Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Proposed Rules 53775 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect on the States, on 

the relationship between the national 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify this proposed regulation: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); and 

3. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

We prepared a regulatory evaluation 

of the estimated costs to comply with 

this proposed AD and placed it in the 

AD docket. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 14 CFR part 

39 as follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

1. The authority citation for part 39 

continues to read as follows: 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

2. The FAA amends § 39.13 by adding 

the following new AD: 

Bombardier, Inc. (Formerly Canadair): 

Docket No. FAA–2008–0977; Directorate 

Identifier 2008–NM–124–AD. 

Comments Due Date 

(a) We must receive comments by October 

17, 2008. 

Affected ADs 

(b) None. 

Applicability 

(c) This AD applies to Bombardier Model 

CL–600–2B19 (Regional Jet Series 100 & 440) 

airplanes, certificated in any category, as 

specified in paragraphs (c)(1) and (c)(2) of 

this AD. 

(1) Airplanes having serial numbers 7003 

through 7067 and 7069 through 7939 that 

have not had the modification of the refuel/ 

defuel shutoff valves incorporated according 

to the original issue of Bombardier Service 

Bulletin 601R–28–053, dated July 12, 2004; 

(2) Airplanes having serial numbers 7989, 

7990, and 8000 through 8034. 

Subject 

(d) Air Transport Association (ATA) of 

America Code 28: Fuel. 

Reason 

(e) The mandatory continuing 

airworthiness information (MCAI) states: 

Bombardier Aerospace has completed a 

system safety review of the CL–600–2B19 

aircraft fuel system against the new fuel tank 

safety standards, introduced in Chapter 525 

of the Airworthiness Manual through Notice 

of Proposed Amendment (NPA) 2002–043. 

The identified non-compliances were 

assessed using Transport Canada Policy 

Letter No. 525–001 to determine if mandatory 

corrective action is required. 

The assessment showed that insufficient 

electrical bonding between the refuel/defuel 

shutoff valves and the aircraft structure could 

occur due to the presence of a nonconductive gasket (Gask-O-Seal). In addition, 

it was also determined that the presence of 

an anodic coating on the shutoff valve 

electrical conduit connection fitting could 

affect electrical bonding. The above 

conditions, if not corrected, could result in 

arcing and potential ignition source inside 

the fuel tank during lightning strikes and 

consequent fuel tank explosion. 

To correct the unsafe condition, this 

directive mandates the modification of the 

[shutoff valves in the] refuel/defuel system. 

Actions and Compliance 

(f) Unless already done, do the following 

actions. 

(1) Within 5,000 flight hours after the 

effective date of this AD, modify the refuel/ 

defuel system in the center wing fuel tank in 

accordance with the Accomplishment 

Instructions of Bombardier Service Bulletin 

601R–28–053, Revision C, dated March 14, 

2006. 

(2) Modifying the refuel/defuel system is 

also acceptable for compliance with the 

requirements of paragraph (f)(1) of this AD if 

done before the effective date of this AD in 

accordance with one of the following service 

bulletins: Bombardier Service Bulletin 601R– 

28–053, Revision A, dated April 21, 2005; or 

Revision B, dated September 15, 2005. 

FAA AD Differences 

Note 1: This AD differs from the MCAI 

and/or service information as follows: No 

differences. 

Other FAA AD Provisions 

(g) The following provisions also apply to 

this AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. Send information to ATTN: Rocco 

Viselli, Aerospace Engineer, Airframe and 

Propulsion Branch, ANE–171, FAA, New 

York ACO, 1600 Stewart Avenue, Suite 410, 

Westbury, New York 11590; telephone (516) 

228–7331; fax (516) 794–5531. Before using 

any approved AMOC on any airplane to 

which the AMOC applies, notify your 

appropriate principal inspector (PI) in the 

FAA Flight Standards District Office (FSDO), 

or lacking a PI, your local FSDO. 

(2) Airworthy Product: For any requirement 

in this AD to obtain corrective actions from 

a manufacturer or other source, use these 

actions if they are FAA-approved. Corrective 

actions are considered FAA-approved if they 

are approved by the State of Design Authority 

(or their delegated agent). You are required 

to assure the product is airworthy before it 

is returned to service. 

(3) Reporting Requirements: For any 

reporting requirement in this AD, under the 

provisions of the Paperwork Reduction Act, 

the Office of Management and Budget (OMB) 

has approved the information collection 

requirements and has assigned OMB Control 

Number 2120–0056. 

Related Information 

(h) Refer to MCAI Canadian Airworthiness 

Directive CF–2008–20, dated June 12, 2008; 

and Bombardier Service Bulletin 601R–28– 

053, Revision C, dated March 14, 2006; for 

related information. 

Issued in Renton, Washington, on 

September 9, 2008. 

Michael J. Kaszycki, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. E8–21730 Filed 9–16–08; 8:45 am] 

BILLING CODE 4910–13–P 

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: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

amend its bottled water regulations to 

require that source water, which is 

currently subject to weekly 

microbiological testing, be tested 

specifically for total coliform as is done 

for finished bottled water products. 

Further, FDA is proposing that if any 

coliform organisms are detected in 

source water or finished bottled water 

products, bottled water manufacturers 

would be required to test for the 

bacterium Escherichia coli (E. coli), an 

indicator of fecal contamination. FDA 

also is proposing to amend the 

adulteration provision of the bottled 

water standard to reflect the possibility 


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of adulteration caused by the presence 

of filth. Bottled water containing E. coli 

would be considered adulterated, and 

source water containing E. coli would 

not be considered to be of a safe, 

sanitary quality and would be 

prohibited from use in the production of 

bottled water. In addition, this rule 

would require bottlers to rectify or 

eliminate the source of E. coli 

contamination in source water and keep 

records of such actions. Existing 

regulatory provisions would require 

bottled water manufacturers to keep 

records of new testing required by this 

rule. FDA tentatively concludes that this 

proposed rule, if finalized, 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: Submit written or electronic 

comments on the proposed rule by 

November 17, 2008. Submit comments 

on information collection issues under 

the Paperwork Reduction Act of 1995 by 

October 17, 2008 (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). See section XI of the 

SUPPLEMENTARY INFORMATION section of 

this document for the proposed effective 

date of the final rule based on the 

proposed rule. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2008–N– 

0446, by any of the following methods, 

except that comments on information 

collection issues under the Paperwork 

Reduction Act of 1995 must be 

submitted to the Office of Regulatory 

Affairs, Office of Management and 

Budget (OMB) (see the ‘‘Paperwork 

Reduction Act of 1995’’ section of this 

document). 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Fax: 301–827–6870. 

• Mail/Hand delivery/Courier (for 

paper, disk, or CD–ROM submissions): 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal, as 

described previously in the ADDRESSES

portion of this document under 

Electronic Submissions. 

Instructions: All submissions received 

must include the agency name and 

docket number for this rulemaking. All 

comments received may be posted 

without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

in the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

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: 

Table of Contents 

I. Background 

II. EPA’s Ground Water Rule 

A. Sanitary Surveys 

B. Triggered Source Water Monitoring 

C. Assessment Source Water Monitoring 

D. Corrective Action Treatment Technique 

Requirements 

E. Compliance Monitoring for 4-Log Viral 

Disinfection 

F. Public Notification Requirements 

G. Reporting and Recordkeeping 

Requirements 

H. Effective Date of the GWR 

III. FDA Standards 

A. Standard of Quality 

B. Microbiological Quality Standard 

C. Current Good Manufacturing Practices 

IV. FDA Proposal 

A. Proposed Changes 

B. Microbiological Quality Standard 

C. CGMP Regulations for Bottled Water 

D. Analytical Methods for E. coli Testing 

E. Monitoring and Recordkeeping 

Provisions of CGMP Regulations for 

Bottled Water 

V. Legal Authority 

VI. Environmental Impact Analysis 

VII. Executive Order 12866 and Regulatory 

Flexibility Act 

A. Preliminary Economic Impact Analysis 

B. Small Entity Analysis 

VIII. Paperwork Reduction Act of 1995 

IX. Federalism 

X. Comments 

XI. Effective Date of the Related Final Rule 

XII. References 

I. Background 

FDA has established specific 

regulations for bottled water in Title 21 

of the Code of Federal Regulations, 

including standard of identity 

regulations in part 165 (21 CFR part 

165) (§ 165.110(a)) that define different 

types of bottled water and standard of 

quality regulations (§ 165.110(b)) that 

establish allowable levels for 

contaminants in bottled water. FDA also 

has established current good 

manufacturing practice (CGMP) 

regulations for the processing and 

bottling of bottled water (part 129 (21 

CFR part 129)). 

