[Federal Register Volume 66, Number 195 (Tuesday, October 9, 2001)]
[Rules and Regulations]
[Pages 51530-51534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25022]



[[Page 51529]]

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Part III





Department of Justice





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Drug Enforcement Administration



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21 CFR Part 1308



Interpretation and Clarification of Listing of 
``Tetrahydrocannabinols'' in Schedule I; Exemption From Control of 
Certain Industrial Products and Materials Derived From the Cannabis 
Plant; Final Rules and Proposed Rule

  Federal Register / Vol. 66, No. 195 / Tuesday, October 9, 2001 / 
Rules and Regulations  

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-204]
RIN 1117-AA55


Interpretation of Listing of ``Tetrahydrocannabinols'' in 
Schedule I

AGENCY: Drug Enforcement Administration, Justice.

ACTION: Interpretive rule.

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SUMMARY: For the reasons provided herein, the Drug Enforcement 
Administration (DEA) interprets the Controlled Substances Act (CSA) and 
DEA regulations to declare any product that contains any amount of 
tetrahydrocannabinols (THC) to be a schedule I controlled substance, 
even if such product is made from portions of the cannabis plant that 
are excluded from the CSA definition of ``marihuana.'' Consistent with 
this interpretation, DEA is publishing today a proposed rule in a 
separate Federal Register document that immediately follows this 
interpretive rule. The proposed rule proposes to revise the wording of 
the DEA regulations to make clear that the listing of THC in schedule I 
refers to both natural and synthetic THC. In a third Federal Register 
document being published today (following the proposed rule), DEA is 
issuing an interim rule, which exempts from control certain industrial 
products, processed plant materials, and animal feed mixtures made from 
those portions of the cannabis plant that are excluded from the 
definition of marijuana, to the extent such products, plant materials, 
and feed mixtures contain THC but are not used, or intended for use, 
for human consumption. The interim rule also provides a 120-day grace 
period for persons to dispose of existing inventories of THC-containing 
``hemp'' products that are not exempted from control.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, (202) 307-7183.

SUPPLEMENTARY INFORMATION:

Why Is DEA Issuing This Interpretive Rule?

    Over the past several months, DEA has received numerous public 
inquiries regarding the interpretation of the CSA with respect to 
certain products made from plants of the genus Cannabis (hereafter, 
``cannabis plant''). These inquiries have raised the following 
question: If a product contains THC but is made from a portion of the 
cannabis plant that is excluded from the CSA definition of marijuana, 
is such product a controlled substance? This document answers this 
question and provides the public with the in-depth legal analysis that 
DEA has undertaken.

Legal Analysis

A. Relevant Statutory Provisions

    Under the CSA, marijuana is defined as follows:

    The term ``marihuana'' \1\ means all parts of the plant Cannabis 
sativa L., whether growing or not; the seeds thereof; the resin 
extracted from any part of such plant; and every compound, 
manufacture, salt, derivative, mixture, or preparation of such 
plant, its seeds or resin. Such term does not include the mature 
stalks of such plant, fiber produced from such stalks, oil or cake 
made from the seeds of such plant, any other compound, manufacture, 
salt, derivative, mixture, or preparation of such mature stalks 
(except the resin extracted therefrom), fiber, oil, or cake, or the 
sterilized seed of such plant which is incapable of germination.
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    \1\ ``Marihuana'' is the spelling used in the CSA. In this 
document, the common spelling ``marijuana'' is used, except when 
directly quoting the CSA or citing the ``Marihuana Tax Act of 
1937.''

