Federal Register 66 FR 16858 March 28, 2001

[Federal Register: March 28, 2001 (Volume 66, Number 60)]
[Rules and Regulations]
[Page 16858-16868]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr01-10]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 129 and 165

[Docket No. 01N-0126]

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 allowable levels for
three residual disinfectants (chloramine, chlorine, and chlorine
dioxide) and three types of disinfection byproducts (DBP's) (bromate,
chlorite, and haloacetic acids (HAA5)). FDA also is revising the
existing allowable level for the DBP total trihalomethanes (TTHM).
Finally, FDA is revising, for the three residual disinfectants and four
types of DBP's only, the monitoring requirement for source water found
in the current good manufacturing practice (CGMP) regulations for
bottled water . As a consequence of FDA's amending the quality standard
for these residual disinfectants and DBP's, bottled water manufacturers
are required to monitor their finished bottled water products for these
disinfectants and DBP's at least once each year under the CGMP
regulations for bottled water . Bottled water manufacturers also are
required to monitor for these contaminants at least once each year in
their source water , unless the bottlers meet the criteria for source
water monitoring exemptions under the CGMP regulations. This direct
final rule will ensure that the minimum quality of bottled water , as
affected by the previously mentioned disinfectants and DBP's, 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 significant adverse comment and withdraws
this direct final rule. The companion proposed rule and direct final
rule are substantively identical.

DATES: This rule is effective January 1, 2002. Submit written comments
by June 11, 2001. 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 July 5, 2001, 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 July 5, 2001. 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 51 of certain publications in
Sec. 165.110(b)(4)(iii)(I) as of January 1, 2002.

ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick, Center for Food Safety
and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-358-3568.

SUPPLEMENTARY INFORMATION:

I. Background

On December 16, 1998, EPA published the Stage 1 Disinfection
Byproducts Rule (Stage I DBPR) (63 FR 69390) to address potential
public health effects from the presence of disinfectants and DBP's in
drinking water . This rulemaking finalized a proposed rule that EPA
published in the Federal Register on July 29, 1994 (59 FR 38668).
Disinfectants are chemicals, such as chlorine and ozone, that are
added to drinking water to control microbial contamination. Both
bottlers and public water systems may use disinfectants. Public water
systems typically add disinfectants to drinking water at levels
sufficient to maintain a disinfectant residual throughout the
distribution system (i.e., the system of pipes that takes water from
water treatment plants to customers). DBP's are chemicals that result
from the unintentional interaction of the disinfectants with inorganic
or organic compounds present in the water supply. Examples of DBP's
include chloroform (a byproduct of treatment with chlorine) and bromate
(a byproduct of ozonation). Both disinfectants and DBP's can have
adverse health effects (59 FR 38668 at 38679-38710).
National primary drinking water regulations (NPDWR's) are issued by
EPA to protect the public health from the adverse effects of
contaminants in drinking water . NPDWR's specify maximum contaminant
levels (MCL's) or treatment techniques for drinking water contaminants.
In addition, at the same time that it issues NPDWR's, EPA publishes
maximum contaminant level goals (MCLG's), 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 its proposed rule on
disinfectants and DBP's (59 FR 38668), EPA also introduced the concept
of maximum residual disinfectant levels (MRDL's) and maximum residual
disinfectant level goals (MRDLG's). MRDL's and MRDLG's are comparable
to MCL's and MCLG's, in that they set contaminant levels and health
goals, respectively. EPA used the terms MRDL and MRDLG for
disinfectants, rather than using the terms MCL and MCLG, to reflect the
fact that disinfectants have beneficial properties (63 FR 69390 at
69398; 59 FR 38668 at 38672, 38679).
In the Stage I DBPR (63 FR 69390), EPA issued NPDWR's consisting of
MCL's for the DBP's bromate, chlorite, HAA5, and TTHM. EPA also
published MRDL's for the chlorine-based disinfectants chlorine,
chloramine, and chlorine dioxide. Finally, EPA published MCLG's and
MRDLG's for these contaminants, as well as approved methods of testing
for these contaminants.
Under section 410 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 349), 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),\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

[[Page 16859]]

