[Federal Register Volume 68, Number 41 (Monday, March 3, 2003)]
[Rules and Regulations]
[Pages 9873-9882]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 03-4971]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 03N-0068]


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its bottled 
water quality standard regulations by establishing an allowable level 
for the contaminant uranium. As a consequence, bottled water 
manufacturers are required to monitor their finished bottled water 
products for uranium at least once each year under the current good 
manufacturing practice (CGMP) regulations for bottled water. Bottled 
water manufacturers are also required to monitor their source water for 
uranium as often as necessary, but at least once every 4 years unless 
they meet the criteria for the source water monitoring exemptions under 
the CGMP regulations. FDA will retain the existing allowable levels for 
combined radium-226/-228, gross alpha particle radioactivity, and beta 
particle and photon radioactivity. This direct final rule will ensure 
that the minimum quality of bottled water, as affected by uranium, 
combined radium-226/-228, gross alpha particle radioactivity, and beta 
particle and photon radioactivity, remains comparable with the quality 
of public drinking water that meets the Environmental Protection 
Agency's (EPA's) standards. FDA is issuing a direct final rule for this 
action because the agency expects that there will be no significant 
adverse comment on this rule. Elsewhere in this issue of the Federal 
Register, FDA is publishing a companion proposed, rule under the 
agency's usual procedure for notice-and-comment rulemaking, to provide 
a procedural framework to finalize the rule in the event the agency 
receives any significant adverse comments and withdraws this direct 
final rule. The

[[Page 9874]]

companion proposed rule and direct final rule are substantively 
identical.

DATES: This rule is effective December 8, 2003. Submit written or 
electronic comments by May 2, 2003. If FDA receives no significant 
adverse comments during the specified comment period, the agency will 
publish a document in the Federal Register no later than June 11, 2003, 
confirming the effective date of the direct final rule. If the agency 
receives any significant adverse comment during the comment period, FDA 
intends to withdraw this direct final rule by publication in the 
Federal Register no later than June 11, 2003. The Director of the 
Office of the Federal Register approves the incorporation by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in Sec.  165.110(b)(5)(ii) as of December 8, 2003.

ADDRESSES: Submit written comments on the direct final rule to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments 

FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety and 
Applied Nutrition (HFS-306), Food and Drug Administration, 5100 Paint 
Branch Pkwy., College Park, MD 20740, 301-436-1640.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 7, 2000 (65 FR 76708), EPA 
published the Radionuclides Rule to address potential public health 
effects from the presence of radionuclides in drinking water. This 
rulemaking finalized a proposed rule that EPA published in the Federal 
Register of July 18, 1991 (56 FR 33050).
    Radionuclides are radioactive elements that occur naturally in the 
Earth's crust or are formed as a result of cosmic ray interactions. 
Human activities can also add radionuclides to the environment. 
Radionuclides emit ionizing radiation when they radioactively decay. 
The potential for harmful health effects from radionuclide exposure 
results from the ability of ionizing radiation to chemically change 
molecules that make up biological tissue through a process called 
ionization. Studies have shown long-term exposure to radionuclides 
including uranium in drinking water may result in increased risk of 
cancer and that exposure to uranium can have adverse health effects on 
kidney function (65 FR 76708 at 76712-76713).
    National primary drinking water regulations (NPDWRs) are issued by 
EPA to protect the public health from the adverse effects of 
contaminants in drinking water. NPDWRs specify maximum contaminant 
levels (MCLs) or treatment techniques for drinking water contaminants. 
In addition, at the same time that it issues NPDWRs, EPA publishes 
maximum contaminant level goals (MCLGs), which are not regulatory 
requirements but rather are nonenforceable health goals that are based 
solely on considerations of protecting the public from adverse health 
effects of drinking water contamination.
    In the Radionuclides Rule, EPA issued an NPDWR containing an MCL 
for uranium. EPA retained the existing MCLs for combined radium-226/-
228, gross alpha particle radioactivity, and beta particle and photon 
radioactivity and indicated the analytical methods it approved for 
testing for uranium and three other contaminants. Finally, EPA 
published an MCLG of zero for all radionuclides. EPA's NPDWR has an 
effective date of December 8, 2003.
    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 Safe Drinking Water Act (SDWA) (42 U.S.C. 300g-l), 
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 but not in water used for 
bottled water. The effective date for any such standard of quality 
regulation is to be the same as the effective date of the NPDWR. In 
addition, section 410(b)(2) of the act provides that a quality standard 
regulation issued by FDA shall include monitoring requirements that the 
agency determines to be appropriate for bottled water. Further, section 
410(b)(3) of the act requires a quality standard 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.

II. Direct Final Rulemaking

    FDA has determined that the subjects of this rulemaking are 
suitable for a direct final rule. The actions taken should be 
noncontroversial and the agency does not anticipate receiving any 
significant adverse comment.
    FDA is adopting EPA's MCL for uranium as an allowable level in the 
quality standard regulation for bottled water. FDA is also retaining 
the existing allowable levels for combined radium-226/-228, gross alpha 
particle radioactivity, and beta particle and photon radioactivity in 
the quality standard regulation for bottled water. The existing 
allowable levels for these radionuclides in bottled water are identical 
to the existing MCLs for the same radionuclides in drinking water that 
EPA retained in their Radionuclides Rule. FDA also is specifying 
analytical methods for determining whether the bottled water is in 
compliance with the quality standards.
    As a consequence of FDA's amending the quality standard for uranium 
in part 165 (21 CFR part 165), bottled water manufacturers are required 
to monitor their finished bottled water products for uranium at least 
once each year (part 129 (21 CFR part 129)). In addition, bottled water 
manufacturers are required to monitor their source water for uranium at 
least once every 4 years, unless they meet the criteria for the source 
water monitoring exemptions under the CGMP regulations (part 129).
    If FDA does not receive significant adverse comment on or before 
May 2, 2003, the agency will publish a notice in the Federal Register 
no later than June 11, 2003, confirming the effective date of the 
direct final rule. The agency intends to make the direct final rule 
effective December 8, 2003.
    A significant adverse comment is one that explains why the rule 
would be inappropriate, including challenges to the rule's underlying 
premise or approach, or why it would be ineffective or unacceptable 
without a change. In determining whether a significant adverse comment 
is sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered adverse under this procedure. A comment recommending a 
change to the rule that is in addition to the rule will not be 
considered a significant adverse comment, unless the comment states why 
this rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to part of the rule 
and that part can be severed from the remainder of the rule, FDA may 
adopt as final those parts of the rule that are not the subject of a 
significant adverse comment. If timely significant adverse comments are 
received, the agency will publish a notice of significant adverse 
comment in the

