[Federal Register Volume 68, Number 55 (Friday, March 21, 2003)]
[Rules and Regulations]
[Pages 14119-14126]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6805]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[DEA-206F]
RIN 1117-AA55
Exemption From Control of Certain Industrial Products and
Materials Derived From the Cannabis Plant
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Final rule.
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SUMMARY: The Drug Enforcement Administration (DEA) is adopting as final
an interim rule exempting from control (i.e., exempting from all
provisions of the Controlled Substances Act (CSA)) certain items
derived from the cannabis plant and containing tetrahydrocannabinols
(THC). Specifically, the interim rule exempted THC-containing
industrial products, processed plant materials used to make such
products, and animal feed mixtures, provided they are not used, or
intended for use, for human consumption (and therefore cannot cause THC
to enter the human body).
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, D.C. 20537; Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
What Does This Rule Accomplish and by What Authority Is It Being
Issued?
This final rule revises the DEA regulations to add a provision
exempting from CSA control certain THC-containing industrial products,
processed plant materials used to make such products, and animal feed
mixtures, provided such products, materials, and feed mixtures are made
from those portions of the cannabis plant that are excluded from the
definition of marijuana and are not used, or intended for use, for
human consumption. Among the types of industrial products that are
exempted as a result of this final rule are: (i) Paper, rope, and
clothing made from cannabis stalks; (ii) processed cannabis plant
materials used for industrial purposes, such as fiber retted from
cannabis stalks for use in manufacturing textiles or rope; (iii) animal
feed mixtures that contain sterilized cannabis seeds and other
ingredients (not derived from the cannabis plant) in a formulation
designed, marketed, and distributed for animal (nonhuman) consumption;
and (iv) personal care products that contain oil from sterilized
cannabis seeds, such as shampoos, soaps, and body lotions (provided
that using such personal care products does not cause THC to enter the
human body).
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. In addition, the Attorney General is
authorized to exempt, by regulation, any compound, mixture, or
preparation containing any controlled substance from the application of
all or any part of the CSA if he finds such compound, mixture, or
preparation meets the requirements of section 811(g)(3). 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 DEA Exempting From Control Certain THC-Containing Substances Not
Intended for Human Consumption?
Without the exemptions made by the interim rule, which are adopted
as final in this rule, a wide variety of legitimate industrial products
derived from portions of the cannabis plant would be considered
schedule I controlled substances. For example, paper, rope, and
clothing (made using fiber from cannabis stalks) and industrial
solvents, lubricants, and bird seed mixtures (made using sterilized
cannabis seeds or oil from such seeds) would, in the absence of the
interim rule, be considered schedule I controlled substances if they
contained THC. If such products were considered schedule I controlled
substances, their use would be severely restricted.\1\ Under the
interim rule, however, which DEA is adopting as final here, DEA
exempted such legitimate industrial products from control, provided
they are not used, or intended for use, for human consumption. As
explained below, DEA believes this approach protects the public welfare
within the meaning of the CSA while striking a fair balance between the
plain language of the Act and the intent of Congress under prior
marijuana legislation.
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\1\ The CSA and DEA regulations permit industrial use of
schedule I controlled substances, but only under strictly regulated
conditions.
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THC is an hallucinogenic substance with a high potential for abuse.
Congress recognized this fact by placing it in schedule I of the CSA.
Because of this, there are only two ways that THC may lawfully enter a
person's body: (1) If the THC is contained in a drug product that has
been approved by the Food and Drug Administration (FDA) as being safe
and effective for human use; \2\
[[Page 14120]]
or (2) if an experimental drug containing THC is provided to a research
subject in clinical research that has been approved by FDA and
conducted by a researcher registered with DEA.\3\ Disallowing human
consumption of schedule I controlled substances except in the foregoing
limited circumstances is an absolute necessity to conform with the CSA
and protect the public welfare within the meaning of the Act.\4\
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\2\ 21 U.S.C. 331, 355, 811(b), 812(b). At present, Marinol[reg]
is the only THC-containing drug product that has been approved for
marketing by FDA. Marinol[reg] is the brand name of a product
containing synthetic dronabinol (a form of THC) in sesame oil and
encapsulated in soft gelatin capsules that 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. Because Marinol[reg] is the only THC-containing
drug approved by FDA, it is the only THC-containing substance listed
in a schedule other than schedule I. DEA recently transferred
Marinol[reg] from schedule II to schedule III, thereby lessening the
CSA regulatory requirements governing its use as medicine. See 64 FR
35928 (1999).
\3\ 21 U.S.C. 823(f); 21 CFR 5.10(a)(9), 1301.18, 1301.32.
\4\ In enacting the CSA, Congress stated: ``The illegal
importation, manufacture, distribution, and possession and improper
use of controlled substances have a substantial and detrimental
effect on the health and general welfare of the American people.''