21 U.S.C. 802(16). As the second sentence of this definition indicates, 
Congress expressly exempted certain portions of the cannabis plant from 
the definition of marijuana. At the same time, however, Congress 
expressly declared in the scheduling provisions of the CSA that ``any 
material, compound, mixture, or preparation, which contains any 
quantity of * * * Tetrahydrocannabinols [THC]'' is a schedule I 
controlled substance. 21 U.S.C. Sec. 812(c), schedule I(c)(17).
    Given the foregoing provisions of the CSA, several persons have 
recently asked DEA about the legal status of products marketed in the 
United States that are made from portions of the cannabis plant that 
are excluded from the definition of marijuana. Such products include, 
among other things, certain types of paper, clothing, bird seed, food, 
beverages, shampoos, and body lotions. Often, such products are labeled 
or advertised as being made from ``hemp.'' (Some members of the public 
refer to these as ``hemp'' products.) In some cases, the labeling 
indicates that the products contain a certain percentage of THC. Given 
the recent increase in marketing of these so-called ``hemp'' products 
in the United States, and given that many such products have recently 
been determined to contain THC, DEA has repeatedly been asked in recent 
months whether the THC content of such products renders them controlled 
substances despite the fact that they are reportedly made from portions 
of the cannabis plant that are excluded from the definition of 
marijuana.
    In DEA's view, the answer lies in the plain language of the CSA, 
which states that ``any material, compound, mixture, or preparation, 
which contains any quantity of * * * Tetrahydrocannabinols'' is a 
schedule I controlled substance. The CSA does not state that any 
material, compound, mixture, or preparation containing THC is only a 
controlled substance if it fits within the definition of marijuana.
    Several members of the public who have corresponded with DEA 
disagree with the above interpretation of the CSA. Some have contended 
that classifying what they term ``hemp'' products as controlled 
substances is contrary to the history of the federal drug laws, DEA's 
own regulations, and reported court decisions. In light of such 
comments from the public, set forth below is a detailed analysis of 
pertinent legal authorities.

B. Historical Development of the Law

    Congress' definition of marijuana has remained unchanged since 
1937. The definition that appears in the CSA today is identical to the 
definition that was contained in the Marihuana Tax Act of 1937. 
Congress carried this definition forward when it enacted the CSA in 
1970. (The CSA repealed and superseded the Marihuana Tax Act.)
    The question presented here is not answered by the legislative 
history of the CSA. The 1970 Congress seems to have adopted the 
definition of marijuana from the 1937 Marihuana Tax Act without 
reported discussion. In contrast, the legislative history of the 
Marihuana Tax Act contains substantial discussion of the definition of 
marijuana. The Senate Report to the 1937 Act states:

    The term ``marihuana'' is defined so as to bring within its 
scope all parts of the plant having the harmful drug ingredient, but 
so as to exclude the parts of the plant in which the drug is not 
present. The testimony before the committee showed definitely that 
neither the mature stalk of the hemp plant nor the fiber produced 
therefrom contains any drug, narcotic, or harmful property 
whatsoever and because of that fact the fiber and mature stalk have 
been exempted from the operation of law.

S. Rep. No. 900, 75th Cong., 1st Sess., at 4 (1937).
    The foregoing legislative history was reiterated by the United 
States Court of Appeals for the District of Columbia Circuit in a 1975 
case, United States v. Walton, 514 F.2d 201. The court stated:

    Looking at the legislative history of [the Marihuana Tax Act of 
1937], we find that the

[[Page 51531]]

definition of marijuana was intended to include those parts of 
marijuana which contain THC and to exclude those parts which do not. 
* * * The legislative history is absolutely clear that Congress 
meant to outlaw all plants popularly known as marijuana to the 
extent those plants possessed THC.