[[Page 9875]]

Federal Register withdrawing this direct final rule no later than June 
11, 2003.
    The companion proposed rule, which is in essence identical to the 
direct final rule, provides a procedural framework within which the 
rule may be finalized in the event the direct final rule is withdrawn 
because of significant adverse comment. The comment period for the 
direct final rule runs concurrently with that of the companion proposed 
rule. Any comments received under the companion proposed rule will be 
treated as comments on the direct final rule. Likewise, significant 
adverse comments submitted to the direct final rule will be considered 
as comments to the companion proposed rule, and the agency will 
consider the comments in developing a final rule. FDA will not provide 
additional opportunity for comment on the companion proposed rule. A 
full description of FDA's policy on direct final rule procedures may be 
found in a guidance document published in the Federal Register of 
November 21, 1997 (62 FR 62466).

III. EPA Standards

    The SDWA, as amended in 1996, requires EPA to publish an NPDWR that 
specifies either an 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)). The SDWA (section 
300g-l(a)(3)) also requires that EPA issue MCLGs at the same time it 
issues NPDWRs. MCLGs are nonenforceable health goals that are based 
solely on considerations of protecting the public from the adverse 
health effects of contaminants, and not on other considerations, such 
as potential costs of regulating contaminants and potential technical 
difficulties of achieving the health goals (59 FR 38668 at 38671). EPA 
sets MCLs, the enforceable contaminant levels, as close as feasible to 
the nonenforceable MCLGs.
    In its proposed rule on radionuclides (56 FR 33050), EPA proposed 
comprehensive changes to radionuclides standards in drinking water. 
However, after conducting a review of costs, benefits, and treatment 
technologies, in the Radionuclides Rule, EPA established an MCL of 30 
micrograms per liter ([micro]g/L) for uranium and retained the existing 
MCLs of 5 picocuries per liter (pCi/L) for combined radium-226/-228, 15 
pCi/L for gross alpha (excluding radon and uranium), and 4 millirem 
(mrem)/year for beta particle and photon radioactivity (65 FR 76708 at 
76722).
    Because uranium is a kidney toxin as well as a carcinogen, EPA 
chose an MCL for uranium, expressed in [micro]g/L, that is protective 
of both kidney toxicity and carcinogenicity (65 FR 76708 at 76716). 
Analytical methods approved by EPA for uranium monitoring include 
activity and mass concentration analyses. If uranium is determined by 
activity-type methods, a 0.67 pCi/[micro]g conversion factor is used to 
convert activity to mass concentration (65 FR 76708 at 76725).

IV. FDA Standards

A. The Agency's Approach to the Bottled Water Quality Standards 
Established Under Section 410 of the Act

    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 quality standard for bottled water that is set forth in 
Sec.  165.110.
    Producers of bottled water are responsible for assuring, 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 quality standard 
(Sec.  165.110(b)). Bottled water that is of a quality below the 
prescribed standard is required by Sec.  165.110(c) to be labeled with 
a statement of substandard quality. Moreover, 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.
    FDA has traditionally fulfilled its obligation under section 410 of 
the act to respond to EPA's issuance of NPDWRs by amending the quality 
standard regulations for bottled water introduced or delivered for 
introduction into interstate commerce to maintain compatibility with 
EPA's drinking water regulations. In general, FDA believes that, with 
few exceptions, EPA standards for contaminants in drinking water are 
appropriate as allowable levels for contaminants in the quality 
standard for bottled water when bottled water may be expected to 
contain the same contaminants.
    FDA generally has not duplicated the efforts of EPA in judging the 
adequacy of MCLs or treatment techniques in NPDWRs for contaminants 
when determining their applicability to bottled water in order to 
protect the public health. FDA believes that, in general, it would be 
redundant for FDA to reevaluate the drinking water standards prescribed 
by EPA. 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. 
Therefore, FDA's view is that generally in cases where bottled water is 
subject to the same contaminants as tap water, FDA should establish a 
standard of quality levels in bottled water at the same levels that EPA 
establishes as MCLs for such contaminants in tap water.

B. Quality Standard for Radionuclides

    The quality standard for bottled water, as set forth in Sec.  
165.110(b)(5)(i), prescribes that bottled water shall not contain: (A) 
combined radium-226/-228 activity in excess of 5 picocuries per liter 
of water, (B) gross alpha particle activity (including radium-226, but 
excluding radon and uranium) in excess of 15 picocuries per liter of 
water, and (C) beta particle and photon radioactivity from manmade 
radionuclides in excess of that which would produce an annual dose 
equivalent to the total body or any internal organ of 4 millirems per 
year calculated on the basis of an intake of 2 liters of the water per 
day. If two or more beta or photon-emitting radionuclides are present, 
the sum of their annual dose equivalent to the total body or to any 
internal organ shall not exceed 4 millirems per year. The quality 
standard for bottled water, however, does not currently prescribe an 
allowable level for uranium.
    With the exception of uranium, FDA's existing allowable levels for 
radionuclides (i.e., combined radium-226/-228, gross alpha particle 
radioactivity, and beta particle and photon radioactivity) in the 
bottled water quality standard are the same as EPA's existing MCLs for 
the same radionuclides in drinking water that EPA retained in the 
Radionuclides Rule. Therefore, FDA will not change the existing 
allowable levels for these radionuclides in bottled water.

