Opinion ID: 494127
Heading Depth: 1
Heading Rank: 2

Heading: Accepted Medical Use And Safety Under The CSA.

Text: 14 We turn first to petitioner's claim that the Administrator erred in interpreting the phrases accepted medical use in treatment in the United States and accepted safety for use ... under medical supervision in section 812(b)(1) to mean, in essence, approved for interstate marketing by the FDA under the FDCA. Before embarking on an analysis of that issue, however, we begin by explaining the appropriate standard of review in a case, such as this, where a court must assess an agency's interpretation of a statute it administers. 15
16 The Administrator argues correctly that we must review his interpretation of the CSA in light of the guidelines set forth by the Supreme Court in Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). In Chevron the Court explained that a reviewing court must employ a two-step analysis that focuses initially on the intentions of Congress: 17 First, always, is the question whether Congress had directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. 18 Id. at 842-43, 104 S.Ct. at 2781 (emphasis supplied). In the absence of congressional intent, however, the court must proceed to a second inquiry:If ... the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction on the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. 19 Id. at 843, 104 S.Ct. at 2781-82 (footnote omitted; emphasis supplied). 20 It is undisputed that Congress has not directly spoken to the question at issue here, namely, the proper means of interpreting the second and third criteria of section 812(b)(1). The absence of express intent, however, does not compel us to proceed to the deferential second step of the Chevron scheme. As the Supreme Court indicated in a footnote to its Chevron opinion, [i]f a court, employing traditional tools of statutory construction, ascertains that Congress had an intention on the precise question at issue, that intention is law and must be given effect. Id. at 843 n. 9, 104 S.Ct. at 2781 n. 9. Recently the Supreme Court has reaffirmed this proposition, holding in INS v. Cardoza-Fonseca, --- U.S. ----, 107 S.Ct. 1207, 94 L.Ed.2d 434 (1987), that a court faced with a pure question of statutory interpretation should rely upon traditional methods of statutory construction in an attempt to determine the intent of Congress. Id. 107 S.Ct. at 1221; International Union, UAW v. Brock, 816 F.2d 761, 764-65 (D.C.Cir.1987) (applying traditional tools of statutory construction to invalidate agency's interpretation of statutory language as conflicting with intent of Congress). 21 The Administrator contends that congressional intent favoring his interpretation of the CSA can be gleaned from the language of the statute, its legislative history, and the language and history of subsequent legislative enactments designed to enhance the regulatory system established by the CSA in 1970. In the alternative, he argues that if the intent of Congress is ambiguous, then his construction of the statute is permissible in view of the statutory scheme. 5 Our review of the sources identified by the litigants convinces us that Congress neither expressed nor implied an affirmative intent regarding how the second and third Schedule I criteria should be interpreted. Nevertheless, these same sources--the language and structure of the CSA and FDCA, the legislative history of the CSA, and the subsequent handiwork of Congress in the area of controlled substance regulation--lead us to conclude that the Administrator's construction of subsections (B) and (C) of 21 U.S.C. Sec. 812(b)(1) is contrary to congressional intent. 6 22
23 The Administrator begins by arguing that the language of the CSA itself is evidence of congressional intent favoring his construction of the statute. His argument is based on the definitions of terms chosen by Congress in drafting the relevant provisions of the CSA. He first cites the definition of the term United States as used in accepted medical use in treatment in the United States. 21 U.S.C. Sec. 812(b)(1)(B). This term is the only portion of the Schedule I criteria that Congress has expressly defined in the CSA, providing that [t]he term 'United States,' when used in a geographic sense, means all places ... subject to the jurisdiction of the United States. 21 U.S.C. Sec. 802(28) (emphasis supplied). Coupling this statutory definition of United States with the dictionary definition of accepted--which means generally approved or generally agreed upon--the Administrator argues that the phrase accepted medical use in treatment in the United States, 21 U.S.C. Sec. 812(b)(1)(B), must contemplate an administrative determination that the substance has been generally approved for use in treatment in all places subject to United States jurisdiction. In other words, FDA interstate marketing approval is necessary to satisfy this criterion because, otherwise, the substance could not be deemed to be generally approved everywhere in the United States. 