23790 Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules and Regulations 

imports, exports, engages in research or 

conducts instructional activities with 

lacosamide, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in instructional 

activities or conduct research with 

lacosamide, must be registered to 

conduct such activities in accordance 

with Part 1301 of Title 21 of the Code 

of Federal Regulations (CFR). Any 

person who is currently engaged in any 

of the above activities and is not 

registered with DEA must submit an 

application for registration on or before 

June 22, 2009 and may continue their 

activities until the DEA has approved or 

denied the application. 

Security. Lacosamide is subject to 

schedule III–V security requirements 

and must be manufactured, distributed, 

and stored in accordance with 

§§ 1301.71, 1301.72(b), (c), and (d), 

1301.73, 1301.74, 1301.75(b) and (c), 

1301.76, and 1301.77 of Title 21 of the 

CFR on and after June 22, 2009. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of lacosamide which are distributed on 

or after June 22, 2009 must comply with 

requirements of §§ 1302.03–1302.07 of 

Title 21 of the Code of Federal 

Regulations. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of lacosamide must keep an 

inventory of all stocks of lacosamide on 

hand pursuant to §§ 1304.03, 1304.04 

and 1304.11 of Title 21 of the CFR on 

or after June 22, 2009. Every registrant 

who desires registration in schedule V 

for lacosamide must conduct an 

inventory of all stocks of the substance 

on hand at the time of registration. 

Records. All registrants must keep 

records pursuant to §§ 1304.03, 1304.04, 

1304.21, 1304.22, and 1304.23 of Title 

21 of the Code of Federal Regulations on 

or after June 22, 2009. 

Prescriptions. All prescriptions for 

lacosamide pharmaceutical products 

must be issued pursuant to 21 CFR 

1306.03–1306.06 and 1306.21, 1306.23– 

1306.27 on or after June 22, 2009. 

Importation and Exportation. All 

importation and exportation of 

lacosamide must be in compliance with 

part 1312 of Title 21 of the CFR on or 

after June 22, 2009. 

Criminal Liability. Any activity with 

lacosamide not authorized by, or in 

violation of, the CSA or the Controlled 

Substances Import and Export Act 

occurring on or after June 22, 2009 shall 

be unlawful. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

§ 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this final rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Lacosamide pharmaceutical products 

will be prescription drugs used for the 

treatment of partial-onset seizures. 

Handlers of lacosamide often handle 

other controlled substances used in the 

treatment of central nervous system 

disorders which are already subject to 

the regulatory requirements of the CSA. 

Executive Order 12988 

This regulation meets the applicable 

standards set forth in §§ 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 

provisions of the Unfunded Mandates 

Reform Act of 1995. 

Congressional Review Act 

This rule is not a major rule as 

defined by § 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 costs or prices: 

or significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or on the 

ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ Under the authority vested in the 

Attorney General by section 201(a) of 

the CSA (21 U.S.C. 811(a)), and 

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to Title 

28, Part 0, Appendix to Subpart R, 

Section 12, the Deputy Administrator 

hereby amends 21 CFR part 1308 as 

follows: 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 1. The authority citation for 21 CFR 

part 1308 continues to read as follows: 

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

unless otherwise noted. 

■ 2. Section 1308.15 is amended by 

revising paragraph (e)(1) and adding a 

new paragraph (e)(2) to read as follows: 

§ 1308.15 Schedule V. 

* * * * * 

(e) * * * 

(1) Lacosamide [(R)-2-acetoamido-Nbenzyl-3-methoxy-propionamide]—2746 

(2) Pregabalin [(S)-3-(aminomethyl)-5- 

methylhexanoic acid]—2782 

Dated: May 12, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–11927 Filed 5–20–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1308 

[Docket No. DEA–319F] 

Schedules of Controlled Substances: 

Placement of Tapentadol Into Schedule 

II 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: With the issuance of this final 

rule, the Deputy Administrator of the 

Drug Enforcement Administration 

(DEA) places the substance tapentadol, 

including its isomers, esters, ethers, 

salts and salts of isomers, esters and 

ethers whenever the existence of such 

isomers, esters, ethers, and salts is 

possible, into schedule II of the 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules and Regulations 23791 

Controlled Substances Act (CSA). As a 

result of this rule, the regulatory 

controls and criminal sanctions of 

schedule II will be applicable to the 

manufacture, distribution, dispensing, 

importation, and exportation of 

tapentadol and products containing 

tapentadol. 

DATES: Effective Date: June 22, 2009. 

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, Virginia 22152, Telephone: 

(202) 307–7183. 