[[Page 9876]]

    FDA has evaluated the MCL for uranium established by EPA for 
drinking water. FDA concludes that EPA's MCL for uranium, as a standard 
of quality level for bottled water, is adequate for the protection of 
public health. Certain waters used for bottled water may be expected to 
contain uranium; thus, FDA believes that adopting EPA's MCL for uranium 
will ensure that the quality of bottled water is equivalent to the 
quality of public drinking water that meets EPA standards.
    Therefore, FDA is establishing in a new paragraph (b)(5)(i)(D) in 
Sec.  165.110, an allowable level for uranium of 30 micrograms per 
liter of water.

C. Analytical Methods for Radionuclides

    In the Radionuclide Rule, EPA listed the analytical methods that it 
had approved for use by public water systems to determine compliance 
with the radionuclide MCLs (i.e. for uranium, combined radium-226/-228, 
gross alpha particle radioactivity, and beta particle and photon 
radioactivity) (65 FR 76708 at 76724). FDA is revising Sec.  
165.110(b)(5)(ii) by incorporating by reference EPA approved analytical 
methods (65 FR 76708 at 76725) for determining compliance with the 
quality standard for uranium activity in bottled water. FDA is also 
revising Sec.  165.110(b)(5)(ii) by incorporating by reference EPA 
approved analytical methods for determining compliance with the quality 
standard for combined radium-226/-228, gross alpha particle 
radioactivity, and beta particle and photon radioactivity in bottled 
water (65 FR 76708 at 76725). FDA believes that these methods are 
sufficient to use for determining the level of uranium in bottled 
water.

D. Monitoring Provisions of CGMP Regulations for Bottled Water

    FDA has established CGMP regulations for bottled water in part 129. 
Under Sec.  129.35(a)(3)(i), source water must be analyzed by the plant 
as often as necessary, but at least once every 4 years for radiological 
contaminants. Therefore, once the rule becomes effective, bottlers will 
be required to test their source water as often as necessary but at 
least once every 4 years for uranium, combined radium-226/-228, gross 
alpha particle radioactivity, and beta particle and photon 
radioactivity, unless the bottlers meet the provisions in Sec.  
129.35(a)(4) for source water monitoring exemptions. Further, to ensure 
that a plant's production complies with applicable standards, Sec.  
129.80(g)(2) requires radiological analysis by the plant, at least 
annually, 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. Therefore, once this rule becomes effective, 
bottlers will be required to test their finished bottled water products 
at least once a year for uranium, combined radium-226/-228, gross alpha 
particle radioactivity, and beta particle and photon radioactivity. In 
addition, bottled water must comply with the allowable levels for 
radionuclides in the quality standard for bottled water (Sec.  
165.110(b)(5)(i)) unless the label bears a statement of substandard 
quality under Sec.  165.110(c). As stated in Sec.  165.110(d), bottled 
water is deemed adulterated if it contains a substance at a level 
considered injurious to health under section 402(a)(1) of the act (21 
U.S.C. 342).

V. Environmental Impact

    The agency has determined under 21 CFR 25.32(a) 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.

VI. Economic Impact

A. Regulatory Impact Analysis

    FDA has examined the economic implications of this direct final 
rule as required by Executive Order 12866. 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). Executive Order 12866 
classifies a rule as significant if it meets any one of a number of 
specified conditions, including: Having an annual effect on the economy 
of $100 million, adversely affecting a sector of the economy in a 
material way, adversely affecting competition, or adversely affecting 
jobs. A regulation is also considered a significant regulatory action 
if it raises novel legal or policy issues. FDA has determined that this 
direct final rule is not a significant regulatory action as defined by 
Executive Order 12866.
1. The Need for Regulation
    In the Radionuclides Rule, EPA published an NPDWR establishing an 
MCL for uranium. Under section 410 of the act, when EPA issues a 
regulation establishing an MCL for a contaminant in public drinking 
water, 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. FDA's 
standard of quality regulations must also include appropriate 
monitoring requirements. Of the radionuclide standards addressed in 
EPA's final rule, only the uranium requirement does not have a current 
standard of quality regulation for bottled water. If FDA does not issue 
a standard of quality regulation by 180 days before the effective date 
of EPA's NPDWRs or make a finding that such a regulation is not 
necessary to protect the public health, the NPDWRs become applicable to 
bottled water.
2. Regulatory Options
    FDA considers three options for this analysis:
    Option 1. FDA does not establish a uranium quality standard 
regulation or make a finding that it is not necessary to protect the 
public health because uranium is not found in water used for bottled 
drinking water. Bottled water producers would be subject to the 
requirements set forth in the NPDWR for uranium.
    Option 2. FDA establishes a uranium quality standard regulation. 
Bottled water producers would be subject to allowable levels in Sec.  
165.110 and CGMP monitoring requirements in Sec. Sec.  129.35 and 
129.80.
    Option 3. Bottled water producers are not subject to either an FDA 
quality standard regulation or an EPA NPDWR for uranium.
    Note on Option 3: Since water used for bottled water comes from 
sources that likely contain some level of naturally occurring uranium, 
section 410(b)(1) of the act does not allow this option. The act 
specifies two alternatives: ``promulgate a standard of quality 
regulation under this subsection,'' or find that ``such a regulation is 
not necessary to protect the public health because the contaminant is 
contained in water in public water systems * * * but not in water used 
for bottled drinking water.'' However, the Office of Management and 
Budget cost-benefit analysis guidelines recommend discussing statutory 
requirements that affect the selection of regulatory approaches. These 
guidelines also recommend analyzing the opportunity cost of legal 
constraints that prevent the selection of the regulatory action that 
best satisfies the philosophy and principles of Executive Order 12866. 
Our analysis finds that option 3 does not have the highest net 
benefits.

