Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 25651 

1 In FDA’s discussion, ‘‘follow-up’’ testing refers 

to testing to determine whether any of the coliform 

organisms detected in source water or finished 

bottled water products are E. coli. 

15 CFR CHAPTER IX 

PART 902—NOAA INFORMATION 

COLLECTION REQUIREMENTS UNDER 

THE PAPERWORK REDUCTION ACT: 

OMB CONTROL NUMBERS 

■ 1. The authority citation for part 902 

continues to read as follows: 

Authority: 44 U.S.C. 3501 et seq. 

■ 2. In § 902.1, amend the table in 

paragraph (b), under the entry ‘‘50 CFR’’ 

by revising the entries for ‘‘§ 665.13’’, 

‘‘§ 665.14’’, ‘‘§ 665.16’’ and ‘‘§ 665.41’’ to 

read as follows: 

§ 902.1 OMB control numbers assigned 

pursuant to the Paperwork Reduction Act. 

* * * * * 

(b) * * * 

CFR part or 

section 

where the information 

collection requirement is 

located 

Current OMB control number 

(all numbers begin with 0648–) 

*****

50 CFR .

*****

665.13 –0490, and 0586.

665.14 –0214, and 0586.

*****

665.16 –0360, and 0586.

*****

665.41 –0490, and 0586.

*****

[FR Doc. E9–12428 Filed 5–28–09; 8:45 am] 

BILLING CODE 3510–22–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 129 and 165 

[Docket No. FDA–2008–N–0446] 

Beverages: Bottled Water 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending its 

bottled water regulations to require that 

bottled water manufacturers test source 

water for total coliform, as is required 

for finished bottled water products, and 

to require, if any coliform organisms are 

detected in source water, that bottled 

water manufacturers determine whether 

any of the coliform organisms are 

Escherichia coli (E. coli), an indicator of 

fecal contamination. FDA also is 

amending its bottled water regulations 

to require, if any coliform organisms are 

detected in finished bottled water 

products, that bottled water 

manufacturers determine whether any 

of the coliform organisms are E. coli. 

FDA also is amending the adulteration 

provision of the bottled water standard 

to reflect the possibility of adulteration 

caused by the presence of filth. Bottled 

water containing E. coli will be 

considered adulterated, and source 

water containing E. coli will not be 

considered to be of a safe, sanitary 

quality and will be prohibited from use 

in the production of bottled water. FDA 

is also amending its bottled water 

regulations to require that, before a 

bottler can use source water from a 

source that has tested positive for E. 

coli, the bottler must take appropriate 

measures to rectify or eliminate the 

cause of E. coli contamination of that 

source, and that the bottler must keep 

records of such actions. Existing 

regulatory provisions require bottled 

water manufacturers to keep records of 

new testing required by this rule. This 

final rule will ensure that FDA’s 

standards for the minimum quality of 

bottled water, as affected by fecal 

contamination, will be no less 

protective of the public health than 

those set by the Environmental 

Protection Agency (EPA) for public 

drinking water. 

DATES: This rule is effective December 1, 

2009. The incorporation by reference of 

certain publications listed in the rule is 

approved by the Director of the Federal 

Register as of December 1, 2009. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Posnick Robin, Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1639. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

17, 2008 (73 FR 53775), FDA published 

a proposed rule to amend its bottled 

water regulations in parts 129 and 165 

(21 CFR parts 129 and 165) to provide 

increased protection against fecal 

contamination in water sources used for 

bottled water and in finished bottled 

water products (hereafter ‘‘the proposed 

rule’’ or ‘‘the September 17, 2008 

proposal’’). FDA’s current good 

manufacturing practice (CGMP) 

regulations for the processing and 

bottling of bottled water are contained 

in part 129. FDA’s bottled water 

standard, contained in part 165, 

includes standard of identity 

regulations, which define different types 

of bottled water (§ 165.110(a)); standard 

of quality regulations, which establish 

allowable levels for contaminants in 

bottled water (§ 165.110(b)); required 

label statements for water of 

substandard quality (§ 165.110(c)); and 

an adulteration provision (§ 165.110(d)). 

FDA proposed a number of changes to 

part 129. FDA proposed to amend 

§ 129.35(a)(3)(i) to require that bottled 

water manufacturers that obtain their 

source water from other than a public 

water system (PWS) test their source 

water at least weekly for total coliform, 

and that when source water is total 

coliform positive, that they conduct 

follow-up1 testing to determine whether 

any of the coliform organisms are E. 

coli. Further, FDA proposed to amend 

§ 129.35(a)(3)(i) to indicate that if source 

water is found to contain E. coli, then 

the water would not be considered 

water of a safe, sanitary quality as 

required by § 129.35(a)(1). FDA also 

proposed in § 129.35(a)(3)(i) to require a 

bottler to rectify or otherwise eliminate 

the cause of the E. coli contamination. 

FDA also proposed that source water 

previously found to contain E. coli 

would be considered negative for E. coli 

after five samples collected from the 

source water supply over a 24-hour 

period are tested and found to be E. coli 

negative. FDA proposed in 

§ 129.35(a)(3)(i) that bottlers maintain 

records of corrective measures taken to 

rectify or eliminate E. coli 

contamination in source water. FDA 

also proposed in § 129.80(g)(1) that if 

any coliform organisms are detected in 

weekly total coliform testing of finished 

bottled water, that bottlers must conduct 

follow-up testing to determine whether 

any of the coliform organisms are E. 

coli. Finally, FDA proposed revising 

§ 129.35(a)(4)(iv) to include a reference 

to section 402(a)(3) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 342(a)(3)) as a basis for 

adulteration, in addition to section 

402(a)(1) of the act. 

FDA proposed a number of changes to 

part 165. FDA proposed to add 

§ 165.110(b)(2)(i)(B) to indicate that if E. 

coli is present in a sample of finished 

bottled water products, then the bottled 

water would be deemed adulterated 


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25652 Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 

2 In FDA’s discussion, ‘‘secondary’’ testing refers 

to testing to determine whether a source previously 

found to contain E. coli can now be considered 

negative for E. coli. 

under § 165.110(d). FDA also proposed 

to cite the multiple-tube fermentation 

(MTF) and membrane filter (MF) 

methods for both total coliform and E. 

coli testing in § 165.110(b)(2)(ii). 

Finally, FDA proposed to amend the 

adulteration provision of the bottled 

water standard in § 165.110(d) to reflect 

the possibility of adulteration caused by 

the presence of filth and to indicate that 

if E. coli is present in bottled water, then 

the bottled water will be deemed 

adulterated under section 402(a)(3) of 

the act. 

FDA issued the proposed rule in 

response to EPA’s issuance of a new 

National Primary Drinking Water 

Regulation (NPDWR), the Ground Water 

Rule (GWR), in the Federal Register of 

November 8, 2006 (71 FR 65574). The 

new NPDWR provides for increased 

protection against fecal microbial 

pathogens in PWSs that use ground 

water sources (also referred to as ground 

water systems (GWSs)). Under section 

410(b)(1) of the act (21 U.S.C. 349(b)(1)), 

not later than 180 days before the 

effective date of an NPDWR issued by 

EPA for a contaminant under section 

1412 of the Safe Drinking Water Act 

(SDWA) (42 U.S.C. 300g-1), FDA is 

required to issue a standard of quality 

regulation for that contaminant in 

bottled water, or make a finding that 

such a regulation is not necessary to 

protect the public health because the 

contaminant is contained in water in 

PWSs but not in water used for bottled 

water. If FDA fails to take action within 

the prescribed time period in response 

to the NPDWR issued by EPA, section 

410(b)(4)(A) of the act provides that 

EPA’s NPDWR will apply to bottled 

water. 

II. Summary of and Response to 

Comments 

A. Summary of Comments 

The agency received 19 responses, 

each containing one or more comments, 

to the September 17, 2008, proposal. 

The comments were from trade 

associations, industry, a law firm, an 

environmental advocacy organization, 

and consumers. The comments 

generally supported the proposed rule. 

Some comments addressed issues that 

are outside the scope of the proposed 

rule (e.g., testing of water in general; 

testing for agricultural chemicals, 

industrial chemicals, and parasites such 

as Giardia; public disclosure of test 

results for contaminants other than E. 

coli; and general labeling requirements) 

and thus will not be discussed here. A 

number of comments suggested certain 

modifications to the proposed rule. A 

summary of these comments and the 

agency’s responses follow. 

B. Response to Comments 

(Comment 1) One comment suggested 

FDA make clear that when a bottler 

conducts secondary2 sampling of source 

water previously found to contain E. 

coli, the sampling should include the 

original site where the E. coli positive 

occurred, if there is more than one 

sampling site at the source. 

(Response) FDA agrees that the 

sampling site where an E. coli positive 

occurred must be used in secondary 

testing to determine whether the source 

can now be considered negative for E. 

coli. Proposed § 129.35(a)(3)(i) provided 

that source water previously found to 

contain E. coli would be considered 

negative for E. coli after five samples 

collected from the source water supply 

over a 24-hour period are tested and 

found to be E. coli negative. To 

eliminate any possible ambiguity related 

to the phrases ‘‘source water’’ and 

‘‘source water supply’’ and to make 

clear what is required before bottlers 

can use source water from a source that 

has tested positive for E. coli, FDA is 

revising proposed § 129.35(a)(3)(i), in 

pertinent part, as follows: ‘‘Before a 

bottler can use source water from a 

source that has tested positive for E. 

coli, the bottler must take appropriate 

measures to rectify or otherwise 

eliminate the cause of E. coli 

contamination of that source in a 

manner sufficient to prevent its 

reoccurrence. A source previously 

found to contain E. coli will be 

considered negative for E. coli after five 

samples collected over a 24-hour period 

from the same sampling site that 

originally tested positive for E. coli are 

tested and found to be E. coli negative.’’ 

FDA notes that some manufacturers 

combine source waters from multiple 

sources. Weekly microbiological testing 

is required for each separate source in 

use by the plant. If E. coli is detected in 

one of these sources, secondary testing 

must be conducted at that same source 

and at the same sampling site that 

originally tested positive for E. coli. 