SUPPLEMENTARY INFORMATION: 

Background 

On November 20, 2008, the Food and 

Drug Administration (FDA) approved 

tapentadol for marketing in the United 

States as a prescription drug product for 

the treatment of moderate-to-severe 

acute pain. Tapentadol is a new 

molecular entity with centrally-acting 

analgesic properties. 

Tapentadol has dual modes of action, 

namely mu (μ) opioid receptor agonistic 

action and inhibition of reuptake of 

norepinephrine at the norepinephrine 

transporter. The chemical name of its 

monohydrochloride salt form is 3- 

[(1R,2R)-3-(dimethylamino)-1-ethyl-2- 

methylpropyl]phenol hydrochloride. 

Tapentadol shares substantial 

pharmacological effects and abuse 

potential with other schedule II opioid 

analgesics, e.g., morphine, oxycodone, 

and hydromorphone. 

Since tapentadol is a new molecular 

entity, there has been no evidence of 

diversion, abuse, or law enforcement 

encounters involving the drug. 

On November 13, 2008, the Assistant 

Secretary for Health, Department of 

Health and Human Services (DHHS), 

sent the Deputy Administrator of DEA a 

scientific and medical evaluation and a 

letter recommending that tapentadol be 

placed into schedule II of the CSA. 

Enclosed with the November 13, 2008, 

letter was a document prepared by the 

Food and Drug Administration (FDA) 

entitled, ‘‘Basis for the Recommendation 

for Control of Tapentadol in Schedule II 

of the Controlled Substances Act.’’ The 

document contained a review of the 

factors which the CSA requires the 

Secretary to consider (21 U.S.C. 811(b)). 

After a review of the available data, 

including the scientific and medical 

evaluation and the scheduling 

recommendation from DHHS, the 

Deputy Administrator of the DEA 

published a Notice of Proposed 

Rulemaking entitled ‘‘Schedules of 

Controlled Substances: Placement of 

Tapentadol into Schedule II’’ on 

February 17, 2009 (74 FR 7386), which 

proposed placement of tapentadol into 

schedule II of the CSA. The proposed 

rule provided an opportunity for all 

interested persons to submit their 

written comments on or before March 

19, 2009. 

Comments Received 

The DEA received three comments in 

response to the Notice of Proposed 

Rulemaking. One comment was from a 

consulting firm, one comment was from 

a concerned citizen, and the last 

comment was from a company which 

does research and development on 

pharmaceutical drugs. 

The first commenter recommended 

that the DEA expedite the issuance and 

effective date of the Final Rule placing 

tapentadol in schedule II. The 

commenter stated that tapentadol will 

provide a safe and effective substitute 

for other schedule II analgesics and that 

the conditions of public health 

necessitate and justify this request. In 

response, DEA believes that providing 

30 days for this rule to become effective 

is both expeditious and sufficient to 

allow handlers to apply for registration 

with DEA and to comply with the 

regulatory requirements for handling 

schedule II controlled substances. 

A second commenter stated that since 

tapentadol induces effects similar to 

oxycodone and morphine, both 

schedule II substances, then it should be 

placed in schedule II of the Controlled 

Substances Act based on tapentadol’s 

abuse potential. Thus, the commenter 

agreed with DHHS’ recommendation 

and the action proposed by DEA. No 

response from DEA is necessary to this 

comment because it is consistent with 

the DEA’s final action. 

The third commenter had four 

questions/comments regarding the 

implementation of this Final Rule. Each 

question/comment is addressed below. 

The commenter requested that DEA 

registrants be allowed enough time to 

make the changes needed to carry out 

handling tapentadol as a schedule II 

substance, as dictated in 21 CFR 

1301.51, 1301.71, and 1304.04. In 

response to this comment, the effective 

date of the Final Rule placing 

tapentadol in schedule II of the 

Controlled Substances Act will be thirty 

(30) days from the date of publication of 

the Final Rule, thus allowing ample 

time for those that wish to handle 

tapentadol to meet DEA regulatory 

requirements for handling schedule II 

substances. It has been DEA’s 

experience that this is sufficient time to 

meet the regulatory requirements 

provided below. 