[[Page 9877]]

 Therefore, even if option 3 were permissible, the statute does not 
preclude the option with the highest net benefits.
    Assumptions and Estimations Applicable to all Options
    For the purposes of this analysis, FDA makes the following 
assumptions:
    [sbull] Option 3, which has zero costs and benefits, will be 
considered the baseline for this analysis.
    [sbull] The regulatory options we consider will have no 
organoleptic effect on the final bottled water product, and thus no 
impact on sales due to product quality. The cost of the regulation will 
be limited to the direct cost of testing, recordkeeping, and possible 
treatment technology investment or other compliance activity.
    [sbull] Bottled water producers market their products based on 
meeting government safety testing requirements. However, any change in 
sales resulting from successful marketing either transfers revenue from 
one producer to another with no net loss to society, or causes 
increased sales of bottled water, which would mitigate the cost of this 
regulatory effort.
    [sbull] Both the EPA NPDWR and the FDA standard of quality 
regulations will compel facilities to comply with the new uranium 
standard. Therefore, FDA assumes that options 1 or 2 will not differ in 
terms of the number of illnesses avoided or the burden placed on 
facilities compelled to adopt treatment technology. However, EPA and 
FDA do have differing monitoring requirements.
    [sbull] The number of facilities: Approximately 1,550 plants 
produced bottled water in 1998 (63 FR 25764, May 11, 1998). According 
to another database search conducted in 2002, the industry contains 
only 914 plants that would be subject to these rules. The 2002 count 
may not include bottled water services to business, but the decrease in 
facilities may also be a result of industry consolidation (Ref. 1). 
Because of this uncertainty, we use both totals to define our 
uncertainty interval.
    [sbull] Facilities out of compliance: As in the EPA NPDWR analysis, 
we estimate the baseline incidence of facilities out of compliance by 
using the EPA's National Inorganics and Radionuclides Survey (NIRS). 
EPA took the results of the concentration of radionuclides found in the 
NIRS and extrapolated to the expected percent of municipal water 
facilities that would be out of compliance--by type and population 
served--for various uranium levels. Since most bottled water facilities 
that do not use a public water source use ground water, and are 
relatively small when compared to municipal water plants, we assume 
that the percent of bottled water plants out of compliance with the 
uranium standard is approximately the same percent as the number of 
ground water municipal plants that serve less than 500 people. EPA used 
two methods to extrapolate the NIRS results to all facilities. Using 
both approaches, small ground water facilities have by far the largest 
estimated out of compliance percentages, so this is a conservative 
assumption. Table 1 of this document presents the four possible numbers 
of facilities out of compliance, using our two bottled water facility 
counts and EPA's two percentage estimates for groundwater 
facilities.\1\ The lowest and the highest number of facilities 
identified here (8-22 facilities) will be used as the out of compliance 
uncertainty interval for cost calculations.
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    \1\ This is actually a percentage out of compliance for all 
facilities, but the percentage is dominated by small groundwater 
facilities. Above an MCL of 40 [micro]g/L, no facilities other than 
groundwater facilities serving less than 500 people were predicted 
to be out of compliance. Since EPA did not directly estimate 
compliance percentages for the EPA MCL of 30 [micro]g/L, we must 
assume that the number of facilities that are not small groundwater 
and are out of compliance would be negligible.

  Table 1.--Number of Facilities Potentially Out of Compliance with the
                            Uranium Standard
------------------------------------------------------------------------
                              EPA Method 1 (1.4%     EPA Method 2 (0.9%
Total Number of Facilities    out of compliance)     out of compliance)
------------------------------------------------------------------------
1550                        22                      14
914                          13                     8
------------------------------------------------------------------------

    Cost Calculations under Options 1 and 2
    This cost analysis is separated into two sections: Possible 
compliance activity that firms may have to undertake to meet the 
uranium standard, and monitoring requirement for all facilities. 
Between 914 and 1,550 facilities may have to adopt a test for the 
uranium standard, and between 8 and 22 facilities may also have to take 
measures to come into compliance with the uranium standard. Uranium 
testing is a standard procedure that is available in many labs around 
the country. Firms can choose among many types of treatment options to 
come into compliance, including water softening/iron removal, point-of-
use reverse osmosis, point-of-use anion exchange/activate alumina, 
blending, or finding an alternative source.
    Compliance costs. FDA assumes that all facilities will come into 
compliance under options 1 and 2, so the relative ranking of options 1 
and 2 is not affected by compliance cost calculations. In their 2000 
NPDWR analysis, EPA estimated compliance investment needed per volume 
of water treated (here presented as per 83,000 gallons, which is the 
annual per household water use estimate used by EPA) for each of their 
extrapolation methods mentioned above, for each facility size category, 
and for several different uranium standards. However, they did not 
directly estimate the compliance cost of the 30 [micro]g/L standard 
considered here. We use an average of the compliance costs per gallon 
between the 40 and 20 [micro]g/L standard levels for which costs were 
estimated directly tested by EPA. We also assume that each facility out 
of compliance is of average size. According to EPA's per capita total 
water use estimates applied to bottled water, an average bottled water 
facility processes as much water as a municipal system serving between 
42 and 72 households, so we use the compliance cost estimated for 
groundwater facilities serving between 100 and 500 people, which is the 
closest category EPA presents.
    The extrapolation methods used to construct the uncertainty 
intervals explained above affect both the percent of facilities out of 
compliance and the total amount of uranium that would need to be 
removed to come into compliance. Therefore, the per volume costs will 
be different under EPA's different estimation methods even for 
identically sized facilities. As mentioned previously, firms can choose 
among many types of treatment options. Our central value of uncertain 
compliance cost estimates is based on EPA's study of technology 
adoption for previous standards and their decision tree analysis, and 
our uncertainty interval is defined by the least (alternative sourcing) 
and most (point-of-use methods) expensive options being adopted by 
every one of the 8-22 facilities assumed to be affected.
    Table 2 of this document summarizes these calculations. 
Considerable economies of scale exist in water treatment, but EPA only 
estimates the effect of economies of scale between their grouped size 
categories. Therefore, within the EPA size category we are assuming 
applies to bottled water, total treatment cost depends only on the 
amount of water treated, even though it is probable that larger 
facilities within this class have a lower per volume cost of treating 
their water. Also, for these options we base estimates of the amount of 
bottled water treated per facility not on our uncertain number of 
facilities but

[[Page 9878]]

on a fixed total estimate of bottled water production in the United 
States. Therefore, except for rounding, our compliance cost estimate is 
not dependent on the number of facilities. We do expect that fewer 
facilities treating a larger amount of water would lead to lower per 
volume costs, but our most accurate estimate cannot take this into 
account, and this uncertainty does not affect the ranking of 
alternatives. We assume costs are incurred every year indefinitely into 
the future. The annual volume of bottled water consumed in the United 
States increased by an average of 7 percent over the past 11 years 
(Ref. 3), but again since the cost of treating water is subject to 
considerable economies of scale (Ref. 2) we assume that per year 
compliance costs will be roughly constant in the future. The discount 
rate used is 7 percent. We use the average of all four estimates of the 
middle value to construct the measure of central tendency, and the 
average of the two rounded lowest values and the two rounded highest 
values to construct the uncertainty interval. According to this 
analysis, total present value compliance costs will average 
approximately $1,085,000, with a range of $61,000-$2,660,000 for both 
options 1 and 2.

