Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 20039 

monkfish, skates, Atlantic mackerel, 

squid, butterfish, scup, black sea bass, 

bluefish, spiny dogfish, Atlantic herring, 

tilefish, or Atlantic deep-sea red crab; or 

a moratorium permit for summer 

flounder; to carry a NMFS-approved sea 

sampler/observer. Also, any vessel or 

vessel owner/operator that fishes for, 

catches or lands hagfish, or intends to 

fish for, catch, or land hagfish in or from 

the exclusive economic zone must carry 

a NMFS-approved sea sampler/observer 

when requested by the Regional 

Administrator in accordance with the 

requirements of this section. 

* * * * * 

[FR Doc. 07–1953 Filed 4–20–07; 8:45 am] 

BILLING CODE 3510–22–S 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1310 

[Docket No. DEA–299I] 

RIN 1117–AB12 

Control of a Chemical Precursor Used 

in the Illicit Manufacture of Fentanyl as 

a List I Chemical 

AGENCY: Drug Enforcement 

Administration (DEA), U.S. Department 

of Justice. 

ACTION: Interim rule with request for 

comments. 

SUMMARY: This rulemaking controls the 

chemical N-phenethyl-4-piperidone 

(NPP) as a List I chemical under the 

Controlled Substances Act (CSA) (21 

U.S.C. 801 et seq.). Clandestine 

laboratories are using this chemical to 

illicitly manufacture the schedule II 

controlled substance fentanyl. 

The recent distribution of illicitly 

manufactured fentanyl has caused an 

unprecedented outbreak of hundreds of 

suspected fentanyl-related overdoses, at 

least 972 confirmed fentanyl-related 

deaths, and 162 suspected fentanylrelated deaths occurring mostly in 

Delaware, Illinois, Maryland, Michigan, 

Missouri, New Jersey, and 

Pennsylvania. NPP has been identified 

as the starting material in several seized 

fentanyl clandestine laboratories. In 

addition to DEA’s concern regarding the 

deaths associated with illicitly 

manufactured fentanyl, DEA is 

extremely concerned about the safety of 

law enforcement officers encountering 

these clandestine laboratories. 

Therefore, DEA is regulating NPP as a 

List I chemical through this Interim 

Rulemaking. DEA is soliciting 

comments on this Interim Rule. 

This rulemaking will subject handlers 

of NPP to the chemical regulatory 

provisions of the CSA and its 

implementing regulations, including 21 

CFR Parts 1309, 1310, 1313, and 1316. 

This rulemaking does not establish a 

threshold for domestic and international 

transactions of NPP. As such, all 

transactions involving NPP, regardless 

of size, shall be regulated. This 

rulemaking also specifies that chemical 

mixtures containing NPP will not be 

exempt from regulatory requirements at 

any concentration. Therefore, all 

transactions of chemical mixtures 

containing any quantity of NPP will be 

regulated and will be subject to control 

under the CSA. 

DATES: This rulemaking will become 

effective on April 23, 2007. Persons 

seeking registration must apply on or 

before June 22, 2007 to continue their 

business pending final action by DEA 

on their application. 

Written comments must be 

postmarked, and electronic comments 

must be sent on or before June 22, 2007. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–299I’’ on all written and 

electronic correspondence. Written 

comments via regular mail should be 

sent to the Deputy Assistant 

Administrator, Office of Diversion 

Control, Drug Enforcement 

Administration, Washington, DC 20537, 

Attention: DEA Federal Register 

Representative/ODL. Written comments 

sent via express mail should be sent to 

DEA Headquarters, Attention: DEA 

Federal Register Representative/ODL, 

2401 Jefferson-Davis Highway, 

Alexandria, VA 22301. Comments may 

be sent directly to DEA electronically by 

sending an electronic message to 

dea.diversion.policy@usdoj.gov. 

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 formats other than those specifically 

listed here. 

FOR FURTHER INFORMATION CONTACT: 

Christine A. Sannerud, Ph.D., Chief, 

Drug and Chemical Evaluation Section, 

Office of Diversion Control, Drug 

Enforcement Administration, 

Washington, DC 20537 at (202) 307–

7183. 

SUPPLEMENTARY INFORMATION:

Background 

The DEA is extremely concerned with 

the increase in the illicit manufacture 

and distribution of fentanyl, which has 

resulted in hundreds of fentanyl-related 

overdoses and fentanyl-related deaths 

across the country. Fentanyl is a 

schedule II controlled substance. 

Fentanyl and analogues of fentanyl are 

the most potent opioids available for 

human and veterinary use. Fentanyl 

produces opioid effects that are 

indistinguishable from morphine or 

heroin. However, fentanyl has a greater 

potency and a shorter duration of 

action. Fentanyl is approximately 50 to 

100 times more potent than morphine 

and 30 to 50 times more potent than 

heroin depending on the physiological 

or behavioral endpoints being 

measured, the route of administration, 

and other factors. 

The legitimate medical use of fentanyl 

is for anesthesia and analgesia, but 

fentanyl’s euphoric effects are highly 

sought after by narcotic addicts. 

Fentanyl can serve as a direct 

pharmacological substitute for heroin in 

opioid dependent individuals. However, 

fentanyl is a very dangerous substitute 

for heroin because the amount that 

produces a euphoric effect also induces 

respiratory depression. Furthermore, 

due to fentanyl’s increased potency over 

heroin, illicit drug dealers have trouble 

adjusting (‘‘cutting’’) pure fentanyl into 

proper dosage concentrations. As a 

result, unsuspecting heroin users or 

heroin users who know the substance 

contains fentanyl have difficulty 

determining how much to take to get 

their ‘‘high’’ and mistakenly take a 

lethal quantity of the fentanyl. 

Unfortunately, only a slight excess in 

the amount of fentanyl taken can be, 

and is often, lethal because the resulting 

level of respiratory depression is 

sufficient to cause the user to stop 

breathing. 

