Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 27735 

List of Subjects in 21 CFR Part 522 

Animal drugs. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 522 is amended as follows: 

PART 522—IMPLANTATION OR 

INJECTABLE DOSAGE FORM NEW 

ANIMAL DRUGS 

■ 1. The authority citation for 21 CFR 

part 522 continues to read as follows: 

Authority: 21 U.S.C. 360b. 

■ 2. Revise § 522.1192 to read as 

follows: 

§ 522.1192 Ivermectin. 

(a) Specifications—(1) Each milliliter 

(mL) of solution contains 20 milligrams 

(mg) ivermectin. 

(2) Each mL of solution contains 10 

mg ivermectin. 

(3) Each mL of solution contains 2.7 

mg ivermectin. 

(b) Sponsors. See sponsors in 

§ 510.600(c) of this chapter for use as in 

paragraph (e) of this section. 

(1) No. 050604 for use of the product 

described in paragraph (a)(1) of this 

section as in paragraph (e)(1) of this 

section; the product described in 

paragraph (a)(2) of this section as in 

paragraphs (e)(2)(i), (e)(2)(ii)(A), 

(e)(2)(ii)(C), (e)(2)(iii), (e)(3), (e)(4) and 

(e)(5) of this section; and the product 

described in paragraph (a)(3) of this 

section as in paragraphs (e)(3) and (e)(6) 

of this section. 

(2) Nos. 059130 and 055529 for use of 

the product described in paragraph 

(a)(2) of this section as in paragraphs 

(e)(2)(i), (e)(2)(ii)(A), (e)(2)(ii)(B), 

(e)(2)(iii), (e)(3), (e)(4), and (e)(5) of this 

section. 

(c) Related tolerances. See § 556.344 

of this chapter. 

(d) Special considerations—(1) See 

§ 500.25 of this chapter. 

(2) Labeling shall bear the following 

precaution: ‘‘This product should not be 

used in other animal species as severe 

adverse reactions, including fatalities in 

dogs, may result.’’

(e) Conditions of use—(1) Horses—(i) 

Amount. 200 micrograms per kilogram 

(μg/kg) of body weight by intramuscular 

injection. 

(ii) Indications for use. For the 

treatment and control of large strongyles 

(adult) (Strongylus vulgaris, S. 

edentatus, Triodontophorus spp.), small 

strongyles (adult and fourth stage 

larvae) (Cyathostomum spp., 

Cylicocyclus spp., Cylicostephanus 

spp.), pinworms (adult and fourth-stage 

larvae) (Oxyuris equi), large 

roundworms (adult) (Parascaris 

equorum), hairworms (adult) 

(Trichostrongylus axei), large mouth 

stomach worms (adult) (Habronema 

muscae), neck threadworms 

(microfilariae) (Onchocerca spp.), and 

stomach bots (Gastrophilus spp.). 

(iii) Limitations. Not for use in horses 

intended for human consumption. 

Federal law restricts this drug to use by 

or on the order of a licensed 

veterinarian. 

(2) Cattle—(i) Amount. 200 μg/kg of 

body weight by subcutaneous injection. 

(ii) Indications for use—(A) For the 

treatment and control of gastrointestinal 

nematodes (adults and fourth-stage 

larvae) (Haemonchus placei, Ostertagia 

ostertagi (including inhibited larvae), O. 

lyrata, T. axei, T. colubriformis, 

Cooperia oncophora, C. punctata, C. 

pectinata, Oesophagostomum radiatum, 

Nematodirus helvetianus (adults only), 

N. spathiger (adults only), Bunostomum 

phlebotomum); lungworms (adults and 

fourth-stage larvae) (Dictyocaulus 

viviparus); grubs (parasitic stages) 

(Hypoderma bovis, H. lineatum); 

sucking lice (Linognathus vituli, 

Haematopinus eurysternus, Solenopotes 

capillatus); mites (scabies) (Psoroptes 

ovis (syn. P. communis var. bovis), 

Sarcoptes scabiei var. bovis). 