            Table 2.--Compliance Cost for EPA Methods 1 and 2
------------------------------------------------------------------------
                               Cost /
     EPA           No. of      83,000     Cost Per    Total     Present
 Calculation    Facilities    Gallons    Facility    Annual    Value ($)
    Method                      ($)         ($)        ($)
------------------------------------------------------------------------
1               22            100 (10-   4,200       92,000    1,406,000
                              190)       (300-7,90   (7,000-   (107,000-
                                         0)          174,000   2,660,000
                                                     )         )
1               13            100 (10-   7,200       94,000    1,437,000
                              190)       (500-13,4   (7,000-   (107,000-
                                         00)         174,000   2,660,000
                                                     )         )
2               14            80 (10-    3,600       50,000    764,000
                              190)       (300-7,90   (4,000-   (61,000-1
                                         0)          111,000   ,697,000)
                                                     )
2               8             80 (10-    6,000       48,000    734,000
                              190)       (500-13,4   (4,000-   (61,000-1
                                         00)         107,000   ,636,000)
                                                     )
------------------------------------------------------------------------

    Monitoring Costs. FDA has collected several estimates for uranium 
testing cost, ranging from $25-$150 per sample.\2\ We will use the 
average of these testing costs of $105 as a most likely value and the 
entire range to define uncertainty. EPA and FDA required testing 
frequencies under options 1 and 2 differ substantially, as explained 
below.
---------------------------------------------------------------------------

    \2\ A private lab called General Engineering Laboratories (GEL) 
in Charleston, SC, provides uranium testing of private wells at a 
cost of $25 per sample: http://www.scdhec.net/eqc/water/html/
urtest2.html, accessed August 15, 2002. The New Hampshire Department 
of Environmental Services charges $140 per uranium test: http://
www.des.state.nh.us/factsheets/ws/ws-3-11.htm, accessed August 15, 
2002. The Maine Health and Environmental Testing Laboratory charges 
$150 per uranium test: http://www.state.me.us/dhs/etl/pubgd99w.html, 
accessed August, 15, 2002.
---------------------------------------------------------------------------

    Option 1 (EPA) Testing Frequency. Under the EPA testing regime, the 
914 or 1,550 facilities would have to adopt a test for the uranium 
standard. According to the Radionuclides Rule (65 FR 76708 at 76711), 
all facilities would have to first perform four consecutive quarterly 
samples. We assume that bottled water facilities would test these 
samples in the first year after adoption. Based on the average results 
of these samples, facilities would have to sample once every 3 years 
(average greater than 50 percent of MCL), once every 6 years (average 
less than 50 percent of MCL), or once every 9 years (not detected). We 
assume one-third of facilities would fall in each of these categories, 
and that future tests would be uniformly distributed across years; for 
example, one-third of the facilities that only have to test once every 
3 years will conduct the test in any one year.
    Option 2 (FDA) Testing Frequency. Under Sec.  129.35(a)(3), bottled 
water producers are required to test their source water for 
radiological contaminants at least once every 4 years unless exempted 
from such testing under Sec.  129.35(a)(4). For example, one possible 
exemption is that the 25 percent of bottled water facilities that use a 
public water source already subject to EPA regulations may substitute 
public water system testing results for source water testing. We assume 
that no facilities that use a public water source will need to test 
their source water for uranium, and that all bottled water producers 
using nonpublic water will need to test their source water. All bottled 
water producers are required to test their final bottled water product 
for radiological contaminants at least once per year under Sec.  
129.80(g)(2).
    Table 3 of this document presents the calculations for each option. 
The low bound is calculated by the low facility count multiplied by the 
low testing cost estimate, the high bound is calculated by the high 
facility count multiplied by the high testing cost estimate, and the 
middle value is the average of the low and high facility counts 
multiplied by the average of the testing cost estimates. Multiplying 
all low and high estimates together probably renders the low and high 
bounds extremely unlikely, but since we do not have a probability 
distribution associated with these values we have no other method of 
defining uncertainty. The present value is calculated as if all testing 
were to be continued indefinitely, with a discount rate of 7 percent.

                   Table 3.--Monitoring Cost Estimates
------------------------------------------------------------------------
                                                   Subsequent
   Options       Year 1    Year 1    Subsequent    year cost     Present
                 tests   Cost ($)   year tests        ($)      Value ($)
------------------------------------------------------------------------
Option 1        4         517,000   .61           79,000        1,645,00
 (EPA)                    (91,000                 (14,000-142   0
                          -930,00                 ,000)         (291,000
                          0)                                    -2,956,0
                                                                00)
Option 2        1.19      154,000   1.19          154,000       2,353,00
 (FDA)                    (27,000                 (27,000-277   0
                          -277,00                 ,000)         (416,000
                          0)                                    -4,229,0
                                                                00)
------------------------------------------------------------------------


[[Page 9879]]

