[Federal Register: March 3, 2003 (Volume 68, Number 41)]
[Rules and Regulations]
[Page 9873-9882]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03mr03-5]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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.
---------------------------------------------------------------------------
\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,
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,
$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
Foods Home
|
FDA Home
|
HHS Home
|
Search/Subject Index
|
Disclaimers & Privacy Policy
|
Accessibility/Help