[Federal Register Volume 75, Number 124 (Tuesday, June 29, 2010)]
[Rules and Regulations]
[Pages 37301-37307]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15518]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-222F]
RIN 1117-AA64
Exempt Chemical Mixtures Containing Gamma-Butyrolactone
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: This rulemaking finalizes a November 12, 2008, Notice of
Proposed Rulemaking in which DEA proposed that chemical mixtures that
are 70 percent or less gamma-butyrolactone (GBL), by weight or volume,
be automatically exempt from regulatory controls under the Controlled
Substances Act (CSA). DEA is seeking through this rulemaking to exempt
only those chemical mixtures that do not represent a significant risk
of diversion. This regulation makes GBL chemical mixtures, in
concentrations greater than 70 percent, subject to List I chemical
regulatory requirements of the CSA, except if exempted through an
existing categorical exemption. DEA is taking this action because there
is a serious threat to the public safety associated with the ease by
which GBL is chemically converted to the schedule I controlled
substance gamma-hydroxybutyric acid (GHB).
DEA recognizes that concentration criteria alone cannot identify
all mixtures that warrant exemption. As a result, DEA regulations
provide for an application process by which manufacturers may obtain
exemptions from CSA regulatory controls for those GBL chemical mixtures
that are not automatically exempt under the concentration criteria.
DATES: This rulemaking becomes effective July 29, 2010. Persons seeking
registration must apply on or before July 29, 2010 to continue their
business pending final action by DEA on their application.
[[Page 37302]]
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, 8701 Morrissette Drive, Springfield, VA
22152; Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and Controlled Substances Import and Export Act (21 U.S.C. 801 et
seq.), as amended. DEA publishes the implementing regulations for these
statutes in Title 21 of the Code of Federal Regulations (CFR), parts
1300 to end. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical
purposes and to deter the diversion of controlled substances to illegal
purposes. The CSA mandates that DEA establish a closed system of
control for manufacturing, distributing, and dispensing controlled
substances. Any person who manufactures, distributes, dispenses,
imports, exports, or conducts research or chemical analysis with
controlled substances must register with DEA (unless exempt) and comply
with the applicable requirements for the activity. The CSA as amended
also requires DEA to regulate the manufacture and distribution of
chemicals that may be used to manufacture controlled substances. Listed
chemicals that are classified as List I chemicals are important to the
manufacture of controlled substances. Those classified as List II
chemicals may be used to manufacture controlled substances.
Illicit Uses of Gamma-Butyrolactone
Gamma-Butyrolactone, or GBL, is a chemical that is used as a
precursor in the illicit manufacture of the schedule I controlled
substance gamma-hydroxybutyric acid, or GHB. GBL is a necessary and
important chemical precursor in the clandestine synthesis of GHB
because, to date, no other chemical has been identified as a substitute
for GBL in the clandestine process. Congress recognized this and
regulated GBL as a List I chemical upon enactment of Pub. L. 106-172,
the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act
of 2000, on February 18, 2000.
GBL and GHB induce a sense of euphoria and intoxication and are
abused for their central nervous system (CNS) depressant effect. An
overdose from GBL or GHB may result in respiratory depression, coma,
and even death. Both substances have been associated with drug-
facilitated sexual assaults. The Drug Abuse Warning Network (DAWN) is a
national surveillance system operated by the Substance Abuse and Mental
Health Services Administration (SAMHSA) to monitor trends in drug
emergency department visits. SAMHSA collects information on GHB and GBL
separately but reports GHB and GBL together in its publications. This
reflects the similar threat to public safety and abuse liability of GBL
to GHB.
The conversion of GBL to GHB in a clandestine laboratory is a
simple one-step process. Availability of GBL is the determining factor
in producing GHB, not the execution of complicated chemical procedures
or having sophisticated scientific equipment. GBL is a unique chemical
precursor. It can be either converted into GHB by a simple chemical
reaction or efficiently converted into GHB by the body upon ingestion,
thus producing the same pharmacological effects as ingesting GHB. For
this reason, abusers or predators seeking to use GBL on their victims
routinely substitute GBL for GHB to obtain the same type of
intoxication.