21 U.S.C. 801(2).
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Where, however, a schedule I controlled substance is contained in a
product not used for human consumption, the CSA provides DEA with
discretionary authority to issue regulations exempting such product
from control.\5\ DEA has carefully considered whether it is appropriate
to exercise this discretionary authority when it comes to industrial
``hemp'' products (i.e., products made from portions of the cannabis
plant excluded from the CSA definition of marijuana). The text of the
CSA and its legislative history make no mention of industrial uses of
the cannabis plant. However, DEA has taken into account that, under
prior legislation (the Marihuana Tax Act of 1937), Congress intended to
permit the use of certain cannabis-derived industrial products. The
Senate Report accompanying the 1937 Act stated:
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\5\ See 21 U.S.C. 811(g)(3); see also 21 U.S.C. 871(b)
(providing discretionary authority to DEA Administrator to
``promulgate and enforce any rules, regulations, and procedures
which he may deem necessary and appropriate for the efficient
execution of his functions under [the CSA].'').
The [cannabis] plant * * * has many industrial uses. From the
mature stalks, fiber is produced which in turn is manufactured into
twine, and other fiber products. From the seeds, oil is extracted
which is used in the manufacture of such products as paint, varnish,
linoleum, and soap. From hempseed cake, the residue of the seed
after the oil has been extracted, cattle feed and fertilizer are
manufactured. In addition, the seed is used as a special feed for
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pigeons.
S. Rep. No. 900, 75th Cong., 1st Sess., at 2-3 (1937). DEA
recognizes that the intent of Congress in 1937 to allow the foregoing
industrial ``hemp'' products is no longer controlling because the CSA
(enacted in 1970) repealed and superseded the 1937 Marihuana Tax Act.
DEA further recognizes that the allowance that Congress made for such
products under the now-rescinded Marihuana Tax Act was based on a 1937
assumption (now refuted) that such products contained none of the
psychoactive drug now known as THC. (In contrast, when Congress enacted
the CSA in 1970, it expressly declared that anything containing THC is
a schedule I controlled substance.) \6\ Still, for the reasons provided
below, DEA believes it is an appropriate exercise of the
Administrator's discretionary authority under the CSA to issue an
exemption allowing the legitimate industrial uses of ``hemp'' that were
allowed under the 1937 Act. At the same time, DEA has been careful to
ensure that this exemption comports with the CSA by maintaining the
rule that no humans may lawfully take THC into their bodies except when
they are (i) using an FDA-approved drug product or (ii) the subjects of
FDA-authorized research.
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\6\ A detailed comparison of the 1937 Marihuana Tax Act and the
CSA is provided in the October 9, 2001 interpretive rule. 66 FR at
51530-51531.
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DEA may not arbitrarily exempt a controlled substance from
application of the CSA. Rather, such an exemption must be based on a
provision of the CSA. As cited above, the exemption of certain ``hemp''
products under this final rule is issued pursuant to two CSA
provisions: 21 U.S.C. 811(g)(3)(B) and 871(b).
Pursuant to 811(g)(3)(B), the Administrator of DEA may exempt from
control ``[a] compound, mixture, or preparation which contains any
controlled substance, which is not for administration to a human being
or animal, and which is packaged in such form or concentration, or with
adulterants or denaturants, so that as packaged it does not present any
significant potential for abuse.'' This provision, which was added to
the CSA in 1984, was aimed primarily at analytic standards and
preparations which are not for use in humans and pose no significant
abuse threat by nature of their formulation. It bears emphasis,
however, that Congress did not mandate that DEA exempt from control all
mixtures and preparations that DEA determines meet the criteria of
section 811(g)(3)(B). Rather, as the word ``may'' in the first line of
section 811(g)(3) indicates, Congress gave DEA discretionary authority
to issue such exemptions.
The DEA regulation that implements section 811(g)(3)(B) is 21 CFR
1308.23. Section 1308.23(a) provides that the Administrator may exempt
from control a chemical preparation or mixture containing a controlled
substance that is ``intended for laboratory, industrial, educational,
or special research purposes and not for general administration to a
human being or other animal'' if it is packaged in such a form or
concentration, or with adulterants or denaturants, so that the presence
of the controlled substance does not present any significant potential
for abuse.
DEA believes that industrial ``hemp'' products such as paper,
clothing, and rope, when used for legitimate industrial purposes (not
for human consumption) meet the criteria of section 811(g)(3)(B) and
Sec. 1308.23. Legitimate use of such products cannot result in THC
entering the human body. Moreover, allowing these products to be
exempted from CSA control in no way hinders the efficient enforcement
of the CSA. Accordingly, DEA believes that these types of industrial
products should be exempted from application of the CSA, provided they
are not used, or intended for use, for human consumption. For the same
reasons, processed cannabis plant materials that cannot readily be
converted into any form that can be used for human consumption, and
which are used in the production of such legitimate industrial
products, are being exempted from control under this final rule.
The use of sterilized cannabis seeds \7\ that contain THC in animal
feed fails to meet the criteria of section 811(g)(3)(B) and section
1308.23 because this involves the use of a controlled substance (THC)
in animals.\8\ Nonetheless, pursuant to 21 U.S.C. 871(b), DEA believes
it is appropriate to exempt from application of the CSA animal feed
mixtures containing such seeds, provided the seeds are mixed with other
ingredients that are not derived from the cannabis plant in a
formulation designed, marketed and distributed for animal consumption
(not for use in humans). 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. It should be underscored that section
871(b) is not a catchall provision that can be used to justify any
exemption. For the following
[[Page 14121]]
reasons, however, DEA believes that the use of sterilized cannabis
seeds in animal feed mixtures is a unique situation that warrants an
exemption pursuant to section 871(b).
