[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Rules and Regulations]
[Pages 14114-14119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6804]



[[Page 14113]]

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Part VII





Department of Justice





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Drug Enforcement Agency



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21 CFR 1308



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

  Federal Register / Vol. 68, No. 55 / Friday, March 21, 2003 / Rules 
and Regulations  

[[Page 14114]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA-205F]
RIN 1117-AA55


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

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: The Drug Enforcement Administration (DEA) is revising the 
wording of the DEA regulations to clarify that the listing of 
``Tetrahydrocannabinols'' (THC) in schedule I of the Controlled 
Substances Act (CSA) and DEA regulations refers to both natural and 
synthetic THC.

DATES: This final rule becomes effective on April 21, 2003.

FOR FURTHER INFORMATION CONTACT: Frank Sapienza, Chief, Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537; Telephone: (202) 307-7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and by What Authority Is It Being 
Issued?

    This final rule clarifies that, under the CSA and DEA regulations, 
the listing of ``Tetrahydrocannabinols'' in schedule I refers to both 
natural and synthetic THC.
    This rule is being issued pursuant to 21 U.S.C. 811, 812, and 
871(b). Sections 811 and 812 authorize the Attorney General to 
establish the schedules in accordance with the CSA and to publish 
amendments to the schedules in the Code of Federal Regulations, part 
1308 of title 21. Section 871(b) authorizes the Attorney General to 
promulgate and enforce any rules, regulations, and procedures which he 
may deem necessary and appropriate for the efficient enforcement of his 
functions under the CSA. These functions vested in the Attorney General 
by the CSA have been delegated to the Administrator and Deputy 
Administrator of DEA. 21 U.S.C. 871(a); 28 CFR 0.100(b) and 0.104, 
appendix to subpart R, sec. 12.

Why Is There A Need To Clarify The Meaning of 
``Tetrahydrocannabinols''?

    As DEA explained in its October 9, 2001 interpretive rule (66 FR 
51530; hereafter ``interpretive rule''), it is DEA's interpretation of 
the plain language of the CSA and DEA regulations that the listing of 
``Tetrahydrocannabinols'' in schedule I refers to both natural and 
synthetic THC. Despite the wording of the statute, some members of the 
public were under the impression (prior to the publication of the 
interpretive rule) that the listing of ``Tetrahydrocannabinols'' in 
schedule I includes only synthetic THC--not natural THC. To eliminate 
any uncertainty, DEA is hereby revising the wording of its regulations 
to refer expressly to both natural and synthetic THC.

Why Should Natural THC Be Considered a Controlled Substance?

