Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 25665 

Federal Food, Drug, and Cosmetic Act 

dealing with adulterated foods. 

* * * * * 

■ 3. Section 129.80 is amended by 

revising paragraph (g)(1) to read as 

follows: 

§ 129.80 Processes and controls. 

* * * * * 

(g) * * * 

(1) For bacteriological purposes, take 

and analyze at least once a week for 

total coliform a representative sample 

from a batch or segment of a continuous 

production run for each type of bottled 

drinking water produced during a day’s 

production. The representative sample 

shall consist of primary containers of 

product or unit packages of product. If 

any coliform organisms are detected, 

follow-up testing must be conducted to 

determine whether any of the coliform 

organisms are E. coli. 

* * * * * 

PART 165—BEVERAGES 

■ 4. The authority citation for 21 CFR 

part 165 continues to read as follows: 

Authority: 21 U.S.C. 321, 341, 343, 343–1, 

348, 349, 371, 379e. 

■ 5. Section 165.110 is amended by 

revising paragraphs (b)(2), (b)(3) 

introductory text, (c)(1), and (d) to read 

as follows: 

§ 165.110 Bottled water. 

* * * * * 

(b) * * * 

(2) Microbiological quality. (i) Bottled 

water shall, when a sample consisting of 

analytical units of equal volume is 

examined by the methods described in 

paragraph (b)(2)(ii) of this section, meet 

the following standards of 

microbiological quality: 

(A) Total coliform—(1) Multiple-tube 

fermentation (MTF) method. Not more 

than one of the analytical units in the 

sample shall have a most probable 

number (MPN) of 2.2 or more coliform 

organisms per 100 milliliters and no 

analytical unit shall have an MPN of 9.2 

or more coliform organisms per 100 

milliliters; or 

(2) Membrane filter (MF) method. Not 

more than one of the analytical units in 

the sample shall have 4.0 or more 

coliform organisms per 100 milliliters 

and the arithmetic mean of the coliform 

density of the sample shall not exceed 

one coliform organism per 100 

milliliters. 

(B) E. coli. If E. coli is present, then 

the bottled water will be deemed 

adulterated under paragraph (d) of this 

section. 

(ii) Analyses conducted to determine 

compliance with paragraphs (b)(2)(i)(A) 

and (b)(2)(i)(B) of this section and 

§ 129.35(a)(3)(i) of this chapter shall be 

made in accordance with the multipletube fermentation (MTF) or the 

membrane filter (MF) methods 

described in the applicable sections of 

‘‘Standard Methods for the Examination 

of Water and Wastewater,’’ 21st Ed. 

(2005), American Public Health 

Association. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain a copy from the American Public 

Health Association, 800 I St. NW., 

Washington, DC 20001, 202–777–2742 

(APHA). You may inspect a copy at the 

Center for Food Safety and Applied 

Nutrition’s Library, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–2163, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(3) Physical quality. Bottled water 

shall, when a composite of analytical 

units of equal volume from a sample is 

examined by the method described in 

applicable sections of ‘‘Standard 

Methods for the Examination of Water 

and Wastewater,’’ 15th Ed. (1980), 

American Public Health Association, 

which is incorporated by reference in 

accordance with 5 U.S.C. 552(a) and 1 

CFR part 51 (copies may be obtained 

from the American Public Health 

Association, 800 I St. NW., Washington, 

DC 20001, 202–777–2742 (APHA), or a 

copy may be examined at the National 

Archives and Records Administration 

(NARA), or at the Center for Food Safety 

and Applied Nutrition’s Library, 5100 

Paint Branch Pkwy., College Park, MD 

20740, 301–436–2163, for information 

on the availability of this material at 

NARA, call 202–741–6030, or go to: 

http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html), meet the following 

standards of physical quality: 

* * * * * 

(c) Label statements. * * * 

(1) ‘‘Contains Excessive Bacteria’’ if 

the bottled water fails to meet the 

requirements of paragraph (b)(2)(i)(A) of 

this section. 