7 24 We find this argument to be strained and unpersuasive. The CSA's definition of United States plainly does not require the conclusion asserted by the Administrator simply because section 802(28) defines United States as all places subject to the jurisdiction of the United States. 21 U.S.C. Sec. 802(28) (emphasis supplied). Congress surely intended the reference to all places in section 802(28) to delineate the broad jurisdictional scope of the CSA and to clarify that the CSA regulates conduct occurring any place, as opposed to every place, within the United States. As petitioner aptly notes, a defendant charged with violating the CSA by selling controlled substances in only two states would not have a defense based on section 802(28) if he contended that his activity had not occurred in all places subject to United States jurisdiction. We add, moreover, that the Administrator's clever argument conveniently omits any reference to the fact that the pertinent phrase in section 812(b)(1)(B) reads in the United States, (emphasis supplied). We find this language to be further evidence that the Congress did not intend accepted medical use in treatment in the United States to require a finding of recognized medical use in every state or, as the Administrator contends, approval for interstate marketing of the substance. 25 Nor does the dictionary definition of accepted offered by the Administrator convince us that Congress intended FDA approval to be the equivalent of the second and third Schedule I criteria. Use of the term accepted in sections 812(b)(1)(B) and 812(b)(1)(C) may indicate that Congress intended the medical use or safety of the substance to be generally agreed upon, but this alone does not inform us as to who must generally be in agreement. The Administrator reads accepted to mean that the FDA must have approved the drug for interstate marketing. Dr. Grinspoon, on the other hand, prefers to interpret accepted as meaning that the medical community generally agrees that the drug in question has a medical use and can be used safely under medical supervision. Our conclusion is that the term accepted does not cure the statute's ambiguity. We are simply unable to extrapolate from the drafters' choice of the word accepted and thereby ascertain a general congressional intention favoring the interpretation advanced by the Administrator. 26 In another argument focusing upon the language of the statute, the Administrator urges us to adopt his interpretation of the CSA because it is entirely consistent with the interpretation of the phrase accepted medical use in treatment in the United States employed in the Commissioners' Notes to the Uniform Controlled Substances Act, Secs. 203-12, 9 U.L.A. 221-35 (1979) (Uniform CSA). 8 At first glance, this argument appears to have considerable merit. The Uniform CSA, like its federal counterpart, creates five schedules of controlled substances and, indeed, was modeled on the federal CSA. 9 U.L.A. 187, 188 (1979). 9 But, while we agree that the Uniform CSA offers an interesting comparison, we fail to see how the interpretation of the Uniform CSA offered by the Commissioners has any bearing at all on the intent of Congress, which enacted the federal CSA prior to the creation of the Uniform CSA. We can only conclude, therefore, that this argument, despite its facial appeal, has no bearing on the claim that the language of the federal CSA evidences congressional intent to adopt the construction of the statute favored by the Administrator. 27 While the Administrator's arguments fail to persuade us that Congress affirmatively intended his construction of the CSA, we believe nevertheless that the language and structure of the two relevant statutes, the CSA and the FDCA, are helpful in determining whether the Administrator's interpretation squares with congressional intent. Although, as the District of Columbia Circuit has stated, [t]he interrelationship between the two Acts [CSA and FDCA] is far from clear, National Organization for Reform of Marijuana Laws (NORML) v. DEA, 559 F.2d 735, 750 (D.C.Cir.1977), we are persuaded that this interrelationship precludes the Administrator's reliance on the absence of FDA approval as a substitute for the second and third Schedule I criteria under the CSA. 28 The CSA clearly provides that a substance may not be placed in Schedule I unless it lacks both a currently accepted medical use in treatment in the United States and accepted safety for use ... under medical supervision. The FDCA, on the other hand, provides that a substance may fail to obtain FDA interstate marketing approval (or exemption) for any of seven specific reasons. 21 U.S.C. Sec. 355(d)(1)-(7). Although approval may be withheld because the substance lacks both safety, 21 U.S.C. Sec. 355(d)(2), and efficacy for a particular use, 21 U.S.C. Sec. 355(d)(5), it is equally possible for a substance to be disapproved for interstate marketing because it lacks only one of these attributes, or because the application fails to contain relevant patent information, 21 U.S.C. Sec. 355(d)(6), or even because the labeling proposed for the drug is false or misleading in any particular. 