(Comment 2) One comment stated 

that FDA should join EPA in mandating 

sanitary surveys as an effective measure 

of risk reduction. The comment also 

stated that sanitary surveys can identify 

and eliminate risks or weaknesses 

which weekly water testing cannot, 

such as cracks in sanitary seals around 

wells. Finally, the comment stated that 

if the lack of a primacy program 

arrangement with the States is the real 

reason for the lack of a sanitary survey 

requirement, FDA should look into 

establishing a primacy program 

arrangement, such as having the same 

State agencies and inspectors, which 

EPA trains and uses to conduct sanitary 

surveys of public water sources, also 

conduct sanitary surveys of bottled 

water sources. 

(Response) FDA disagrees with this 

comment. Although FDA does not have 

a primacy program arrangement with 

States to conduct sanitary surveys, FDA 

believes that the requirement for weekly 

source water testing for total coliform 

(and for E. coli, should total coliform be 

detected) in this rule, combined with 

the existing requirement in the bottled 

water CGMP regulations for source 

inspection and approval, will ensure 

that FDA’s standards for the minimum 

quality of bottled water, as affected by 

fecal contamination, will be no less 

protective of the public health than 

those set by EPA for public drinking 

water. 

While sanitary surveys may help 

identify potential risks for fecal 

contamination in source water, such as 

cracks in sanitary seals, actual fecal 

contamination of source water is 

identified by source water testing. This 

rule requires weekly source water 

testing for total coliform, with E. coli 

testing in case of a total coliform 

positive. In addition, as FDA noted in 

the proposed rule, FDA’s CGMP 

regulations for bottled water already 

require in § 129.35(a)(1) that product 

water be from an approved source, 

defined in § 129.3(a) as ‘‘a source of 

water and the water therefrom, whether 

it be from a spring, artesian well, drilled 

well, municipal water supply, or any 

other source, that has been inspected 

and the water sampled, analyzed, and 

found to be of a safe and sanitary quality 

according to applicable laws and 

regulations of State and local 

government agencies having 

jurisdiction.’’ Additionally, 

§ 129.35(a)(1) specifies that the 

approved source be ‘‘properly located, 

protected, and operated and shall be 

easily accessible, adequate, and of a 

safe, sanitary quality* * *’’ FDA also 

notes that certain elements of the GWR’s 

sanitary survey, as outlined by EPA (71 

FR 65574 at 65577 and 65586 through 

65587), are not relevant to bottled water 

plants (e.g., distribution system surveys) 

or are relevant only to EPA’s unique 

regulatory structure (e.g., operator 

compliance with State requirements), 

and therefore would not be appropriate 

for FDA to include in this rule. 


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Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 25653 

Therefore, FDA believes that the 

proposed requirement for weekly source 

water testing for total coliform (and for 

E. coli, should total coliform be 

detected), combined with the existing 

requirement in the bottled water CGMP 

regulations for source inspection and 

approval, will ensure that FDA’s 

standards for the minimum quality of 

bottled water, as affected by fecal 

contamination, will be no less 

protective of the public health than 

those set by EPA for public drinking 

water. 

(Comment 3) A number of comments 

questioned the proposed requirements 

for frequency of testing of source water 

and/or finished products in part 129. 

Some comments suggested that EPA 

requires more samples than FDA, while 

citing different numbers for how many 

samples EPA requires. Another 

comment stated that weekly testing 

would not detect intermittent 

contamination, and that daily testing 

would be more appropriate, as 

evidenced by FDA’s proposal that a 

source previously found to contain E. 

coli will be considered negative for E. 

coli after five samples collected from the 

same source water supply over a 24- 

hour period are tested and found to be 

E. coli negative. Several comments made 

the point that the cost of testing would 

be low compared with the cost of a 

disease outbreak resulting from 

contaminated water. 

(Response) FDA disagrees with these 

comments on the proposed 

requirements for the frequency of testing 

of source water and finished products. 

FDA does not believe that it is 

appropriate to compare the number of 

tests required by EPA for total coliform 

in PWSs to the number of tests required 

by FDA for total coliform in source and 

finished bottled water. To monitor the 

microbiological safety of their 

distribution systems, PWSs must take 

samples throughout their distribution 

systems and in a pattern that is 

representative of the distribution 

system. Bottled water plants do not have 

distribution systems and monitor 

finished bottled water products from a 

filling line. Therefore, FDA does not 

believe that the number of tests required 

for a PWS distribution system serving a 

large geographical area is comparable to 

the monitoring required for a bottled 

water manufacturing plant. 

In this rule FDA is amending its 

bottled water regulations to require that 

bottled water manufacturers test source 

water at least weekly for total coliform, 

as is required for finished bottled water 

products, and to require, if any coliform 

organisms are detected in source water, 

that bottled water manufacturers 

determine whether any of the coliform 

organisms are E. coli, an indicator of 

fecal contamination (§ 129.35(a)(3)(i)). 

By contrast, EPA requires testing of 

source water for E. coli only when 

triggered by a coliform positive in the 

distribution system. FDA also is 

amending its bottled water regulations 

to require that if any coliform organisms 

are detected in finished bottled water 

products, that bottled water 

manufacturers determine whether any 

of the coliform organisms are E. coli 

(§ 129.80(g)(1)). (FDA notes that weekly 

sampling is the minimum required 

under the CGMP regulations for bottled 

water, and that manufacturers should 

test as frequently as needed to ensure 

the safety of their products.) 

Also, FDA previously established 

additional microbiological testing 

requirements to help ensure the safety 

of finished bottled water products. The 

CGMP regulations for bottled water in 

§ 129.80(a) state that product water 

samples shall be taken after processing 

and prior to bottling by the plant and 

analyzed as often as is necessary to 

assure uniformity and effectiveness of 

the processes performed by the plant. 

FDA also requires in § 129.80(f) that at 

least once each 3 months, a 

bacteriological swab and/or rinse count 

should be made from at least four 

containers and closures selected just 

prior to filling and sealing. All of the 

samples are required to be free of 

coliforms, and no more than one of the 

four samples may exceed more than one 

bacteria per milliliter of capacity or one 

colony per square centimeter of surface 

area. 

For these reasons, FDA believes that 

the frequency of testing of source water 

and finished products, as set forth in the 

new and revised requirements under 

part 129, will ensure that FDA’s 

standards for the minimum quality of 

bottled water, as affected by fecal 

contamination, will be no less 

protective of the public health than 

those set by EPA for public drinking 

water. 

(Comment 4) One comment stated 

that the requirement that bottled water 

manufacturers ‘‘take and analyze at least 

once a week 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’’ in § 129.80(g)(1) fails to 

specify that the day’s production that is 

to be sampled must have been produced 

during the week in question. 

(Response) FDA believes that 

§ 129.80(g)(1) requires that the sample 

mandated to be taken ‘‘at least once a 

week’’ must be taken from bottled water 

produced during the week it is sampled. 

It would not make sense to interpret this 

provision to allow otherwise in light of 

the clear intent to mandate regular, 

timely testing. Further, FDA is not 

aware of any bottlers who have 

understood the provision as not 

requiring the sample to have been 

produced during the week in question. 

Therefore, FDA does not believe it is 

necessary to make any changes to 

§ 129.80(g)(1) based on this comment. 

(Comment 5) One comment suggested 

that FDA establish specific 

requirements, like the EPA GWR, as to 

how bottlers should correct E. coli 

contamination. The comment also stated 

that the FDA should consider 

employing EPA’s various treatment 

options in order to ensure that bottlers 

are using methods that are known to be 

effective. 

(Response) FDA does not agree that it 

is necessary to include specific 

requirements in its regulations for 

rectifying or eliminating the cause of E. 

coli contamination. Bottled water 

manufacturers are responsible for 

ensuring that their manufacturing 

operations comply with all applicable 

provisions of the act and FDA’s 

regulations for bottled water, including 

the new provision providing that source 

water found to contain E. coli is not 

considered water of a safe, sanitary 

quality as required for use in bottled 

water. As noted in the proposed rule (73 

FR 53775 at 53780), bottlers may wish 

to consult with States or with EPA, or 

review EPA guidance (http:// 

www.epa.gov/safewater/disinfection/ 

gwr/compliancehelp.html), for advice 

on how to eliminate causes of 

contamination. FDA notes that, under 

§ 129.35(a)(1), bottled water 

manufacturers are responsible for using 

water from sources that have been 

approved by the government agency or 

agencies (e.g., State or local agencies) 

having jurisdiction. These government 

agencies may have helpful advice on 

rectifying or eliminating the cause of E. 

coli contamination at a specific source 

based on local conditions, since the 

cause of contamination may vary from 

site to site. 

(Comment 6) One comment suggested 

that FDA update the reference in 

proposed § 165.110(b)(2)(ii) to the most 

current version of ‘‘Standard Methods 

for the Examination of Water and 

Wastewater.’’ 

(Response) FDA agrees that the most 

current edition should be cited in the 

final rule. In the proposed rule, FDA 

cited the 20th Edition of ‘‘Standard 

Methods for the Examination of Water 

and Wastewater.’’ However, there is a 

21st Edition of ‘‘Standard Methods for 

the Examination of Water and 


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25654 Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 

Wastewater.’’ Therefore, FDA is revising 

§ 165.110(b)(2)(ii) to incorporate by 

reference the 21st Edition (2005) of 

‘‘Standard Methods for the Examination 

of Water and Wastewater.’’ 

(Comment 7) One comment suggested 

the need for guidance on demonstrating 

comparable results when labs are 

comparing other methods to the MTF 

and MF methods. The comment further 

recommended that an established or 

pre-agreed-upon protocol should be 

used to prove comparability. 

(Response) FDA does not believe that 

such guidance is necessary. As stated in 

the proposed rule (73 FR 53775 at 

53782), bottlers can use different 

methods approved by the government 

agency or agencies having jurisdiction 

as long as their methods give 

comparable results to the methods used 

by FDA. Laboratories routinely adopt 

new analytical methods and have 

standard practices to follow for 

validating the performance of these 

methods and for comparing the 

sensitivity, accuracy, and precision of 

the new methods to currently used 

methods. These practices, along with 

the information provided by FDA on 

allowable levels of E. coli and total 

coliform (revised § 165.110(b)(2)(i)), 

sampling (§ 165.3(b)), and methodology 

(revised § 165.110(b)(2)(ii)), should 

provide laboratories with sufficient 

information to compare different 

methods to those used by FDA. 

