[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]
[[Page Unknown]]
[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