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\7\ Unless otherwise indicated, all references in this document
to ``cannabis seeds'' or `` `hemp' seeds'' refer to sterilized seeds
(incapable of germination). In contrast to sterilized cannabis
seeds, unsterilized cannabis seeds fit within the CSA definition of
marijuana and are not exempted from control under this interim rule.
\8\ If, however, the ``hemp'' seeds used in animal feed are
sterilized cannabis seeds that contain no THC, such seeds are not a
controlled substance. Under such circumstances, there is no need to
exempt such seeds from control.
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As stated above and in the interpretive rule, the legislative
history of the 1937 Marihuana Tax Act reveals that Congress expressly
contemplated allowing ``hemp'' animal feed. The 1937 Congress
categorized such use of ``hemp'' as a legitimate ``industrial'' use. It
is true that the intent of the 1937 Congress is no longer controlling
since the CSA repealed the 1937 Act and declared anything containing
THC to be a schedule I controlled substance. However, because neither
the text nor the legislative history of the CSA addresses the legality
of using sterilized cannabis seeds in animal feed, or the possibility
that such seeds might contain THC, what was viewed under the 1937 Act
as ``legitimate industrial use'' of such seeds in animal feed continued
uninterrupted following the enactment of the CSA in 1970.
The historical lack of federal regulation of some THC-containing
products (whether based on differences between prior law and the CSA,
lack of awareness of the THC content of such product, or other
considerations) does not--by itself--justify exempting such product
from control under the CSA. DEA remains obligated to apply the
provisions of the CSA to all controlled substances absent a statutory
basis to exempt a particular substance from control. However, with
respect to animal feed mixtures containing sterilized cannabis seeds,
additional factors (combined with Congress' express desire under prior
legislation to allow such products) justify an exemption pursuant to
section 871(b). The presence of a controlled substance in animal feed
poses less potential for abuse than in a product intended for human use
and does not entail the administration of THC to humans. Moreover, when
sterilized cannabis seeds are mixed with other animal feed ingredients
and not designed, marketed, or distributed for human use, there is
minimal risk that they will be converted into a product used for human
consumption. Therefore, such legitimate use in animal feed mixtures
poses no significant danger to the public welfare. Accordingly, given
the unique circumstances and history surrounding the use of sterilized
cannabis seeds in animal feed, DEA believes that it comports with the
CSA to continue to treat such activity as a legitimate industrial use--
not subject to CSA control--provided the foregoing conditions are met.
How Is ``Human Consumption'' Defined Under This Rule?
Under this final rule, a material, compound, mixture, or
preparation containing THC will be considered ``used for human
consumption'' (and therefore not exempted from control) if it is: (i)
Ingested orally or (ii) applied by any means such that THC enters the
human body. A material, compound, mixture, or preparation containing
THC will be considered ``intended for use for human consumption'' and,
therefore, not exempted from control if it is: (i) Designed by the
manufacturer for human consumption; (ii) marketed for human
consumption; or (iii) distributed, exported, or imported with the
intent that it be used for human consumption.
In any legal proceeding arising under the CSA, the burden of going
forward with the evidence that a material, compound, mixture, or
preparation containing THC is exempt from control pursuant to this rule
shall be upon the person claiming such exemption. 21 U.S.C. 885(a)(1).
In order to meet this burden with respect to a product or processed
plant material that has not been expressly exempted from control by the
Administrator pursuant to 21 CFR 1308.23 (as explained below under the
heading ``What Is the Control Status of Personal Care Products Made
from 'Hemp'?''), the person claiming the exemption must present
rigorous scientific evidence, including well-documented scientific
studies by experts trained and qualified to evaluate the effects of
drugs on humans.
How Are ``Processed Plant Material'' and ``Animal Feed Mixture''
Defined Under This Rule?
Under this final rule, any portion of the cannabis plant excluded
from the CSA definition of marijuana will be considered ``processed
plant material'' if it has been subject to industrial processes, or
mixed with other ingredients, such that it cannot readily be converted
into any form that can be used for human consumption. For example,
fiber that has been separated from the mature stalks by retting for use
in textiles is considered processed plant material, which is exempted
from control, provided it is not used, or intended for use, for human
consumption. In comparison, mature stalks that have merely been cut
down and collected do not fit within the definition of ``processed
plant material'' and, therefore, are not exempted from control. As
another example, if a shampoo contains oil derived from sterilized
cannabis seeds, one would expect that, as part of the production of the
shampoo, the oil was subject to industrial processes and mixed with
other ingredients such that, even if some THC remains in the finished
product, the shampoo cannot readily be converted into a product that
can be consumed by humans. Under such circumstances, the product is
exempted from control under this final rule. In comparison, a personal
care product that consists solely of oil derived from cannabis seeds
does not meet the definition of ``processed plant material'' under this
final rule and, therefore, is not exempted from control.
