[Federal Register Volume 63, Number 179 (Wednesday, September 16, 1998)]
[Proposed Rules]
[Pages 49506-49517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-24293]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300 and 1310
[DEA Number 137P]
RIN 1117-AA31
Exemption of Chemical Mixtures
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Proposed rule.
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SUMMARY: The DEA is proposing regulations to implement those portions
of the Domestic Chemical Diversion Control Act of 1993 [Pub. L. 103-
200] (DCDCA) that exempt from regulation under the Controlled
Substances Act (CSA) certain chemical mixtures that contained regulated
chemicals. The DCDCA amended the CSA to require that only those
chemical mixtures identified by regulation shall be exempt from
application of DEA's regulatory controls. These proposed regulations
identify those mixtures, or categories of mixtures, that will be exempt
from regulation. This proposal also defines an application process that
can be used to exempt chemical mixtures that do not meet the criteria
for automatic exemption.
DATES: Written comments or objections must be submitted on or before
November 16, 1998.
ADDRESSES: Comments and objections should be submitted in quintuplicate
to the Acting Deputy Administrator, Drug Enforcement Administration,
Washington, DC 20537, Attention: DEA Federal Register Representative/
CCR.
FOR FURTHER INFORMATION CONTACT:
Frank Sapienza, Chief, Drug and Chemical Evaluation Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC
20537, Telephone (202) 307-7138.
SUPPLEMENTARY INFORMATION: The Chemical Diversion and Trafficking Act
of 1998 (PL 100-690) (CDTA) was passed by Congress to curtail the
diversion of specific chemicals used in the illicit manufacture of
controlled substances. The CDTA established recordkeeping and reporting
requirements necessary for DEA to identify and track chemical
diversion. While the CDTA achieved initial success in curtailing the
diversion of chemicals, traffickers soon found and took advantage of
certain shortcomings in the law. In the United States (U.S.),
traffickers were able to obtain needed supplies by purchasing products
that were exempted from regulation under the CDTA. Foreign traffickers
were able to obtain chemicals from sources outside the U.S., while
taking advantage of U.S. brokers and traders because of these
shortcomings. Additionally, taking action against unscrupulous
suppliers proved difficult.
To address the weaknesses in the CDTA, Congress passed the Domestic
Chemical Diversion Control Act of 1993 (DCDCA), which was enacted in
April of 1994. One provision of the DCDCA dealt with the exemption of
chemical mixtures, which are defined as ``a combination of two or more
chemical substances, at least one of which is not a list I chemical or
a list II chemical, except that such term does not include any
combination of a list I chemical or a list II chemical with another
chemical that is present solely as an impurity.''
Prior to the enactment of the DCDCA, the term regulated transaction
was defined to exclude `any transaction in a chemical mixture' (21
U.S.C. 802 (39)(A)(v)). Therefore, transactions involving all chemical
mixtures were exempt from recordkeeping and other chemical regulatory
control requirements of the CSA. This exemption provided traffickers
with an unregulated source for obtaining chemicals for use in the
manufacture of controlled substances. Furthermore, this exemption was
inconsistent with the requirements of Article 12, Paragraph 14 of the
United Nations 1988 Convention on Psychotropic Substances. Article 12
states, in part, that ``The provisions of this article shall not apply
to pharmaceutical preparations, nor to other preparations containing
substances in Table I or Table II that are compounded in such a way
that such substances cannot be easily used or recovered by readily
applicable means''. To address these problems, the DCDCA amended the
exemption to provide that only those chemical mixtures specified by
regulation would be exempt.
The DCDCA amended the definition of a regulated transaction to
exclude only those mixtures which the Attorney General has by
regulation designated as exempt. This designation is ``based on a
finding that the mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance and
that the listed chemical or chemicals contained in the mixture cannot
be readily recovered''. Accordingly, with this proposal, the DEA is
seeking to enact regulations that prevent diversion of mixtures which
contain listed chemicals, while removing from the regulatory scheme
mixtures which meet the above legal criteria [21 U.S.C. 802(39)(A)(v)].
Chemical mixtures which contain listed chemicals are of concern to
DEA if they can be used in the manufacturing of controlled substances.
Laboratory operators have continually searched for unregulated sources
of materials in their efforts to illegally manufacture controlled
substances. These efforts have led to the diversion and illicit
utilization of chemical mixtures.
Chemical mixtures can and do play a role in the illicit production
of controlled substances such as heroin, cocaine and amphetamine
related compounds, including methamphetamine. Some examples follow.
The chemicals used in the production of cocaine are included
primarily on list II of the CSA. Suspicious shipments of mixtures
containing solvents in list II to cocaine producing areas have been
identified by DEA. Additionally, diversion of such chemical mixtures
for the illicit production of cocaine in foreign countries has been
established by DEA. DEA continually monitors the chemical composition
of seized cocaine hydrochloride. The DEA laboratory system is able to
detect the trace quantities of solvents present in seized cocaine
hydrochloride. Such solvents are utilized in the final stage of cocaine
production whereby cocaine base is converted to cocaine hydrochloride.
Recent data indicate that a broader range of solvents and solvent
combinations are being caused in cocaine processing. This laboratory
data supports intelligence information that chemical mixtures are used
in the production of cocaine hydrochloride.
Chemical mixtures also play a role in the production of
methamphetamine, the most prevalent controlled substance illicitly
synthesized in the United States. During calendar years 1994 through
1997, the DEA was involved in the domestic seizure of over 2,800
clandestine methamphetamine laboratories. The chemicals ephedrine and/
or pseudoephedrine were utilized as the precursor material at the vast
majority of these laboratories.
The clandestine manufacture, distribution and abuse of
methamphetamine are serious public
[[Page 49507]]
health problems. Nationally, the Drug Abuse Warning Network (DAWN) has
documented approximately 2,900 methamphetamine/speed related deaths in
the United States between January 1992 and December 1996.
Despite considerable efforts by Federal, state and local law
enforcement, the illicit production, distribution and abuse of
methamphetamine continue. Recent DEA seizure statistics indicate that
the number of methamphetamine laboratory seizures has increased
dramatically in 1996 and 1997. During 1997, the DEA participated in
more than 1,400 methamphetamine laboratory seizures. This figure does
not take into account the many laboratory seizures conducted
independently by state and local law enforcement agencies. The problem
continues into 1998.
During the 1970's and early 1980's, P2P was the primary precursor
used in the clandestine production of methamphetamine in the U.S. P2P
was controlled as a Schedule II controlled substance in 1980 through
the administrative provision authorizing control of immediate
precursors under the CSA (21 U.S.C. 811(e)). In an attempt to
circumvent the control of P2P, traffickers sought P2P in unregulated
international markets and resorted to the manufacture of P2P in
clandestine laboratories utilizing phenylacetic acid and acetic
anhydride.
In the middle 1980's, U.S. clandestine laboratory operators began
utilizing the ephedrine reduction method of manufacturing
methamphetamine. Since ephedrine was unregulated at the time, most
laboratory operators abandoned the P2P method and instead moved to the
use of bulk ephedrine powder as their source of precursor material.
The Chemical Diversion and Trafficking Act of 1988 (CDTA) modified
the Controlled Substances Act (CSA) to give DEA authority to exercise
regulatory control of the chemicals used for the refinement and
synthesis of illicitly manufactured controlled substances. The CDTA
imposed recordkeeping, reporting, and import/export notification
requirements for regulated transactions of listed chemicals in order to
prevent the diversion of these chemicals to the illicit manufacture of
controlled substances. The CDTA included bulk ephedrine and
pseudoephedrine as listed chemicals.
However, under the CDTA, products containing a listed chemical
which were marketed or distributed lawfully under the Federal Food,
Drug, and Cosmetic Act were exempt from the CSA's chemical regulatory
control provisions. This included over-the-counter (OTC) products which
contained ephedrine and pseudoephedrine. Clandestine laboratory
operators soon learned that they could obtain the needed precursor
materials through the unregulated purchase of millions of dosage units
of single-entity OTC ephedrine products.