Unlike bottled water, which is 

regulated as a food by FDA, public 

drinking water in the United States is 

regulated by the EPA. The Safe Drinking 

Water Act (SDWA) (42 U.S.C. 300f et 

seq.), as amended in 1996, requires EPA 

to publish a National Primary Drinking 

Water Regulation (NPDWR) that 

specifies either a maximum 

contaminant level (MCL) or a treatment 

technique requirement for contaminants 

that may ‘‘have an adverse effect on the 

health of persons,’’ are ‘‘known to occur 

or [have] a substantial likelihood [of 

occurring] in public water systems with 

a frequency and at levels of public 

health concern,’’ and for which 

‘‘regulation * * * presents a meaningful 

opportunity for health risk reduction for 

persons served by public water 

systems’’ (SDWA section 1412(b)(1)(A) 

(42 U.S.C. 300g–1(b)(1)(A))). Under 

section 410(b)(1) of the Federal Food, 

Drug, and Cosmetic Act (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 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 public water systems (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. EPA’s Ground Water Rule 

In the Federal Register of November 

8, 2006 (71 FR 65574), EPA published 

a new NPDWR, the Ground Water Rule 

(GWR), to provide for increased 

protection against fecal microbial 

pathogens in PWSs that use ground 

water sources (also referred to as ground 

water systems (GWSs)). In the GWR, 


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1The term ‘‘primacy’’ refers to EPA granting a 

State primary enforcement responsibility for 

NPDWRs after determining that the State had 

adopted regulations that are no less stringent than 

EPA’s. See 71 FR 65574 at 65579. 

2For purposes of the EPA GWR, a ‘‘sanitary 

survey, as conducted by the State, includes but is 

not limited to, an onsite review of the water 

source(s) (identifying sources of contamination by 

using results of source water assessments or other 

relevant information where available), facilities, 

equipment, operation, maintenance, and monitoring 

compliance of a public water system to evaluate the 

adequacy of the system, its sources and operations 

and the distribution of safe drinking water.’’ See 40 

CFR 141.401(b). 

3States are required to complete the initial 

sanitary survey cycle for community water systems 

(CWSs) by December 31, 2012 (except those CWSs 

that meet certain performance criteria), or by 

December 31, 2014, in the case of all 

noncommunity water systems (NCWSs) and CWSs 

that meet certain performance criteria (71 FR 65574 

at 65586). 

EPA established treatment techniques 

intended to identify and target GWSs 

that are susceptible to fecal 

contamination and require such GWSs 

to monitor and, when necessary, take 

corrective action to prevent or remove 

such contamination. Corrective action 

can include correcting all significant 

deficiencies, providing an alternative 

source of water, eliminating the source 

of contamination, or providing 

treatment that reliably achieves at least 

4-log (99.00 percent) treatment of 

viruses (71 FR 65574 at 65602). The 

GWR also contains compliance 

monitoring requirements to ensure that 

treatment effectiveness is maintained 

when treatment is used as a corrective 

action, as well as notification 

requirements when GWS deficiencies 

occur. 

EPA issued the GWR to protect public 

health because some GWSs may be at 

risk of supplying water that contains 

harmful microbial pathogens from fecal 

contamination. Ingestion of 

contaminated water can result in 

gastrointestinal illness, typically 

characterized by diarrhea, vomiting, 

nausea, and abdominal discomfort. Most 

gastrointestinal illnesses are mild and 

self-limiting, but these diseases can be 

more serious and potentially fatal in 

sensitive individuals, such as the 

elderly, young children, and persons 

with compromised immune systems. 

More serious illnesses such as 

meningitis, hepatitis, Legionnaires’ 

disease, and myocarditis can also result 

from exposure to waterborne microbial 

contaminants (71 FR 65574 at 65576 

and 65580). 

The potential for illness to arise from 

fecal pathogen-contaminated ground 

water is demonstrated by data from the 

Centers for Disease Control and 

Prevention (CDC) indicating that GWSs 

were associated with 68 waterborne 

disease outbreaks and 10,926 illnesses 

between 1991 and 2000 (71 FR 65574 at 

65576). These 68 outbreaks accounted 

for 51 percent of waterborne disease 

outbreaks in the United States from 

1991 to 2000. The CDC identified source 

water contamination and inadequate 

treatment (or treatment failures) as the 

likely cause of the outbreaks (71 FR 

65574 at 65576). 

Ground water may also be 

contaminated with fecal indicators, 

such as E. coli, enterococci, or 

coliphage. Such fecal indicators 

typically are not harmful themselves, 

but their presence demonstrates that 

there is a pathway for pathogenic 

enteric viruses (e.g., echovirus, 

Coxsackie viruses, hepatitis A and E 

viruses, rotavirus, and noroviruses) and 

pathogenic enteric bacteria (e.g., 

Salmonella, Shigella, Vibrio cholerae, 

and pathogenic strains of E. coli) to 

enter ground water sources (71 FR 

65574 at 65576). 

In the GWR, EPA reviewed studies 

that showed the presence of fecal 

indicators or viral pathogens in dozens 

of public ground water wells (71 FR 

65574 at 65576 and 65583). For 

example, analysis by EPA of a subset of 

15 studies found that approximately 26 

percent of the wells included in the 

studies sometimes have fecal 

contamination, as indicated by E. coli, 

and approximately 27 percent of the 

wells sometimes have viral 

contamination, as indicated by 

enterovirus (71 FR 65574 at 65583 

through 65584). 

In the GWR, EPA identified different 

pathways by which fecal contamination 

may reach ground water sources. One 

pathway involves travel through the 

subsurface to the intake zone of a 

ground water source, with movement 

being more likely through materials 

such as karst, gravel, or fractured 

bedrock. Potential sources of subsurface 

fecal contamination include improperly 

stored or managed manure, runoff from 

land-applied manure, leaking sewer 

lines, or failed septic systems (71 FR 

65574 at 65581). A second pathway is 

for fecal contamination from the surface 

to enter a well along the casing or 

through cracks in the sanitary seal if the 

well is not properly constructed, 

protected, or maintained (71 FR 65574 

at 65581). 

EPA has found that existing 

regulatory provisions for GWSs do not 

adequately address the potential for 

fecal contamination of ground water 

sources. Prior to the GWR, there were no 

Federal regulations requiring 

monitoring or disinfection of ground 

water sources or requiring corrective 

action when fecal contamination or a 

risk of fecal contamination is found (71 

FR 65574 at 65576). 

Based on data from ground waterrelated outbreaks, the occurrence of 

fecal indicators in ground water sources, 

and the lack of regulations addressing 

fecal contamination of ground water 

sources, EPA concluded that the GWR is 

necessary to protect public health from 

potential exposure to bacterial and viral 

pathogens in fecally contaminated or atrisk ground water sources (71 FR 65574 

at 65576). 

EPA uses what that agency referred to 

as a ‘‘risk-targeted’’ approach in the 

GWR to identify public drinking-water 

GWSs susceptible to fecal 

contamination and to target those 

systems that must take corrective action 

to protect public health. EPA 

requirements include the following (71 

FR 65574 at 65577): 

A. Sanitary Surveys 

Under the GWR, EPA, or States with 

primacy1 for enforcing EPA’s 

regulations, are required to perform 

regular comprehensive sanitary surveys2

of up to eight components of GWSs: (1) 

Source; (2) treatment; (3) distribution 

system; (4) finished water storage; (5) 

pumps, pump facilities, and controls; 

(6) monitoring, reporting, and data 

verification; (7) system management and 

operation; and (8) operator compliance 

with State requirements (71 FR 65574 at 

65577 and 65586 through 65587). These 

requirements are codified at 40 CFR 

141.401. The purpose of the surveys is 

to identify ‘‘significant deficiencies’’ 

that are causing or could cause the 

introduction of contamination into 

water delivered to consumers. Examples 

of significant deficiencies related to 

water sources for GWSs include the 

following: (1) A well near a source of 

fecal contamination, such as a failing 

septic system or a leaking sewer line; (2) 

a well in a flood zone; (3) an improperly 

constructed well (e.g., improper surface 

or subsurface seal); and (4) spring boxes 

that are poorly constructed and/or 

subject to flooding. Examples of 

significant deficiencies related to 

treatment and finished water storage 

include inadequate treatment process 

monitoring and inadequate internal 

cleaning and maintenance of storage 

tanks (71 FR 65574 at 65587). 

States with primacy must conduct 

initial sanitary surveys of GWSs by 

December 31, 2012, or December 31, 

2014, depending on the type of GWS 

and whether certain performance 

criteria are met,3 and repeat those 

surveys every 3 or 5 years, depending 

on the type of GWS and performance 

history. GWSs must correct significant 


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4 In the Total Coliform Rule (54 FR 27544, June 

29, 1989), EPA set both health goals (maximum 

contaminant level goals or MCLGs) and legal limits 

(MCLs) for the presence of total coliform in 

drinking water. The rule also details the type and 

frequency of testing that water systems must 

undertake. The rule applies to all PWSs. 

deficiencies identified in the surveys 

within 120 days of State notification (or 

be in compliance with a State-approved 

corrective action plan and schedule). 