``Animal feed mixture'' is defined under this final rule to mean
sterilized cannabis seeds mixed with other ingredients in a formulation
that is designed, marketed, and distributed for animal consumption (and
not for human consumption). For example, sterilized cannabis seeds
mixed with seeds from other plants and for sale in pet stores fit
within the definition of ``animal feed mixture'' and are exempted from
control under this final rule provided the feed mixture is not used, or
intended for use, for human consumption. (In contrast, a container of
pure sterilized cannabis seeds--mixed with no other ingredients--does
not meet the definition of ``animal feed mixture'' under this final
rule and, therefore, is not exempted from control.)
Which ``Hemp'' Products Are Exempted From Control Under This Rule?
It is impossible to list every potential product that might be made
from portions of the cannabis plant excluded from the definition of
marijuana. Therefore, DEA cannot provide an exhaustive list of ``hemp''
products that are exempted from control under this final rule.
Nonetheless, in order to provide some guidance to the public, the
following are some of the more common ``hemp'' products that are
exempted (noncontrolled) under this final rule, provided they are not
used, or intended for use, for human consumption: paper, rope, and
clothing made from fiber derived from cannabis stalks, industrial
solvents made with oil from cannabis seeds, and bird seed containing
sterilized cannabis seed mixed with seeds from other plants (or other
ingredients not derived from the cannabis plant). Personal care
products (such as lotions and shampoos) made with oil from cannabis
seeds are also generally exempted, as explained below.
Which ``Hemp'' Products Are Not Exempted From Control Under This Rule?
Other than those substances that fit within the exemption being
issued in
[[Page 14122]]
this final rule, all other portions of the cannabis plant, and products
made therefrom, that contain any amount of THC are schedule I
controlled substances.
Again, because one cannot list every conceivable ``hemp'' product,
it is impossible to examine here every ``hemp'' product for a
determination of whether such product is used, or intended for use, for
human consumption within the meaning of this final rule. Therefore,
this document contains no exhaustive list of ``hemp'' products that are
not exempted from control under this final rule. Nonetheless, to
provide some guidance, the following are some of the ``hemp'' products
that are not exempted from control under this final rule (and therefore
remain controlled substances) if they contain THC: any food or beverage
(such as pasta, tortilla chips, candy bars, nutritional bars, salad
dressings, sauces, cheese, ice cream, and beer) or dietary supplement.
What Is the Control Status of Personal Care Products Made From
``Hemp''?
DEA has not conducted chemical analyses of all of the many and
varied personal care products that are marketed in the United States,
such as lotions, moisturizers, soaps, or shampoos that contain oil from
sterilized cannabis seeds. Indeed, it appears that there is no reliable
source of information on these products. Accordingly, DEA does not know
whether every personal care product that is labeled a ``hemp'' product
necessarily was made using portions of the cannabis plant, and if so,
whether such portions of the plant are those excluded from the
definition of marijuana. Even if one assumes that a product that says
``hemp'' on the label was made using cannabis seeds or other portions
of the plant, one cannot automatically infer, without conducting
chemical analysis, that the product contains THC.\9\ Assuming, however,
that a ``hemp'' product does contain THC, and assuming further that
such product is marketed for personal care (e.g., body lotion or
shampoo), the question remains whether the use of the product results
in THC entering the human body. DEA is unaware of any scientific
evidence that definitively answers this question. Therefore, DEA cannot
state, as a general matter, whether ``hemp'' personal care products are
exempted from control under this final rule. Nonetheless, given the
information currently available, DEA will assume, unless and until it
receives evidence to the contrary, that most personal care products do
not cause THC to enter the human body and, therefore, are exempted
under this final rule. For example, DEA assumes at this time that
lotions, moisturizers, soaps, and shampoos that contain oil from
sterilized cannabis seeds meet the criteria for exemption under this
final rule because they do not cause THC to enter the human body and
cannot be readily converted for human consumption. However, if a
personal care ``hemp'' product is formulated and/or designed to be used
in a way that allows THC to enter the human body, such product is not
exempted from control under this final rule.
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\9\ Any product that (i) is made from portions of the cannabis
plant excluded from the CSA definition of marijuana and (ii)
contains no THC (nor any other controlled substance) is not a
controlled substance.
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Again, it must be emphasized that, although DEA believes that most
personal care ``hemp'' products currently marketed in the United States
meet the criteria for exemption under this final rule, it is not
possible for DEA to provide an exhaustive list of every such product
and to state whether such product is exempted. Should manufacturers,
distributors, or importers of ``hemp'' personal care products wish to
have their products expressly exempted from control, they should take
steps to determine whether such products contain THC and, if they do
contain THC, whether use of the products results in THC entering the
human body. Any such manufacturer, distributor, or importer who
believes that its product satisfies the criteria for exemption under
this final rule may request that DEA expressly declare such product
exempted from control by submitting to DEA an application for an
exemption, together with appropriate scientific data, in accordance
with the procedures set forth in 21 CFR 1308.23(b) and (c).