This loophole in the law was closed by the passage of the Domestic
Chemical Diversion Control Act (DCDCA) which became effective on April
16, 1994. This Act further amended the CSA and removed the exemption
for those transactions involving products which are marketed or
distributed lawfully under the Federal Food, Drug, and Cosmetic Act, if
these products contain ephedrine as the only active medicinal
ingredient. Thus, single entity ephedrine products became subject to
the chemical regulatory control requirements of the CSA.
In response to these actions taken against OTC ephedrine products,
clandestine laboratory operators again attempted to circumvent CSA
chemical controls in an effort to obtain precursor material. The search
for unregulated source of precursor material led to the diversion and
illicit utilization of OTC pseudoephedrine products and combination OTC
ephedrine products. In response, the Comprehensive Methamphetamine
Control Act of 1996 placed regulatory controls on the sale and
distribution of such OTC products.
Today, the vast majority (approximately 97 percent) of U.S.
clandestine laboratories continue to utilize ephedrine and/or
pseudoephedrine as the precursor material. At practically all of these
laboratories, the precusor material was obtained via the diversion of
ephedrine or pseudoephedrine products marketed in tablet and capsule
form and was not obtained through the diversion of bulk powder.
While the vast majority of products seized at illicit
methamphetamine laboratories were OTC drug products, dietary supplement
products containing ephedrine and/or pseudoephedrine (i.e ephedra) have
been seized at clandestine methamphetamine laboratories. At this time,
the frequency with which these products are encountered is small.
However, DEA studies indicate that the ephedrine/pseudoephedrine
contained in this material can be readily recovered and ephedra
material can be easily used in the production of methamphetamine.
Ephedra (in the form of dietary supplements or ephedra extract),
therefore, can and is being used as the source of precursor material
for the illicit production of methamphetamine.
Regulation of chemical mixtures is appropriate to guard against
their diversion if the products are not formulated in such a way that:
(1) they cannot be easily used in the illicit production of a
controlled substance; or (2) the listed chemicals cannot be readily
recovered. The DCDCA provides DEA with the means to regulate the
mixtures and yet allows enough flexibility to ensure that the impact of
the regulations can legitimate commerce is minimized.
Regulations regarding the exemption of chemical mixtures were
initially proposed by DEA on October 13, 1994 (59 FR 51888). In
response to industry concerns, the proposed regulations regarding the
exemption of chemical mixtures were withdrawn on December 9, 1994 (59
FR 63738). Between withdrawal of the proposed regulations regarding the
exemption of chemical mixtures and the publication of this action as a
final rule, all transactions involving chemical mixtures as defined in
21 U.S.C. 802(40) remain exempt from the definition of regulated
transaction under the CSA. Based on the discussions and input from
industry, DEA is proposing new regulations regarding the exemption of
chemical mixtures.
Following withdrawal of the initial proposal, DEA solicited input
from, and engaged in discussions with, organizations representing the
manufacturers and distributors of products containing listed chemicals.
DEA met with representatives from associations (and affiliated members)
representing chemical manufacturers, the paint and coating industry,
flavor and fragrance manufacturers, chemical distributors and the
dietary supplements industry. These different groups expressed unique
concerns that the DEA attempted to address within this notice. More
recently, however, the DEA has become aware of additional concerns
raised by other segments of the affected industries including the
dietary supplement industry. While DEA has received input from several
associations and firms within these industries, because of the
diversity of these industries, the DEA believes that others may have
information that the DEA should consider. The DEA is therefore
soliciting input from all sectors of the chemical and dietary
supplements industry potentially affected by this proposed rulemaking.
The DEA recognizes that there may be situations within unique segments
of one or more of the affected industries which may not be specifically
addressed in this
[[Page 49508]]
proposed rulemaking. These may involve products which are not
automatically exempt and entities which would not likely be sources of
diversion since their products cannot be easily used in the illicit
production of a controlled substance or the listed chemicals, which
they contain, cannot be readily recovered. In the event that not all
exemption provisions for chemical mixtures are included, specific
mixtures can be exempted by an application process. The application
process is designed to exempt those chemical mixtures that are not
automatically exempted under this proposal, but meet the criteria of
Title 21 U.S.C. 802(39)(a)((v). As described below, these are processes
which individual firms can use to apply for exemption from some or all
regulatory controls.
One of the potentially affected industries is the dietary
supplement industry which markets non-drug products containing
ephedrine/pseudoephedrine. DEA has recently received information from a
coalition of direct marketers of these dietary supplements regarding
the perceived impact of the proposed regulations on their industry. The
principal concern of the direct marketers is how the chemical
registration, recordkeeping, reporting requirements may affect those
individuals engaged in the direct marketing of the products to the
public. DEA emphasizes that it does not foresee the need for the
regulation of individuals engaged in the direct marketing of the
products to the public, provided certain basic conditions are met. This
is consistent with the established intent of the Comprehensive
Methamphetamine Control Act of 1966 (MCA) with respect to OTC drug
products. While the MCA placed certain regulatory controls on the sale
and distribution of pseudoephedrine, phenylpropanolamine and
combination ephedrine drug products, it went to great lengths to ensure
continued public access to these products at the retail level for face-
to-face transactions.
Correspondingly, DEA is proposing in this notice a process by which
manufacturers may request exemption for their products. Additionally,
DEA can exempt a category of transaction from regulation if it is
determined to be unnecessary for enforcement of the CSA (21 U.S.C.
802(39)(a)(iii)) and can exempt any manufacturers or distributors, from
the registration requirement if it is consistent with the public health
and safety (21 U.S.C. 822(d)). DEA has already received and responded
favorably to a request from a direct marketing organization of
regulated drug products, excluding the individual marketers from
regulations and requiring only that the wholesale activities be
regulated. The information submitted by the coalition regarding the
manner in which their dietary supplement products are marketed does not
to be significantly different from the manner in which these OTC drug
products are distributed.
Listed chemicals cover a wide sector of industry because of their
varied uses. Some are routinely utilized in legitimately produced
chemical formulations while others are not. The DEA has attempted to
better understand the degree with which specific listed chemicals are
formulated in chemical mixtures that are legitimately produced. An
accurate assessment has proved difficult for various reasons. One
reason is that, although some examples of formulated products were made
available, many manufacturers either did not have this information or
were reluctant to discuss their formulations due to concerns regarding
the disclosure of trade secrets. Another reason is that chemical
mixtures are used in a wide variety of industrial sectors. A complete
assessment would involve many diverse sectors such as those involved in
paints, coatings, plastics, refineries, and other industrial processes.
Additionally, many chemical mixtures are intended for human
consumption. These include food and dietary supplements, food
additives, flavorings and fragrances.
After careful consideration of the available information, including
the input from the chemical industry, DEA is proposing a three-tiered
approach to the exemption of chemical mixtures. This approach best
captures those chemical mixtures that are ``formulated in such a way
that they cannot be easily used in the illicit production of a
controlled substance and that the listed chemical or chemicals
contained in the mixture cannot be readily recovered'', in accordance
with Title 21 U.S.C. Section 802 (39)(A)(v). A mixture will be exempt
if: (1) it contains a listed chemical at or below an established
concentration limit; or (2) it falls within a specifically defined
category; and (3) the manufacturer of the mixture applies for and is
granted a specific exemption for the product.
I. Concentration Limits
DEA is proposing to use a system of concentration limits as the
primary means to determine the regulatory status of chemical mixtures.
The use of such a quantitative system is necessary due to the
complexity of chemical-based commodities and the huge variety of
products. The use of a narrative approach is too subjective and would
be in danger of inconsistent interpretation, both by industry and DEA.
Use of the concentration limit eliminates subjective interpretation; if
the amount of listed chemical in a mixture is less than, or equal to,
the concentration limit, then the mixture is exempt.
