FOR ORAL ARGUMENT MARCH 19, 2002
No. 01-1182
IN THE UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT
JON GETTMAN AND HIGH TIMES MAGAZINE,
Petitioners
v.
DRUG ENFORCEMENT ADMINISTRATION,
Respondent
PETITION FOR REVIEW OF A FINAL DETERMINATION
OF THE DRUG ENFORCEMENT ADMINISTRATION
DENYING A PETITION TO INITIATE RULEMAKING PROCEEDINGS
BRIEF FOR THE RESPONDENT
MICHAEL CHERTOFF
Assistant Attorney General
ROSE A. BRICENO
Trial Attorney
Narcotic and Dangerous Drug Section
U.S. Department of Justice
10th and Constitution Ave., N.W. Criminal Division
Bond Building
Washington, D.C. 20530
(202) 616-5580
DANIEL DORMONT
Senior Attorney
Drug Enforcement Administration
Washington, D.C. 20537
(202) 307-8010
CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES
- Parties and Amici: The parties to the administrative proceedings and in this Court are the petitioners, Jon Gettman and High Times Magazine, and the respondent, the Drug Enforcement Administration.
- Ruling Under Review:The ruling under review is a March20, 2001 letter issued by Donnie R. Marshall, then-Administrator, Drug Enforcement Administration, denying a petition to initiate rulemaking proceedings.The letter was reproduced in the Federal Register.66 Fed. Reg. 20,038 (April 18, 2001).
- Related Cases: The undersigned is not aware of any related cases.
[signed]
Daniel Dormont
Attorney.
TABLE OF CONTENTS (Page)
CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES (ii)
JURISDICTIONAL STATEMENT (1)
STATEMENT OF THE ISSUES (1)
STATEMENT OF THE CASE (2)
- STATUTORY AND REGULATORY FRAMEWORK (2)
- PROCEEDINGS BELOW (5)
SUMMARY OF THE ARGUMENT (6)
ARGUMENT 9)
- STANDARDS OF REVIEW (9)
- THE SCHEDULING OF MARIJUANA IS NO MORE OR LESS TENTATIVE THAN THAT OF ANY OTHER CONTROLLE SUBSTANCE 12)
III. THE ADMINISTRATOR PROPERLY CONDUCTED THE EIGHT-FACTOR ANALYSIS SET FORTH IN 21 U.S.C. 811(c} (14)
- THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS A HIGH POTENTIAL FOR ABUSE WAS MADE IN ACCORDANCE WITH THE CSA AND IS SUPPORTED BY SUBSTANTIAL EVIDENCE(17)
V,. THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS NO CURRENTLY ACCEPTED MEDICAL USE IN TREATMENT IN THE UNITED STATES IS SUPPORTED BY SUBSTANTIAL EVIDENCE (23)
- UNDER THE CSA, A SCHEDULE I CONTROLLED SUBSTANCE THAT CONT1NUES TO HAVE NO CURRENTLY ACCEPTED MEDICAL USE IN TREATMENT IN THE UNITED STATES, AND A POTENTIAL FOR ABUSE SUFFICIENT TO WARRANT CONTROL, MUST REMAIN IN SCHEDULE I(27)
VII. UNDER THE CSA RESCHEDULING PROVISIONS, RULEMAKING PROCE_DINGS, AND HEARINGS THEREON, ARE NOT INITIATED UNLESS THE ADMINISTRATOR DETERMINES THAT THERE IS SUBSTANTIAL EVIDENCE TO WARRANT RESCHEDULING OF A CONTROLLED SUBSTANCE (36)
(page iii)
TABLE OF CONTENTS (continued) (Page)
CONCLUSION (39)
CERTIFICATE OF COMPLIANCE
CERTIFICATE OF SERVICE
(Page iv)
TABLE OF AUTHORITIES
Cases: (Pages)
Alliance for Cannabis Therapeutics V.” Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir. 1994) (13, 24, 26)
American Horse Protection Association, Inc. v. Lyng, 812 F.2d 1 (D.C. Cir. 1987) (11)
American Textile Manufacturers Institute, Inc. v. Donovan, 452 U. S. 11 90 (1981) (10)
Cellnet Communication, Inc. v. Federal Communications Commission, 965 F. 2d 1106 (D. C. Cir. 1992) (11, 38)
Chevron U.S.A Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984)(10, 17, 29, 35, 38)
Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402(1971) (9)
Consolo v. Federal Maritime commission, 383 U. S. 607 (1966) (10)
Grinspoon v. Drug Enforcement Administration, 828 F.2d 881 (1st Gir. 1987) (24)
National Customs Brokers & Forwarders Association or America, Inc. v. United States, 883 F.2d 93 (D.C. Cir.1989) (10, 11, 38)
National Organization ,for the Reform of Marijuana Laws v. Drug Enforcement Administration, 559 F.2d 735 (D.C. Cir. 1977) (33-35, 37-38)
National Organization for the Reform of Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974) (34)
Oakland Cannabis Buyers’ Cooperative, 532 U.S. 483, 121 S. Ct. 1711 (2001) (13, 21, 26, 29)
United States v.’ Cannabis Cultivators Club, 5 F.Supp.2d 1086 (N.D. Cal. 1998) (13)
United States v. Everett, 700 F.2d 900 (3d Cir. 1983) (17)
United States v. Kiffer, 477 F.2d 349 (2d Cir. 1973) cert. denied, 414 U.S. 831 (1973) (12)
(Page v)
TABLES OF AUTHORITIES (continued)
Cases: (Paqes)
United States v. Moore, 423 U.S. 122 (1975) (16)
Universal Camera Corp_ v. National Labor Relations, Board, 340 U. S. 474 (1951) (10)
Weinberger v. Hynson, 412 U.S. 609 (1973) (26)
WorldCom, Inc. v. Federal Communications Commission, 238 F.3d 449 (D_C. Cir. 2001) (10)
WWHT, Inc. v. Federal Communications Commission, 656 F.2d 807 (D.C. Cir. 1981) (11 ,38)
Drug Enforcement Administration Final Orders:
66 Fed. Reg. 20,038 (April 18,2001) (notice of denial
of petition to initiate rulemaking proceedings to reschedule marijuana) (ii, passim)
64 Fed. Reg. 35,928 (July 2, 1999) (final rule, transferring Marinol® , from schedule II to schedule III) (20)
57 Fed. Reg. 10,499 (March 26, 1992) (final order concluding that marijuana has no currently accepted medical use and denying petition to reschedule marijuana) (13, passim)
Statutes:
5 U.S.C. 553 …..(page 37)
5 U.S.C. 706 (2)…..(page 10)
21 U.S.C. 801(2)…..(page 31-32)
21 U.S.C. 802 (5)…..(page 2, 36)
21 U.S.C. 802 (6)…..(page 22)
21 U.S.C. 811…..(page 1, passim)
21 U.S.C. 812 …..(page 1, passim)
21 U.S.C. 823(f)…..(page 27,31)
21 U.S.C. 826…..(page 15)
TABLE OF AUTHORITIES (continued)
Statutes:
21 U.S.C. 828…..(page 15)
21 U.S.C. 829…..(page 28,29,31)
21 U.S.C. 841(a)(1)…..(page 31)
21 U.S.C. 871(a)…..(page 1)
21 U.S.C. 877…..(page 1,9)
Pub. L. No. 105-277, Div. F., 112 Stat 2681 (1988)…..(page 25,33)
Legislative Materials: H.R. Rep. No. 1444, 91st Cong., 2d Sess. Pt. 1 (1970), reprinted in 1970 U.S.C.C.A.N. 456…..(page 14-16, 19, 31)
Regulations:
21 C.F.R. 314.126 (page 26)
21 C.F.R.. 1308.11 to 1308.15 (page 3)
21 C.F.R. 1308.11(d)(27) (page 20)
21 C.F.R. 1308.43 (page 1,3,4)
21 C.F.R. 1308.44 page 4)
21 C.F.R. 1308.45 (page 4)
28 C.F.R. O.lOO(b) (page 1,3)
Miscellaneous: 58 Fed. Reg. 35,460 (July 1, 1993) (delegation of authority within Department of Health and Human Services (page 3)
50 Fed. Reg. 9518 (March a, 1985) (memorandum of understanding within Department of Health and Human Services)(page 3)
Brief for the Respondents in Oakland Cannabis Buyers’ Cooperative, 2001 WL 173541 (Feb. 20, 2001) (page 13)
(page vii)
JURISDICTIONAL STATEMENT
In the proceedings below, the Administrator of the Drug Enforcement Administration (DEA) had jurisdiction over the petition to initiate rulemaking proceedings pursuant to 21 D.S.C. 811, 812, and 871(a), 28 C.F.R. O.100(b), and 21 C.F.R. 1308.43. . . The Administrator denied the petition by letter dated March 20, 2001. Appendix (“A”) 416-421. The Administrator published notice of the denial of the petition in the Federal Register on April 18, 2001. 66 Fed. Reg. 20,038.