A manufacturer, distributor, or importer of a ``hemp'' product that
meets the criteria for exemption under this final rule need not obtain
an express exemption from DEA in order to continue to handle such
product. Rather, this is a voluntary procedure. DEA leaves it to the
individual manufacturer, distributor, or importer to decide whether
there is sufficient uncertainty about its product to seek an express
exemption from DEA. However, any person who continues to handle a
``hemp'' product that does not meet the criteria for an exemption under
this final rule is subject to liability under the CSA.
What Is the Legal Status of ``Hemp'' Products That Contain No THC?
Any portion of the cannabis plant, or any product made therefrom,
or any product that is marketed as a ``hemp'' product, that is both
excluded from the definition of marijuana and contains no THC--natural
or synthetic--(nor any other controlled substance) is not a controlled
substance. Accordingly, such substances need not be exempted from
control under this final rule, since they are, by definition,
noncontrolled.
What Is the Justification for Issuing the Exemptions Under This Rule?
DEA believes it is both necessary for the most effective
enforcement of the CSA and consistent with the public interest to allow
the exemptions contained in this rule. Otherwise, as provided in the
CSA and DEA regulations, all products containing any amount of THC are
schedule I controlled substances. In other words, in the absence of
this final rule, legitimate industrial ``hemp'' products such as paper,
rope, clothing, and animal feed mixtures would be schedule I controlled
substances if they contain THC. Thus, without the exemptions that are
being finalized in this rule, anyone who sought to import such products
for legitimate industrial uses would need to obtain a DEA registration
and an import permit. 21 U.S.C. 952(a)(2), 957(a). Likewise,
distributors of such products would need a DEA registration and would
be required to utilize DEA order forms and maintain strict records of
all transactions. 21 U.S.C. 822(a)(1), 827(a), 828(a). DEA believes
that such regulatory requirements are unnecessary to protect the public
welfare and achieve the goals of the CSA, provided such products are
not used, or intended for use, for human consumption. Furthermore, DEA
believes that it would not be an appropriate prioritization of limited
agency resources to take on the responsibility of regulating these
products as schedule I controlled substances when they are not being
used for human consumption. Therefore, as long as there is no
possibility that humans will consume THC by using something other than
an FDA-approved drug product or a product that the FDA has authorized
for clinical research, DEA believes that it is consistent with the
purposes and structure of the CSA to exempt industrial ``hemp''
products, processed plant materials, and animal feed mixtures in the
manner specified in this final rule.
[[Page 14123]]
What Are the Registration Requirements for Handlers of ``Hemp''
Products Under This Final Rule?
In light of the exemptions provided under this rule, the following
registration requirements should be considered:
Who must obtain a registration--Persons who wish to manufacture or
distribute any THC-containing product or plant material that is not
exempted from control under this rule must apply for the corresponding
registration to handle a schedule I controlled substance. Absent such
registration, it is unlawful to manufacture, distribute, or dispense,
import, or export any such product or plant material. 21 U.S.C. 822(b),
841(a)(1), 957(a), 960(a). The circumstances under which DEA may grant
registrations to handle schedule I controlled substances are limited,
as set forth in 21 U.S.C. 823.
In addition, no person may cultivate the cannabis plant for any
purpose except when expressly registered with DEA to do so. This has
always been the case since the enactment of the CSA. 21 U.S.C. 822(b),
823(a); 21 CFR Part 1301; see New Hampshire Hemp Council, Inc. v.
Marshall, 203 F.3d 1 (1st Cir. 2000). Further, the CSA prohibits the
importation of schedule I controlled substances except as authorized by
21 U.S.C. 952(a)(2). Similarly, the CSA prohibits the exportation of
schedule I nonnarcotic controlled substances except as authorized by 21
U.S.C. 953(c).
Who need not obtain a registration--Persons who import and
distribute ``hemp'' products and processed cannabis plant material that
are exempted from control under this final rule are not subject to any
of the CSA requirements, including the requirement of registration. For
example, a person who imports ``hemp'' clothing is not considered to be
importing a controlled substance and is, therefore, not subject to any
of the CSA requirements. Similarly, a person who has imported into the
United States processed cannabis plant material that is exempted under
this rule (such as retted fiber) and converts such material into an
exempted ``hemp'' product (such as clothing) is not considered to be
manufacturing a controlled substance and, therefore, need not obtain a
controlled substance manufacturing registration.
It is worth repeating here that, if a product marketed as a
``hemp'' product actually contains no THC (or any other controlled
substance), it is noncontrolled and handlers of the product are not
subject to any of the CSA provisions, such as the registration
requirement.
Comments That DEA Received in Response to the Interim Rule
Following publication of the interim 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. In accordance with the Administrative
Procedure Act, DEA carefully considered all of the comments it
received.
Most of the comments that DEA received relate to both of the rules
that DEA published on October 9, 2001: (i) DEA 205 (66 FR 51535), a
proposed rule, which proposed to clarify that the listing of THC
includes both natural and synthetic THC and (ii) DEA 206 (66 FR 51539),
an interim rule, which exempted certain THC-containing products and
plant materials from control. Those comments that DEA received which
pertain primarily to the interim rule are addressed here. Those
comments which pertain primarily to the proposed rule are addressed in
the final DEA 205 rule, which appears in a separate Federal Register
document that immediately precedes 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. The
issues raised overlapped to a large extent as many persons submitted
form letters or signed petitions written by groups which themselves
submitted lengthy comments. In this document, together with the final
proposed rule, DEA has addressed all the major issues raised by the
commenters. Some of these issues are addressed above in the text that
precedes this section. The remaining issues are addressed below.