    There are several reasons why natural THC should be considered a 
controlled substance. First, as explained in the interpretive rule, it 
is evident from the plain language of the CSA that Congress intended 
all THC--natural or synthetic--to be a schedule I controlled substance. 
Congress did so by listing ``Tetrahydrocannabinols'' in schedule I of 
the CSA--without limiting ``Tetrahydrocannabinols'' to either natural 
or synthetic form. 21 U.S.C. 812(c), Schedule I(c)(17). The basic 
dictionary definition of the word ``tetrahydrocannabinols'' refers 
collectively to a category of chemicals--regardless of whether such 
chemicals occur in nature or are synthesized in the laboratory.\1\
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    \1\ 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.
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    Second, every molecule of THC has identical physical and chemical 
properties and produces identical psychoactive effects, regardless of 
whether it was formed in nature or by laboratory synthesis.\2\ 
Likewise, a product that contains THC in a given formulation will cause 
the same reaction to the human who ingests it regardless of whether the 
THC is natural or synthetic. Indeed, some researchers are currently 
investigating the possibility of using natural THC (extracted from 
cannabis plants) in drug products.\3\
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    \2\ In this context, ``every molecule of THC'' refers to every 
molecule of the same isomer of THC. For example, all molecules of 
\9\-(trans)-THC are identical, regardless of whether they are 
natural or synthetic.
    It should also be noted that ``Tetrahydrocannabinols'' refers to 
a class of substances which includes \9\-(trans)-THC, its isomers, 
and other related substances. Collectively, this class will be 
referred to in this document as ``THC,'' unless otherwise indicated.
    \3\ At present, Marinol[reg] is the only THC-containing drug 
product that has been approved for marketing by FDA. Marinol[reg] 
contains synthetic dronabinol (an isomer of THC) in sesame oil and 
encapsulated in soft gelatin capsules. This product has been 
approved for the treatment of nausea and vomiting associated with 
cancer chemotherapy as well as the treatment of anorexia associated 
with weight loss in patients with AIDS. See 64 FR 35928 (1999) (DEA 
final order transferring Marinol[reg] from schedule II to schedule 
III).
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    Third, regardless of its source, THC meets the criteria for 
classification in schedule I of the CSA. It is an hallucinogenic 
substance with a high potential for abuse and no currently accepted 
medical use.\4\ See 21 U.S.C. 812(b)(1). Thus, for purposes of CSA 
scheduling, there is no basis for distinguishing natural THC from 
synthetic THC.
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    \4\ There are no FDA-approved drug products that consist solely 
of THC. However, as stated in the preceding footnote, the FDA has 
approved a drug product (Marinol[reg]), which contains synthetic THC 
with other ingredients in a specified product formulation.
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    Fourth, to ignore the foregoing considerations and to treat natural 
THC as a noncontrolled substance would provide a loophole in the law 
that might be exploited by drug traffickers. If natural THC were a 
noncontrolled substance, those portions of the cannabis plant that are 
excluded from the CSA definition of marijuana (the stalks and 
sterilized seeds of the plant) would be legal, noncontrolled 
substances--regardless of their THC content. As a result, it would be 
legal to import into the United States, and to possess, unlimited 
quantities of cannabis stalks and sterilized seeds--again, regardless 
of their THC content. Anyone could then obtain this raw cannabis plant 
material to produce an extract of THC--all without legal consequence. 
This would give drug traffickers an essentially limitless supply of raw 
plant material from which they could produce large quantities of a 
highly potent extract that would be considered a noncontrolled 
substance and, therefore, entirely beyond the reach of law enforcement. 
To provide such a safe harbor to drug traffickers would be plainly at 
odds with the purpose and structure of the CSA.\5\
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    \5\ As one United States Court of Appeals has stated, ``a 
reading of the [CSA] and its legislative history makes it apparent 
that Congress, in legislating against drug use, intended to 
encompass every act and activity which could lead to proliferation 
of drug traffic. Nothing in the statute indicates any congressional 
intent to limit the reach of this legislation, which is described in 
its title as `Comprehensive.' '' United States v. Everett, 700 F.2d 
900, 907 (3d Cir. 1983) (internal citations omitted).
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Does This Rule Change the Legal Status of ``Hemp'' Products?

    This rule does not change the legal status of so-called ``hemp'' 
products (products made from portions of the cannabis plant that are 
excluded from the CSA definition of marijuana).

[[Page 14115]]

Rather, this rule clarifies provisions of the law and regulations that 
have been in effect since 1971. For the reasons provided in the 
interpretive rule, it is DEA's view that the CSA and DEA regulations 
have always (since their enactment more than 30 years ago) declared any 
product that contains any amount of tetrahydrocannabinols to be a 
schedule I controlled substance. This interpretation holds regardless 
of whether the product in question is made from ``hemp'' or any other 
material.
    Nor does this rule add to, or subtract from, the exemptions issued 
by DEA in the October 9, 2001 interim rule. Every type of ``hemp'' 
product that was exempted from control under that interim rule will 
remain exempted following the finalization of this rule. Thus, given 
DEA's interpretation of current law (expressed in the interpretive 
rule), this rule does not change the legal status of any ``hemp'' 
product.

What Is the Difference Between This Final Rule and the Previously-
Issued Interpretive Rule?