Systems that fail to make corrections 

will be in violation of treatment 

technique requirements. GWSs must 

also notify customers of uncorrected 

significant deficiencies and timelines 

for correction (71 FR 65574 at 65586 

through 65587). 

B. Triggered Source Water Monitoring 

Triggered source water monitoring is 

followup monitoring for fecal indicators 

in source water that occurs when total 

coliforms are found in distribution 

systems. The GWR requires GWSs to 

conduct triggered source water 

monitoring within 24 hours of receiving 

notification that a routine monitoring 

sample collected under the Total 

Coliform Rule (TCR)4 is total coliformpositive. Triggered source water 

monitoring consists of testing at least 

one ground water sample from each 

ground water source in use at the time 

the TCR-positive sample was collected 

for a fecal indicator. If a triggered 

sample is fecal-indicator positive, the 

GWS must notify the State and the 

public. Unless directed by the State to 

take immediate corrective action, the 

GWS then must collect five additional 

source water samples from the site that 

tested positive within 24 hours for 

testing for the same fecal indicator. If 

any of the five additional samples tests 

positive for the fecal indicator, the GWS 

must notify the State and the public and 

comply with treatment technique 

requirements (71 FR 65574 at 65577 and 

65590 through 65594). The GWR 

requires States to designate one of three 

EPA-approved fecal indicators for each 

GWS: E. coli, enterococci, or coliphage. 

EPA also has approved seven methods 

for E. coli testing, three methods for 

enterococci, and two methods for 

coliphage, and specified a minimum 

100-milliliter (mL) sample volume (71 

FR 65574 at 65597). 

The GWR provides exemptions from 

triggered source water monitoring for 

systems providing at least 4-log 

treatment of viruses or when samples 

are either invalidated or determined to 

be related to distribution system 

contamination. The GWR also 

establishes criteria for representative 

source water monitoring for GWSs with 

multiple sources and triggered source 

monitoring requirements for GWSs that 

purchase or sell finished drinking water 

(71 FR 65574 at 65592). The 

requirements for triggered source water 

monitoring are codified at 40 CFR 

141.402 of EPA’s regulations. 

C. Assessment Source Water Monitoring 

The GWR provides States with the 

option of requiring GWSs at higher risk 

of fecal contamination to conduct more 

stringent assessment source water 

monitoring. Although the exact 

monitoring scheme is left to the State, 

EPA recommends collecting and 

analyzing a minimum of 12 ground 

water samples representing each month 

the system is providing water. The fecal 

indicators and approved methods for 

assessment monitoring are the same as 

for triggered source water monitoring 

(71 FR 65574 at 65594 through 65597). 

(See 40 CFR 141.402(b) of EPA’s 

regulations.) 

D. Corrective Action Treatment 

Technique Requirements 

Under the GWR, GWSs are subject to 

treatment technique requirements to 

address significant deficiencies 

identified during sanitary surveys or 

during monitoring (i.e., fecal 

contamination in ground water). When 

a GWS receives notice of a significant 

deficiency or a fecal indicator-positive 

sample, the GWS must consult with the 

State to develop a corrective action 

schedule within 30 days and complete 

the State-approved corrective actions 

within 120 days (or within the timeline 

approved by the State) (71 FR 65574 at 

65601 through 65602). 

Corrective action options allowed 

under the GWR include: (1) Correct 

significant deficiencies (e.g., repair well 

pads and sanitary seals), (2) use an 

alternate water source, (3) eliminate the 

source of contamination (e.g., provide or 

fix fencing or housing of wellhead, 

redirect drainage and runoff), and (4) 

provide treatment that reliably achieves 

at least 4-log treatment of viruses (using 

inactivation, removal, or a Stateapproved combination of 4-log virus 

inactivation and removal) (71 FR 65574 

at 65602). (See 40 CFR 141.403(a) of 

EPA’s regulations.) 

E. Compliance Monitoring for 4-Log 

Viral Disinfection 

The GWR establishes compliance 

monitoring requirements for GWSs that 

use at least 4-log disinfection treatment 

of viruses as a corrective action or as an 

alternative to triggered source water 

monitoring. GWSs using chemical 

disinfection must maintain a Stateapproved residual disinfectant 

concentration every day the GWS 

provides water from the source, with 

exact monitoring requirements 

depending on system size. If 

disinfectant concentrations fall below 

levels required for 4-log viral 

inactivation for more than 4 hours, the 

systems will incur a treatment 

technique violation (71 FR 65574 at 

65602). Likewise, systems that use 

membrane technologies or alternative 

treatment technologies (such as 

ultraviolet radiation) for disinfection 

must meet State requirements for 

maintaining, operating, and monitoring 

these technologies. Systems that fail to 

meet State operation or integrity 

requirements must correct the problem 

within 4 hours or be in violation of 

treatment technique requirements (71 

FR 65574 at 65602 through 65603). (See 

40 CFR 141.403(b) and 141.404 of EPA’s 

regulations.) 

F. Public Notification Requirements 

The GWR requires GWSs to notify the 

public if monitoring samples are 

positive for a fecal indicator, if the 

GWSs fail to take required corrective 

actions or follow a State-approved 

corrective action plan and schedule, or 

if they fail to maintain 4-log treatment 

of viruses when they have elected to 

provide 4-log treatment in lieu of 

triggered source water monitoring. In 

addition, GWSs must notify the public 

if they fail to conduct source water 

monitoring or if they fail to conduct 

monitoring to demonstrate compliance 

with the 4-log disinfection treatment 

requirement (71 FR 65574 at 65607). 

(See also 40 CFR 141.402(g), 141.403(d), 

and 141.404(d) of EPA’s regulations.) 

Depending on how soon they take 

corrective actions, GWSs may also be 

required to provide annual notice of 

uncorrected significant deficiencies or 

fecal-indicator positive source water 

samples in annual Consumer 

Confidence Reports or in annual public 

notices (71 FR 65574 at 65608). (See 40 

CFR 141.403(a)(7) of EPA’s regulations.) 

G. Reporting and Recordkeeping 

Requirements 

The GWR also introduces new 

reporting and recordkeeping 

requirements for GWSs. New reporting 

requirements for GWSs include: 

Reporting completion of corrective 

actions, reporting failure to meet 

disinfection compliance requirements 

for more than 4 hours, and submitting 

documentation of findings that total 

coliform positive samples result from 

distribution system conditions rather 

than from source water contamination 

(71 FR 65574 at 65610). New 

recordkeeping requirements for GWSs 

include maintaining documentation of 


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the following items: Corrective actions, 

GWR-related public notices, 

determinations that total coliform 

positive samples result from 

distribution system conditions, 

disinfection compliance monitoring 

records, and notifications of TCRpositive samples by systems that sell 

water to other systems (71 FR 65574 at 

65610). The GWR also establishes new 

reporting, recordkeeping, and primacy 

requirements that States must meet to 

assume and maintain enforcement 

primacy for their PWSs (71 FR 65574 at 

65610). (See 40 CFR 141.405 of EPA’s 

regulations.) 

H. Effective Date of the GWR 

The compliance date for triggered 

source water monitoring, compliance 

monitoring, and treatment technique 

requirements for GWSs under the GWR 

is December 1, 2009 (71 FR 65574 at 

65577 through 65578). States with 

primacy for enforcing EPA’s regulations 

have until December 31, 2012, to 

complete the initial sanitary survey 

cycle for community water systems 

(CWSs), except those that meet certain 

performance criteria, and until 

December 31, 2014, to complete the 

initial sanitary survey cycle for all 

noncommunity water systems (NCWSs) 

and CWSs that meet certain 

performance criteria (71 FR 65574 at 

65586 through 65587). 

III. FDA Standards 

Under section 410(b)(1) of the act, not 

later than 180 days before the effective 

date (EPA compliance date) of an 

NPDWR issued by EPA for a 

contaminant under section 1412 of the 

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. Section 410(b)(3) of the act 

requires the standard of quality for a 

contaminant in bottled water to be no 

less stringent than EPA’s MCL and no 

less protective of the public health than 

EPA’s treatment technique requirements 

for the same contaminant. The effective 

date for any such standard of quality 

regulation is to be the same as the 

effective date of the NPDWR. If FDA 

fails to take any action within the 

prescribed time period in response to 

the NPDWR issued by EPA, then section 

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

EPA’s NPDWR will apply to bottled 

water. In addition, section 410(b)(2) of 

the act provides that a standard of 

quality regulation issued by FDA shall 

include monitoring requirements that 

the agency determines to be appropriate 

for bottled water. 