21 U.S.C. Sec. 355(d)(7). Thus, we find no necessary linkage between failure to obtain FDA interstate marketing approval and a determination that the substance in question is unsafe and has no medical use. Indeed, the FDCA does not even mention the term medical use. In short, it is plainly possible that a substance may fail to obtain interstate marketing approval even if it has an accepted medical use. 29 Another possible reason for failure to obtain FDA new drug approval is that the manufacture, distribution, and use of a substance might not involve interstate marketing. 10 Unlike the CSA scheduling restrictions, the FDCA interstate marketing provisions do not apply to drugs manufactured and marketed wholly intrastate. Compare 21 U.S.C. Sec. 801(5) with 21 U.S.C. Sec. 321(b), 331, 355(a). Thus, it is possible that a substance may have both an accepted medical use and safety for use under medical supervision, even though no one has deemed it necessary to seek approval for interstate marketing. Indeed, as Dr. Grinspoon argues, there is no economic or other incentive to seek interstate marketing approval for a drug like MDMA because it cannot be patented and exploited commercially. The prospect of commercial development, of course, is irrelevant to one who, like Grinspoon, seeks only to do research. 30 These considerations tend to indicate that the absence of FDA approval for interstate commerce does not foreclose the possibility that a substance might still possess an accepted medical use or even be considered safe for use under medical supervision. It appears, instead, that blind reliance on the lack of FDA interstate marketing approval could cause a substance to be placed in Schedule I, even though one or two of the three requirements prescribed by Congress for placement of a drug in Schedule I have not been proven. Based solely on the language of the CSA and the FDCA, therefore, we find it unlikely that substituting the lack of FDA interstate marketing approval for the statutory requirements that a substance lack both an accepted medical use and accepted safety for use ... under medical supervision is consistent with the intent of Congress in enacting the CSA. We turn now to consider whether the legislative history of the CSA confirms or rebuts this tentative conclusion. 31
32 The Administrator purports to have identified portions of the CSA's legislative history that support his construction of the statutory language. First, he cites a passage from the House Committee Report that states: 33 Under Reorganization Plan No. 1 of 1968 [reprinted in 1968 U.S.Code Cong. & Ad.News 4734] a Bureau of Narcotics and Dangerous Drugs has been established in the Department of Justice to regulate all these drugs (including legitimate importation, exportation, manufacture, and distribution) to prevent diversion from legitimate channels. Safety and efficacy will continue to be regulated under the Federal Food, Drug, and Cosmetic Act by [HHS]. 34 H.R.Rep. No. 1444, 91st Cong., 2d Sess. (1970), reprinted in 1970 U.S.Code Cong. & Ad.News 4566, 4584 (hereinafter cited as House Committee Report). From this, the Administrator draws the proposition that Congress clearly intended that the 'safety and efficacy' of narcotic and dangerous drugs (e.g., whether such drugs are acceptable for medical use and safe for such use) be determined by [HHS] under the [FDCA]. Respondent's Brief at 17-18 (emphasis deleted). The Administrator's conclusion is objectionable, however, because his parenthetical comment--equating a finding of safety and efficacy by the FDA with a finding of accepted medical use and accepted safety for use ... under medical supervision--is totally unsupported by the quoted passage from the House Committee Report. Nowhere does Congress equate safety and efficacy under the FDCA with the second and third Schedule I criteria contained in section 812(b)(1). This, indeed, is the point at issue in this litigation, and we are loath to accept such a disingenuous argument. 35 Second, the Administrator looks to the history underlying the legislative scheduling of the drug alphacetylmethadol in Schedule I for support. With regard to the scheduling of this substance, there is evidence that the Director of the Bureau of Narcotics and Dangerous Drugs represented to Congress that the FDA had not issued an NDA or an IND for alphacetylmethadol, and claimed that this lack of FDA approval settled the issue whether alphacetylmethadol had a currently accepted medical use. Because Congress eventually did schedule alphacetylmethadol in Schedule I of the CSA, see 21 U.S.C. Sec. 812, Schedule I(a)(3), the Administrator contends that it directly approved the statutory interpretation he advances today. We are unpersuaded, however, that this isolated instance--with no indication of express congressional approval or even tacit reliance on the Director's statement--is reason enough to defer to the Administrator's construction of the statute. Indeed, the impermissibility of substituting FDCA standards for CSA scheduling criteria becomes even more apparent when we compare the dearth of support in the legislative history for such an interpretation with the language and history of several subsequent legislative enactments in the controlled substance field.D. Subsequent Legislation. 