[Federal Register Volume 73, Number 219 (Wednesday, November 12, 2008)]
[Proposed Rules]
[Pages 66815-66821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26606]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[Docket No. DEA-222P]
RIN 1117-AA64


Exempt Chemical Mixtures Containing Gamma-Butyrolactone

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of Proposed Rulemaking.

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SUMMARY: DEA is proposing 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. If finalized as proposed, this regulation would result in 
GBL chemical mixtures, in concentrations greater than 70 percent, 
becoming 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, 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 criteria.

DATES: Written comments must be postmarked and electronic comments sent 
on or before January 12, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-222p'' on all written and electronic correspondence. 
Written comments sent via regular or express mail should be sent to 
Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be directly sent to DEA electronically by sending an 
electronic message to [email protected]. Comments may also 
be sent electronically through http://www.regulations.gov using the 
electronic comment form provided on that site. An electronic copy of 
this document is also available at the http://www.regulations.gov Web 
site. DEA will accept attachments to electronic comments in Microsoft 
Word, WordPerfect, Adobe PDF, or Excel file formats only. DEA will not 
accept any file format other than those specifically listed here.
    Posting of Public Comments: Please note that all comments received 
are considered part of the public record and made available for public 
inspection online at http://www.regulations.gov and in the Drug 
Enforcement Administration's public docket. Such information includes 
personal identifying information (such as your name, address, etc.) 
voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your

[[Page 66816]]

comment, but do not want it to be posted online or made available in 
the public docket, you must include the phrase ``CONFIDENTIAL BUSINESS 
INFORMATION'' in the first paragraph of your comment. You must also 
prominently identify confidential business information to be redacted 
within the comment. If a comment has so much confidential business 
information that it cannot be effectively redacted, all or part of that 
comment may not be posted online or made available in the public 
docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the Drug Enforcement Administration's public docket file. Please note 
that the Freedom of Information Act applies to all comments received. 
If you wish to inspect the agency's public docket file in person by 
appointment, please see the FOR FURTHER INFORMATION CONTACT paragraph.

FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., 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 this 
statute 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 Public Law 106-
172, the ``Hillory J. Farias and Samantha Reid Date-Rape Drug 
Prohibition Act of 2000,'' on February 18, 2000.
    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 in order to obtain the same type of 
intoxication.
    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. In sum, the information available from the sources discussed 
above suggests a similar threat to public safety and abuse liability of 
GBL to GHB.

Other Regulations 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 (21 U.S.C. 
802(32)).\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 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 pretend 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

[[Page 66817]]

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.
    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) [as amended by Title VII of Pub. L. 109-172] is 
necessary to reduce the threat to the public health and safety.

Information Gathered by DEA Concerning GBL Chemical Mixtures

    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.

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) as amended by Title VII of Pub. 
L. 109-172).
    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) [as amended by Title VII of Pub. L. 109-172].
    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 was not a listed chemical when DEA initiated this 
regulatory action in 1998, regulation of chemical mixtures containing 
gamma-butyrolactone was not addressed but is the subject of this 
separate regulatory action.
    DEA has concluded that some mixtures of GBL are especially prone to 
diversion. Since the conversion of GBL to GHB is a simple chemical 
process, DEA is proposing to automatically exempt only those GBL 
chemical mixtures that meet the exemption criteria specified in 21 
U.S.C. 802(39)(A)(vi) as amended by Title VII of Pub. L. 109-172, i.e., 
those chemical mixtures 1) that are formulated in such a way that the 
chemical mixture cannot be easily used in the illicit production of a 
controlled substance and 2) in which the List I or List II chemical 
cannot be readily recovered.

