Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 37301 

This action therefore corrects part 

1308 to remove any reference to control 

of benzylfentanyl and thenylfentanyl in 

schedule I. 

Regulatory Certifications 

Administrative Procedure Act (5 U.S.C. 

553) 

An agency may find good cause to 

exempt a rule from certain provisions of 

the Administrative Procedure Act (5 

U.S.C. 553), including notice of 

proposed rulemaking and the 

opportunity for public comment, if it is 

determined to be unnecessary, 

impracticable, or contrary to the public 

interest. The temporary placement of 

benzylfentanyl and thenylfentanyl in 

Schedule I expired on November 29, 

1986. The substances were never 

scheduled and should have been 

removed from Title 21 of the Code of 

Federal Regulations, part 1308. This 

Final Rule corrects this by removing 

benzylfentanyl and thenylfentanyl from 

the listing of controlled substances in 

schedule I. As this Final Rule makes a 

technical correction by removing 

benzylfentanyl and thenylfentanyl from 

the Code of Federal Regulations, DEA 

finds it unnecessary and impracticable 

to permit public notice and comment. 

Therefore, DEA is publishing this 

document as a final rule. Further, as the 

removal of these substances prevents 

confusion about the scheduling of these 

substances, DEA finds there is good 

cause to make this final rule effective 

immediately upon publication. 

Regulatory Flexibility Act 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

601–612), and by approving it certifies 

that this regulation will not have a 

significant economic impact upon a 

substantial number of small entities. 

This action removes the substances 

benzylfentanyl and thenylfentanyl from 

the schedules of controlled substances. 

These substances were temporarily 

scheduled in 1985 under the emergency 

scheduling provisions (21 U.S.C. 811, 21 

CFR 1308.11(g)) and that temporary 

scheduling expired on November 29, 

1986; however, the substances were 

never removed from the listing. 

Executive Order 12866 

The Deputy Administrator certifies 

that this rulemaking has been drafted in 

accordance with the principles in 

Executive Order 12866 § 1(b). It has 

been determined that this is not ‘‘a 

significant regulatory action.’’ Therefore, 

this action has not been reviewed by the 

Office of Management and Budget. 

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 are 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 foreignbased companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Reporting and recordkeeping 

requirements. 

■ For the reasons set out above, 21 CFR 

part 1308 is amended as follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1308 

continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b) 

unless otherwise noted. 

■ 2. Section 1308.11 is amended by 

revising paragraph (g) to read as follows: 

§ 1308.11 Schedule I. 

* * * * * 

(g) Temporary listing of substances 

subject to emergency scheduling. Any 

material, compound, mixture or 

preparation which contains any 

quantity of the following substances: 

(1) [Reserved.] 

(2) [Reserved.] 

Dated: June 19, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–15529 Filed 6–28–10; 8:45 am] 

BILLING CODE 4410–09–P 

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 gammahydroxybutyric 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. 


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37302 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 

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. 

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 gammahydroxybutyric 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 onestep 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. 

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 


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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 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 nonlisted 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 GBLcontaining 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 filmforming 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 solventbased 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 


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37304 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 

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 GBLcontaining 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 


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Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 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 Statesbased 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. 


wwoods2 on DSK1DXX6B1PROD with RULES
37306 Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 

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 foreignbased 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. 

■ 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 

■ 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: 

§ 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 GBLcontaining 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. 

■ 3. Section 1310.12 is amended in the 

Table of Concentration Limits in 

paragraph (c) by adding gammabutyrolactone 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: 

§ 1310.12 Exempt chemical mixtures. 

* * * * * 

(c) * * * 

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 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, 


wwoods2 on DSK1DXX6B1PROD with RULES
Federal Register / Vol. 75, No. 124 / Tuesday, June 29, 2010 / Rules and Regulations 37307 

temporary protective coatings and filmforming 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0430] 

Drawbridge Operation Regulation; 

Black River, Port Huron, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: Commander, Ninth Coast 

Guard District, issued a temporary 

deviation from the regulation governing 

the operation of the Military Street 

Bridge at Mile 0.33, 7th Street Bridge at 

Mile 0.50, and the 10th Street Bridge at 

Mile 0.94 over the Black River, at Port 

Huron, MI. This deviation temporarily 

changes the bridge operating schedules 

to accommodate the City’s special 

events for 2010. This temporary 

deviation allows the bridges to remain 

secured to masted navigation on the 

dates and times listed. 