The commenter asked if quantities of 

tapentadol held by a DEA registrant 

would have to be reported once the 

scheduling of tapentadol as a schedule 

II substance was finalized. In response, 

the reporting and recordkeeping 

requirements for handling schedule II 

substances can be found in 21 CFR part 

1304. Specifically, 21 CFR 1304.11(b) 

states that ‘‘Every person required to 

keep records shall take an inventory of 

all stocks of controlled substances on 

hand on the date he/she first engages in 

the manufacture, distribution, or 

dispensing of controlled substances 

* * *’’ In order for a manufacturer to 

handle a schedule II substance, a 

manufacturing or procurement quota 

has to be requested in accordance with 

the requirements of 21 U.S.C. 826(c) and 

21 CFR part 1303. The manufacturer’s 

inventory of the substance is used, in 

part, to determine the manufacturer’s 

quota. 

The commenter asked about the 

process for adding the CSA drug code 

for tapentadol to their registration. In 

response, the regulatory process 

required to obtain a DEA registration is 

outlined generally in 21 CFR 1301.11 

through 1301.19, and the process 

required to modify an existing DEA 

registration is outlined in 21 CFR 

1301.51. Information relating to 

registration may be found on the 

Internet, http:// 

www.DEAdiversion.usdoj.gov, or by 

contacting DEA’s Registration Call 

Center, toll free at 1–800–882–9539. 

Finally, the commenter inquired 

about the process for establishing an 

NDC number for tapentadol with the 

Automation of Reports and 

Consolidated Orders System (ARCOS). 

National Drug Code (NDC) numbers are 

assigned by the Food and Drug 

Administration (FDA) in conjunction 

with registration and drug listing 

requirements of the Federal Food, Drug, 

and Cosmetic Act. Accordingly, a 

person manufacturing a product 

containing tapentadol must obtain an 

NDC number from FDA in accordance 

with 21 CFR 207.35. Once the drug code 

for tapentadol is added to an existing 

manufacturer’s registration or a new 

registration is issued to an applicant, 

then that DEA-registered manufacturer 

must provide the DEA’s ARCOS Unit 

with its established NDC number for 

their product containing tapentadol. 

Once that information is obtained, it can 

be used to report ARCOS reportable 

transactions pursuant to 21 CFR 

1304.33. 

Scheduling of Tapentadol 

Based on the recommendation of the 

Assistant Secretary for Health, received 


dwashington3 on PROD1PC60 with RULES
23792 Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules and Regulations 

in accordance with § 201(b) of the Act 

(21 U.S.C. 811(b)), and the independent 

review of the available data by DEA, and 

after a review of the comments received 

in response to the Notice of Proposed 

Rulemaking, the Deputy Administrator 

of DEA, pursuant to §§ 201(a) and 201(b) 

of the Act (21 U.S.C. 811(a) and 811(b)), 

finds that: 

(1) Tapentadol has a high potential for 

abuse; 

(2) Tapentadol has a currently 

accepted medical use in treatment in the 

United States; and 

(3) Abuse of tapentadol may lead to 

severe psychological or physical 

dependence. 

Based on these findings, the Deputy 

Administrator of DEA concludes that 

tapentadol, including its isomers, esters, 

ethers, salts and salts of isomers, esters 

and ethers whenever the existence of 

such isomers, esters, ethers, and salts is 

possible, warrants control in schedule II 

of the CSA (21 U.S.C. 812(b)(2)). 

Requirements for Handling Tapentadol 

Registration. Any person who 

manufactures, distributes, dispenses, 

imports, exports, engages in research or 

conducts instructional activities with 

tapentadol, or who desires to 

manufacture, distribute, dispense, 

import, export, engage in instructional 

activities or conduct research with 

tapentadol, must be registered to 

conduct such activities in accordance 

with part 1301 of Title 21 of the Code 

of Federal Regulations. Any person who 

is currently engaged in any of the above 

activities and is not registered with DEA 

must submit an application for 

registration on or before June 22, 2009 

and may continue their activities until 

DEA has approved or denied that 

application. 

Security. Tapentadol is subject to 

schedule II security requirements and 

must be manufactured, distributed, and 

stored in accordance with §§ 1301.71, 

1301.72(a), (c), and (d), 1301.73, 

1301.74, 1301.75(b) and (c), 1301.76 and 

1301.77 of Title 21 of the Code of 

Federal Regulations on or after June 22, 

2009. 

Labeling and Packaging. All labels 

and labeling for commercial containers 

of tapentadol must comply with 

requirements of §§ 1302.03 through 

1302.07 of Title 21 of the Code of 

Federal Regulations on or after June 22, 

2009. 

Quotas. Quotas for tapentadol must be 

established pursuant to part 1303 of 

Title 21 of the Code of Federal 

Regulations. 

