[Federal Register Volume 59, Number 230 (Thursday, December 1, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29517]


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[Federal Register: December 1, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 103

[Docket No. 91N-0141]

 

Quality Standards for Foods With No Identity Standards; Bottled 
Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
standard of quality regulations for bottled water to establish or 
modify allowable levels for 9 inorganic chemicals (IOC's) and 26 
synthetic organic chemicals (SOC's), including 11 synthetic volatile 
organic chemicals (VOC's), 14 pesticides, and polychlorinated biphenyls 
(PCB's). FDA, however, is not taking final action at this time to adopt 
the maximum contaminant levels (MCL's) of the Environmental Protection 
Agency (EPA) for the pesticides aldicarb, aldicarb sulfone, and 
aldicarb sulfoxide as allowable levels in bottled water because EPA has 
stayed the effective date of the MCL's for these pesticides in public 
drinking water pending further review. Further, FDA is not adopting 
EPA's MCL for asbestos as an allowable level in the quality standard 
for bottled water because the agency finds that a level for this 
contaminant is not needed for bottled water. FDA concludes that 
available data and information on the occurrence of asbestos in source 
waters for bottling or in bottled water products do not support the 
need to establish a quality standard for asbestos in bottled water at 
this time. This final rule will ensure that the minimum quality of 
bottled water, as affected by the above 35 chemicals, remains 
comparable with the quality of public drinking water that meets EPA's 
standards.

DATES: Effective May 30, 1995. The Director of the Office of the 
Federal Register approves the incorporations by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 
CFR 103.35(d)(3), effective May 30, 1995.

FOR FURTHER INFORMATION CONTACT: Henry S. Kim, Center for Food Safety 
and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 410 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 349), whenever EPA prescribes interim or revised 
National Primary Drinking Water Regulations (NPDWR's) under section 
1412 of the Public Health Service Act (The Safe Drinking Water Act 
(SDWA) (42 U.S.C. 300f through 300j-9)), FDA is required to consult 
with EPA and either amend its regulations for bottled drinking water 
(21 CFR 103.35) or publish in the Federal Register its reasons for not 
making such amendments.
    In the Federal Register of January 30, 1991 (56 FR 3526), EPA 
published a final rule (hereinafter referred to as the January 1991, 
final rule) promulgating NPDWR's consisting of MCL's or treatment 
technique requirements for 26 SOC's and 7 IOC's. In that same final 
rule, EPA also established National Secondary Drinking Water 
Regulations (NSDWR's) consisting of secondary maximum contaminant 
levels (SMCL's) for 2 IOC's (aluminum and silver). Moreover, in the 
Federal Register of July 1, 1991 (56 FR 30266), EPA published a final 
rule (hereinafter referred to as the July 1991, final rule) 
promulgating NPDWR's consisting of MCL's for one IOC (barium) and four 
SOC's (aldicarb, aldicarb sulfone, aldicarb sulfoxide, and 
pentachlorophenol).
    In accordance with section 410 of the act, in the Federal Register 
of January 5, 1993 (58 FR 382), FDA published a proposal (hereinafter 
referred to as the January 1993, proposal) to adopt as allowable levels 
in the quality standard for bottled water EPA's SMCL's for two IOC's 
(aluminum and silver) and EPA's MCL's for 8 IOC's and 28 SOC's, 
including 10 VOC's, 17 pesticides, and PCB's. In addition, FDA proposed 
to adopt as an allowable level in the bottled water quality standard 
the MCL for para-dichlorobenzene (p-DCB) that EPA had established in 
its final rule of July 8, 1987 (52 FR 25960). FDA originally intended 
to adopt the SMCL that EPA had proposed for p-DCB in the Federal 
Register of May 22, 1989 (54 FR 22062 at 22138), but EPA deferred 
establishing an SMCL for this chemical in its January 1991, final rule. 
Further, FDA did not propose to establish allowable levels for 
acrylamide and epichlorohydrin (EPA established treatment technique 
requirements for these two SOC's in the January 1991, final rule) in 
the quality standard for bottled water because EPA determined that 
establishing MCL's for these chemicals (used as flocculents in public 
drinking water) was not feasible, and because FDA regulations issued 
under the Food Additives Amendment of 1958 (Pub. L. 85-929) prohibit 
unsafe use of acrylamide and epichlorohydrin (as flocculents) in the 
production of bottled water.
    On November 8, 1990, the Nutrition Labeling and Education Act of 
1990 (Pub. L. 101-535) was enacted. This law removed standard of 
quality rulemakings from the list of rulemakings subject to the formal 
rulemaking procedure in section 701(e) of the act (21 U.S.C. 371(e)). 
FDA, therefore, proposed the amendments to the bottled water quality 
standard for the 39 chemical contaminants using notice and comment 
procedures under section 701(a) of the act (21 U.S.C. 371(a)). 
Interested persons were given until March 8, 1993, to comment on the 
proposed regulation.

II. Summary of and Response to Comments

A. Summary of Comments

    FDA received approximately 130 responses to the January 5, 1993, 
proposal, from industry, consumers, trade associations, Federal 
Government officials, State government agencies, and consumer advocacy 
organizations. Each of the responses contained one or more comments. 
The comments generally supported the proposal. Many comments addressed 
issues that are outside the scope of the proposal (e.g., allowable 
levels for total trihalomethanes (TTHM), chlorine, phenol, and fluoride 
in the quality standard for bottled water) and thus will not be 
discussed here. A number of comments suggested modifications to, or 
were opposed to, various provisions of the proposal. A summary of the 
suggested changes, the opposing comments, and the agency's responses 
follows.