36 The Administrator has cited three subsequent legislative enactments as support for his position that Congress has approved his construction of the second and third criteria for Schedule I substances. Our review of these legislative enactments, however, leads us to find that the subsequent legislation tends to weaken, not strengthen, the position espoused by the Administrator in this litigation. We can only conclude, despite the Administrator's claim that Congress has repeatedly approved his construction of the CSA, that Congress has never expressly or implicitly approved an interpretation of section 812(b)(1) that would direct findings of no currently accepted medical use and lack of accepted safety for use ... under medical supervision whenever a substance lacked FDA interstate marketing approval. Rather, we are persuaded to the contrary that the subsequent enactments by Congress buttress our conclusion that the Administrator's construction of the CSA conflicts with congressional intent. To demonstrate why this is so, we shall review each of the three pieces of subsequently enacted legislation relevant to the current dispute in the paragraphs that follow. 37 First, in 1984, Congress amended the CSA to include an emergency scheduling provision. See 21 U.S.C. Sec. 811(h). This provision allows the Attorney General to place certain substances into Schedule I on a temporary basis without regard to the regular scheduling criteria and procedures if such emergency scheduling is necessary to avoid an imminent hazard to the public safety. 21 U.S.C. Sec. 811(h)(1). This amendment to the CSA, however, expressly states that the Attorney General's authority to schedule substances in this expedited manner does not apply where an exemption or approval is in effect for the substance under section 355 of this title, 11 i.e., where the FDA has permitted the substance to be marketed in interstate commerce. Id. The fact that Congress expressly authorized the Attorney General to use expedited procedures and rely upon the absence of FDA interstate marketing approval, rather than the usual Schedule I criteria, only in temporary emergency situations suggests to us that these shorthand methods are not appropriate in routine (i.e., nonemergency) situations such as the one before us in the instant case. We do not interpret the explicit reference to FDA approval in the emergency scheduling provision to mean, as the Administrator would have us believe, that Congress sought to permit blind reliance on FDA standards as a legitimate shortcut in the general run of cases. 38 Second, Congress amended the CSA again in 1986 when it enacted the Controlled Substance Analogue Enforcement Act, Pub.L. No. 99-570, Secs. 1201-04, 100 Stat. 3207 (codified at 21 U.S.C. Secs. 802(32)(A), 813). This amendment defines a controlled substance analogue as a substance having a chemical structure and effect on the central nervous system substantially similar to that of a Schedule I or II controlled drug. 21 U.S.C. Sec. 802(32)(A). It provides that analogues of Schedule I and II controlled substances shall, to the extent intended for human consumption, be subject to the same controls and penalties as the controlled substances themselves. 21 U.S.C. Sec. 813. As the Administrator points out, the provision expressly excludes from its definition of controlled substance analogue, and hence from the scope of the amendment's substantive controls pending final scheduling, any substance for which there is an approved new drug application or an exemption for investigational use under section 355 of the FDCA. 21 U.S.C. Sec. 802(32)(B)(ii), (iii). Again, however, we are unpersuaded by the Administrator's argument that explicit permission to rely on FDA standards in the case of analogues evidences congressional approval of his use of this shorthand method in all scheduling determinations. We believe instead that the authorization to impose Schedule I controls based on the lack of FDA approval, rather than satisfaction of the scheduling criteria set out in section 812(b)(1), in the unique situation of analogues intended for human consumption constitutes a special, and justifiable, exception to the general procedure mandated by section 812(b)(1). We believe, however, that in other cases involving nonanalogues, or analogues intended for uses other than human consumption, absolute reliance on the absence of FDA approval would be inappropriate and, indeed, contrary to the intent of Congress in enacting the CSA. 39 Third, in 1984, Congress legislatively placed the drug methaqualone in Schedule I. Despite its reputation as a widely abused substance, methaqualone was universally acknowledged to have an accepted medical use and had been approved for interstate marketing by the FDA. The House Committee Report concerning the scheduling of methaqualone stated: 40 the [DEA] does not have authority to impose Schedule I controls on a drug which has been approved by the [FDA] for medical use. The statutory findings required for agency scheduling decisions clearly state that the agency may not, in the absence of Congressional action, subject drugs with a currently accepted medical use in the United States to Schedule I controls. 