Inventory. Every registrant required to 

keep records and who possesses any 

quantity of tapentadol must keep an 

inventory of all stocks of tapentadol on 

hand pursuant to §§ 1304.03, 1304.04 

and 1304.11 of Title 21 of the Code of 

Federal Regulations on or after June 22, 

2009. Every registrant who desires 

registration in schedule II for tapentadol 

must conduct an inventory of all stocks 

of the substance on hand at the time of 

registration. 

Records. All registrants must keep 

records pursuant to §§ 1304.03, 1304.04, 

1304.21, 1304.22, and 1304.23 of Title 

21 of the Code of Federal Regulations on 

or after June 22, 2009. 

Reports. All registrants required to 

submit reports to the Automation of 

Reports and Consolidated Order System 

(ARCOS) in accordance with § 1304.33 

of Title 21 of the Code of Federal 

Regulations must do so for tapentadol. 

Orders for Tapentadol. All registrants 

involved in the distribution of 

tapentadol must comply with the order 

form requirements of part 1305 of Title 

21 of the Code of Federal Regulations on 

or after June 22, 2009. 

Prescriptions. All prescriptions for 

tapentadol or prescriptions for products 

containing tapentadol must be issued 

pursuant to §§ 1306.03 through 1306.06 

and 1306.11 through 1306.15 of Title 21 

of the Code of Federal Regulations on 

and after June 22, 2009. 

Importation and Exportation. All 

importation and exportation of 

tapentadol must be in compliance with 

part 1312 of Title 21 of the Code of 

Federal Regulations on or after June 22, 

2009. 

Criminal Liability. Any activity with 

tapentadol not authorized by, or in 

violation of, the CSA or the Controlled 

Substances Import and Export Act shall 

be unlawful on or after June 22, 2009. 

Regulatory Certifications 

Executive Order 12866 

In accordance with the provisions of 

the CSA (21 U.S.C. 811(a)), this action 

is a formal rulemaking ‘‘on the record 

after opportunity for a hearing.’’ Such 

proceedings are conducted pursuant to 

the provisions of 5 U.S.C. 556 and 557 

and, as such, are exempt from review by 

the Office of Management and Budget 

pursuant to Executive Order 12866, 

section 3(d)(1). 

Regulatory Flexibility Act 

The Deputy Administrator, in 

accordance with the Regulatory 

Flexibility Act (5 U.S.C. 601–612), has 

reviewed this final rule and by 

approving it certifies that it will not 

have a significant economic impact on 

a substantial number of small entities. 

Tapentadol products will be 

prescription drugs used for the 

treatment of moderate-to-severe acute 

pain. Handlers of tapentadol also handle 

other controlled substances used to treat 

pain which are already subject to the 

regulatory requirements of the CSA. 

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 

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 costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

on the ability of United States-based 

companies to compete with foreign 

based companies in domestic and 

export markets. 

List of Subjects in 21 CFR Part 1308 

Administrative practice and 

procedure, Drug traffic control, 

Narcotics, Prescription drugs. 

■ Under the authority vested in the 

Attorney General by section 201(a) of 

the CSA (21 U.S.C. 811(a)), and 

delegated to the Administrator of DEA 

by Department of Justice regulations (28 

CFR 0.100), and redelegated to the 

Deputy Administrator pursuant to Title 

28, Part 0, Appendix to Subpart R, 

Section 12, the Deputy Administrator 

hereby amends 21 CFR part 1308 as 

follows: 


dwashington3 on PROD1PC60 with RULES
Federal Register / Vol. 74, No. 97 / Thursday, May 21, 2009 / Rules and Regulations 23793 

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 1308.12 is amended in the 

table by adding a new paragraph (c)(28) 

to read as follows: 

§ 1308.12 Schedule II. 

* * * * * 

(c) * * * 

(28) Tapentadol ................................. 9780 

* * * * * 

Dated: May 15, 2009. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. E9–11933 Filed 5–20–09; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0089] 

RIN 1625–AA00 

Safety Zone; Red Bull Air Race, Detroit 

River, Detroit, MI 

AGENCY: Coast Guard, DHS. 

ACTION: Temporary final rule. 

SUMMARY: The Coast Guard is 

establishing a temporary safety zone on 

the Detroit River, Detroit, Michigan. 

This zone will restrict vessels from 

portions of the Detroit River during the 

Red Bull Air Race. This temporary 

safety zone is necessary to protect 

spectators and vessels from the hazards 

associated with air races. 