Other Laws That Apply to GBL: Controlled Substance Analogue Provisions
Section 802(32)(B) of Title 21 provides that the designation of
GBL, or any other chemical, as a listed chemical does not preclude a
finding that the chemical is a controlled substance analogue under
subparagraph (A) of the definition 21 U.S.C. 802(32)(A).\1\ A
controlled substance analogue is treated, for purposes of Federal law,
as a schedule I controlled substance to the extent intended for human
consumption (21 U.S.C. 813). The analogue provision of the CSA has been
applied to prosecute individuals who have diverted GBL for human
consumption. Although a chemical commodity when used by legitimate
industry, diversion of GBL is tantamount to diversion of a schedule I
controlled substance if intended for human consumption.
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\1\ 21 U.S.C. 802(32)(A) Except as provided in subparagraph (C),
the term ``controlled substance analogue'' means a substance-- (i)
The chemical structure of which is substantially similar to the
chemical structure of a controlled substance in schedule I or II;
(ii) Which has a stimulant, depressant, or hallucinogenic effect
on the central nervous system that is substantially similar to or
greater than the stimulant, depressant, or hallucinogenic effect on
the central nervous system of a controlled substance in schedule I
or II; or
(iii) With respect to a particular person, which such person
represents or intends to have a stimulant, depressant, or
hallucinogenic effect on the central nervous system that is
substantially similar to or greater than the stimulant, depressant,
or hallucinogenic effect on the central nervous system of a
controlled substance in schedule I or II.
(B) The designation of gamma butyrolactone or any other chemical
as a Listed chemical pursuant to paragraph (34) or (35) does not
preclude a finding pursuant to paragraph (A) of this paragraph that
the chemical is a controlled substance analogue.
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Concern Over GBL-Containing Chemical Mixtures
Prior to control as a List I chemical, GBL had been sold under
false pretenses to disguise its intended use. Suppliers pretended that
GBL was being sold for use as ink jet printer cleaners, room
deodorizers, and as educational kits (which purport to demonstrate the
scientific principle of an exothermic chemical reaction).
Since the designation of GBL as a List I chemical in 2000, persons
who manufacture, distribute, import, or export GBL must be registered
with DEA and maintain records of transactions in GBL. These regulatory
requirements prevent unscrupulous persons from freely distributing GBL.
Persons without a legitimate business need to manufacture or distribute
GBL do not receive the required registration from DEA. DEA believes
that those wishing to traffic GBL are less willing to purchase GBL from
DEA-approved registrants who are required to maintain records that are
accessible to DEA.
DEA has observed the retail marketing and promotion of chemical
mixtures containing GBL. Exempt chemical mixtures containing GBL were
sold as cosmetic products and contained greater than 99 percent GBL
(along with dye(s), fragrance(s), skin conditioners, and other
ingredients). DEA became aware that persons were purchasing such
products for conversion to GHB or directly ingesting these products for
their GBL content. Retailers reported that they quickly sold out of
these products. DEA notified retailers of the potential for abuse,
which resulted in the voluntary withdrawal of these products from store
shelves. Manufacturers of said products stated their intent to
reformulate these products.
DEA is concerned that legitimate businesses may be unintentionally
contributing to the diversion of GBL. Without regulatory controls, DEA
is unable to monitor distributions of such chemical mixtures containing
GBL, since registration and recordkeeping requirements do not apply.
Regulation of GBL chemical mixtures pursuant to 21 U.S.C.
802(39)(A)(vi) is necessary to
[[Page 37303]]
reduce the threat to the public health and safety.
Defining a Chemical Mixture
Title 21 U.S.C. 802(40) defines the term ``chemical mixture'' 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.''
Therefore, a chemical mixture contains any number of listed chemicals
in combination with any number of non-listed chemicals.
DEA does not consider a chemical mixture to mean the combination of
a listed chemical and an inert carrier. An inert carrier is any
chemical that does not modify the function of the listed chemical but
is present to aid in the delivery of the listed chemical. Examples
include, but are not limited to, dilutions in water and the presence of
a carrier gas. For purposes of control under the CSA, these examples
would be controlled as List I or List II chemicals, not as a chemical
mixture containing a List I or List II chemical.