used for bottled drinking 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 regulation 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.
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\1\FDA considers EPA's compliance date for subpart H public
water systems (systems using surface water or ground water under the
direct influence of surface water ) that serve a population of 10,000
or more to be the effective date for purposes of section 410 of the
act. The compliance date was set at December 16, 2001, in the Stage
I DBPR (63 FR 69390) and updated in a subsequent rule to January 1,
2002 (65 FR 20303, April 14, 2000).
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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's for bromate, chlorite, HAA5, and TTHM
and EPA's MRDL's for chloramine, chlorine, and chlorine dioxide as
allowable levels for these contaminants in the quality standard
regulation for bottled water . FDA also is adopting, for these
contaminants in bottled water , the analytical methods that EPA approved
for monitoring these contaminants in public drinking water . Finally,
FDA is adding an exemption to source water testing, under the newly
added Sec. 129.35(a)(4)(iii), for the three residual disinfectants and
four types of DBP's. Bottled water manufacturers are required to
monitor for contaminants at least once each year in their source water
unless the bottlers meet the criteria for source water monitoring
exemptions under the CGMP regulations. Under the newly added
Sec. 129.35(a)(4)(iii), FDA will not require bottled water
manufacturers to test under Sec. 129.35(a)(3)(i) their source water for
the residual disinfectants and DBP's listed in
Sec. 165.110(b)(4)(iii)(H), if their source water is not from a public
water system and has not been treated with a chlorine-based
disinfectant or ozone. However, bottled water manufacturers whose
nonpublic source drinking water has been treated with a chlorine-based
disinfectant or ozone must test, consistent with 129.35(a)(3)(i), their
source water for the residual disinfectants and the DBP's listed in
Sec. 165.110(b)(4)(iii)(H) that are likely to result from such
treatment. Under Sec. 129.35(a)(3)(i), bottled water manufacturers who
use a public water system are required to test their source water for
these residual disinfectants and DBP's at a minimum frequency of once
each year, unless they meet the requirements in Sec. 129.35(a)(4)(i).
As a consequence of FDA's amending the quality standard for these
residual disinfectants and DBP's in part 165 (21 CFR part 165), bottled
water manufacturers are required to monitor their finished water
bottled products for these disinfectants and DBP's at least once each
year under the CGMP regulations for bottled water in part 129 (21 CFR
part 129).
If FDA does not receive significant adverse comment on or before
June 11, 2001, the agency will publish a notice in the Federal Register
no later than July 5, 2001, confirming the effective date of the direct
final rule. The agency intends to make the direct final rule effective
January 1, 2002.
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 Federal Register withdrawing this direct final rule no
later than July 5, 2001.
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-1(a)(3)) also requires that EPA promulgate MCLG's at the time that
it promulgates NPDWR's. MCLG's 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 MCL's, the enforceable contaminant levels, as
close as feasible to the nonenforceable MCLG's.
In its proposed rule on disinfectants and DBP's (59 FR 38668), EPA
also introduced the concept of MRDL's and MRDLG's. MRDL's and MRDLG's
are comparable to MCL's and MCLG's, in that they set contaminant levels
and health goals. EPA used the terms MRDL and MRDLG for disinfectants,
rather than using the terms MCL and MCLG, to reflect the fact that
disinfectants have beneficial properties and are intentionally added to
drinking water to kill disease-causing organisms (63 FR 69390 at 69398;
59 FR 38668 at 38672, 38679).
In the Stage I DBPR (63 FR 69390 at 69396), EPA established an MCL
of 0.060 milligram per liter (mg/L) for the total of the five
haloacetic acids that make up HAA5 (i.e., mono-, di-, and
trichloroacetic acid, and mono- and dibromoacetic acid). EPA also
reduced the existing MCL for TTHM from 0.10 mg/L to 0.080 mg/L (63 FR
69390 at 69396). EPA also established MCL's for two inorganic DBP's:
0.010 mg/L for

[[Page 16860]]

bromate and 1.0 mg/L for chlorite (63 FR 69390 at 69396). Finally, EPA
established MRDL's for three disinfectants: 4.0 mg/L (as Cl
2) for chlorine, 4.0 mg/L (as Cl2) for
chloramine, and 0.8 mg/L (as ClO2) for chlorine dioxide (63
FR 69390 at 69396).

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 (21 CFR 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 that is 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 NPDWR's 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 MCL's or treatment techniques in NPDWR's 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
standard of quality levels in bottled water at the same levels that EPA
establishes as MCL's for such contaminants in tap water .
In its proposed rule on disinfectants and DBP's (59 FR 38668), EPA
introduced the term MRDL. As explained in section III of this document,
EPA used this term when it first proposed enforceable disinfectant
levels (MRDL's) to reflect the fact that disinfectants have beneficial
properties. However, disinfectants may have adverse health effects (59
FR 38668 at 38679 to 38694), and they may be expected to be in some
source waters used for bottled water . Therefore, FDA is establishing a
standard of quality for these disinfectants for bottled water in
response to EPA's issuance of NPDWR's for these disinfectants in
drinking water .

B. Quality Standard for Disinfectants and DBP's

The quality standard for bottled water , as set forth in
Sec. 165.110(b)(4)(i)(A), prescribes that bottled water shall not
contain TTHM in excess of 0.10 mg/L. It does not, however, prescribe
allowable levels for bromate, chlorite, HAA5, chloramine, chlorine, or
chlorine dioxide in bottled water .
FDA has evaluated the MRDL's for chloramine, chlorine, and chlorine
dioxide, and the MCL's for bromate, chlorite, HAA5, and TTHM that EPA
has established for drinking water . Further, FDA has concluded that
EPA's MRDL's and MCL's for these contaminants, as standard of quality
levels for bottled water , are adequate for the protection of the public
health. Certain waters used for bottled drinking water may be expected
to contain these contaminants; thus, adopting allowable levels for
these contaminants will ensure that the quality of bottled water is
comparable to the quality of public drinking water that meets EPA
standards.
Therefore, FDA is establishing in a new paragraph (b)(4)(iii)(H) in
Sec. 165.110, allowable levels for the following disinfectants and
DBP's: chloramine at 4.0 mg/L (as Cl2), chlorine at 4.0 mg/L
(as Cl2), chlorine dioxide at 0.8 mg/L (as ClO2),
and bromate at 0.010 mg/L, chlorite at 1.0 mg/L, HAA5 at 0.060 mg/L,
and TTHM at 0.080 mg/L. FDA is removing the existing entry for TTHM in
Sec. 165.110(b)(4)(i)(A).