Comments Regarding Which Products To Exempt From Control
None of the commenters objected to the basic purpose of this rule:
To exempt from control certain THC-containing industrial products and
animal feed mixtures made from ``hemp'' (portions of the cannabis plant
excluded from the definition of marijuana). To the contrary, all the
commenters who expressed an opinion on this particular issue agreed
with these exemptions.\10\ However, many commenters said that DEA
should go further by also exempting ``hemp'' food and beverage products
that contain THC. DEA declined to adopt this suggestion for the reasons
provided herein.
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\10\ Some commenters were under the mistaken impression that DEA
failed to exempt any products from control. These commenters asked
DEA to exempt what DEA had already exempted under the interim rule.
For example, several commenters objected to DEA's supposed failure
to exempt ``hemp'' clothing and paper, even though the interim rule
stated repeatedly that such products were being exempted.
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Those commenters who requested that DEA exempt THC-containing
``hemp'' food and beverage products made two main claims in support of
this request: (i) That ``hemp'' foods and beverages contain only
minimal amounts of THC, which, they asserted, cannot cause any
psychoactive effects; and (ii) that the oil from ``hemp'' seeds
(sterilized cannabis seeds) provides nutritional value and is a safe
food ingredient.\11\
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\11\ Some commenters also expressed concern about the economic
impact of disallowing THC-containing ``hemp'' food and beverage
products. This issue is addressed in the final 205 rule, in the
regulatory certifications.
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As to the issue of THC content, many of the comments appeared to be
asking DEA simply to assume that the placement of the word ``hemp'' on
the label of a food or beverage product automatically means that the
product contains a certain low amount of THC. In fact, the existence of
the word ``hemp'' on the label of a food container provides no
definitive proof of its contents. The FDA cannot and does not evaluate
the contents of every food product sold in the United States. Since
there is no reliable information about the contents of all foods and
beverages marketed as ``hemp'' products, it cannot automatically be
assumed that all such products will never cause a psychoactive effect
or a positive drug test for THC.
One scientific study published in 1997 examined ``hemp'' salad oil
(containing oil from cannabis seeds) sold in ``hemp shops'' and health
food stores in Switzerland. The authors of the study stated that all
the human subjects who ate the cannabis seed oil reported THC-specific
psychotropic symptoms and had urine samples positive for THC.\12\ In
citing this study, DEA is not
[[Page 14124]]
suggesting that all ``hemp'' food and beverage products cause
psychoactive effects. Rather, DEA mentions this study in response to
the assertions made by some commenters that eating ``hemp'' foods
cannot possibly cause psychoactive effects.\13\
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\12\ T. Lehman, Institute of Pharmacy, University of Bern, et
al., Excretion of Cannabinoids in Urine after Ingestion of Cannabis
Seed Oil, Journal of Analytical Toxicology, vol. 21 (September
1997).
\13\ In a later study, financed by various ``hemp'' companies,
human subjects were given oil from cannabis seeds containing lower
doses of THC than in the Lehman study. G. Leson, et al., Evaluating
the Impact of Hemp Food Consumption on Workplace Drug Tests, Journal
of Analytic Toxicology, vol. 25 (November/December 2001). The
authors of this study reported that ingestion of cannabis seed oil
containing these lower doses of THC resulted in little or no
positive screening for THC, depending on the amount of THC consumed
and the sensitivity of the urine testing. Companies who financed
this study assert that the lower THC content given to the subjects
of this study is commensurate with the current methods employed by
these companies for cleaning the cannabis seeds before removing the
oil from them for use in food products.
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Attached to one of the comments was another study, which was also
financed by various ``hemp'' companies. This study, entitled
``Assessment of Exposure to and Human Health Risk from THC and other
cannabinoids in hemp foods,'' reached similar conclusions about the
reduced levels of THC in currently marketed ``hemp'' foods and the
diminished likelihood of testing positive for THC when consuming such
products.
As for the comments claiming that ``hemp'' foods provide essential
nutrients and are safe to eat, it is not DEA's role under the CSA to
assess the nutritional value or safety of foods.\14\ Regardless of
whether the oil from cannabis seeds contains certain nutrients,\15\ the
CSA does not provide for DEA to exempt food products that contain THC.