Id. at 203-204.
    Thus, it is evident that the 1937 Congress exempted certain 
portions of the cannabis plant from the definition of marijuana based 
on the assumption (now refuted) that such portions of the plant contain 
none of the psychoactive component now known as THC.\2\ Although the 
1970 Congress did not revisit this issue when it carried forward the 
1937 definition of marijuana, it did separately specify that ``any 
material, compound, mixture, or preparation, which contains any 
quantity of * * * ``Tetrahydrocannabinols'' is a schedule I controlled 
substance. This is consistent with the conclusion of the Court of 
Appeals in Walton that, in enacting both the 1937 Act and the CSA, 
``Congress meant to outlaw all plants popularly known as marijuana to 
the extent those plants possessed THC.''
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    \2\ The technology used for chemical analysis has improved 
significantly since 1937. Using advanced methods of testing that are 
currently available, the analysis of all portions of today's 
cannabis plant, including those portions that are excluded from the 
definition of marijuana, will result in the identification of some 
amounts of THC within the structure of all portions of the plant. 
Additional amounts of THC might also be detected on the surface of 
those portions of the plant excluded from the definition of 
marijuana due to resin or particulate matter from other portions of 
the plant that adhered to the excluded portions during the 
harvesting process.
    Some members of the public who have corresponded with DEA 
correctly point out that the legislative history of the 1937 Act 
contains testimony from witnesses who believed that some portions of 
the cannabis plant that were being excluded from the definition of 
marijuana did contain small amounts of the psychoactive drug. Other 
witnesses who appeared before the 1937 Congress testified to the 
contrary--that the portions of the plant that were being excluded 
from the definition of marijuana contained none of the psychoactive 
drug. In the final analysis, the Senate concluded (as quoted above) 
that the 1937 Act defined marijuana ``so as to bring within its 
scope all parts of the plant having the harmful drug ingredient, but 
so as to exclude the parts of the plant in which the drug is not 
present.''
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    It cannot be assumed (as some members of the public have asserted 
in recent correspondence with DEA) that because Congress adopted the 
1937 definition of marijuana when it enacted the CSA, it intended to 
control marijuana in precisely the same manner as under the Marihuana 
Tax Act. As the United States Court of Appeals for the First Circuit 
recently stated: ``While in 1937 Congress had indicated in legislative 
history that production for industrial uses would be protected 
(primarily by a relatively low tax), we can find no indication that 
Congress in 1970 gave any thought to how its new statutory scheme would 
affect such production.'' New Hampshire Hemp Council, Inc. v. Marshall, 
203 F.3d 1 (1st Cir. 2000) (citations omitted). The First Circuit 
further explained that basic differences between the 1937 Act and the 
CSA disallow interpreting the two acts in the same way:

    Congress' main vehicle for protecting industrial-use plant 
production in 1937 was not its basic definition of ``marijuana,'' 
which included plants ultimately destined for industrial use; it was 
the complex scheme of differential tax rates and other requirements 
for transfers. That is the regime that was drastically modified in 
1970 in favor of a broad criminal ban (subject only to federal 
licensing), a ban which read literally embraces production of 
cannabis plants regardless of use.
    The possibility remains that Congress would not have adopted the 
1970 statute in its present form if it had been aware of the effect 
on cultivation of plants for industrial uses. But that is only a 
possibility and not a basis for reading the new statute contrary to 
its literal language, at least absent a clear indication that 
Congress intended to protect plant production for industrial use as 
it existed under the prior tax statute. Nor, given Congress' 
enlargement of drug crimes and penalties in recent years, would one 
bank on its adoption of an exception strongly opposed by the DEA as 
a threatened loophole in the ban on illegal drugs.

Id. at 7 (footnote and citation omitted). Thus, industrial uses of 
marijuana that were permitted under the 1937 Tax Act are not 
necessarily permissible under the CSA, even though the definition of 
marijuana has remained the same in both acts.
    One might reasonably ask: Why would Congress exempt certain 
portions of the cannabis plant from the CSA definition of marijuana if 
such portions would nonetheless be subject to CSA control to the extent 
they contain THC? The answer now seems clear. As indicated above, the 
1970 Congress did not address the possibility that portions of the 
cannabis plant excluded from the definition of marijuana might contain 
THC.