(Comment 8) Several comments 

recommended that FDA consider a test 

result for E. coli to be a valid ‘‘positive’’ 

only if it has been confirmed. 

(Response) FDA agrees that a 

presumed positive test result for E. coli 

should be confirmed. This rule cites the 

MTF and MF methods, which 

incorporate confirmation steps for E. 

coli including streaking presumptive E. 

coli positive cultures on eosin 

methylene blue (EMB) agar, selecting 

colonies with the typical appearance of 

E. coli, and using a series of biochemical 

assays or rapid identification tests to 

identify E. coli isolates (Ref. 1). 

As noted in the proposed rule, 

bottlers can use methods other than the 

MTF and MF methods to analyze water 

for total coliform and E. coli. However, 

FDA will use the MTF and MF methods 

when it tests source water or finished 

bottled water products. Bottlers that 

want to use different methods must 

ensure that their methods give 

comparable results. FDA notes that 

alternate methods must be capable of 

quantifying total coliform, if coliform is 

present, to meet the standard in 

§ 165.110(b)(2)(i)(A). Furthermore, all 

methods, including those used to 

confirm presumed positive E. coli, must 

be methods approved by the 

government agency or agencies having 

jurisdiction, as required under 

§ 129.35(a)(3)(ii). 

(Comment 9) One comment stated 

that not all strains of E. coli bacteria are 

pathogenic, and therefore, water with E. 

coli in it is also not necessarily 

contaminated. The comment added that 

testing for specific pathogenic strains of 

E. coli and other intestinal parasites 

would prove more effective than general 

E. coli tests in determining whether 

water is contaminated. 

(Response) FDA agrees that not all 

strains of E. coli are pathogenic. 

However, FDA disagrees that water with 

E. coli in it is not contaminated and that 

testing bottled water products for 

specific pathogenic strains would be 

more effective than testing for generic E. 

coli. In the GWR, EPA stated that 

ground water is fecally contaminated 

when fecal indicators such as E. coli are 

present. Because E. coli is indicative of 

fecal contamination, FDA provided in 

the proposed rule that bottled water 

containing E. coli would be considered 

adulterated under section 402(a)(3) of 

the act, in that it ‘‘consists in whole or 

in part of any filthy, putrid, or 

decomposed substance, or * * * is 

otherwise unfit for food.’’ Because 

testing for generic E. coli is sufficient to 

determine whether bottled water is 

fecally contaminated, it is not necessary 

to require testing for specific strains. 

In addition, as noted in the GWR, 

while fecal indicators typically are not 

harmful when ingested, their presence 

demonstrates that there is a pathway for 

pathogenic viruses and bacteria to enter 

ground water sources (71 FR 65574 at 

65576). Therefore, it is not necessary to 

test for specific pathogenic strains to 

demonstrate that there is a pathway for 

pathogenic viruses and bacteria to enter 

ground water sources. Confining testing 

to a few specific pathogenic strains 

would be less effective at detecting fecal 

contamination than the broader E. coli 

testing required by this rule. Therefore, 

FDA is not making changes in the final 

rule to require testing only for 

pathogenic strains of E. coli. 

(Comment 10) One comment 

suggested that FDA adopt EPA’s 

maximum contaminant level goals 

(MCLGs) as enforceable standards for 

chemical and microbiological 

contaminants in bottled water. 

(Response) FDA notes that with the 

exception of fecal contaminants, this 

comment is outside of the scope of this 

rulemaking. MCLGs are unenforceable 

health goals established by EPA. EPA 

establishes enforceable standards for 

contaminants in drinking water in the 

form of maximum contaminant levels 

(MCLs) or treatment techniques (TTs). 

The SDWA (section 1412(b)(4) (42 

U.S.C. 300g-1(b)(4))) requires EPA to set 

MCLs and TTs as close to the MCLGs as 

is feasible, with feasibility including 

technical and economic considerations. 

Section 410(b)(3)(A) of the act provides 

that an FDA regulation issued in 

response to an EPA MCL shall establish 

an MCL for the contaminant in bottled 

water which is no less stringent than the 

MCL provided in EPA’s NPDWR. 

Likewise, section 410(b)(3)(B) of the act 

provides that an FDA regulation issued 

in response to an EPA TT shall be no 

less protective of the public health than 

the TT required by EPA’s NPDWR. 

Therefore, FDA’s response to NPDWRs 

is based on the legally enforceable MCLs 

and TTs, as provided for in the act. 

(Comment 11) Several comments 

suggested that FDA require companies 

to disclose source information on 

bottled water labels. One comment said 

that there are ground water sources and 

surface water sources that are fouled by 

fecal pollution or other contaminants, 

and that public disclosure, on the bottle 

label, of the precise location of the water 

withdrawal site, of potential 

contamination of source water, or of 

pollutants in bottled waters will provide 

consumers with the evidence on which 

to make the decisions to purchase the 

product that would best suit their needs 

and the needs of their families. 

(Response) FDA disagrees that it 

should require disclosure of source 

information as part of this rulemaking. 

FDA addressed the issue of source 

disclosure in the final rulemaking 

establishing a standard of identity for 

bottled water (§ 165.110(a)) (60 FR 

57076 at 57104, November 13, 1995). 

FDA noted that under section 201(n) of 

the act (21 U.S.C. 321(n)), the agency 

must consider whether specific water 

source labeling information is a material 

fact whose nondisclosure will render 

the labeling misleading. FDA concluded 

that the specific name of the source is 

not material to ensure the safety of the 

product, given the requirements for 

source approval and operation in 

§§ 129.3(a) and 129.35(a)(1). FDA 

believes that the specific name of the 

source is not material to ensure the 

safety of the product from fecal 

contamination, in light of the 

requirements cited above and those 

added by this rule. 

For this reason, FDA is not making 

any changes in response to these 

comments. 

(Comment 12) Several comments 

suggested that FDA require bottled 

water companies to disclose test results 

for E. coli in source water and/or 

finished bottled water products to the 


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Federal Register / Vol. 74, No. 102 / Friday, May 29, 2009 / Rules and Regulations 25655 

public. One comment stated that the 

FDA rule should include a provision for 

public notification as found in EPA tap 

water regulations, which require PWSs 

that use ground water to notify the 

public if monitoring samples test 

positive for a fecal indicator or if the 

appropriate water protection measures 

have not been taken in a timely manner. 

(Response) FDA disagrees that it 

should require companies to routinely 

disclose test results for E. coli in source 

water and finished products to the 

public. Routine public disclosure of 

source water testing results is not 

necessary because source water 

containing E. coli will not be considered 

to be of a safe, sanitary quality under 

revised § 129.35(a)(3)(i) and thus will be 

prohibited from use in the production of 

bottled water under § 129.35(a)(1). 

Likewise, routine public disclosure of 

test results for E. coli in finished bottled 

water products is not necessary because 

bottled water products that test positive 

for the fecal indicator E. coli are deemed 

adulterated under new 

§ 165.110(b)(2)(i)(B) and revised 

§ 165.110(d). Adulterated products 

cannot be introduced or delivered for 

introduction into interstate commerce 

under section 301 of the act (21 U.S.C. 

331), and FDA may take enforcement 

action against adulterated products, 

including pursuing product seizure 

(section 304 of the act (21 U.S.C. 334)). 

In addition, FDA notes that its recall 

guidance in 21 CFR part 7 includes 

recommendations for public 

communication of recalls. Therefore, the 

new regulations are sufficient to ensure 

the safety of bottled water products, 

with regard to the presence of fecal 

contamination, without requiring 

routine public disclosure of testing 

results. Accordingly, FDA is not making 

any changes in response to this 

comment to require routine public 

disclosure of monitoring results. 

(Comment 13) One comment 

requested that FDA limit the 

applicability of the proposed rule to 

bottled water manufacturers that use 

ground water, noting that FDA modeled 

its proposed rule after the EPA GWR, 

which expressly limits its application to 

PWSs that use ground water. The 

comment also states that if FDA intends 

to regulate manufacturers that use 

surface water, it should adopt the 

analogous provisions of EPA’s 

regulations in 40 CFR part 141, subparts 

C and H, which were designed 

specifically for surface water PWSs, and 

which are based on filtration and 

disinfection requirements rather than 

FDA’s proposed requirements for an E. 

coli-free source and regular source 

testing. This comment also stated that 

source testing and corrective action 

should not be required for 

manufacturers that use surface water, 

since EPA does not impose these 

requirements on surface water PWSs. As 

further support for its position, the 

comment argued that these 

requirements are not necessary for 

manufacturers that use surface water 

because E. coli are removed during 

treatment processes such that the 

amount of coliform in the source has no 

bearing on the final product. The 

comment also stated that the imposition 

of the corrective action requirements in 

this rule on any ‘‘source,’’ regardless of 

origin, would unfairly force 

manufacturers that use surface water to 

either shut down their intakes and 

undertake the impossible task of 

eliminating E. coli that is going to be 

eliminated anyway during treatment or, 

alternatively, purchase water from 

PWSs. 

(Response) FDA disagrees with the 

comment that it should apply this rule 

specifically to bottled water 

manufacturers that use ground water, 

that any FDA requirements for bottled 

water manufacturers that use surface 

water should be modeled after EPA’s 

regulations for surface water PWSs, and 

that FDA should not adopt its own 

source and testing requirements for 

bottled water because EPA has different 

requirements for surface water PWSs. 

The application of this rule to all bottled 

water manufacturers is consistent with 

the adulteration provisions in section 

402(a)(3) and (a)(4) of the act and with 

FDA’s obligations under section 410 of 

the act. Specifically, under section 

410(b)(1) of the act, FDA is required to 

respond to EPA’s issuance of an 

NPDWR for a contaminant in drinking 

water by issuing a standard of quality 

regulation for that contaminant in 

bottled water, or make a finding that 

such a regulation is not necessary to 

protect the public health because the 

contaminant is contained in water in 

PWSs but not in water used for bottled 

water. Section 410(a)(b)(2) of the act 

also provides that a standard of quality 

regulation issued by FDA shall include 

monitoring requirements that the agency 

determines to be appropriate for bottled 

water. 

