[Federal Register Volume 66, Number 60 (Wednesday, March 28, 2001)]
[Rules and Regulations]
[Pages 16858-16868]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-7561]


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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