    This final rule is a legislative rule. It is important to 
understand the difference between a legislative rule and an 
interpretive rule, such as the interpretive rule on THC that DEA issued 
on October 9, 2001. The following is a brief explanation of the 
difference between legislative rules and interpretive rules.
    Under the Administrative Procedure Act (APA), agencies may issue 
interpretive rules to advise the public of how the agency interprets a 
particular provision of a statute or regulation which the agency 
administers.\6\ By definition, interpretive rules are simply the 
agency's announcement of how it interprets existing law. Interpretive 
rules are not new laws and are not binding on the courts. Even though 
courts often defer to an agency's interpretive rule, they are always 
free to choose otherwise.
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    \6\ See Shalala v. Guernsey Memorial Hosp., 514 U.S. 87, 99 
(1995).
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    Legislative rules, on the other hand, have the full force of law 
and are binding on all persons, and on the courts, to the same extent 
as a congressional statute.\7\ Because of this crucial difference, the 
APA requires agencies to engage in notice-and-comment proceedings 
before a legislative rule takes effect.\8\ By the same reasoning, since 
interpretive rules do not have the full force of law and are not 
binding on the courts, the APA expressly allows agencies to issue 
interpretive rules without engaging in notice-and-comment. 5 U.S.C. 
553(b)(A), (d)(2).
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    \7\ National Latino Media Coalition v. F.C.C., 816 F.2d 785, 788 
(D.C. Cir. 1987).
    \8\ Syncor Int'l Corp. v. Shalala, 127 F.3d 90, 95 (D.C. Cir. 
1997) (``it is because the agency is engaged in lawmaking [when it 
issues a legislative rule] that the APA requires it to comply with 
notice and comment'').
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    Consistent with these APA principles, DEA published the 
interpretive rule in October 2001 without notice and comment, whereas 
the legislative rule that is being finalized in this document has gone 
through notice and comment. As a result, this final rule will have the 
full force of law and be binding on the courts--just as with all the 
other DEA regulations that have gone through notice and comment.\9\ In 
contrast, the interpretive rule was not binding on the courts. The 
practical effect of this distinction can be seen by considering the 
following hypothetical scenarios. If, prior to the publication of this 
final rule, a federal prosecution was commenced based solely on DEA's 
interpretive rule, the presiding court would have been free to choose 
between applying DEA's interpretation or its own interpretation of the 
law. But once this rule becomes final, if a person were to refuse to 
abide by the regulation and a federal prosecution were commenced, the 
court would be required to apply the new regulation.\10\
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    \9\ The DEA regulations are published in Title 21 of the Code of 
Federal Regulations, Part 1300.
    \10\ Legislative regulations are controlling on the courts 
unless they are ``arbitrary, capricious, or manifestly contrary to 
the statute.'' Chevron, U.S.A. v. Natural Resources Defense Council, 
467 U.S. 837, 844 (1984).
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Comments That DEA Received in Response to the Proposed Rule

    Following publication of the proposed rule, DEA received comments 
from thousands of individuals and groups. The comments were in the form 
of original letters, form letters, petitions, and a cookbook. Those who 
submitted comments included companies that manufacture and distribute 
various ``hemp'' products, associations that represent such 
manufacturers and distributors, domestic and Canadian government 
officials, and individuals. These commenters expressed criticisms on a 
variety of issues. In accordance with the APA, DEA carefully considered 
all of the comments it received.
    Most of the comments that DEA received relate to both the proposed 
rule (DEA 205; 66 FR 51535) and the interim rule (DEA 206; 66 FR 
51539), which were published together (along with the interpretive 
rule) in the October 9, 2001 Federal Register. Those comments that 
pertain primarily to DEA 205 are addressed in this final rule. Those 
comments that pertain primarily to DEA 206 are addressed in the final 
DEA 206 rule, which appears in a separate Federal Register document 
that immediately follows this document. Both DEA 205 and DEA 206 
contain a summary of the pertinent comments, along with an explanation 
of how DEA considered them in deciding to finalize the rules.
    The number of individuals and groups that participated in the 
comment process far exceeded the number of different issues raised. 
Many of the comments were similar to one another, partly because many 
persons submitted form letters or signed petitions written by groups 
which themselves submitted lengthy comments. In this document, together 
with the final rule finalizing the DEA 206 interim rule, DEA has 
addressed the major issues raised by the commenters. Some of these 
issues have already been addressed in the text that precedes this 
section. The remaining issues are addressed below and in the DEA 206 
final rule.

