[Federal Register Volume 66, Number 129 (Thursday, July 5, 2001)]
[Notices]
[Pages 35439-35441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16910]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0280]


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
does not need to issue a standard of quality regulation for bottled 
water in response to the Environmental Protection Agency's (EPA's) 
issuance of National Primary Drinking Water Regulations (NPDWRs) for 
the control of Cryptosporidium contamination in surface water sources 
for public drinking water, to protect the public health. This action is 
in accordance with the Federal Food, Drug, and Cosmetic Act (the 
FFDCA), which requires that, whenever EPA issues NPDWRs for a 
contaminant in public drinking water, FDA must issue a standard of 
quality regulation for the same contaminant in bottled water or make a 
finding that such a regulation is not necessary to protect the public 
health because the contaminant is contained in water in public water 
systems but not in water used for bottled drinking water.

FOR FURTHER INFORMATION CONTACT: Paul South, Center for Food Safety and 
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St. 
SW., Washington, DC 20204, 202-358-3571.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 16, 1998 (63 FR 69478), EPA 
published the Interim Enhanced Surface Water Treatment Rule (IESWTR) 
that established NPDWRs consisting of treatment technique requirements 
for reduction of Cryptosporidium in surface water and in ground water 
under the direct influence of surface water that public water systems 
serving 10,000 people or more use as their source water. This 
rulemaking finalized a proposed rule that EPA published in the Federal 
Register on July 29, 1994 (59 FR 38832).
    Cryptosporidium is a gastrointestinal illness caused by ingestion 
of Cryptosporidium oocysts. The mode of transmission for 
Cryptosporidium is through the fecal-oral route and occurs by ingestion 
of infective oocysts from contaminated water or food, or by direct or 
indirect contact with infected persons or animals. While 
cryptosporidiosis generally is considered a self-limiting disease, it 
can be chronic and life threatening in immunocompromised individuals. 
Recently, a waterborne outbreak of Cryptosporidium was documented in 
association with public drinking water (Ref. 1).
    Under the Safe Drinking Water Act (SDWA), as amended in 1996, EPA 
issues NPDWRs to protect the public health from the adverse effects of 
contaminants in public drinking water. NPDWRs specify maximum 
contaminant levels (MCLs) or treatment techniques for public drinking 
water contaminants. At the same time that it issues NPDWRs, EPA 
publishes maximum contaminant level goals (MCLGs), which are not 
regulatory requirements, but rather nonenforceable health goals that 
are based solely on considerations of protecting the public from 
adverse health effects of public drinking water contamination.
    Under section 410(b)(1) of the FFDCA (21 U.S.C. 349(b)(1)), not 
later than 180 days before the effective date of a NPDWR issued by EPA 
for a contaminant under section 1412 of the SDWA (42 U.S.C. 300g-l)\1\, 
FDA is required to issue a standard of quality regulation for the 
contaminant in bottled water or make a finding that such a regulation 
is not necessary to protect the public health because the contaminant 
is contained in water in public water systems, but not in water used 
for bottled drinking water. The effective date for any such standard of 
quality regulation is to be the same as the effective date of the 
NPDWR. In addition, section 410(b)(2) of the FFDCA provides that a 
quality standard regulation issued by FDA shall include monitoring 
requirements that the agency determines to be appropriate for bottled 
water. Further, section 410(b)(3) of the FFDCA requires a quality 
standard regulation for a contaminant in bottled water to be no less 
stringent than EPA's MCL and no less protective of the public

[[Page 35440]]

health than EPA's treatment technique requirements for the same 
contaminant.
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    \1\FDA considers EPA's compliance date for subpart H public 
water systems (systems using surface water or ground water under the 
direct influence of surface water) that serve a population of 10,000 
or more to be the effective date for purposes of section 410 of the 
FFDCA. The compliance date was set at December 16, 2001, in the 
IESWTR (63 FR 69478, December 16, 1998) and revised in a subsequent 
rule to January 1, 2002 (65 FR 20304, April 14, 2000).
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II. EPA Standards

