```

[Federal Register: June 29, 2010 (Volume 75, Number 124)]
[Rules and Regulations]               
[Page 37301-37307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jn10-10]                         

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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
```