C. Analytical Methods

In the Stage 1 DBPR that established MCL's for bromate, chlorite,
HAA5, and TTHM and MRDL's for chlorine, chloramine, and chlorine
dioxide, EPA stipulated that analyses for determining compliance with
the MCL's and MRDL's shall be performed by approved analytical methods
(63 FR 69390 at 69466). EPA has approved one method for bromate
monitoring, two methods for monthly chlorite monitoring, three methods
for HAA5 monitoring, three methods for TTHM monitoring, six methods for
chloramine monitoring, seven methods for chlorine monitoring, and two
methods for chlorine dioxide monitoring. Therefore, in a new paragraph
(b)(4)(iii)(I) in Sec. 165.110, FDA is incorporating by reference the
24 analytical methods cited by the EPA (63 FR 69390 at 69417) for
determining the levels of these contaminants 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 annually for chemical contaminants.
Further, to ensure that a plant's production complies with applicable
standards, Sec. 129.80(g)(2) requires 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 drinking water
produced during a day's production. The CGMP regulation in
Sec. 129.80(a) also requires sampling and analysis, as often as
necessary, of product water taken after processing but before bottling,
to assure uniformity and effectiveness of the processes performed by
the plant.
Disinfectants and DBP's are special types of contaminants in that
they result from the deliberate addition of disinfectants to water to
control microbial contamination. Because public water systems add
disinfectants to water , FDA expects that source water from public water
systems will contain disinfectants and DBP's. Therefore, FDA is
requiring bottlers who obtain their source water from public water
systems to test that water , as specified in Sec. 129.35(a)(3)(i), for
the disinfectants

[[Page 16861]]

chloramine, chlorine, and chlorine dioxide, and the DBP's bromate,
chlorite, HAA5, and TTHM, unless they meet the requirements contained
in Sec. 129.35(a)(4)(i). In some cases, bottlers disinfect source water
that is not from public water systems (e.g., prior to bulk
transportation of that source water to the bottling plant). Such source
water would contain residual disinfectants and also may contain DBP's.
Therefore, FDA is adding a new paragraph (a)(4)(iii) in Sec. 129.35,
stating that firms that do not use a public water system as the source
of their water and whose source water has not been treated with a
chlorine-based disinfectant or ozone do not have to test their source
water for the residual disinfectants and DBP's listed in
Sec. 165.110(b)(4)(iii)(H). Firms that do not use a public water system
as the source of their water but whose source water has been treated
with a chlorine-based disinfectant or ozone must test their source
water for the residual disinfectants and the DBP's listed in
Sec. 165.110(b)(4)(iii)(H) that are likely to result from such
treatment. Treatment of water with ozone is expected to produce the
disinfection byproducts (or components of the disinfection byproducts)
bromate, HAA5, and TTHM. Treatment of water with chlorine or chloramine
is expected to produce the disinfection byproducts (or components of
the disinfection byproducts) HAA5 and TTHM.
However, all bottlers, whether or not they obtain their source
water from public or nonpublic drinking water sources and whether or
not they treat their water with chlorine, chloramine, chlorine dioxide,
or ozone, are required to test for the residual disinfectants
chloramine, chlorine, and chlorine dioxide and the DBP's bromate,
chlorite, HAA5, and TTHM in their finished bottled water products under
Sec. 129.80(g)(2) in the CGMP regulations for bottled water . FDA
believes that the potential for the presence of disinfectants and DBP's
in the finished bottled water product exists. For example, some
manufacturers may treat their water with a disinfectant during
processing. Further, contamination of the bottled water product with
disinfectants may occur during the manufacturing process, for example,
if poor manufacturing practices are followed, such as inadequate
rinsing of equipment that has undergone sanitizing operations. Section
129.80(d) in the CGMP regulations for bottled water allows for the use
of disinfectants (ozone and chlorine-based disinfectants) for
sanitizing operations.
Bottled water must comply with the sampling and testing
requirements for disinfectants and DBP's under Sec. 129.80(g)(2). In
addition, bottled water must comply with the allowable levels for the
disinfectants and DBP's in the quality standard for bottled water
(Sec. 165.110 (b)) 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 to be adulterated if it contains a substance at a level
considered injurious to health under section 402(a)(1) of the act.

V. Environmental Impact

The agency has determined under 21 CFR 25.32(a) and 25.30(j) 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, public 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 Federal Register of December 16, 1998 (63 FR 69390), EPA
published a final rule issuing NPDWR's consisting of MRDL's for the
disinfectants chlorine, chloramine, and chlorine dioxide; and MCL's for
the DBP's bromate, chlorite, HAA5, and TTHM. 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. If FDA does not issue a standard
of quality regulation by 180 days before the effective date of EPA's
NPDWR's, the NPDWR's become applicable to bottled water .
In the following analysis, FDA finds that issuing standard of
quality regulations and monitoring requirements for these residual
disinfectants and DBP's under FDA bottled water CGMP regulations has
the highest net benefits. FDA's testing requirements are less costly
than the testing requirements under our assumptions of how EPA NPDWR's
would apply to bottled water , with the same health benefits, and the
health benefits of testing for these contaminants outweigh the cost.
2. Cost of the Regulation
If FDA does not establish a regulation for quality standards for
these residual disinfectants and DBP's, bottled water producers would
be subject to NPDWR testing and monitoring requirements for these
contaminants. Therefore, we consider this possibility the baseline for
the purposes of this analysis. Also, we assume that 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, so the cost of the regulation will be limited to the direct
cost of testing, record keeping, and possible disinfection technology
investment.
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.
FDA considers three options for this analysis:
(1) FDA does not establish residual disinfectant and DBP quality
standard regulations or make a finding that they are not necessary to
protect the public health because these contaminants are not used in
water used for bottled drinking water . Bottled water producers would be
subject to the requirements set forth in the NPDWR's for these
contaminants.
(2) FDA establishes residual disinfectant and DBP quality standard
regulations. For these contaminants, bottled water producers would be
subject to allowable levels in 21 CFR Sec. 165.110 and CGMP monitoring