B. Response to Comments

    1. Many comments opposed FDA's proposal to adopt as allowable 
levels EPA's MCL's for barium, chromium, selenium, and 2,4,5-TP 
(Silvex) and EPA's SMCL for silver because EPA's levels for these five 
chemical contaminants in public drinking water are higher than the 
existing allowable levels for these contaminants in the bottled water 
quality standard. One comment maintained that bottlers can meet, and 
have met, without exception, the more stringent allowable levels for 
these five chemicals in bottled waters without undue economic hardship 
and will probably continue to meet the more stringent levels. The 
comment further argued that FDA did not provide any scientific, health, 
or practical reasons for proposing to change the existing allowable 
levels for these chemical contaminants.
    One comment from a State government agency urged FDA to adopt its 
State drinking water standards for chlordane, ethylene dibromide, and 
p-DCB as allowable levels in the bottled water quality standard. The 
comment stated that its calculated Excess Lifetime Cancer Risk (ELCR) 
of about 6 in 100,000 equates to a level of 0.0005 milligram per liter 
(mg/L) for chlordane, and it urged the agency to adopt this level as 
the allowable level in bottled water instead of EPA's MCL of 0.002 mg/
L. For ethylene dibromide, the comment maintained that its ELCR 
calculation of approximately 1 in 10,000 equates to a level of 0.00002 
mg/L, which FDA should adopt as the allowable level for this chemical 
in bottled water instead of the 0.00005 mg/L established by EPA. 
Finally, the comment stated that it has classified p-DCB as a probable 
human carcinogen and has calculated the ELCR of approximately 1 in 
100,000 for this chemical at a level of 0.005 mg/L. The comment further 
argued that FDA had originally intended to adopt the SMCL of 0.005 mg/L 
that EPA had proposed on May 22, 1989 (54 FR 22062 at 22138), based on 
a reported odor detection threshold for p-DCB of 0.003 mg/L. Therefore, 
based on both the health and aesthetic criteria, the comment urged FDA 
to adopt an allowable level of 0.005 mg/L, rather than EPA's MCL of 
0.075 mg/L, for p-DCB in the quality standard for bottled water.
    A comment from another State government agency stated that, based 
on its policy to reduce to the lowest level feasible all drinking water 
contaminants that may cause cancer, birth defects, or other chronic 
diseases, it has established standards for bottled water that are more 
stringent than EPA's MCL's for many of the chemical contaminants that 
FDA proposed to adopt as allowable levels in bottled water. 
Specifically, these chemicals are barium, chromium, selenium, cis-1,2-
dichloroethylene, trans-1,2-dichloroethylene, monochlorobenzene, 
xylenes, carbofuran, chlordane, ethylene dibromide, heptachlor, 
heptachlor epoxide, 2,4,5-TP (Silvex), and silver. The comment further 
stated that a survey of out-of-state bottlers that currently ship 
bottled waters into this State indicated that compliance with the 
State's standards has not caused any negative economic impact or undue 
burden on interstate commerce to any of the bottlers. Therefore, the 
comment urged FDA to adopt either its (the State's) standards or EPA's 
MCL's, whichever are lower, as allowable levels for these chemical 
contaminants in the bottled water quality standard.
    FDA disagrees with the comments' call for the retention of the 
existing allowable levels in its bottled water quality standard that 
are lower than EPA's standards for barium, chromium, selenium, 2,4,5-TP 
(Silvex), and silver. Further, FDA is not persuaded by the comments' 
suggestions that the agency adopt drinking water standards established 
by individual States that are more stringent than EPA's standards as 
allowable levels in the bottled water quality standard (e.g., for 
chlordane, ethylene dibromide, p-DCB, or any other chemical 
contaminants addressed in this final rule). FDA recognizes that many 
water bottlers can and do produce bottled water products with levels of 
chemical contaminants that are lower than EPA's standards without undue 
economic hardship. However, based on three factors, FDA has decided not 
to adopt allowable levels for most contaminants in bottled water that 
are lower than EPA's standards for public drinking water.
    First, no Federal mandate exists that requires that bottled water 
be of a better quality than public drinking water, or that there be 
stricter limits for contaminants for bottled water than for public 
drinking water. When FDA originally established a standard of quality 
for bottled water (38 FR 32558, November 26, 1973), it stated that the 
quality of tap and bottled water can vary widely because of the 
different nature of available source waters (e.g., underground wells or 
springs or surface waters such as rivers and lakes) and treatment 
techniques (e.g., chemical precipitation and flocculation, pH 
treatments, filtration, softening, chlorination, and fluoridation, and 
substitution of minerals), and that, thus, there is no basis for 
assuming that bottled water is better in quality than tap water. FDA, 
therefore, adopted the U.S. Public Health Drinking Water Standards (27 
FR 2152, March 6, 1962), which were considered minimum standards based 
on health criteria for public drinking water, to represent the minimum 
standard of quality for bottled water. Moreover, section 410, which was 
added to the act in 1974 under the SDWA (Pub. L. 93-523), does not 
mandate that FDA establish stricter standards for bottled water than 
for public drinking water. Rather, as the legislative history states, 
it directs FDA ``* * * to amend [the] regulations applicable to bottled 
drinking water to take account of the administrator's [EPA's] action'' 
(Ref. 2).
    Second, in carrying out its mandate under section 410 of the act, 
FDA's policy has been to maintain a minimum quality standard for 
bottled water that is compatible with EPA's drinking water standards 
for contaminants that may be expected to be present in bottled drinking 
water. Such a regulatory approach maintains consistency between Federal 
agencies (i.e., FDA and EPA) in the regulation of identical 
contaminants in similar products (i.e., bottled water and tap water); 
prevents duplication of effort, and the resulting waste of financial 
and personnel resources, by Federal agencies in evaluating the health 
effects of contaminants in drinking water; and prevents public 
confusion in determining which Federal agency standards for 
contaminants in drinking water (whether it is obtained from a bottle or 
from a tap) are more appropriate for protecting the public health. In 
this regard, FDA will generally rely on EPA's efforts in judging the 
adequacy of NPDWR's for the protection of the public health and in 
judging the adequacy of the National Secondary Drinking Water 
Regulations (NSDWR's) for the control of aesthetic characteristics 
affecting consumer acceptance of drinking water. FDA, therefore, will 
generally adopt the MCL's (NPDWR's) and SMCL's (NSDWR's) prescribed by 
EPA, the agency with the primary responsibility for these standards, as 
allowable levels in the quality standard for bottled water.
    However, in unusual circumstances, for public health protection, 
FDA may conduct its own review of health effect studies on a 
contaminant in bottled water or may establish an allowable level for a 
contaminant that is lower than EPA's standard for that contaminant in 
public drinking water. For example, in the Federal Register of May 25, 
1994 (59 FR 26933) FDA established an allowable level for lead in 
bottled water that is lower than EPA's standard for lead in public 
drinking water. Significant unavoidable contamination of public 
drinking water with lead is the result of corrosion of lead-containing 
materials in public water distribution systems. Therefore, instead of 
establishing an MCL for lead in public drinking water, EPA chose to 
establish treatment technique requirements for controlling lead levels 
in public drinking water when more than 10 percent of the targeted tap 
water samples contain lead levels above 0.015 mg/L. However, because 
bottlers do not use the public water distribution systems to deliver 
their finished products, and because source waters for bottling 
generally are free of significant lead contamination, FDA established a 
lower allowable level of 0.005 mg/L for lead in bottled water.
    FDA believes that this allowable level for lead in bottled water is 
consistent with EPA's maximum contaminant level goal (MCLG) of zero for 
lead because it is the lowest level that can be measured reliably with 
the best available analytical methods for enforcement action, and 
because it will provide public health protection at least equivalent to 
that provided by EPA's standard for lead in public drinking water. 
Nevertheless, generally, FDA will rely on EPA's standards for most 