In April 2006, DEA issued an officer 

safety alert regarding the special 

precautions that must be observed when 

handling and processing suspected 

fentanyl. DEA is concerned with the 

unusual health hazards posed to law 

enforcement officers and forensic 

chemists from exposure to high purity 

fentanyl during law enforcement 

operations. Since high purity fentanyl 

can be fatal if sub-milligram quantities 

are accidentally swallowed, inhaled, or 

absorbed through the skin, the potential 

for lethal fentanyl exposure to law 

enforcement officers exists during raids 

of fentanyl clandestine laboratories, 

during seizures of drug exhibits, and 

during subsequent testing of pure 

fentanyl in the forensic laboratories. The 


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20040 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 

1The Chemical Abstracts Service Registry 

Number (CASRN) is created by the Chemical 

Abstracts Service (CAS) Division of the American 

Chemical Society and is part of an automated 

information system housing data and information 

on specific, definable chemical substances. The 

CAS registry number provides consistent and 

unambiguous identification of chemicals and 

facilitates sharing of chemical information. 

primary lethal exposure routes from 

high purity fentanyl are the following: 

accidental inhalation of airborne 

fentanyl powder; accidental transfer of 

fentanyl powder/liquid from 

contaminated hands/gloves that 

inadvertently touch the mouth, nose, or 

other mucous membranes; and 

accidental transfer through cuts in the 

skin or roughly abraded skin. 

Illicit Manufacture of Fentanyl 

DEA has determined from the forensic 

testing of seized illicit fentanyl that both 

the Janssen synthesis route and the 

Siegfried method are being used to 

clandestinely produce fentanyl. In 1965, 

Janssen Pharmaceutical patented the 

original synthesis procedure for 

fentanyl, which used n-benzyl-4- 

piperidone as the starting material. The 

Janssen synthesis route is difficult to 

perform and is beyond the rudimentary 

skills of most clandestine laboratory 

operators. Only individuals who have 

acquired advanced chemistry 

knowledge and skills have successfully 

used this synthesis route. Forensic 

laboratories can determine whether 

fentanyl was manufactured illicitly by 

the Janssen route by detecting the 

impurity benzylfentanyl in the tested 

fentanyl drug exhibit. 

In the early 1980s, an alternate 

fentanyl synthesis route was published 

in the scientific literature that uses NPP 

as the starting material. The Chemical 

Abstracts Service Registry Number 1

(CASRN) for NPP is 39742–60–4. The 

NPP synthesis route is described on the 

Internet and is referred to as the 

Siegfried method. The detection of the 

impurity 4-anilino-N-phenethyl-4- 

piperidine (ANPP) without the presence 

of benzylfentanyl in the fentanyl drug 

exhibit suggests that the fentanyl was 

manufactured by the Siegfried method 

(i.e., a small amount of ANPP is not 

consumed in the last reaction in the 

synthesis and a trace amount of ANPP 

can be found in the illicit fentanyl 

produced). 

Since 2000, four of the five domestic 

fentanyl clandestine laboratories seized 

by law enforcement have used the 

Siegfried method or a modified version 

of the Siegfried method to manufacture 

the illicit fentanyl. From these four 

domestic clandestine laboratories, about 

800 grams equivalent of pure fentanyl 

were seized. Furthermore, enough of the 

unused NPP precursor chemical was 

also seized to make an additional 5,000 

grams of pure fentanyl. Therefore, from 

the amount of illicit fentanyl and 

precursor chemicals found at these four 

domestic fentanyl laboratories using the 

Seigfried method or modified Seigfried 

method, the laboratories could have 

potentially generated a total of 5,800 

grams of illicit fentanyl. Since fentanyl 

is potent in sub-milligram quantities, 

the subsequent ‘‘cutting’’ of 5,800 grams 

of illicit fentanyl would be sufficient to 

make about 46 million fentanyl doses. 

Three of the domestic fentanyl 

clandestine laboratories seized by law 

enforcement are known to have 

obtained the NPP precursor chemical 

from domestic suppliers. This rule will 

make the purchase of NPP from 

domestic or international suppliers a 

regulated transaction. In this way, DEA 

will be informed of the sale of NPP and 

can take appropriate action, if 

necessary. Thus, DEA is regulating the 

chemical NPP as a List I chemical under 

the CSA (21 U.S.C. 801 et seq.). 

Furthermore, under 21 U.S.C 811(e) of 

the CSA, DEA also intends to control 

ANPP as a schedule II immediate 

precursor to fentanyl under a separate 

rulemaking. 

Illicit Fentanyl-Related Deaths 

DEA has seen a recent increase in the 

illicit manufacture of fentanyl. In just 

the last three years, a total of four 

domestic fentanyl clandestine 

laboratories have been seized. 

Furthermore, in 2006, DEA saw a sharp 

increase in the seizures of illicit 

fentanyl. Law enforcement seized a one 

kilogram package of high purity illicitlymanufactured fentanyl hydrochloride in 

California, a variety of illicit tablets 

containing fentanyl whose appearance 

is designed to mimic Ecstasy and 

OxyContin tablets, and various 

mixtures of illicitly-manufactured 

fentanyl powders combined with heroin 

or cocaine from locations across the 

United States. 

The distribution of illicit fentanyl or 

illicit fentanyl combined with heroin or 

cocaine (i.e., a ‘‘speedball’’) has resulted 

in an outbreak of hundreds of suspected 

fentanyl-related overdoses, at least 972 

confirmed fentanyl-related deaths, and 

162 suspected fentanyl-related deaths 

occurring mostly in Delaware, Illinois, 

Maryland, Michigan, Missouri, New 

Jersey, and Pennsylvania according to 

the Centers for Disease Control and 

Prevention (CDC) and local medical 

examiners. DEA terms fentanyl-related 

deaths ‘‘suspected’’ until confirmed 

through the completion of an autopsy, a 

positive toxicological testing result for 

fentanyl in the blood, and the reporting 

of the death to the DEA. 