Comments

    DEA received nine responses to the ANPRM, six from industrial firms 
and three from national associations. In general, the comments 
expressed a willingness to inform DEA of their formulations to provide 
assistance in drafting regulations. Most respondents claimed that GBL 
could not be readily extracted from their chemical mixtures. All 
respondents stated that good business practices, such as knowing their 
customer, prevent (limit) diversion. Responses also stated that selling 
to end-users (non-retail), the high cost of their GBL-containing 
chemical mixtures, and the customer not having knowledge of the 
composition, were also deterrents to diversion. The respondents use 
GBL-

[[Page 66818]]

containing chemical mixtures for the following applications: 
herbicides, automotive coatings, varnishes, electronics, polymers, and 
other specialty products.
    Specifically, two comments stated that GBL is used in chemical 
mixtures having application to automotive coatings. Because of the low 
concentration of GBL and the complex composition of these chemical 
mixtures, DEA agrees with the commenters' statements that these 
mixtures do not pose a significant risk of diversion. In a Final Rule 
published in the Federal Register on December 15, 2004 (69 FR 74957; 
corrected at 70 FR 294, January 4, 2005), DEA amended 21 CFR 1310.12 by 
adding subparagraph 1310.12(d)(2) that defines completely formulated 
paints and coatings as automatically exempt from CSA regulatory control 
pertaining to chemicals. This exemption also applies to completely 
formulated paints and coatings that contain GBL.
    In addition, three comments informed DEA that GBL is contained in 
chemical mixtures used in agricultural chemicals. GBL and other solvent 
chemicals act as a delivery system for the active ingredient and 
prevent crystallization. Other chemicals used in these chemical 
mixtures are emulsifying and defoaming agents. The commenters stated 
that these chemical mixtures contain up to 20 percent GBL, that the GBL 
is difficult to extract, and that these chemical mixtures are toxic.
    Four comments notified DEA that some chemical mixtures have 
application in the semiconductor industry contain GBL. In general, 
these chemical mixtures are used to form films and/or for the 
processing and cleaning of these films and associated equipment. 
Commenters indicated that the concentration of GBL ranges from a few 
percent to approximately 90 percent. From a review of the comments, DEA 
concludes that the majority of these chemical mixtures are film 
forming. DEA notes that 21 CFR 1310.12(d)(2) automatically exempts from 
CSA regulatory control completely formulated paints and coatings and 
includes these types of film-forming chemical mixtures. This exemption 
is based on the codified definition of completely formulated paints and 
coatings in 21 CFR 1310.12(d)(2) that includes a ``functional adherent 
film.'' In an effort to further clarify that these film forming agents 
are automatically exempt from CSA chemical regulatory controls, DEA is 
proposing that 21 CFR 1310.12(d)(2) be revised to state that, 
``Included in this category are clear coats, top-coats, primers, 
varnishes, sealers, adhesives, lacquers, stains, shellacs, inks, 
temporary protective coatings and film-forming agents.''
    One of the aforementioned commenters had concerns about small 
amounts of GBL in discarded waste streams and informed DEA that these 
waste materials should be exempt. DEA has finalized regulations (69 FR 
74957, December 15, 2004; corrected at 70 FR 294, January 4, 2005) that 
exempt ``chemical mixtures that are distributed directly to an 
incinerator for destruction or authorized waste recycler or reprocessor 
where such distributions are documented on United States Environmental 
Protection Agency Form 8700-22'' (21 CFR 1310.12(d)(1)).
    Finally, DEA was informed that some foods and food flavorings 
contain GBL in minute amounts that are measured in parts per million 
(ppm). In 1972, an expert panel of the Flavor and Extract Manufacturers 
Association of the United States concluded that these levels of GBL to 
be Generally Recognized as Safe (GRAS) as flavoring agents. The 
commenter informed DEA that typical concentrations are extremely small 
and less than 22 ppm. DEA recognizes that foods and flavorings that 
contain GBL levels in the ppm concentration range are GRAS and that 
such food items have no pharmacological activity.
    Food flavorings are chemical mixtures, and if above concentration 
limits, these mixtures are subject to CSA regulatory controls and 
provisions. GBL can be treated as a schedule I controlled substance 
analogue if intended for human consumption. However, currently marketed 
food flavorings that contain GBL and are GRAS are very unlikely to lead 
to criminal prosecution as schedule I controlled substance analogues. 
This is based on (1) Food flavorings being concentrates and consumed 
only after addition to a food item and not meant to be consumed in the 
concentrated form, (2) the food flavoring lacks abuse potential because 
the low concentration of GBL (i.e., ppm concentrations) does not 
produce pharmacological activity, and (3) treatment of GBL use in food 
flavorings as GRAS had been in effect prior to placement of GBL in the 
CSA with no threat to public safety. However, persons who divert food 
flavorings that contain GBL above the GRAS ppm concentrations for the 
purposes of manufacturing a controlled substance in violation of the 
CSA or for human consumption are subject to prosecution. Also, knowing 
or intentional distribution of GBL or GBL mixtures, regardless of 
concentration, to persons for the purpose of abuse is subject to 
prosecution.