[[Page 16862]]

requirements in part 129, as modified in this direct final rule.
(3) Bottled water producers are not subject to either FDA quality
standard regulations or EPA NPDWR's for these residual disinfectants
and DBP's.
Regarding option 3, because it is not the case that these
contaminants are contained in water used in public drinking water
systems, but not in water used for bottled water , section 410(b)(1) of
the Federal Food, Drug, and Cosmetic Act does not permit 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 (OMB) 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 may
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, therefore, even
if option 3 were permissible, the statute does not preclude the option
with the highest net benefits.
a. Testing costs. Option 3 is the least cost option. If producers
are not subject to any disinfectant residual and DBP regulations,
bottled water firms incur no additional costs. Firms already test for
TTHM under the CGMP regulations, so the new lower bound of the TTHM
test should cause only a small increase in cost per plant. However, the
TTHM frequency differences still affect the choice between options 1
and 2, so we include TTHM testing in the analysis.
We assume the following testing frequency and requirements under
option 1. This option considers the cost if bottled water facilities
were subject to EPA NPDWR's by interpreting how such requirements may
apply to bottled water facilities. EPA bases testing frequencies for
public water systems on the size of the population served by the
treatment plant. Since bottled water plants do not fall into the size
and type categories established in the 1998 Stage 1 DBPR regulations,
for the purposes of this analysis, we assume that all bottled water
facilities would be regulated as if they were a small ground water
treatment system. This is the smallest category identified in the 1998
Stage 1 DBPR analysis.
EPA regulations also provide two testing process exemptions. If a
public water system does not use ozone for oxidation or disinfection,
then EPA does not require a bromate test; and if a public water system
does not use chlorine dioxide for oxidation or disinfection, then EPA
requires neither a chlorine dioxide nor a chlorite test. All plants
have to test for HAA5, TTHM, chlorine, and chloramine regardless of
disinfection method. For this analysis, the bottled water industry
would be subject to the following monitoring:
i. TTHM and HAA5: One test per plant per year, decreasing to one
test per 3 years in the event of 1 or 2 years of very low levels of
both TTHM and HAA5.
ii. Chlorite: A three-sample set per month only for plants using
chlorine dioxide as a disinfectant. Reduced to a three-sample set per
quarter if low levels of chlorites found in routine monitoring in a 1-
year period.
iii. Bromate: One test per month only for plants using ozone for
oxidation or disinfection. Reduced to one test per quarter if average
water bromide is low, based on 1-year average of monthly samples.
iv. Chlorine and Chloramine: One test per plant per month.
Monitoring may not be reduced.
v. Chlorine Dioxide: One test per day, at the distribution system
entrance, only for plants using chlorine dioxide as a disinfectant.
Monitoring may not be reduced.
Because few bottled water facilities use chlorine dioxide for
disinfection, we assume that they all will qualify for the chlorite
testing exemption. For the HAA5 and TTHM frequency requirements, we
assume that one-third of the plants will qualify for the frequency
reductions after 1 year, one-third will qualify for the reductions
after 2 years, and one-third will continue to have to test once yearly.
Finally, we assume that no bottled water facility will qualify for the
bromate testing exemption, but that half of the plants will qualify for
lower frequency testing under option 1.
For option 2, under 21 CFR Sec. 129.35(a)(3), bottled water
producers are required to test their source water for contaminants at
least once per year unless exempted from such testing under
Sec. 129.35(a)(4). For example, 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 residual disinfectants and DBP's. Bottled water
manufacturers that do not use a public water system as the source of
their water and whose source water has not been treated with a
chlorine-based disinfectant or ozone do not have to test their source
water for these disinfectants and the DBP's likely to result from such
treatment. Manufacturers that do not use a public water system as the
source of their water but whose source water has been treated with a
chlorine-based disinfectant or ozone must test their source water for
the residual disinfectants and the DBP's likely to result from such
treatment. For example, some source water may be disinfected if it is
transported across large distances prior to entering the bottled water
plant. We assume in this analysis (explained below) that 75 percent of
bottled water producers use nonpublic sources. Of these, we assume that
one-third of 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 contaminants at least once
per year under Sec. 129.80(g)(2).
Table 1 of this document contains the required annual testing
frequencies for source and final product water for the four types of
DBP's and three disinfectants under options 1 and 2. For this table, we
split option 2 into 2a and 2b, referring to whether or not the facility
uses a public water source. This table is for ``year 1'' testing; under
our assumptions no firm has yet qualified for less frequent testing
requirements under option 1. We assume that facilities will perform
separate tests for free chlorine and combined chlorine (which detects
chloramine) and that all facilities use ozone for oxidation or
disinfection. Under option 2a, all facilities must perform at least one
final product test annually, and 25 percent (one-third of the 75
percent of the facilities using a nonpublic water source) of facilities
must perform an annual source water test, for an average of 1.25 tests
per facility.