Confirmed illicit fentanyl-related 

deaths have been reported to the DEA 

for the following six jurisdictions: 

Philadelphia, Pennsylvania; Cook 

County, Illinois; Wayne County, 

Michigan; St. Louis County, Missouri; 

the entire state of New Jersey, and the 

entire state of Delaware. Between April 

13, 2006, and September 27, 2006, the 

Philadelphia Medical Examiner’s Office 

confirmed 179 fentanyl-related deaths. 

Between April 18, 2005, and November 

9, 2006, the Chief Medical Examiner of 

Cook County, Illinois confirmed 314 

fentanyl-related deaths in the city of 

Chicago and its suburbs. Between 

August 27, 2005, and December 31, 

2006, the Wayne County Medical 

Examiner confirmed 230 fentanylrelated deaths in the city of Detroit and 

the surrounding county. Between 

August 16, 2005, and August 28, 2006, 

the St. Louis Medical Examiner 

confirmed 33 fentanyl-related deaths in 

St. Louis County. Between January 25, 

2006, and September 21, 2006, the New 

Jersey Department of Health confirmed 

86 fentanyl-related deaths in the entire 

State of New Jersey. Between April 20, 

2006, and September 2, 2006, the Chief 

Medical Examiner for Wilmington, 

Delaware, confirmed 19 fentanyl-related 

deaths in the entire state of Delaware. 

Since autopsies and toxicological testing 

for fentanyl take several weeks to 

complete and report, the above medical 

examiner reports represent the most 

current information regarding confirmed 

deaths linked to fentanyl available to 

DEA. 

The graph below shows the monthly 

rate of fentanyl-related deaths in the city 

of Chicago and its suburbs (Cook 

County, Illinois) through the beginning 

of November 2006. The rapid onset of 

the illicit fentanyl outbreak can be 

observed in the graph. 

BILLING CODE 4410–09–P 


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BILLING CODE 4410–09–C 


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20042 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 

Beyond these 972 confirmed fentanylrelated deaths in the six jurisdictions 

outlined above, other areas of the 

country have also been significantly 

impacted by this problem. There are 162 

suspected fentanyl-related deaths in 

these areas: 

• Grundy County, Illinois. 

• Macomb, Oakland & Genesee 

Counties of Michigan. 

• Rest of Pennsylvania. 

• Maryland, Massachusetts, Virginia, 

New Hampshire, Maine, Kentucky, and 

Ohio. 

From the information and data 

collected, there is a strong indication 

that the fentanyl in these confirmed and 

suspected fentanyl-related deaths is 

illicitly manufactured rather than 

diverted from legal pharmaceutical 

manufacturers. Deaths related to 

fentanyl pharmaceutical products were 

eliminated from the fentanyl-related 

deaths reported to the DEA by both the 

Cook County and Philadelphia medical 

examiners. Furthermore, forensic testing 

of seized fentanyl drug exhibits has 

identified the illicit fentanyl impurities 

benzylfentanyl and/or ANPP in the 

majority of these exhibits. The current 

forensic data suggests that most of these 

fentanyl-related deaths are from 

fentanyl illicitly manufactured by the 

Siegfried method using NPP. 

Availability of the Precursor Chemical 

DEA has determined that the 

precursor chemical, NPP, is readily 

available from commercial chemical 

suppliers. DEA has identified at least 62 

suppliers of NPP, of which 14 are 

located domestically and 48 are located 

internationally in Germany, India, and 

China. Since 2000, law enforcement has 

evidence to support that the NPP 

precursor chemical was obtained from 

domestic suppliers for three domestic 

fentanyl clandestine laboratories. 

Furthermore, a fentanyl clandestine 

laboratory in Mexico is believed to have 

obtained the NPP precursor chemical 

from an international supplier. Law 

enforcement has identified four separate 

chemical suppliers that have distributed 

NPP to illicit fentanyl clandestine 

laboratories. This rule will make the 

domestic sale of NPP a regulated 

transaction. This rule will also make the 

importation of NPP from an 

international supplier a regulated 

transaction. Documenting the domestic 

sale and importation of NPP is needed 

by law enforcement to identify the 

domestic diversion of NPP for the illicit 

manufacture of fentanyl in the United 

States. 

Regulation of NPP as a List I Chemical 

The CSA, specifically 21 U.S.C. 

802(34), 21 U.S.C. 802(35), and its 

implementing regulations at 21 CFR 

1310.02(c), provide the Attorney 

General with the authority to specify, by 

regulation, additional precursor or 

essential chemicals as ‘‘listed 

chemicals’’ if they are used in the 

manufacture of controlled substances in 

violation of the CSA. NPP is being used 

by clandestine laboratories as the 

starting material for the illicit 

manufacture of fentanyl. This interim 

rule regulates NPP as a List I chemical 

because DEA finds that NPP is used in 

the illicit manufacture of the controlled 

substance fentanyl and is important to 

the illicit manufacture of the controlled 

substance fentanyl. 

Handlers of NPP will become subject 

to the chemical regulatory provisions of 

the CSA, including 21 CFR Parts 1309, 

1310, 1313, and 1316. This rulemaking 

does not establish a threshold for 

domestic and import transactions of 

NPP pursuant to the provisions of 21 

CFR 1310.04(g). Due to the high potency 

of fentanyl, even a single gram (i.e., 1/ 

28th of an ounce) of NPP can be used 

illicitly to make about 7,750 dosage 

units of fentanyl. Therefore, all NPP 

transactions regardless of size shall be 

regulated transactions as defined in 21 

CFR 1300.02(b)(28). As such, all NPP 

transactions will be subject to 

recordkeeping, annual manufacturer 

reporting of inventory and use data, 

import/export controls, and other CSA 

chemical regulatory requirements. 