C. Control of Natural and Synthetic THC

    Some members of the public who have corresponded with DEA have 
expressed the view that the listing of THC in schedule I of the CSA 
applies only to synthetic THC, rather than natural THC. (For purposes 
of this document, ``natural THC'' means THC found in nature in the 
cannabis plant, as opposed to THC synthesized by humans.) Based on this 
supposition, some have contended that the THC content of ``hemp'' 
products is irrelevant because only synthetic THC (not natural THC) is 
controlled under the CSA. As explained below, DEA rejects this 
contention because it is DEA's interpretation that the listing of THC 
in schedule I includes both natural and synthetic THC.
1. Listing of THC in the CSA
    When Congress established the initial schedules of controlled 
substances in 1970, it simply listed ``Tetrahydrocannabinols'' in 
schedule I. The CSA makes no mention of synthetic versus natural THC. 
Furthermore, the commonly understood meaning of 
``Tetrahydrocannabinols'' includes both natural THC and synthetic THC, 
since ``Tetrahydrocannabinols'' is simply a name that refers 
collectively to a category of chemicals--regardless of whether such 
chemicals occur in nature or are synthesized in a laboratory. For 
example, Merriam-Webster's Collegiate Dictionary (10th ed. 1999) 
defines ``THC'' as ``a physiologically active chemical 
C21H30O2 from hemp plant resin that is 
the chief intoxicant in marijuana--called also tetrahydrocannabinol;'' 
this definition does not mention synthetic THC.
2. Listing of THC in the DEA Regulations
    In the DEA regulations, THC is listed in schedule I as follows:


Tetrahydrocannabinols...........................................    7370
 

    Synthetic equivalents of the substances contained in the plant, or 
in the resinous extractives of Cannabis, sp. and/or synthetic 
substances, derivatives, and their isomers with similar chemical 
structure and pharmacological activity such as the following:

1 cis or trans tetrahydrocannabinol, and their 
optical isomers
6 cis or trans tetrahydrocannabinol, and their 
optical isomers
3,4 cis or trans tetrahydrocannabinol, and its 
optical isomers

(Since nomenclature of these substances is not internationally 
standardized, compounds of these structures, regardless of numerical 
designation of atomic positions covered.)

21 CFR 1308.11(d)(27). DEA interprets this regulation at face value. 
The first line--``Tetrahydrocannabinols''--refers to all forms of THC 
(natural or synthetic), while the subsequent lines refer to synthetic 
equivalents of the substances contained in the cannabis plant and 
synthetic substances with similar chemical structure and 
pharmacological activity. That the regulation refers specifically to 
certain synthetic equivalents of THC does not