[[Page 16863]]

Table 1.--Annual Average Plant Testing Frequency\1\
----------------------------------------------------------------------------------------------------------------
Option 2a CGMP Option 2b CGMP
Option 1 NPDWR's Regulations Apply Regulations Apply
Test Apply (Nonpublic Source (Public Source
Water ) Water )
----------------------------------------------------------------------------------------------------------------
Bromate............................................. 12 1.25 1
Chlorite............................................ 0 1.25 1
TTHM................................................ 1 1.25 1
HAA5................................................ 1 1.25 1
Chorine............................................. 12 1.25 1
Chloramine.......................................... 12 1.25 1
Chlorine Dioxide.................................... 0 1.25 1
----------------------------------------------------------------------------------------------------------------

The cost estimates in table 2 of this document include labor, and
are the same testing costs EPA used for the 1998 Stage 1 DBPR impact
analysis (Ref. 1). FDA also collected other testing cost estimates
(Ref. 2); the EPA testing costs generally are in the high end of the
range of the estimates we collected. FDA considers EPA's cost estimates
reliable for this analysis. FDA believes it likely that a bottled water
plant would be able to test for these substances at a cost close to
this range. However, we do not define ``likely'' in any statistical
sense. We examine the sensitivity of our final results to sample
testing cost estimates.

Table 3.--Annual Plant Testing Costs (Dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Option 2a CGMP
Regulations Apply Option 2b CGMP
Test Option 1 NPDWR's Apply (Nonpublic Source Regulations Apply
Water ) (Public Source Water )
----------------------------------------------------------------------------------------------- -------------------------------------------
Bromate........................................................ 1,200 125 100
Chlorite....................................................... 0 156.25 125
TTHM........................................................... 100 125 100
HAA5........................................................... 200 250 200
Chlorine....................................................... 240 25 20
Chloramine..................................................... 240 25 20
Chlorine Dioxide............................................... 0 25 20
----------------------------------------------------------------------------
Total.......................................................... 1,980 731.25 585
--------------------------------------------------------------------------------------------------------------------------------------------------------

Table 4 of this document applies these totals and assumptions to
the structure of the bottled water industry. We also recombine options
2a and 2b in table 4. Approximately 1,550 plants produce bottled water
(63 FR 25764, May 11, 1998). According to another database search
conducted for this analysis, the industry contains only 914 plants that
would be subject to these rules, but the current count may not include
bottled water services to business. Because of this uncertainty, we
estimate totals for both 914 and 1,550 plants. This affects neither the
relative ranking of options nor the sensitivity analysis.
About 25 percent of bottled water products sold are produced by
facilities that use public source water . Based on this, FDA assumes
that 25 percent of bottled water plants use public source water , and
that 75 percent use nonpublic sources (mostly ground water .) For ease
of computation, table 4 of this document also assumes an equal
distribution of the once per 3-year cost across later years, so one-
third of the TTHM and HAA5 cost is incurred in any one year for plants
meeting the less frequent testing requirements under option 1.

[[Page 16864]]

Table 4.--Total Cost to Industry (in Dollars, assuming 1,550 plants)
----------------------------------------------------------------------------------------------------------------
Year 2002 2003 2004 2005
----------------------------------------------------------------------------------------------------------------
Option 2 (a and b).......................................... 1,076,766 1,076,766 1,076,766 1,076,766
Option 1.................................................... 3,069,000 2,268,167 2,164,833 2,164,833
----------------------------------------------------------------------------------------------------------------

Assuming a 7 percent discount rate and no relative testing cost
increases, the present (year 2001) value costs of the testing regimes
are $18,787,984 (914 plants) to $31,861,461 (1,550 plants) under option
1 and $9,070,634 (914 plants) to $15,382,366 (1,550 plants) under
option 2.
FDA ran a rough sensitivity analysis to determine how the range of
testing costs, exemptions, and frequency assumptions affected the
relative cost of options 1 and 2. This is a break-even analysis, which
identifies how much the costs or assumptions would have to change in
order to alter our conclusions.
(1) Testing costs; the major components of the higher option 1 cost
are bromate, chlorine, and chloramine testing requirements. Even if
bromate testing cost dropped to zero, option 1 cost would still be
higher than option 2. If chorine and chloramine testing costs dropped
to zero, and the cost of testing a water sample for bromate dropped
from $100 to $52 (or if only 52 percent of bottled water plants have to
test for bromate), the cost of options 1 and 2 would be roughly the
same. This is in the range of the lowest bromate testing cost estimates
collected by FDA (Ref. 2). TTHM and HAA5 testing costs do not have a
significant impact on the relative cost of the options.
(2) Frequency and requirement exemptions; even if all bottled water
plants qualified for less frequent bromate, TTHM, and HAA5 testing,
option 1 costs would still be higher than option 2 costs.
(3) Discount rate; since option 2 costs, under the original
assumptions, were lower for every year, the option ranking is not
affected by the choice of the discount rate.
FDA concludes that under the most likely assumptions and in a wide
range around those assumptions, testing costs under option 1 exceed
those under option 2.
b. Recordkeeping costs. Bottled water producers already must follow
FDA CGMP requirements for other contaminants, so option two
recordkeeping requirements may be lower in cost than option 1. Firms
have sufficient experience with recordkeeping, so we believe that any
cost differences are minimal.
c. Residual disinfectants and DBP control costs. The 1998 Stage I
DBPR impact analysis estimated costs for public water systems to come
into compliance if a test found unacceptable residual disinfectant or
DBP levels. However, bottled water producers differ from public water
suppliers in two ways. First, we assume one-fourth of bottled water
producers use source water already subject to EPA regulations. For the
purposes of this analysis, we assume they will not have to adopt any
costly technology to come into compliance. Second, almost all producers
who do not use public water systems for their source water use ground
water . In the 1998 Stage I DBPR analysis, EPA estimated that only 12
percent of small ground water facilities will have to adopt new
disinfection technology in order to avoid excessive residual
disinfectants or DBP's. FDA considers this a high estimate of the
number of bottled water plants that may need to adopt new technology,
because these plants do not use as many different types of
disinfectants. Therefore, at most only 9 percent (0.75 x 0.12) of
bottled water plants may have to adopt new technology. FDA cannot
discriminate between the EPA and FDA testing regimes under options 1
and 2 in terms of the degree to which they will require new
disinfection technology in bottled water plants. Once again, no
standards will guarantee that producers will not have to invest in new
compliance technology, so option 3 would have the lowest cost.
3. Benefits of the Regulation
In this case, FDA assumes that both option 1 and option 2
adequately protect the health of the public. FDA cannot discriminate
between options 1 and 2 in terms of their ability to guarantee the
absence of residual disinfectants and DBP's in bottled water . Option 3
is the lowest cost, but in the 1998 Stage 1 DBPR analysis, EPA
concluded that testing for these substances in water destined for human
consumption has net positive benefits (63 FR 69390, December 16, 1998).
Water used by bottled water producers, from both public and nonpublic
sources, may need some manner of disinfection, so we believe the
economic argument from the Stage 1 DBPR analysis applies equally well
to bottled water . We do not estimate the number of illnesses avoided
under these different testing options.
4. Net Benefits
Option 2 has lower testing costs and may have lower record-keeping
costs than option 1, and protects the health of the public at least as
well as option 1. Option 2 also has higher net benefits than option 3,
since the Stage 1 DBPR conclusion that testing for these substances has
net positive benefits applies equally well to bottled water . Therefore,
option 2, where FDA issues standard of quality regulations for these
residual disinfectants and DBP's under part 165 and where the
monitoring requirements in part 129 apply, has the highest net
benefits.