As explained above and in the text accompanying the interim rule, the
CSA prohibits human consumption of ``any quantity'' of a schedule I
hallucinogenic substance outside of an FDA-approved product or FDA-
approved research. Other than drugs that have been approved by the FDA
for prescription use, or drugs that may be lawfully sold over the
counter without a prescription, DEA may not exempt controlled
substances to allow them to be used for human consumption--even in the
case of products that supposedly contain only ``trace amounts'' of a
controlled substance. 21 U.S.C. 811(g). Thus, DEA may not, as some
commenters proposed, pick an arbitrary cutoff line allowing a certain
percentage of THC in foods and beverages. Moreover, notwithstanding the
statutory prohibition, DEA believes it would be inappropriate to
attempt to establish an acceptable level of schedule I hallucinogens in
food products. For example, it would not be appropriate to allow food
products to contain ``trace amounts'' of such other schedule I
hallucinogens as LSD or MDMA (``ecstasy''). Finding that it is contrary
to the public welfare to allow human consumption of ``any quantity'' of
schedule I hallucinogens, Congress did not give DEA the authority to
determine what constitutes a ``safe amount'' of such drugs in food.\16\
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\14\ In the context of the CSA, the public ``safety'' (and DEA's
role therein) is implicated by the use of controlled substances for
other than a legitimate medical purpose or in any other manner not
authorized by the CSA.
\15\ Although this rule is not a food safety measure, because
DEA received so many comments regarding this issue, some members of
the public may be interested in the following information. Under the
Federal Food, Drug, and Cosmetic Act, a substance that is added to
food is not subject to the requirement of premarket approval if its
safety is generally recognized among qualified scientific experts
under the conditions of its intended use. 21 U.S.C. 321(s). A
substance added to a food may be considered ``generally recognized
as safe'' (GRAS) through experience based on ``common use in food,''
which requires a substantial history of consumption for food use by
a significant number of consumers. 21 CFR 170.3(f), (h); 21 CFR
170.30. The FDA evaluated an industry submission claiming GRAS
status for certain food uses of ``hempseed oil'' and expressly
stated that it did not believe the submission provided a sufficient
basis to classify ``hempseed oil'' as GRAS through experience based
on common use in food. See FDA Center for Food Safety & Applied
Nutrition, Office of Premarket Approval, Agency Response Letter,
GRAS Notice No. GRN 00035 (August 24, 2000), reproduced at
www.cfsan.fda.gov/rdb/opa-g035.html. In making this determination,
the FDA did not evaluate whether there would be a basis for GRAS
status through scientific procedures or whether ``hempseed oil''
would meet the standard for premarket approval as a food additive.
Id.
\16\ To establish a violation of the CSA, the government does
not have to prove that the controlled substance in question was of
sufficient quantity to produce a psychoactive effect. United States
v. Nelson, 499 F.2d 965 (8th Cir. 1974).
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Accordingly, DEA has limited the exemptions provided in this final
rule to those cannabis-derived ``hemp'' products that do not cause THC
to enter the human body.
Comments Regarding Testing Methods To Evaluate THC Content of Foods and
Beverages
Many commenters asked the agency to indicate how it will determine
whether a food or beverage product contains THC. Under federal law, it
is legally sufficient to demonstrate a violation of the CSA based on
the presence of any measurable amount of a prohibited controlled
substance.\17\ Thus, the questions raised by the commenters are: ``What
testing methods will DEA utilize to determine whether a food product
contains a measurable amount of THC and how sensitive are such
methods?''
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\17\ See, e.g., United States v. Holland, 884 F.2d 354, 357 (8th
Cir. 1989), cert. denied, 493 U.S. 997 (1989); see also 21 U.S.C.
812(c), schedule I(c) (listing ``any material, compound, mixture, or
preparation, which contains any quantity'' of hallucinogenic
substances in schedule I).
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DEA will utilize testing assays or protocols used in standard
analytical laboratories that have demonstrated valid and reliable
sensitivity for the measurements of THC.\18\ The methodology, level of
sensitivity, and degree of testing accuracy in the fields of analytical
and forensic chemistry have evolved since the first discovery of THC in
the 1960s. A variety of analytical equipment, testing methodologies,
and protocols are described in the published scientific literature.\19\
Such methods may include (but are not limited to) gas chromatography,
liquid chromatography, and mass spectrometry analyses. DEA has not, and
will not, utilize any one method to the exclusion of others.\20\
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\18\ In this context, ``valid'' means that the technique
measures what it is designed to measure, and ``reliable'' means that
the technique can be replicated by other laboratories.
\19\ See, e.g., M.V. Doig & R. Andela, Analysis of
pharmacologically active cannabinoids by GC-MS, Chromatographia 52
(Supp.): S101-S102 (2000); P.D. Felgate & A.C. Dinan, The
determination of delta-9-tetrahydrocannabinol and 11-Nor-9-carboxy-
delta-9-tetrahydrocannabinol in whole blood using solvent extraction
combined with polar solid-phase extraction, Journal of Analytical
Toxicology 24:127-132 (2000); K. Ndjoko, et al., Analysis of
cannabinoids by liquid chromatography-thermospray mass spectrometry
and liquid chromatography-tandem mass spectrometry, Chromatographia
47:72-76 (1998); B.J. Gudzinowicz & M.J. Gudzinowicz, Analysis of
drugs and metabolites by gas chromatography-mass spectrometry,
Volume 7: Natural, pyrolytic, and metabolic products of tobacco and
marijuana, NY: Marcel Dekker, Inc. (1980).
\20\ What constitutes the appropriate method of testing may vary
depending on the circumstances. In any criminal prosecution, civil
or administrative action, or other legal proceeding arising under
the CSA, where the government must prove the presence of a
controlled substance, the government may do so by the introduction
of any evidence sufficient under law to prove such fact. See, e.g.,
United States v. Bryce, 208 F.3d 346, 352-354 (2d Cir. 2000).