Chemical Mixtures of NPP 

This rulemaking also specifies that 

chemical mixtures containing NPP will 

not be exempt from regulatory 

requirements at any concentration, 

unless an application for exemption of 

a chemical mixture is submitted by a 

NPP manufacturer and the application 

is reviewed and accepted by the DEA 

under 21 CFR 1310.13 (Exemption by 

Application Process). Since even a small 

amount of NPP is able to make a 

significant amount of fentanyl, the 

control of chemical mixtures containing 

any amount of NPP is necessary to 

prevent the illicit extraction, isolation, 

and use of the NPP. Therefore, all 

chemical mixtures containing any 

quantity of NPP will be subject to CSA 

control, unless the NPP manufacturer is 

granted an exemption by the application 

process discussed below. This interim 

rule modifies the Table of Concentration 

Limits in 21 CFR 1310.12(c) to reflect 

the fact that chemical mixtures 

containing any amount of NPP are 

subject to CSA chemical control 

provisions. 

Exemption by Application Process 

DEA has implemented an application 

process to exempt mixtures from the 

requirements of the CSA and its 

implementing regulations (21 CFR 

1310.13). This application process was 

finalized in the Final Rule (68 FR 

23195) published May 1, 2003. Under 

the application process, manufacturers 

may submit an application for 

exemption for those mixtures that do 

not qualify for automatic exemption. 

Exemption status can be granted if DEA 

determines 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 cannot be readily 

recovered (i.e., it meets the conditions 

in 21 U.S.C. 802(39)(A)(vi)). 

Requirements for Handling List I 

Chemicals 

The designation of NPP as a List I 

chemical will subject NPP handlers to 

all of the regulatory controls and 

administrative, civil, and criminal 

sanctions applicable to the manufacture, 

distribution, importing, and exporting of 

a List I chemical. Persons potentially 

handling NPP, including regulated 

chemical mixtures containing NPP, will 

be required to comply with the 

following List I chemical regulations: 

1. Registration. Any person who 

manufactures or distributes a List I 

chemical, or proposes to engage in the 

manufacture or distribution of a List I 

chemical, must obtain a registration 

pursuant to the CSA (21 U.S.C. 822). 

Regulations describing registration for 

List I chemical handlers are set forth in 

21 CFR Part 1309. 

Consistent with 21 CFR Parts 1309 

and 1310, separate registrations will be 

required for manufacturing, 

distribution, importing, and exporting of 

NPP. Different locations operated by a 

single entity require separate 

registration if any location is involved 

with the distribution, importation, or 

exportation of NPP. Further, a separate 

registration is required for each 

principal place of business at one 

general physical location where List I 

chemicals are distributed, imported, or 

exported by a person (21 CFR 1309.23). 

Any person distributing, importing, or 

exporting an NPP chemical mixture will 

be subject to the registration 

requirement under the CSA as well. 

Effective April 23, 2007, any person 

manufacturing, distributing, importing, 

or exporting NPP or a chemical mixture 

containing NPP will become subject to 

the registration requirement under the 


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Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 20043 

CSA. DEA recognizes, however, that it 

is not possible for persons who are 

newly subject to the registration 

requirement to complete and submit an 

application for registration and for DEA 

to issue registrations for those activities 

immediately. Therefore, to allow 

continued legitimate commerce, DEA is 

establishing in § 1310.09(h) a temporary 

exemption from the registration 

requirement for persons desiring to 

engage in the manufacture, distribution, 

importation, or exportation of NPP, 

provided that DEA receives a properly 

completed application for registration 

on or before June 22, 2007. The 

temporary exemption for such persons 

will remain in effect until DEA takes 

final action on their application for 

registration or on their application for 

exemption for a chemical mixture 

containing NPP pursuant to § 1310.13. 

The temporary exemption applies 

solely to the registration requirement; 

all other chemical control requirements, 

including recordkeeping and reporting, 

are effective on April 23, 2007. 

Additionally, the temporary exemption 

does not suspend applicable Federal 

criminal laws relating to this chemical, 

nor does it supersede state or local laws 

or regulations. All manufacturers, 

distributors, importers, and exporters of 

NPP or chemical mixtures containing 

NPP must comply with applicable state 

and local requirements in addition to 

the CSA regulatory controls. 

2. Records and Reports. The CSA (21 

U.S.C. 830) requires that certain records 

be kept and reports be made with 

respect to listed chemicals. Regulations 

describing recordkeeping and reporting 

requirements are set forth in 21 CFR 

Part 1310. Pursuant to 21 CFR 1310.04, 

a record must be made and maintained 

for two years after the date of a 

transaction involving a listed chemical, 

provided the transaction is a regulated 

transaction. 

Each regulated bulk manufacturer of a 

listed chemical will be required to 

submit manufacturing, inventory and 

use data on an annual basis (21 CFR 

1310.05(d)). Existing standard industry 

reports containing the required 

information will be acceptable, 

provided the information is readily 

retrievable from the report. 

Title 21 CFR 1310.05(a) requires that 

each regulated person shall report to 

DEA 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 and its corresponding regulations. 

3. Import/Export. All imports/exports 

of a listed chemical shall comply with 

the CSA import and export provisions 

including 21 U.S.C. 957 and 971. 

Regulations for importation and 

exportation of List I chemicals are 

described in 21 CFR Part 1313. 

4. Security. All applicants and 

registrants shall provide effective 

controls against theft and diversion of 

chemicals as described in 21 CFR 

1309.71. 

5. Administrative Inspection. Places, 

including factories, warehouses, or 

other establishments and conveyances, 

where registrants or other regulated 

persons may lawfully hold, 

manufacture, distribute, dispense, 

administer, or otherwise dispose of a 

regulated chemical/chemical mixture 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 1316 Subpart A. 