Jon Gettman and High Times Magazine (petitioners) filed a timely petition for review on April 19, 2001. This Court has jurisdiction pursuant to 21 U.S.C. 877.
STATEMENT OF THE ISSUES
In challenging DEA’s denial of their petition to initiate rulemaking proceedings to reschedule marijuana, petitioners raise the following issues:
- Whether DEA and the Department of Health and Human Services (HHS) properly considered the eight statutory factors in 21 U.S.C. 811(0) that must be considered when evaluating a petition to reschedule a controlled substance.
- Whether DEA’s determination – that, based on the HHS scientific and medical evaluation and all other relevant data, there is no substantial evidence that marijuana should be removed from schedule I – is supported by substantial evidence.
(page 1)
- Whether the Controlled Substances Act (CSA) permits DEA to transfer a schedule I controlled substance to schedules III, IV, or V where DEA and HHS have determined that the drug continues to have “no currently accepted medical use in treatment in the United States” within the meaning. of the CSA.
- Whether the CSA requires PEA to conduct a hearing whenever a person submits a petition to DEA to initiate rulemaking proceedings to reschedule a controlled substance.
STATEMENT OF THE CASE
- STATUTORY AND REGULATORY FRAMEWORK
When Congress enacted the CSA in 1970, it set forth the initial schedules of controlled substances in 21 U.S._. 812(c). To allow for advances in scientific understanding and changing patterns of abuse, Congress established procedures to add a drug or other substance to the schedules (control), to remove a drug or other substance from the schedules (decontrol), or to transfer a drug or other substance between schedules (reschedule). (n1) Congress assigned this responsibility to the Attorney General, in consultation with the Secretary of HHS. The CSA provides that the schedules of controlled substances may be amended by the Attorney General in rulemaking proceedings prescribed by the Administrative Procedure Act (APA), and that the Attorney General
(page 2)
will publish updated schedules on an annual basis. 21 U.S.C. 811, 8_2. The Attorney General has delegated these functions to the Administrator of DEA. 28 C.F.R. O.100(b}. The current schedules are published in 21 C.F.R. 1308.11 to 1308.15.
Congress specified three methods by which the Administrator may initiate rulemaking proceedings to revise the schedules. Such proceedings may be initiated by the Administrator (1) on his own motion, (2) at the request of the Secretary of HHS, or (3) on the petition of any interested party. 21 U.S.C. 811(a}; 21 C.F.R. l308.43(a).
Before initiating rulemaking proceedings to control, decontrol, or reschedule a drug or other substance, the Administrator must request from the secretary of HHS a scientific and medical evaluation and recommendation as to whether such drug or other substance should be controlled, decontrolled, or rescheduled. 21 U.S.C. 811(b}; 21 C.F.R. 1308.43(d). The Secretary has delegated this function to the Assistant Secretary for Health. 58 Fed. Reg. 35,460 (July 1, 1993).(n2) In making scheduling determinations, the Administrator and the Assistant Secretary are required to consider the following eight factors with respect to the drug or other substance:
page 3)
(1) Its actual or relative potential, for abuse;
(2) Scientific evidence of its pharmacological effect, if known;
(3) The state of current scientific knowledge regarding the drug or other substance;
(4) ,Its history and current pattern of abuse;
(5) The scope, duration, and_significance of abuse;
(6) What, if any, risk there is to the public health;
(7) Its psychic or physiological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance already controlled under the CSA. 21 U.S.C. 811(b) and (c).
The recommendations of the Assistant Secretary are binding on the Administrator as to scientific and medical cons1derations involved in the eight-factor analysis, as described in 21 U.S.C. 811 (b) . However, the ultimate decision as to whether to initiate rulemaking proceedings to reschedule a controlled substance is made by the Administrator. 21 U. S . C . 811 (a), (b). If the Administrator determines that the Assistant Secretary’s scientific and medical evaluation and scheduling recommendation, and all other relevant data, constitute substantial evidence to warrant control, decontrol, or rescheduling of the drug or other substance, he shall initiate rulemaking proceedings to do so. Id.; 21 C.F.R. l308.43(e).(n3)
(page 4)
- PROCEEDINGS BELOW
On July 10, 1995, petitioners Jon Gettman and High Times Magazine (n4) petitioned DEA to initiate rulemaking proceedings under the CSA rescheduling provisions. A3-A290. Specifically, they petitioned DEA to propose rules, pursuant to 21 U.S.C. 811(a), to reschedule four different controlled substances_ marijuana; tetrahydrocannabinols; dronabinol; and nabilone. A4. Because this petition required both DEA and HHS to undertake lengthy and complex data collection and analyses that are distinct for each substance, DEA chose to evaluate each substance separately. A4.16. The final agency action at issue in this appeal is the denial of the petition to initiate rulemaking proceedings with respect to marijuana. A416-A421 (reprinted in 66 Fed. Reg. 20,038 (April 18, ‘2001).
In their petition to DEA, petitioners claimed that “there is no scientific evidence that [marijuana has] sufficient abuse potential to warrant schedule I or II status under the [CSA].” A4. In accordance with 21 U.S.C. 811(b), DEA gathered the necessary data and, on December 17, 1997, forwarded that information and the petition to the HHS for a scientific and medical evaluation and scheduling recommendation. A293_A294. On January 17,2001, HHS forwarded its scientific and medical
(page 5)
evaluation and scheduling recommendation to DEA. A302-A337. HHS concluded that marijuana does continue to meet the criteria for placement in schedule I: a high potential for abuse, no currently accepted medical use in treatment in the United States’, and a lack of accepted safety for use under medical supervision. Id. HHS therefore recommended that marijuana remain in schedule I. Id. Based on the HHS evaluation and all other relevant data, the Administrator likewise concluded that the evidence overwhelmingly leads to the conclusion that marijuana has a high potential for abuse”, and that there is no substantial evidence that marijuana should be removed from schedule I. A418. Accordingly, DEA denied the petition to initiate rulemaking proceedings with respect to marijuana. A416, A421.
DEA’s denial of the petition was published in the Federal Register, along with the entire contents of the HHS scientific and medical, evaluation and scheduling recommendation, as well as the other relevant data considered by DEA. 66 Fed. Reg. 20,038.