contaminants in public drinking water as being protective of the public 
health and will adopt those standards as allowable levels in the 
quality standard for bottled water.
    Third, FDA believes that establishing allowable levels for 
contaminants in bottled water that are lower than EPA's standards will 
lead the public to perceive that bottled water is of better quality 
than tap water. This perception will not necessarily be true, however. 
For example, the existing allowable levels for barium, chromium, 
selenium, 2,4,5-TP (Silvex), and aluminum are the U.S. Public Health 
Drinking Water Standards (27 FR 2152, March 6, 1962) which FDA adopted 
when the agency originally established the bottled water quality 
standard on November 26, 1973 (38 FR 32558). However, in 1991 (56 FR 
3526 and 56 FR 30266), based on its evaluation of current available 
health effects information for these five chemical contaminants in 
drinking water, EPA established public drinking water standards that 
were less restrictive than the existing allowable levels in the bottled 
water quality standard. Consequently, before proposing to adopt EPA's 
standards for these five chemical contaminants in the quality standard 
for bottled water, FDA considered EPA's evaluation of the health 
effects information on these five contaminants. Based upon this 
consideration, FDA finds that no significant difference exists, with 
respect to providing public health protection, between EPA's standards 
and the lower existing allowable levels in the bottled water quality 
standard. Thus, FDA concludes that adopting EPA's standards for these 
five chemical contaminants as allowable levels will protect the public 
health without leading the public to perceive that bottled water is of 
better quality than tap water.
    As stated above, before proposing to adopt EPA's MCL's for barium, 
chromium, selenium, and silvex and its SMCL for silver as allowable 
levels in bottled water, FDA considered EPA's review of the available 
health effects information for these chemical contaminants in drinking 
water. Based on its review of the available toxicological studies, EPA 
established MCLG's, which are health goals that are based solely on 
considerations of protecting the public from adverse effects of 
drinking water contamination, for barium, chromium, selenium, and 
silvex. In addition, EPA established MCL's, which are set as close as 
feasible to the MCLG's. For these four chemical contaminants, the MCL's 
are the same as the MCLG's. Therefore, the MCL's for barium, chromium, 
selenium, and silvex will fully protect the public from the adverse 
health effects of these four chemical contaminants.
    Furthermore, as discussed in the January 1993, proposal, EPA 
established an SMCL for silver to protect the general public from the 
adverse cosmetic effect of argyria (a discoloration of the skin) from 
lifetime exposure to this chemical. FDA proposed to adopt this level in 
the quality standard because the bottled water quality standard should 
protect the consumer from any adverse effects on the body.
    In the case of p-DCB, FDA did intend to propose to establish an 
allowable level of 0.005 mg/L based on EPA's proposed SMCL for this 
chemical. However, as discussed in the January 1993, proposal, FDA 
proposed to adopt EPA's existing MCL of 0.075 mg/L for p-DCB as the 
allowable level in bottled water because EPA had not established an 
SMCL for this chemical. EPA still has not done so. Should EPA establish 
an SMCL for p-DCB in the future, FDA will consider revising the 
allowable level for this chemical in bottled water to reflect the SMCL.
    In summary, for the chemical contaminants addressed in this final 
rule (including barium, chromium, selenium, silvex, chlordane, ethylene 
dibromide, and p-DCB), based upon its review of EPA's evaluation of 
available health and aesthetic effect information for these chemical 
contaminants in drinking water, FDA considers EPA's standards to be 
adequate to protect the public health and to control the aesthetic 
characteristics affecting consumer acceptance. Therefore, for the 
reasons discussed above, FDA concludes that adopting EPA's MCL's and 
SMCL's for the chemical contaminants addressed in this final rule as 
allowable levels in the standard of quality for bottled water is 
appropriate to protect the public from the adverse health effects of 
these chemical contaminants in bottled water.
    2. One comment contended that FDA's proposal to adopt EPA's MCL's 
for the majority of the chemical contaminants as allowable levels in 
bottled water is flawed because the agency overlooks the critical 
difference between public drinking water and bottled water. The comment 
maintained that, because no practical, economically feasible method 
exists to remove most of the contaminants from a municipal water 
supply, EPA's MCL's are considerably more permissive than its MCLG's, 
which are based solely on health concerns. However, the comment 
asserted that carbon filtration of source water before bottling is a 
standard good manufacturing practice within the bottled water industry, 
and therefore, bottled water should not contain any levels of 
contaminants (e.g., pesticides and a number of other contaminants 
addressed in FDA's proposal) that can be readily removed by filtration 
with granulated activated carbon. The comment further argued that EPA's 
MCLG's for many contaminants are attainable in bottled water and urged 
FDA to adopt EPA's MCLG's as allowable levels in the bottled water 
quality standard for all contaminants that can be removed by carbon 
filtration.
    A second comment also expressed the view that the quality standard 
for bottled water should be more stringent than the standards for 
public drinking water. The comment argued that EPA erroneously sets 
MCL's for contaminants at levels based on analytical testing 
limitations rather than at lower levels that can be achieved by 
treatment technologies (e.g., granulated activated carbon filtration or 
aeration) and urged FDA not to adopt the same logic for bottled water. 
The comment further argued that, because the bottled water industry can 
afford more sophisticated treatment technologies and the services of 
the most sophisticated laboratories, allowable levels for contaminants 
in bottled water should ideally meet the MCLG's that EPA establishes 
for those contaminants. When an MCLG of zero for a contaminant cannot 
be achieved, the comment maintained that FDA should establish the 
lowest level that can be achieved by the best available treatment 
technologies and set monitoring requirements at the level of detection 
achievable by the best laboratories in the country.
    FDA acknowledges that it is more economically feasible for water 
bottlers than for public water systems to use the best available 
treatment technologies (e.g., carbon filtration) to achieve lower 
levels than EPA's standards for many chemical contaminants in bottled 
water. Moreover, FDA recognizes that many water bottlers do produce 
bottled water products with levels of chemical contaminants that are 
lower than EPA's standards.
    Nevertheless, as stated above, FDA concludes that, in general, 
adopting EPA's standards for chemical contaminants as allowable levels 
in bottled water is appropriate because it will protect the public 
health, maintain consistent standards for identical contaminants in 
bottled and tap water, prevent duplication of efforts between FDA and 
EPA in evaluating the effects of contaminants in drinking water, 
prevent public confusion concerning the significance of different 
standards for bottled water and public drinking water, and not foster 
public perception that bottled water is required to be of better 
quality than tap water. Therefore, FDA will generally adopt EPA's 
standards for chemical contaminants in public drinking water as an 
allowable level in the quality standard for bottled water. 
Consequently, FDA will not require bottlers to use treatment 
technologies to achieve lower levels of contaminants in bottled water 
in cases where FDA believes that it is appropriate to adopt EPA's MCL's 
as allowable levels for bottled water.
    FDA disagrees with the comment that states that EPA's MCL's are 
considerably more permissive than its MCLG's. As shown in Table 1, in 
all cases in which the MCLG is above zero for chemical contaminants 
addressed in this final rule, EPA established the MCL at the same level 
as the MCLG (52 FR 25690, 56 FR 3526, and 56 FR 30266). FDA recognizes 
that, as shown in Table 1, EPA established MCL's at levels that are 
different than the MCLG's in all cases in which the MCLG is zero (EPA 
establishes MCLG's of zero for chemical contaminants that are known or 
probable human carcinogens (category 1 chemicals)). However, EPA 
established the MCL's for these category 1 chemicals as close as 
feasible to the MCLG's of zero.