Justification for Interim Rulemaking 

Under 5 U.S.C. 553(b)(B), an agency 

may forgo a Notice of Proposed 

Rulemaking and the accompanying 

period of public comment where ‘‘the 

agency for good cause finds (and 

incorporates the finding and a brief 

statement of the reasons therefore in the 

rules issued) that notice and public 

procedure thereon are impracticable, 

unnecessary, or contrary to the public 

interest.’’ DEA is implementing these 

controls as an Interim Rule because DEA 

has determined that the delay 

necessitated by following public notice 

and comment procedures would be 

‘‘contrary to the public interest.’’

The public harm caused by the 

current illicit manufacture and 

distribution of fentanyl is 

unprecedented. The higher potency of 

fentanyl relative to heroin prevents 

illicit drug dealers from adjusting 

(‘‘cutting’’) pure fentanyl into fixed, 

predictable, non-lethal dosage 

concentrations resulting in overdoses 

and deaths among the heroin user 

population. The manufacture and 

distribution of illicit fentanyl has 

generated a pattern of outbreaks of 

overdoses and deaths across the United 

States. Since April 2005, the current 

outbreak of illicit fentanyl is responsible 

for at least 972 confirmed fentanylrelated deaths and an additional 162 

suspected fentanyl-related deaths. Most 

of the fentanyl-related deaths have 

occurred since February 2006 and have 

occurred mostly in the Chicago, Detroit, 

and Philadelphia metropolitan areas. 

These fentanyl-related deaths are 

continuing at a sustained rate. 

The current volume of deaths is 

creating a growing crisis for law 

enforcement and health authorities. In 

response to the emerging crisis, DEA 

joined Chicago area law enforcement 

agencies to convene an emergency twoday conference on fentanyl in Chicago 

in June 2006 and the Office of National 

Drug Control Policy (ONDCP) convened 

a one-day demand reduction forum in 

Philadelphia in July 2006. Numerous 

law enforcement and health authorities 

expressed concern regarding recent 

increases in clandestine production of 

fentanyl and the resulting overdoses and 

deaths. The testing of drug exhibits by 

Federal, State, and local forensic 

laboratories confirms that the bulk of 

the fentanyl being distributed in the 

outbreak areas has been manufactured 

illicitly. Furthermore, the lack of a 

sudden increase in the diversion of 

fentanyl-containing pharmaceutical 

products supports the conclusion that 

the current outbreak of fentanyl-related 

deaths is from illicitly manufactured 

fentanyl. 

The increase in street-level fentanyl 

may be the result of the relative ease 

with which fentanyl can be produced 

via the Siegfried method and the 

widespread distribution of the Siegfried 

method on the Internet. Preliminary 

data indicates that the majority of the 

deaths in the current fentanyl outbreak 

have been caused by the distribution of 

illicit fentanyl that was made by the 

Siegfried method. This determination is 

based on the identification of ANPP and 

the absence of the benzylfentanyl 

impurity in seized fentanyl drug 

exhibits. The starting material for the 

Siegfried method, NPP, is currently 

unregulated and readily available from 

both domestic and international 

chemical supply companies. 

Immediate action at the Federal level 

is warranted to prevent the unregulated 

manufacture, importation, exportation, 

and distribution of the NPP precursor 

chemical. DEA, as well as other law 

enforcement and public health 

authorities, have concluded that this 

action is necessary to prevent any 

further domestic illicit production of 

fentanyl. Law enforcement has 

postulated that many of the fentanylrelated overdoses and deaths in the 

Chicago and Detroit areas may be 

associated with a clandestine fentanyl 

laboratory recently seized in Mexico. 

However, a significant number of the 

fentanyl-related overdoses and deaths 

may also be associated with domestic 

clandestine fentanyl laboratories. 

Control of NPP will aid DEA’s efforts to 

combat domestic production of illicit 


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20044 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 

fentanyl by enabling DEA to track NPP 

from its importation through all 

domestic transactions. Furthermore, the 

regulatory controls on the exportation of 

NPP to potential source countries will 

help DEA prevent the use of NPP 

exported from the United States for the 

foreign production of illicit fentanyl. 

In April 2006, DEA issued an officer 

safety alert regarding the special 

precautions that must be observed when 

handling and processing suspected 

fentanyl. DEA is concerned with the 

unusual health hazards posed to law 

enforcement officers and forensic 

chemists from exposure to high purity 

fentanyl during law enforcement 

operations. Since high purity fentanyl 

can be fatal if sub-milligram quantities 

are accidentally swallowed, inhaled, or 

absorbed through the skin, the potential 

for lethal fentanyl exposure to law 

enforcement officers exists during raids 

of fentanyl clandestine laboratories, 

during seizures of drug exhibits, and 

during subsequent testing of pure 

fentanyl in the forensic laboratories. The 

primary lethal exposure routes from 

high purity fentanyl are the following: 

Accidental inhalation of airborne 

fentanyl powder; accidental transfer of 

fentanyl powder/liquid from 

contaminated hands/gloves that 

inadvertently touch the mouth, nose, or 

other mucous membranes; and 

accidental transfer through cuts in the 

skin or roughly abraded skin. 

Another reason DEA is issuing the 

regulation of NPP as an Interim Rule is 

to prevent illicit fentanyl manufacturers 

from stockpiling NPP. A Notice of 

Proposed Rulemaking would provide 

advance warning to illicit fentanyl 

manufacturers of DEA’s intent to control 

NPP. The illicit fentanyl manufacturers 

could easily stockpile multiple 

kilograms of NPP undetected before the 

chemical becomes regulated. Due to the 

potency of fentanyl, the stockpiling of as 

little as 10 kilograms of NPP is sufficient 

to cause another outbreak of fentanylrelated deaths of the unprecedented 

magnitude the U.S. is currently 

experiencing. 