SUMMARY 0F THE ARGUMENT
Petitioners submitted a petition to DEA asserting that marijuana has less than a “high potential for abuse” and, therefore, DEA should propose a rule to transfer marijuana to schedule III, IV, or V of the CSA. In response, the Administrator and the Assistant Secretary conducted a thorough evaluation of all relevant scientific and medical information. This evaluation was conducted in strict accordance with the CSA
(page 6)
scheduling criteria and, in particular, the eight-factor analysis required by 21 D.S.C. 811(c). Based on this in-depth analysis, the Administrator determined that the evidence overwhelmingly leads to the conclusion that marijuana has a “high potential for abuse” and that there is no substantial evidence that marijuana should be removed from schedule I. Accordingly the Administrator denied the petition to initiate rulemaking proceedings.
Petitioners disregard the extensive collection of data and thorough analysis undertaken by HHS and DEA. The record reveals, among other things, that marijuana remains the most widely abused illicit drug in the United States and continues to meet each of the criteria for placement in schedule I. Petitioners’ criticisms of the Administrator’s denial of their petition are due to a variety of legal and factual errors. For example, they suggest that a rescheduling petition requires DEA to consider whether the nation would be better off if marijuana trafficking and possession were decriminalized. Such a suggestion is at odds with both the text and legislative history of the CSA. They also contend that the use of marijuana by individuals for claimed medical purposes must be considered, even though such use is prohibited by the CSA and the United States Supreme Court recently reaffirmed that “for purposes of the [CSA], marijuana has ‘no currently accepted medical use’ at all.” Petitioner’s further argue that widespread marijuana use is not indicative of
(page 7)
a high potential for abuse, even though the CSA, the legislative history of the Act, and medical and scientific data indicate otherwise. They argue that HHS and DEA did not consider the “current medical and scientific record” even though the record contains multiple references to recently available data and information.
Although they did not assert in their petition to DEA, that marijuana has a currently accepted medical use in treatment in the United States petitioners now make such a claim. They contend there has been a sea change in evidence concerning marijuana’s medical utility that has emerged since they submitted their petition to DEA. In fact, as HHS advised DEA, there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition. The “evidence” that petitioners would present consists mainly of anecdotal information that would be irrelevant in a CSA rescheduling proceeding.
Independent of the factual determination that marijuana continues to meet the criteria for placement in schedule I, the Administrator advised petitioners that their petition to reschedule marijuana contained a faulty legal premise, which remains in their brief to this Court. Petitioners contend that DEA can transfer marijuana to a schedule less restrictive than schedule I even if DEA concludes that marijuana continues to have no currently accepted medical use in treatment in the United
(page 8)
States. In making this contention, petitioners ignore that Congress established schedule I as the only schedule with the criterion of “no currently accepted medical use in treatment in the United States.”
Finally, the Administrator properly denied the petition without conducting a hearing. Under the CSA, APA rulemaking proceedings regarding the proposed rescheduling of a controlled substance (including hearings thereon) are initiated where the Administrator determines that HHS’s scientific and medical evaluation and scheduling recommendation, and all other relevant data, constitute “substantial evidence” to warrant control, decontrol, or rescheduling of the drug or other substance. Where, as here, the Administrator finds no such substantial evidence to propose a scheduling action, rulemaking proceedings do not commence and DEA has ‘no reason or duty to conduct a hearing.
ARGUMENT
- STANDARDS OF REVIEW
The Administrator’s findings of fact are conclusive if supported by substantial evidence. 21 U.S.C. 877. Although this Court conducts a “searching and careful” inquiry into administratively determined facts, the ultimate standard of review is a narrow one.” Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 416 (1971). Substantial evidence is “such relevant evidence as a reasonable mind might accept as adequate
(page 9)
to support a conclusion.” American Textile Manufacturers Institute, Inc. v. Donovan, 452 U.S. 490, 522 (1981) (quoting Universal Camera Corp. v. National Labor Relations Board, 340 U.S. 474, 477 (1951)). Substantial evidence may support an administrative agency’s finding even when there exists “the possibility of drawing two inconsistent conclusions from the evidence.” American Textile Manufacturers Institute, Inc., 452 0.5. at 523 (quoting Consolo v. Federal Maritime Commission, 383 U.S. 607, 620 (1966).
Under the APA, this Court determines whether an agency’s action is “arbitrary and capricious, an abuse of discretion, or otherwise not in accordance with the law.” 5 U.S.C. 706(2) (A). See WorldCom, Inc. v. Federal Communications Commission, 238 F.3d 449, 457 (D.C. Giro 2001) (“This is a deferential standard that presumes the validity of agency action.”) (internal quotation marks and citations omitted).
Where petitioners challenge the Administrator’s interpretation of the CSA, the following standard applies: ” [U]nder the instruction’ furnished in Chevron U. S. A., Inc. v. Natural Resources Defense Council, Inc, 467 u.s. 837, ‘842-45,’ . . . (1984), to the extent that the intent of Congress is not clear, we must accept an agency’s reasonable interpretation of . the substantive terms. of a statute it is charged to administer.” National Customs Brokers & Forwarders Ass’n or America, Inc. v. United States, 883 F.2d 93, 97 (D.C. Cir. 1989).
(page 10)
The foregoing are the general standards of review to be applied on appeal of an agency action. While these general standards call for a measure of deference to the agency, there is an even greater level of deference that must be applied here, given the nature of this appeal: a challenge to an agency’s denial of a petition to initiate rulemaking proceedings. This Court has made clear that it will overturn an agency’s decision not to initiate a rulemaking only for compelling cause, such as plain error of law or a fundamental change in the factual premises previously considered by the agency. National Customs Brokers & Forwarders, 883 F.2d at 96-97.
This Court has further explained: _Review under the ‘arbitrary and capricious’ tag line. . . encompasses a range of levels of deference to the agency [and] an agency’s refusal to initiate rulemaking proceedings, is at the high end of the range.” American Horse Protection Ass’n, Inc. v. Lyng, 812 F.2d 1, 4-5 (D. C .Cir. 1987) (citations omitted). Indeed, this Court has stated that “an agency’s refusal to initiate a rulemaking is evaluated with a deference so broad as to make the process akin to nonreviewability.” Cellnet Communication, Inc. v. Federal Communications Commission, 965 F.2d 1106, 1111 (D.C.Cir. 1992); see also WWHT, Inc. v. Federal Communications Commission, 656 F.2d 807, 818 (D.C.Cir. 1981) (_It is only in the rarest and most compelling of circumstances that this court has acted to overturn an agency judgment not to initiate rulemaking.”).
(page 11)
As explained below, petitioners would fail to satisfy their burden even under the general standard of review of an agency action. Their failure to meet their burden is even more pronounced under the heightened standard of review that applies on appeal of the denial of a petition to initiate rulemaking proceedings. Petitioners show no factual or legal errors in the agency’s action, much less the type of egregious errors and compelling circumstances that warrant the seldom-imposed reversal of a denial of a petition to initiate rulemaking proceedings.
- THE SCHEDULING OF MARIJUANA IS NO LESS “TENTATIVE” THAN THAT OF ANY OTHER CONTROLLED SUBSTANCE.
Petitioners devote a substantial portion of their introductory argument to historical events that pertain to marijuana but have no bearing on this appeal. For example, petitioners discuss a 1972 report to Congress on marijuana prepared by the Shafer Commission, .in an apparent effort to suggest that marijuana’s current placement in schedule I is “only tentative.” Br. at 17. Petitioners also quote from a 1988 recommended opinion of a former DEA Administrative Law Judge in the prior marijuana rescheduling proceedings. Br. at 19. These recommendations were rejected by their recipients, Congress and the DEA Administrator, respectively. (n5).