41 H.R.Rep. No. 534, 98th Cong., 2d Sess. 4 (1984), reprinted in 1984 U.S.Code Cong. & Ad.News 540, 543. The Administrator cites this passage in yet another attempt to demonstrate congressional approval of his position that a substance cannot have an accepted medical use unless the FDA has already approved it for interstate marketing. In fact, however, the actions of Congress with respect to methaqualone demonstrate at most the converse of this proposition: that FDA approval precludes scheduling of a substance in Schedule I. In other words, the methaqualone legislation demonstrates Congress' belief that FDA approval is sufficient to establish the existence of an accepted medical use, but not that the lack of FDA approval--the issue in this case--necessarily negates the possibility that the substance in question has an accepted medical use and is safe for use under medical supervision. We therefore do not find the methaqualone legislation to be persuasive authority for the proposition that the Administrator's interpretation of section 812(b)(1) is consistent with congressional intent. 42 E. Need For A Meaningful Hearing. 43 We believe there is yet one additional policy reason, no doubt related to some of the other factors already discussed, for rejecting the construction of the CSA advanced by the Administrator as contrary to congressional intent. Under the statutory scheme set up by Congress, the Attorney General may not schedule a substance under the CSA without first obtaining the recommendation of the FDA, through its parent agency, HHS, 21 U.S.C. Sec. 811(b), and providing an opportunity for a hearing pursuant to the rulemaking procedures prescribed by [the Administrative Procedure Act]. 21 U.S.C. Sec. 811(a). It is plain, therefore, that while Congress intended the recommendation of HHS to have significant weight in the decisionmaking process, it also intended that there be an opportunity for a meaningful hearing after receipt of the HHS report. It would surely be anomalous if the FDA's recommendation, based solely on the absence of approval for interstate marketing, sufficed to determine the ultimate conclusion prior to the hearing. 44 If we were to accept the Administrator's construction of section 812(b)(1) in this case, the opportunity for a meaningful hearing would be lost, and satisfaction of the accepted medical use and accepted safety criteria would turn solely on the existence of FDA approval for interstate marketing. A hearing on issues of the sort required by the statute--Does the substance have an accepted medical use in treatment in the United States? Is the substance safe for use under medical supervision?--would be reduced to an empty formality and, for participants like Dr. Grinspoon, would amount to an exercise in futility. We hesitate to interpret the CSA in a manner that would cause its important provision requiring a administrative hearing to be meaningless as to two of the three requirements for scheduling a substance in Schedule I. We believe instead that, for the hearing opportunity to be a significant one on these issues, the agency must remain flexible enough to weigh and consider claims raised at the administrative hearing to the effect that a substance has an accepted use and is accepted as safe even though it is not approved for distribution in interstate commerce. 45 The importance of a meaningful hearing prior to scheduling can best be appreciated when one considers those situations for which Congress has permitted the Administrator to regulate substances in the absence of a hearing. Neither the emergency scheduling provision, 21 U.S.C. Sec. 811(h), nor the provision for treatment of controlled substance analogues, 21 U.S.C. Sec. 813, requires the Administrator to hold a hearing prior to taking regulatory action. Congress crafted both of these sections to serve as stop-gap measures to be employed pending a final scheduling determination by the DEA, following a full evidentiary hearing, for the substance in question. Significantly, it is only in these provisions for temporary controls pending final scheduling that Congress has emphasized the absence of FDA interstate marketing approval, 21 U.S.C. Sec. 811(h)(1) (emergency scheduling provision); 21 U.S.C. Sec. 802(32)(B)(ii), (iii) (controlled substance analogue act). In the case of emergency scheduling, it appears that Congress has already done the balancing and determined that the risk of ongoing abuse amounting to an imminent hazard to the public safety justifies temporary scheduling without a hearing in the absence of FDA approval. Likewise in the latter case, Congress has responded to the need for expedited investigation and prosecution of clandestine chemists who develop subtle chemical variations of controlled substances (called analogues or 'designer drugs') for illicit distribution and use, H.R.Rep. No. 848, 99th Cong., 2d Sess., pt. 1, 2 (1986), and permitted Schedule I controls to take effect without first requiring a hearing so long as FDA approval is lacking. Thus, in both emergency situations for which Congress has seen fit to place particular weight on the absence of FDA interstate marketing approval, it has also determined that a hearing procedure is unwarranted. Clearly, this is not the case in the general administrative scheduling proceedings and the hearing requirement should be given full effect rather than being shortcircuited by blind reliance on the absence of FDA approval. 