3. Benefits of the Regulatory Options

    FDA assumes that both option 1 and option 2 would compel all 
bottled water facilities to come into compliance with the 30 [micro]g/L 
uranium standard. Uranium carries two distinct risks: An increased risk 
of cancer and kidney toxicity. In addition, treatment technologies put 
in place to remove uranium will also reduce the concentration of other 
bottled water contaminants. However, EPA was unable to quantify the 
effect of uranium on kidney toxicity and the effect of uranium 
treatment technology on cocontaminants due to lack of information, and 
FDA has not found any information made available that would allow the 
quantification of these effects since EPA's 2000 analysis.
    Cases of Cancer Avoided
    Exposure. According to the Bottled Water Reporter, Americans 
consumed a per capita average of approximately 73.8 liters of bottled 
water in 2001 (Ref. 3). This is approximately 18 percent of the per 
capita consumption of water from all sources estimated by the EPA (Ref 
2). Bottled water consumption has been increasing at a rate of 
approximately 7 percent per year in the United States over the past 11 
years, and this trend may continue (Ref 3).
    Risk and Valuation of Risk. In September 1999, EPA updated a series 
of coefficients they developed to express the incremental lifetime risk 
of cancer morbidity or mortality per unit of intake. They then combined 
this per unit risk to the average and 90th percentile annual and 
lifetime intake of water from all sources (including bottled water, but 
they adjusted for bottled water that did not originate in the municipal 
water supplies they regulated) to calculate: (1) The total morbidity 
and mortality cancer risk due to drinking water containing uranium, and 
(2) the reduction in risk due to their proposed NPDWR for uranium. We 
adjust these values based on our calculation of the average annual 
intake of bottled water described above. The mortality risk coefficient 
per ug of uranium ingested is 3.97E-11, and the morbidity coefficient 
is 6.13E-11 (Ref. 4). In other words, for each g of uranium ingested 
the lifetime risk of getting cancer increases by approximately 6 in 100 
billion, while the lifetime risk of dying from cancer increases by 
approximately 4 in 100 billion.
    This risk estimate is applied to the decrease in Uranium ingested 
due to options 1 and 2. Between 0.9 percent and 1.4 percent of bottled 
water is expected to initially have uranium concentrations over 30 
[micro]g/L. Based on 2001 total bottled water consumption, this 
translates into between 49 million and 76 million gallons of bottled 
water possibly above the standard. In the Radionuclides rule, EPA 
expected that the reduction in uranium concentration in the out of 
compliance municipal water facilities would yield an annual decrease in 
the number of new fatal and nonfatal statistical\3\ cancer cases of 
0.82 from an affected number of gallons of approximately 73 million.
---------------------------------------------------------------------------

    \3\A statistical cancer case refers to expectations. For 
example, if this risk of contracting cancer sometime during one's 
life increases for each person by 1 in a million, and the affected 
population consisted of 1 million people, it is expected that the 
number of eventual cancer cases observed would increase by 1. 
However, 1 is only the measure of central tendency in a distribution 
of effects.
---------------------------------------------------------------------------

    For the calculations below, we assume that every bottled water 
consumer has an equal chance of drinking water from a facility that 
would be out of compliance with the standard. This makes the 
calculation much simpler, and since the mortality and morbidity risk 
coefficients are linear and are not based on past exposure, the total 
reduction in risk is identical. If out-of-compliance bottled water 
facilities have uranium concentrations roughly equal to the EPA 
estimates, then applying this assumed reduction and the total annual 
per capita consumption attributable to the affected bottled water 
facilities yields a total number of fatal and nonfatal cancer cases 
avoided of between 0.55 and 0.85 per year for both options 1 and 2. We 
use a 6 percent growth rate to take into account an increase in 
exposure and population, in relation to the 7 percent discount rate 
used for the cost calculations. We also assume that the cancer 
mortality will occur 20 years in the future. The central estimate is 
somewhat sensitive to these assumptions, so we test different 
assumptions in the net benefits section below. Using standard valuation 
techniques for cancer morbidity and mortality yields an expected 
present value benefit of between $8,700,000 and $13,500,000. The 
calculations summary is in Table 4 of this document.

                     Table 4.--Benefits Calculations
------------------------------------------------------------------------
                                                 Present
                  Cases of        Cases of    Value ($) of      Total
   Options        Cancer          Cancer         Annual        Present
               Avoided: EPA    Avoided: EPA   Cancer Cases    Value ($)
                 Method 1        Method 2      (low-high)    (low-high)
------------------------------------------------------------------------
1 and 2              .85             .55       629,000       11,112,000
                                               (494,000-76   (8,731,000-
                                               4,000)        13,493,000)
------------------------------------------------------------------------

    A final source of uncertainty we need to account for is the upper 
and lower bound estimated by EPA for their cancer risk coefficients. In 
the 2000 analysis, EPA assumes an uncertainty cancer risk interval 
extending one order of magnitude above and below their risk 
coefficients. Applying this uncertainty interval to the benefits we 
have already calculated yields a final benefits interval of between 
$870,000 and $135,000,000. Although EPA does not include a 
probabilistic confidence interval associated with this additional 
source of uncertainty, they do state that the central tendency values 
they use for their main calculations are more likely (Ref. 2).
    Sensitivity to Assumptions and Uncertainty: Benefits
    These benefits calculations are subject to considerable 
uncertainty. The uncertainty interval used in the analysis is due to 
the uncertainty in the incidence and concentration of naturally 
occurring uranium and uncertainty in the uranium risk coefficients. 
However, the main uncertain benefits that we do not quantify are; (1) 
The reduction in kidney disease due to reducing uranium concentration 
in bottled water, and (2) the reduction in cocontaminants due to the 
adoption of treatment technologies for uranium. Therefore, the 
quantified cancer benefits probably underestimate the true positive 
impact of the uranium standard.