 Table 1.--EPA's MCLG's and MCL's for Chemical Contaminants Addressed in
                             This Final Rule                            
------------------------------------------------------------------------
                                                     MCLG (mg/  MCL (mg/
                    Contaminant                          L)        L)   
------------------------------------------------------------------------
Barium.............................................     2        2      
Cadmium............................................     0.005    0.005  
Chromium...........................................     0.1      0.1    
Mercury............................................     0.002    0.002  
Nitrate............................................    10       10      
Nitrite............................................     1        1      
Total Nitrate and Nitrite..........................    10       10      
Selenium...........................................     0.05     0.05   
o-Dichlorobenzene..................................     0.6      0.6    
p-Dichlorobenzene..................................     0.075    0.075  
cis-1,2-Dichloroethylene...........................     0.07     0.07   
trans-1,2-Dichloroethylene.........................     0.1      0.1    
Ethylbenzene.......................................     0.7      0.7    
Monochlorobenzene..................................     0.1      0.1    
Styrene............................................     0.1      0.1    
Toluene............................................     1        1      
Xylenes............................................    10       10      
Atrazine...........................................     0.003    0.003  
Carbofuran.........................................     0.04     0.04   
2,4-D..............................................     0.07     0.07   
Lindane............................................     0.0002   0.0002 
Methoxychlor.......................................     0.04     0.04   
2,4,5-TP (Silvex)..................................     0.05     0.05   
1,2-Dichloropropane................................     0        0.005  
Tetrachloroethylene................................     0        0.005  
Alachlor...........................................     0        0.002  
Chlordane..........................................     0        0.002  
1,2-Dibromo-3-chloropropane........................     0        0.0002 
Ethylene dibromide.................................     0        0.00005
Heptachlor.........................................     0        0.0004 
Heptachlor epoxide.................................     0        0.0002 
Polychlorinated biphenyls..........................     0        0.0005 
Toxaphene..........................................     0        0.003  
Pentachlorophenol..................................     0        0.001  
Aluminum\1\........................................  .........  ........
Silver\1\..........................................  .........  ........
------------------------------------------------------------------------
\1\EPA established SMCL only.                                           