Comments Expressing Legal Disagreement With the Proposed Rule

    Many commenters disagreed with DEA's legal interpretation of those 
provisions of the CSA and DEA regulations that are relevant to the 
proposed rule. Specifically, these commenters disagreed with DEA's view 
that, under the plain language of the CSA, ``any material, compound, 
mixture, or preparation, which contains any quantity of * * * 
Tetrahydrocannabinols (THC)'' is a schedule I controlled substance. 21 
U.S.C. 812(c), schedule I(c)(17); 21 CFR 1308.11(d)(27). These 
commenters asserted that THC content is irrelevant when it comes to 
products made from portions of the cannabis plant that are excluded 
from the definition of marijuana. According to these commenters, DEA 
should allow the CSA definition of marijuana to dictate which portions 
of the cannabis plant are controlled substances. DEA addressed this 
issue in detail in the legal analysis contained in the interpretive 
rule. Nonetheless, many commenters asserted that their point of view is 
the correct reading of the law and should be substituted for that of 
DEA. DEA reexamined this issue in view of the comments. While 
recognizing that many proponents of ``hemp'' products are steadfast in 
their view that natural THC content is irrelevant in deciding what is a 
controlled substance, DEA continues to believe that its interpretation 
follows directly from the plain language of the

[[Page 14116]]

CSA and the DEA regulations and is consistent with the legislative 
history of the statute and regulations. Moreover, DEA believes that the 
analysis contained in the interpretive rule refutes all of the contrary 
legal arguments expressed in the comments. As the agency responsible 
for administering the CSA, it is DEA's obligation to ensure that the 
regulations clearly reflect what the agency believes are the purpose 
and intent of the Act.

Comments as to Whether This Rule Constitutes a Rescheduling Action

    Some commenters expressed the view that this rule is a rescheduling 
action within the meaning of 21 U.S.C. 811 and that DEA should have 
gone through the procedures set forth in that section prior to issuing 
this rule.\11\ These comments appear to be based on a misunderstanding 
of the nature of the procedures under section 811. By its express 
terms, section 811 applies only where DEA seeks to add a substance to a 
schedule or remove one from a schedule. For example, if DEA were 
seeking to move a controlled substance from schedule II to schedule 
III, the agency would be required to follow the procedures set forth in 
section 811. The final rule being published today, however, does not 
change the schedule of THC or any other controlled substance. To the 
contrary, when this final rule becomes effective, on April 21, 2003, 
THC will remain in the same schedule in which it has been since the 
enactment of the CSA in 1970: Schedule I.
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    \11\ Under 21 U.S.C. 811, to change the schedule of a controlled 
substance, DEA must first request from the Secretary of Health and 
Human Services a scientific and medical evaluation and scheduling 
recommendation and follow additional procedures set forth in section 
811. However, as discussed above, section 811 is inapplicable where, 
as in this final rule, DEA is not changing the schedule of a 
controlled substance.
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    Nor would engaging in the rescheduling procedures set forth in 
section 811 be consistent with the purpose of this rule. Section 811 
sets forth the procedures to determine whether a particular substance 
meets the criteria for placement in a particular schedule. The purpose 
of this rule is not to determine whether THC meets the criteria for 
classification in schedule I; rather, this rule serves to clarify that 
the longstanding placement of THC in schedule I includes both natural 
and synthetic THC. There is no question about whether THC meets the 
criteria for placement in schedule I.\12\ Even those commenters who 
suggested that this rule should be issued under section 811 do not 
dispute that all THC (natural or synthetic) meets the criteria for 
placement in schedule I. As discussed above, the chemical THC has the 
identical physical and chemical properties, and produces the same 
psychoactive effects, regardless of whether it is natural or synthetic. 
For these reasons, section 811 is inapplicable to this rule.
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    \12\ The criteria for placement in schedule I are: ``no 
currently accepted medical use in treatment in the United States,'' 
``a lack of accepted safety for use * * * under medical 
supervision,'' and ``a high potential for abuse.'' 21 U.S.C. 
812(b)(1).
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Comments Regarding Poppy Seeds