A. Standard of Quality 

Under section 401 of the act (21 

U.S.C. 341), the agency may issue a 

regulation establishing a standard of 

quality for a food under its common or 

usual name, when in the judgment of 

the Secretary of Health and Human 

Services ‘‘such action will promote 

honesty and fair dealing in the interest 

of consumers.’’ On November 26, 1973 

(38 FR 32558), FDA established a 

standard of quality for bottled water that 

now is set forth in § 165.110(b). 

Manufacturers of bottled water are 

responsible for ensuring, through 

appropriate manufacturing techniques 

and sufficient quality control 

procedures, that all bottled water 

products introduced or delivered for 

introduction into interstate commerce 

comply with the standard of quality 

(§ 165.110(b)). Bottled water that is of a 

quality below the prescribed standard is 

required by § 165.110(c) to be labeled 

with a statement of substandard quality 

or it is deemed misbranded under 

section 403(h)(1) of the act (21 U.S.C. 

343(h)(1)). FDA notes that a statement of 

substandard quality only prevents 

bottled water that exceeds an allowable 

level for a contaminant from being 

misbranded with regard to that 

contaminant; it does not prevent the 

water from being adulterated or 

otherwise misbranded. This is reflected 

in FDA’s general food standards which 

state in relevant part that ‘‘[n]o 

provision of any regulation prescribing 

a * * * standard of quality * * * shall 

be construed as in any way affecting the 

concurrent applicability of the general 

provisions of the act and the regulations 

thereunder relating to adulteration and 

misbranding’’ (21 CFR 130.3(c)). In 

addition, for purposes of emphasis, the 

regulations currently provide that any 

bottled water containing a substance at 

a level that causes the food to be 

adulterated under section 402(a)(1) of 

the act (21 U.S.C. 342(a)(1)) is subject to 

regulatory action, even if the bottled 

water bears a label statement of 

substandard quality (§ 165.110(d)). 

FDA has in the past most often 

fulfilled its obligation under section 410 

of the act to respond to EPA’s issuance 

of NPDWRs by amending the standard 

of quality regulations for bottled water 

to maintain compatibility with EPA’s 

drinking water regulations (e.g., most 

recently by lowering the allowable level 

for arsenic (70 FR 33694, June 9, 2005)). 

In these rules, FDA has found that the 

relevant EPA standards for particular 

contaminants in drinking water were 

generally appropriate as allowable 

levels for contaminants in the standard 

of quality for bottled water when bottled 

water may be expected to contain the 

same contaminants. Further, because 

bottled water is increasingly used in 

some households as a replacement for 

tap water, consumption patterns 

considered by EPA for tap water can be 

used as an estimate for the maximum 

expected consumption of bottled water 

by some individuals. 

B. Microbiological Quality Standard 

Under the current standard of quality 

for bottled water, as set forth in 

§ 165.110(b)(2), bottled water must meet 

one of the following standards of 

microbiological quality: (1) By the 

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 mL 

and no analytical unit shall have an 

MPN of 9.2 or more coliform organisms 

per 100 mL; or (2) by the 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 mL and the 

arithmetic mean of the coliform density 

of the sample shall not exceed one 

coliform organism per 100 mL. 

C. Current Good Manufacturing 

Practices 

FDA has established CGMP 

regulations for bottled water in part 129. 

The CGMPs address source approval, 

plant construction and design, sanitary 

facilities and operations, equipment, 

and production and process controls. 

Under § 129.35(a)(3)(i), source water 

obtained from other than a PWS is to be 

sampled and analyzed for 

microbiological contaminants at least 

once each week. To ensure that a plant’s 

production complies with applicable 

standards, including the standard of 

quality for bottled water products in 

§ 165.110(b), § 129.80(g)(1) of the CGMP 

regulations requires bacteriological 

analysis by the plant, at least once a 

week, of a representative sample from a 

batch or segment of a continuous 

production run for each type of bottled 

water produced during a day’s 

production. In addition, the CGMPs 

require maintenance of testing records 

for 2 years (§ 129.80(g)(3) and (h)). 

IV. FDA Proposal 

A. Proposed Changes 

Ground water is the source water for 

approximately 70 to 75 percent of U.S. 

bottled water products (Ref. 1). As a 

result, the potential for fecal 


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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, as is 

currently required for finished bottled 

water products. Further, FDA is 

proposing that if any coliform organisms 

are detected in source water or in 

finished bottled water products, bottled 

water manufacturers would be required 

to test for E. coli, an indicator of fecal 

contamination. FDA tentatively 

concludes that the proposed 

requirements, as discussed in the 

following paragraphs, would help 

ensure that bottled water is subject to 

requirements no less protective of the 

public health than the treatment 

techniques adopted by EPA in the GWR 

for public drinking water. 

1. Finished Bottled Water Testing 

The bottled water CGMP regulations 

contain compliance procedures 

(§ 129.80(g)) that require that bottlers 

test a representative sample of finished 

bottled water at least once a week for 

bacteriological purposes. The bottled 

water standard of quality regulations 

establish allowable levels for total 

coliform in finished bottled water 

products (§ 165.110(b)(2)). FDA is 

proposing that if the total coliform test 

in finished bottled water products is 

positive (i.e., even if below the 

allowable levels for total coliform), 

bottlers would be required to test for E. 

coli. FDA is proposing to use the 

presence of any coliform as a trigger for 

E. coli testing, rather than the allowable 

levels in § 165.110(b)(2), because the 

presence of any amount of total coliform 

indicates the potential for fecal 

contamination. This is consistent with 

EPA’s approach to triggered testing in 

the GWR. As discussed further in the 

legal authority section of this document, 

if bottled water products test positive 

for E. coli, the products would be 

deemed adulterated under section 

402(a)(3) of the act. 

2. Source Water Testing 

The bottled water CGMPs 

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

conduct microbiological tests of source 

water obtained from other than a PWS 

at least once a week, but do not specify 

the type of testing (i.e., for what 

organism) or an allowable level of 

microbiological contamination. FDA is 

proposing that bottlers that obtain their 

water from other than a PWS test their 

source water at least once a week for 

total coliform and, if any coliform 

organisms are detected, that they 

conduct followup testing for E. coli. 

(PWSs are covered by EPA’s GWR and 

bottlers that obtain their water from a 

PWS are exempt from source water 

testing (§ 129.35(a)(3)).) If the followup 

test is positive for E. coli, FDA would 

consider the source water to be not of 

a safe, sanitary quality, and therefore its 

use in bottled water would be 

prohibited. FDA is proposing to specify 

that the microbiological testing must be 

for total coliform to make testing 

requirements for source and finished 

bottled water uniform and to remove 

any uncertainty in the CGMPs about the 

appropriate microbiological tests for 

bottlers to conduct. FDA believes that 

most bottlers currently use total 

coliform testing to conduct source water 

tests, as is required for finished product 

tests in the quality standard. In 

addition, triggered testing requirements 

for fecal indicators such as E. coli in the 

EPA GWR are also based on initial total 

coliform results. 

FDA is proposing to require followup 

source water testing for E. coli to 

increase public health protection by 

determining whether source water is 

contaminated and prohibiting use of 

such water. These requirements would 

help ensure that bottled water is subject 

to requirements no less protective of the 

public health than those applicable to 

drinking water under the GWR. As 

noted previously, 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 

public health. Based on its concerns, 

EPA is requiring testing for a fecal 

indicator (E. coli, enterococci, or 

coliphage) in source water in response 

to a total coliform positive finding in the 

distribution system. Similarly, FDA 

believes that it is appropriate to require 

E. coli testing in response to a total 

coliform positive finding from weekly 

source water sampling. 

FDA is proposing that source water 

that tests positive for E. coli would not 

be considered to be of a safe, sanitary 

quality for bottling, as is required for 

use in bottled water by § 129.35(a)(1). 

Therefore, bottlers could not use this 

water for production of bottled water 

until they have rectified or otherwise 

eliminated the source water 

contamination, and the source water has 

been retested sufficiently to be 

considered negative for E. coli. FDA is 

further proposing that a source would 

be considered negative for E. coli after 

five samples collected from the source 

over a 24-hour period are tested and 

found to be E. coli negative. FDA solicits 

comment on alternative criteria for 

allowing use of source water following 

an E. coli positive test. 

This proposal does not include 

specific requirements regarding how to 

rectify or otherwise eliminate E. coli 

contamination of source water. 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 sources of 

contamination. 