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mean that natural THC is excluded. The regulation does not state, for 
example: ``Tetrahydrocannabinols, meaning only synthetic equivalents. * 
* *''
    To better understand this regulation, it is helpful to examine the 
historical control of THC under federal law.
3. Historical Control of THC Under Federal Law
    Natural THC found in marijuana has been controlled, at least 
implicitly, under federal law since 1937. As stated above, under the 
Marihuana Tax Act of 1937, marijuana was defined exactly as it is now 
under the CSA--to include, among other things, any ``compound, 
manufacture, salt, derivative, mixture, or preparation of'' the 
cannabis plant. This definition included natural THC (to the extent 
such THC was contained in, or derived from, those portions of the 
cannabis plant included in the definition of marijuana). Thus, from 
1937 until 1971 (the year the CSA became effective and the Marihuana 
Tax Act was repealed), such natural THC was federally controlled under 
the Marihuana Tax Act.
    Synthetic THC, however, was not controlled under the 1937 Marihuana 
Tax Act since it did not fit within the Act's definition of marijuana. 
Nor were there any other federal drug laws in existence in 1937 that 
controlled synthetic hallucinogenic substances. Moreover, there was no 
reason in 1937 to expressly control THC (natural or synthetic) since 
this chemical had not been isolated in 1937 and it was not synthesized 
in the laboratory until 1964. In the late 1960s, when synthetic THC 
began showing up in the illicit market, federal officials concluded 
that federal control over the drug was necessary to prevent abuse. At 
that time, however (approximately three years before the enactment of 
the CSA), the federal laws governing drugs of abuse were not unified 
into a single act as they are now under the CSA. Marijuana and its 
derivatives were controlled under the Marihuana Tax Act; narcotics were 
controlled under a variety of acts, including the Harrison Narcotics 
Act of 1914; and what were termed ``depressant and stimulant drugs'' 
(which included some hallucinogenic substances) were controlled under 
the Drug Abuse Control Amendments of 1965 (DACA), which were part of 
the Food, Drug, and Cosmetic Act.
    Because synthetic THC is a synthetic hallucinogenic substance, any 
federal control of the drug in 1968 could only be accomplished pursuant 
to DACA. Accordingly, the Bureau of Narcotics and Dangerous Drugs 
(BNDD, which was DEA's predecessor) promulgated a regulation, effective 
September 21, 1968, listing synthetic THC under DACA. This 1968 BNDD 
regulation was identical to the current listing of THC in the DEA 
regulations, except that the general reference to 
``Tetrahydrocannabinols'' was absent. Thus, the 1968 regulation was 
expressly limited to synthetic THC (and synthetic equivalents thereof). 
This was because DACA prohibited BNDD from promulgating a regulation 
that would list under DACA any substance included in the definition of 
marijuana under the Marihuana Tax Act of 1937. In other words, if a 
drug was controlled under the Marihuana Tax Act, it could not also be 
controlled under DACA. Since natural THC (derived from marijuana) fit 
within the definition of marijuana and was thereby controlled under the 
Marihuana Tax Act, the BNDD regulation listing THC had to exclude such 
natural THC. Therefore, the BNDD regulation listing THC under DACA was 
limited to the synthetic form.
    Thus, during the brief period from September 21, 1968, until May 1, 
1971 (the effective date of the CSA), natural and synthetic THC were 
separately controlled under distinct federal acts. Natural THC (as a 
derivative of marijuana) was controlled under the Marihuana Tax Act of 
1937, while synthetic THC was controlled under DACA.
    When Congress enacted the CSA in 1970, one of its aims was to unify 
what had been the ``plethora of legislation'' controlling narcotics and 
dangerous drugs into ``one piece of legislation.'' H. Rep. No. 91-1444, 
1970 U.S.C.C.A.N. 4566, 4571. One result was that, following the 
enactment of the CSA, THC no longer had to be separately categorized 
into ``natural'' versus ``synthetic'' in order to maintain the 
Congressionally mandated separation between drugs controlled under DACA 
and those controlled under the Marihuana Tax Act. Thus, Congress was 
able to list ``Tetrahydrocannabinols'' in schedule I without having to 
distinguish between natural and synthetic. Likewise, the first 
regulations implementing the CSA (the 1971 BNDD regulations) did not 
simply carry forward, without change, the prior regulation that listed 
only ``synthetic'' THC (as was required under DACA). Rather, BNDD added 
the general term ``Tetrahydrocannabinols'' to the beginning of the 
listing, above the references to ``synthetic equivalents,'' since the 
regulation no longer had to be limited to synthetic THC.
    Thus, it is DEA's interpretation that the listing of THC in 
schedule I of the CSA and DEA regulations has always included both 
natural and synthetic THC.
4. Case Law Addressing Natural and Synthetic THC
    It appears that no court has ever undertaken the foregoing 
extensive analysis of the control of natural and synthetic THC. 
Further, the few reported cases that have addressed the issue reach 
differing conclusions.
    The first case to address the issue was United States v. Wuco, 535 
F.2d 1200 (9th Cir. 1976), where the defendants were initially charged 
with trafficking in marijuana. When the defense indicated that they 
would argue the ``species defense'' (i.e., that the CSA only prohibits 
trafficking in ``Cannabis sativa L.''--not the supposedly other variety 
of cannabis with which defendants ``were caught red-handed''), the 
United States Attorney's Office sought to preclude this defense by 
filing a superseding indictment that charged defendants with 
trafficking in ``marijuana, a substance containing * * * 
tetrahydrocannabinol * * *, a schedule I controlled substance.'' 
Defendants were convicted of the latter charge and, on appeal, sought 
to reverse their conviction on the ground that this charge required the 
government to prove ``that the substance they possessed contained 
synthetic THC.'' For reasons that are not revealed in the court's 
opinion, the United States Attorney's Office ``conceded'' on appeal 
that the listing of ``Tetrahydrocannabinols'' in schedule I was limited 
to synthetic THC. The court agreed with this ``concession'' without 
explanation. The Wuco opinion contains no analysis of the CSA, DEA 
regulations, or legislative history. The opinion simply indicates that 
the court and the government agreed for purposes of that case that the 
listing of ``Tetrahydrocannabinols'' in schedule I meant only synthetic 
THC.
    United States v. Lochan, 674 F.2d 960 (1st Cir. 1982), was another 
case in which the defendant was charged with, and convicted of, 
trafficking in ``tetrahydrocannabinols'' (in this case, hashish)--
rather than ``marihuana''. Defendant argued on appeal that the 
government was required to prove that the hashish contained THC. The 
appeals court disagreed, indicating that it was sufficient for the 
government to prove ``that the material was in fact hashish.'' In 
addressing this issue, the court stated: ``Hashish is a schedule I 
substance if it contains tetrahydrocannabinols (THC), 21 U.S.C. 812, 
Schedule I (c)(17), which is the `active ingredient' in hashish.'' This 
statement by the court is consistent with