The concentration of a chemical in a mixture can be determined by
either volume or weight, depending on the physical state of the
mixture. It is more common to determine the concentration of a solid or
gas based on weight, as this more accurately reflects the relative
amounts of components in the mixture. The relative amount of a solid or
gas in a mixture may not be accurately reflected if based on volume
because the weight may change disproportionally relative to volume. The
volume is commonly used to determine concentration in liquid--liquid
mixtures. For listed chemicals that are liquids, the volume is proposed
to be used in determining concentration. The density parameter allows
for easy conversion between volume and weight for liquids.
Concentration limits are proposed to be determined by weight if the
listed chemical exist as a solid or gas at ambient temperature. The
weight of the free base or acid will be used to determine the
concentration of a listed chemical if it is a salt. A mixture is exempt
if the listed chemical or chemicals are less than or equal to the
percentages and other conditions described in the ``Table of
Concentration Limits.''
Where a mixture contains more than one listed chemical, determining
the concentration limit will depend on the properties of the chemicals
included in the mixture. Some chemicals, such as the different
solvents, are cumulative, i.e., the concentration of the mixture will
be determined by adding the concentrations of each individual solvent
in the mixture. This approach is necessary when chemicals can be
interchanged to carry out an illicit manufacturing procedure. The
combined volume of two or more such chemicals would be functionally
equivalent to the same volume of either one of the chemicals. If the
chemicals are not cumulative, then the concentration of each chemical
is considered individually in determining if the mixture is regulated.
Those chemicals that are cumulative are identified in the ``Table of
Concentration Limits'' in the proposed new Section 1310.12(c).
List I Chemicals
The DEA proposes that N-acetylanthranilic acid, anthranilic acid,
[[Page 49509]]
benzyl cyanide, ethylamine, hydriodic acid, 3 4-methylenedioxyphenyl-2-
propane, methylamine, nitroethane, phenylacetic acid, piperidine,
piperonal, propionic anhydride, isosafrole and safrole have a
concentration limit of 20 percent. List I chemicals are used as
precursors with the exception of hydriodic acid which is a reagent in
the production of controlled substances. These chemicals are extremely
valuable to traffickers and, in concentrations of greater than 20
percent, represent a viable source of material for the illegal
manufacture of controlled substances. The concentration limit proposed
by the DEA takes into consideration the information supplied by the
private sector and DEA concerns. The 20 percent limit for these
chemicals maintains exemption status for chemical mixtures that are not
likely to be diverted while excluding from regulation the majority of
the present commerce in these mixtures, as identified by DEA. Safrole
and isosafrole are sufficiently similar precursors when used
clandestinely, that they will be cumulative. DEA is proposing the
following concentration limits for the remaining List I chemicals:
Ephedrine and Pseudoephedrine--2 Percent
Combinations of ephedrine and pseudoephedrine will be cumulative
because these two chemicals are completely interchangeable as
precursors in the same reaction to make methamphetamine and
methcathinone. Thus, if the total concentration of ephedrine and
pseudoephedrine is greater than 2 percent, the mixture is treated by
DEA as a regulated chemical.
Ephedrine and pseudoephedrine are major precursors for clandestine
mathamphetamine and methcathinone production. As previously noted,
clandestine laboratory operators have migrated to unregulated sources
of precursor material. This has led to the diversion of marketed tablet
and capsule pharmaceutical products containing ephedrine and
pseudoephedrine. While OTC drug products have been a major source for
these chemicals in clandestine laboratories, DEA has also identified
non-drug products (i.e. ephedra extracts and dietary supplements) in
seized laboratories.
Regulations pertaining to OTC drug products containing ephedrine
and pseudoephedrine have been established under separate rulemaking.
Non-drug products, including dietary and nutritional supplements are
chemical mixtures and therefore shall be subject to these proposed
provisions.
Representatives of retail sectors from the dietary and nutritional
supplement industry have represented that their products contain
amounts consistent with those found in most natural sources. The 2
percent limit has been deliberately proposed at a level greater than
the concentrations found in most natural sources. Representatives of
the dietary and nutritional supplement retail industry have represented
in meetings that the proposed concentration limit would be adequate,
however, DEA has subsequently become aware of concerns from other,
previously unidentified segments of the dietary and nutritional
supplement industry that the proposed regulations could have a
significant impact on their operations. This new information revealed
that the proposed limit may not be appropriate to exempt certain
distributions from the regulatory process.
Of great concern to DEA, however, is the seizure of dietary
supplements and ephedra bulk material at clandestine laboratories. Some
of this seized material has been found to contain concentrations as low
as 3 to 4 percent ephedrine/pseudoephedrine. The 2 percent threshold
would therefore capture such material.
Under this proposal, products and material containing less than 2
percent would be automatically exempt. Additionally, harvested plant
material will be exempt provided that it is unaltered from its natural
state. Manufacturers of products containing greater than 2 percent
would be able to apply for exemption based on the criteria in 21 U.S.C.
802(39)(A)(v). In meetings with dietary supplement firms and
association, the DEA has requested information on the specific types,
composition and volume of dietary supplement products in the
marketplace. Responses to these inquires have been sparse.
The 2 percent concentration threshold was established in the
consideration of a single entity product containing ephedrine/
pseudoephedrine and combination products from which ephedrin/
pseudoephedrine can be easily removed. It is likely that multiple
ingredient products containing higher concentrations of ephedrin/
pseudoephedrine may, in fact, be more difficult to use in the
clandestine synthesis of methamphetamine. As such, these products would
likely qualify for exemption.
To ensure that DEA has all possible information regarding both the
extent and volume of this industry and the impact of any regulations on
it, DEA is requesting comments from interested persons who market
products that contain ephedrine and/or pseudoephedrine (either as
dietary/nutritional supplements or as other products). Comments should
identify the type of industry, including the number of companies/
individuals involved and the annual volume of business they conduct;
how the proposed regulatory requirements would impact that industry,
(through the registration, recordkeeping, and reporting requirements),
and within the confines of statutory requirements, any suggestions or
comments on how the final regulations might better be tailored to the
industry without compromising the basic mandate of the law to prevent
the diversion of ephedrine and pseudoephedrine for the illicit
manufacture of controlled substances.
The DCDCA initiated provisions for the regulatory control of
chemical mixtures. However, the DCDCA included exemption provisions for
chemical mixtures formulated in such a way that they cannot be easily
used in the illicit production of a controlled substance and the listed
chemical or chemicals contained in the mixture cannot be readily
recovered. Accordingly, if a dietary supplement or any other
formulations meet the exemption criteria, these chemical mixtures will
receive exemption status. Therefore, the dietary and nutritional
supplement industry is requested to provide information as to the
nature of these products in relation to the exemption criteria and
specify any unique attributes such as formulation, composition, or
method of distribution which would prevent diversion for illicit uses.
Additionally, the DEA invites comments in response to its concerns
regarding the seizure of dietary supplements and ephedra bulk material
at clandestine laboratories and the potential expanded role that these
products may play in the illicit production of methamphetamine.
Norpseudoephedrine/Phenylpropanolamine--0.6 Percent
N-methylephedrine/N-Methylpseudoephedrine--0.1 Percent
In each set of the above chemical pairs, the chemicals are
interchangeable in the clandestine synthesis of controlled substances.
Therefore, the concentration limit is proposed to be determined by
adding the concentration of each chemical in the pair.
These chemicals can be used in the manufacture of amphetamine and
methamphetamine. Commercially, they are used in the manufacture of drug
products and can appear in dietary and
[[Page 49510]]
nutritional supplements. As with ephedrine and pseudoephedrine, the
limits are set higher than concentrations found in most natural
sources, even when paired. Therefore, the limit should not affect the
dietary and nutritional supplement products.
Benzaldehyde--30 Percent
Benzaldehyde is used for the clandestine manufacture of amphetamine
and methamphetamine. DEA has identified it as being widely used in
flavoring and as a source of derivatives.