    Under the SDWA, the term ``feasible'' is defined as ``feasible with 
the use of the best technology, treatment techniques, and other means, 
which the Administrator (EPA) finds, after examination for efficacy 
under field conditions and not solely under laboratory conditions, are 
available (taking costs into consideration).'' Thus, when EPA 
establishes an MCLG of zero for a chemical contaminant, it sets the MCL 
at the lowest level that can be achieved by the best treatment 
technologies available and that can be measured reliably by 
laboratories certified by the States or by EPA for water analysis under 
routine laboratory operating conditions. Furthermore, when EPA 
establishes an MCL for a contaminant, it evaluates the health risks 
associated with various levels of that contaminant to ensure that the 
MCL is protective of the public health.
    Consequently, when FDA adopts EPA's MCL for chemical contaminants 
as allowable levels in the quality standard for bottled water, in many 
cases it is adopting allowable levels that are equivalent to EPA's 
MCLG's. Moreover, when FDA adopts EPA's MCL's for category 1 chemicals 
as allowable levels in the quality standard for bottled water, it is 
establishing allowable levels that are set as close as feasible to 
EPA's MCLG's with the use of best technology or treatment technique, 
and at levels that laboratories certified by the States or by EPA for 
water analyses can reliably measure within specified limits of 
precision and accuracy under routine laboratory operating conditions. 
Therefore, FDA generally is already practicing the comments' 
recommendation to adopt allowable levels for chemical contaminants in 
bottled water that are equivalent to EPA's MCLG's or, for known or 
probable human carcinogens, as close as feasible to their MCLG's.
    3. In the Federal Register of May 27, 1992 (57 FR 22178), EPA 
published a notice announcing that it is staying the January 1, 1993, 
effective date of the NPDWR's (MCL's) that it had established in the 
July 1991, final rule for aldicarb, aldicarb sulfone, and aldicarb 
sulfoxide in public drinking water. EPA took this action in response to 
a petition from Rhone-Poulenc for reconsideration of the MCLG's and 
MCL's for aldicarb and its derivatives and for a stay of the January 1, 
1993, effective date of regulation for these chemicals. In a letter to 
Rhone-Poulenc (see 57 FR 22178), EPA stated that, in light of new 
information that the company submitted with its petition concerning the 
health effects of aldicarb, aldicarb sulfone, and aldicarb sulfoxide, 
it had decided to reconsider its MCLG's and MCL's for aldicarb and its 
derivatives and to stay the effective date of the regulations for these 
chemicals. FDA, however, did not consider the effect of EPA's notice of 
May 27, 1992, in its proposal to adopt as allowable levels the MCL's 
that EPA had established in the July 1991, final rule for aldicarb and 
its derivatives.
    Consequently, several comments, including one from EPA, reminded 
FDA that EPA had stayed the January 1, 1993, effective date of the 
aldicarb MCL's. The EPA comment stated that, in light of new 
information submitted by Rhone-Poulenc regarding the critical study on 
which the risk assessment for aldicarb and its derivatives was based, 
it may propose different MCL's and MCLG's for these chemicals. Other 
comments requested that FDA postpone adopting the proposed MCL's for 
aldicarb and its derivatives as allowable levels in the quality 
standard for bottled water pending EPA's reconsideration.
    FDA agrees with the comments that requested that the agency 
postpone adopting the MCL's that EPA had established in the July 1991, 
final rule for aldicarb and its derivatives as allowable levels in the 
bottled water quality standard. Given that EPA has stayed the effective 
date for regulating the MCL's for aldicarb and its derivatives in 
public drinking water, that EPA may propose different MCLG's and MCL's 
for these chemicals, and that FDA concludes consistency between its 
regulations on drinking water and those of EPA to be of great 
importance (see response to comment 1, supra), it would be 
inappropriate for FDA to adopt EPA's MCL's as allowable levels for 
aldicarb and its derivatives in the bottled water quality standard at 
this time. Therefore, until EPA completes its rulemaking to establish 
NPDWR's for aldicarb and its derivatives, FDA is not taking final 
action to establish allowable levels for these chemicals in the bottled 
water quality standard.
    4. A majority of the comments from industry and bottled water trade 
associations opposed FDA's proposal to establish an allowable level for 
asbestos in the quality standard for bottled water. The comments 
maintained that, because the presence of asbestos, when it occurs in 
public drinking water, is primarily caused by corrosion of asbestos-
cement pipes in the distribution systems, and because this circumstance 
does not occur in the production of most bottled water products, 
asbestos contamination is not a problem for bottled water. One comment 
from a bottled water trade association supported this contention by 
presenting a bottled water manufacturer's data on the results of its 
testing of its source waters and bottled water products for asbestos 
fibers longer than 2.5 micrometers (m). (EPA's MCL for 
asbestos addresses fiber sizes longer than 10 m.) The 
manufacturer did not find any asbestos fibers in its source or product 
water.
    The comments acknowledged that some bottlers use water from public 
water systems that may be vulnerable to asbestos contamination but 
asserted that those bottlers can process the source water to remove 
asbestos. One comment further stated that, because a single analysis 
for asbestos in water samples costs $500, the annual testing 
requirement for asbestos in the source water and in the finished 
product would impose an additional annual cost estimated at between 
$750,000 and $1 million on the bottled water industry. Therefore, the 
comment argued, contamination of bottled water with asbestos at levels 
that would pose any health concerns is highly improbable, and 
establishing an allowable level with required annual testing for this 
contaminant in bottled water would be cost prohibitive without 
providing any public health benefit.
    As discussed above, section 410 of the act requires that, whenever 
EPA prescribes interim or revised NPDWR's, FDA amend its regulations on 
bottled drinking water or publish in the Federal Register its reasons 
for not making such amendments. FDA stated in the January 1993, 
proposal that it will make its own determination as to whether it is 
appropriate to have an allowable level in the quality standard for 
bottled water for a chemical for which EPA has promulgated an NPDWR (58 
FR 382 at 383). FDA noted that it may take a different approach than 
EPA in circumstances where the presence of a contaminant in tap water 
is the result of circumstances peculiar to public water systems, and it 
can be avoided by bottlers. Thus, FDA has considered whether the 
presence of asbestos in drinking water is peculiar to public water 
systems that directly supply residences and buildings, such that it 
would not be necessary to have an allowable level for asbestos in the 
bottled water quality standard.
    FDA agrees with the comments' contention that source waters for 
bottling or bottled water products generally would not contain any 
significant levels of asbestos for the following reasons:
    First, data from EPA's occurrence document for asbestos in drinking 
water (Ref. 3) show that the major source of asbestos fibers in public 
drinking water that pose a health risk (i.e., at levels greater than 
EPA's MCLG and MCL of 7 million fibers that exceed 10 m in 
length per liter of water) is the leaching of asbestos fibers into the 
water from asbestos-cement pipes used in distribution for public 
drinking water. For example, less than 0.5 percent of the natural 
asbestos fibers present in raw surface waters from the western coast of 
the United States (primary area in the United States where erosion of 
asbestos containing minerals causes the presence of natural asbestos 
fibers in surface waters) exceeded 10 m in length (Ref. 3). 
However, 11 percent of the asbestos fibers present in public drinking 
waters exposed to asbestos-cement pipes in the distribution system 
(sampled in Florida, South Carolina, and Connecticut) exceeded 10 
m in length (Ref. 3).
    Further, data from EPA's asbestos occurrence document show that 126 
of the 132 water samples representing ground water sources throughout 
the United States contained significantly less than 1 million asbestos 
fibers of all sizes per liter of water (69 percent contained less than 
0.1 million asbestos fibers per liter of water) (Ref. 3). These ground 
water samples were taken before the water entered the public water 
distribution systems (i.e., before the water was exposed to potential 
asbestos contamination from asbestos-cement pipes), and thus, the 
occurrence of asbestos was the result of natural erosion of asbestos-
containing minerals. According to EPA's asbestos occurrence document, 
contamination of ground water with surface water containing high levels 
of asbestos from mineral erosion in California and questionable 
analytical results from New Mexico were believed to be the reasons for 
the six ground water samples that contained more than 1 million 
asbestos fibers per liter of water (Ref. 3). EPA's asbestos occurrence 
document also stated that no conclusive evidence exists that shows the 
presence of any asbestos fibers exceeding 10 m in length in 
ground waters (outside California) distributed through nonasbestos-
cement pipes (Ref. 3). Although EPA's asbestos occurrence document did 
not provide specific data, ground waters in California may contain some 
natural asbestos fibers exceeding 10 m in length caused by 
erosion of asbestos containing minerals. However, based on EPA's 
asbestos occurrence data showing that only 0.5 percent of natural 
asbestos fibers exceed 10 m in length, and that ground waters 
contain significantly less than 1 million asbestos fibers of all sizes 
per liter of water (Ref. 3), the number of fibers exceeding 10 
m in length in California ground waters would be expected to 
be significantly less than 7 million per liter of water.
    Therefore, available data presented in EPA's occurrence document 
for asbestos in drinking water (Ref. 3) establish that the presence of 
asbestos fibers exceeding 10 m in length in source waters 
obtained from other than public water systems (i.e., ground waters such 
as wells and springs) for bottling is highly unlikely. Thus, this 
evidence does not provide a basis for establishing a quality standard 
for asbestos in bottled water.
    Second, FDA notes that in its January 1991, final rule, EPA 
established infrequent base monitoring requirements for asbestos in 
public water systems and stated that there is such a low probability of 
occurrence of this contaminant in sources for public drinking water 
that it anticipates that most public water systems will be granted 
waivers for monitoring asbestos.
    Moreover, public water systems vulnerable to asbestos contamination 
(i.e., public water systems without waivers for monitoring asbestos) 
would have to comply with EPA's requirements for asbestos monitoring 
and, if the asbestos level is above the MCL, use the best available 
technologies (e.g., filtration and corrosion control) to reduce the 
asbestos level for compliance with the MCL. Therefore, most, if not all 
bottlers, using source waters obtained from public water systems also 
will be unlikely to encounter any significant levels of asbestos in 
their water source.
    Under the current good manufacturing practice (CGMP) requirements 
for bottled water (21 CFR part 129), water bottlers are required to 
take samples of their source water for bottling and have them analyzed 
as often as necessary, but at least once each year, for chemical 
contaminants (Sec. 129.35(a)(3)). However, in the January 5, 1993, 
Federal Register proposal to establish an identity standard for bottled 
water (58 FR 393), FDA also proposed to permit bottlers using public 
water systems as the source of their water to substitute public water 
system testing results showing full compliance with the EPA primary and 
secondary drinking water regulations (or a certificate to this effect) 
for the source water chemical contaminant testing required in 
Sec. 129.35(a)(3). Consequently, in an unlikely event that a public 
water system is not in compliance with EPA's MCL for asbestos, water 
from that public water system for bottling would not be from an 
approved source, and under Sec. 129.35(a)(1) of the CGMP regulations 
for bottled water, bottlers will not be permitted to use such source 
water for bottling.
    Third, asbestos is only permitted for use in contact with food (as 
an indirect food additive) during the processing, packing, 
transporting, or holding of food under 21 CFR part 175 as a component 
in adhesives (Sec. 175.105) and as a component of coatings 
(Sec. 177.2410 and Sec. 177.2420). No other use of asbestos containing 
materials in contact with food (e.g., plumbing materials that transport 
source waters from wells or springs to the bottling plant and all food 
contact materials within the plant), including in the manufacture of 
bottled water products, is permitted. Consequently, source waters for 
bottling should not be exposed to substances that contain asbestos 
during processing, packing, and distribution, and the finished bottled 
water products should not contain any significant levels of asbestos.
    For these reasons, FDA considers the presence of any significant 
level of asbestos in bottled water to be highly unlikely. The agency is 
not aware of any evidence that would indicate otherwise. Therefore, FDA 
concludes that available data and information on the occurrence of 
asbestos in source waters for bottling or in bottled water products do 
not support the need for the establishment of a quality standard for 
asbestos in bottled water at this time.
    FDA, however, reminds water bottlers that they are responsible for 
ensuring that all bottled water products introduced or delivered for 
introduction into interstate commerce are safe, wholesome, and 
truthfully labeled. Moreover, any bottled water containing any 
substance (including asbestos) at a level that may be injurious to 
health under section 402 of the act (21 U.S.C. 342) is adulterated and 
will be subject to regulatory action. Consequently, FDA advises water 
bottlers, particularly those bottling source waters from regions where 
natural erosion of asbestos containing minerals may occur, to ensure, 
through appropriate manufacturing techniques and sufficient quality 
control procedures, that their bottled water products are free of any 
significant asbestos contamination.
    5. One comment maintained that because some of the chemical 
contaminants (i.e., asbestose, Silvex, chlordane, and heptachlor) have 
been banned, the potential for bottled water to be contaminated with 
these chemicals is zero. The comment, therefore, called for eliminating 
the yearly testing requirement for these chemical contaminants in 
bottled water if they are not detected in the initial testing of the 
source and product water. The comment further maintained that, because 
VOC's and the pesticides aldicarb, aldicarb sulfone, aldicarb 
sulfoxide, and carbofuran are unstable, these chemical contaminants 
will break down during normal distribution of bottled water and will 
have no effect on public health. Therefore, the comment stated that 
testing requirements for these chemical contaminants in bottled water 
should also be eliminated.
    FDA disagrees with this comment. With respect to VOC's and the 
pesticides Silvex, chlordane, heptachlor, and carbofuran, EPA noted 
that most of these chemical contaminants have been detected in public 
drinking water from ground water and surface water sources (50 FR 
46936, November 13, 1985). Thus, EPA established NPDWR's for these 
chemical contaminants in its January 1991, final rule to protect the 
public from adverse health effects of these contaminants in public 
drinking water. Furthermore, available bottled water survey information 
(Ref. 1) showed the presence of some of these chemical contaminants 
(e.g., VOC's) in bottled waters, and thus some sources for bottled 
water can be expected to contain these contaminants. FDA, therefore, 
concludes that adopting EPA's MCL's for these chemical contaminants as 
allowable levels in the quality standard for bottled water is 
appropriate under section 410 of the act to protect the public from the 
adverse health effects of these contaminants in bottled water and to 
maintain the quality of bottled water that is comparable to public 
drinking water that meets EPA's standards.