Past Regulations Regarding Chemical Mixtures
The Chemical Diversion and Trafficking Act of 1988 (Pub. L. 100-
690) (CDTA) created the legal definition of a ``chemical mixture'' (21
U.S.C. 802(40)), and exempted chemical mixtures from regulatory
coverage. The CDTA established 21 U.S.C. 802(39)(A)(v) to exclude ``any
transaction in a chemical mixture'' from the definition of a
``regulated transaction.'' The result of such exemption was that it
provided traffickers with an unregulated source for obtaining listed
chemicals for use in the illicit manufacture of controlled substances.
The Domestic Chemical Diversion Control Act of 1993 (Pub. L. 103-
200) (DCDCA), enacted in April 1994, subjected all chemical mixtures
containing List I and List II chemicals to CSA regulatory requirements,
unless such chemical mixtures were specifically exempted by regulation.
The regulatory requirements include recordkeeping, reporting, and
security for all regulated chemical mixtures with the additional
requirement of registration for handlers of List I chemical mixtures.
The DCDCA also provided the Attorney General with the authority to
establish regulations exempting chemical mixtures from the definition
of a ``regulated transaction,'' ``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'' (21 U.S.C. 802(39)(A)(vi)).
DEA treats all chemical mixtures containing List I and List II
chemicals as non-regulated (upon the withdrawal of its proposed rule
``Implementation of the Domestic Chemical Diversion Control Act of 1993
(DCDCA)'' (59 FR 51887, October 13, 1994; withdrawn at 59 FR 63738,
December 9, 1994)) until it promulgates a final rule that identifies
chemical mixtures that are exempt for each List I and List II chemical.
The withdrawal sought to prevent the immediate regulation of qualified
chemical mixtures, which was not necessary and would impose an undue
burden on industry. It also provided DEA the opportunity to gather
information to implement regulations pursuant to 21 U.S.C.
802(39)(A)(vi).
In 2003, DEA published a Final Rule (68 FR 23195, May 1, 2003) that
identified exempt mixtures containing the chemicals ephedrine, N-
methylephedrine, N-methylpseudoephedrine, norpseudoephedrine,
phenylpropanolamine, and pseudoephedrine, with an effective date of
June 2, 2003. In a second Final Rule (69 FR 74957, December 15, 2004;
corrected at 70 FR 294, January 4, 2005,) DEA promulgated regulations
that defined exempt chemical mixtures for 27 of the remaining 38 listed
chemicals. The effective date was January 14, 2005. As gamma-
butyrolactone (GBL) was not a listed chemical when DEA initiated this
regulatory action in 1998, regulation of chemical mixtures containing
gamma-butyrolactone was not addressed but was the subject of a separate
regulatory action.
Regulations Regarding Chemical Mixtures Containing GBL
On July 19, 2002, DEA published in the Federal Register an Advance
Notice of Proposed Rulemaking (ANPRM) (67 FR 47403; corrected at 67 FR
53842, August 19, 2002; corrected at 67 FR 56776, September 5, 2002) in
anticipation of identifying GBL-containing chemical mixtures to exempt
by regulation. The ANPRM invited interested persons to submit
information related to legitimate formulations containing GBL,
including the concentration of GBL in their mixtures. Comments received
to that ANPRM provided information DEA used in its Notice of Proposed
Rulemaking.
On November 12, 2008, DEA published a Notice of Proposed Rulemaking
(73 FR 66815) which proposed the control of certain GBL chemical
mixtures.
Defining Exempt Chemical Mixtures Containing GBL
In defining exempt chemical mixtures containing GBL for purposes of
the proposed rule, the clandestine use of GBL and the requirements of
21 U.S.C. 802(39)(A)(vi) were heavily considered. The requirements
described by statute do not allow for exemptions based on such factors
as: (1) Manufacturers selling only to known customers, (2) the cost of
the mixture, (3) the customer's knowledge of the product's chemical
content, packaging, and/or such related topics. 21 U.S.C.
802(39)(A)(vi) requires DEA to establish an exemption based on the
finding (1)that the mixture is formulated in such a way that it cannot
be easily used in the illicit production of a controlled substance and
(2) that the listed chemical or chemicals contained in the mixture
cannot be readily recovered.