Mixtures containing more than 30 percent benzaldehyde can be
readily used in clandestine synthesis, especially when the other
chemicals are solvents. This is also true when benzaldehyde is mixed
with several other chemicals if those additional chemicals are not
reactive in the synthetic pathways used to manufacture illicit
substances. DEA is aware that this concentration limit may not capture
most mixtures, especially with respect to flavoring and fragrance
products. However, with the increasing effectiveness of the chemical
controls against the diversion of other amphetamine/methamphetamine
source materials, the potential for diversion of benzaldehyde,
including mixtures, may increase significantly. The DEA is interested
in soliciting comments from interested persons involved with chemical
mixtures containing benzaldehyde. For products which contain greater
than 30 percent benzaldehyde, the proposal establishes an application
process by which individual or group exemptions can be obtained.
Ergonovine and Ergotamine--No Concentration Limit
DEA is proposing to regulate all mixtures containing ergonovine and
ergotamine. The natural concentrations of these chemicals is on the
order of a few hundredths of a percent. The alkaloids are precursors
for the manufacture of hallucinogens that are potent in microgram
dosages; little material is required to manufacture viable quantities
of illicit drugs. Commercially, these chemicals are only found in
prescription drug products, which are already exempt; therefore their
regulation in chemical mixtures should not have any impact.
List II Chemicals
List II chemicals, while not precursors of the controlled
substances, are essential for carrying out the illegal manufacture of
controlled substances. DEA is proposing the following concentration
limits for List II chemicals:
Acetone, Methyl Ethyl Ketone (MEK), Methyl Isobutyl Ketone (MIBK),
Toluene, and Ethyl Ether--35 Percent
These chemicals are interchangeable and also are effective when
used in combination in clandestine operations; therefore, they are
cumulative.
These solvents are used, either singly or in combination, in the
processing of cocaine hydrochloride. Commercially, they are used in a
wide variety of industrial processes and represent the majority of
mixtures affected by the chemical regulations. In reviewing the
properties of these solvents, DEA has determined that in mixtures with
concentrations of greater than 35 percent, either individually or in
combination with another solvent, the mixture emulates the properties
of the listed solvent. Therefore, the concentration limit for such
mixtures is proposed to be 35 percent.
Acetic Anhydride, Benzyl Chloride, Hydrochloric Acid, Iodine and
Sulfuric Acid--20 Percent
Potassium Permanganate--15 Percent
These chemicals are used as reagents and precursors in the process
of manufacturing controlled substances. Reagents and precursors are
typically solutes which are dissolved in a solvent in order for a
chemical reaction to be carried out. Because they are dissolved, the
amount of listed precursor or reagent needed is less than the amount of
listed solvent needed to manufacture a controlled substance. This puts
mixtures containing less than the 35 percent concentration limit, as
set for solvents, at risk of diversion. Consequently, a 20 percent
concentration limit is proposed for these chemicals, except for
potassium permanganate, for which the proposed concentration limit is
15 percent. DEA has not identified any mixtures that contain potassium
permanganate in concentrations greater than 15 percent.
II. Specific Mixture Categories
While the concentration limits will suffice for the majority of
chemical mixtures, there are certain categories of mixtures that fall
outside of the limits provided, but are not considered to be likely
sources for diversion. DEA has identified three such categories: (1)
waste materials regulated by the Environmental Protection Agency (EPA);
(2) paints and coatings; and (3) harvested plant material.
(1) Waste mixtures that: (a) are subject to the requirements of 40
CFR Sections 262 and 263.20-22; (b) must be documented on U.S.
Environmental Protection Agency Form 8700-22/22A (Uniform Hazardous
Waste Manifest); and (c) are being distributed to another person solely
for the purpose of disposal by incineration are exempt. These mixtures
include only those that are covered by EPA regulations and have a
`cradle to grave' paper trail. Further, the exemption applies only to
the extent that the Form 8700-22/22A is available for inspection and
copying by DEA. If the generator fails to release, or permit the
release, of the necessary information required by DEA, then the
mixtures will be treated as a regulated mixture. Finally, any change in
the requirements with respect to Form 8700-22/22A, including EPA
exemption of a mixture or a waste management site, could result in
modification or removal of the exemption.
(2) Completely formulated paints and coatings. DEA recognizes that
while paints and coatings, as defined below, may contain a higher
concentration of a listed chemical than allowed for exemption, they
also contain other ingredients, such as pigments, that render them
unsuitable as a source of supply for chemical traffickers.
For purposes of the exemption, a completely formulated paint or
coating is defined as any clear or pigmented liquid, liquefiable, or
mastic composition designed for application to a substrate in a thin
layer which is converted to a clear or opaque solid protective,
decorative, or functional adherent film after application. A completely
formulated paint or coating contains all the components of the paint/
coating mixed without the need to add any other material except a
thinner for use in the final application. Included in this category are
paints, clear coats, topcoats, primers, varnishes, sealers, adhesives,
lacquers, stains, shellacs, inks and temporary protective coatings. To
qualify for the exemption, a paint or coating must meet the American
Society for Testing Materials specifications for the specific product.
(3) Harvested plant material. Harvested plant material that
contains listed chemicals, while meeting the definition of chemical
mixture, will be exempt provided that the plant material is unaltered
from its natural state. Changes in the physical state that preserve the
natural composition of the material, such as grining, chopping,
mulching, or cutting, do not affect the exemption status. However,
changes that alter the natural composition of the material, such as
that resulting from chemical or physical extraction, concentrating,
enhancement, or by chemical reaction or any such
[[Page 49511]]
treatment, will disqualify the mixture from exemption.
III. Exemption By Application
For those chemical mixtures that may not otherwise qualify for an
exemption, but are formulated in such a manner that the listed
chemicals cannot be readily recovered from the mixture and the mixture
itself cannot be used for illicit drug manufacture, DEA is proposing a
procedure by which the manufacturer of the mixture may apply for an
exemption of the mixture or group of mixtures. The application may be
submitted for a single mixture or a group of mixtures containing the
same listed chemical at equal concentration with variations in the
concentration of the other non-listed chemicals in the mixture.
Consideration will also be given to applications for mixtures in which
the concentration of the listed chemical varies without regard to the
specific concentrations of the other non-listed chemicals in the
mixture. In either group, variation of the concentration of any
chemical within the mixture that will result in a change in the
function of the mixture will disqualify the mixture from the group. The
Administrator may determine that a specific mixture does not qualify as
part of a group. Each manufacturer must request exemption status for
its particular products; exemption of a product for one manufacturer
does not carry over to the same or similar products for another
manufacturer.
An application for exemption must contain identifying information
about the applicant, qualitative and quantitative data regarding the
mixture, and justification as to why the mixture should be exempted.
DEA may request additional information on the formulation and
distribution of the mixture or clarification of any submitted
information, as needed. The application for exemption will contain a
consent for the termination of exemption by decision of the
Administrator upon evidence that the product has been diverted for the
use of producing a controlled substance.
Termination of Exemption
The Administrator may terminate or modify the exemption for any
chemical mixture that has been granted an exemption if evidence of
diversion or attempted diversion is found. Evidence that a chemical
mixture has been or is being used in the manufacuturing of a controlled
substance will be adequate reason to revoke exemption status for a
specific product or all similar chemical mixtures which the DEA
determines can be used in the illicit manufacdturing process for which
the evidence is obtained.
Procedures are given in this proposed rule for the termination of
an exemption granted pursuant to 21 CFR 1310.12 or 1310.13 and differ
according to whether removal of exemption status is product specific or
by change of any criterion in 21 CFR 1310.12(c) or 1310.12(d). The DEA
will issue and publish in the Federal Register notification of the
termination of exemption of a specific exempt product or group of
exempt products for which evidence of diversion has been found. This
order shall specify the date on which the termination of exemption
shall take effect. The Administrator shall permit any interested party
to file written comments on or objections to the notice within 60 days
of the date of publication of the order in the Federal Register. If any
such comments or objections raise significant issues regarding any
finding of fact or conclusion of law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until reconsideration of the order in light of comments and objections
filed. Thereafter, the Administrator shall reinstate, terminate, or
amend the original order as deemed appropriate. The DEA shall send
written notification to the manufacturer only in instances where the
manufacturer of affected products has been readily identified, advising
of an action prior to publication in the Federal Register.