(page 12)
Marijuana’s placement in schedule I is no more or less “tentative” than the placement of any other controlled substance in its current schedule. As with every controlled substance, marijuana must remain in its current schedule unless and until either (i) the Administrator reschedules it in accordance with the procedures and scheduling criteria set forth in 21 U.S.C. 811 and 812 or {ii} Congress reschedules it by legislation. Neither the Shafer report nor the former ALJ” s recommendation warrants deviation from these statutory procedures or provides a head start “to anyone petitioning DEA to reschedule marijuana. In fact, for purposes of evaluating a petition to reschedule marijuana, the Shafer report and the former ALJ’s recommendation are wholly irrelevant. (n6)
(page 13)
III. THE ADMINISTRATOR PROPERLY CONDUCTED THE EIGHT-FACTOR ANALYSIS SET FORTH IN 21 U.S.C. 811(c).
Petitioners assert that DEA _did not weigh all relevant factors under 21 U.S.C. 811(c}.” Er. at 25. Yet, petitioners make no such showing in the text of their argument. Nor could they, since it is clear from the record that both HHS and DEA thoroughly analyzed all eight of the factors in section 811(c). HHS’s scientific and medical evaluation and scheduling recommendation ‘contains 28 pages of analysis, which specifically addresses all eight factors. A305-A332. DEA’s summary of the additional scientific data it considered contains another 55 pages of eight-factor analysis. A338-A392. The depth of the Government’s eight-factor analysis is self-evident. Petitioners do not acknowledge this portion of the record. Having failed to do so, they have no basis’ to claim that the government’s factual conclusions are not supported by substantial evidence.
On closer inspection, petitioners are not actually asserting that the government failed to undertake the eight_ factor analysis. Nor do they claim that the ‘government failed to adhere to any statutory provision in section 811. Rather, their complaint is that the government did not interpret one of the eight factors in the manner that petitioners would choose based on their reading of the legislative history. Specifically, they contend that under factor five (_The scope, duration, and significance of abuse”), the government failed to consider “the economics of regulation and enforcement” of keepinq marijuana in –
(page 14)
schedule I and _the social significance and impact of such a decision upon those people, especially the young, that would be affected by it. ff Br. at 25 (quoting H.R. Rep. No. 1444, 91st Cong.,’ 2d Sess. Pt. 1 (1970), reprinted in 1970 ‘U.S.C.C.A.N. 4566, 4603). In making the foregoing contention, petitioners accurately quote from the legislative history of the CSA. However, petitioners misconstrue the meaning of these quotations.
A fair reading of the 1970 House report, in view of the text of_the CSA, leads to the following conclusions. Congress was referring in the above quotations to the need for the Attorney General (today, the Administrator of DEA, by delegation) to consider whether and how the production and distribution of licit pharmaceutical controlled substances (those in schedules II through V with a lawful and an accepted medical use) would be affected by any increased regulation associated with the placement of such drugs into a higher schedule. For example, the transfer of a controlled substance from schedule III to schedule II entails increased regulatory controls to safeguard against diversion, such as limiting production of the drug to established quotas (21 U.S.C. 826) and requiring order forms for all distributions of the drug (21 U.S.C. 828). These heightened regulatory measures translate into higher compliance costs for. the legitimate pharmaceutical industry as well as increased demand on law enforcement to devote resources to monitor compliance by the legitimate industry. These are the economics
(page 15)
of regulation and enforcement” that Congress wanted the Attorney General to consider before changing the schedule of a pharmaceutical controlled substance.
The quotation in the House report regarding “the social significance and impact of [a scheduling] decision upon those people, especially the young, that would be affected by it” was a reference to the need to consider the extent of the harm caused by illicit use of the particular controlled substance being considered for a scheduling action. (This harm is addressed in various parts of the HHS scientific and medical evaluation. A306-A308, A322-328.) Contrary to petitioners’ suggestion, Congress was not directing that, in response to .every rescheduling petition, DEA must reevaluate the policy decision made by Congress that the use of psychoactive and addictive drugs should be regulated and that the trafficking and possession of such drugs in violation of federal law should be a criminal offense. Such a reading of the Act would be flatly at odds with its text and legislative history, which reflect that Congress was adamant -in its desire to take all necessary steps to curb trafficking and use of illicit controlled substances. See, e.g., United States v. Moore, 423 U.s. 122, 132 (1975) (the CSA “was intended to ‘strengthen,’ rather than to weaken, ‘existing law enforcement authority in the field of drug abuse.”‘) (citations
(page 16)
omitted) . (n7)
As stated above, Chevron mandates that on appeal of an agency’s construction of the statute it administers, the reviewing court must accept an agency’s reasonable interpretation of the substantive terms of a statute it is charged to administer. DEA’s interpretation of how the eight factors of section 811(c) are to be applied is consistent with the plain meaning of the text of the CSA and the legislative history. In contrast, petitioners’ reading of the statute cannot be reconciled with the text or the legislative history and, therefore, cannot displace DEA’s reasonable interpretation.
- THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS A HIGH POTENTIAL FOR ABUSE WAS MADE IN ACCORDANCE WITH THE CSA AND IS SUPPORTED BY SUBSTANTIAL EVIDENCE.
Petitioners claim that the Administrator erred in determining that marijuana continues to have a “high potential for abuse,” supposedly by failing to compare marijuana’s abuse potential with that of other schedule I controlled substances. Br. at 21-23. Petitioners’ argument is flawed in several respects.
(page 17)
First, petitioners isolate, and attach undue weight to, the following statement made by HHS in its scientific and medical evaluation and scheduling recommendation: “Marijuana has relatively low levels of toxicity and physical dependence as . compared to other illicit drugs.” Br. at 23 (referring toA331). Petitioners emphasize this isolated sentence as if it, by itself, should have led HHS and DEA to conclude that marijuana does not
have a high potential for abuse. In full context, this sentence appeared in the following paragraph:
“Data show that humans prefer higher doses of marijuana to lower doses, demonstrating that marijuana has dose-dependent reinforcing effects. Marijuana has relatively low levels of toxicity and physical dependence as compared to other illicit drugs. However, as discussed above, physical dependence and toxicity are not the only factors to consider in determining a substance’s abuse potential. The large number of individuals using marijuana on a regular basis and the vast amount of marijuana that is available for illicit use are indicative of widespread use. In addition, there is evidence that marijuana use can result in psychological dependence in a certain proportion of the population.”
A331. Thus, HHS was actually stating that, despite marijuana’s relatively low levels of toxicity and physical dependence as compared to other illicit drugs, the high levels of actual abuse and the widespread availability of the drug, along with its dose dependent reinforcing effects and potential for psychological dependence, lead to the conclusion that marijuana does have a high potential for abuse.(n)8 Consideration of these factors by HHS
(page 18)
and DEA is consistent with the eight factors enumerated in 21 U.S.C. 811(c) and the legislative history.(n9)
‘Second, petitioners overlook the fact that HHS and DEA did compare data on marijuana with that of other illicit substances in determining marijuana’s abuse potential. Even a cursory review of the record so reveals. For example, HHS’s scientific and medical evaluation contains substantial data regarding the prevalence of marijuana use and side-by-side comparisons of marijuana abuse data with that of heroin and cocaine. A307-30a, A322-A328. The additional data considered by DEA include a comparison of marijuana’s abuse and dependence liabilities in both animals and humans with those of tetrahydrocannabinols (THC, a schedule I controlled substance). A338-A352
(page 19)
Third, petitioners mistakenly state that dronabinol is a schedule III controlled substance. Br. at 23. Dronabinol is a schedule I controlled substance (being an isomer of THC). 21 D.S.C. 812{c), Schedule I (c) (17); 21 C.F.R 1308.11 (d) (27); see’ 64 Fed. Reg. 35,9_8 (July 2, 1999) (DEA final order transferring Marinol® from schedule II to schedule III and explaining nature of dronabinol). Having misundertood the schedule of dronabinol, petitioners failed to recognize that by comparing marijuana to dronabinol (THC), DEA was comparing marijuana to another schedule I controlled substance.
