[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]]
-----------------------------------------------------------------------
Part III
Department of Justice
-----------------------------------------------------------------------
Drug Enforcement Administration
-----------------------------------------------------------------------
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
[[Page 51530]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
\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.''
---------------------------------------------------------------------------
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
[[Page 51532]]
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
[[Page 51533]]
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