FDA also did not include a 

requirement for a sanitary survey in this 

proposal. First, FDA does not have a 

primacy program arrangement with the 

States for conducting sanitary surveys of 

ground water sources used by bottled 

water manufacturers, unlike EPA, which 

has a primacy program with the States 

under the SDWA for sanitary surveys of 

ground water sources used by PWSs. 

Second, the CGMPs 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.’’ In addition, this proposal 

requires both weekly source water 

testing and finished bottled water 

testing for total coliform, with E. coli 

testing in case of a total coliform 

positive. In contrast, EPA’s GWR, which 

does require a sanitary survey, does not 

require source water testing for ground 

water sources unless total coliform is 

detected in the distribution system. FDA 

tentatively concludes 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 CGMPs for source inspection and 

approval would help ensure that bottled 

water is subject to requirements no less 

protective of the public health than 

those applicable to drinking water 

under the GWR. 

The bottled water CGMPs currently 

require that bottlers maintain at the 

plant records regarding any sampling 

and analysis of source water 

(§ 129.35(a)(3)(i)), and that such records 

be maintained at the plant for not less 

than 2 years (§ 129.80(h)). This 

requirement would include any records 


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related to testing and retesting for E. 

coli, in addition to at least weekly 

testing for total coliform. 

FDA also is proposing in 

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

records of corrective measures taken to 

rectify or otherwise eliminate the cause 

of E. coli contamination in source water. 

Such records would need to be 

maintained at the plant for not less than 

2 years under § 129.80(h). Examples of 

appropriate records could include 

receipts demonstrating that expenses 

were incurred to have equipment 

repaired or a memorandum outlining 

how a source of contamination was 

identified and removed. 

3. Fecal Indicator 

Under the GWR, EPA is allowing 

States with primacy the discretion to 

designate E. coli, enterococci, or 

coliphage as fecal indicators following a 

total coliform positive test, noting that 

the most appropriate indicator, in the 

context of a PWS, may vary from State 

to State or site to site (71 FR 65574 at 

65597). EPA found that testing for any 

one of these microorganisms as a single 

fecal indicator provides a cost-effective 

means for identifying fecally 

contaminated wells and protecting 

public health (71 FR 65574 at 65597). In 

this proposed rule, FDA is proposing to 

require a single fecal indicator, E. coli, 

rather than allowing bottlers to choose 

from among the three fecal indicators 

identified in the GWR. We believe that 

requiring that all bottlers test for the 

same specific fecal indicator will allow 

FDA to most effectively administer and 

enforce its bottled water regulations. We 

have chosen E. coli as the appropriate 

fecal indicator because approved 

analytical methods for E. coli are 

commercially available, simple, reliable, 

and inexpensive (see 71 FR 65574 at 

65597). We note that EPA believes that 

E. coli will be the fecal indicator most 

likely designated by States with primacy 

for implementation of the GWR, because 

E. coli is already used for followup 

testing under the TCR, and PWSs are 

familiar with its use and interpretation 

(71 FR 65574 at 65583). 

B. Microbiological Quality Standard 

Section 129.80(g) of the bottled water 

CGMPs contains compliance procedures 

for the standard of quality in 

§ 165.110(b) and requires that bottlers 

test a representative sample of each type 

of bottled drinking water produced 

during a day’s production at least once 

a week for bacteriological purposes. 

FDA is proposing that E. coli shall not 

be present in bottled water under a new 

microbiological quality standard in 

§ 165.110(b)(2)(i)(B). Further, under 

proposed § 129.80(g)(1), if any coliform 

organisms are detected in a sample of 

bottled water, bottled water 

manufacturers would be required to 

conduct followup testing for the fecal 

indicator E. coli. If E. coli is detected, 

then the batch or daily production run 

of bottled water represented by the 

sample would be deemed adulterated 

under § 165.110(d) of the bottled water 

standard, as revised. 

This followup testing would help 

ensure the absence of fecal 

contamination in finished bottled water 

products and help ensure that bottled 

water is subject to requirements no less 

protective of the public health than 

those applicable to drinking water. 

The requirement for bottled water to 

meet the allowable level for total 

coliform in the standard of quality 

unless the label bears a statement of 

substandard quality under § 165.110(c) 

for bottled water would remain. The 

labeling provision would be relevant if 

bottled water exceeds the total coliform 

standard but tests negative for E. coli. In 

contrast, because any E. coli in bottled 

water causes the water to be adulterated, 

the substandard labeling provision is 

not relevant for E. coli. 

FDA is also proposing to revise the 

adulteration provision in § 165.110(d) to 

clarify the potential application of 

section 402(a)(3) of the act to bottled 

water, in addition to section 402(a)(1) of 

the act. Current § 165.110(d) provides 

that bottled water containing a 

substance injurious to health under 

section 402(a)(1) of the act is deemed to 

be adulterated, regardless of whether the 

bottle bears a label statement of 

substandard quality prescribed by 

§ 165.110(c). Section 402(a)(3) of the act 

provides another basis for adulteration 

if the food item ‘‘consists in whole or in 

part of any filthy, putrid, or 

decomposed substance, or if it is 

otherwise unfit for food.’’ Section 

402(a)(3) would apply, for example, in 

situations where bottled water is found 

to be contaminated with E. coli. Section 

165.110(d) would be revised by adding 

the phrase ‘‘consists in whole or in part 

of any filthy, putrid, or decomposed 

substance, or if it is otherwise unfit for 

food under section 402(a)(3)’’ between 

the words ‘‘402(a)(1)’’ and ‘‘the act.’’ To 

clarify the applicability of § 165.110(d) 

in cases involving E. coli, § 165.110(d) 

also would be revised by adding the 

statement: ‘‘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 notes 

that although the regulations as 

proposed would specifically identify 

section 402(a)(1) and (a)(3) as applicable 

to bottled water, other adulteration 

provisions in section 402 of the act, 

such as section 402(a)(4) (insanitary 

conditions) apply as well. 

C. CGMP Regulations for Bottled Water 

FDA is proposing in § 129.35(a)(3)(i) 

that bottled water manufacturers that 

obtain their source water from other 

than a PWS test their source water at 

least weekly for total coliform and that 

they conduct followup testing for E. coli 

when source water is total coliform 

positive. Further, 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). To make these changes, 

FDA would revise the CGMP regulations 

by replacing the phrase 

‘‘microbiological contaminants’’ with 

the phrase ‘‘total coliform’’ in the 

second sentence of § 129.35(a)(3)(i), and 

by adding the following two sentences 

to the section: ‘‘If any coliform 

organisms are detected, followup testing 

must be conducted to determine 

whether any of the coliform organisms 

are Escherichia coli * * * 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.’’ 

FDA is also proposing that a bottler 

could not use source water found to 

contain E. coli for production of bottled 

water until the bottler has rectified or 

otherwise eliminated the source water 

contamination, and the source water has 

been sufficiently retested such that it 

can be considered negative for E. coli. 

To make these changes, FDA would 

revise the CGMP regulations by adding 

the following sentences to 

§ 129.35(a)(3)(i): ‘‘The bottler must take 

appropriate measures to rectify or 

otherwise eliminate the cause of E. coli 

contamination in a manner sufficient to 

prevent its reoccurrence. Source water 

previously found to contain E. coli will 

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.’’ 

In addition, FDA is also proposing to 

require that bottlers maintain records of 

corrective measures taken to rectify or 

eliminate E. coli contamination. To 

make this change, FDA is revising 

§ 129.35(a)(3)(i) to include ‘‘records 

describing corrective measures taken in 

response to a finding of E. coli’’ among 

the records required to be maintained 

on file at bottled water plants. Finally, 

FDA would revise § 129.35(a)(4)(iv) to 

include a reference to the potential 

application of section 402(a)(3) of the 

act as a basis for adulteration, in 


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addition to section 402(a)(1), for the 

reasons discussed previously. 

D. Analytical Methods for E. coli Testing 

In the GWR, EPA listed numerous 

analytical methods that it had approved 

for use by PWSs for monitoring source 

water for E. coli, enterococci, and 

coliphage. However, FDA is not 

proposing to adopt new analytical 

methods or to change the allowable 

levels or testing requirements for total 

coliform in the current microbiological 

standard of quality for bottled water. 

The MTF and MF methods cited in 

§ 165.110(b)(2) would still be 

appropriate for total coliform testing. 

The MTF and MF methods are not 

presence/absence methods, but allow 

enumeration of total coliform levels, 

unlike some of the methods approved 

by EPA in the GWR. The MTF and MF 

methods also can be used for followup 

E. coli testing, if needed. Therefore, FDA 

is proposing to cite the existing MTF 

and MF methods for both total coliform 

and E. coli testing in the new 

§ 165.110(b)(2)(ii). FDA notes that 

bottlers can use different methods 

approved by the government agency or 

agencies having jurisdiction, if they 

desire. However, FDA will use the MTF 

and MF methods when it tests products 

and bottlers that want to use different 

methods must ensure that their methods 

give comparable results. 