* * * * * 

(d) Adulteration. Bottled water 

containing a substance at a level 

considered injurious to health under 

section 402(a)(1) of the Federal Food, 

Drug, and Cosmetic Act (the act), or that 

consists in whole or in part of any 

filthy, putrid, or decomposed substance, 

or that is otherwise unfit for food under 

section 402(a)(3) of the act is deemed to 

be adulterated, regardless of whether or 

not the water bears a label statement of 

substandard quality prescribed by 

paragraph (c) of this section. If E. coli is 

present in bottled water, then the 

bottled water will be deemed 

adulterated under section 402(a)(3) of 

the act. 

Dated: May 21, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–12494 Filed 5–26–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2009–0391] 

RIN 1625–AA00 

Safety Zone; Chicago Harbor, Navy 

Pier Southeast, Chicago, IL 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of enforcement of 

regulation. 

SUMMARY: The Coast Guard will enforce 

the Navy Pier Southeast Safety Zone in 

Chicago Harbor from May 2009 through 

June 2009. This action is necessary 

protect vessels and people from the 

hazards associated with fireworks 

displays. During the enforcement 

period, no person or vessel may enter 

the security zone without the 

permission of the Captain of the Port 

Lake Michigan Zone. 

DATES: The regulations in § 165.931 will 

be enforced from May 23, until June 27, 

2009. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this notice, call 

or e-mail BM2 Kraft, Prevention 

Department, Coast Guard Sector Lake 

Michigan, Milwaukee, WI at (414) 747– 

7154, e-mail adam.d.kraft@uscg.mil. 

SUPPLEMENTARY INFORMATION: The Coast 

Guard will enforce the Safety Zone; 

Chicago Harbor, Navy Pier Southeast, 

Chicago, IL in 33 CFR 165.931 for the 

following events during the dates and 

times indicated below: 

(1) Navy Pier Sunday Fireworks; on 

May 24, 2009 from 9:15 p.m. through 

9:45 p.m. 

(2) Navy Pier Wednesday Fireworks; 

on May 27, 2009 from 9:15 p.m. through 

9:45 p.m.; on June 3, 2009 from 9:15 


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25666 Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 

p.m. through 9:45 p.m.; on June 10, 

2009 from 9:15 p.m. through 9:45 p.m.; 

on June 17, 2009 from 9:15 p.m. through 

9:45 p.m.; on June 24, 2009 from 9:15 

p.m. through 9:45 p.m. 

(3) Navy Pier Saturday Fireworks; on 

May 23, 2009 from 10 p.m. through 

10:40 p.m.; on May 30, 2009 from 10 

p.m. through 10:40 p.m.; on June 6, 

2009 from 10 p.m. through 10:40 p.m.; 

on June 13, 2009 from 10 p.m. through 

10:40 p.m.; on June 20, 2009 from 10 

p.m. through 10:40 p.m.; on June 27, 

2009 from 10 p.m. through 10:40 p.m. 

All vessels must obtain permission 

from the Captain of the Port or his 

designated representative to enter, move 

within or exit the safety zone. Vessels 

and persons granted permission to enter 

the safety zone shall obey all lawful 

orders or directions of the Captain of the 

Port or a designated representative. 

While within a safety zone, all vessels 

shall operate at the minimum speed 

necessary to maintain a safe course. 

This notice is issued under authority 

of 33 CFR 165.931 Safety Zone, Chicago 

Harbor, Navy Pier Southeast, Chicago, 

IL. (published on June 13, 2007 at 72 FR 

32520) and 5 U.S.C. 552 (a). In addition 

to this notice in the Federal Register, 

the Coast Guard will provide the 

maritime community with advance 

notification of these enforcement 

periods via broadcast Notice to Mariners 

or Local Notice to Mariners. The 

Captain of the Port will also issue a 

Broadcast Notice to Mariners notifying 

the public when enforcement of the 

safety zone established by this section is 

suspended. The Captain of the Port may 

be contacted via U.S. Coast Guard 

Sector Lake Michigan on channel 16, 

VHF–FM. 

Dated: May 14, 2009. 

Bruce C. Jones, 

Captain, U.S. Coast Guard, Captain of the 

Port Lake Michigan. 