Petitioners also appear to confuse the substance dronabinol with the product Marinol® . Marinol® is an FDA-approved product that contains synthetic dronabinol in sesame oil and encapsulated in soft gelatin capsules. 64 Fed. Reg. at 35,928. DEA, in consultation with HHS, determined in separate rescheduling proceedings that Marinol® ’s product formulation results in the drug having less than the high potential for abuse commensurate with schedules I and II. Id. Because petitioners do not accept the fact that Marinol® ® has a lower potential for abuse than pure THC (dronabinol) or marijuana, they insist that if Marinol® is placed in schedule III, then marijuana must, simultaneously be moved to schedule III. There is no legal or factual support for this argument.
The record also belies petitioners’ contention that there is no substantial evidence to support the Administrator’s factual
(page 20)
determination that marijuana has a high potential for abuse. Both the HHS scientific and medical evaluation and the additional evidence considered by DEA examine this issue in detail. A305 A331, A338-A392. Among the many facts that led the Administrator to reach this conclusion is that an estimated 11 million Americans engage in illegal marijuana use on a monthly basis, making it the most extensively used illegal drug in the United states. A321-A33L, A352-A354.
Petitioners argue that the government is mistaken in considering the widespread use Of marijuana relevant in determining the drug’s potential for abuse. Br. at 24. As a threshold matter, this argument rests on the false premise that the use of marijuana for its hallucinogenic effects (and in violation of federal law) is anything other than “abuse” within the meaning of the CSA. The United States Supreme Court’s ruling in Oakland Cannabis Buyers’ Cooperative dispels the notion that there is any legitimate use of marijuana outside of federally authorized research. 121 s_ Ct. at 1718 (_for purposes of the , Controlled Substances Act, marijuana has ‘no currently accepted medical use.’ at.a!l”),. Furthermore, HHS directly responded to this argument in its scientific and medical evaluation:
“Throughout his petition, Mr. Gettman argues that while many people “use” marijuana, few “abuse” it. He appears to equate abuse with the level of physical dependence and toxicity resulting from marijuana ‘use. Thus, he appears to be arguing that a substance that causes only low levels of physical dependence and toxicity must be considered to have a low potential for abuse. The Secretary does not agree with this
(page 21)
argument. Physical dependence and toxicity are not the only factors that are considered in determining a substance’s abuse potential. The actual use and frequency of use of a substance, especially when that use may result in harmful consequences such as failure to fulfill major obligations at work or school, physical risk-taking, or even substance-related legal problems, are indicative of a substance’s abuse potential.”
A307.
In their brief to the Court, .petitioners ignore the foregoing along with essentially all of the other data collection and analysis conducted by HHS and DEA and contained in the record.
Petitioners also claim that HHS and DEA erred in failing to compare the dangers of marijuana abuse with those of alcohol, caffeine, and nicotine, other drugs whose use is far more prevalent in the United States than marijuana.” Br. at 10. By making this claim, petitioners fail to take into account that HHS and DEA have no authority to make such a comparison as a basis for rescheduling. Congress expressly exempted distilled spirits, wine, malt beverages, or tobacco from the definition of ”controlled substance.” 21 U.S.C. 802(6). Such substances therefore have no potential for abuse” within the meaning of the CSA, and the health risks they pose are irrelevant under the Act.
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- THE ADMINISTRATOR’S DETERMINATION THAT MARIJUANA HAS NO CURRENTLY ACCEPTED MEDICAL USE IN TREATMENT IN THE UNITED STATES IS SUPPORTED BY SUBSTANTIAL EVIDENCE.
In their petition to DEA to initiate rulemaking proceedings to reschedule marijuana, petitioners did not assert as a basis for the proposed rescheduling that marijuana has a currently accepted medical use in treatment in the United States. Rather, their contention was that marijuana does not have a “high
potential for abuse” sufficient to warrant control in schedule I or II. A4. Accordingly, whether marijuana has a currently accepted medical use in treatment’ in the United States was not the primary focus of HHS or DEA in evaluating the petition.
Nonetheless, contrary to petitioners’ contention in this’ appeal, neither HHS nor DEA “blindly relied, on marijuana’s lack of FDA approval as “conclusive evidence” that marijuana has no currently accepted medical use in treatment in the United States. See BI:. at 30. Whether a drug has been approved by the FDA is clearly relevant to the determination of currently accepted medical use, since a drug currently approved by the FDA has a currently accepted medical use within the meaning of the CSA. Yet, neither DEA nor HHS took the position that the lack of FDA approval ends the inquiry. Rather, in its scientific and medical evaluation submitted to the Administrator, HHS explained several bases for reaching this conclusion. A331-A332. In doing so, HHS expressly considered the five factors established by DEA (and upheld by this Court) for determining whether a drug or other
(page 23)
substance has a currently accepted medical use within the meaning of the CSA. Id.(n10) Among other thinqs, HHS noted that there have been no studies that have scientifically assessed the efficacy of marijuana for any medical condition.” A332. As HHS indicated, under DEA’s five-factor test, the lack of adequate scientific studies proving marijuana’s efficacy is one of several facts that precludes finding it has a currently accepted medical use. Id.
By considering all relevant factors in determining whether marijuana has a currently accepted medical use, HHS and DEA did not (as petitioners contend, Br. at 33-31) act in conflict with the First Circuit’s interpretation of the CSA in Grinspoon v. Drug Enforcement Administration, 828 F.2d 881, 891 (1st Cir. 1987) – that DEA may not treat the absence of FDA approval as conclusive evidence that a controlled substance has no currently accepted medical use for CSA scheduling purposes. (n11)
(page 24)
petitioners further criticize DEA for quoting a 1998 Sense of Congress stating that marijuana and other Schedule I drugs have not been approved by the Food and Drug Administration to treat any disease or condition.” Br. at 32 (referring to Pub. L. No. 105-277, Div. F., 112 Stat. 2681 (1998). DBA emphasized this statement by Congress to help explain the nature of schedule I controlled substances as compared to controlled substances in schedules II through V (see section VI, below) – not, as petitioners state, in “blind reliance on lack of FDA approval as a substitute for current scientific evidence.”
Petitioners also claim that ” [d]uring the past four years, . . ., there has been a sea change in evidence concerning marijuana’s medical utility and safety, which DEA and HHS have ignored. ” Br. at 29. However, petitioners supply this Court, with no “evidence” that would be relevant in a rescheduling proceeding. Petitioners’ “evidence” consists of: (1) the enactment ‘by several states of laws which purport to legalize the use of marijuana for “medical” purposes; and (2) the testimony of individuals who have illegally used marijuana for claimed medical purposes. Br. at 29-30, 32.
The existence” of state marijuana legalization laws provides no factual information of any value. Not one, of the state laws contains any scientific basis for concluding that marijuana has medical utility. These laws were enacted based on popular will, rather than the scientific criteria mandated by
(page 25)
Congress under the CSA scheduling provisions. Moreover, the United States Supreme Court recently ruled, unequivocally, that marijuana’s placement in schedule I of the CSA reflects that the drug has “no medical benefits” under federal law. Oakland Cannabis Buyers’ Cooperative. 121 S. Ct. at 1718.