    Some of the commenters asserted that DEA should not take literally 
the plain language of the CSA: that ``any material, compound, mixture, 
or preparation, which contains any quantity of * * * 
Tetrahydrocannabinols [THC]'' is a schedule I controlled substance. To 
read this provision literally, some commenters said, would mean that 
poppy seeds must be considered controlled substances if they contain 
trace amounts of opiates (such as morphine, codeine, or thebaine). This 
concern is unfounded because, under the CSA and DEA regulations, 
substances that contain opiates are controlled differently than 
substances that contain schedule I hallucinogens (such as THC). It is 
true that poppy seeds are excluded from the definition of opium poppy 
(21 U.S.C. 802(19)) just as sterilized cannabis seeds are excluded from 
the definition of marijuana. However, while it is the case that ``any 
material, compound, mixture, or preparation, which contains any 
quantity of'' an hallucinogenic controlled substance is a controlled 
substance (21 U.S.C. 812(c), schedule I (c); 21 CFR 1308.11(d)), it is 
not the case that any material, compound, mixture, or preparation which 
contains any quantity of an opiate is a controlled substance. Rather, 
naturally-occurring opiates found in substances of vegetable origin are 
subject to control under the CSA only if they are extracted from the 
substances of vegetable origin. 21 U.S.C. 812(c), schedule II(a); 21 
CFR 1308.12(b)).\13\
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    \13\ Plant materials that are the source of narcotics, such as 
opium poppy, poppy straw, and opium, are specifically listed in 
schedule II. However, as stated above, the listing of opium poppy 
does not include poppy seeds, since the seeds are excluded from the 
definition of opium poppy.
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Comments Regarding the Single Convention on Narcotic Drugs

    Several commenters asserted that the proposed rule is impermissible 
in view of a certain provision of the Single Convention on Narcotic 
Drugs, 1961 (``Single Convention''). The Single Convention, which the 
United States ratified in 1967, was designed to establish effective 
control over international and domestic traffic in controlled 
substances, and parties to the Convention are required to implement 
certain minimum measures. Article 28 of the Single Convention imposes 
on parties certain restrictions on the cultivation of the cannabis 
plant. However, paragraph 2 of Article 28 states that the Single 
Convention does not apply ``to the cultivation of the cannabis plant 
exclusively for industrial purposes (fibre [sic] and seed) or 
horticultural purposes.'' Several commenters asserted that this 
provision means that the United States is prohibited from imposing any 
restrictions on ``hemp.'' This assertion is incorrect.
    The Single Convention sets minimum standards of drug control 
measures that the parties must apply--not maximum measures. Parties are 
free to impose whatever additional measures they believe are necessary 
to prevent the misuse, and illicit traffic in, controlled substances. 
Indeed, various provisions of the CSA go beyond the minimum measures 
required by the Single Convention. Congress's decision under the CSA to 
control anything that contains ``any quantity'' of THC is the decisive 
factor for purposes of this rule, regardless of whether a less 
restrictive rule would be permissible under the Single Convention.\14\
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    \14\ To fully address the distinctions between the control of 
cannabis under the Single Convention and the control of marijuana 
and THC under CSA would require a lengthy discussion. Such a 
discussion is unnecessary here because this rule is based on how THC 
is controlled under the CSA. Thus, there is no need to address here 
whether the reference in the Single Convention (Article 28, 
paragraph 2) to cannabis grown for ``industrial'' or 
``horticultural'' purposes includes cannabis grown to make foods or 
beverages, or whether such reference is limited to non-human-
consumption items such as rope, paper, textiles, industrial 
solvents, and birdseed.
    A full analysis of the international drug control treaties would 
also require discussion of the Convention on Psychotropic 
Substances, 1971 (Psychotropic Convention). THC is a substance 
listed in the schedules of the Psychotropic Convention. Accordingly, 
the United States, as a party to the Psychotropic Convention, has 
certain obligations thereunder with respect to the control of THC. 
However, it is unnecessary to examine the scope of those obligations 
in this document because Congress stated expressly in United States 
domestic law that anything that contains ``any quantity'' of THC is 
a schedule I controlled substance, unless listed in another schedule 
or expressly exempted. Adherence to this rule and the corresponding 
provisions of the CSA ensures that the United States meets its 
obligations under the Psychotropic Convention with respect to THC.