In this rule, FDA is responding to an 

EPA NPDWR on fecal contamination in 

ground water. Fecal contamination can 

be found in surface water as well as 

ground water. Therefore, FDA believes 

that it is appropriate for it to respond to 

EPA’s issuance of a NPDWR on fecal 

contamination in GWSs by establishing 

a regulation that will apply to all 

manufacturers of bottled water. As FDA 

explained in the proposed rule, ‘‘[T]he 

potential for fecal contamination 

addressed in the EPA GWR also exists 

for ground water sources used for 

bottled water. The potential also exists 

for bottled water products from ground 

water sources to be contaminated during 

processing and for bottled water 

products from other sources to be 

contaminated from source water or 

during processing. Therefore, FDA is 

proposing to require that source water 

currently subject to weekly 

microbiological testing be analyzed 

specifically for total coliform * * *.’’ 

(73 FR 53775 at 53779 through 53780). 

FDA notes that this rule is consistent 

with its regulatory approach, which has 

not been to establish separate 

regulations for ground water and surface 

water sources under parts 129 and 165. 

In response to the comment’s 

contention that the microbiological 

source testing and rectification 

requirements of this rule are not 

necessary for manufacturers that use 

surface water because microbiological 

contaminants are removed during 

treatment processes, FDA emphasizes 

that all bottled water products are 

subject to existing requirements related 

to the water supply. FDA’s CGMP 

regulations for bottled water define ‘‘an 

approved source’’ as ‘‘a source of water 

and the water therefrom * * * that has 

been inspected and the water sampled, 

analyzed, and found to be of a safe and 

sanitary quality according to applicable 

laws and regulations of State and local 

government agencies having 

jurisdiction’’ (§ 129.3(a)). The CGMP 

regulations require that the product 

water supply be of a ‘‘safe, sanitary 

quality’’ (§ 129.35(a)(1)). FDA does not 

consider source water containing E. coli 

to be of a safe and sanitary quality. The 

CGMP regulations also require at least 

weekly microbiological testing under 

§ 129.35(a)(3)(i) for source water 

obtained from other than a PWS. 

Therefore, sources other than PWSs that 

have not been sampled and analyzed for 

microbiological contaminants are not in 

compliance with FDA’s CGMP 

regulations for source water. 

One existing exemption to the 

microbiological testing requirement is 

for source water from PWSs. As 

explained in the final rule establishing 

this exemption, PWSs are subject to 

EPA regulations to ensure the safety of 

public drinking water, including water 

from surface sources (60 FR 57076 at 

57111). In this case, FDA considers the 

source water for bottling to be the 

treated water from the PWS, not the 

original surface water source from 

which the PWS drew its water. 

Therefore, this rule’s requirement for 

coliform and, potentially, E. coli testing 


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of source water does not apply to 

manufacturers that obtain their source 

water from PWSs that use surface water. 

In response to concerns regarding the 

rule’s impact on manufacturers that use 

surface water, FDA noted in the 

proposed rule that 70 to 75 percent of 

bottled water manufacturers use ground 

water (73 FR 53775 at 53779). FDA 

believes that the vast majority of the 

remaining manufacturers obtain their 

source water from PWSs, rather than 

from surface water sources, based on 

information provided by industry (66 

FR 35439 at 35440 through 35441, July 

5, 2001). FDA also notes that this 

comment did not provide any specific 

information identifying manufacturers 

using surface water that might be 

affected by the rule. For these reasons, 

FDA is unaware of evidence of any 

bottled water manufacturers using 

surface water directly from a surface 

water source that would be negatively 

affected by this rule, e.g., manufacturers 

using sources that are potentially 

contaminated with E. coli. 

For the reasons summarized above, 

FDA is not making changes to the final 

rule in response to this comment. 

III. Conclusion 

The comments to the September 17, 

2008, proposal (73 FR 53775) supported 

most of the provisions that FDA is 

adopting in this final rule. After review 

and consideration of the comments 

received in response to the September 

17, 2008, proposal, FDA concludes that 

it should amend part 129 and part 165 

as set forth in the proposed rule but 

with the specific modifications to the 

proposed regulation discussed in this 

document. For the purposes of this final 

rule, certain changes, in addition to 

those discussed in this document, were 

made for editorial purposes, clarity, and 

consistency only. These changes do not 

modify any matter of substance. 

Therefore, FDA is amending parts 129 

and 165 to provide the following: 

• Bottled water manufacturers that 

obtain their source water from other 

than a PWS must test their source water 

at least weekly for total coliform, and if 

that source water is total coliform 

positive, must conduct follow-up testing 

to determine whether any of the 

coliform organisms are E. coli 

(§ 129.35(a)(3)(i)); 

• Source water found to contain E. 

coli will not be considered water of a 

safe, sanitary quality as required for use 

in bottled water by § 129.35(a)(1) 

(§ 129.35(a)(3)(i)); 

• Before a bottler can use source 

water from a source that has tested 

positive for E. coli, the bottler must take 

appropriate measures to rectify or 

otherwise eliminate the cause of E. coli 

contamination of that source in a 

manner sufficient to prevent its 

reoccurrence. A source previously 

found to contain E. coli will be 

considered negative for E. coli after five 

samples collected over a 24-hour period 

from the same sampling site that 

originally tested positive for E. coli are 

tested and found to be E. coli negative 

(§ 129.35(a)(3)(i)); 

• Bottlers must maintain records of 

corrective measures taken to rectify or 

eliminate E. coli contamination 

(§ 129.35(a)(3)(i)); 

• If any coliform organisms are 

detected in weekly total coliform testing 

of finished bottled water, follow-up 

testing must be conducted to determine 

whether any of the coliform organisms 

are E. coli (§ 129.80(g)(1)); 

• Section 402(a)(3) of the act, in 

addition to section 402(a)(1), may apply 

as a basis for adulteration 

(§ 129.35(a)(4)(iv)); 

• Analyses conducted to determine 

compliance with the standards for 

microbiological quality for total 

coliform and E. coli must be made in 

accordance with the MTF and MF 

methods (§ 165.110(b)(2)(ii)); and 

• If E. coli is present in bottled water, 

then the bottled water is deemed to be 

adulterated under section 402(a)(3) of 

the act (§ 165.110(b)(2)(i)(B); 

§ 165.110(d)). 

As a result of these amendments to 

parts 129 and 165, upon the effective 

date of this final rule, December 1, 2009, 

any source water containing E. coli will 

not be considered water of a safe, 

sanitary quality and cannot be used for 

the production of bottled water. Also, 

any finished bottled water product that 

contains E. coli is deemed to be 

adulterated under section 402(a)(3) of 

the act. 

IV. Environmental Impact 

The agency has previously considered 

the environmental effects of this rule as 

announced in the proposed rule. No 

new information or comments have 

been received that would affect the 

agency’s previous determination that 

there is no significant impact on the 

human environment and that an 

environmental impact statement is not 

required. 

V. Analysis of Impacts 

A. Executive Order 12866 and 

Regulatory Flexibility Act 

FDA has examined the impacts of the 

final rule under Executive Order 12866 

and the Regulatory Flexibility Act (5 

U.S.C. 601–612), and the Unfunded 

Mandates Reform Act of 1995 (Public 

Law 104–4). Executive Order 12866 

directs agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). The agency 

believes that this final rule is not a 

significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because the costs per entity of 

this rule are small, the agency certifies 

that the final rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $130 

million, using the most current (2007) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this final rule to result in any 1-year 

expenditure that would meet or exceed 

this amount. 

This final economic impact analysis 

revises the analysis set forth in the 

proposed rule (73 FR 53775) in response 

to comments received. Except as 

indicated below, the analysis in this 

final rule is the same as the analysis of 

the proposed rule. 

1. Need for Regulation 

FDA did not receive any comments on 

the need for regulation in the analysis 

of the proposed rule. Under section 410 

of the act, FDA is required to respond 

to the GWR published by EPA by 

issuing its own standard of quality 

regulation for bottled water that is no 

less protective of the public health than 

the treatment techniques adopted by 

EPA in the GWR, unless it makes a 

finding that such additional regulations 

are not necessary to protect the public 

health. EPA published the GWR, in part, 

because data indicated that GWSs are 

susceptible to fecal contamination. Prior 

to the GWR, there were no Federal 

regulations requiring monitoring or 

disinfection of ground water sources or 

requiring corrective action when fecal 


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contamination or a risk of fecal 

contamination is found. The GWR puts 

in place a regulatory process, including 

treatment techniques, to identify and 

target GWSs that are susceptible to fecal 

contamination, and to require higher 

risk GWSs to monitor and, when 

necessary, take corrective action. As 

noted previously, if FDA fails to take 

action within the prescribed time period 

in response to the GWR, then under 

section 410(b)(4)(A) of the act, EPA’s 

GWR will apply to bottled water. 

Further, section 410(b)(2) of the act 

requires that a standard of quality 

regulation issued by FDA shall include 

monitoring requirements that the agency 

determines to be appropriate for bottled 

water. 

EPA determined that there is the 

potential for ground water to be 

contaminated with pathogenic bacteria 

or viruses, or both, and that the 

presence of fecal indicators can 

demonstrate a pathway for pathogenic 

enteric bacteria and viruses to enter 

GWSs. Ground water sources supply 

water for 70 to 75 percent of all U.S. 

bottled water products (Ref. 2). Based on 

EPA’s findings in the GWR, FDA 

concludes that the potential for fecal 

contamination that exists for PWS 

ground water sources regulated by 

EPA’s GWR also exists for bottled water 

using ground water sources. The 

potential also exists for bottled water 

products from ground water sources to 

be contaminated during processing and 

for bottled water products from other 

sources to be contaminated from source 

water or during processing. 