III. Conclusion

    The agency is adopting the provisions concerning allowable levels 
for 35 of the 39 chemical contaminants (excluding aldicarb, aldicarb 
sulfone, aldicarb sulfoxide, and asbestos) in the quality standard for 
bottled water as proposed (58 FR 382), with the exception of the 
changes concerning analytical methodology and method availability noted 
below. The majority of the comments to the January 1993, proposal 
supported the provisions that FDA is adopting in this final rule. 
Furthermore, after carefully considering the comments that the agency 
received that suggested modifications to, or that were opposed to, the 
various provisions of the proposal, the agency determined that no 
changes in the final rule other than those discussed above concerning 
aldicarb, aldicarb sulfone, aldicarb sulfoxide, and asbestos are 
warranted. Therefore, upon the effective date of this rule, May 30, 
1995, any bottled water that contains an amount of any of these 35 
chemical contaminants that exceeds the allowable levels will be 
misbranded under section 403(h)(1) of the act (21 U.S.C. 343(h)(1)), 
unless it bears a statement of substandard quality as provided by 
Sec. 103.35(f)(2)(ii).
    Because FDA has decided not to establish an allowable level for 
asbestos in the quality standard for bottled water, the agency is not 
including an entry in the table in Sec. 103.35(d)(3)(i) or in 
Sec. 103.35(d)(3)(v) for asbestos. Similarly, given the agency's 
conclusions on aldicarb, aldicarb sulfone, and aldicarb sulfoxide, the 
agency is not including entries in the table in Sec. 103.35(d)(3)(iii) 
or in Sec. 103.35(d)(3)(vi) for these substances.
    In regard to analytical methods for the determination of chemical 
contaminants, FDA is making the following additional changes in 
Sec. 103.35(d)(3):
    In Sec. 103.35(d)(3)(v), FDA cites the updated version of EPA 
Method 200.7, and in Sec. 103.35(d)(3)(vii), FDA cites updated versions 
of EPA Methods 200.7, 200.8, and 200.9. These methods are contained in 
the manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, that are 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The source for the manual containing the three methods is the 
National Technical Information Service (NTIS) rather than EPA. Also, 
the source for the publication ``Methods of Chemical Analysis of Water 
and Waste,'' EPA Environmental Monitoring and Support Laboratory, 
Cincinnati, OH 45268 (EPA-600/4-79-020), March 1983, cited in 
Sec. 103.35(d)(3)(v) and Sec. 103.35(d)(3)(vii), is the NTIS rather 
than EPA. This change is consistent with the agency's practice of 
relying on readily available commercial sources for incorporated 
materials when possible.
    Finally, FDA is deleting proposed Sec. 103.35(d)(3)(v)(F)(5) that 
contains the analytical method, WeWWG/5880, which is one of five 
methods that FDA proposed to adopt for determining nitrate in bottled 
water. Method WeWWG/5880 is contained in the manual entitled ``Orion 
Guide to Water and Wastewater Analysis,'' Orion Research, Inc., 
Cambridge, MA, 1985, and copies of the manual were available from Orion 
Research, Inc. However, Orion Research, Inc. (the publisher) recently 
discontinued printing the 1985 version of the manual. Consequently, 
method WeWWG/5880 is no longer commercially available. Therefore, 
because method WeWWG/5880 is no longer commercially available, and 
because FDA is incorporating by reference four other EPA methods for 
determining nitrate in bottled water, FDA is not adopting method WeWWG/
5880.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (58 FR 382, January 5, 
1993). No new information or comments were submitted to FDA that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA has received no comments on the economic 
impact of this rule, and thus has no basis to alter its finding in the 
proposal, the agency certifies that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
Therefore, under the Regulatory Flexibility Act, no further analysis is 
required.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, room 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA FY 90 Bottled Water Survey, 1990.
    2. ``United States Code, Congressional and Administrative News,'' 
93d Congress, 2d sess., vol. 4, Legislative History, Proclamations, 
Executive Orders, Tables and Index, pp. 6 and 495, 1974.
    3. ``Draft Occurrence/Exposure of Asbestos in Drinking Water,'' 
EPA, Office of Drinking Water, Criteria and Standards Division, 
December, 1986.