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[[Page 14117]]

Comments Regarding Trade Agreements

    Some commenters expressed the view that the proposed rule violates 
certain obligations of the North American Free Trade Agreement (NAFTA) 
and the World Trade Organization (WTO) agreements. Many of these same 
commenters expressed these assertions to DEA before the proposed rule 
was published in October 2001. As a result, both before and after 
publication of the proposed rule, DEA sought the input of the 
Department of State and other components of the Executive Branch with 
the relevant expertise and responsibility for such matters and 
concluded that the proposed rule--which simply clarifies longstanding 
federal law with respect to schedule I hallucinogenic controlled 
substances--does not violate NAFTA or the WTO agreements.
    One of the bases for these treaty claims asserted by commenters is 
the contention that the proposed rule provides more favorable treatment 
to United States and foreign, non-Canadian investors and their 
investments than to Canadian ``hemp'' investors and their investments 
in the United States. In reality, the rule applies to and treats all 
``hemp'' industry investors and their investments the same--i.e., 
regardless of nationality of ownership. No company (whether Canadian-
owned, foreign but non-Canadian-owned, or United States-owned) can 
manufacture, distribute or market products used, or intended for use, 
for human consumption that contain any amount of THC. DEA has made no 
exception to this rule for any United States company or any foreign 
company.

Comments Requesting an Extension of the Comment Period

    Some commenters asked DEA to extend the comment period. DEA did not 
do so for the following reasons. In the notice of the proposed rule, 
DEA provided a 60-day comment period from the date of the publication 
in the Federal Register, which allowed ample time for any interested 
persons to express their opinions.
    DEA considered all comments that were postmarked within the comment 
period, even where the agency did not receive the comments until 
several months after the comment period closed.\15\ It is evident from 
the number and variety of comments that were submitted, and the 
detailed nature of such comments, that a wide range of viewpoints was 
expressed to the agency during the comment period. Nearly all of the 
types of comments that were submitted during the comment period were 
repeated many times over by a number of commenters, which further 
indicates that interested parties have had sufficient opportunity to 
express their comments.
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    \15\ At the time the comment period closed, postal deliveries to 
DEA and other agencies were delayed after the widely-reported 
incidents of anthrax being sent through the mail. Because of this, 
although the proposed rule indicated that DEA would only consider 
comments received on or before December 10, 2001, the agency 
considered all comments postmarked by that date, even if they 
arrived late.
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    DEA provided the public with advance notice of the rules. In the 
year preceding the October 9, 2001 publication of the rules, DEA 
announced twice in the Federal Register that the agency would be 
issuing the proposed rule, along with the interpretive rule and the 
interim rule, and described the nature of the rules. See Department of 
Justice Unified Agenda, 66 FR 25624 (May 14, 2001), 65 FR 74024 
(November 30, 2000). It is evident from the comments submitted on the 
proposed rule that the advance notice gave interested persons ample 
time to assemble and articulate their thoughts and opinions. Some of 
those persons who requested an extension of the comment period 
themselves submitted lengthy comments, indicating that they have 
already fully expressed their views. In light of these considerations, 
extending the comment period was unnecessary.

Comments Regarding Economic Impact of the Proposed Rule

    Many commenters expressed concern about how the proposed rule might 
impact economically various businesses that deal in ``hemp'' products. 
These economic considerations are addressed in the next section of this 
document (regulatory certifications).