Dun’s Market Identifiers database lists 

378 U.S. establishments under North 

American Industry Classification 

System (NAICS) code 312112 Bottled 

Water Manufacturing (69 FR 70082 at 

70084, December 2, 2004). These 378 

establishments correspond to 318 firms. 

Because a firm may own more than one 

establishment and each establishment 

may be a source, a bottling plant or 

both, this analysis will assume that each 

establishment corresponds to one 

source. Foreign bottled water 

establishments that produce and export 

their bottled water products for 

consumption in the United States will 

have to meet the same FDA 

requirements as domestic 

establishments. FDA is aware of at least 

35 major brands of bottled water that are 

imported into the United States. When 

sales of a particular brand constitute a 

significant portion of the market share 

for this industry, then the brand is 

considered a major brand. If each 

imported brand corresponds to one 

foreign establishment, then an 

additional 35 foreign establishments 

will also be affected, giving a total of 

413 establishments covered by this rule 

(Ref. 3). Because FDA assumes that each 

establishment is equivalent to a single 

water source, we estimate that 413 

bottlers, both domestic and foreign, will 

be covered by this regulation. FDA 

received no comments on these 

estimates. However, in response to a 

comment on sampling after an E. coli 

positive, FDA noted that in some cases, 

bottlers may have more than one 

sampling site at a source or may 

combine water from more than one 

source for bottling. Because none of the 

comments provided information 

regarding the possible number of 

sources per bottler, for purposes of this 

analysis, FDA maintains in this final 

rule the one source to one establishment 

correspondence used in the cost 

estimates of the proposed rule. 

2. Regulatory Options 

FDA evaluated three regulatory 

options in the analysis of this rule: 

Option 1. Take no action. If FDA fails 

to issue a standard of quality regulation 

or make a finding that such a regulation 

is not necessary to protect the public 

health, then EPA’s GWR will apply to 

bottled water. 

Option 2. Issue the regulations, as 

outlined in Option 3, but remove the 

existing exemption for weekly 

microbiological testing of source water 

from PWSs. 

Option 3. Issue the regulations in this 

final rule. FDA is requiring that source 

water currently subject to weekly 

microbiological testing be analyzed 

specifically for total coliform and if any 

coliform organisms are detected in 

source water or in finished bottled water 

products, then bottled water 

manufacturers will be required to test 

for E. coli. Source water containing E. 

coli will not be considered to be of a 

safe, sanitary quality and will be 

prohibited from use in the production of 

bottled water. Before a bottler can use 

source water from a source that has 

tested positive for E. coli, the bottler 

must take appropriate measures to 

rectify or otherwise eliminate the cause 

of the contamination. A source 

previously found to contain E. coli will 

be considered negative for E. coli after 

five samples collected over a 24-hour 

period from the same sampling site that 

originally tested positive for E. coli are 

tested and found to be E. coli negative. 

Finished bottled water products 

containing E. coli will be deemed 

adulterated. 

Several comments recommended that 

FDA consider an E. coli test result to be 

‘‘positive’’ only if it has been confirmed 

so it is considered valid. In response, 

FDA pointed out that the test methods 

specified in the rule include 

confirmatory steps. 

In evaluating the testing costs of the 

proposed rule, FDA based its estimates 

on EPA’s GWR estimates for testing 

costs. At least some of the methods 

approved by EPA in the GWR include 

confirmatory testing for the fecal 

indicator organism. Therefore the costs 

of confirmatory testing are already 

included in the overall testing cost 

estimates used by EPA. Thus, the 

estimated testing costs in the economic 

impact analysis of the proposed rule 

remain the same for the economic 

impact analysis of this final rule. 

Costs and Benefits of Options 

Option 1. Take no action. If FDA does 

not issue a regulation by the statutory 

deadline, EPA’s GWR for drinking water 

would become applicable to bottled 

water. EPA’s GWR is designed for 

PWSs, which differ in significant ways 

from bottled water plants. Some of its 

provisions, such as those that address 

public water distribution systems, 

cannot be applied literally to bottled 

water plants, which do not have such 

distribution systems. Accordingly, FDA 

believes that Option 1 is not efficient 

and therefore less desirable than the 

chosen option. 

Option 2. Change the testing 

requirements for source water and 

finished bottled water products to 

include total coliform testing of source 

water for all bottlers (i.e., remove the 

existing exemption for weekly 

microbiological testing of source water 

from PWSs) and require follow-up 

testing for E. coli when total coliform 

positives occur. 

Bottlers that obtain their water from 

PWSs are not required to conduct 

microbiological testing of their source 

water under the CGMPs 

(§ 129.35(a)(3)(i)). FDA considered 

removing this exemption. This would 

have the advantage of requiring all 

bottlers to conduct the same tests (i.e., 

to test their source water for total 

coliform) and to conduct follow-up 

testing for E. coli when total coliform 

positives occur. However, removing the 

exemption for weekly microbiological 

testing of source water would be 

inefficient because PWSs are already 

covered by EPA drinking water 

regulations, including the GWR. 

Option 3. FDA’s Final Regulatory 

Action. Each requirement of FDA’s 

regulatory action is evaluated separately 

in the following order: 

1. Require that source water currently 

subject to weekly microbiological 

testing be analyzed specifically for total 

coliform; 


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2. Require follow-up testing for E. coli 

when total coliform positives occur in 

source water or finished bottled water 

products; and 

3. Require bottlers, in the event the 

source water tests positive for E. coli, to 

rectify or otherwise eliminate the cause 

of contamination of the source, and then 

subsequently test samples from the 

same sampling site sufficiently until the 

source is considered negative for E. coli. 

Finished bottled water products that test 

positive for E. coli will be deemed 

adulterated. 

Option 3 Explained 

1. Require that source water currently 

subject to weekly microbiological testing 

be analyzed specifically for total 

coliform. The bottled water CGMPs at 

§ 129.35(a)(3)(i) require that bottlers that 

obtain source water from other than a 

PWS conduct microbiological tests at 

least once a week. The CGMPs do not 

specify what organism to test for or the 

allowable level of bacterial 

contamination. FDA is now requiring 

that bottlers that obtain their water from 

other than a PWS must test their source 

water at least once a week for total 

coliform. FDA expects that most bottlers 

currently use total coliform testing to 

conduct these microbiological tests. For 

example, the Model Code of the 

International Bottled Water Association 

(IBWA), a trade association representing 

a large segment of the bottled water 

industry, requires total coliform testing 

of source water (Ref. 4). Furthermore, 

the 35 foreign producers mentioned in 

this analysis are members of IBWA. 

Because microbiological testing is 

already a requirement of the existing 

CGMPs and total coliform testing is a 

widely used test for microbiological 

quality of water, and because producers 

are already required to test for total 

coliform in finished products, FDA 

expects that the number of 

establishments affected by this 

requirement will be negligible and no 

additional costs are estimated for this 

provision. 

2. Require follow-up testing for E. coli 

when total coliform positives occur in 

source water or finished bottled water 

products. As noted previously, FDA is 

requiring that bottlers that obtain their 

water from other than a PWS test their 

source water at least weekly for total 

coliform. Finished water products are 

already required to be tested for total 

coliform under the existing CGMPs. 

FDA is now requiring that if any 

coliform organisms are detected in 

source water or in finished water 

products, then the bottler must conduct 

follow-up testing for E. coli. The 

presence of any coliform indicates that 

the water may contain E. coli, an 

indicator of fecal contamination. 

Further, FDA agrees with EPA’s 

conclusions that ground water sources 

may be vulnerable to fecal 

contamination and that such fecal 

contamination may pose a threat to 

health. Because ground water is the 

source water for approximately 75 

percent of U.S. bottled water products, 

the potential for fecal contamination 

also exists for ground water sources 

used for bottled water. The potential 

also exists for finished bottled water 

products, whether from ground water 

sources or from other sources such as 

PWSs, to be contaminated during 

processing. FDA has determined that it 

is appropriate to require E. coli testing 

in response to a total coliform positive 

finding from weekly source and finished 

bottled water sampling. In this final 

rule, FDA estimates the costs of E. coli 

testing resulting from a total coliform 

positive. The estimated costs are based 

on the probability that the source water 

or a finished product will test positive 

for total coliform during any given year. 

3. Require bottlers, in the event the 

source water tests positive for E. coli, to 

rectify or otherwise eliminate the cause 

of contamination of the source, and 

then subsequently test samples from the 

same sampling site sufficiently until the 

source is considered negative for E. coli. 

Finished bottled water products that test 

positive for E. coli will be deemed 

adulterated. If source water tests 

positive for E. coli, this cost model 

assumes that bottlers will respond by 

taking action to rectify or eliminate the 

cause of the contamination, by keeping 

records of those actions, and by 

subsequently testing samples from the 

same sampling site sufficiently until the 

source is considered negative for E. coli. 

The source will be considered negative 

for E. coli after five samples collected 

over a 24-hour period from the same 

sampling site that originally tested 

positive for E. coli are tested and found 

to be E. coli negative. 

Finished bottled water products that 

test positive for E. coli will be deemed 

adulterated under section 402(a)(3) of 

the act and revised § 165.110(d) of the 

regulations. Costs to rectify or otherwise 

eliminate the cause of contamination in 

finished bottled water products are not 

estimated in this analysis. 

Per Sample Testing Costs for E. coli 

For purposes of this analysis, FDA 

assumes that 75 percent of domestic 

bottled water establishments obtain 

their water directly from sources other 

than a PWS and that the other 25 

percent obtain their water from PWSs 

(66 FR 35439 at 35440 through 35441). 

FDA is assuming that all 35 foreign 

producers that export bottled water to 

the United States obtain their water 

from other than a PWS and are currently 

testing their sources for total coliform. 

As mentioned previously, FDA assumes 

that for all domestic and foreign 

producers, one establishment 

corresponds to one source. Thus, we 

estimate that 284 (75 percent) of 378 

domestic establishments and all 35 

foreign bottled water establishments 

(284 + 35 = 319) whose products are 

consumed in the United States obtain 

their water from other than a PWS. 

Based on this estimate, we further 

surmise that all 319 establishments are 

already conducting total coliform testing 

of their source water. And 

approximately 25 percent of the 

estimated total of 378 domestic bottled 

water establishments (approximately 95) 

obtains their water from a PWS. 