4. Net Benefits

    Table 5 below presents the total costs and benefits for all three 
options:

[[Page 9880]]



                      Table 5.--Costs and Benefits
------------------------------------------------------------------------
                           Total Costs ($) (low-     Total Benefits ($)
         Options                   high)                (low-high)
------------------------------------------------------------------------
1 (EPA Monitoring          2,930,000 (352,000-     11,112,000 (8,731,000-
 Requirement)              5,616,000)              13,493,000)
2 (FDA Monitoring          3,438,000 (477,000-     11,112,000 (8,731,000-
 Requirement)              6,889,000)              13,493,000)
3 (No Action Taken)        0                       0
------------------------------------------------------------------------

    In the most likely central values in the distribution of cost and 
benefits, EPA option 1 has positive net measured benefits and FDA 
option 2 has positive net measured benefits. The ranking of option 1 
and 2 depends completely on the frequency of required testing: FDA 
would require an average of 1.19 tests per year per facility, while 
EPA, after a series of four tests, would only require an average of .61 
test per year per facility. We tested the effects of 5 percent-7 
percent discount rates and 15-30 year delays in cancer onset in our 
benefits calculations, and both options still yield positive net 
benefits. The choice of the discount rate or time period before onset 
does not affect the relative ranking of options 1 and 2.
    The range of uncertainty between costs and benefits overlaps, but 
many of the determinants of the range of uncertainty affect both costs 
and benefits equally, so low costs are associated with low benefits and 
high costs are associated with high benefits. The exception to this is 
the uncertainty in the cancer risk coefficient; since this interval is 
not probabilistic, FDA cannot estimate a probability that this rule 
will have negative net or positive net benefits for any of these 
options. However, FDA does consider our central estimates the most 
likely outcomes. Also note the potentially large benefits from a 
reduction in kidney toxicity and cocontaminants that we were not able 
to quantify, which could also affect the size and range of the net 
benefits.
    Finally, our cost-best analysis reaches a different result than 
EPA's 2000 radionuclide analysis, which concluded that testing for 
uranium in water destined for human consumption has negative net 
quantifiable benefits (65 FR 76708). The reason for the difference 
between our results and EPA's results is that most of the costs of the 
EPA rule are applied to water that will not be consumed. People do not 
drink the vast majority of water treated by municipal facilities. Most 
of that water is used for cleaning, waste disposal, and outdoor uses. 
In contrast, almost all bottled water is used for human consumption. In 
fact, a typical bottled water facility processes as much water for 
drinking as a much larger municipal water facility. Consequently, fewer 
bottled water facilities would have to incur compliance costs to afford 
the same level of protection for water consumed as assumed in the EPA 
analysis.

B. Small Entity Analysis

    Under section 603(a) of the Regulatory Flexibility Act, for any 
proposed rule for which the agency is required by section 553 of the 
Administrative Procedure Act or any other law to publish a general 
notice of proposed rulemaking, the agency is required to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The agency has published, in the companion proposed 
rule published elsewhere in this Federal Register, an initial 
regulatory flexibility analysis. Because the companion proposed rule is 
a proposed rule for which a general notice of proposed rulemaking is 
required, and therefore, is subject to the Regulatory Flexibility Act, 
the agency will consider any comments it receives on the initial 
regulatory flexibility analysis in the companion proposed rule when 
deciding whether to withdraw this direct final rule.
    FDA has examined the economic implications of this direct final 
rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). 
If a rule has a significant economic impact on a substantial number of 
small entities, the Regulatory Flexibility Act requires agencies to 
analyze regulatory options that would lessen the economic effect of the 
rule on small entities. FDA finds that this rule would have a 
significant economic impact on a substantial number of small entities.
    FDA feels that the flexibility allowed in source testing 
requirements under option 2 in the impact analysis is the maximum 
amount of flexibility possible in this regulation. FDA is not 
establishing exemptions for final product testing since there is a need 
to test for naturally occurring uranium, which could be present in all 
source water.
    According to the latest database search across the bottled water 
industry mentioned above, approximately 72 percent of firms qualify as 
small by the Small Business Administration (SBA) standard of having 
less than 500 full-time-equivalent employees. We assume that all SBA 
small firms operate a single facility for the purposes of this 
analysis. Since all facilities must adopt uranium testing, between 658 
and 1,116 small firm facilities will incur a testing burden. Assuming 
the same distribution of size among out of compliance plants means that 
between 6 and 16 small facilities will incur the more costly burden of 
devoting resources to bring their water into compliance with the 
uranium standard issued in this rule. Table of this document presents 
the average and maximum annual costs attributable to this rule for each 
small firm.

           Table 6.--Annual Average and Maximum Costs Per Firm
------------------------------------------------------------------------
         Category                Average ($)             Maximum ($)
------------------------------------------------------------------------
Monitoring                  125                     179
Compliance                  5,246                   13,383
Total                       5,400                   13,600
------------------------------------------------------------------------

    Most small firms will only incur a $125 (1.19 tests per year at an 
average cost of $105 per test) uranium testing cost, although a few may 
incur up to $179 (1.19 tests per year at an average cost of $150 per 
test) in annual testing costs, which is 0.03 percent of the $580,000 
annual revenue of the median small bottled water firm. If a small firm 
operates more than one facility, testing costs would be multiplied by 
the number of facilities they operate. However, between 6 and 16 small 
firms will incur an average of $5,400 in total costs, and may incur as 
much as $13,600 in total costs if for some reason they need to adopt 
the most expensive treatment option, although FDA considers this 
unlikely. The average treatment cost estimates represent .9 percent of 
median annual small firm sales, but could be as much as 2.3 percent of 
annual sales. However, 75 percent of the total reduction in cancer 
incidence of this rule is due to these small firms lowering the amount 
of uranium in their water, so it is essential that they adopt some sort 
of treatment technology.

C. Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 (Public Law 104-4), 
requiring cost-benefit and other analyses, in section 1531 (a) defines 
a significant rule as ``a Federal mandate that may result in the 
expenditure by State, local, and tribal governments in the aggregate, 
or by the private sector, of $100 million (adjusted annually for 
inflation) in any 1 year.'' FDA has determined that this direct final 
rule does not constitute a significant rule under the Unfunded Mandates 
Reform Act.