Regulatory Certifications

    Certain provisions of Federal law and executive orders (specified 
below) require agencies to assess how their rules might impact the 
economy, small businesses, and the states. (Hereafter in this document, 
these provisions will be referred to collectively as the 
``certification provisions.'') DEA has conducted these certifications. 
However, before discussing the economics, the nature of this rule 
should be reiterated. This rule revises the wording of the DEA 
regulations to clarify for the public the agency's understanding of 
longstanding federal law. In other words, through this rule, DEA is 
implementing what it believes to be the mandate of Congress under the 
CSA. (This mandate is that every substance containing THC be listed in 
schedule I, unless the substance is specifically exempted from control 
or listed in another schedule.) Regardless of how this rule might 
impact the economy, small businesses, or the states, DEA must carry out 
the mandate.
    It is also critical to bear in mind that only a very narrow 
category of ``hemp'' products will be prohibited under the rules that 
DEA is publishing today. As a result of the exemptions issued by DEA 
under the interim rule, all ``hemp'' products that do not cause THC to 
enter the human body are entirely exempted from control, regardless of 
their THC content. Thus, items such as ``hemp'' clothing, industrial 
solvents, personal care products, and animal feed mixtures are 
considered noncontrolled substances (not subject to any of the CSA 
requirements) regardless of their THC content. This rule therefore 
causes no economic impact whatsoever on such exempted products.
    It also must be considered that when Congress enacted the CSA, it 
created a system of controls that was comprehensive in scope to protect 
the general welfare of the American people within the context of the 
Act.\16\ Incidental restrictions on economic activity resulting from 
enforcement of the CSA have never been viewed as a proper basis to 
cease such enforcement. The certification provisions are no exception 
to this principle.
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    \16\ See 21 U.S.C. 801(2).
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    Moreover, one of the chief aims of the certification provisions is 
to ensure that agencies consider the potential economic ramifications 
of imposing new regulations. This rule, however, does not create any 
new category of regulation governing the handling of controlled 
substances. Rather, the rule merely helps to clarify what products are, 
or are not, subject to what DEA believes are preexisting CSA 
requirements.
    DEA recognizes, however, that some members of the public disagree 
with DEA's interpretation of the law with respect to THC. As a result, 
some companies may be continuing to market in the United States 
``hemp'' food and beverage products that contain THC. Accordingly, for 
purposes of calculating the economic impact of these rules, DEA has 
assumed THC-containing ``hemp'' foods and beverages are lawful products 
until this rule becomes final.
    In the regulatory certifications that accompanied the proposed 
rule, DEA explained in detail its analysis of the economic activity 
relating to ``hemp'' food and beverage products (referred to therein 
and hereafter in this document as ``edible `hemp' products''). 66 FR at 
51536-51537. In that analysis, using

[[Page 14118]]

conservative assumptions (erring on the side of inclusiveness), DEA 
estimated that the total sales of edible ``hemp'' products in the 
United States is no more than $20 million per year with no more than 
500 persons employed in connection with these products. In the 
publication of the proposed rule, DEA urged any manufacture or 
distributor of ``hemp'' products to submit during the comment period 
any data on this economic activity that might warrant adjustments to 
these estimates. The comments that DEA received suggest that the agency 
might have overestimated the amount of economic activity tied to edible 
``hemp'' products. The highest estimate submitted by representatives of 
businesses that produce and distribute edible ``hemp'' products was 
that the total sales of such products in the United States is 
approximately $6 million.
    It also must be noted that not every such edible product marketed 
as a ``hemp'' product is necessarily prohibited under the rule being 
finalized today. As DEA stated repeatedly in the text accompanying the 
proposed rule and the interim rule, if a product says ``hemp'' on the 
label but contains no THC (or any other controlled substance), it is 
not a controlled substance and, therefore, not affected by this rule. 
At least one ``hemp'' food company claims that its products are THC-
free.\17\ If this is correct, such products are not controlled 
substances and not prohibited by the CSA. Thus, even if the edible 
``hemp'' products business is a $6 million industry in the United 
States, some of that business might be able to continue under this 
final rule.
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    \17\ On January 28, 2002, a company that sells ``hemp'' food 
products issued the following statement on its website (http://www.thehempnut.com): It is the position of HempNut, Inc. and the 
Hemp Food Association (HFA) that this Rule [published by DEA on 
October 9, 2001] is merely a clarification and confirmation of the 
basis under which DEA, US Customs, and all responsible hempseed 
importers have already been operating under for quite some time, 
namely, that hempseed products may not contain tetrahydrocannabinol 
(THC). A survey of hempseed importers revealed that all were in full 
compliance with the Rule, and have no THC in their products.
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    The one other category of products that might be impacted 
economically by this rule is that in which pure cannabis seeds are sold 
as birdseed. (As set forth in the interim rule, which is being 
finalized today, DEA is exempting animal feed mixtures containing 
sterilized cannabis seeds with other ingredients, but not pure 
sterilized cannabis seeds.) In the regulatory certifications attached 
to the proposed rule, DEA estimated that no more than $77,000 worth of 
birdseed that contains cannabis seeds is imported into the United 
States for sale in this country. It appears likely that most of this 
birdseed is sold in a mixture that is exempted under the interim rule. 
Accordingly, the total amount of pure ``hempseeds'' sold as birdseed in 
this country is probably much less than $77,000.