Table 1 of this document covers E. 

coli testing costs per sample. The 

estimates of the laboratory fees and 

testing costs are derived from the GWR 

(Ref. 5). EPA estimated the national 

average testing costs per sample for E. 

coli based on 25 to 100 tests conducted 

annually. The estimated costs per 

sample can vary depending on whether 

the test is conducted in-house or at a 

commercial laboratory. 

TABLE 1.—E. coli TESTING COSTS PER SAMPLE

Laboratory Type Hourly Labor 

Cost 

Labor Hours 

for Sample 

Collection 

Cost of Sample Collection 

Labor Hours 

for Sample 

Analysis 

Analysis Materials Per Sample 

Analysis Cost 

Total Costs 

per Sample 

In-house $ 21.44 0.5 $ 10.72 0 .5 $ 8.95 $ 19.67 $ 30.39 

Commercial $ 21.44 0.5 $ 10.72 0 $ 74.80 $ 74.80 $ 85.52 


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For in-house laboratories, the 

laboratory materials cost per sample is 

estimated to be $8.95 and the labor cost 

to be $21.44 for 1 labor hour per sample 

(one-half hour for collecting and 

handling the sample and another half 

hour for conducting the analysis). For 

an independent commercial laboratory 

analysis, the test cost per sample would 

include a shipping and commercial 

analysis fee of $74.80 and a labor cost 

of one-half hour to collect the sample 

and arrange for delivery to the 

laboratory. 

FDA is not aware of how many 

potentially affected establishments will 

either use in-house testing facilities or 

outsource testing to commercial 

laboratories. For the purpose of this 

analysis, FDA assumes that all large 

bottlers will use in-house testing 

facilities and that either 50 percent 

(low-cost assumption) or 100 percent 

(high-cost assumption) of small bottled 

water establishments will outsource 

their testing. According to the Small 

Business Administration’s definition of 

small business for this industry, about 

82 percent of bottled water 

establishments are defined as small (69 

FR 70082 at 70088). This may 

overestimate the number of bottlers that 

will outsource testing and thus may 

overestimate the cost of the rule. FDA 

did not receive any significant 

comments on this section. 

Table 2 of this document shows the 

breakdown of bottlers by the low-cost 

and high-cost testing models, based on 

laboratory choice and an 82-percent 

small business rate. For the 319 bottlers 

using other than a PWS source, either 

188 bottlers (59 percent) will use inhouse testing facilities and 131 bottlers 

(41 percent) will use commercial 

laboratories or 57 bottlers (18 percent) 

will use in-house testing facilities and 

262 bottlers (82 percent) will use 

commercial laboratories. For the 95 

bottlers using PWS sources, either 56 

bottlers (59 percent) will use in-house 

testing facilities and 39 bottlers (41 

percent) will use commercial 

laboratories or 17 bottlers (18 percent) 

will use in-house testing facilities and 

78 bottlers (82 percent) will use 

commercial laboratories. 

TABLE 2.—HIGH-COST AND LOW-COST ASSUMPTIONS ABOUT THE NUMBER OF BOTTLED WATER ESTABLISHMENTS USING

EITHER IN-HOUSE OR COMMERCIAL LABORATORIES

Number of Bottlers Using Pther Than a PWS Source Number of Bottlers Using a PWS Source 

Low Cost High Cost Low Cost High Cost 

In-house laboratory 188 (59%) 57 (18%) 56 (59%) 17 (18%) 

Commercial laboratory 131 (41%) 262 (82%) 39 (41%) 78 (82%) 

319 319 95 95 

Total Coliform Frequency Estimates 

To estimate the number of samples 

that are likely to test positive for total 

coliform each year, FDA assumes that 

the frequency of total coliform positive 

samples is proportional to EPA’s total 

coliform positive frequency estimates 

(Ref. 6). FDA did not receive any 

comments on this section. 

EPA’s total coliform positive 

frequency estimates are dependent on 

the probability of a total coliform 

positive, which is dependent on the 

annual number of samples tested, which 

varies by system size. FDA requirements 

include at least weekly testing for total 

coliform in source water and finished 

products, or at least 52 source water 

samples and 52 finished product 

samples per year. For example, bottlers 

whose source is other than a PWS will 

have to test their source water at least 

once a week and also their finished 

product at least once a week. Bottlers 

whose source is a PWS are only 

required to test their finished product. 

(For this model, FDA assumes that each 

bottler is testing one type of finished 

product.) EPA found that the frequency 

rate for total coliform positives in 

ground water PWSs testing between 31 

and 82 samples for total coliform each 

year, ranged between 0.22 and 3 

samples per year per system (Ref. 6). 

FDA assumes that the same frequency 

rates are applicable to bottled water 

plants testing 52 samples a year, thus 

the expected annual frequency rate of 

total coliform positive samples per 

bottled water source is at most 3 per 

year. FDA further assumes that the 

annual frequency of a total coliform 

positive for finished product testing is 

also at most three per bottler. For 

example, bottlers that are conducting 

total coliform tests for both their source 

and finished product can expect to find 

three total coliform positives from their 

source and three total coliform positives 

in their finished product or a total of six 

total coliform positive samples per year. 

This means that they will need to 

conduct six tests for E. coli in 1 year. 

Bottlers whose sources are PWSs and 

are only required to conduct total 

coliform tests of their finished products 

can expect three positive samples per 

year. Combining this information, table 

3 of this document shows E. coli testing 

costs for source water and finished 

bottled water products. 

TABLE 3.—COSTS OF TESTING SOURCE WATER AND FINISHED BOTTLED WATER PRODUCTS FOR E. coli1

A B C (A X B X 6) + ( A X C X 3) 

Cost per Sample 

Number of Bottlers Testing Both Source Water 

and Finished Product 

(Six Tests/Year) 

Number of Bottlers Testing Only Finished Product (Three Tests/Year) 

Total Annual Costs of E. coli 

Testing 

Low-cost assumption 

In-house laboratory $30 188 56 $39,000 

Commercial laboratory $86 131 39 $77,000 

Total low-cost assumption $116,000 


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TABLE 3.—COSTS OF TESTING SOURCE WATER AND FINISHED BOTTLED WATER PRODUCTS FOR E. coli1—Continued 

A B C (A X B X 6) + ( A X C X 3) 

Cost per Sample 

Number of Bottlers Testing Both Source Water 

and Finished Product 

(Six Tests/Year) 

Number of Bottlers Testing Only Finished Product (Three Tests/Year) 

Total Annual Costs of E. coli 

Testing 

High-cost assumption 

In-house laboratory $30 57 17 $12,000 

Commercial laboratory $86 262 78 $154,000 

Total high-cost assumption $166,000 

1Estimates are not exact due to rounding. 

Source water that tests positive for E. 

coli will not be considered to be of a 

safe and sanitary quality for bottling, as 

required in § 129.35(a)(1), and finished 

products that test positive for E. coli 

will be considered adulterated under 

section 402(a)(3) of the act and revised 

§ 165.110(d) of the regulations. 

A bottler could not use source water 

from a source found to contain E. coli 

for production of bottled water until the 

bottler has rectified or otherwise 

eliminated the cause of the 

contamination of the source, and has 

subsequently sufficiently tested samples 

from the same sampling site until the 

source can be considered negative for E. 

coli. A source previously found to 

contain E. coli will be considered 

negative for E. coli after five samples 

collected over a 24-hour period from the 

same sampling site that originally tested 

positive for E. coli are tested and found 

to be E. coli negative. 

This cost model assumes that bottlers 

will take action to rectify or eliminate 

the cause of contamination based on the 

first positive E. coli sample. Thus, the 

estimated number of bottlers that will 

find an E. coli positive sample per year 

will be equal to the estimated number 

of bottlers that will take action to rectify 

contamination each year. To estimate 

the number of establishments that are 

likely to take action to rectify 

contamination, FDA relied on EPA’s 

estimate of the percentage of PWSs that 

use ground water sources with 

identified deficiencies (Ref. 7). EPA’s 

estimate in turn was based on survey 

data from the Association of State 

Drinking Water Administrators 

(ASDWA 1997). FDA lacks better or 

more recent data. Establishments that 

have significant deficiencies or that 

detect fecal contamination are required 

to take corrective actions under the 

GWR. The survey responses indicated 

that 17 percent of systems had wells 

that were not constructed according to 

State regulations. FDA uses this 

percentage as an estimate of the number 

of systems that will have an E. coli 

positive result in source or product 

water over a 25-year period. EPA’s cost 

model assumes deficiencies occur 

equally beginning in year 4 through 25 

(22 years) of the analysis, which 

translates into 0.77 percent of all GWSs 

taking a corrective action each year over 

a 22-year period. Thus, of the 319 

bottling establishments that use sources 

other than PWSs, about 53 (17 percent) 

are likely to take corrective action as a 

result of an E. coli finding in a 22-year 

period. This translates to 2.5 bottlers 

every year. For its analysis, FDA also 

assumes that each of these 2.5 bottlers 

will incur an E. coli positive finding 

only once in a given year. Table 4 of this 

document summarizes these estimates. 

TABLE 4.—NUMBER OF BOTTLERS

THAT INCUR AN E. coli POSITIVE IN

SOURCE WATER AND MUST RECTIFY

CONTAMINATION

Number of bottlers that use 

sources other than a PWS 319 

Fraction of bottlers with potential source water contamination (17 percent/22 years) 0.0077 

Number of bottlers that must 

rectify contamination each 

year over a 22-year period 2.5 

As stated earlier, a source will be 

considered negative for E. coli after five 

samples collected over a 24-hour period 

from the same sampling site that 

originally tested positive for E. coli are 

tested and found to be negative. 

Therefore the number of bottlers that 

will test five more source samples after 

taking some type of action to rectify 

contamination is also 2.5. Assuming this 

secondary testing is conducted in-house 

or in a commercial laboratory, total 

annual costs of testing five additional 

samples for E. coli is estimated to be 

either $380 or $1,069 per year. Table 5 

of this document summarizes these 

estimates. 