The Administrative Procedure Act 

permits an agency to forgo the delay in 

effective date associated with 

substantive rules ‘‘for good cause found 

and published with the rule’’ (5 U.S.C. 

553(d)(3)). For the same reasons 

discussed above, in order to protect the 

public health and prevent further illicit 

production of fentanyl, this rule shall be 

effective immediately upon publication. 

Furthermore, pursuant to its authority 

under 21 U.S.C. 821 and 871, DEA has 

concluded that the threat to public 

health and safety is such that it is 

necessary and appropriate for DEA to 

forgo the requirements of 21 CFR 

1310.02(c) that the agency publish a 

proposal 30 days prior to adding a listed 

chemical by final rule. 

Handling of Confidential or Proprietary 

Information 

Confidential or proprietary 

information may be submitted as part of 

a comment regarding this Interim 

Rulemaking. Confidential or proprietary 

information should be clearly identified 

at the beginning of the comment. 

Information designated as confidential 

or proprietary will be treated 

accordingly. The release of confidential 

business information is protected from 

disclosure by Exemption 4 of the 

Freedom of Information Act (FOIA), 5 

U.S.C. 552(b)(4), and the U.S. 

Department of Justice procedures set 

forth in 28 CFR 16.8. Comments may be 

submitted using the information 

provided in the ADDRESSES section of 

this document, and must be postmarked 

on or before June 22, 2007. 

Regulatory Certifications 

Regulatory Flexibility Act and Small 

Business Concerns 

The Deputy Administrator hereby 

certifies that this rulemaking has been 

drafted in accordance with the 

Regulatory Flexibility Act (5 U.S.C. 

605(b)). The Regulatory Flexibility Act 

(RFA) applies to rules that are subject to 

notice and comment. DEA is issuing this 

rule as an emergency action and an 

interim final rule. Therefore, the RFA 

provisions do not apply. DEA did 

consider, however, the impact on small 

entities. 

Some of the firms DEA identified as 

potentially handling NPP are small 

entities. The highest cost that the rule 

would impose on these firms is less 

than $2,500 for registration. The 

smallest firm (1 to 4 employees) in the 

organic chemical sector has annual 

revenues of about $1.1 million. For 

those not already registered with DEA, 

the cost of registration represents 0.2 

percent of annual revenues, which does 

not constitute a significant economic 

impact. Consequently, this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

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 ‘‘a 

significant regulatory action.’’

Therefore, this action has been reviewed 

by the Office of Management and 

Budget. 

DEA is listing NPP as a List I 

chemical. Anyone manufacturing, 

distributing, importing, or exporting 

NPP will have to register each location 

where NPP is handled, maintain records 

of transactions involving NPP, and take 

steps to ensure that the chemicals are 

secure (e.g., stored in sealed containers 

in areas where access can be controlled 

or monitored). The requirement for 

records of transactions can be met using 

routine business records (e.g., purchase 

orders, shipping papers). 

DEA has identified 14 domestic 

chemical companies that supply NPP 

and that would be required to comply 

with this rule. Furthermore, DEA has 

determined that the vast majority of the 

domestic use of NPP is for the 

manufacture of the schedule II drug 

fentanyl. Eight companies may 

domestically manufacture NPP, of 

which two of these companies may also 

import NPP. However, DEA has not 

been able to determine whether these 

companies are currently manufacturing 

NPP. Some companies may not 

manufacture NPP, but rather purchase 

NPP in order to redistribute it to meet 

special orders. Other companies may 

manufacture NPP upon receiving an 

order; one company indicated that it has 

not produced NPP for two years. DEA 

has identified an additional six 

domestic companies that appear to only 

import NPP for subsequent domestic 

distribution. DEA has been able to 

document one domestic pharmaceutical 

company that uses NPP to manufacture 

fentanyl or fentanyl analogues. 

The cost of compliance with the 

chemical requirements is basically the 

cost of the annual registration fee 

($2,430 for manufacturers; $1,215 for 

distributors, importers, and exporters) 

plus the time required to complete the 

registration form (0.5 hours); 

registrations can be completed online. 

The recordkeeping requirements can be 

met with normal business records. The 

FDA requirements for manufacturing 

practices for pharmaceutical 

ingredients, together with the value of 

the products, generally ensure that firms 

already have security measures 

adequate to meet DEA’s requirements. 

Even if the two firms that could 

manufacture or import obtained 

separate registrations for the two 

business activities, the total cost of the 

rule would be less than $30,000, which 

is the rounded estimate of the cost for 

all fourteen firms to register with DEA 

in their respective business activities. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in Sections 3(a) and 


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Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 20045 

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. 

Paperwork Reduction Act 

This Interim Rulemaking will subject 

persons handling NPP to CSA List I 

regulatory requirements. Any person 

who manufactures, distributes, imports, 

or exports NPP must register with DEA. 

As discussed previously, DEA has 

identified 14 domestic chemical 

companies who would be required to 

register with DEA. Persons wishing to 

register with DEA to handle List I 

chemicals must do so using DEA Form 

510, Application for Registration under 

Domestic Chemical Diversion Control 

Act of 1993, and persons wishing to 

renew their registration must do so 

using DEA Form 510a, Renewal 

Application for Registration under 

Domestic Chemical Diversion Control 

Act of 1993 [OMB control # 1117–0031]. 

Persons importing, exporting, and 

conducting international transactions 

involving NPP must comply with 

regulatory requirements regarding the 

notification of DEA of pending 

transactions. As DEA cannot estimate 

how many of the 14 identified firms 

import, export, or conduct international 

transactions with NPP, DEA is 

estimating that all identified firms 

conduct such transactions. DEA has no 

information regarding actual number of 

transactions conducted annually, but 

based on the uses of NPP believes that 

the number of transactions is very low. 