(B) For control of infections of D. 

viviparus for 28 days after treatment, 

and O. ostertagi for 21 days after 

treatment, and H. placei, T. axei, C. 

punctata, C. oncophora, and O. 

radiatum for 14 days after treatment. 

(C) For control of infections and to 

protect from reinfection with D. 

viviparus and O. radiatum for 28 days 

after treatment; O. ostertagi, T. axei, and 

C. punctata for 21 days after treatment; 

H. placei and C. oncophora for 14 days 

after treatment. 

(iii) Limitations. Do not treat cattle 

within 35 days of slaughter. Because a 

withdrawal time in milk has not been 

established, do not use in female dairy 

cattle of breeding age. A withdrawal 

period has not been established for this 

product in pre-ruminating calves. Do 

not use in calves to be processed for 

veal. 

(3) Swine—(i) Amount. 300 μg/kg of 

body weight by subcutaneous injection. 

(ii) Indications for use. For the 

treatment and control of gastrointestinal 

roundworms (adults and fourth-stage 

larvae) (large roundworm, Ascaris 

suum; red stomach worm, 

Hyostrongylus rubidus; nodular worm, 

Oesophagostomum spp.; threadworm, 

Strongyloides ransomi (adults only)); 

somatic roundworm larvae 

(threadworm, S. ransomi (somatic 

larvae)); lungworms (Metastrongylus 

spp. (adults only)); lice (H. suis); and 

mites (S. scabiei var. suis). 

(iii) Limitations. Do not treat swine 

within 18 days of slaughter. 

(4) American bison—(i) Amount. 200 

μg/kg of body weight by subcutaneous 

injection. 

(ii) Indications for use. For the 

treatment and control of grubs (H. 

bovis). 

(iii) Limitations. Do not slaughter 

within 56 days of last treatment. 

(5) Reindeer—(i) Amount. 200 μg/kg 

of body weight by subcutaneous 

injection. 

(ii) Indications for use. For the 

treatment and control of warbles 

(Oedemagena tarandi). 

(iii) Limitations. Do not treat reindeer 

within 56 days of slaughter. 

(6) Ranch-raised foxes—(i) Amount. 

200 μg/kg of body weight by 

subcutaneous injection. Repeat in 3 

weeks. 

(ii) Indications for use. For treatment 

and control of ear mites (Otodectes 

cynotis). 

Dated: May 7, 2007. 

Bernadette Dunham, 

Deputy Director, Center for Veterinary 

Medicine. 

[FR Doc. E7–9515 Filed 5–16–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 100 

[CGD13–07–013] 

RIN 1625–AA00 

Special local regulation: ULHRA 

Hydroplane Races, Howard Amon 

Park, Richland, WA 

AGENCY: Coast Guard, DHS. 

ACTION: Special local regulation 

temporary final rule. 

SUMMARY: The Coast Guard is 

undertaking two actions with regard to 

the above captioned regulation. The first 

is to withdraw the temporary final rule 

previously published on April 23, 2007 

because it erroneously described the 

race area. The second is to correct the 

previous error by 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 

Howard Amon Park, Richland, WA. 

These special local regulations limit the 

movement of non-participating vessels 

in the regulated race area. This 


cprice-sewell on PROD1PC71 with RULES
27736 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 

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. (PDT) to 7 p.m. (PDT) 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 Sector 

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, or if the effective date of this 

rule were delayed by 30 days, 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 

contrary to the public interest. 

Background and Purpose 

The Coast Guard is undertaking two 

actions in this document. The first is to 

withdraw the temporary final rule 

previously published on April 23, 2007 

at 72 FR 20047 because it erroneously 

described the race area. The second is 

to correct the previous error by 

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 Howard Amon Park, 

Richland, WA. 

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 the 

vicinity of Howard Amon Park in 

Richland, WA and is scheduled to start 

at 7 a.m. (PDT) and last until 7 p.m. 