B. Small Entity Analysis

Under Section 603(a) of the Regulatory Flexibility Act (RFA), 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.
This rule would have an impact on small entities, but that impact
would not be large. In addition, option 2 in the

[[Page 16865]]

impact analysis is more flexible and has a smaller testing frequency
burden than the NPDWR requirements for drinking water under option 1,
therefore lowering the impact of this rule on small businesses while
still protecting the public health. FDA also believes that adopting
residual disinfectant and DBP standards yields net positive benefits
regardless of the size of the bottled water facility, so option 2 in
the impact analysis is more appropriate than option 3 for small
businesses.
FDA also believes 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 these disinfectant residuals and DBP's: bottled water
producers use these disinfectants, residual disinfectants and DBP's may
be present in both public and nonpublic source water , and disinfectants
may be used for equipment or other sanitation in any bottled water
plant under CGMP regulations.
According to the latest database search across the bottled water
industry mentioned above, approximately 72 percent of firms qualify as
small by Small Business Administration (SBA) standards. Assuming the
same exemptions and frequency requirements, the yearly average cost per
plant for both small and large entities is between $585 (public source)
and $731 (nonpublic source) for firms under the FDA requirements in
option 2 in the impact analysis, and between $1,397 (year 3) and $1,980
(year 1) for the NPDWR requirements in option 1. We assume that almost
all small entities in the bottled water industry are single plant
firms. Although FDA does consider the option 2 higher cost of $731 per
plant per year a significant impact for small firms, this number
represents 0.13 percent of the $580,000 annual revenue of the median
small bottled water firm.

C. Unfunded Mandate

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 proposed rule
does not constitute a significant rule under the Unfunded Mandates
Reform Act.

VII. Paperwork Reduction Act

FDA tentatively concludes that this final rule contains no
collections of information. Therefore, clearance by the 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
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the order and, consequently, a federalism
summary impact statement is not required.

IX. Comments

Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this direct final rule on or
before June 11, 2001. Two copies of any comments are to be submitted,
except that individuals may submit one 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 office above
between 9 a.m. and 4 p.m., Monday through Friday.

X. Effective Date

The agency intends to make the direct final rule effective January
1, 2002. 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. U.S. EPA, Regulatory Impact Analysis of Final Disinfectant/
Disinfection By-Products Regulations, Washington, DC, app. E, pp. E-
4 and E-5, EPA 815-B-98-002, PB 99-111304, 1998.
2. Memorandum from Dominic Mancini to the record, March 13,
2001.

List of Subjects

21 CFR Part 129

Beverages, Bottled water , Food packaging, Reporting and
recordkeeping requirements.

21 CFR part 165

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

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

PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

1. The authority citation for 21 CFR part 129 continues to read as
follows:

Authority: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.
2. Section 129.35 is amended by redesignating paragraph (a)(4)(iii)
as paragraph (a)(4)(iv) and by adding new paragraph (a)(4)(iii) to read
as follows:

Sec. 129.35 Sanitary facilities.

* * * * *
(a) * * *
(4) * * *
(iii) Firms that do not use a public water system as the source of
their water and whose source water has not been treated with a
chlorine-based disinfectant or ozone do not have to test their source
water for the residual disinfectants and DBP's listed in
Sec. 165.110(b)(4)(iii)(H) of this chapter. Firms that do not use a
public water system as the source of their water but whose source water
has been treated with a chlorine-based disinfectant or ozone must test
their source water for the residual disinfectants and the DBP's listed
in Sec. 165.110(b)(4)(iii)(H) that are likely to result from such
treatment.
* * * * *

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 revising paragraph (b)(1)(ii); by
adding paragraphs (b)(1)(iii), (b)(4)(iii)(H), and (b)(4)(iii)(I); and
in the table in paragraph (b)(4)(i)(A) by removing the entry for
``Organics: Total Trihalomethanes'' to read as follows:

Sec. 165.110 Bottled water .