TABLE 5.—TOTAL ANNUAL COSTS OF TESTING FIVE MORE SAMPLES FOR E. coli AFTER A POSITIVE FINDING1

A B A X B X 5 

Cost per Sample 

Number of 

Bottlers Testing 

Source Water 

Total Annual 

Costs of Testing 

Five Samples for 

E. coli 

In-house laboratory $30 2.5 $380 

Commercial laboratory $86 2.5 $1,069 

1Estimates are not exact due to rounding. 

Costs to Rectify Contaminated Sources 

As noted previously, FDA requires 

bottlers to rectify or otherwise eliminate 

the cause of contamination of a source 

before source water can be used from 

that source. FDA drew on EPA’s 

Economic Impact Analysis of the GWR 

to provide estimates for costs of 

rectifying or eliminating contamination. 


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EPA estimated costs using a high- and 

low-cost distribution. The low-cost 

scenario assumes a greater percentage 

(60 percent) of systems with significant 

deficiencies will have less expensive 

(low-cost) deficiencies to correct. The 

high-cost scenario assumes a greater 

percentage of systems will have more 

expensive (high-cost) deficiencies to 

correct. EPA provides examples of a 

low-cost deficiency (replacing a sanitary 

well seal) and a high-cost deficiency 

(rehabilitating an existing well) (Ref. 7). 

Unit costs for these repairs are based on 

the Technology and Cost Documents for 

the Final GWR (Ref. 8) and appear here 

in table 6 of this document. EPA expects 

that the costs of these significant 

deficiencies represent the range of costs 

that establishments would be expected 

to incur although there are many other 

corrective actions that could be taken. 

For example, drilling a new well or 

purchasing water from a different 

supplier could be done but in most 

cases would probably be more 

expensive than the options listed 

earlier. 

Based on EPA’s assumptions, FDA 

estimates one-time costs to bottlers of 

rectifying contamination range from 

approximately $17,000 to $22,000 each 

year. 

TABLE 6.—ESTIMATED ANNUAL COSTS OF RECTIFYING CONTAMINATED SOURCES1

Action Unit Cost Distribution of 

Actions 

Number of 

Bottlers That 

Will Rectify a 

Contaminated 

Source Each 

Year 

Total Annual 

Costs of Rectifying Contaminated Sources 

Replace a sanitary well seal $3,627 .60 2.5 $5,441 

Rehabilitate an existing well $11,986 .40 2.5 $11,986 

Total costs assuming a low-cost distribution (rounding up) $17,427 

Replace a sanitary well seal $3,627 .40 2.5 $3,627 

Rehabilitate an existing well $11,986 .60 2.5 $17,979 

Total costs assuming a high-cost distribution (rounding up) $21,606 

1Estimates are not exact due to rounding. 

Based on discussions with experts, 

EPA suggests that still other corrective 

actions such as fencing off or limiting 

access to protective wells could actually 

cost less than the two options listed 

previously from their model (Ref. 7). 

In addition to the costs of a sanitary 

well or the costs of rehabilitating an 

existing well, other potential costs could 

include product loss, temporarily 

shutting down the operation, or 

changing to an alternate source. FDA 

did not receive any comments on this 

section. 

Recordkeeping Costs 

Under this final rule, those bottlers 

that are required to test their source 

water and finished bottled water 

products at least weekly for total 

coliform (and for E. coli if any coliform 

organisms are detected) will be required 

to maintain records of the 

microbiological test results and 

corrective measures taken in response to 

a finding of E. coli for at least 2 years 

under revised § 129.35(a)(3)(i), as well 

as current § 129.80(g) and (h) of the 

CGMP regulations. The existing CGMP 

regulations already reflect the time and 

associated recordkeeping costs for those 

bottlers that are required to conduct 

microbiological testing of their source 

water, as well as total coliform testing 

of their finished bottled water products. 

FDA concludes that any additional costs 

in recordkeeping based on the new 

testing requirements for source water 

and finished bottled water products 

would be negligible. 

Summary of Costs 

Total costs for this final rule, 

including the estimated annual costs for 

E. coli testing and for rectifying 

contaminated sources, are shown in 

tables 7 through 11 of this document. 

Annual testing costs are estimated as 

either low or high costs depending on 

the number of bottlers that use either inhouse testing laboratories or outsource 

testing to commercial laboratories. Costs 

of rectifying contaminated sources are 

estimated using the low- and high-cost 

distribution from EPA’s Economic 

Impact Analysis of the GWR. 

FDA estimates that 95 establishments 

that use PWSs are likely to find a total 

coliform positive three times a year in 

their finished product and thus will 

incur testing costs for E. coli three times 

a year as shown in table 7 of this 

document. Of the 95 bottlers that use 

PWS sources in table 7, either 56 

bottlers (59 percent) will use in-house 

testing facilities at $30 per sample and 

39 bottlers (41 percent) will use 

commercial laboratories at $86 per 

sample totaling approximately $15,000 

under the low-cost assumption, or about 

17 bottlers (18 percent) will use inhouse testing facilities at $30 per sample 

and 78 bottlers (82 percent) will use 

commercial laboratories at $86 per 

sample costing about $21,000 under the 

high-cost assumption. 

TABLE 7.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED E. coli TESTING COSTS TO BOTTLERS THAT USE PWSS1

Total E. coli Testing Costs Annual Costs 

Discounted Costs 

(20 years at 7 percent) 

Number of bottlers with PWS source = 95 

Total cost of finished product testing (low-cost assumption) $15,000 $160,000 


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TABLE 7.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED E. coli TESTING COSTS TO BOTTLERS THAT USE PWSS1— 

Continued 

Total E. coli Testing Costs Annual Costs 

Discounted Costs 

(20 years at 7 percent) 

Total cost of finished product testing (high-cost assumption) $21,000 $230,000 

1Estimates are not exact due to rounding. 

FDA estimates that 319 

establishments that use sources other 

than PWSs are likely to find a total 

coliform positive about six times a year 

(three times in their source and three 

times in their finished product) and 

therefore, will incur testing costs for E. 

coli six times a year as shown in table 

8 of this document. Of the 319 bottlers 

that obtain their water from other than 

a PWS, 188 bottlers (59 percent) will use 

in-house testing facilities at $30 per 

sample and 131 bottlers (41 percent) 

will use commercial laboratories at $86 

per sample totaling approximately 

$101,000 under the low-cost 

assumption, and about 57 bottlers (18 

percent) will use in-house testing 

facilities at $30 per sample and 262 

bottlers (82 percent) will use 

commercial laboratories at $86 per 

sample costing about $145,000 under 

the high-cost assumption. 

TABLE 8.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED E. coli TESTING COSTS TO BOTTLERS THAT USE SOURCES

OTHER THAN PWSS1

E. coli Testing Costs Annual Costs 

Discounted Costs 

(20 years at 7 percent) 

Number of Bottlers = 319 

Total costs of source and finished product testing (low-cost assumption) $101,000 $1 million 

Total costs of source and finished product testing (high-cost assumption) $145,000 $1.5 million 

1Estimates are not exact due to rounding. 

Of the 319 establishments that obtain 

their water from other than a PWS, it is 

likely that 2.5 establishments will test 

positive for E. coli annually over 22 

years and may need to take corrective 

action and conduct secondary testing. 

Estimated costs to rectify the cause of 

contamination using low- and high-cost 

assumptions appear in table 9 of this 

document. 

TABLE 9.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED COSTS TO RECTIFY CONTAMINATION1

Costs to Rectify Contamination Annual Costs 

Discounted 

Costs (20 

years at 7 percent) 

Number of bottlers = 2.5 

Total costs to rectify contamination (low cost) $17,000 $ 185,000 

Total costs to rectify contamination (high cost) $22,000 $ 230,000 

1Estimates are not exact due to rounding. 

Secondary testing costs are shown in 

table 10 of this document and illustrate 

costs for bottlers that will use either inhouse or commercial laboratories. 

TABLE 10.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED SECONDARY TESTING COSTS FOR E. coli 

Testing Costs Annual Costs 

Discounted 

Costs (20 

years at 7 percent) 

Number of bottlers 2.5 2.5 

Total costs of five additional tests if using in-house laboratory $380 $4,000 

Total costs of five additional tests if using commercial laboratory $1,069 $11,000 


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Table 11 of this document shows the 

estimated total annual costs of this final 

rule (Option 3) by adding tables 7, 8, 9, 

and 10 to be $134,000 (low cost) and 

$189,000 (high cost). The estimated total 

discounted or present value costs (using 

a 7-percent interest rate over a 20-year 

period) are $1.4 million (low) and $1.9 

million (high). 

TABLE 11.—ESTIMATED TOTAL ANNUAL AND DISCOUNTED COSTS OF

FINAL RULE

Total Annual 

Costs of 

Final Rule 

Total Discounted 

Costs of 

Final Rule 

(20 years at 

7 percent) 

Low cost $134,000 $1.4 million 

High cost $189,000 $1.9 million 

Benefits 

FDA is not aware of any outbreaks or 

enforcement actions associated with 

fecal pathogens in bottled water in the 

United States in the last 10 years. 

Therefore, we are not able to quantify 

any public health benefits of this option. 

However, while FDA is not aware of 

any recent outbreaks associated with 

fecal pathogens in bottled water, this 

does not mean that such outbreaks 

could never occur. Under the current 

FDA regulations, the potential exists for 

fecal pathogens in ground water to be 

undetected and be distributed to 

consumers in bottled water and cause 

illness. Testing for the fecal indicator E. 

coli, if total coliform is present, and 

prohibiting E. coli-contaminated water 

from being used as source water or 

product water, would reduce this 

potential. 

By issuing this regulation, FDA will 

ensure that FDA’s standards for the 

minimum quality of bottled water, as 

affected by fecal contamination, will be 

no less protective of the public health 

than those set by EPA for public 

drinking water. 