After examination of the comments on the ANPRM and after weighing
the risk of diversion, on November 12, 2008 (73 FR 66815), DEA proposed
a 70 percent concentration limit (by weight or volume) to identify GBL
chemical mixtures that do not pose a significant risk of diversion. In
that NPRM, DEA stated that it anticipated that chemical mixtures over
70 percent, as identified for use as protective coatings and films,
will be automatically exempt pursuant to 21 CFR 1310.12(d)(2)
(``Completely formulated paints and coatings''), which is being revised
to clarify that film-forming agents are exempted. Additionally, the
NPRM clarified that other chemical mixtures having concentrations of
GBL over 70 percent may qualify for exemption via the application
process (21 CFR 1310.13). DEA proposed a 70 percent concentration limit
in an effort to prevent the automatic exemption of chemical mixtures
with higher concentration limits such as solvent-based mixtures (e.g.,
cleaners or thinners) which DEA had concluded could be useful to
traffickers.
Comments
In response to the November 12, 2008, Notice of Proposed Rulemaking
(73 FR 66815), DEA received three comments. One comment was from the
American Chemistry Council's GBL/1,4-Butanediol (BDO) Panel comprised
of companies that domestically produce and/or distribute GBL. The Panel
member companies manufacture a large
[[Page 37304]]
percentage of the total GBL produced in the United States. The Panel
stated that DEA's GBL proposal offers a reasonable approach to help
protect the public from risks of potential diversion ``without
unnecessary administrative and financial burden'' and further stated
that the Panel ``believes that exempting chemical mixtures containing
70 percent or less of GBL from List I requirements of the CSA
``provides a balanced criteria for regulatory exemption.''
A second comment was received directly from one of the Panel's
member companies, which is a major manufacturer and supplier of GBL.
The comment stated that this firm is in agreement with the Panel's
comments in support of DEA's proposed regulation. The commenter further
stated that it believed DEA ``thoroughly evaluated the information
gathered in response to the Advanced Notice of Proposed Rulemaking for
the exemption of GBL chemical mixtures published July 19, 2002 [67 FR
47403] and that DEA has ``proposed a reasonable approach for exempting
such mixtures.''
A third comment was received from the Healthcare Distribution
Management Association (HDMA) which represents the nation's primary,
full service healthcare product distributors. The comment stated that
HDMA reached out to groups in the chemical industry, and to its own
members, in an attempt to identify specific products containing GBL (in
concentrations greater than 70 percent) which would be subject to the
proposed regulatory controls. To date, HDMA stated that it has not
identified any such products which are distributed by healthcare
product distributors. This conclusion is consistent with information
developed by DEA. DEA does not believe that any products distributed by
healthcare distributors will fall under the proposed regulatory
controls. Therefore, DEA does not believe that this final rule will
have any impact upon HDMA members.
After careful consideration of the comments received, DEA is hereby
finalizing these regulatory controls exactly as proposed in the
November 12, 2008, Notice of Proposed Rulemaking (73 FR 66815).
Therefore, chemical mixtures that are 70 percent or less gamma-
butyrolactone (GBL), by weight or volume, are automatically exempt from
regulatory controls under the CSA. This regulation makes GBL chemical
mixtures, in concentrations greater than 70 percent, subject to List I
chemical regulatory requirements of the CSA, except if exempted through
an existing categorical exemption as provided in 21 CFR 1310.12(d).
Most notably, 21 CFR 1310.12(d)(2) provides a category exemption for
completely formulated paints and coatings. As such, completely
formulated paints and coatings consisting of greater that 70 percent
GBL shall not become regulated as a result of this final rule and
remain exempt from CSA chemical regulatory controls such as
recordkeeping, reporting, registration, and import/export requirements.
DEA recognizes that concentration and category criteria alone
cannot identify all mixtures that warrant exemption. As a result, 21
CFR 1310.13 provides for an application process by which manufacturers
may obtain exemptions from CSA regulatory controls for those GBL
chemical mixtures that are not automatically exempt under the
concentration or categorical criteria.