(PDT) 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 

that a full Regulatory Evaluation under 

the regulatory policies and procedures 

of DHS is unnecessary. This expectation 

is based on the fact that the regulated 

area established by this rule 

encompasses an area on the Columbia 

River near Howard Amon Park in 

Richland, WA not frequented by 

commercial navigation. The regulation 

is established for the benefit and safety 

of the recreational boating public and 

the event will pause in order to allow 

the ferry to pass through the area at its 

allotted times, any negative recreational 

boating impact is offset by the benefits 

of allowing the hydroplanes to race. 

This rule would be enforced from 7 a.m. 

to 7 p.m. Pacific Daylight Time each day 

on May 19 and 20, 2007. For the above 

reasons, the Coast Guard does not 

anticipate any significant economic 

impact. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises 

small businesses, not-for-profit 

organizations that are independently 

owned and operated and are not 

dominant in their fields, and 

governmental jurisdictions with 

populations of less than 50,000. 

The Coast Guard certifies under 5 

U.S.C. 605(b) that this rule will not have 

a significant economic impact on a 

substantial number of small entities. 

This rule will affect the following 

entities, some of which may be small 

entities: The owners or operators of 

vessels intending to transit or anchor in 

a portion of the Columbia River during 

the time mentioned under Background 

and Purpose. This Special local 

regulation will not have a significant 

economic impact on a substantial 

number of small entities due to its short 

duration and small area. The only 

vessels likely to be impacted will be 

recreational boaters, small passenger 

vessel operators, and a ferry that runs 

through the regulated area twice a day. 

The event is held for the benefit and 

entertainment of the recreational and 

small passenger vessel operators, and 

the event will pause in order to allow 

the ferry to pass through the area at its 

allotted times. Because the impacts of 

this proposal are expected to be so 

minimal, the Coast Guard certifies 

under 605(b) of the Regulatory 

Flexibility Act (5 U.S.C. 601 et seq.) that 

this temporary rule will not have a 

significant economic impact on a 

substantial number of small entities. 

If you think that your business, 

organization, or governmental 

jurisdiction qualifies as a small entity 

and that this temporary rule would have 

a significant economic impact on it, 

please submit a comment (see 

ADDRESSES) explaining why you think it 

qualifies and how and to what degree 

this rule would economically affect it. 

Assistance for Small Entities 

Under section 213(a) of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996 (Pub. L. 104–121), 

we offered to assist small entities in 

understanding the rule so that they can 


cprice-sewell on PROD1PC71 with RULES
Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 27737 

better evaluate its effects on them and 

participate in the rulemaking process. 

Small businesses may send comments 

on the actions of Federal employees 

who enforce, or otherwise determine 

compliance with, Federal regulations to 

the Small Business and Agriculture 

Regulatory Enforcement Ombudsman 

and the Regional Small Business 

Regulatory Fairness Boards. The 

Ombudsman evaluates these actions 

annually and rates each agency’s 

responsiveness to small business. If you 

wish to comment on actions by 

employees of the Coast Guard, call 1–

888–888–REG–888–FAIR (1–888–734–

3247). 

Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501–

3520). 

Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that order and have 

determined that this rule does not have 

implications for federalism under that 

Order. 

Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

state, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

an expenditure, we do discuss the 

effects of this rule elsewhere in this 

preamble. 

Taking of Private Property 

This rule will not effect taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not concern an environmental risk 

to health or risk to safety that may 

disproportionately affect children. 

Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian tribal governments, because 

it does not have a substantial direct 

effect on one or more Indian tribes, on 

the relationship between the federal 

government and Indian tribes, or on the 

distribution of power and 

responsibilities between the federal 

government and Indian tribes. 

Energy Effects 

We have analyzed this rule under 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use. We have 

determined that it is not a ‘‘significant 

energy action’’ under that order because 

it is not a ‘‘significant regulatory action’’

under Executive Order 12866 and is not 

likely to have a significant adverse effect 

on the supply, distribution, or use of 

energy. The Administrator of the Office 

of Information and Regulatory Affairs 

has not designated it as a significant 

energy action. Therefore, it does not 

require a Statement of Energy Effects 

under Executive Order 13211. 