Trade Secrets
Information required by the DEA to exempt a product includes
qualitative and quantitative data for the product. Industry groups
expressed concern regarding confidenticality and trade secrets. The DEA
has considerable experience in safeguarding trade secrets. The issue of
protection of confidential business information has been addressed by
the DEA in the Federal Register Final Rule published on June 22, 1995
which finalized specific provisions of the DCDCA (60 FR 32453). The
release of confidential business information that is protected from
disclosure under Exemption 4 of the Freedom of Information Act, 5
U.S.C. 552(b)(4) (FOIA), is governed by Section 310 (c) of the CSA (21
U.S.C. 830(c)) and the Department of Justice procedures set forth in 28
CFR 16.7.
Section 310(c) of the CSA provides that information collected under
Section 310 that is protected from disclosure under Exemption 4 may
only be released in circumstances related to the enforcement of
controlled substance or chemical laws, custom laws, or for compliance
with U.S. obligations under treaty or international agreements. The
Department of Justice procedures establish that if a FOIA request is
received for release of information that is protected under Exemption
4, the submitter of the protected information must be notified of such
a request, given an opportunity to object to the disclosure and allowed
to provide justification as to why the information should not be
disclosed.
Regulation of Chemical Mixtures
There are some chemical mixtures that will not meet the proposed
exemption criteria and will be subject to regulation. It is proposed
that the threshold be determined by taking the entire weight or volume
of the regulated mixture for mixtures regulated due to the presence of
acetone, ethyl ether, methyl ethyl ketone, methyl isobutyl ketone and
toluene. In mixtures that contain two or more listed chemicals, other
than acetone, ethyl ether, methyl ethyl ketone, methyl isobutyl ketone
and toluene, each chemical shall be compared against its respective
threshold. Where the mixture contains two or more chemicals that are
cumulative, other than acetone, ethyl ether, methyl ethyl ketone,
methyl isobutyl ketone and toluene, then the summed concentration of
the listed chemicals that are cumulative will be considered; where the
total weight of the cumulative listed chemicals exceeds the threshold
for any one of the listed chemicals contained in the mixture, then the
transaction will be regulated. Thresholds are proposed to be determined
by taking the weight or volume of listed chemical contained in the
mixture for all other listed chemicals.
Further, the provisions regarding excluded transactions, as set out
in 21 CFR 1310.08, will apply equally to mixtures containing the
specified chemicals.
Regulatory Flexibility and Small Business Concerns
The Domestic Chemical Diversion Control Act of 1993 replaced the
existing blanket exemption from regulation for chemical mixtures with a
provision that only those chemical mixtures specifically identified by
regulation would be exempt from DEA's chemical controls, based on a
finding that each mixture cannot be easily used in the illicit
manufacture of a controlled substance and that the chemical(s)
contained in the mixtures cannot be readily recovered. This change was
necessary to make the U.S.'s chemical controls consistent with Article
12,
[[Page 49512]]
Paragraph 14 of the United Nations 1998 Convention Against Illicit
Traffic in Narcotic Drugs and Psychotropic Substances (1988
Convention), which requires that chemical controls apply to the
chemicals themselves and to products containing the chemicals that are
compounded in such a way that such chemicals cannot be easily used or
recovered by readily applicable means.
In considering application for the new requirement, DEA recognized
that neither regulation nor exemption of all mixtures were a feasible
approach. Regulation of all chemical mixtures would cast too broad a
net, encompassing products that are not of significant concern to DEA
as sources for the diversion of listed chemicals and resulting in an
unnecessary regulatory burden on both industry and DEA. Also of
significance, exemption of all chemical mixtures would leave products
that are suitable for use in the illicit manufacture of controlled
substances open for diversion. With the growing effectiveness of
chemical controls, such unregulated mixtures could become a significant
source of chemicals for diversion, which would be inconsistent with
both DEA's mandate and the U.S.'s responsibilities under the 1988
Convention. Therefore, it was necessary to identify some middle ground
that would minimize the impact on industry while still satisfying the
intent of the requirement and the U.S.'s obligations under the 1988
Convention.
Originally, DEA proposed a system whereby manufacturers would
request exemptions for their specific products. However, industry
expressed concerns that the administrative burdens, for both industry
and DEA, would be too great, given the number of chemical mixtures in
commerce. Based on those concerns, DEA withdrew the proposal and opened
a dialogue with representative from the manufacturing, distributing,
and related segments of the chemical industry regarding how to best
address the matter of exemption.
An important DEA objective in establishing exemption criteria was
to obtain recommendations from the affected industry. The DEA met with
several interested parties including associations representing chemical
manufacturers, paint and coatings industry, flavor and extract
manufacturing, dietary supplement manufacturers and distributors, and
chemical distributors and affiliated members. These discussions, along
with available DEA information pertaining to the illicit manufacture of
controlled substances, were considered in the establishment of
exemption criteria under this proposal. The DEA realizes that, because
of the diverse industries affected by these regulations, not all
interested persons may have been fully represented prior to the
publication of this proposal. The DEA is therefore requesting that
comments be submitted to help ensure that the concerns of all
interested parties are considered.
Comments should identify the type of industry, including the number
of companies/individuals involved and the annual volume of business
they conduct; how the proposed regulatory requirements would impact
that industry (through the registration, recordkeeping, and reporting
requirements), and within the statutory requirements, any suggestions
or comments on how the final regulations might better be tailored to
the industry without compromising the basic mandate of the law to
prevent the diversion of listed chemicals for the illicit manufacture
of controlled substances.
The initial concern in addressing the matter of exemption was to
establish a system for the identification of the categories of chemical
mixtures to be exempted that would be objective and specific enough to
allow nontechnical personnel to easily understand and apply the
criteria and to allow accurate identification of those mixtures that
could readily be used in the illicit manufacture of controlled
substances while not encumbering those that could not.
Two options were considered: (1) The used of general product
categories, such as paints, coatings, adhesives, and sealants; refinery
and chemical plant streams; waste products; insecticides, pesticides,
and herbicides; consumer products, including cosmetics; and solutions
containing more than 5 percent solids by weight; and (2) the use of
concentration limits, expressed as the percentage of chemical, either
by volume or weight, that a mixture may contain.
Examination of the use of product categories revealed problems
involving their subjective nature, which could lead to confusion
regarding whether certain products might be included in the category.
In addition, the lack of specificity in such a system would cause
difficulties in identifying products that should not be included in a
category because of the manner in which they are formulated. It quickly
became apparent that use of product categories as the primary means to
identify exempt chemical mixtures would require the development of a
cumbersome, highly technical, and complicated set of definitions and
criteria in order to identify the mixtures to be granted exemption.
The concentration limits, by contrast, provide a clear cut,
objective means to identify whether a chemical mixture is or is not
exempt. By focusing specifically on the amount of chemical contained in
a given amount of mixture, which is of primary concern to DEA, the
system provides and unequivocal standard that is easily understood by
expert and layman alike. There is no need to establish a large, complex
and highly technical set of definitions and crtiera that must be used
to make a subjective determinations to what category a mixture belongs
in and whether it meets the exemptions criteria or not.
While the system of concentration limits can be used satisfactorily
with most chemical mixtures, it does not address those circumstances
where the formulation of the mixture or the manner in which the mixture
is distributed may be factors for consideration in determining
exemption status. Therefore, DEA is proposing the use of certain
limited categories for exemption. Additionally, DEA recognizes that
there will be those individual products which may not meet the
established exemption criteria but are deserving of consideration for
exemption due to specific factors that may limit their use in the
illicit manufacture of controlled substances. Therefore, provisions
have been made in the proposed regulations for a system for which a
manufacture may request exemption of a specific mixture.