    The SDWA, as amended in 1996, requires EPA to publish an NPDWR that 
specifies either an MCL or treatment technique requirement for 
contaminants that may have an adverse effect on the health of persons, 
are known to occur or have a substantial likelihood of occurring in 
public water systems with a frequency and at levels of public health 
concern, and for which regulation presents a meaningful opportunity for 
health risk reduction for persons served by public water systems 
(section 1412(b)(1)(A) of the SDWA). The SDWA (section 300g-l(a)(3)) 
also requires that EPA issue MCLGs at the time that it issues NPDWRs. 
MCLGs are nonenforceable health goals based solely on considerations of 
protecting the public from the adverse health effects of contaminants, 
and are not based on other considerations, such as potential cost of 
regulating contaminants and potential technical difficulties of 
achieving the health goals. EPA sets MCLs, the enforceable contaminant 
levels, as close as feasible to the nonenforceable MCLGs. When it is 
not economically or technologically feasible to set MCLs, EPA 
establishes treatment technique requirements that can reduce the levels 
of such contaminants to protect the public health (section 
1412(b)(1)(A) of the SDWA).
    In the Federal Register of December 16, 1998 (63 FR 69478), EPA 
published the IESWTR establishing treatment technique requirements for 
public water systems that use surface water or ground water under the 
direct influence of surface water and serve at least 10,000 people. The 
primary purpose of the IESWTR is to improve control of microbial 
pathogens in public drinking water, particularly for the protozoan 
Cryptosporidium. Key provisions established in the IESWTR include (63 
FR 69478 at 69483):
    (a) An MCLG of zero for the protozoan genus Cryptosporidium.
    (b) A 2-log (99 percent) removal of Cryptosporidium in public water 
systems that use surface water or ground water under the direct 
influence of surface water, serve 10,000 or more people, and are 
required to filter their source water under the Surface Water Treatment 
Rule (SWTR) (54 FR 27486, June 29, 1989).
    (c) Strengthened turbidity performance requirements for the 
combined filter effluent. The turbidity of a system's combined filtered 
water at each plant must be below levels established by EPA for public 
water systems when the plant uses surface water or ground water under 
the direct influence of surface water, serves 10,000 or more people, 
and is required to filter its source water under the SWTR.
    (d) New requirements for individual filters. The turbidity for each 
individual filter effluent at each plant must be monitored continuously 
and be below levels established by EPA for public water systems when 
the plant uses surface water or ground water under the direct influence 
of surface water, serves 10,000 or more people, and is required to 
filter its source water under the SWTR.

III. FDA Standards

A. The Agency's Approach to Bottled Water Quality Standards Established 
Under Section 410 of the FFDCA

    Under section 401 of the FFDCA (21 U.S.C. 341), FDA may issue a 
regulation establishing a standard of quality for a food under its 
common or usual name when the Secretary of Health and Human Services 
determines that such action will promote honesty and fair dealing in 
the interest of consumers. On November 26, 1973 (38 FR 32558), FDA 
established a quality standard for bottled water set forth in 
Sec. 165.110 (21 CFR 165.110).
    Producers of bottled water are responsible for ensuring, through 
appropriate manufacturing techniques and sufficient quality control 
procedures, that all bottled water products introduced or delivered for 
introduction into interstate commerce comply with the quality standard 
(Sec. 165.110(b)). Bottled water that is of a quality below the 
prescribed standard is required bySec. 165.110(c) to be labeled with a 
statement of substandard quality. Moreover, any bottled water 
containing a substance at a level that causes the food to be 
adulterated under section 402(a)(1) of the FFDCA (21 U.S.C. 342(a)(1)) 
is subject to regulatory action, even if the bottled water bears a 
label statement of substandard quality.
    FDA traditionally has fulfilled its obligation under section 410 of 
the FFDCA to respond to EPA's issuance of NPDWRs by amending the 
quality standard regulations for bottled water to maintain 
compatibility with EPA's public drinking water regulations. In general, 
FDA believes that, with few exceptions, EPA standards for contaminants 
in public drinking water are appropriate as allowable levels for 
contaminants in the quality standard for bottled water when bottled 
water may be expected to contain the same contaminants.
    FDA generally has not duplicated the efforts of EPA in judging the 
adequacy of MCLs or treatment techniques in NPDWRs for contaminants 
when determining their applicability to bottled water in order to 
protect the public health. FDA believes that it would be redundant for 
FDA to reevaluate the public drinking water standards prescribed by 
EPA. Further, because bottled water increasingly is used in some 
households as a replacement for tap water, consumption patterns 
considered by EPA for tap water can be used as an estimate for the 
maximum expected consumption of bottled water by some individuals. 
Therefore, in cases where bottled water is subject to the same 
contaminants as tap water, FDA believes it should establish standard of 
quality regulations for bottled water that are no less stringent and no 
less protective of the public health, respectively, than EPA's MCLs and 
treatment technique requirements.