DEA is estimating that each firm will 

conduct five import transactions, and 

two export transactions annually. DEA 

has not identified any firms serving as 

United States brokers conducting 

international transactions involving 

NPP. Therefore, DEA has not estimated 

any international transactions involving 

NPP. 

The U.S. Department of Justice, Drug 

Enforcement Administration, has 

submitted the following information 

collection requests to the Office of 

Management and Budget (OMB) for 

review and clearance in accordance 

with review procedures of the 

Paperwork Reduction Act of 1995. The 

information collections are published to 

obtain comments from the public and 

affected agencies. 

All comments and suggestions, or 

questions regarding additional 

information, to include obtaining a copy 

of the proposed information collection 

instrument with instructions, should be 

directed to Mark W. Caverly, Chief, 

Liaison and Policy Section, Office of 

Diversion Control, Drug Enforcement 

Administration, Washington, DC 20537. 

Written comments and suggestions 

from the public and affected agencies 

concerning the collections of 

information are encouraged. Your 

comments on the information 

collection-related aspects of this rule 

should address one or more of the 

following four points: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

(2) Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

(4) Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. 

Overview of Information Collections 

1117–0031: 

(1) Type of Information Collection: 

Revision of an existing collection. 

(2) Title of the Form/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. 

(3) Agency form number, if any, and 

the applicable component of the U.S. 

Department of Justice sponsoring the 

collection: 

Form Number: DEA Form 510 and 

DEA Form 510a. 

Office of Diversion Control, Drug 

Enforcement Administration, U.S. 

Department of Justice. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: Not-for-profit, government 

agencies. 

Abstract: The Domestic Chemical 

Diversion Control Act requires that 

manufacturers, distributors, importers, 

and exporters of List I chemicals which 

may be diverted in the United States for 

the production of illicit drugs must 

register with DEA. Registration provides 

a system to aid in the tracking of the 

distribution of List I chemicals. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: DEA estimates that 2,301 

persons respond to this collection 

annually. DEA estimates that it takes 30 

minutes for an average respondent to 

respond when completing the 

application on paper, and 15 minutes 

for an average respondent to respond 

when completing an application 

electronically. This application is 

submitted annually. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: DEA estimates that this 

collection has a public burden of 783 

hours annually. 

Form Number 

respondents 

Total burden hours 

DEA–510 (paper) ............................................................................................................................................................. 187 93.5 

DEA–510 (electronic) ....................................................................................................................................................... 102 25.5 

DEA–510a (paper) ........................................................................................................................................................... 644 322 

DEA–510a (electronic) ..................................................................................................................................................... 1,368 342 

Total .......................................................................................................................................................................... .................... 783 


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20046 Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 

Overview of Information Collection 

1117–0023: 

(1) Type of Information Collection: 

Revision of an existing collection. 

(2) Title of the Form/Collection: 

Import/Export Declaration for List I and 

List II Chemicals. 

(3) Agency form number, if any, and 

the applicable component of the U.S. 

Department of Justice sponsoring the 

collection: 

Form Number: DEA Form 486. 

Office of Diversion Control, Drug 

Enforcement Administration, U.S. 

Department of Justice. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: 

Primary: Business or other for-profit. 

Other: None. 

Abstract: Persons importing, 

exporting, and conducting international 

transactions with List I and List II 

chemicals must notify DEA of those 

transactions in advance of their 

occurrence, including information 

regarding the person(s) to whom the 

chemical will be transferred and the 

quantity to be transferred. For 

importations, persons must also provide 

return declarations, confirming the date 

of the importation and transfer, and the 

amounts of the chemical transferred. 

This information is used to prevent 

shipments not intended for legitimate 

purposes. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: 

Number of respondents Number of responses Average time per response Total hours 

Form 486 (export) .................................................................... 239 7,945 0.2 hour (12 minutes) ............. 1,589 

Form 486 (export return declaration) ....................................... 239 7,945 0.08 hour (5 minutes) ............. 662 .08 

Form 486 (import) .................................................................... 230 2,348 0.25 hour (15 minutes) ........... 587 

Form 486 (import return declaration)* ...................................... 230 2,583 0.08 hour (5 minutes) ............. 215 .2 

Form 486 (international transaction) ........................................ 9 111 0.2 hour (12 minutes) ............. 22 .2 

Form 486 (international transaction return declaration) ........... 9 111 0.08 hour (5 minutes) ............. 9 .25 

Quarterly reports for imports of acetone, 2-butanone, and toluene.110 440 0.5 hour (30 minutes) ............. 220 

Total .................................................................................. 239 ........................ ................................................. 3,304 .73 

* DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate submission of a subsequent return 

declaration. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: DEA estimates that this 

collection will take 3,305 hours 

annually. 

If additional information is required, 

contact: Lynn Bryant, Department 

Clearance Officer, Information 

Management and Security Staff, Justice 

Management Division, U.S. Department 

of Justice, Patrick Henry Building, Suite 

1600, 601 D Street NW., Washington, 

DC 20530. 

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 $114,000,000 or more 

in any one year, and will not 

significantly or uniquely affect small 

governments. Therefore, no actions were 

deemed necessary under the provisions 

of the Unfunded Mandates Reform Act 

of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by Section 804 of the 

Congressional Review Act/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 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 1310.02 is amended by 

adding a new paragraph (a)(28) to read 

as follows: 

§ 1310.02 Substances covered. 

* * * * * 

(a) * * * 

(28) N-phenethyl-4-piperidone 

(NPP)—8332. 

* * * * * 

■ 3. Section 1310.04 is amended by 

adding a new paragraph (g)(1)(vi) to 

read as follows: 

§ 1310.04 Maintenance of records. 