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the view that the listing of ``Tetrahydrocannabinols'' in schedule I 
does include natural (not merely synthetic) THC.
    United States v. McMahon, 861 F.2d 8 (1st Cir. 1988) was another 
case in which the indictment charged the defendant with trafficking in 
``hashish, a substance containing tetrahydrocannabinol, a Schedule I 
controlled substance.'' Based on this charge, the defendant contended 
that the government was required to prove the presence of THC in order 
to convict. The court upheld the conviction, ruling that ``the 
government is not required to prove that the substance contained THC, 
organic or synthetic; [i]t merely has to prove * * * that the substance 
was hashish and thus a derivative of marijuana, a Schedule I controlled 
substance.'' In attempting to explain this ruling, the court stated 
that ``the substance referred to in Schedule I(c)(17) is synthetic, not 
organic, THC.'' As support for this statement, the court cited Wuco and 
pointed to the separate listings of ``Marihuana'' and 
``Tetrahydrocannabinols'' in schedule I of the DEA regulations. The 
court referred to the DEA regulations as ``describing THCs listed in 
schedule I as `[s]ynthetic equivalents of substances contained in the 
plant . * * * '' '
    In DEA's view, the McMahon court erred in suggesting that the 
separate listings of ``Marihuana'' and ``Tetrahydrocannabinols'' in 
schedule I are mutually exclusive. Congress gave no indication in the 
CSA that there can be no overlap between separate listings in a 
particular schedule. An example serves to illustrate. In schedule I of 
both the CSA and DEA regulations, ``peyote'' is listed separately from 
``mescaline''. Mescaline is to peyote what THC is to marijuana: the 
former is the psychoactive chemical component of the plant, while the 
latter is the plant itself (including derivatives thereof). Both 
natural and synthetic mescaline are known to exist. Yet, the fact that 
natural mescaline falls under the listing of ``peyote'' (as an extract, 
compound, derivative or preparation of such plant--see 21 CFR 
1308.11(d)(22)) does not mean that the separate listing of 
``mescaline'' refers only to the synthetic form. On the contrary, the 
listing of ``mescaline'' refers to the chemical in any form (natural or 
synthetic).
    Moreover, the McMahon court acknowledged that its interpretation of 
``Tetrahydrocannabinols'' appears inconsistent with that of the Lochan 
court. See 861 F.2d at 11 n.1. To resolve this apparent discrepancy 
between these two First Circuit cases, the McMahon court suggested that 
it may be possible that natural THC fits within the listing of both 
``Tetrahydrocannabinols'' and ``Marihuana'' in schedule I. Id. In doing 
so, the McMahon court effectively acknowledged that the listing of THC 
in schedule I is not limited to synthetic THC.
    Because the foregoing three cases arrive at no consensus about the 
issue of natural versus synthetic THC, and because none of the cases 
contains an in-depth study of the control of THC, these decisions fail 
to resolve the issue here. More instructive is the Walton decision 
(discussed earlier), which points out that THC content was of paramount 
concern to Congress in deciding how to control marijuana.