Thresholds and Excluded Transactions for Regulated GBL Chemical
Mixtures
The List I chemical GBL, as described in 21 CFR 1310.04(g)(1), does
not have a threshold. Therefore, all transactions in regulated GBL
chemical mixtures are regulated transactions. Certain transactions
described in 21 CFR 1310.08 are excluded from the definition of a
regulated transaction. These excluded transactions, as specified in 21
CFR 1310.08(d), are domestic, import, and export distributions of GBL
weighing 4,000 kilograms (net weight) or more in a single container.
This exclusion also applies to chemical mixtures.
Requirements That Apply to Regulated List I Chemical Mixtures
Persons interested in handling chemical mixtures containing List I
chemicals (here referred to as regulated chemical mixtures) must comply
with the following:
Registration. Any person who manufactures, distributes, imports or
exports a regulated chemical mixture, or proposes to engage in the
manufacture, distribution, importation or exportation of a regulated
chemical mixture, shall obtain a registration pursuant to the CSA (21
U.S.C. 822 and 957). Regulations describing registration for List I
chemical handlers are set forth in 21 CFR part 1309.
A separate registration is required for manufacturing,
distribution, importing, and exporting. Different locations operated by
a single entity require separate registration if any location is
involved with the manufacture, distribution, import, or export of
regulated chemical mixtures. DEA recognizes, however, that it is not
possible for persons who manufacture, distribute, import, or export
GBL-containing regulated chemical mixtures to immediately complete and
submit an application for registration and for DEA to issue
registrations immediately for those activities. To allow continued
legitimate commerce in GBL-containing regulated chemical mixtures, DEA
is establishing in 21 CFR 1310.09(k) a temporary exemption from the
registration requirement for persons desiring to manufacture,
distribute, import, or export GBL-containing regulated chemical
mixtures, provided that DEA receives a properly completed application
for registration on or before July 29, 2010. The temporary exemption
for such persons will remain in effect until DEA takes final action on
their application for registration. The temporary exemption applies
solely to the registration requirement; all other chemical control
requirements, including recordkeeping and reporting, remain in effect.
Additionally, the temporary exemption does not suspend applicable
federal criminal laws relating to GBL-containing regulated chemical
mixtures, nor does it supersede state or local laws or regulations. All
handlers of regulated chemical mixtures must comply with their state
and local requirements in addition to the CSA and other federal
regulatory controls.
DEA notes that warehouses are exempt from the requirement of
registration and may lawfully possess List I chemicals, if the
possession of those chemicals is in the usual course of business (21
U.S.C. 822(c)(2), 21 U.S.C. 957(b)(1)(B)). For purposes of this
exemption, the warehouse must receive the List I chemical from a DEA
registrant and shall only distribute the List I chemical back to the
DEA registrant and registered location from which it was received. All
other activities conducted by a warehouse do not fall under this
exemption; a warehouse that distributes List I chemicals to persons
other than the registrant and registered location from which they were
obtained is conducting distribution activities and is required to
register accordingly (21 U.S.C. 802(39)(A)(ii)).
Records and Reports. The CSA (21 U.S.C. 830) requires that certain
records be kept and reports be made that involve listed chemicals.
Regulations describing recordkeeping and reporting requirements are set
forth in 21 CFR part 1310. A record must be made and maintained for two
years after the date of a transaction involving a List I chemical,
provided the transaction is a regulated transaction. Because GBL is a
listed chemical for which no minimum threshold has been established (21
CFR
[[Page 37305]]
1310.04(g)(1)(v)), a distribution, receipt, sale, importation, or
exportation of a GBL-containing regulated chemical mixture in any
amount, except those very large distributions described in 21 CFR
1310.08(k), is a regulated transaction (21 CFR 1300.02(b)(28)). Title
21 CFR 1310.08(k) exempts domestic, import, and export distributions of
GBL weighing 4,000 kilograms (net weight) or more in a single container
from the definition of regulated transaction. This exemption also
applies to its chemical mixtures. The net weight of the mixture is
determined by measuring the mass of the mixture, not the mass of the
GBL contained in the mixture.
Further, 21 U.S.C. 830(b) and 21 CFR 1310.05(a) requires that each
regulated person shall report to DEA: (1) Any regulated transaction
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 CSA; (2) any proposed regulated transaction
with a person whose description or other identifying characteristics
the Administration has previously furnished to the regulated person;
(3) any unusual or excessive loss or disappearance of a listed chemical
under the control of the regulated person, and any in-transit loss in
which the regulated person is the supplier; and (4) any domestic
regulated transaction in a tableting or encapsulating machine.