Defining Exempt Chemical Mixtures Containing GBL

    In defining exempt chemical mixtures containing GBL for purposes of 
this 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 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.
    After examination of the comments on the ANPRM and after weighing 
the risk of diversion, DEA is proposing a 70 percent concentration 
limit (by weight or volume) to identify GBL chemical mixtures that do 
not pose a significant risk of diversion. The comments on the ANPRM 
suggest that some companies' formulations are no more than 70 percent 
GBL. DEA anticipates 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). Other chemical 
mixtures identified in the comments having concentrations of GBL over 
70 percent may qualify for exemption via the application process (21 
CFR 1310.13). DEA is proposing 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). DEA has concluded that these products could be 
useful to traffickers.

Thresholds and Excluded Transactions for Regulated GBL Chemical 
Mixtures

    GBL, a List I chemical 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 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.

[[Page 66819]]

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 958). 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. In order to allow 
continued legitimate commerce in GBL-containing regulated chemical 
mixtures, DEA is proposing to establish in 21 CFR 1310.09(i) 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 60 days after 
publication of the Final Rule implementing this Notice of Proposed 
Rulemaking. 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 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 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 proposed rule will have a significant economic 
impact upon a substantial number of small entities. The proposed 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 
proposed rule would 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

[[Page 66820]]

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.
    In accordance with the Regulatory Flexibility Act, the Acting 
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 recognizes that there may be products of 
which it is not aware that could be subject to the rule and seeks 
comments on that subject. 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.

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 proposes that chemical mixtures regulated due to 
the presence of GBL are automatically exempt if the concentration of 
GBL is 70 percent or less by weight or volume. Under this proposed 
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. For persons handling chemical mixtures containing 
GBL in concentration levels of greater than 70 percent, 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.
    For the reasons set out above, 21 CFR Part 1310 is proposed to be 
amended as follows:

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES

    1. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.

    2. Section 1310.09 is amended by adding new paragraph (k) to read 
as follows:


Sec.  1310.09  Temporary exemption from registration.

* * * * *
    (k) Each person required by section 302 of the Act (21 U.S.C. 822) 
to obtain a registration to distribute, import, or export regulated 
GBL-containing chemical mixtures, pursuant to Sec. Sec.  1310.12 and 
1310.13, is temporarily exempted from the registration requirement, 
provided that DEA receives a proper application for registration or 
application for exemption on or before [60 days from date of 
publication of the Final Rule implementing this Notice of Proposed 
Rulemaking]. 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.
    3. Section 1310.12 is amended in the Table of Concentration Limits 
in paragraph (c) by adding an entry for 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) * * *

[[Page 66821]]



                                          Table of Concentration Limits
----------------------------------------------------------------------------------------------------------------
                                           DEA Chemical
                                             Code No.       Concentration (percent)       Special 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 the component 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, temporary protective 
coatings and film-forming agents.

    Dated: October 31, 2008.
Michele M. Leonhart,
Acting Administrator.
[FR Doc. E8-26606 Filed 11-10-08; 8:45 am]
BILLING CODE 4410-09-P