Petitioners’ lack of adherence to the CSA rescheduling criteria is underscored by their suggestion that DEA be compelled to conduct a hearing in which individuals would provide anecdotal information about the perceived benefits of their illegal use of marijuana. As the Administrator made clear in the prior marijuana rescheduling provisions, in a final order upheld by this Court, “lay testimonials, impressions of physicians,’ isolated case studies, random clinical experience, reports so lacking in details that they cannot be scientifically evaluated, and all other forms of anecdotal proof are not relevant to a determination of whether a drug is safe and effective for medical use in the United States.'” 57 Fed. Reg. at 10,505-10,507 (citing 21 C.F.R. 314.126 and Weinberger v. Hynson, 412 U.S. 609, 630 (1973)), aff’d, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) (n12)
(page 26)
Petitioners did not cite a single clinical study, which HHS or DEA failed to consider, in which human subjects were given marijuana to demonstrate that the drug can be used safely or effectively as medicine. The fact is, to this day, there has not been a single study that has scientifically assessed the efficacy of marijuana for any medical condition. The Assistant Secretary so advised the Administrator on January 17, 2001 (A332), and DEA has received no information to the contrary since then.1J Excluding irrelevant anecdotal testimonials, petitioners do not offer to present any new information that would constitute evidence in a CSA rescheduling proceeding.
- UNDER THE CSA, A SCHEDULE I CONTROLLED SUBSTANCE THAT CONTINUES TO HAVE “NO CURRENTLY ACCEPTED MEDICAL USE IN TUATMENT IN THE UNITED STATES,” AND A POTENTIAL FOR ABUSE SUFFICIENT TO WARRANT CONTROL, MUST REMAIN IN SCHEDULE I.
Petitioners state that DEA erroneously’ concluded that marijuana “must remain in schedule I because it has no currently accepted medical use in treatment in the United States and lacks safety for use under medical supervision.” Br. at 26. Although this Court can deny petitioners’ appeal without even addressing
(page 27)
—
this issue (since, as explained above, the denial of the petition to initiate rulemaking proceedings was based on a consideration of all three schedule I criteria and is supported by substantial evidence), DEA’s statutory interpretation was sound.
“DEA’s denial of your, petition is based exclusively on the scientific and medical findings of HHS, with which DEA concurs, that lead to the conclusion that marijuana has a high potential for abuse. Nonetheless, independent of this ‘scientific and medical basis for denying your petition, there is a logical flaw in your proposal that should be noted.”
A4l9 (italics added). The Administrator then explained how, aside from the fact that marijuana has a high potential for abuse, the petition to initiate rulemaking proceedings to reschedule marijuana failed to take into account that under the CSA, “Congress established only one schedule – schedule I – for drugs of abuse: with ‘no currently accepted medical use in treatment in the United States’ and ‘lack of accepted safety for use. . . under_ medical supervision.’ 21 use 812(b).” A421. The Administrator went on to explain how, under the CSA, Congress, allowed practioners only to dispense those controlled substances listed in schedules II through V (21 U.S.C. 829) because those are the only schedules containing controlled substances with a currently accepted medical use in treatment in
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the United States. A419-A420. The Administrator concluded:
“Thus, when it comes to a drug that is currently listed in schedule I, if it is undisputed that such drug has no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical supervision, and it is further undisputed that the drug has at least some potential for abuse sufficient to warrant control under the CSA, the drug must remain in schedule I. In such circumstances, placement of the drug in schedules II through V would conflict with the CSA since such drug would not meet the criterion of “a currently accepted medical use in treatment in the United States.” 21 USC 812(b).
A421.Petitioners now challenge this interpretation of the CSA made by the Administrator.
As stated above, Chevron mandates that on appeal of an agency’s construction of the statute it administers, deference must be given to an agency’s reasonable interpretation of the ,substantive terms of the statute. Here, the above-quoted interpretation of the CSA made by the Administrator is consistent with the plain language of the CSA and is reasonable. (n14)
(page 29)
It is irrefutable that, as the Administrator stated, “Congress established only one schedule – schedule I – for drugs of abuse with ‘no currently accepted medical use in treatment in the United States’ and ‘lack of accepted safety for ‘use . . . under medical supervision.'” For a controlled substance to be listed in schedule II through V, it must have a “currently accepted medical use in treatment in the United States” or (in the case of schedule II controlled substances) “a currently accepted medical use with severe restrictions.” 21 U.S.C. 812 (b) .
Congress created no schedule for drugs of abuse with the specified criteria of “no currently accepted medical use in treatment in the United States” and a potential for abuse less than “a high potential for abuse.” One can infer from this that ‘congress viewed it as an impossibility that a controlled substance with no currently accepted medical use could have less than a high potential for abuse. (n15) This is a reasonable inference because, if a drug or other substance has abuse potential sufficient to warrant control under the CSA and no currently accepted medical use, then, in essence, any consumption of the drug would necessarily be illegal and for the purpose Of abuse.
(page 30)
Stated alternatively, in the absence of an accepted medical use of a drug or other substance, the potential for abuse is maximized since there is no legitimate medical use of such drug or other substance only abuse. (n16)
The Administrator’s interpretation of the plain language of the CSA regarding this issue is also supported by the legislative history of the CSA. The 1970 House report states that, in order for a drug or other substance to have “potential for abuse” within the meaning of the CSA, “there must exist [i] ‘a substantial potential for the occurrence of significant diversions from legitimate channels, [it] significant use by individuals contrary to professional advice, or [iii] substantial capability of creating hazards to the health of the user or the safety of the community.'” 1970 D.S.C.C.A.N. at 4602 (numbering and italics added). Each of these three factors is at its peak when 1’t comes to schedule I controlled substances under the statutory scheme of the CSA: (i) there are no legitimate channels of distribution of schedule I controlled substances for human consumption; (i1) practitioners may not prescribe or dispense schedule I controlled substances to patients (21 U.S.C. 829, 841(a) (1»); and (iii) the use of schedule I controlled substances is illegal and, as Congress declared (21 U_S.C. 801(2), has a
(page 31)
“substantial and detrimental effect on the health and welfare of the American people.”
Petitioners correctly observe that there are some controlled substances listed in schedule II that have no currently accepted medical use. Br. at 27. Specifically, certain narcotic raw materials, such as poppy, straw, were placed in schedule II by Congress when it enacted the CSA in 1970, and these narcotic raw materials remain in schedule II today. The CSA expressly provides that certain categories of controlled substances are exempt from the scheduling criteria: (1) those substances that are immediate precursors of other controlled substances and (ii) those substances that must be controlled because of United States treaty obligations. 21 U.S.C. 811(d), ,(e); 21 V.S.C. 812 (b). When Congress enacted the CSA, it placed poppy straw and certain other narcotic raw materials in schedule II consistent with the fact that they are precursors of schedule II narcotic drugs with accepted medical uses, such as morphine and codeine. (n17)
(page 32)
Notwithstanding the foregoing exemptions from the scheduling criteria made for precursors and drugs controlled under international treaties, the overall text and structure of the Act indicate the intent of Congress that DEA maintain in schedule! all drugs of abuse which continue to have no currently accepted medical use. This intent was recently reiterated by Congress, when it declared, in a provision entitled, “NOT LEGALIZING MARIJUANA FOR MEDICINAL USE” that “before any drug can be approved as a medication in the United States, it must meet. Extensive scientific and medical standards established by the Food and Drug Administration to ensure it is safe and effective” and that “marijuana and other Schedule I drugs have not been approved by the Food and Drug Administration to treat any disease or condition.” Pub. L. No. 105-277, Div. F., 112 Stat. 2681-760 to 2681-761 (1998).