Once the basic framework for the exemption process had been
established, DEA consulted with representatives of the regulated
industry, including chemical manufacturers and distributors, as well as
the paint and coatings, the flavoring and fragrances, and the dietary
and nutritional supplements industries, to identify the concentration
limits or other criteria that would satisfy the requirements of the law
with the least possible burden on regular commerce. The proposed
concentration limits were based on consideration of how useful the
mixtures would be in the illicit manufacture of controlled substances
and how great a percentage of the mixtures in regular commerce could be
exempted from regulation; the proposed limits provide a good balance
between the requirements of the law and the need to minimize the impact
of the law on legitimate commerce. Representatives of the chemical
manufacturers and distributors have indicated that the proposed
concentration limits should provide for
[[Page 49513]]
exemption of the majority of chemical mixtures in commerce.
In those instances where a chemical mixture will be subject to
regulation, the regulatory requirements are not unduly burdensome and
should not present any restriction on regular commerce. The primary
requirement, recordkeeping, applies only to those transactions that
meet or exceed the threshold established for the chemical contained in
the mixture. The information required to be maintained in the records
is minimal and can usually be found in the normal business records
maintained by anyone following good business practices. Additionally,
the chemicals contained in the mixture may be subject to other Federal
or state recordkeeping requirements, in which case the records
maintained may be used to satisfy DEA's requirement, provided the
necessary information is readily available. In addition, this proposed
rule will exempt persons from registration if the only List I chemicals
which they distribute, import or export are contained in exempt
mixtures; it is DEA's understanding that the bulk of chemical mixtures
in commerce contain List II, rather than List I chemicals.
In summary, the proposed system provides for the exemption of the
greatest possible population of mixtures while remaining consistent
with the requirements of the law and obligations under the U.N.
Convention. The combination of exemptions, together with the threshold
system and requirement that registration be obtained only for
activities involving List I chemicals allows for the lease possible
burden and cost to industry. Therefore the Acting Deputy Administrator,
in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)),
has reviewed this proposed rule and by approving it certifies that it
will not have a significant economic impact on a substantial number of
small business entities.
With respect to the specific economic and regulatory burdens
associated with the regulation of chemical mixtures (in those instances
where exemption is not possible), there are three different
requirements to be considered:
Registration
This requirement applies solely to persons who distribute, import,
or export List I chemicals, including those contained in regulated
chemical mixtures. Registration is required on an annual basis. The
initial registration cost is $595.00 and the annual registration
renewal cost is $477.00. Completion of the application requires
approximately 30 minutes.
The impact of the registration requirement will vary depending on
the type of industry and type of transactions. As noted, the
registration requirement applies only to List I chemicals.
Recordkeeping
Regulated persons must keep records regarding regulated
transactions. The records must reflect the name, address, and, if
required, DEA registration number of each party to the transaction; the
date of the transaction; the name, quantity, and form of packaging of
the listed chemical; the method of transfer (company truck, picked up
by customer, etc.); and the type of identification used by the
purchaser and any unique number on that identification.
As noted in 21 CFR 1310.06(b), normal business records shall be
considered adequate for satisfying the recordkeeping requirement, if
they contain the required information and are readily retrievable from
the other business records of the regulated person. It has been DEA's
experience that regulated persons at the non-retail level maintain such
information in their normal business records; therefore, no additional
burden is considered to apply. At the retail level, such information is
not normally kept, therefore, any records to be maintained would have
to be considered as part of the regulatory burden.
Reporting
Regulated persons must make reports of any regulated transactions
involving an extraordinary quantity of a listed chemical, an uncommon
method of payment or delivery, or any other circumstance that the
regulated person believes may indicate that the listed chemical will be
used in violation of the regulations (21 CFR 1310.05(a)(1)).
Additionally, any unusual or excessive loss or disappearance of a
listed chemical must be reported. It must be emphasized that this
requirement does not apply to all sales of listed chemicals; it applies
only to those sales involving suspicious/unusual circumstances or
thefts/losses.
In addition to the above reporting requirement, the Comprehensive
Methamphetamine Control Act of 1996 (MCA) established the requirement
that each regulated person who engages in a transaction with a
nonregulated person which involves ephedrine, pseudoephedrine, or
phenylpropanolamine (including drug products containing those
chemicals) and uses or attempts to use the Postal Service or any
private or commercial carrier, shall, on a monthly basis, submit a
report of each such transaction conducted during the previous month to
the Attorney General (21 U.S.C. 830(b)(3)). This requirement has been
the subject of much discussion and it is generally accepted that the
manner in which it is written provides DEA with no discretion to
exclude any person from the requirement. Legislative amendment of this
requirement to allow DEA some measure of discretion in its application
is being explored.
Total Regulatory Impact
The total regulatory impact of these requirements will vary based
on the type of industry involved and the types of transactions being
conducted. With the chemical industry, the total impact should be
limited. DEA has been informed by representatives of the chemical
industries that the bulk of chemical mixtures will contain List II
chemicals. Further, many of the companies that handle List I chemical
mixtures are already registered to handle List I chemicals. Therefore,
the registration requirement will have limited impact on that industry.
With respect to the recordkeeping requirements, the bulk of the
chemical mixture transactions are commercial in nature and involve
materials that are subject to stringent Federal and state requirements;
the information required to satisfy DEA's recordkeeping requirements
will already be available as part of the business records being
maintained by the regulated persons. Therefore, no additional burden is
anticipated to satisfy the recordkeeping requirement. With respect to
reporting, DEA is adjusting its existing, OMB approved information
collection regarding Reports of Suspicious Orders or Theft/Loss of
Listed Chemicals/Machines (OMB Number 1117-0024), to increase the
estimated number of annual reports by 2,000 and the estimated burden
hours by 340 hours per year.
With the dietary and nutritional supplement industry, the issue is
somewhat less clear. DEA has been informed by the manufacturers and
distributors of products that are sold at retail that their products
contain concentrations of ephedrine that are consistent with the
proposed exemption limit; therefore, the retail side of the industry
should experience little, if any, regulatory impact. However, DEA was
recently contacted by representatives of a segment of the industry
involved in the direct marketing of these products, who expressed grave
concern regarding the potential impact of the requirements on direct
marketers, especially the individual marketers selling small
[[Page 49514]]
amounts of the product to friends and neighbors.
DEA is well aware of the potential impact that the regulations
could have on such operations, having dealt with the issue with respect
to the direct marketing of drug products containing ephedrine,
pseudoephedrine, and phenylpropanolamine. As was stated in the
discussion regarding Exemption by Application earlier in this document,
it is not the intent of DEA to regulate those individuals engaged in
direct marketing sales of small amounts of these products in face-to-
face transactions. In addition to the proposed regulations allowing for
exemption by application, there are existing exemption procedures
available for types of transactions and categories of persons. An
exemption has already been provided to one direct marketing
organization and discussions are underway with another to also provide
an exemption provided certain circumstances are met. It must be noted
that the exemptions apply to individuals engaged in direct marketing
sales of small amounts of these products in face-to-face transactions;
manufacturers and wholesale distributors of the products remain subject
to the regulatory requirements.
Assessing the overall impact of the regulations on the dietary and
nutritional supplement industry has been hampered by the lack of
information regarding the overall scope and population of the industry.
DEA has, along with others, requested demographic information from the
industry; however, to date, we have not received the details necessary
to adequately estimate the potential impact of the regulations. As
stated elsewhere in this document, interested persons are invited to
submit comments identifying the scope and population of the industry;
the effect of the regulations on the industry, both in terms of the
extent to which proposed and existing exemptions will exclude the
industry from regulation and, where the exemptions do not extend, how
the above requirements will impact the industry; and any comments or
suggestions on how the regulations might be adjusted to address
industry concerns without compromising their intent to prevent the
diversion of listed chemicals to the illicit manufacture of controlled
substances.
This proposed rule has been reviewed pursuant to Executive Order
12866 and has been determined to be a significant regulatory action.