Import/Export. All imports/exports of a regulated chemical mixture
shall comply with the CSA (21 U.S.C. 957 and 971). Regulations for
importation and exportation of List I chemicals are found in 21 CFR
part 1313. Separate registration is necessary for each activity (21 CFR
1309.22).
Administrative Inspection. Places, including factories, warehouses,
or other establishments and conveyances, where regulated persons may
lawfully hold, manufacture, or distribute, dispense, administer, or
otherwise dispose of regulated chemical mixtures or where records
relating to those activities are maintained, are controlled premises as
defined in 21 CFR 1316.02(c). The CSA (21 U.S.C. 880) allows for
administrative inspections of these controlled premises as provided in
21 CFR part 1316 Subpart A.
Regulatory Certifications
Regulatory Flexibility and Small Business Concerns
The Regulatory Flexibility Act (5 U.S.C. 601-612) requires agencies
to determine whether a rule will have a significant economic impact
upon a substantial number of small entities. The final rule would
impose no new requirements on manufacturers, distributors, importers,
and exporters that are already registered to handle GBL. DEA has not
been able to identify any United States firm that handles high purity
GBL mixtures that would be subject to the rule. Therefore, the rule
will not affect a substantial number of small entities.
In addition, the requirements of the rule other than the
registration fee can be met with standard business records, that is,
with orders, invoices, shipping papers, etc. that the business creates
and maintains in the normal course of business. The registration fee is
$2,293 for manufacturers, and $1,147 for distributors, importers, and
exporters. DEA registration and reregistration application fees are
established by rulemaking in accordance with DEA statutory mandates (21
U.S.C. 886a). The sectors that could be affected by this rule are
organic chemical manufacturers (NAICS 325199) and chemical wholesalers
(NAICS 42469); importers and exporters could be either manufacturers or
wholesalers. The smallest firms (those with fewer than five employees)
in the organic chemical manufacturing and chemical wholesale sector
have annual shipments and sales of about $1.27 million and $1.05
million, respectively, based on the 2002 Economic Census, updated to
2007 dollars. The registration fee would represent 0.2 percent of a
small chemical manufacturer's shipments and 0.1 percent of a
wholesaler's sales. Consequently, even if a United States-based small
entity exists that markets high purity GBL mixtures, the rule would not
impose a significant economic burden.
Further, as discussed above, commenters supported this regulatory
action and were, themselves, unable to identify any entities that would
be directly impacted by this rule.
In accordance with the Regulatory Flexibility Act, the Deputy
Administrator has reviewed this regulation and by approving it
certifies that this regulation will not have a significant economic
impact upon a substantial number of small entities.
Executive Order 12866
This regulation has been drafted and reviewed in accordance with
Executive Order 12866, Section 1(b), Principles of Regulation. It has
been determined that this rule is a ``significant regulatory action''
under Executive Order 12866, Section 3(f), Regulatory Planning and
Review, and accordingly this rule has been reviewed by the Office of
Management and Budget.
As noted in the previous section, DEA is unaware of any United
States firm that will have to register as a manufacturer, distributor,
importer, or exporter of a GBL mixture. Most commercial mixtures that
may exceed the 70 percent concentration are coatings and films, which
are already exempt. The only mixtures that DEA has been able to
identify that will be covered are essentially pure GBL (99.6-99.9
percent) being sold as paint strippers and cleaners in Europe. Anyone
wanting to import these products would be required to register, but DEA
considers it unlikely that anyone with a legitimate need for a paint
stripper or cleaner would pay the high prices ($120 to $160 per liter)
when substitute products are readily available in the U.S. for a
fraction of the cost. DEA also notes that any mixture that is more than
70 percent GBL by weight or volume may qualify for an exemption if GBL
cannot be readily recovered from the mixture and the mixture cannot be
easily used to produce controlled substances.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking 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 rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
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
$120,000,000 or more (adjusted for inflation) 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.
[[Page 37306]]
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in cost
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.