VII. Paperwork Reduction Act

    FDA tentatively concludes that this direct final rule contains no 
collections

[[Page 9881]]

of information. Therefore, clearance by OMB under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
has 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 of the act (21 U.S.C. 343-1) is an 
express preemption provision. Section 403A(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 this 
rule has preemptive effect in that it would preclude States from 
issuing requirements for uranium levels in bottled water that are not 
identical to the allouable level for uranium as set forth in this 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 Safe 
Drinking Water Act (SDWA) (42 U.S.C. 300g-1), FDA is required to issue 
a standard of quality regulation for that contaminant in bottled water 
or make a finding that such a regulation is not necessary to protect 
the public health because the contaminant is contained in water in 
public water systems but not in water used for bottled water. Further, 
section 410(b)(3) of the act requires a quality standard 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 December 7, 2000, EPA issued an 
NPDWR containing an MCL for uranium (65 FR 76708). FDA has determined 
that the MCL for uranium that EPA established for public drinking water 
is appropriate as a standard of quality for bottled water, and is 
issuing this regulation consistent with section 410 of the act.
    Further, section 4(e) of the Executive Order provides that ``when 
an agency proposed 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 an MCL for uranium in public 
drinking water provided notice of possible FDA action for a standard of 
quality for uranium in bottled water. FDA did not receive any 
correspondence from State and local officials regarding a uranium 
standard for bottled water subsequent to EPA's NPDWR on the MCL for 
uranium. Moreover, FDA is not aware of any States that have 
requirements for uranium in bottled water that would be affected by 
FDA's decision to establish a bottled water quality standard for 
uranium that is consistent with EPA's standard for public drinking 
water. In addition, we are providing an opportunity for State and local 
officials to comment on FDA's standard of quality for uranium in 
bottled water 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 
the final rule are consistent with Executive order 13132.

IX. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or elctronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/
dockets/ecomments or two hard copies of any written comments, except 
that individuals may submit one hard 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 Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

X. Effective Date

    The agency intends to make the direct final rule effective December 
8, 2003. The agency will publish a confirmation notice for the direct 
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.

XI. References

    1. Hamon, J., ``Bottled Water Industry, 2001'' Special Industries 
Spotlight, January 2001. Available at www.merger.com.
    2. Industrial Economics, Inc., Economic Analysis of the 
Radionuclides National Primary Drinking Water Regulations. Available 
from the Office of Ground Water and Drinking Water, U.S. Environmental 
Protection Agency. November 2000.
    3. Rodwan, J. G., ``The 2001 Stat: Bottled Water Sales Reach New 
Heights,'' Bottled Water Reporter, p. 14-20, April/May 2002.
    4. Eckerman, K., R. Leggett, C. Nelson, J. Pushkin, and A. 
Richardson, Cancer Risk Coefficients for Environmental Exposure to 
Radionuclides, Federal Guidance Report No. 13, 1999. (EPA 402-R-99-
001). Note that FDA used the risk coefficients as adjusted and reported 
in Ref. 2 of this document in order to be consistent with the EPA 
radionuclide impact analysis.

List of Subjects in 21 CFR Part 165

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
165 is amended as follows:

PART 165--BEVERAGES

    1. The authority citation for 21 CFR part 165 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 341, 343, 343-l, 348, 349, 371, 379e.

    2. Section 165.110 is amended by adding paragraph (b)(5)(i)(D) and 
by revising paragraph (b)(5)(ii) to read as follows:


Sec.  165.110  Bottled water.

* * * * *
    (b) * * *
    (5) * * *
    (i)* * *
    (D) The bottled water shall not contain uranium in excess of 30 
micrograms per liter of water.
    (ii) Analyses conducted to determine compliance with the 
requirements of paragraph (b)(5)(i) of this section shall

[[Page 9882]]

be made in accordance with the methods described in the applicable 
sections of ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th Ed., which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of ``Standard 
Methods for the Examination of Water and Wastewater,'' 20th Ed., may be 
obtained from the American Public Health Association, 1015 15th St. 
NW., Washington, DC 20005. Copies of the methods incorporated by 
reference in this paragraph (b)(5)(ii) may also be examined at the 
Office of the Federal Register, 800 North Capital St. NW., suite 700, 
Washington, DC, or at the Center for Food Safety and Applied 
Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD.
    (A) Combined radium-226/-228 shall be measured using the following 
methods:
    (1) Method 7500-Ra B--``Precipitation Method,'' which is contained 
in ``Standard Methods for the Examination of Water and Wastewater,'' 
20th Ed., which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in the introductory text of paragraph (b)(5)(ii) 
of this section.
    (2) Method 7500-Ra D--``Sequential Precipitation Method,'' which is 
contained in ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th Ed., which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
this incorporation by reference is given in the introductory text of 
paragraph (b)(5)(ii) of this section.
    (B) Gross alpha particle radioactivity shall be measured using the 
following method: Method 7110 C--``Coprecipitation Method for Gross 
Alpha Radioactivity in Drinking Water,'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in the introductory text of paragraph (b)(5)(ii) of 
this section.
    (C) Beta particle and photon radioactivity shall be measured using 
the following methods:
    (1) Method 7500-Sr B--``Precipitation Method,'' which is contained 
in ``Standard Methods for the Examination of Water and Wastewater,'' 
20th Ed., which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation 
by reference is given in the introductory text of paragraph (b)(5)(ii) 
of this section.
    (2) Method 7500-\3\H B--``Liquid Scintillation Spectrometric 
Method,'' which is contained in ``Standard Methods for the Examination 
of Water and Wastewater,'' 20th Ed., which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability 
of this incorporation by reference is given in the introductory text of 
paragraph (b)(5)(ii) of this section.
    (3) Method 7120 B--``Gamma Spectroscopic Method,'' which is 
contained in ``Standard Methods for the Examination of Water and 
Wastewater,'' 20th Ed., which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
this incorporation by reference is given in the introductory text of 
paragraph (b)(5)(ii) of this section.
    (D) Uranium shall be measured using the following methods:
    (1) Method 7500-U B--``Radiochemical Method'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in the introductory text of paragraph (b)(5)(ii) of 
this section.
    (2) Method 7500-U C--``Isotopic Method'' which is contained in 
``Standard Methods for the Examination of Water and Wastewater,'' 20th 
Ed., which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The availability of this incorporation by 
reference is given in the introductory text of paragraph (b)(5)(ii) of 
this section.
* * * * *

    Dated: February 26, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4971 Filed 2-27-03; 11:42 am]
BILLING CODE 4160-01-S