Conclusion

    By stating that ``any material, compound, mixture, or preparation, 
which contains any quantity of * * * Tetrahydrocannabinols'' is a 
schedule I controlled substance, the plain language of the CSA leads to 
the conclusion that all products containing any amount of THC are 
schedule I controlled substances. The legislative history supports this 
conclusion by revealing that Congress wrote the definition of marijuana 
intending to control all parts of the cannabis plant that were believed 
to contain THC. When the CSA was enacted, the implementing regulations 
did not simply adopt, verbatim, the prior regulations that were 
expressly limited to synthetic forms of THC. Rather, the word 
``Tetrahydrocannabinols'' was inserted in the regulations at the top of 
the listing, thereby including all forms of THC (natural and 
synthetic). DEA therefore interprets the CSA and DEA regulations such 
that any product that contains any amount of THC is a schedule I 
controlled substance, even if such product is made from portions of the 
cannabis plant that are excluded from the definition of marijuana.
    DEA recognizes that this interpretive rule, standing alone, would 
effectively prohibit the use of an assortment of industrial products 
made from the cannabis plant (such as certain paper products, fiber, 
rope, and animal feed) that Congress intended to allow under the 1937 
Marihuana Tax Act. Although the intent of the now-repealed 1937 Act is 
no longer controlling, DEA is issuing today, in a separate Federal 
Register document that accompanies this document, an interim rule that 
will except from CSA control the types of industrial products that were 
allowed under the 1937 Act, provided such products do not cause THC to 
enter the human body. See [insert Federal Register cite for interim 
rule]. As explained further in the interim rule, all other products 
made from any of the excluded portions of the cannabis plant (such as 
edible ``hemp'' products) remain controlled substances if they cause 
THC to enter the human body.
    Also as set forth in the interim rule, a 120-day grace period is 
being provided for persons to dispose of existing inventories of THC-
containing ``hemp'' products that are not exempted from control.

Regulatory Certifications

    This document is an interpretive rule. It is not a proposed rule, 
general notice of which the agency must publish in accordance with the 
Administrative Procedure Act. See 5 U.S.C. 553. Therefore, the 
following provisions, which require the agency to include regulatory 
certifications in proposed rules, are not applicable to this document: 
Regulatory Flexibility Act (5 U.S.C. 601-612); Executive Order 12988 
(civil justice reform); Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1531-1538); and Small Business Regulatory Enforcement Fairness Act (5 
U.S.C. 801-808). All of the foregoing certification provisions are 
addressed, however, in the proposed rule that accompanies this 
interpretive rule. See [insert Federal Register cite for proposed 
rule].

Executive Order 12866

    This interpretive rule has been drafted and reviewed in accordance 
with Executive Order 12866, Regulatory Planning and Review, Sec. 1(b), 
Principles of Regulation. This rule has been determined to be a 
``significant regulatory action'' under Executive Order 12866, 
Sec. 3(f). Accordingly, this interpretive rule has been reviewed by the 
Office of Management and Budget for purposes of Executive Order 12866.

Executive Order 13132

    This interpretive rule does not preempt or modify any provision of 
state law; nor does it impose enforcement responsibilities on any state 
or diminish the power of any state to enforce its own laws. 
Accordingly, this interpretive rule does not have federalism 
implications warranting the application of Executive Order 13132.

Paperwork Reduction Act of 1995

    This interpretive rule does not involve collection of information 
within the meaning of the Paperwork Reduction Act of 1995.

Plain Language

    In writing this interpretive rule, DEA has attempted to use plain 
language in

[[Page 51534]]

an easy-to-read manner, consistent with the June 1, 1998 directive of 
the President. See 63 FR 31885. If you have any suggestions to make 
this document more clear, call or write Patricia Good, Chief, Liaison 
and Policy Section, Office of Diversion Control, Washington, D.C. 
20537; telephone: (202) 307-7297.

    Dated: October 2, 2001.
Asa Hutchinson,
Administrator.
[FR Doc. 01-25022 Filed 10-5-01; 8:45 am]
BILLING CODE 4410-09-P