Regulatory Flexibility Act

    For the reasons provided above, the Acting Administrator hereby 
certifies that this rule will not have a significant impact on a 
substantial number of small entities within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 605(b)). The economic activity 
that would be disallowed under this rule is already illegal under DEA's 
interpretation of existing law. Even if one were to assume that such 
economic activity were legal under current law, the prohibition on such 
activity resulting from this rule (summarized above) would not 
constitute significant impact on a substantial number of small entities 
within the meaning of the Regulatory Flexibility Act. Therefore, a 
final regulatory flexibility analysis is not required for this rule.

Executive Order 12866

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

Executive Order 13132

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

Executive Order 12988--Civil Justice Reform

    This rule meets the applicable standards set forth in sections 3(a) 
and 3(b)(2) of Executive Order 12988.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year. Therefore, no actions are 
necessary under the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    For the reasons provided above, this rule is not likely to result 
in any of the following: An annual effect on the economy of 
$100,000,000 or more; a major increase in costs or prices for 
consumers, individual industries, federal, state, or local government 
agencies, or geographic regions; or significant adverse effects on 
competition, employment, investment, productivity, innovation, or on 
the ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets. The economic activity 
disallowed under this rule is already illegal under DEA's 
interpretation of existing law. Even if one were to assume that such 
economic activity were legal under current law, the prohibition on such 
activity resulting from this rule would not render the rule a major 
rule under the Small Business Regulatory Enforcement Fairness Act of 
1996 (SBREFA), 5 U.S.C. 804. Therefore, the provisions of SBREFA 
relating to major rules are inapplicable to this rule. However, a copy 
of this rule has been sent to the Office of Advocacy, Small Business 
Administration. Further, a copy of this final rule will be submitted to 
each House of the Congress and to the Comptroller General in accordance 
with SBREFA (5 U.S.C. 801).

Paperwork Reduction Act of 1995

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

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Narcotics, Prescription drugs.

Final Rule

    Pursuant to the authority vested in the Attorney General under 
sections 201, 202, and 501(b) of the CSA (21 U.S.C. 811, 812, and 
871(b)), delegated to the Administrator and Deputy Administrator 
pursuant to section 501(a) (21 U.S.C. 871(a)) and as specified in 28 
CFR 0.100 and 0.104, appendix to subpart R, sec. 12, the Acting 
Administrator hereby orders that Title 21 of the Code of Federal 
Regulations, part 1308, be amended as follows:

PART 1308--[AMENDED]

    1. The authority citation for part 1308 continues to read as 
follows:


[[Page 14119]]


    Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.

    2. Section 1308.11(d)(27) is revised to read as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (d) * * *
(27) Tetrahydrocannabinols--7370
    Meaning tetrahydrocannabinols naturally contained in a plant of the 
genus Cannabis (cannabis plant), as well as synthetic equivalents of 
the substances contained in the cannabis plant, or in the resinous 
extractives of such plant, and/or synthetic substances, derivatives, 
and their isomers with similar chemical structure and pharmacological 
activity to those substances contained in the plant, 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.)
* * * * *

    Dated: March 18, 2003.
John B. Brown III,
Acting Administrator.
[FR Doc. 03-6804 Filed 3-20-03; 8:45 am]
BILLING CODE 4410-09-P