List of Subjects in 21 CFR Part 103

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
103 is amended as follows:

PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS

    1. The authority citation for 21 CFR part 103 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 
349, 371, 379e).

    2. Section 103.35 is amended in the table in paragraph (d)(1)(i) by 
removing the entries for ``Barium,'' ``Cadmium,'' ``Chromium,'' 
``Mercury,'' ``Nitrate (N),'' ``Selenium,'' ``Silver,'' ``Lindane * * 
*,'' ``Methoxychlor * * *,'' ``Toxaphene * * *,'' ``2,4-D (2,4-
dichlorophenoxyacetic acid),'' and ``2,4,5-TP (Silvex) * * *,'' by 
revising the introductory text of paragraph (d)(3), by alphabetically 
adding new entries in the tables in paragraphs (d)(3)(i) and 
(d)(3)(ii), respectively, by adding new paragraphs (d)(3)(iii) and 
(d)(3)(iv), by revising the introductory text of paragraph (d)(3)(v) 
and paragraph (d)(3)(vi), and by adding new paragraphs (d)(3)(v)(A) 
through (F) and (d)(3)(vii) to read as follows:


Sec. 103.35  Bottled water.

* * * * *
    (d) * * *
    (3) Having consulted with the U.S. Environmental Protection Agency 
(EPA) as required by section 410 of the Federal Food, Drug, and 
Cosmetic Act, the Food and Drug Administration has determined that 
bottled water, when a composite of analytical units of equal volume 
from a sample is examined by the methods listed in paragraphs 
(d)(3)(v), (d)(3)(vi), and (d)(3)(vii) of this section, shall not 
contain the following chemical contaminants in excess of the 
concentrations specified in paragraphs (d)(3)(i), (d)(3)(ii), 
(d)(3)(iii), and (d)(3)(iv) of this section.
    (i) * * *

------------------------------------------------------------------------
                                       Concentration in milligrams per  
            Contaminant                    liter (or as specified)      
------------------------------------------------------------------------
Barium.............................  2                                  
Cadmium............................  0.005                              
Chromium...........................  0.1                                
                                                                        
                                  *****                                 
Mercury............................  0.002                              
Nitrate............................  10 (as nitrogen)                   
Nitrite............................  1 (as nitrogen)                    
Total Nitrate and Nitrite..........  10 (as nitrogen)                   
Selenium...........................  0.05                               
------------------------------------------------------------------------

    (ii) * * *

------------------------------------------------------------------------
                                                           Concentration
                Contaminant (CAS Reg. No.)                 in milligrams
                                                             per liter  
------------------------------------------------------------------------
                                                                        
                                  *****                                 
o-Dichlorobenzene (95-50-01).............................        0.6    
p-Dichlorobenzene (106-46-7).............................        0.075  
                                                                        
                                  *****                                 
cis-1,2-Dichloroethylene (156-59-2)......................        0.07   
trans-1,2-Dichloroethylene (156-60-5)....................        0.1    
1,2-Dichloropropane (78-87-5)                                    0.005  
Ethylbenzene (100-41-4)..................................        0.7    
Monochlorobenzene (108-90-7).............................        0.1    
Styrene (100-42-5).......................................        0.1    
Tetrachloroethylene (127-18-4)...........................        0.005  
Toluene (108-88-3).......................................        1      
                                                                        
                                  *****                                 
Xylenes (1330-20-7)......................................       10      
------------------------------------------------------------------------

    (iii) The allowable levels for pesticides and other synthetic 
organic chemicals are as follows:

------------------------------------------------------------------------
                                                           Concentration
                Contaminant (CAS Reg. No.)                 in milligrams
                                                             per liter  
------------------------------------------------------------------------
Alachlor (15972-60-8)....................................       0.002   
Atrazine (1912-24-9).....................................       0.003   
Carbofuran (1563-66-2)...................................       0.04    
Chlordane (57-74-9)......................................       0.002   
1,2-Dibromo-3-chloropropane (96-12-8)....................       0.0002  
2,4-D (94-75-7)..........................................       0.07    
Ethylene dibromide (106-93-4)............................       0.00005 
Heptachlor (76-44-8).....................................       0.0004  
Heptachlor epoxide (1024-57-3)...........................       0.0002  
Lindane (58-89-9)........................................       0.0002  
Methoxychlor (72-43-5)...................................       0.04    
Pentachlorophenol (87-86-5)..............................       0.001   
PCB's (as decachlorobiphenyl) (1336-36-3)................       0.0005  
Toxaphene (8001-35-2)....................................       0.003   
2,4,5-TP (Silvex) (93-72-1)..............................       0.05    
------------------------------------------------------------------------

    (iv) The allowable levels for certain chemicals for which EPA has 
established secondary maximum contaminant levels in its drinking water 
regulations are as follows:

------------------------------------------------------------------------
                                                           Concentration
                       Contaminant                         in milligrams
                                                             per liter  
------------------------------------------------------------------------
Aluminum.................................................          0.2  
Silver...................................................          0.1  
------------------------------------------------------------------------

