed muster as objections. As stated previously, all but one of the objections were denied by the Commissioner; ICMAD’s next formulation of its objections to the labeling regulation is to be found in its complaint for declaratory and injunctive relief filed on 27 August 1975. As framed in the complaint and the petition for review, ICMAD objects to the labeling regulation on three basic grounds. First, ICMAD contends that the Commissioner acted in excess of his statutory authority by 1) treating all cosmetic products as a single commodity; 2) by failing to make a determination on a commodity-by-commodity basis that this ingredient labeling regulation is necessary to achieve the statutory objective; and 3) by requiring manufacturers to divulge all ingredients, and therefore to divulge trade secrets. As the second ground for challenge, IC-MAD argues that, even if the FPLA empowers the Commissioner to promulgate a labeling regulation governing all cosmetic products as one commodity, the Commissioner has failed to meet the statutory burdens of finding that this regulation is necessary to prevent the deception of consumers or to facilitate value comparisons. As the third ground for challenging the regulation, ICMAD points to numerous alleged procedural irregularities which it believes render the regulation unlawful. III. JUDICIAL REVIEW OF LABELING REGULATIONS Judicial review of the cosmetic ingredient labeling regulation at issue in these cases is governed by section 701(f) of the Food, Drug, and Cosmetic Act. In relevant part this section provides: “(f)(1) In a case of actual controversy as to the validity of any order under subsection (e) of this section, any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. . . . The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of Title 28. “(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence. “(3) . . . ****** “(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.” The FDA contends that section 701(f)(1) makes review in the court of appeals the exclusive avenue for relief for ICMAD in this case. ICMAD, on the other hand, points to the “saving clause” in clause 6 to justify district court jurisdiction in the matter. ICMAD’s principal argument is that it is unsure of which court to go to in order to secure judicial review; ICMAD did, therefore, file for judicial review in the district court and in the court of appeals on the same day. The question which will occupy the greater part of the remainder of this dissent involves the interrelationship between the saving clause and the statutorily prescribed review procedure. In particular, the issue boils down to the following question: under what circumstances is it mandatory that review of a regulation promulgated pursuant to section 701(e) be sought in the court of appeals? IV. ANALYTICAL FRAMEWORK Congress undoubtedly has the power to designate the forum in which challenges to federal administrative action are to be brought. In this regard the Supreme Court has admonished that special review procedures, such as that found in section 701(f) of the Food and Drug Act, are to be “construed both with precision and with fidelity to the terms by which Congress has expressed its wishes.” There are two sources which will be examined in an attempt to discern the Congressional intent as regards the proper forum in these cases brought by ICMAD. First, the words of the statute itself will be examined; this exercise will be followed by a close examination of the legislative history. After discussing the legislative intent, relevant judicial precedents, including in particular the Supreme Court’s decision in Abbott Laboratories v. Gardner, will be examined. In examining these various sources, the purpose is to formulate a set of precise, relevant questions to apply to the facts of this case in order to determine the proper forum. A. Statutory Language. A literal reading of the first three clauses of section 701(f) would appear to indicate that the challenges to be heard by the court of appeals are those that are based on the factual findings made by the Commissioner when promulgating regulations. This conclusion derives from two statutory references. First, upon receipt of a copy of the petition for review, the Secretary is required to file with the court “the record of the proceedings on which the Secretary based his order . . . .” Furthermore, the statute envisions a record which can be reviewed under the “substantial evidence” test. Thus, the primary concern of the special review procedure appears to be with the factual findings made when regulations are issued. The idea that the statutorily provided review procedure is primarily concerned with the review of factual matters finds further support in clause (2) of section 701(f). This section provides that a petitioner may request that the court of appeals order the taking of additional evidence before the agency. Significantly, such additional evidence must also include rebuttal evidence. After taking the additional evidence, the statute authorizes the Secretary at his discretion to “modify his findings as to the facts, or make new findings by reason of the additional evidence . .” In so stating, the implication is clear that the Secretary has already made factual findings based on the record sent to the court of appeals. Clause (2) merely provides for the addition of evidence to that original record. Clause (2) also requires the Secretary to file his new or modified findings with the court; such a requirement serves to ensure that the court of appeals has the fullest possible record on which to review the factual findings of the Secretary. In summary, a reading of the statutory language yields the conclusion that review in the court of appeals is premised on the existence of two conditions: 1) a record which is 2) capable of being reviewed for substantial evidence. If there is no record, or if it is such that cannot be meaningfully reviewed for substantial evidence, the implication is that the saving clause in § 701(f)(6) provides the remedy. This implication flows from the positioning of the saving clause at the end of the subsection which specifies the statutory review procedure; if the special procedure is not applicable, then the saving clause must come into operation. The fuller meaning and intent behind the special review procedure and the saving clause will now be explored by examining the legislative history. B. Legislative History. As stated previously, the legislative history is of great importance in these cases. While recognizing the importance of this source of information, it is appropriate to qualify this characterization with two observations. First, the Food and Drug Act was enacted in 1938, over a decade before the Administrative Procedure Act went into effect. The Food and Drug Act, in its judicial review provisions, uses such terms as “order,” “substantial evidence,” and “record.” These terms were later incorporated into the APA and given somewhat more precise definitions than existed in the pre-APA period. In addition, these terms have undergone some significant redefinition in recent years as the courts have begun to focus more heavily on the review of federal agency action. Therefore, it would serve no useful purpose to search the legislative history of the Food and Drug Act to determine the precise intent with respect to some of these key terms which have gone through at least two stages of redefinition. Rather, in a case such as this, the legislative history should be consulted in order to identify the basic underlying congressional concerns. Once these underlying concerns have been identified, a court can then seek to reconcile these concerns with the current, accepted tenets of federal administrative law. Such an approach in no way denigrates the importance or significance of congressional intent but merely recognizes that the intent expressed in 1938 cannot control current court actions with total specificity. Second, the fact that the FPLA incorporates by reference the judicial review provisions of the Food and Drug Act is of some significance in this case. At the time it was enacted, the Food and Drug Act represented a marked increase in federal interest and activity in protecting consumers in an area in which they are particularly vulnerable— food and drugs. The legislative history is filled with frightening stories concerning the effects of unsafe, untested, and adulterated food and drug products which made their way on to the market because of the lack of effective regulation. The point to be made is that the subject mat