Petitioners cite this Court’s 1977 decision in the prior marijuana rescheduling litigation, National Organization for the Reform of Marijuana Laws (NORML) v. Drug Enforcement Administration, 559 F.2d 735 (D.C. Cir. 1977) as dispositive here. Yet, for a variety of reasons, the 1977 NORML decision is not controlling. Among the many factual and procedural distinctions between NORML and this case are the following. In 1972, NORML petitioned the Bureau of Narcotics and Dangerous Drugs (DEA’s predecessor until 1973) to remove marijuana entirely
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from the schedules or place it in schedule V.(n18) Thus, NORML called into question whether marijuana had any “potential for abuse” sufficient to warrant control under the CSA. In contrast, petitioners here do not contend that marijuana has no “potential for abuse.1I Rather, they contend only that marijuana’s abuse potential is not “high” and, therefore, it must be removed from’ schedule I or II. This is a critical fact that the Administrator expressly took into account in the statements (quoted on pages 28-29 above) about which petitioners now complain. Partly because this fact was not presumed by this Court when it issued its 1977 decision in NORML, the Court found it necessary for DEA to consider whether marijuana had any potential for abuse regardless of whether, marijuana was found at the time to have no currently, accepted medical use.(n19)
Another key distinction between the 1977 NORML decision and this case concerns the basis on which DEA concluded that marijuana had no currently accepted medical use. In 1977, this Court ‘ruled that DEA erred in failing to request a scientific and medical evaluation and scheduling recommendation from HHS in accordance with the procedures set forth in 21 U.S.C. 811. DEA had relied on an informal 1975 letter from the Acting Assistant
(page 34)
Secretary for Health as the sole basis to conclude that marijuana had no currently accepted medical use. 559 F.2d’at 742-743. This Court stated: “[E]ven if lack of medical use is dispositive of a classification decision, we do not think the finding in ,this case was established in conformity with the statute.” Id. at 748-749.
Finally, throughout the 1977 NORML decision, the questions addressed by this Court were steeped in considerations of treaty issues, none Of which are present here.
For all the foregoing reasons, the Administrator properly interpreted the plain language of the CSA to mean that when it comes to a drug that is currently listed in schedule I, if such drug has no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical .supervision, and the drug has at least some potential for abuse , sufficient to warrant control under the CSA, the drug must remain in schedule I. Even if a reviewing court were to arrive at a different interpretation of the CSA, the Administrator’s interpretation cannot be said to be unreasonable and therefore, under Chevron, must be upheld.
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VII. UNDER THE CSA RESCHEDULING PROVISIONS, RULEMAKING PROCEEDINGS,’ AND HEARINGS THEREON, ARE NOT INITIATED UNLESS TUB ADMINISTRATOR DETERMINES THAT – THERE IS “SUBSTANTIAL EVIDENCE” TO WARRANT RESCHEDULING OF A CONTROLLED SUBSTANCE.
Petitioners contend that they are entitled to a hearing “to resolve factual contradictions in the record and to afford petitioners the opportunity to present current scientific evidence ignored by the DEA and HHS.” Br. at 32. This contention fails in two respects.
First, petitioners have failed to demonstrate to this Court any “factual contradictions in the record.” As explained’ above, petitioners overlook substantial portions of the record and misconstrue those portions of the record that they claim demonstrate agency error.
Second, the CSA does not entitle a person to a hearing simply because such person has petitioned DEA to initiate rulemaking proceedings -to reschedule a controlled substance. Rather, the CSA provides that APA proceedings shall be initiated where the Administrator determines that the HHS scientific and medical evaluation and scheduling recommendation and “all other relevant data” “”constitute substantial evidence of potential for abuse such as to warrant contro1(n20) or substantial evidence that the, drug or other substance should be removed entirely from the schedules. ” 21 U.S. C . 811 (b) .
(page 36)
Here, HHS conducted a thorough scientific and medical evaluation, which the Assistant Secretary delivered to the Administrator along with HHS’s recommendation that marijuana should remain in schedule I. A302_A337. DEA then collected and analyzed “all other relevant data.” A338-A415. The Administrator carefully reviewed these materials and advised petitioners; “Based on the HHS evaluation and all other relevant data, DEA has concluded that there is no substantial evidence that marijuana should be removed from schedule 1.’1 A416. Having made this determination, the Administrator was under no obligation to conduct a hearing under 21 U.S.C. 811(b).
Nor would it be logical or consistent with the CSA or APA for DEA to conduct a hearing where it concludes that the HHS evaluation and all other relevant data provide insubstantial evidence to reschedule a controlled substance. Consistent with the APA, the CSA contemplates that rulemaking proceedings. (including the opportunity for a hearing) are to be commenced where DEA is proposing a rule. See 5 U.S.C. 553. Where the agency finds no basis to propose a rule, neither the APA nor the CSA requires the agency to initiate rulemaking proceedings. Indeed, it would be incongruous for rulemaking proceedings to commence when the agency has not proposed any rule.
It is true, as petitioners point out, that DEA conducted a hearing in the prior marijuana rescheduling litigation (the NORML litigation; see Br. at 34). That remedy was directed by this
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Court in light of the particular and complex. nature of that litigation. (See discussion of NORML, section VI., above,) However, that such an approach was taken in the prior litigation did not (and could not) establish a rule binding in all subsequent cases and directly at odds with the statute.
As the agency charged with administering the CSA, DEA is entitled to Chevron deference in its interpretation of all provisions of the Act, including those governing the commencement of rulemaking proceedings to reschedule a controlled substance (and hearings thereon) Moreover, what is ultimately at issue here is DEA’s denial of a petition to initiate rulemaking proceedings. As stated earlier, “an agency’s refusal to initiate a rulemaking is evaluated with a deference so broad as to make the process akin to nonreviewability,” Cellnet Communication, Inc., 965 F.2d at 1111. “It is only in the rarest and most compelling of circumstances that this court has acted to .overturn an agency judgment not to initiate rulemaking.” WWHT, Inc., 656 F.2d at 818. Petitioners have failed to demonstrate that DEA’s denial of their petition was based on any error of law or factual finding not supported by substantial evidence – much less the plain errors of law or factual findings completely devoid of support in the record necessary to reverse the denial of a petition to initiate rulemaking proceedings. See National Customs Brokers & Forwarders, 883 F.2d at 96-97. Accordingly, their appeal must be denied.
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CONCLUSION
For the foregoing reasons this Court should deny
petitioners’ request for a remand of the Administrator’s denial
of their petition to initiate rulemaking proceedings and deny their request that DEA be ordered to conduct a hearing thereon.
Respectfully submitted,
MICHAEL CHERTOFF
Assistant Attorney General
ROSE A. BRICEM0
Trial Attorney
Narcotic and Dangerous Drug Section
Criminal Division
U.S. Department of Justice
DANIEL DORMONT [signed]
Senior Attorney
Drug Enforcement Administration
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CERTIFICATE OF COMPLIANCE
Pursuant to Fed. R. App. P. 32(a) (7) (C) and. Circuit Rule 32, I. hereby certify that the foregoing brief is presented in monospaced Courier font of lO characters per inch. This brief (excluding the cover, tables of contents, and authorities, and certificates of service and compliance) contains 9,487 words, according to the count Of this office’s word processing system.
[signed]
Daniel Dormont
Attorney
January 14,2002
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CERTIFICATE 0F SERVICE
I hereby certify that, on this 14th day of, January, 2002, I served the foregoing “BRIEF FOR’THE RESPONDENT” by causing the original and 14 copies to be sent to this Court by hand delivery, and by causing two copies to be served upon the following counsel by overnight mail:
Michael Kennedy, Esquire
Law Offices of Michael Kennedy
425 Park Avenue, 26th Floor
New York, New York 10022
Tel: (212) 935-4500
[signed]
Daniel Dormant
Attorney
(page break)
(1) The CSA definition of _control” includes both adding a drug or other substance to the schedules and transferring a drug or other substance between schedules. 21 U.S.C. 802(5). In the above discussion, the terms “control,” “decontrol,” and “reschedule” are used for simplicity and easier understanding.
(2) As set forth in a memorandum of understanding entered into by HHS, the Food and Drug Administration (FDA), and the National Institute on Drug Abuse (NIDA), FDA acts as the lead agency within HHS in carrying out the Secretary’s scheduling responsibilities under the CSA, with the concurrence of NIDA. 50 Fed. Reg. 9518 (March 8, 1985).