46 F. Conclusion. 47 For the reasons listed above, we conclude that the Administrator erroneously applied an interpretation of the accepted medical use in treatment in the United States and accepted safety for use ... under medical supervision criteria of section 812(b)(1) that directly conflicts with congressional intent. We therefore vacate the Administrator's determination that MDMA should be placed in Schedule I of the CSA and remand the rule for further consideration by the DEA. On remand, the Administrator will not be permitted to treat the absence of FDA interstate marketing approval as conclusive evidence that MDMA has no currently accepted medical use and lacks accepted safety for use under medical supervision. 48 Petitioner Grinspoon has offered his own theory concerning the type of inquiry the Administrator must make under the statute. He urges us to adopt a standard for the second and third criteria that is based upon the opinion of members of the medical community. He contends that Congress drafted the CSA with this type of standard in mind. To support this contention, Grinspoon cites the testimony of two representatives of the Bureau of Narcotics and Dangerous Drugs (BNDD), DEA's predecessor agency, during legislative consideration of Pub.L. No. 91-513, the Comprehensive Drug Abuse Prevention and Control Act of 1970. Michael R. Sonnenreich, Deputy Chief Counsel of the BNDD, testified that drugs in Schedule I would have no medical use as determined by the medical community, and that the medical community would decide whether or not the drug has [a] medical use.... Hearings on Drug Abuse Control Amendments Before the Subcomm. on Public Health and Welfare of the House Comm. on Interstate and Foreign Commerce, 91st Cong., 2d Sess. 696, 718 (1970) (House Hearings). Likewise, John Ingersoll, Director of the BNDD, testified that substances placed in Schedule I would be those drugs that the medical profession has already determined to have no legitimate medical use in the United States. House Hearings at 678. 49 While we acknowledge that the statements by the BNDD witnesses before the House Subcommittee tend to support Dr. Grinspoon's position, we do not believe they are entitled to much weight as indicia of congressional intent in fashioning the accepted medical use and accepted safety for use ... under medical supervision criteria. See McCaughn v. Hershey Chocolate Co., 283 U.S. 488, 493-94, 51 S.Ct. 510, 512, 75 L.Ed. 1183 (1931) (statements ... made to committees of Congress ... are without weight in the interpretation of a statute). This is especially true where, as here, there is no indication whatsoever in either the legislative history or the history of any subsequent amendments that Congress concurred with the views expressed by the witnesses. In short, we do not find Grinspoon's evidence to be persuasive on the issue of affirmative congressional intent to have certain members of the medical community determine whether a substance has an accepted medical use in treatment in the United States or accepted safety for use ... under medical supervision.. 50 The nature of our review further constrains us from requiring the Administrator to adopt Dr. Grinspoon's proposed construction of section 812(b)(1). Although we find that the Administrator's present interpretation of the second and third Schedule I criteria contravenes congressional intent, we are unable to ascertain with any certainty what Congress intended to be the proper interpretation of subsections (B) and (C). In other words, while we are satisfied that Congress intended to preclude reliance on the absence of FDA approval in assessing whether a substance has an accepted medical use and accepted safety for use ... under medical supervision, we have found nothing to indicate how Congress affirmatively intended these two ambiguous statutory phrases to be construed and applied. It appears to us that Congress has implicitly delegated to the Administrator the authority to interpret these portions of the CSA, and we must therefore refrain from imposing our own statutory interpretation upon the agency. Chevron, 467 U.S. at 843, 104 S.Ct. at 2781. Hence, to avoid unduly infringing upon the Administrator's legitimate discretion to develop a legally acceptable standard--i.e., one that does not conflict with the intentions of Congress, and makes sense in light of the statutory language, the legislative history, and the purposes of the entire legislative scheme--we remand the rule to the Administrator for reconsideration and for further proceedings not inconsistent with this opinion. 51