Technical Standards 

The National Technology Transfer 

and Advancement Act (NTTAA) (15 

U.S.C. 272 note) directs agencies to use 

voluntary consensus standards in their 

regulatory activities unless the agency 

provides Congress, through the Office of 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

Environment 

We have analyzed this rule under 

Commandant Instruction M16475.1D 

and Department of Homeland Security 

Management Directive 5100.1, which 

guide the Coast Guard in complying 

with the National Environmental Policy 

Act of 1969 (NEPA) (42 U.S.C. 4321–

4370f), and have concluded that there 

are no factors in this case that would 

limit the use of a categorical exclusion 

under section 2.B.2 of the Instruction. 

Therefore, this rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(h) of Commandant Instruction 

M16475.1D, from further environmental 

documentation. Special local 

regulations issued in conjunction with a 

regatta or marine event permit are 

specifically excluded from further 

analysis and documentation under that 

section. 

Under figure 2–1, paragraph (34)(h) of 

the instruction, an ‘‘Environmental 

Analysis Check List’’ and a categorical 

exclusion determination are not 

required for this rule. 

List of Subjects in 33 CFR Part 100 

Marine Safety, Navigation (water), 

Reporting and Recordkeeping 

requirements, Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR Part 100 as follows: 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 33 U.S.C. 1233; Department of 

Homeland Security Delegation No. 0170.1. 

§ 100.T13–009 [Withdrawn]. 

■ 2. Withdraw temporary § 100.T13–

009. 

■ 3. Add temporary § 100.T13–010 to 

read as follows: 

§ 100.T13–010 ULHRA Hydroplane Races 

Howard Amon Park, Richland, Washington. 

(a) Regulated Area. The regulated area 

is defined as the waters of the Columbia 

River from bank to bank in the vicinity 

of Howard Amon Park on the Columbia 

River in Richland, Washington 

commencing at the Interstate 182 Bridge 

and continuing up river Northward 3.0 

miles and terminating at the Columbia 

River Mile 339. 

(b) Special Local Regulations. This 

event will take place from 7 a.m. PDT 

to approximately 7 p.m. PDT May 19 to 

20, 2007, in the described waters of the 

Columbia River in Richland, 

Washington. 

(1) No persons may enter or remain in 

the regulated area except for 

participants in the event, supporting 

personnel, vessels registered with the 

event organizer, and personnel or 


cprice-sewell on PROD1PC71 with RULES
27738 Federal Register / Vol. 72, No. 95 / Thursday, May 17, 2007 / Rules and Regulations 

vessels authorized by the Coast Guard 

Patrol Commander. 

(2) The Coast Guard Patrol 

Commander is a commissioned, 

warrant, petty officer, or auxiliarist of 

the Coast Guard who has been 

designated by Commander, Coast Guard 

Sector Portland. A Coast Guard 

Auxiliarist, when so appointed by the 

COTP per 14 U.S.C 831, may act as the 

Patrol Commander. The Patrol 

Commander is empowered to control 

movement of vessels in the regulated 

area and adjoining waters during the 

hours these regulations are in effect. 

(3) A succession of sharp, short 

signals by whistle, siren, or horn from 

vessels patrolling the area shall serve as 

a signal to stop. Vessels or persons 

signaled shall stop and shall comply 

with the orders of the patrol vessels. 

Failure to due so may result in the 

expulsion from the area, citation, for 

failure to comply or both. 

(4) Any spectator vessel may anchor 

outside the regulated area specified in 

paragraph (a) of this section, but may 

not block a navigable channel. 

Dated: May 4, 2007. 

K.S. Cook, 

Captain, U.S. Coast Guard, Acting 

Commander, 13th Coast Guard District. 

[FR Doc. 07–2460 Filed 5–15–07; 9:58 am] 

BILLING CODE 4910–15–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 151 

[USCG–2007–28201] 

RIN 1625–ZA13 

Vessels Carrying Oil, Noxious Liquid 

Substances, Garbage, Municipal or 

Commercial Waste, and Ballast Water; 

Technical, Organizational and 

Conforming Amendment 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: This rule makes a nonsubstantive change to Title 33 of the 

Code of Federal Regulations. The 

purpose of this rule is to make a 

conforming amendment and technical 

correction to a Coast Guard navigation 

and navigable water regulation. This 

rule will have no substantive effect on 

the regulated public. 