E. Monitoring and Recordkeeping 

Provisions of CGMP Regulations for 

Bottled Water 

Under proposed § 129.35(a)(3)(i) in 

the CGMP regulations, all source waters 

other than from a PWS would have to 

be analyzed by bottled water plants for 

total coliform at least once each week. 

Bottlers would also be required to test 

for E. coli, if any coliform organisms are 

detected in the source water. If E. coli 

is detected in the source water, bottlers 

would also be required to rectify or 

otherwise eliminate the source water 

contamination and subsequently retest 

for E. coli. In addition, under proposed 

§ 129.80(g)(1) in the CGMP regulations, 

bottlers would have to test finished 

products for total coliform at least once 

a week, and for E. coli, if any coliform 

organisms are detected in the finished 

bottled water. 

Section 129.80(h) of the CGMP 

regulations currently provides that all 

records required under part 129 shall be 

maintained at the plant for not less than 

2 years and shall be available for official 

review at reasonable times. The required 

records include records of analytical 

results for microbiological tests of both 

source and finished bottled water. 

Section 129.80(h) would apply to the 

new testing requirements for total 

coliform and E. coli for source water and 

finished bottled water, as well as new 

recordkeeping relating to measures 

taken to rectify or otherwise eliminate 

source water contamination, as 

discussed previously. 

V. Legal Authority 

FDA is proposing changes to both the 

bottled water standard (§ 165.110) and 

the bottled water CGMP regulations 

(part 129). The proposed 

microbiological quality standard for E. 

coli in finished water is authorized 

under sections 401 and 410 of the act. 

Section 401 of the act explicitly 

provides for the issuance of standards of 

quality. Further, section 410(b)(1) of the 

act requires that not later than 180 days 

before the effective date of an NPDWR 

issued by EPA for a contaminant under 

section 1412 of the 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. 

Section 410(b)(3) of the act requires 

the standard of quality for a 

contaminant in bottled water to be no 

less stringent than EPA’s MCL and no 

less protective of the public health than 

EPA’s treatment technique requirements 

for the same contaminant. In addition, 

section 410(b)(2) of the act provides that 

a standard of quality regulation issued 

by FDA shall include monitoring 

requirements that the agency determines 

to be appropriate for bottled water. 

On November 8, 2006, EPA published 

an NPDWR to provide for increased 

protection against fecal microbiological 

pathogens in PWSs that use ground 

water sources. FDA tentatively 

concludes that this proposed rule, if 

finalized, 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 EPA for public drinking 

water. 

FDA is proposing to revise 

§ 165.110(d), Adulteration, of the 

bottled water standard to provide that 

bottled water containing E. coli is 

deemed to be adulterated under section 

402(a)(3) of the act. Under section 

402(a)(3), a food is deemed adulterated 

if ‘‘it consists in whole or in part of any 

filthy, putrid, or decomposed substance, 

or if it is otherwise unfit for food.’’ As 

EPA recognized in its GWR, water that 

contains E. coli is fecally contaminated. 

Such water consists in part of a ‘‘filthy’’ 

or ‘‘putrid’’ substance under section 

402(a)(3) of the act. Therefore, if bottled 

water products test positive for E. coli, 

the products would be adulterated 

under section 402(a)(3) of the act. 

In addition to the change to the 

bottled water standard, FDA is 

proposing to amend the bottled water 

CGMP regulations. FDA is proposing to 

amend the current requirement in 

§ 129.35(a)(3)(i) of the CGMP regulations 

to test source water obtained from other 

than a PWS for microbiological 

contaminants to specifically identify 

total coliform as the contaminant 

subject to mandatory testing. Such 

testing for total coliform is currently 

required for finished bottled water by 

§ 129.80(g). The presence of any 

coliform indicates that the water may 

contain E. coli, an indicator of fecal 

contamination. Therefore, if either 

source water or finished water tests 

positive for total coliform, FDA is 

proposing to require that the water be 

tested for E. coli (under proposed 

§ 129.35(a)(3)(i) for source water and 

under proposed § 129.80(g)(1) for 

finished bottled water) to determine 

whether it is fecally contaminated. 

Source water that is fecally 

contaminated would not be considered 

water of a safe, sanitary quality under 

the CGMPs, and therefore its use in 

bottled water would be prohibited. 

Finished bottled water that is fecally 

contaminated would be deemed 

adulterated under section 402(a)(3), as 

reflected in proposed § 165.110(d) of the 

bottled water standard. 

After testing indicates that source 

water is fecally contaminated, FDA is 

proposing to require that bottlers could 

not use this water for production of 

bottled water until they have rectified or 

otherwise eliminated the source water 

contamination, and the source water has 

been retested sufficiently to be 

considered negative for E. coli. FDA is 

further proposing that a source would 

be considered negative for E. coli after 

five samples collected from the source 

over a 24-hour period are tested and 

found to be E. coli negative. Failure to 

remedy the cause of the contamination 

would create the possibility of future 

contamination from the same cause. 

FDA’s legal authority for these 

proposed requirements is based on the 

act’s adulteration provisions in section 

402(a)(3) and (a)(4), and under section 

701(a) of the act (21 U.S.C. 371(a)). As 

described previously, water containing 

E. coli consists in part of a ‘‘filthy’’ or 

‘‘putrid’’ substance under section 

402(a)(3) and is therefore adulterated 

under section 402(a)(3). Under section 

402(a)(4) of the act, a food is adulterated 

‘‘if it has been prepared, packed, or held 


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under insanitary conditions whereby it 

may have become contaminated with 

filth, or whereby it may have been 

rendered injurious to health.’’ Failure to 

ensure the water is prepared, packed, 

and held under conditions in which 

water does not become fecally 

contaminated constitutes an insanitary 

condition and thus renders the water 

adulterated under section 402(a)(4) of 

the act. Under section 701(a) of the act, 

FDA is authorized to issue regulations 

for the efficient enforcement of the act. 

A regulation that requires measures to 

prevent bottled water from consisting in 

part of filth and from being prepared, 

packed, and held under insanitary 

conditions allows for the efficient 

enforcement of the act. 

FDA’s proposal includes a 

requirement that bottlers maintain 

records of measures taken to address a 

positive E. coli finding in source water. 

Records of corrective measures are 

needed for FDA to determine 

compliance with the rule’s requirement 

that bottlers take appropriate measures 

to rectify or otherwise eliminate the 

cause of E. coli contamination in source 

water. Records would provide assurance 

to both the bottler and FDA that the risk 

of water becoming fecally contaminated 

is being minimized. Failure to take and 

document these measures would result 

in a bottler producing water under 

insanitary conditions whereby the water 

may become contaminated with filth 

under section 402(a)(4) of the act. 

VI. Environmental Impact Analysis 

The agency has determined under 21 

CFR 25.30(h) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

VII. Executive Order 12866 and 

Regulatory Flexibility Act 

A. Preliminary Economic Impact 

Analysis 

FDA has examined the impacts of the 

proposed 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 

tentatively concludes that this proposed 

rule is not a significant regulatory action 

as defined by 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 

tentatively concludes that the proposed 

rule will not have a significant 

economic impact on a substantial 

number of small entities. FDA requests 

comment on the impact of this rule on 

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 $127 

million, using the most current (2006) 

Implicit Price Deflator for the Gross 

Domestic Product. FDA does not expect 

this proposed rule to result in any 1- 

year expenditure that would meet or 

exceed this amount. 

1. Need for Regulation 

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 

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. 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. 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. 1). Based on 

EPA’s findings in the GWR, FDA 

tentatively 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. 2). 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 our proposed regulation. 

FDA asks for comments on these 

estimates. 

2. Regulatory Options 

FDA evaluates three regulatory 

options in this analysis: 

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 


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health, then EPA’s GWR will apply to 

bottled water. 

Option 2. Issue the regulations in this 

proposed rule, 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 

proposed rule. FDA is proposing to 

require 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 would be 

required to test for E. coli. Source water 

containing E. coli would not be 

considered to be of a safe, sanitary 

quality and would be prohibited from 

use in the production of bottled water 

until the bottler has taken appropriate 

measures (as evidenced by records) to 

rectify or otherwise eliminate the cause 

of the contamination. 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. Finished bottled water 

products containing E. coli will be 

deemed adulterated. 

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 

proposed 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 followup 

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 (21 CFR 

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 followup 

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 proposed action. 

Each requirement of FDA’s proposed 

action will be evaluated separately in 

the following order: 

1. Require that source water currently 

subject to weekly microbiological 

testing be analyzed specifically for total 

coliform; 

2. Require followup 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 (as evidenced by 

records), and then retest the source 

water sufficiently until it 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 proposing 

to specify 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. 3). 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 also 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 followup testing for E. coli 

when total coliform positives occur in 

source water or finished bottled water 

products. 