DATES: This rule is effective from 9 a.m. 

on June 11, 2009 through 6:30 p.m. on 

June 14, 2009. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2009–0089 and are 

available online by going to http:// 

www.regulations.gov, selecting the 

Advanced Docket Search option on the 

right side of the screen, inserting USCG– 

2009–0089 in the Docket ID box, 

pressing Enter, and then clicking on the 

item in the Docket ID column. This 

material is 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 CDR Joseph Snowden, 

Prevention Department, Sector Detroit, 

Coast Guard; telephone (313) 568–9580, 

e-mail Joseph.H.Snowden@uscg.mil. If 

you have questions on viewing the 

docket, call Renee V. Wright, Program 

Manager, Docket Operations, telephone 

202–366–9826. 

SUPPLEMENTARY INFORMATION: 

Regulatory Information 

On April 16, 2009, we published a 

notice of proposed rulemaking (NPRM) 

entitled Safety Zone; Red Bull Air Race, 

Detroit River, Detroit, MI in the Federal 

Register (74 FR 17627). We received one 

comment on the proposed rule. No 

public meeting was requested, and none 

was held. 

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

Guard finds that good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. Delaying this rule would be 

contrary to the public interest of 

ensuring, to the extent practicable, the 

safety and security of the spectators and 

participants during this event and 

immediate action is necessary to 

prevent possible injury, loss of life, or 

property. 

Background and Purpose 

This temporary safety zone is 

necessary to ensure, to the extent 

practicable, the safety of vessels and 

spectators from hazards associated with 

an air race. The Captain of the Port 

Detroit has determined air races in close 

proximity to watercraft and 

infrastructure pose significant risk to 

public safety and property. The likely 

combination of large numbers of 

recreation vessels, possible alcohol use, 

airplanes traveling at high speeds and 

performing aerial acrobatics, and large 

numbers of spectators in close 

proximity to the water could easily 

result in serious injuries or fatalities. 

Establishing a safety zone around the 

location of the race course will help 

ensure the safety of persons and 

property at these events and help 

minimize the associated risks. 

Discussion of Comments and Changes 

We received one letter, containing 

several comments on this rulemaking. 

First, the commenter stated that closure 

of the Detroit River for these air races 

violates the Boundary Waters Treaty of 

1909. The Coast Guard disagrees that 

the Coast Guard’s action or the action by 

Canada violates this treaty. The 

Boundary Waters Treaty does guarantee 

that ‘‘navigation of all navigable 

boundary waters’’ shall be ‘‘free and 

open’’ to ‘‘inhabitants * * * ships, 

vessels, and boats’’ of both the United 

States and Canada, ‘‘subject, however, to 

any laws and regulations of either 

country.’’ Both the United States and 

Canada have determined, pursuant to 

each country’s laws and regulations, 

that brief closures of the Detroit River 

are reasonably necessary to protect 

spectators and vessels from hazards 

associated with these air races. 

Moreover, under fundamental 

principles of international law, only the 

States that are a party to an international 

agreement are generally entitled to 

allege a breach of the terms of the 

agreement by the other. For this event, 

Canada has also agreed that a closure of 

a small portion of the river for a short 

period of time is a reasonable and 

necessary measure. 

Second, the commenter stated that the 

proposed rule constituted a ‘‘public 

taking’’ in contravention of the Fifth 

Amendment to the United States 

Constitution; in that vessel owners will 

experience delays that will result in lost 

profits. This commenter did not put 

forward any specific company or vessel 

that would be so affected. The Coast 

Guard disagrees with this comment. In 

general, a ‘‘taking’’ occurs when a 

governmental entity uses its powers to 

permanently deprive a person or entity 

of property. The Captain of the Port has 

considered the needs of port 

stakeholders and the maritime 

community and has determined that 

this safety zone is necessary to protect 

the public and maintain safety of 

navigation. Further, the rule is only 

temporary in nature, not permanent, 

and in the event that this temporary 

safety zone affects shipping, commercial 

vessels may request permission from the 

Captain of the Port Detroit to transit 

through the safety zone. Moreover, the 

safety zone will only be enforced for a 

short period of time on the enforcement 

dates. Lastly, the Coast Guard believes 

vessel owners have had sufficient 

advance notice of this safety zone, such 

that they should be able to work vessel 

schedules around the enforcement 

periods of the proposed safety zone to 

minimize or avoid lost profits. 

Third, the commenter stated that the 

race sponsor must be required to agree 

in advance to reasonably compensate 

vessel owners for losses incurred by 

delays and post a bond sufficient to 

cover anticipated vessel losses. 

Otherwise, this commenter stated, there 

is no incentive for race organizers to 

work collaboratively with vessel 


dwashington3 on PROD1PC60 with RULES