Therefore, it has been reviewed and approved by the Office of
Management and Budget.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 12612, and it has been determined that this
proposed rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
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, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. This rule
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation, or on the ability of United States-based companies to
compete with foreign-based companies in domestic and export markets.
List of Subjects
21 CFR Part 1300
Definitions, Drug traffic control, Controlled substances, List I
and List II chemicals.
21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
For the reasons set out above, it is proposed that 21 CFR parts
1300 and 1310 be amended as follows:
PART 1300--[AMENDED]
1. The authority citation for part 1300 continues to read as
follows:
Authority: 21 U.S.C. 802, 871(b), 951, 958(f).
2. Section 1300.02 is proposed to be amended by revising the
paragraph (b)(28)(i)(E) to read as follows:
Sec. 1300.02. Definitions relating to listed chemicals.
* * * * *
(b) * * *
(28) * * *
(i) * * *
(E) Any transaction in a chemical mixture designated in
Secs. 1310.12 and 1310.13 that the Administrator has exempted from
regulation.
* * * * *
PART 1310--[AMENDED]
1. The authority citation for part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b).
2. Section 1310.04 is proposed to be amended by adding a new
paragraph (h) as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(h) The thresholds and conditions in 21 CFR 1310.04(f) and
1310.04(g) will apply to transactions involving regulated chemical
mixtures. All regulated chemical mixtures containing List I and List II
chemicals with the exception of acetone, ethyl ether, methyl ethyl
ketone, toluene and methyl isobutyl ketone will have the threshold
determined by taking the weight of the listed chemical in the regulated
mixture. Regulated chemical mixtures that contain one or more of the
List II chemicals acetone, ethyl ether, methyl ethyl ketone, toluene
and methyl isobutyl ketone will have the threshold determined by taking
the entire weight of the mixture. The threshold for these mixtures will
be 1500 kilograms for export to the western hemisphere except Canada
and 150 kiograms for domestic transactions.
3. Part 1310 is proposed to be amended by adding new sections
1310.12 and 1310.13 as follows:
Sec. 1310.12 Exempt chemical mixtures.
(a) The chemical mixtures meeting the criteria in paragraphs (c),
(d) and (g) of this section are exempted by the Administrator from
application of sections 302, 303, 310, 1007, and 1008 of the Act (21
U.S.C. 822-3, 830, and 957-8) to the extent described in paragraphs (b)
and (c) of this section.
(b) No exemption granted pursuant to Sec. 1310.12 or Sec. 1310.13
affects the criminal liability of illegal possession, distribution,
exportation, or importation of listed chemicals contained in the exempt
chemical mixture.
(c) Mixtures containing a listed chemical in concentrations equal
to or less than those specified in the `Table of Concentration Limits'
are designated as exempt chemical mixtures for the purpose set forth in
this section. Calculation of percent by weight or by volume is given in
the Table along with the concentration limit and other relative
information.
[[Page 49515]]
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
The DEA
List I chemicals chemical Concentration Special conditions
code no. (percent)
----------------------------------------------------------------------------------------------------------------
N-Acetylanthranilic acid, its 8522 20% by weight........ Concentration based on any combination
salts and esters. of N-acetylanthranilic acid and its
salts and esters.
Anthranilic acid, and its salts 8530 20% by weight........ Concentration based on any combination
and esters. of anthranilic acid and its salts and
esters.
Benzaldehyde...................... 8256 30% by volume........
Benzyl cyanide.................... 8570 20% by volume........
Ephedrine, its salts, optical 8113 2% by weight......... Concentration based on any combination
isomers, and salts of optical of ephedrine, pseudoephedrine, and
isomers. their salts, optical isomers and salts
of optical isomers.
Ergonovine and its salts.......... 8675 Not exempt at any Chemical mixtures containing any amount
concentration. of ergonovine, including its salts, are
not exempt.
Ergotamine and its salts.......... 8676 Not exempt at any Chemical mixtures containing any amount
concentration. of ergotamine, including its salts, are
not exempt.
Ethylamine and its salts.......... 8678 20% by weight........ Ethylamine or its salts in an inert
carrier solvent is not considered a
mixture. Weight is based on ethylamine
in the mixture and not the combined
weight of carrier solvent, if any.
Hydriodic acid.................... 6695 20% by weight........ Aqueous or alcoholic solutions are not
considered mixtures.
Isosafrole........................ 8704 20% by volume........ Concentration in mixture cannot exceed
20% if taken alone or in any
combination with safrole.
Methylamine, and its salts........ 8520 20% by weight........ Methylamine or its salts in an inert
carrier solvent is not considered a
mixture. Weight is based on methylamine
in the mixture and not the combined
weight of carrier solvent, if any.
3,4-Methylenedioxyphenyl-2- 8502 20% by weight........
propanone.
N-Methylephedrine, its salts, 8115 0.1% by weight....... Concentration based on any combination
optical isomers, and salts of of N-methylephedrine, N-
optical isomers. methylpseudoephedrine and their salts,
optical isomers and salts of optical
isomers.
N-Methylpseudoephedrine, its 8119 0.1% by weight....... Concentration based on any combination
salts, optical isomers, and salts of N-methylpseudoephedrine N-
of optical isomers. methylephedrine, and their salts,
optical isomers and salts of optical
isomers.
Nitroethane....................... 6724 20% by volume........
Norpseudoephedrine, its salts, 8317 0.6% by weight....... Concentration based on any combination
optical isomers, and salts of of norpseudoephedrine,
optical isomers. phenylpropanolamine and their salts,
optical isomers and salts of optical
isomers.
Phenylacetic acid, and its salts 8791 20% by weight........ Concentration based on any combination
and esters. of phenylacetic acid and its salts and
esters.
Phenylpropanolamine, its salts, 1225 0.6% by weight....... Concentration based on any combination
optical isomers, and salts of of phenylpropanolamine,
optical isomers. norpseudoephedrine and their salts,
optical isomers and salts of optical
isomers.
Piperidine, and its salts......... 2704 20% by volume........ Concentration based on any combination
of piperidine and its salts.
Piperonal......................... 8750 20% by weight........
Propionic anhydride............... 8328 20% by volume........
Pseudoephedrine, its salts, 8112 2% by weight......... Concentration based on any combination
optical isomers, and salts of of pseudoephedrine, ephedrine, and
optical isomers. their salts, optical isomers and salts
of optical isomers.
Safrole........................... 8323 20% by volume........ Concentration in mixture cannot exceed
20% if taken alone or in any
combination with isosafrole.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
The DEA
List II chemicals chemical Concentration Special conditions
code no. (percent)
----------------------------------------------------------------------------------------------------------------
Acetic Anhydride.................. 8519 20% by volume........
Acetone........................... 6532 35% by volume........ Limit applies to acetone or any
combination of acetone, ethyl ether,
methyl ethyl ketone, methyl isobutyl
ketone and toluene if present in the
mixture by summing the concentrations
for each chemical.
Benzyl chloride................... 8568 20% by volume.
Ethyl ether....................... 6584 35% by volume........ Limit applies to ethyl ether or any
combination of acetone, ethyl ether,
methyl ethyl ketone, methyl isobutyl
ketone and toluene if present in the
mixture by summing the concentrations
for each chemical.
Hydrochloric acid................. 6545 20% by weight........ Aqueous or alcoholic solutions are not
considered mixtures.
Iodine............................ 6699 20% by weight........
Methyl ethyl ketone............... 6714 35% by volume........ Limit applies to methyl ethyl ketone or
any combination of acetone, ethyl
ether, methyl ethyl ketone, methyl
isobutyl ketone and toluene if present
in the mixture by summing the
concentrations for each chemical.
[[Page 49516]]
Methyl isobutyl ketone............ 6715 35% by volume........ Limit applies to methyl isobutyl ketone
or any combination of acetone, ethyl
ether, methyl ethyl ketone, methyl
isobutyl ketone and toluene if present
in the mixture by summing the
concentrations for each chemical.
Potassium permanganate............ 6579 15% by weight........