As noted previously, FDA proposes to 

require 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 proposing that if any 

coliform organisms are detected in 

source water or in finished water 

products, then the bottler must conduct 

followup 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 proposal, 

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 (as evidenced by 

records), and then retest the source 

water sufficiently until it 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 source water 

contamination, by keeping records of 

those actions, and by retesting the 

source water sufficiently until it is 

considered negative for E. coli. The 

source water would be considered 

negative for E. coli after five samples 

collected from the source over a 24-hour 

period are tested and found to be E. coli 

negative. 

Finished bottled water products that 

test positive for E. coli will be deemed 


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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 ((66 FR 35439 at 35440, July 

5, 2001) and (Ref. 1)) and that the other 

25 percent obtain their water from 

PWSs. 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, an 

estimated 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 and 

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. 4). 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 if 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 .5 $ 10 .72 .5 $ 8 .95 $ 19 .67 $ 30 .39 

Commercial $ 21 .44 .5 $ 10 .72 0 $ 74 .80 $ 74 .80 $ 85 .52 

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 one 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, December 2, 2004). This may 

overestimate the number of bottlers that 

will outsource testing and thus may 

overestimate the cost of the rule. FDA 

requests comment on this assumption. 

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 Other 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%) 

Total 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. 5). FDA requests comments on this 

assumption. 

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 

would include at least weekly testing for 

total coliform in source water and 

finished products, or at least 52 source 

samples and 52 finished product 

samples per year. For example, bottlers 

whose source is other than a PWS 

would have to test their source water at 

least once a week and also their finished 


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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. 5). 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, three 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. coli 

A B C (A X B X 6) + 

( A X C X 3) 

Cost per 

sample 

Number of 

Bottlers Testing Both 

Source and 

Finished Product 

Number of 

Bottlers Testing Only Finished Product Total Annual 

Costs of E. coli 

Testing 

(Six Tests/ 

Year) 

(Three Tests/ 

Year) 

Low cost assumption In-house laboratory $30 188 56 $39,000 

Commercial laboratory $86 131 39 $77,000 

Total low cost assumption $116,000 

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 would 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 

would 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 

found to contain E. coli for production 

of bottled water until the bottler has 

rectified or otherwise eliminated the 

source water contamination, and the 

source water has been sufficiently 

retested such that it can be considered 

negative for E. coli. Source water 

previously found to contain E. coli will 

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. 

This cost model assumes that bottlers 

will take action to rectify or eliminate 

source water 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. 6). 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 


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TABLE 4—NUMBER OF BOTTLERS THAT INCUR AN E. coli POSITIVE IN SOURCE WATER AND MUST RECTIFY

CONTAMINATION—Continued 

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, source water would 

be considered negative for E. coli after 

five samples collected from the source 

over a 24-hour period 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 the retesting is 

conducted in-house or in a commercial 

laboratory, total annual costs of retesting 

five 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 RETESTING FIVE MORE SAMPLES FOR E. coli AFTER A POSITIVE FINDING1

A B A X B X 5 

Cost per 

Sample 

Number of 

Bottlers Retesting Source 

Water 

Total Annual 

Costs of Retesting 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 Source Water 

Contamination 

As noted previously, FDA requires 

bottlers to rectify or otherwise eliminate 

the source water contamination. FDA 

drew on EPA’s Economic Impact 

Analysis of the GWR to provide 

estimates for costs of rectifying or 

eliminating contamination. 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). Unit 

costs for these repairs are based on the 

Technology and Cost Documents for the 

Final GWR (Ref. 6) 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. 6). 

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 


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has not quantified these costs and 

requests comments. 

Recordkeeping Costs 

Under this proposed rule, those 

bottlers that would be 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) would be 

required to maintain a record of the 

microbiological test results for at least 2 

years under proposed § 129.35(a)(3)(i), 

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

the CGMP regulations. The current 

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 tentatively concludes 

that any additional costs in 

recordkeeping based on the new 

proposed testing requirements for 

source water and finished bottled water 

products would be negligible. 

Summary of Costs 

Total costs for the proposed action, 

including the estimated annual costs for 

E. coli testing and for rectifying source 

water contamination, 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 source water contamination 

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 

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 retesting. Estimated 

costs to rectify the source water 

contamination using low and high cost 

assumptions appear in table 9 of this 

document. 


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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. 

Retesting costs are shown in table 10 

of this document and illustrate costs for 

bottlers that will use either in-house or 

commercial laboratories. 

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

Retesting 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 

Table 11 of this document shows the 

estimated total annual costs of the 

proposed rule (Option 3) by adding 

tables 7, 8, 9, and 10 of this document 

to be $134,000 (low cost) and $189,000 

(high cost). The estimated total 

discounted or present value costs (using 

7 percent interest rate over 20-year 

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

million (high). 

TABLE 11—ESTIMATED TOTAL ANNUAL AND DISCOUNTED COSTS OF PROPOSED RULE

Total Annual 

Costs of Proposed 

Rule 

Total Discounted 

Costs of Proposed 

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 

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 

microbial quality of bottled water 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 proposed 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. This rule may have a 

significant economic impact on a 

substantial number of 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, 

December 2, 2004). 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 


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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 ENTITY1

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 product only $50 $70 

E. coli retesting $1 $3 

Costs to rectify contamination $50 $60 

Average costs per bottler $380 $540 

1Estimates are not exact due to rounding. 

To investigate the potential 

significance of these impacts, FDA 

entered these costs into a model created 

under contract by Eastern Research 

Group, Inc. (ERG) (Ref. 7). 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 tentatively concludes that 

the proposed rule will not have a 

significant economic impact on a 

substantial number of small entities. 

FDA requests comment on the impact of 

this rule on small entities. 

VIII. Paperwork Reduction Act of 1995 

This proposed rule contains 

information collection provisions that 

are subject to review by OMB under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). A description of 

these provisions is given in the 

following paragraphs with an estimate 

of the annual recordkeeping burden. 

Included in the estimate is the time for 

reviewing instructions, searching 

existing data sources, gathering and 

maintaining the data needed, and 

completing and reviewing each 

collection of information. 

FDA invites comments on: (1) 

Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Recordkeeping Due to New 

Testing Requirements for Bottled Water. 

Description: The FDA is proposing to 

amend its bottled water regulations by 

requiring testing for the fecal indicator 

E. coli if any coliform organisms are 

detected in a weekly sample of finished 

bottled water products. FDA also is 

proposing to amend the adulteration 

provision of the bottled water standard 

to indicate that finished product that 

tests positive for E. coli will be deemed 

adulterated under section 402(a)(3) of 

the act. In addition, FDA is proposing to 

amend the CGMP regulations for bottled 

water by requiring that source water 

from other than a PWS be tested at least 

weekly for total coliform. If any coliform 

organisms are detected in the source 

water, the bottled water manufacturer 

would be required to test the source 

water for E. coli. Source water found to 

contain E. coli would not be considered 

water of a safe, sanitary quality and 

would be unsuitable for bottled water 

production until the bottler has taken 

appropriate measures (as evidenced by 

records) to rectify or otherwise 

eliminate the cause of the 

contamination. 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. 

Description of Respondents: This rule 

would require both domestic and 

foreign bottled water manufacturers that 

sell bottled water in the United States to 

maintain records of E. coli testing in 

addition to existing recordkeeping 

requirements. 

Burden: FDA estimates the burden for 

this information collection in table 13 of 

this document as follows: 

TABLE 13—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Record 

Total Annual 

Records 

Hours per 

Record Total Hours 

§ 129.35(a)(3)(i), § 129.80(h) 319 (bottlers subject to source water 

and finished product testing) 

6 1,914 0 .08 153 


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TABLE 13—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Record 

Total Annual 

Records 

Hours per 

Record Total Hours 

§ 129.80(g), § 129.80(h) 95 (bottlers testing finished product 

only) 

3 285 0 .08 23 

§ 129.35(a)(3)(i), § 129.80(h) 2.5 (bottlers retesting source water) 5 12 0 .08 1 

§ 129.35(a)(3)(i), § 129.80(h) 2.5 (bottlers rectifying source water 

contamination) 

3 7 .5 .25 2 

Total annual burden 179 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The current 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 tentatively concludes that any 

additional burden and costs in 

recordkeeping based on the new 

proposed testing requirements for 

source and finished bottled water would 

be negligible. FDA estimates that the 

labor burden of keeping records of each 

test is about 5 minutes per test. FDA is 

also requiring followup testing of source 

water and finished bottled water 

products for E. coli when total coliform 

positives occur. FDA expects that 319 

bottlers that use sources other than 

PWSs may find a total coliform positive 

sample about three times per year in 

source testing and about three times in 

finished product testing, for a total of 

153 hours recordkeeping. In addition to 

the 319 bottlers, about 95 bottlers that 

use PWSs may find a total coliform 

positive sample about three times per 

year in finished product testing, for a 

total of 23 hours of recordkeeping. Upon 

finding a total coliform sample, bottlers 

will then have to conduct a followup 

test for E. coli. 