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The lower limit of detectability of these assays can vary according
to equipment, methodologies, and the form of the sample. Nonetheless,
using currently available analytical methodologies and extraction
procedures, it is reasonable to reproducibly and accurately detect THC
at or below 1 part per million in cannabis bulk materials or products.
Should more sensitive assays and analytical techniques be developed in
the future, DEA will refine its testing methods accordingly.
Some companies that handle ``hemp'' food products have asked DEA
whether the agency would test the companies' products for THC content.
It is not
[[Page 14125]]
within DEA's authority to serve as such a testing laboratory for
private entities. Nor would it be appropriate for DEA to certify
laboratories for these analyses. Manufacturers and distributors of
``hemp'' food and beverage products may, of course, conduct their own
testing to determine to their own satisfaction that their products
contain no THC. However, they are under no obligation to do so. Whether
or not they conduct such testing, the law remains the same: if a food
or beverage product contains any measurable amount of THC, it is an
illegal schedule I controlled substance; if it contains no THC, it is a
legal, noncontrolled substance.
Comments Regarding Drug Screening
Several commenters asserted that, in deciding whether or not to
exempt THC-containing food and beverage products, DEA should not
concern itself with the possibility that persons who eat such products
then undergo drug screening might test positive for THC. Some of these
commenters suggested that ``hemp'' food and beverage manufacturers have
taken steps to ensure that the amount of THC in their products is low
enough to avoid causing a positive drug screen. Given these comments,
it must be emphasized that, while effective drug screening in
appropriate circumstances is of concern to DEA and was part of the
agency's overall consideration, the ultimate decision about which
products to exempt from control did not turn on drug testing
considerations. Rather, as explained above, DEA exempted certain
products to the extent permissible by the CSA and consistent with the
public welfare within the meaning of the Act.
Although drug testing was not the basis for the exemptions, in view
of the comments about drug testing, it is worth reiterating that there
are no uniform standards of what constitutes a ``hemp'' product. It
cannot be said that, merely because a product has the word ``hemp'' on
the label, it will necessarily contain a certain low amount of THC.
Therefore, it cannot automatically be said that a food or beverage
product marketed as containing ``hemp'' will never cause a positive
drug test for THC. In fact, as noted above, one published scientific
study found that eating ``hempseed'' salad oil (of a variety sold in
``hemp shops'' in Switzerland) did cause human research subjects to
test positive for THC.
Comments Regarding the Cultivation of Cannabis for Industrial Purposes
Some commenters asserted that the United States should promote the
cultivation of cannabis for industrial purposes based on economic and
environmental considerations. These commenters seemed to misunderstand
the nature of the rules being finalized today. The rules do not impose
restrictions on, or even address, the cultivation of cannabis. Rather,
as the text accompanying the rules makes clear, the rules clarify which
cannabis-derived products are controlled and which are exempted from
control.
As stated above, it has always been the case since the enactment of
the CSA in 1970 that any person who seeks to lawfully grow cannabis for
any purpose (including the production of ``hemp'' for industrial
purposes) must obtain a DEA registration. This requirement remains in
effect and is not modified by the rules DEA is finalizing today.
Regulatory Certifications
Economic Impact of This Rule
This rule allows economic activity that would otherwise be
prohibited. As has now been made clear under the DEA regulations being
finalized today, all products that contain any amount of THC are
schedule I controlled substances unless they are specifically listed in
another schedule or exempted from control. Thus, without the exemptions
provided in this final rule, industrial ``hemp'' products such as
paper, rope, clothing, and animal feed would be subject to the
provisions of the CSA and DEA regulations that govern schedule I
controlled substances if they contained THC. The CSA permits the use of
schedule I controlled substances for industrial purposes, but only
under strictly regulated conditions. By virtue of this rule, however,
most industrial ``hemp'' products are exempt from all provisions of the
CSA and DEA regulations. Thus, this rule imposes no regulatory
restrictions on any economic activities; rather, it removes regulatory
restrictions on certain economic activities.
Regulatory Flexibility Act
For the reasons provided in the foregoing paragraph, 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)). Therefore,
a final regulatory flexibility analysis is not required for this final
rule.
Executive Order 12866
This rule has been drafted and reviewed in accordance with
Executive Order 12866, Regulatory Planning and Review, section 1(b),
Principles of Regulation. This rule has been determined to be a
``significant regulatory action'' under Executive Order 12866, section
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
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. Accordingly, under the Small Business Regulatory
Enforcement Fairness Act of 1996 (SBREFA), this is not a major rule as
defined in 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 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.
[[Page 14126]]
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, the Acting Administrator hereby orders that the interim rule
amending title 21 of the Code of Federal Regulations, part 1308, to
include new Sec. 1308.35, which was published at 66 FR 51539, on
October 9, 2001, is adopted as a final rule without change.
Dated: March 18, 2003.
John B. Brown III,
Acting Administrator.
[FR Doc. 03-6805 Filed 3-20-03; 8:45 am]
BILLING CODE 4410-09-P