* * * * *
(b) * * *
(1) * * *
(ii) Total trihalomethanes (TTHM) means the sum of the
concentration in milligrams per liter of the trihalomethane compounds
(trichloromethane, dibromochloromethane,

[[Page 16866]]

bromodichloromethane, and tribromomethane), rounded to three
significant figures.
(iii) Haloacetic acids (five) (HAA5) means the sum of the
concentrations in milligrams per liter of the haloacetic acid compounds
(monochloroacetic acid, dichloroacetic acid, trichloroacetic acid,
monobromoacetic acid, and dibromoacetic acid), rounded to two
significant figures after addition.
(4) * * *
(iii) * * *
(H) The allowable levels for residual disinfectants and
disinfection byproducts are as follows:

----------------------------------------------------------------------------------------------------------------
Concentration in milligrams per
Substance liter
----------------------------------------------------------------------------------------------------------------
Disinfection byproducts
Bromate.................................................................... 0.010
Chlorite................................................................... 1.0
Haloacetic acids (five) (HAA5)............................................. 0.060
Total Trihalomethanes (TTHM)............................................... 0.080
Residual disinfectants
Chloramine................................................................. 4.0 (as Cl2)
Chlorine................................................................... 4.0 (as Cl2)
Chlorine dioxide........................................................... 0.8 (as ClO2)
----------------------------------------------------------------------------------------------------------------

(I) Analysis to determine compliance with the requirements of
paragraph (b)(4)(iii)(H) of this section shall be conducted in
accordance with an applicable method listed in paragraphs
(b)(4)(iii)(I)(1) through (b)(4)(iii)(I)(7) of this section and
described in ``Method 300.1, Determination of Inorganic Anions in
Drinking Water by Ion Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/
600/R-98/118; ``Methods for the Determination of Inorganic Substances
in Environmental Samples,'' U.S. EPA, August 1993, EPA/600/R-93/100;
``Methods for the Determination of Organic Compounds in Drinking Water -
Supplement II,'' U.S. EPA, August 1992, EPA/600/R-92/129; ``Methods for
the Determination of Organic Compounds in Drinking Water -Supplement
III,'' U.S. EPA, August 1995, EPA/600/R-95/131; ``Standard Methods for
the Examination of Water and Wastewater,'' 19th Ed., American Public
Health Association, 1995; and ``Annual Book of ASTM Standards,'' vol.
11.01, American Society for Testing and Materials, 1996, which are
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies of the following publications are available from the
National Technical Information Service (NTIS): EPA/600/R-95/131 (NTIS
number PB95-261616), EPA/600/R-92/129 (NTIS number PB92-207703), EPA/
600/R-93/100 (NTIS number PB94-121811), and EPA/600/R-98/118 (NTIS
number PB98-169196). NTIS can be contacted at NTIS, U.S. Department of
Commerce, 5285 Port Royal Rd., Springfield, VA 22161, 1-800-553-6847 or
703-605-6000, www.ntis.gov. Copies of the publication EPA/600/R-98/118
are also available from the Chemical Exposure Research Branch,
Microbiological and Chemical Exposure Assessment Research Division,
National Exposure Research Laboratory, U.S. EPA, Cincinnati, OH 45268,
513-569-7757, (FAX) 513-569-7757. Copies of ``Standard Methods for the
Examination of Water and Wastewater,'' 19th Ed., are available from the
American Public Health Association, 1015 15th Street, NW., Washington,
DC 20005. All of the publications cited in paragraph (b)(4)(iii)(I) of
this section may be examined at the Office of the Federal Register, 800
North Capitol St. NW., suite 700, Washington, DC, or at the Center for
Food Safety and Applied Nutrition's Library, 200 C St. SW., Washington,
DC 20204. Copies of ``Annual Book of ASTM Standards,'' 1996, vol.
11.01, are available from the American Society for Testing and
Materials, 100 Barr Harbor Dr., West Conshohoken, PA 19428, or may be
examined at the Office of the Federal Register. Copies of the methods
incorporated by reference in paragraph (b)(4)(iii)(I) of this section
may also be examined at the Center for Food Safety and Applied
Nutrition's Library, 200 C St. SW., Washington DC 20204.
(1) Bromate shall be measured using the following method: Method
300.1--``Determination of Inorganic Anions in Drinking Water by Ion
Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/118, 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 paragraph (b)(4)(iii)(I) of this section.
(2) Chlorite shall be measured using the following methods:
(i) Method 300.0--``Determination of Inorganic Anions by Ion
Chromatography,'' Rev. 2.1. The revision is contained in the manual
entitled ``Methods for the Determination of Inorganic Substances in
Environmental Samples,'' U.S. EPA, August 1993, EPA/600/R-93/100, 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 paragraph (b)(4)(iii)(I) of this section.
(ii) Method 300.1--``Determination of Inorganic Anions in Drinking
Water by Ion Chromatography,'' Rev. 1.0, U.S. EPA, 1997, EPA/600/R-98/
118, 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 paragraph (b)(4)(iii)(I) of this section.
(3) HAA5 shall be measured using the following methods:
(i) Method 552.1--``Determination of Haloacetic Acids and Dalapon
in Drinking Water by Ion Exchange Liquid-Solid Extraction and Gas
Chromatography with Electron Capture Detection,'' Rev. 1.0. The
revision is contained in the manual entitled ``Methods for the
Determination of Organic Compounds in Drinking Water -Supplement II,''
U.S. EPA, August 1992, EPA/600/R-92/129, 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 paragraph
(b)(4)(iii)(I) of this section.
(ii) Method 552.2--``Determination of Haloacetic Acids and Dalapon
in Drinking Water by Liquid-Liquid Extraction, Derivatization and Gas
Chromatography with Electron Capture Detection,'' Rev. 1.0. The
revision is contained in the manual entitled ``Methods for the
Determination of Organic Compounds in Drinking Water -Supplement III,''
U.S. EPA, August 1993, EPA/600/R-95/131, 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 paragraph
(b)(4)(iii)(I) of this section.