B. The EPA's IESWTR and Bottled Water

    FDA has evaluated the treatment technique requirements for the 
reduction of Cryptosporidium in public drinking water established in 
EPA's IESWTR and finds that a standard of quality regulation for 
bottled water to reduce Cryptosporidium is not necessary to protect the 
public health.
    According to industry information (Ref. 2), approximately 75 
percent of bottled water sold in the United States originates from 
ground water (e.g., artesian well water, spring water, mineral water). 
Under the standard of identity regulations for bottled water 
(Sec. 165.110(a)), FDA has defined ground water as``* * * water from a 
subsurface saturated zone that is under a pressure equal to or greater 
than atmospheric pressure * * *. Ground water must not be under the 
direct influence of surface water as defined in 40 CFR 141.2.'' (See 21 
CFR 165.110(a)(2)(ii).) In an EPA Federal Register proposal (65 FR 
30194, May 10, 2000) to require a targeted risk-based regulatory 
strategy for all ground water systems to reduce public health risk 
associated with waterborne pathogens (Ground Water Rule), EPA stated 
that, when Cryptosporidium occurs in ground water systems, it occurs in 
ground water under the direct influence of surface water (65 FR 30194 
at 30204). In light of this, ground water, as defined in 
Sec. 165.110(a)(2)(ii), used for bottled water is not expected to 
contain the contaminantCryptosporidium because, by definition, it 
cannot be under the direct influence of surface water. Therefore, FDA 
concludes that

[[Page 35441]]

EPA's IESWTR establishing treatment technique requirements for 
Cryptosporidium in ground water under the influence of surface water 
does not apply to ground water used for the production of bottled 
water.
    In addition, according to industry information (Ref. 2), the 
remaining 25 percent of bottled water sold in the United States is 
derived from public water systems. Public water systems serving at 
least 10,000 people or more, using surface water or ground water under 
the direct influence of surface water, must comply with EPA's IESWTR. 
In the Federal Register of April 10, 2000 (65 FR 19046), EPA published 
a proposed rule (Long Term 1 Enhanced Surface Water Treatment and 
Filter Backwash Rule (LT1FBR)) to establish NPDWRs consisting of 
treatment technique requirements for reduction of Cryptosporidium in 
surface water and in ground water under the direct influence of surface 
water that public water systems serving less than 10,000 people use as 
their source water. Therefore, public water systems serving less than 
10,000 people using surface water or ground water under the direct 
influence of surface water, will be subject to any EPA final rule on 
LT1FBR. Thus, under the EPA's IESWTR and LT1FBR if finalized as 
proposed, all water obtained from public water systems used for bottled 
water would be treated previously by public water systems to reduce the 
contaminant Cryptosporidium.
    FDA concludes that because surface water and ground water under the 
direct influence of surface water would be subject to EPA's treatment 
technique requirements to reduce Cryptosporidium, a standard of quality 
regulation for bottled water derived from public water systems is not 
necessary to protect the public health. The contaminant may be 
contained in public water systems, which would be treated to reduce 
Cryptosporidium before such water would be used for bottled water. 
Further, because bottled water sources other than public drinking water 
are from ground water, which by definition (Sec. 165.110(a)(2)(ii)) 
must not be ground water under the direct influence of surface water, 
Cryptosporidium would not be expected to be present. Thus, FDA also 
concludes that a standard of quality regulation for bottled water 
derived from ground water is not necessary to protect the public health 
because Cryptosporidium would not be in ground water used for bottled 
water.

IV. References

    The following references are on display in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. MacKenzie, W. R., N. J. Hoxie, M. E. Proctor, M. S. Gradus, 
K. A. Blair, D. E. Peterson, J. J. Kazmierczak, D. G. Addiss, K. R. 
Fox, J. B. Rose, and J. P. Davis, ``A Massive Outbreak in Milwaukee 
of Cryptosporidium Infection Transmitted Through the Public Water 
Supply,'' New England Journal of Medicine 331:161-167 (1994).
    2. Yablonski, C., International Bottled Water Association, 
letter to Henry Kim, March 23, 2001.

    Dated: June 27, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16910 Filed 7-2-01; 4:22 pm]
BILLING CODE 4160-01-S