[FR Doc. E9–12602 Filed 5–28–09; 8:45 am] 

BILLING CODE 4910–15–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 60 

[EPA–HQ–OAR–2002–0071; FRL–8910–5] 

RIN 2060–AP13 

Update of Continuous Instrumental 

Test Methods; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction. 

SUMMARY: EPA published a final rule in 

the Federal Register on May 22, 2008, 

that made technical corrections to five 

test methods. Inadvertent printing errors 

were made in the publication. Text 

insertions were misplaced, duplicate 

insertions were made, and the definition 

for system bias was inadvertently 

revised. The purpose of this action is to 

correct these errors. 

DATES: This correction is effective on 

June 29, 2009. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Foston Curtis, Air Quality Assessment 

Division, Office of Air Quality Planning 

and Standards (E143–02), 

Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number (919) 541– 

1063; fax number (919) 541–0516; email address: curtis.foston@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Summary of Amendment 

EPA promulgated revisions to 

continuous instrumental test methods 

on May 22, 2008, where a number of 

technical amendments were made to 

five test methods. Several of the 

revisions were added to the text in the 

wrong places and in some cases 

duplicate insertions were made. The 

definition for system bias was also 

inadvertently revised. This action 

corrects those publication errors. 

Section 553 of the Administrative 

Procedure Act (APA), 5 U.S.C. 

553(b)(3)(B), provides that, when an 

Agency for good cause finds that notice 

and public procedure are impracticable, 

unnecessary, or contrary to the public 

interest, the Agency may issue a rule 

without providing notice and an 

opportunity for public comment. We 

have determined that there is good 

cause for making this technical 

correction final without prior proposal 

and opportunity for comment because 

only simple publication errors are being 

corrected that do not substantially 

change the Agency actions taken in the 

final rule. Thus, notice and public 

procedure are unnecessary. We find that 

this constitutes good cause under 5 

U.S.C. 553(b)(3)(B). (See also the final 

sentence of section 307(d)(1) of the 

Clean Air Act (CAA), 42 U.S.C. 

307(d)(1), indicating that the good cause 

provisions in subsection 553(b) of the 

APA continue to apply to this type of 

rulemaking under section 307(d) of the 

CAA. 

II. Statutory and Executive Order 

Reviews 

Under Executive Order 12866, 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993), this action is 

not a ‘‘significant regulatory action’’ and 

is therefore not subject to review by the 

Office of Management and Budget. This 

action is not a ‘‘major rule’’ as defined 

by 5 U.S.C. 804(2). The technical 

corrections do not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501 et seq.). 

Because EPA has made a ‘‘good 

cause’’ finding that this action is not 

subject to notice and comment 

requirements under the APA or any 

other statute (see Section II), it is not 

subject to the regulatory flexibility 

provisions of the Regulatory Flexibility 

Act [5 U.S.C. 601 et seq.], or to sections 

202 and 205 of the Unfunded Mandates 

Reform Act of 1995 (UMRA) [Pub. L. 

104–4]. In addition, this action does not 

significantly or uniquely affect small 

governments or impose a significant 

intergovernmental mandate, as 

described in sections 203 and 204 of the 

UMRA. 

This action also does not significantly 

or uniquely affect the communities of 

Tribal governments, as specified by 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000). This correction also is not 

subject to Executive Order 13045, 

Protection of Children from 

Environmental Health and Safety Risks 

(62 FR 19885, April 23, 1997) because 

it is not economically significant. 

This technical correction does not 

involve changes to the technical 

standards related to test methods or 

monitoring requirements; thus, the 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272) do not apply. 

This technical correction also does 

not involve special consideration of 

environmental justice-related issues as 

required by Executive Order 12898, 

Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

The Congressional Review Act (CRA), 

5 U.S.C. 801 et seq., as added by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996 (SBREFA), 

generally provides that before a rule 

may take effect, the Agency 

promulgating the rule must submit a 

rule report, which includes a copy of 

the rule, to each House of the Congress 

and to the Comptroller General of the 

U.S. Section 808 allows the issuing 

Agency to make a rule effective sooner 

than otherwise provided by the CRA if 

the Agency makes a good cause finding 

that notice and public procedure is 

impracticable, unnecessary, or contrary 

to the public interest. This 


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