[[Page 16867]]

(iii) Method 6251 B--``Disinfection By-Products: Haloacetic Acids
and Trichlorophenol,'' which is contained in the book entitled
``Standard Methods for the Examination of Water and Wastewater,'' 19th
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 paragraph (b)(4)(iii)(I) of this section.
(4) TTHM shall be measured using the following methods:
(i) Method 502.2--``Volatile Organic Compounds in Water by Purge
and Trap Capillary Column Gas Chromatography with Photoionization and
Electrolytic Conductivity Detectors in Series,'' Rev. 2.1. The revision
is contained in the manual entitled ``Methods for the Determination of
Organic Compounds in Drinking Water -Supplement III,'' U.S. EPA, August
1993, EPA/600/R-95/131, 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 paragraph (b)(4)(iii)(I) of
this section.
(ii) Method 524.2--``Measurement of Purgeable Organic Compounds in
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev.
1.0. The revision is contained in the manual entitled ``Methods for the
Determination of Organic Compounds in Drinking Water -Supplement III,''
U.S. EPA, August 1993, EPA/600/R-95/131, 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 paragraph
(b)(4)(iii)(I) of this section.
(iii) Method 551.1--``Determination of Chlorination Disinfection
Byproducts, Chlorinated Solvents, and Halogenated Pesticides/Herbicides
in Drinking Water by Liquid-Liquid Extraction and Gas Chromatography
with Electron-Capture Detection,'' Rev. 1.0. The revision is contained
in the manual entitled ``Methods for the Determination of Organic
Compounds in Drinking Water -Supplement III,'' U.S. EPA, August 1993,
EPA/600/R-95/131, 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 paragraph (b)(4)(iii)(I) of this
section.
(5) Compliance with the chloramine standard can be determined by
measuring combined or total chlorine. The following methods shall be
used to measure chloramine:
(i) ASTM Method D1253-86--`` Standard Test Method for Residual
Chlorine in Water ,'' which is contained in the book entitled ``Annual
Book of ASTM Standards,'' 1996, vol. 11.01, 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 paragraph
(b)(4)(iii)(I) of this section.
(ii) Method 4500-Cl D--``Amperometric Titration Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(iii) Method 4500-Cl F--``DPD Ferrous Titrimetric Method,'' which
is contained in the book entitled ``Standard Methods for the
Examination of Water and Wastewater,'' 19th 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 paragraph
(b)(4)(iii)(I) of this section.
(iv) Method 4500-Cl G--``DPD Colorimetric Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(v) Method 4500-Cl E--``Low-Level Amperometric Titration Method,''
which is contained in the book entitled ``Standard Methods for the
Examination of Water and Wastewater,'' 19th 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 paragraph
(b)(4)(iii)(I) of this section.
(vi) Method 4500-Cl I--``Iodometric Electrode Technique,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(6) Compliance with the chlorine standard can be determined by
measuring free or total chlorine. The following methods shall be used
to measure chlorine:
(i) ASTM Method D1253-86--``Standard Test Method for Residual
Chlorine in Water ,'' which is contained in the book entitled ``Annual
Book of ASTM Standards,'' 1996, vol. 11.01, 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 paragraph
(b)(4)(iii)(I) of this section.
(ii) Method 4500-Cl D--``Amperometric Titration Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(iii) Method 4500-Cl F--``DPD Ferrous Titrimetric Method,'' which
is contained in the book entitled ``Standard Methods for the
Examination of Water and Wastewater,'' 19th 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 paragraph
(b)(4)(iii)(I) of this section.
(iv) Method 4500-Cl G--``DPD Colorimetric Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(v) Method 4500-Cl E--``Low-Level Amperometric Titration Method,''
which is contained in the book entitled ``Standard Methods for the
Examination of Water and Wastewater,'' 19th 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 paragraph
(b)(4)(iii)(I) of this section.
(vi) Method 4500-Cl I--``Iodometric Electrode Technique,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(vii) Method 4500-Cl H--``Syringaldazine (FACTS) Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th 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 paragraph (b)(4)(iii)(I)
of this section.
(7) Chlorine dioxide shall be measured using the following methods:
(i) Method 4500-ClO2 D--``DPD Method,'' which is
contained in the book entitled ``Standard Methods for the Examination
of Water and Wastewater,'' 19th Ed., which is incorporated by

[[Page 16868]]

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 paragraph
(b)(4)(iii)(I) of this section.
(ii) Method 4500-ClO2E--``Amperometric Method II,''
which is contained in the book entitled ``Standard Methods for the
Examination of Water and Wastewater,'' 19th 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 paragraph
(b)(4)(iii)(I) of this section.
* * * * *

Dated: March 20, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-7561 Filed 3-23-01; 3:50 pm]
BILLING CODE 4160-01-S

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