Paperwork Reduction Act
Persons manufacturing, distributing, importing and exporting
chemical mixtures containing a List I chemical are required to register
with DEA. This rule regulates chemical mixtures due to the presence of
GBL; however, such mixtures are automatically exempt if the
concentration of GBL is 70 percent or less by weight or volume. Under
this method of automatic exemption, persons who handle chemical
mixtures with concentration levels of GBL of 70 percent or less will
not be subject to CSA regulatory controls, including the requirement to
register with DEA. Further, many GBL chemical mixtures are already
categorically exempt from regulatory control as fully formulated paints
and coatings (21 CFR 1310.12(d)(2)). As discussed previously,
commenters supported this regulatory action and were, themselves,
unable to identify handlers of GBL that would be subject to this rule.
For persons handling chemical mixtures containing GBL in concentration
levels of greater than 70 percent who are not otherwise exempt from
regulatory controls, DEA anticipates granting some of these mixtures
exempt status by the application process (21 CFR 1310.13). Therefore,
although DEA believes the impact of this rulemaking under the Paperwork
Reduction Act will be minimal, at this time it is not feasible for DEA
to determine the extent of the impact of this rulemaking on the
regulated industry. Once DEA has determined the impact, it will make
the necessary filing with the Office of Management and Budget to adjust
the burden for its information collection ``application for
Registration under Domestic Chemical Diversion Control Act of 1993 and
Renewal Application for Registration under Domestic Chemical Diversion
Control Act of 1993'' [OMB control number 1117-0031] for the affected
industry.
List of Subjects in 21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting
requirements.
0
For the reasons set out above, 21 CFR part 1310 is amended as follows:
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
0
1. The authority citation for part 1310 continues to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.
0
2. Section 1310.09 is amended by adding new paragraph (k) to read as
follows:
Sec. 1310.09 Temporary exemption from registration.
* * * * *
(k)(1) Each person required by sections 302 or 1007 of the Act (21
U.S.C. 822, 957) to obtain a registration to manufacture, distribute,
import, or export regulated GBL-containing chemical mixtures, pursuant
to sections 1310.12 and 1310.13, is temporarily exempted from the
registration requirement, provided that DEA receives a properly
completed application for registration or application for exemption on
or before July 29, 2010. The exemption will remain in effect for each
person who has made such application until the Administration has
approved or denied that application. This exemption applies only to
registration; all other chemical control requirements set forth in
parts 1309, 1310, and 1313 of this chapter remain in full force and
effect.
(2) Any person who manufactures, distributes, imports or exports a
GBL-containing chemical mixture whose application for exemption is
subsequently denied by DEA must obtain a registration with DEA. A
temporary exemption from the registration requirement will also be
provided for those persons whose applications for exemption are denied,
provided that DEA receives a properly completed application for
registration on or before 30 days following the date of official DEA
notification that the application for exemption has been denied. The
temporary exemption for such persons will remain in effect until DEA
takes final action on their registration application.
0
3. Section 1310.12 is amended in the Table of Concentration Limits in
paragraph (c) by adding gamma-butyrolactone in alphabetical order
between ``Ethylamine and its salts'' and ``Hydriodic acid'' under List
I chemicals and by revising paragraph (d)(2) to read as follows:
Sec. 1310.12 Exempt chemical mixtures.
* * * * *
(c) * * *
Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
DEA chemical code Special
No. Concentration (percent) conditions
----------------------------------------------------------------------------------------------------------------
List I Chemicals
----------------------------------------------------------------------------------------------------------------
* * * * * * *
Gamma-Butyrolactone............ 2011 70% by weight or volume.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
* * * * *
(d) * * *
(2) Completely formulated paints and coatings: Completely
formulated paints and coatings are only those formulations that contain
all of the components of the paint or coating for use in the final
application without the need to add any additional substances except a
thinner if needed in certain cases. 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. Included in
this category are clear coats, top-coats, primers, varnishes, sealers,
adhesives, lacquers, stains, shellacs, inks,
[[Page 37307]]
temporary protective coatings and film-forming agents.
* * * * *
Dated: June 18, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15518 Filed 6-28-10; 8:45 am]
BILLING CODE 4410-09-P