DATES: This deviation is effective on 

June 26, 2010 from 10:45 p.m. to 11:30 

p.m., on July 9, 2010 from 6 p.m. to 8 

p.m., and on July 14, 2010 from 6:15 

p.m. to 9 p.m. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0430 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0430 in the ‘‘Keyword’’ box 

and then clicking ‘‘Search’’. They are 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE, 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Lee D. Soule, Bridge 

Management Specialist, Ninth Coast 

Guard District; telephone 216–902– 

6085, e-mail; lee.d.soule@uscg.mil. If 

you have questions on viewing the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

202–366–9826. 

SUPPLEMENTARY INFORMATION: The City 

of Port Huron, Michigan, who owns and 

operates these drawbridges, requested a 

temporary deviation from the current 

operating regulations set forth in 33 CFR 

117.625. The purpose of this request is 

to facilitate efficient management of all 

transportation needs and provide timely 

public safety services during these 

special events. The most updated and 

detailed current marine information for 

this event, and all bridge operations, is 

found in the Local Notice to Mariners 

and Broadcast Notice to Mariners issued 

by the Ninth District Commander. In 

accordance with 33 CFR 117.35(e), the 

drawbridge must return to its regular 

operating schedule immediately at the 

end of the designated time periods. 

These deviations from the operating 

regulations are authorized under 33 CFR 

117.35. 

Dated: June 11, 2010. 

M. N. Parks, 

Rear Admiral, U.S. Coast Guard, Commander, 

Ninth Coast Guard District. 

[FR Doc. 2010–15703 Filed 6–28–10; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[Docket No. USCG–2010–0522] 

Drawbridge Operation Regulations; 

Milwaukee, Menomonee, and 

Kinnickinnic Rivers and South 

Menomonee and Burnham Canals, 

Milwaukee, WI 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of temporary deviation 

from regulations. 

SUMMARY: Commander, Ninth Coast 

Guard District, issued a temporary 

deviation from the regulation governing 

the operation of the Broadway Street 

Bridge at Mile 0.79, Water Street Bridge 

at Mile 0.94, Saint Paul Avenue Bridge 

at Mile 1.21, the Clybourn Street Bridge 

at Mile 1.28, Michigan Street Bridge at 

Mile 1.37, and the Wisconsin Avenue 

Bridge at Mile 1.46 over the Milwaukee 

River at Milwaukee, WI, during the 

scheduled Festa Italiana, and the 

Summerfest public events for the 2010 

season. 

DATES: This deviation is effective from 

9:30 p.m. to 1 a.m. on June 24, 2010 and 

July 3, 2010. A rain date of June 25 and 

July 4, 2010 are authorized. June 25, 

2010 through July 2, 2010 from 11 p.m. 

to 1 a.m. daily, and July 15, 2010 to July 

18 from 10 p.m. to midnight daily. 

ADDRESSES: Documents mentioned in 

this preamble as being available in the 

docket are part of docket USCG–2010– 

0522 and are available online by going 

to http://www.regulations.gov, inserting 

USCG–2010–0522 in the ‘‘Keyword’’ box 

and then clicking ‘‘Search’’. They are 

also available for inspection or copying 

at the Docket Management Facility (M– 

30), U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Lee D. Soule, Bridge 

Management Specialist, Ninth Coast 

Guard District; telephone 216–902– 

6085, e-mail lee.d.soule@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: The City 

of Milwaukee, WI, which owns and 

operates these drawbridges, has 

requested a temporary deviation from 

the current operating regulations set 

forth in 33 CFR 117.1093. The purpose 

of this request is to facilitate efficient 

management of all transportation needs 

and provide timely public safety 

services during these special events. 

The most updated and detailed current 

marine information for this event, and 

all bridge operations, is found in the 

Local Notice to Mariners and Broadcast 

Notice to Mariners issued by the Ninth 

District Commander. On June 24, 2010 

and including the rain date of June 25, 

2010 the bridges need not open for any 

vessel from 9:30 p.m. to 1 a.m. except 

at the discretion of the Milwaukee 

Police Department. From June 25 

through July 2, 2010 the bridges need 

not open for recreational vessels from 11 

p.m. to 1 a.m. except at the discretion 

of the Milwaukee Police Department. 

From July 15, 2010 through July 18, 

2010 the bridges need not open for 

recreational vessels between the hours 

of 10 p.m. and midnight for recreational 

vessels. In accordance with 33 CFR 

117.35(e), the drawbridge must return to 

its regular operating schedule 

immediately at the end of the 

designated time periods. These 

deviations from the operating 

regulations are authorized under 33 CFR 

117.35. 


wwoods2 on DSK1DXX6B1PROD with RULES