B. Small Entity Analysis 

FDA examined the economic 

implications of this final rule as 

required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612). If a rule has a 

significant economic impact on a 

substantial number of small entities, the 

Regulatory Flexibility Act requires us to 

analyze regulatory options that would 

lessen the economic effect of the rule on 

small entities. The Small Business 

Administration’s definition of a small 

business for NAICS code 312112 Bottled 

Water Manufacturing is an entity with 

500 or fewer employees. Under this 

definition, 82 percent of the bottled 

water firms (260 of 318) in the Dun’s 

Market Identifiers database are 

identified as small firms (69 FR 70082 

at 70088). Assuming that 82 percent of 

total annual costs shown in table 11 of 

this document will be incurred by small 

firms, and that 92 percent of the small 

firms are domestic, then total annual 

domestic costs of $100,000 to $140,000 

will be incurred by the 260 small firms. 

However, because it is possible that a 

firm may not find a total coliform 

positive in any year during a 20-year 

period, subsequent testing for E. coli or 

taking action to rectify contamination 

would not be needed and thus, average 

estimated annual costs per firm can be 

as low as $380. Average estimated 

annual costs per firm can be as high as 

$540 because it is also possible for a 

firm to incur costs to rectify 

contamination in any given year over a 

20-year period as a result of finding total 

coliform and E. coli positives. This rule 

will affect a substantial number of small 

bottled water manufacturers. Although 

the number of small bottlers affected is 

large, the average annual costs per 

business are small. The annual average 

cost per small bottler (weighted by 

requirement costs) is summarized in 

table 12 of this document. 

TABLE 12.—WEIGHTED AVERAGE ANNUAL COSTS PER SMALL ENTITY

Annual Costs per Requirement 

Weighted Average Annual 

Costs per Entity 

Low Cost High Cost 

Number of small firms = 260 

E. coli testing of source water and finished products $285 $407 

E. coli testing finished products only $50 $70 

E. coli secondary testing $1 $3 

Costs to rectify contamination $50 $60 

Average costs per bottler $380 $540 

To investigate the potential 

significance of these impacts, FDA 

entered these costs into a model created 

under contract by the Eastern Research 

Group (ERG) (Ref. 9). The model is 

designed to estimate the percentage of 

small firms that would go out of 

business because of compliance costs if 

those costs accrued to all small firms in 

a given industry. According to this 

model, an annual cost of $380 to $540 

would generate a near zero percent 

probability that a small firm with less 

than 20 employees that faced those costs 

would go out of business. Because the 

costs per entity of this rule are small, 

the agency concludes that this final rule 

will not have a significant economic 

impact on a substantial number of small 

entities. FDA did not receive any 

comments on this section. 

VI. Paperwork Reduction Act of 1995 

This final rule contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

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

3520). Comments on the information 

collection provisions of this final rule 

are being solicited in a separate notice 

published elsewhere in this issue of the 

Federal Register. Prior to the effective 

date of this final rule, FDA will publish 

a notice in the Federal Register 

announcing OMB’s decision to approve, 

modify, or disapprove the information 

collection provisions in this final rule. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 


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3As stated in the Background section of this 

document, if FDA fails to take action within the 

prescribed time period in response to the NPDWR 

issued by EPA, EPA’s NPDWR will apply to bottled 

water. On May 20, 2009, President Obama issued 

a Memorandum for the Heads of Executive 

Departments and Agencies on preemption. FDA 

will analyze this rule in light of the President’s 

Memorandum and will amend the rule if needed to 

reflect the express preemption provision in section 

403A(a) of the act. 

VII. Federalism3

FDA has analyzed this rule in 

accordance with the principles set forth 

in Executive Order 13132. Section 4(a) 

of the Executive Order requires agencies 

to ‘‘construe * * * a Federal statute to 

preempt State law only where the 

statute contains an express preemption 

provision or there is some other clear 

evidence that the Congress intended 

preemption of State law, or where the 

exercise of State authority conflicts with 

the exercise of Federal authority under 

the Federal statute.’’ 

Section 403A of the act (21 U.S.C. 

343–1) is an express preemption 

provision. Section 403A(a) of the act 

provides that: ‘‘* * * no State or 

political subdivision of a State may 

directly or indirectly establish under 

any authority or continue in effect as to 

any food in interstate commerce—(1) 

any requirement for a food which is the 

subject of a standard of identity 

established under section 401 that is not 

identical to such standard of identity or 

that is not identical to the requirement 

of section 403(g) * * *.’’ FDA has 

interpreted this provision to apply to 

standards of quality (21 CFR 

100.1(c)(4)). 

FDA has determined that the 

revisions to the standard of quality for 

bottled water relating to microbiological 

quality (§ 165.110(b)(2)) will have a 

preemptive effect on State law. 

Although this rule has a preemptive 

effect in that it will preclude States from 

issuing requirements for microbiological 

testing in bottled water that are not 

identical to the requirements for 

microbiological testing in bottled water 

as set forth in this rule, this preemptive 

effect is consistent with what Congress 

set forth in section 403A of the act. 

Section 403A(a)(1) of the act displaces 

both State legislative requirements and 

State common law duties (Riegel v. 

Medtronic, 128 S. Ct. 999 (2008)). 

VIII. References 

The following references have been 

placed on display in the Division of 

Dockets Management, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852 

and may be seen by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday. (FDA has verified all 

Web site addresses, but FDA is not 

responsible for any subsequent changes 

to the Web sites after this document 

publishes in the Federal Register.) 

1. Bacteriological Analytical Manual 

(BAM) Online. September 2002. Chapter 4: 

Enumeration of Escherichia coli and the 

Coliform Bacteria. Accessed online at http:// 

www.cfsan.fda.gov/~ebam/bam-4.html. 

2. International Bottled Water Association, 

2007. Personal communication. August 30, 

2007. 

3. Skipton, Hay, Albrecht, ‘‘Drinking 

Water: Bottled or Tap?’’ University of 

Nebraska of Nebraska-Lincoln, Institute of 

Agriculture and Natural Resources, G1448, 

January 2002. Accessed online at http:// 

www.ianrpubs.unl.edu/epublic/live/g1448/ 

build/g1448.pdf. 

4. International Bottled Water Association, 

2005, IBWA Model Code, Version March 

2005. Accessed online at http:// 

www.bottledwater.org/public/pdf/ 

IBWA05ModelCode_Mar2.pdf. 

5. Economic Analysis for the Final 

Groundwater Rule. Office of Water (4606–M) 

EPA 815–R–06–014 October 2006. Section 

6.2.2 Laboratory Fees. Accessed online at: 

http://www.epa.gov/safewater/disinfection/ 

gwr/pdfs/support_gwr_economicanalysis.pdf. 

6. Economic Analysis for the Final 

Groundwater Rule. Office of Water (4606–M) 

EPA 815–R–06–014 October 2006. Section 

4.2.7 Triggered Monitoring Baseline. p. 4–21 

and 4–22. Accessed online at http:// 

www.epa.gov/safewater/disinfection/gwr/ 

pdfs/support_gwr_economicanalysis.pdf. 

7. Economic Analysis for the Final 

Groundwater Rule. Office of Water (4606–M) 

EPA 815–R–06–014 October 2006. Section 

6.4.4 Sanitary Survey Corrective Actions. p. 

6–33. Accessed online at http:// 

www.epa.gov/safewater/disinfection/gwr/ 

pdfs/support_gwr_economicanalysis.pdf. 

8. Technology and Cost Document for the 

Final Ground Water Rule. Office of Water 

(4606–M) EPA 815–R–06–015 October 2006. 

Section 5.3.1 Significant Deficiency 

Corrective Actions. p. 5–11. Accessed online 

at http://www.epa.gov/safewater/ 

disinfection/gwr/pdfs/support_gwr_costtechnologies.pdf. 

9. Eastern Research Group, Inc., ‘‘Model for 

Estimating the Impacts of Regulatory Costs 

on the Survival of Small Businesses and its 

Application to Four FDA-Regulated 

Industries,’’ Contract No. 223–01–2461, June 

7, 2002. 

List of Subjects 

21 CFR Part 129 

Beverages, Bottled water, Food 

packaging, Reporting and recordkeeping 

requirements. 

21 CFR Part 165 

Beverages, Bottled water, Food grades 

and standards, Incorporation by 

reference. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR parts 129 

and 165 are amended as follows: 

PART 129—PROCESSING AND 

BOTTLING OF BOTTLED DRINKING 

WATER 

■ 1. The authority citation for 21 CFR 

part 129 continues to read as follows: 

Authority: 21 U.S.C. 342, 348, 371, 374; 42 

U.S.C. 264. 

■ 2. Section 129.35 is amended by 

revising paragraphs (a)(3)(i) and 

(a)(4)(iv) to read as follows: 

§ 129.35 Sanitary facilities. 

* * * * * 

(a) * * * 

(3) * * * 

(i) Samples of source water from each 

source in use by the plant are to be 

taken and analyzed by the plant as often 

as necessary, but at a minimum 

frequency of once each year for 

chemical contaminants and once every 

4 years for radiological contaminants. 

Additionally, source water obtained 

from other than a public water system 

is to be sampled and analyzed for total 

coliform at least once each week. If any 

coliform organisms are detected, followup testing must be conducted to 

determine whether any of the coliform 

organisms are Escherichia coli. This 

sampling is in addition to any 

performed by government agencies 

having jurisdiction. Source water found 

to contain E. coli is not considered 

water of a safe, sanitary quality as 

required for use in bottled water by 

paragraph (a)(1) of this section. Before a 

bottler can use source water from a 

source that has tested positive for E. 

coli, the bottler must take appropriate 

measures to rectify or otherwise 

eliminate the cause of E. coli 

contamination of that source in a 

manner sufficient to prevent its 

reoccurrence. A source previously 

found to contain E. coli will be 

considered negative for E. coli after five 

samples collected over a 24-hour period 

from the same sampling site that 

originally tested positive for E. coli are 

tested and found to be E. coli negative. 

Records of approval of the source water 

by government agencies having 

jurisdiction, records of sampling and 

analyses for which the plant is 

responsible, and records describing 

corrective measures taken in response to 

a finding of E. coli are to be maintained 

on file at the plant. 

* * * * * 

(4) * * * 

(iv) The finished bottled water must 

comply with bottled water quality 

standards (§ 165.110(b) of this chapter) 

and section 402(a)(1) and (a)(3) of the 


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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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