Sulfuric acid..................... 6552 20% by weight........ Aqueous solutions are not considered
mixtures.
Toluene........................... 6594 35% by volume........ Limit applies to toluene or any
combination of acetone, ethyl ether,
methyl ethyl ketone, methyl isobutyl
ketone and toluene if present in the
mixture by summing the concentrations
for each chemical.
----------------------------------------------------------------------------------------------------------------
(d) The following categories of chemical mixtures are automatically
exempt from the provisions of the Controlled Substances Act as
described in paragraph (a) of this section:
(1) Chemical mixtures that are distributed directly to an
incinerator for destruction and are subject to the United States
Environmental Protection Agency documentation on EPA Form 8700-22 and
8700-22A, provided that the person distributing the mixture to the
incinerator maintains and makes available to agents of the
Administration upon request such documentation for a period of no less
than two years.
(2) Completely formulated paints/coatings that meet the American
Society for Testing Materials specifications for the product. A
completely formulated paint/coating are only those formulations that
contain all the components of the paint/coating for use in the final
application without the need to add any additional substances except
possibly a thinner. A completely formulated paint or coating is defined
as any clear or pigmented liquid, liquefiable or mastic composition
designed for application to a substrate in a thin layer that is
converted to a clear or opaque solid protective, decorative or
functional adherent film after application.
(3) Harvested plant material that is in its natural state or has
been processed in a way that preserves the natural constituents in the
ratios that are found in the plant's natural state. Plant material
subjected to chemical or physical extraction, concentration, chemical
reaction or other treatment that alters the plant's natural
constituents or the ratios of the plant constituents are not exempt.
(e) The Administrator may at any time terminate or modify the
exemption for any chemical mixture which has been granted an exemption
pursuant to the concentration limits as specified in Sec. 1310.12(c);
or the exemption provisions for specific categories of chemical
mixtures as specified in Sec. 1310.12(d), if evidence of diversion or
attempted diversion is found. In terminating or modifying an exemption,
the Administrator shall issue and publish in the Federal Register
notification of the removal of an exempt product or group of exempt
products for which evidence of diversion has been found. This order
shall include a reference to the legal authority under which the order
is based and shall specify the date on which the termination of
exemption shall take effect. The Administrator shall permit any
interested party to file written comments on or objections to the order
within 60 days of the date of publication of the order in the Federal
Register. If any such comments or objections raise significant issues
regarding any finding of fact or conclusion of law upon which the order
is based, the Administrator shall immediately suspend the effectiveness
of the order until he may reconsider the order in light of comments and
objections filed. Thereafter, the Administrator shall reinstate,
terminate, or amend the original order as determined appropriate.
(f) The Administrator may upon evidence of diversion or attempted
diversion modify any part of the criteria for exemption as specified in
Sec. 1310.12(c) and Sec. 1310.12(d). In doing so, the Administrator
shall issue and publish a Notice of Proposed Rulemaking in the Federal
Register. The Administrator shall permit any interested persons to file
written comments on or objections to the proposal. After considering
any comments or objections filed, the Administrator shall publish in
the Federal Register a final order.
Sec. 1310.13 Exemption of chemical mixtures; application.
(a) The Administrator may, by publication of a Final Rule in the
Federal Register, exempt from the application of all or any part of the
Act, a chemical mixture consisting of two or more chemical components,
at least one of which is not a List I or List II chemical, if:
(1) The mixture is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance; and
(2) The listed chemical or chemicals contained in the chemical
mixture cannot be readily recovered.
(b) Any manufacturer seeking an exemption for a chemical mixture,
not exempt under Sec. 1310.12, from the application of all or any part
of the Act, pursuant to paragraph (a) of this section, may apply to the
Administrator, Drug Enforcement Administration, Department of Justice,
Washington, D.C. 20537.
(c) An application for exemption under this section shall contain
the following information:
(1) The name, address, and registration number, if any, of the
applicant;
(2) The date of the application;
(3) The exact trade name(s) of the applicant's chemical mixture
and, if the applicant formulates or manufactures the chemical mixture
for other entities, the exact trade names of the chemical mixtures and
the names of the entities for which the chemical mixtures were
prepared;
(4) The complete qualitative and quantitative composition of the
chemical mixture (including all listed and all non listed chemicals)
and its intended use;
(5) The chemical and physical properties of the mixture and how
they differ from the properties of the listed chemical or chemicals;
(6) A statement which the applicant believes is justification for
granting an exemption for the chemical mixture. The statement must
explain how the chemical mixture meets the exemption criteria set forth
in paragraph (a) of this section.
(7) The application will include a statement that the applicant
accepts the right of the Administrator to terminate exemption from
regulation for the chemical mixture granted exemption
[[Page 49517]]
under Sec. 1310.13 if evidence of diversion of the mixture, or similar
mixture, is found.
(8) The identification of any information on the application which
is considered by the applicant to be a trade secret or confidential and
entitled to protection under U.S. laws restricting the public
disclosure of such information.
(d) The Administrator may require the applicant to submit such
additional documents or written statements of fact relevant to the
application which he deems necessary for determining if the application
should be granted.
(e) Within a reasonable period of time after the receipt of an
application for an exemption under this section, the Administrator will
notify the applicant of acceptance or nonacceptance of the application.
If the application is not accepted, an explanation will be provided.
The Administrator is not required to accept an application if any
information required pursuant to paragraph (c) of this section or
requested pursuant to paragraph (d) of this section is lacking or not
readily understood. The applicant may, however, amend the application
to meet the requirements of paragraphs (c) and (d) of this section. If
the exemption is granted the applicant shall be notified in writing and
the Administrator shall issue and publish in the Federal Register an
order on the application, which shall include a reference to the legal
authority under which the order is based. This order shall specify the
date on which it shall take effect. The Administrator shall permit any
interested persons to file written comments on or objections to the
order. If any comments or objections raise significant issues regarding
any findings of fact or law upon which the order is based, the
Administrator shall immediately suspend the effectiveness of the order
until he has reconsidered the application in light of the comments and
objections filed. Thereafter, the Administrator shall reinstate,
terminate, or amend the original order as deemed appropriate.
(f) The Administrator may at any time terminate or modify any
product or product line granted an exemption pursuant to paragraph (e)
of this section. In terminating or modifying an exemption, the
Administrator shall issue and publish in the Federal Register
notification of the removal of an exempt product or group of exempt
products for which evidence of diversion has been found. This order
shall include a reference to the legal authority under which the order
is based and shall specify the date on which the termination of
exemption shall take effect. The Administrator shall permit any
interested party to file written comments on or objections to the order
within 60 days of the date of publication of the order in the Federal
Register. If any such comments or objections raise significant issues
regarding any finding of fact or conclusion of law upon which the order
is based, the Administrator shall immediately suspend the effectiveness
of the order until he may reconsider the order in light of comments and
objections filed. Thereafter, the Administrator shall reinstate,
terminate, or amend the original order as determined appropriate.
(g) Any change in the quantitative or qualitative composition of a
chemical mixture which has been granted an exemption by application
will require a new application for exemption unless such change causes
the newly formulated mixture to be automatically exempt by definition
in Sec. 1310.12. A new application is not necessary for a change in
name or other designation, code, or any identifier. For such changes or
additions a written notification is required. The DEA must be notified
of any changes at least 60 days in advance of the effective date for
the change.
(h) Each manufacturer which desires a mixture to be exempt must
apply separately as only those products specifically named in this
exempted category will be recognized. Companies which have similar
products to those in an exempted category must request and receive
separate approval for their product line.
(i) The following chemical mixtures, in the form and quantity
listed in the application submitted (indicated as the ``date'') are
designated as exempt chemical mixtures for the purposes set forth in
this section:
Exempt Chemical Mixtures
------------------------------------------------------------------------
Product
Manufacturer name Form Date
------------------------------------------------------------------------
[Reserved]................................ ........ ........ ........
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Dated: September 1, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-24293 Filed 9-15-98; 8:45 am]
BILLING CODE 4410-09-M