* * * * * 

(g) * * * 

(1) * * * 

(vi) N-phenethyl-4-piperidone (NPP) 

* * * * * 

■ 4. Section 1310.09 is amended by 

adding new paragraph (h) to read as 

follows: 

§ 1310.09 Temporary exemption from 

registration. 

* * * * * 

(h) Each person required under 21 

U.S.C. 822 and 21 U.S.C. 957 to obtain 

a registration to manufacture, distribute, 

import, or export regulated Nphenethyl-4-piperidone (NPP), 

including regulated chemical mixtures 

pursuant to § 1310.12, is temporarily 

exempted from the registration 

requirement, provided that DEA 

receives a proper application for 

registration or application for exemption 

for a chemical mixture containing NPP 

pursuant to § 1310.13 on or before June 

22, 2007. 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 the Act 

and parts 1309, 1310, 1313, and 1316 of 

this chapter remain in full force and 

effect. Any person who manufactures, 

distributes, imports or exports a 

chemical mixture containing Nphenethyl-4-piperidone (NPP) whose 

application for exemption is 

subsequently denied by DEA must 

obtain a registration with DEA. A 


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Federal Register / Vol. 72, No. 77 / Monday, April 23, 2007 / Rules and Regulations 20047 

temporary exemption from the 

registration requirement will also be 

provided for those persons whose 

application 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. 

■ 5. Section 1310.12 is amended by 

adding in alphabetical order in the table 

in paragraph (c) an entry for ‘‘Nphenethyl-4-piperidone (NPP)’’ to read 

as follows: 

§ 1310.12 Exempt chemical mixtures. 

* * * * * 

(c) * * * 

TABLE OF CONCENTRATION LIMITS

DEA chemical 

code No. Concentration Special conditions 

* * * * * * * 

N-phenethyl-4-piperidone (NPP) ............ 8332 ................. Not exempt at any concentration ........... Chemical mixtures containing any 

amount of NPP are not exempt. 

* * * * * * * 

* * * * * 

Dated: April 11, 2007. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 07–2015 Filed 4–20–07; 8:45 am] 

BILLING CODE 4410–09–C 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD13–07–013] 

RIN 1625–AA00 

Special Local Regulation: ULHRA 

Hydroplane Races, Columbia Park, 

Kennewick, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary special local 

regulation for the ULHRA National 

Series Hydroplane Race to be held on 

the waters of the Columbia River in the 

vicinity of Columbia Park, Kennewick, 

WA. These special local regulations 

limit the movement of non-participating 

vessels in the regulated race area. This 

temporary rule is needed to provide for 

the safety of life on navigable waters 

during the event. 

DATES: This regulation is effective from 

7 a.m. to 7 p.m. on May 19 and 20, 2007. 

ADDRESSES: Documents indicated in this 

preamble as being available in the 

docket are part of docket (CGD13–07–

013) and are available for inspection or 

copying at U.S. Coast Guard MSO/ 

Group Portland, 6767 N. Basin Avenue, 

Portland, Oregon 97217 between 7 a.m. 

and 4 p.m., Monday through Friday, 

except Federal holidays. 

FOR FURTHER INFORMATION CONTACT: 

Petty Officer Michelle Duty, c/o Captain 

of the Port, Portland 6767 N. Basin 

Avenue, Portland, Oregon 97217, (503) 

240–2590. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B) and 

5 U.S.C. 553 (d)(3), the Coast Guard 

finds that good cause exists for not 

publishing an NPRM and for making 

this rule effective less than 30 days after 

publication in the Federal Register. 

Publishing an NPRM would be contrary 

to public interest since immediate 

action is necessary to ensure the safety 

of vessels and spectators. If normal 

notice and comment procedures were 

followed, this rule would not become 

effective until after the date of the event. 

For this reason, following normal 

rulemaking procedures in this case 

would be impracticable and contrary to 

the public interest. 

Background and Purpose 

The Coast Guard is establishing a 

temporary special local regulation to 

allow for a safe racing event. This event 

occurs on the Columbia River in Lake 

Wallula in the vicinity of Columbia Park 

in Kennewick, WA and is scheduled to 

start at 7 a.m. and last until 7 p.m. on 

May 19 and 20, 2007. This event may 

result in a number of recreational 

vessels congregating near the 

hydroplane races. The hydroplane race 

poses several dangers to the public 

including excessive noise, objects 

falling from any accidents, and 

hydroplanes racing at high speeds in 

proximity to other vessels. Accordingly, 

the special local regulation is needed to 

protect watercraft and their occupants 

from safety hazards associated with the 

event. This special local regulation will 

be enforced by representatives of the 

Captain of the Port, Portland, Oregon. 

The Captain of the Port may be assisted 

by other federal, state, and local 

agencies. 

Discussion of Rule 

This temporary rule will create a 

regulated area to assist in minimizing 

the inherent dangers associated with 

hydroplane races. These dangers 

include, but are not limited to, excessive 

noise, race craft traveling at high speed 

in close proximity to one another and to 

spectator craft, and the risk of airborne 

objects from any accidents associated 

with hydroplanes. In the event that 

hydroplanes require emergency 

assistance, rescuers must have 

immediate and unencumbered access to 

the craft. The Coast Guard, through this 

action, intends to promote the safety of 

personnel, vessels, and facilities in the 

area. Due to these concerns, public 

safety requires these regulations to 

provide for the safety of life on the 

navigable waters. 

Regulatory Evaluation 

This temporary rule is not a 

‘‘significant regulatory action’’ under 

section 3(f) of Executive Order 12866, 

Regulatory Planning and Review, and 

does not require an assessment of 

potential costs and benefits under 

section 6(a)(3) of that Order. The Office 

of Management and Budget has not 

reviewed it under that Order. It is not 

‘‘significant’’ under the regulatory 

policies and procedures of the 

Department of Homeland Security 

(DHS). 

We expect the economic impact of 

this temporary rule to be so minimal 


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