    (v) Analyses to determine compliance with the requirements of 
paragraph (d)(3)(i) of this section shall be conducted in accordance 
with an applicable method or applicable revisions to the methods listed 
in paragraphs (d)(3)(v)(A) through (d)(3)(v)(H) of this section and 
described, unless otherwise noted, in ``Methods for Chemical Analysis 
of Water and Wastes,'' U.S. EPA Environmental Monitoring and Support 
Laboratory (EMSL), Cincinnati, OH 45258 (EPA-600/4-79-020), March 1983, 
which is incorporated by reference in accordance with 5 U.S.C 552(a) 
and 1 CFR part 51. Copies of this publication are available from the 
National Technical Information Service, U.S. Department of Commerce, 
5825 Port Royal Rd., Springfield, VA 22161, or may be examined at the 
Office of Plant and Dairy Foods and Beverages (HFS-305), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 200 C 
St. SW., Washington, DC, or at the Office of the Federal Register, 800 
North Capitol St. NW., Suite 700, Washington, DC.
    (A) Barium shall be measured using the following methods:
    (1) Method 208.2--''Atomic absorption, furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (2) Method 208.1--''Atomic absorption, direct aspiration,'' 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 (d)(3)(v) of this section.
    (3) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of this publication are available from the National 
Technical Information Service, U.S. Department of Commerce, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Office of 
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC, or at the Office of the Federal Register, 800 North 
Capitol St. NW., Suite 700, Washington, DC.
    (B) Cadmium shall be measured using the following methods:
    (1) Method 213.2--''Atomic absorption, furnace technique,'' 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 (d)(3)(v) of this section.
    (2) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (d)(3)(v)(A)(3) of this section.
    (C) Chromium shall be measured using the following methods:
    (1) Method 218.2--''Atomic absorption, furnace technique,'' 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 (d)(3)(v) of this section.
    (2) Method 200.7--''Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma- Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, 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 (d)(3)(v)(A)(3) of this section.
    (D) Mercury shall be measured using the following methods:
    (1) Method 245.1--''Manual cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (2) Method 245.2--''Automated cold vapor technique,'' 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 (d)(3)(v) of this section.
    (E) Nitrate and/or nitrite shall be measured using the following 
methods:
    (1) Method 353.3--''Spectrophotometric, cadmium reduction,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (2) Method 353.2--''Colorimetric, automated, cadmium reduction,'' 
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 (d)(3)(v) of this section.
    (3) Method 300.0--''The Determination of Inorganic Anions in Water 
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017), 
March 1984, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from the National Technical Information Service, U.S. 
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Office of Plant and Dairy Foods and Beverages 
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW, Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suit 700, Washington, DC.
    (4) Method 353.1--''Colorimetric, automated, hydrazine reduction,'' 
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 (d)(3)(v) of this section.
    (F) Selenium shall be measured using the following methods:
    (1) Method 270.2--''Atomic absorption, furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (2) Method 270.3--``Atomic absorption, gaseous hydride,'' 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 (d)(3)(v) of this section.
 * * * * *
    (vi) Analyses to determine compliance with the requirements of 
paragraphs (d)(3)(ii) and (d)(3)(iii) of this section shall be 
conducted in accordance with an applicable method or applicable 
revisions to the methods listed in paragraphs (d)(3(vi)(A) through 
(d)(3)(vi)(M) of this section and described, unless otherwise noted, in 
``Methods for the Determination of Organic Compounds in Drinking 
Water,'' Office of Research and Development, EMSL, EPA/600/4-88/039, 
December 1988, which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies of this publication are 
available from the National Technical Information Service, U.S. 
Department of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or 
may be examined at the Office of Plant and Dairy Foods and Beverages 
(HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.
    (A) Method 502.1--``Volatile Halogenated Organic Compounds in Water 
by Purge and Trap Gas Chromatography,'' revision 2.0, 1989, (applicable 
to VOC's), which is incorporated by reference in accordance with 5 
U.S.C 552(a) and 1 CFR part 51, or
    (B) Method 502.2--``Volatile Organic Compounds in Water by Purge 
and Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series,'' revision 2.0, 1989 
(applicable to VOC's), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (C) Method 503.1--``Volatile Aromatic and Unsaturated Organic 
Compounds in Water by Purge and Trap Gas Chromatography,'' revision 
2.0, 1989 (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (D) Method 524.1--``Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' revision 
3.0, 1989 (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (E) Method 524.2--``Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' 
revision 3.0, 1989 (applicable to VOC's), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (F) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3-
Chloropropane (DBCP) in Water by Microextraction and Gas 
Chromatography,'' revision 2.0, 1989 (applicable to 
dibromochloropropane (DBCP) and ethylene dibromide (EDB)), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (G) Method 505--``Analysis of Organohalide Pesticides and 
Commercial Polychlorinated Biphenyl (PCB) Products in Water by 
Microextraction and Gas Chromatography,'' revision 2.0, 1989 
(applicable to alachlor, atrazine, chlordane, heptachlor, heptachlor 
epoxide, lindane, methoxychlor, toxaphene and as a screen for 
polychlorinated biphenyl's (PCB's)), which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (H) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' revision 2.0, 1989 (applicable to alachlor and 
atrazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (I) Method 508--``Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector,'' revision 
3.0, 1989 (applicable to chlordane, heptachlor, heptachlor epoxide, 
lindane, methoxychlor, toxaphene, and as a screen for PCB's), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (J) Method 508A--``Screening for Polychlorinated Biphenyls by 
Perchlorination and Gas Chromatography,'' revision 1.0, 1989 (used to 
quantitate PCB's as decachlorobiphenyl if detected in Methods 505 or 
508 in paragraph (d)(3)(vi)(G) or (d)(3)(vi)(I) of this section, 
respectively), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (K) Method 515.1--``Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector,'' revision 5.0, 
May 1991 (applicable to 2,4-D, 2,4,5-TP (Silvex) and 
pentachlorophenol), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (L) Method 525.1--``Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry,'' revision 2.2, May 1991 (applicable 
to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, 
lindane, methoxychlor, and pentachlorophenol), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (M) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization,'' revision 3.0, 1989 (applicable to carbofuran), 
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 (d)(3)(vi) of this section.
    (vii) Analyses to determine compliance with the requirements of 
paragraph (d)(3)(iv) of this section shall be conducted in accordance 
with an applicable method and applicable revisions to the methods 
listed in paragraphs (d)(3)(vii)(A) and (d)(3)(vii)(B) of this section 
and described, unless otherwise noted, in ``Methods of Chemical 
Analysis of Water and Wastes,'' 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 (d)(3)(v) of this 
section.
    (A) Aluminum shall be measured using the following methods:
    (1) Method 202.1--``Atomic absorption technique; direct 
aspiration,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51.
    (2) Method 202.2--``Atomic absorption; furnace technique,'' 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 (d)(3)(v) of this section.
    (3) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, in ``Methods for the 
Determination of Metals in Environmental Samples,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of the incorporation by reference is given in 
paragraph (d)(3)(v)(A)(3) of this section.
    (4) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, 
April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) 
of this section.
    (5) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' 
revision 1.2, April 1991, in ``Methods for the Determination of Metals 
in Environmental Samples,'' 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 (d)(3)(v)(A)(3) 
of this section.
    (B) Silver shall be measured using the following methods:
    (1) Method 272.1--``Atomic absorption, direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (2) Method 272.2--``Atomic absorption, furnace technique,'' 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 (d)(3)(v) of this section.
    (3) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' revision 3.3, April 1991, U.S. EPA, EMSL, in ``Methods 
for the Determination of Metals in Environmental Samples,'' 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 (d)(3)(v)(A)(3) of this section.
    (4) Method 200.8--``Determination of Trace Elements in Waters and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' revision 4.4, 
April 1991, in ``Methods for the Determination of Metals in 
Environmental Samples,'' 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 (d)(3)(v)(A)(3) 
of this section.
    (5) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption, Spectrometry,'' 
revision 1.2, April 1991, in ``Methods for the Determination of Metals 
in Environmental Samples,'' 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 (d)(3)(v)(A)(3) 
of this section.
* * * * *
    Dated: November 18, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29517 Filed 11-30-94; 8:45 am]
BILLING CODE 4160-01-P