DATES: This final rule is effective May 

17, 2007. 

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–2007–28201 and are 

available for inspection or copying at 

the Docket Management Facility, U.S. 

Department of Transportation, room PL–

401, 400 Seventh Street, SW., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. You may also find this 

docket on the Internet at http:// 

dms.dot.gov. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call Mr. 

Ray Davis, Coast Guard, telephone 202–

372–1461. If you have questions on 

viewing the docket, call Ms. Renee V. 

Wright, Program Manager, Docket 

Operations, telephone 202–493–0402. 

SUPPLEMENTARY INFORMATION: 

Regulatory History 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under both 5 U.S.C. 

553(b)(A) and (b)(B), the Coast Guard 

finds this rule is exempt from notice 

and comment rulemaking requirements 

because this change involves agency 

organization and practices, and good 

cause exists for not publishing an NPRM 

for the revision in the rule because it is 

a non-substantive change. This rule 

consists only of a technical and 

conforming amendment. The change 

will have no substantive effect on the 

public; therefore, it is unnecessary to 

publish an NPRM. Under 5 U.S.C. 

553(d)(3), the Coast Guard finds that, for 

the same reasons, good cause exists for 

making this rule effective less than 30 

days after publication in the Federal 

Register. 

Background and Purpose 

This rule, which becomes effective 

May 17, 2007, makes a technical 

correction to 33 CFR part 151. This rule 

does not create any substantive 

requirements. 

Discussion of Rule 

This rule corrects the authority 

citation in part 151 and amends 33 CFR 

§ 151.2010. When the Coast Guard 

converted the voluntary ballast water 

management guidelines in 33 CFR part 

151, Subpart D, into a mandatory ballast 

water management program (69 FR 

44952, July 28, 2004), we inadvertently 

did not make changes to § 151.2010 to 

reflect several exemptions. Specifically, 

that crude oil tankers engaged in 

coastwise trade and Department of 

Defense and Coast Guard vessels were 

exempted from the mandatory ballast 

water management requirements in 

§ 151.2035, which had previously been 

a voluntary program as stated by 

statutory language in the National 

Invasive Species Act of 1996 (NISA). We 

discussed this exemption and its 

reasoning in the preamble of the 2004 

final rule, stating, ‘‘NISA authorizes 

specific exemptions for crude oil 

tankers engaged in coastwise trade, and 

Department of Defense and Coast Guard 

vessels. Therefore, we do not currently 

have the authority to include these 

vessels in the applicability for the final 

rule.’’ This statement made clear our 

intention to carry that exemption 

forward into the mandatory program. 

With respect to the exemptions for 

vessels operating exclusively within one 

Captain of the Port (COTP) Zone, the 

language changed to include only 

exemptions for §§ 151.2040 and 

151.2045, but not § 151.2035. This 

exemption is not taken from NISA. The 

Coast Guard established it as a 

discretionary exercise of its regulatory 

authority after notice and comment 

rulemaking. It would be inappropriate 

to expand the ballast water management 

requirements exemption beyond those 

previously granted by means of a 

technical amendment not subject to a 

notice and comment rulemaking. These 

vessels will continue following the 

requirements in § 151.2035. While this 

includes the requirements in 

§ 151.2035(b), which calls for ballast 

water management for vessels operating 

outside the U.S. EEZ, vessels operating 

exclusively in a COTP Zone will not 

operate outside the U.S. EEZ and, 

therefore, compliance with those 

particular requirements is not 

mandatory. These vessels are reminded, 

however, that they must comply with 

§ 151.2035(a), which calls for ballast 

water management inside of U.S. 

waters. 

Regulatory Evaluation 

This 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. We expect the economic impact 

of this rule to be so minimal that a full 

Regulatory Evaluation is unnecessary. 

As this rule involves internal agency 

practices and procedures and a nonsubstantive change, it will not impose 

any costs on the public. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 


cprice-sewell on PROD1PC71 with RULES