FDA expects that recordkeeping for 

the followup test for E. coli will also 

take about 5 minutes per test. As shown 

in table 13 of this document, FDA 

expects that 2.5 bottlers per year will 

have to carry out the additional E. coli 

testing, with a burden of 1 hour. These 

bottlers will also have to keep records 

about rectifying the source 

contamination, for a burden of 2 hours. 

For all expected total coliform testing, E. 

coli testing, and source rectification, 

FDA estimates a total burden of 179 

hours. 

The information collection provisions 

of this proposed rule have been 

submitted to OMB for review. Interested 

persons are requested to fax comments 

regarding information collection by 

October 17, 2008, to the Office of 

Information and Regulatory Affairs, 

OMB. To ensure that comments on 

information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974. 

IX. Federalism 

FDA has analyzed this proposed rule 

in accordance with the principles set 

forth in Executive Order 13132. FDA 

has determined that the proposed 

revisions to the standard of quality for 

bottled water relating to microbiological 

quality (21 CFR 165.110(b)(2)), if 

finalized as proposed, would have a 

preemptive effect on State law. 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(a)(1) of the act (21 U.S.C. 

343–1(a)(1)) 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)). Although the proposed 

revisions relating specifically to the 

standard of quality for bottled water, if 

finalized as proposed, will have 

preemptive effect in that it would 

preclude States from issuing 

requirements for microbiological testing 

in bottled water that are not identical to 

the microbiological testing requirements 

as set forth in this proposed rule, this 

preemptive effect is consistent with 

what Congress set forth in section 403A 

of the act. 

Section 4(c) of the Executive order 

further requires that ‘‘any regulatory 

preemption of State law shall be 

restricted to the minimum level 

necessary’’ to achieve the regulatory 

objective. Under section 410 of the act, 

not later than 180 days before the 

effective date of an NPDWR issued by 

EPA for a contaminant under section 

1412 of the 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. Further, section 410(b)(3) of the 

act requires a standard of quality for a 

contaminant in bottled water to be no 

less stringent than EPA’s MCL and no 

less protective of the public health than 

EPA’s treatment techniques required for 

the same contaminant. On November 8, 

2006, EPA issued an NPDWR containing 

a risk-targeted approach, including 

treatment techniques, identifying and 

targeting GWSs susceptible to fecal 

contamination (71 FR 65574). FDA has 

determined that establishing new 

microbiological testing requirements 

and standards for source water and 

bottled water products is appropriate as 

a response to EPA’s action, and is 

issuing this proposed regulation 

consistent with section 410 of the act. 

Further, section 4(e) of the Executive 

order provides that ‘‘when an agency 

proposes to act through adjudication or 

rulemaking to preempt State law, the 

agency shall provide all affected State 

and local officials notice and an 

opportunity for appropriate 

participation in the proceedings.’’ Given 

the statutory framework of section 410 

of the act for bottled water, EPA’s 

issuance of the GWR provided notice of 


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possible FDA action to revise the 

microbiological quality standard for 

bottled water. FDA did not receive any 

correspondence from State and local 

officials regarding possible changes to 

the microbiological quality standard for 

bottled water subsequent to EPA’s 

issuance of the GWR. In addition, we 

are providing an opportunity for State 

and local officials to comment on 

proposed changes to the CGMPs and 

quality standard in the context of this 

rulemaking. For the reasons set forth 

previously in this document, the agency 

believes that it has complied with all of 

the applicable requirements under the 

Executive order. 

In conclusion, FDA has determined 

that the preemptive effects of this rule, 

if finalized, will be consistent with 

Executive Order 13132. 

X. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

XI. Effective Date of the Related Final 

Rule 

The agency intends to make any final 

rule based on this proposal effective 

December 1, 2009. The agency will 

publish a final rule in the Federal 

Register no later than 180 days before 

the effective date. The agency is 

providing 180 days before the effective 

date to permit affected firms adequate 

time to take appropriate steps to bring 

their product into compliance with the 

standard imposed by the new rule. 

XII. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. (FDA has verified the 

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. International Bottled Water Association, 

2007. Personal communication. August 30, 

2007. 

2. Skipton, S.O., D. Hay, and J.A. 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. 

3. International Bottled Water Association, 

2005, IBWA Model Code, Version March 

2005. Accessed online at http:// 

www.bottledwater.org/public/pdf/ 

IBWA05ModelCode_Mar2.pdf. 

4. Economic Analysis for the Final 

Groundwater Rule, Office of Water (4606–M) 

EPA 85–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. 

5. Economic Analysis for the Final 

Groundwater Rule, Office of Water (4606–M) 

EPA 85–R–06–014, October 2006, Section 

4.2.7 Triggered Monitoring Baseline, pp. 4– 

21 through 4–22. 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 85–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. 

7. ERG (Eastern Research Group, Inc.), 

‘‘Model for Estimating the Impacts of 

Regulatory Costs on the Survival of Small 

Businesses and its Application to Four FDARegulated 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, it is proposed that 

21 CFR parts 129 and 165 be 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 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. The 

bottler must take appropriate measures 

to rectify or otherwise eliminate the 

cause of E. coli contamination in a 

manner sufficient to prevent its 

reoccurrence. Source water previously 

found to contain E. coli will 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. 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 

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 


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production. The representative sample 

shall consist of primary containers of 

product or unit packages of product. If 

any coliform organisms are detected, 

followup 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), (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. No E. coli shall be 

detected. 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) method described 

in the applicable sections of ‘‘Standard 

Methods for the Examination of Water 

and Wastewater,’’ 20th Ed. (1998), 

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. You may inspect a copy at 

the Center for Food Safety and Applied 

Nutrition’s Library, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 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. 

* * * * * 

(c) * * * 

(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 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: September 10, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21619 Filed 9–16–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

RIN 1545–BB67 

[REG–157711–02] 

Unified Rule for Loss on Subsidiary 

Stock 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Partial withdrawal of notice of 

proposed rulemaking. 

SUMMARY: This document withdraws 

proposed regulations relating to the 

application of section 362(e)(2) to 

intercompany transactions and to 

certain modifications to the investment 

adjustment rules. 

FOR FURTHER INFORMATION CONTACT: 

Marcie P. Barese, (202) 622–7790 (not a 

toll-free number). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

On January 23, 2007, the IRS and 

Treasury Department published a notice 

of proposed rulemaking in the Federal 

Register (72 FR 2964) under § 1.1502–36 

(Unified Loss Rule). The proposed 

regulations provided rules under 

§ 1.1502–13(e)(4) that would suspend 

the application of section 362(e)(2) in 

the case of intercompany transactions. 

The proposed regulations also provided 

rules under § 1.1502–32(c)(1)(ii) relating 

to the treatment of items attributable to 

property transferred in an intercompany 

section 362(e)(2) transaction. 

After consideration of the comments 

received responding to the notice of 

proposed rulemaking, the IRS and 

Treasury Department have concluded 

that the proposed rules would not be 

promulgated and, instead, that final 

regulations would make section 

362(e)(2) generally inapplicable to 

intercompany transactions. 

Accordingly, §§ 1.1502–13(e)(4) and 

1.1502–32(c)(1)(ii) of the proposed 

regulations are hereby withdrawn. 

List of Subjects in 26 CFR Part 1 

Income taxes, Reporting and 

recordkeeping requirements. 

Partial Withdrawal of Proposed 

Regulations 

Accordingly, under the authority of 

26 U.S.C. 7805, proposed §§ 1.1502– 

13(e)(4) and 1.1502–32(c)(1)(ii) 

published in the Federal Register on 

January 23, 2007 are withdrawn. 

Linda E. Stiff, 

Deputy Commissioner for Services and 

Enforcement. 

[FR Doc. E8–21005 Filed 9–9–08; 4:15 pm] 

BILLING CODE 4830–01–P 

DEPARTMENT OF THE INTERIOR 

Minerals Management Service 

30 CFR Part 250 

[Docket ID: MMS–2008–OMM–0023] 

RIN 1010–AD50 

Technical Changes to Production 

Measurement and Training 

Requirements 

AGENCY: Minerals Management Service 

(MMS), Interior. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the production measurement 

regulations to establish meter proving, 


pwalker on PROD1PC71 with PROPOSALS