(3) If the Administrator determines that there is substantial evidence to initiate rulemaking proceedings to reschedule a controlled substance, he must propose a rule, published in the Federal Register, providing interested parties the opportunity to comment and request to participate in any hearings on the proposed rule. 21 U.S.C. 811(a); 21 C.F.R. l308.43(f), (g); 21 C.F.R. 1308.44. Following a hearing before an administrative law judge, the Administrator makes the final determination” in a
final order published in the Federal Register, whether to finalize the proposed rule. 21 C.F.R. 1308.45.
(4) As petitioners note in their brief, Mr. Gettman filed the petition with DEA in 1995 and High Times Magazine subsequently joined with him as a petitioner. Brief for Petitioners (“Br.”) at 1 n,l.
(5) Congress declined to adopt the Shafer Commission’s recommendation that neither possession of marijuana for personal use nor casual distribution of small amounts of marijuana not for’ profit :be an offense. See United States v. Kif£er, 477 F.2d 349, 353-355 (2d Cir. 1973), cart: denied, 414 U.S. 831 (1973). DEA’s final order denying the prior petition to reschedule marijuana adopted no part of the ALJ’s recommended ruling, and was upheld by this Court. See 57 Fed. Reg. 10,499 (March 26, 1992), aff’d, Alliance for Cannabis Therapeutics v. DEA, 15 F.3d 1131 (1994).
(6) In United States v. Cannabis Cultivators Club, 5 F.Supp. 2d 1086, 1105 (N.D. Cal. 1998), a “cannabis club” similarly asked the district court to give weight to the Shafer report and the former ALJ’s recommendation. The court declined to do so. Id. When the case went before the Supreme Court, the cannabis club again cited the Shafer report for the proposition that marijuana was only “tentatively” placed in schedule I. 2001 WL 173541 at *26 (Brief for the Respondents, Feb. 20, 2001). The Supreme Court made no mention in its opinion of the Shafer report or the former ALJ’s recommendation. See Oakland Cannabis Buyers’ Cooperative, 532 U..8. 483, 121 S. Ct. 1711 (2001) (rejecting the argument that marijuana dealers who believe that their customers have a “medical necessity” to smoke marijuana may violate the CSA’s prohibitions on the manufacture and distribution of schedule I controlled substances).
(7) In United States v. Everett, 700 F.2d 900, 906-907 (3d Cir. 19a3) (citations omitted}, the Court explained that the history of federal drug laws “reveals the determination of Congress to turn the screws of the criminal machinery — detection, prosecution, and punishment – tighter and tighter. Faced with a drug abuse problem that had grown to ‘epidemic proportions,’ Congress turned the screws still tighter by enacting the [CSA] to strengthen drug laws. . . . Congress, in legislating against drug use, intended to encompass every act and activity which could lead to proliferation of drug traffic.”
(8) It bears emphasis that although marijuana has relatively low levels of toxicity and physical dependence as compared to other illicit drugs, abuse of marijuana poses significant public health and safety risks. Every health-related database and the preponderance of health-related scientific data suggest that marijuana is associated with detrimental health consequences such as chronic lung disease, lung and throat cancers, impaired driving, and impaired cognitive functioning in humans. A3191\388.
(9) The 1970 House report states that, in order for a drug or other substance to’ have “potential for abuse” within the meaning of the CSA, _there must exist a substantial potential for the Occurrence of significant diversions from legitimate channels, significant use by individuals contrary to professional advice, or substantial capability of creating hazards to the health of the user or the safety of the community.” 1970 U.S.C.C.A.N. at 4602 (citing, and adopting, House report to the Drug Abuse Control Amendments of 1965). HHS and DEA specifically addressed these factors in analyzing potential for abuse.
(10) For a drug to have a currently accepted medical use under the CSA, each of the following five elements must be met:
(i) the drug’s chemistry must be known and reproducible;
(ii) there must be adequate safety studies;
(iii) there must be adequate and well-controlled studies
proving efficacy;
(iv) the drug must be accepted by a consensus of qualified
experts;
(v) the scientific evidence must be widely available.
(11) Because HHS and DEA abided by Grinspoon by not relying solely on lack of FDA approval in concluding that marijuana has no currently accepted medical use, this Court need not address whether the Grinspoon court’s interpretation of the CSA was correct on this point.
(12) In Oakland Cannabis Buyers’ Cooperative, the Supreme Court expressly rejected the claim that marijuana can be “medically necessary” even though it has “no currently accepted medical use” under the CSA. The Court stated: “According to the Cooperative, a drug may not yet have achieved general acceptance as a medical treatment but may nonetheless have medical benefits to a particular patient or class of patients. We decline to parse the statute in this manner_” 121 S. Ct. at 1719.
(13) DEA is aware of all ongoing clinical studies involving marijuana because, in order to conduct research with a schedule I controlled substance, the researcher must be registered with DEA and submit an FDA-approved protocol with the application for registration. 21 U.S.C. 823(f). At present, there are researchers registered with DEA to conduct clinical studies involving marijuana being administered to human subjects. However, none of these researchers is currently conducting studies beyond preliminary phase safety studies, which (regardless of the results) would be legally insufficient to demonstrate that marijuana has a currently accepted medical use in treatment in the United States. See note 10, above.
(14) One month after DEA published in the Federal Register its denial of Mr. Gettman’s petition, the United States Supreme Court issued a unanimous (8-Q) ruling containing a description of schedule I controlled substances similar to that provided by the Administrator to Mr. Gettman. In Oakland Cannabis Buyers’ Cooperative, the Court explained how the structure of the CSA, which divides drugs of abuse into five schedules, and imposes restrictions based on such schedules, indicates a determination by Congress that marijuana, being a drug which,meets the criteria for placement in schedule I, “has no medical benefits worthy of an exception (outside the confines of a Government-approved research project).” 121 S. Ct. at 1717-1719. The Court stated: “Whereas some other drugs [those in schedules II through V] can be dispensed and prescribed for medical use, see 21 U.S.C. § 829, . the same is not true for marijuana. Indeed, for purposes’ of the Controlled Substances Act, marijuana has ‘no currently accepted medical use’ at all.” Id. at 1718.
(15) If a drug or other substance has insufficient potential for abuse to warrant control in any schedule, then such drug or other substance is not listed in any schedule (i.e., it is a noncontrolled substance). In such circumstances, it is irrelevant for CSA scheduling purposes whether such drug or other substance has a currently accepted medical use in treatment in the United States.
(16) Schedule I controlled substances may be used in FDA approved, DEA-registered research pursuant to,21 U.S.C. 823(£). ” However, such limited experimental use under highly controlled conditions does not alter the fact that the use by the general public of schedule I drugs is illegal and solely for abuse.
(17) The CSA states: “The Attorney General may, without regard to the findings required by (21 U.S.C. 811(a) or 812(b)] and without regard to the procedures prescribed by subsections [8l1(a) and 811(b)], place an immediate precursor in the same schedule in which the controlled substance of which it is an immediate precursor is placed or’ in any other schedule with a ‘ higher numerical designation.” 21 V.S.C. 811(e) (italics added). Moreover, Congress may pass legislation placing controlled substances in whatever schedule it deems appropriate – without regard to the statutory factors that DEA must consider when it evaluates a rescheduling petition.
(18) See NORML v. Ingersoll, 497 F.2d 654, 655 (D.C. Cir. 1974).
(19) As explained above (note 15), if a controlled substance has insufficient potential for abuse to warrant control in ,any schedule, then it is not a controlled substance regardless of whether it lacks a currently accepted medical use.
(20) In this context, “control” includes both adding a drug or other substance to the schedules and transferring a drug or other substance between schedules. 21 U.S.C. 802(5).