[Federal Register Volume 60, Number 218 (Monday, November 13, 1995)]
[Proposed Rules]
[Pages 57132-57133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27799]




[[Page 57131]]

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Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 165



Beverages; Bottled Water; Proposed Rule

  Federal Register / Vol. 60, No. 218 / Monday, November 13, 1995 / 
Proposed Rules   

[[Page 57132]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 95N-0203]


Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its regulations to exempt mineral water from the allowable level for 
aluminum in FDA's quality standard for bottled water. The agency is 
also proposing to update the testing methods referenced in the quality 
standard for bottled water. Elsewhere in this issue of the Federal 
Register, the agency is publishing a final rule to establish a standard 
of identity for bottled water. This proposal addresses two related 
issues that fell outside the scope of that rulemaking. FDA tentatively 
concludes that the proposed actions will promote honesty and fair 
dealing in the interest of consumers.

DATES: Written comments by January 29, 1996. The agency intends to make 
any final rule based upon this proposal effective 60 days following the 
date of publication of the final rule in the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Shellee A. Davis, 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

    -On January 5, 1993 (58 FR 393), FDA published a proposal in the 
Federal Register to establish a standard of identity in Sec.  
165.110(a) (21 CFR 165.110(a)) for bottled water. At the same time, the 
agency proposed to recodify the standard of quality for bottled water, 
which is currently found in Sec.  103.35 (21 CFR 103.35), to Sec.  
165.110(b), (c), and (d). In addition, FDA proposed to define 
``artesian water,'' ``ground water,'' ``mineral water,'' ``purified 
water,'' ``spring water,'' and ``well water.''
    -Elsewhere in this issue of the Federal Register, FDA is issuing a 
final rule that implements those proposed actions. However, two related 
issues, which fell outside the scope of that rulemaking, are discussed 
in this document along with the comments that the agency received on 
those matters.

A. Exemption for Aluminum

    In the January 5, 1993, proposal (58 FR 393 at 396), FDA proposed 
to include mineral water in the standard for bottled water and, thus, 
to subject mineral water to the requirements of the quality standard 
for bottled water. Some allowable levels in the quality standard are 
based on the Environmental Protection Agency (EPA) secondary maximum 
contaminant levels (SMCL's) that are established for aesthetic reasons 
and not for consumer safety. Mineral water with a high mineral content 
may not meet these allowable levels. Therefore, the agency tentatively 
concluded that certain aesthetically based allowable levels should not 
apply to mineral waters (58 FR 393 at 400). Elsewhere in this issue of 
the Federal Register, FDA is exempting mineral water from the allowable 
levels for color, odor, total dissolved solids, chloride, iron, 
manganese, sulfate, and zinc.
    FDA stated in the January 5, 1993, proposal that if it established 
an allowable level for aluminum, it would propose to exempt mineral 
water from that standard because the standard is intended to control 
aesthetic properties of the water, and not its effect on the body (58 
FR 393 at 401). EPA established an SMCL of 0.2 milligram per liter (mg/
L) for aluminum because of increased turbidity of the water and to 
prevent post-treatment precipitation in public water distribution 
systems ((56 FR 3526, January 30, 1991). On December 1, 1994 (59 FR 
61529), FDA established an allowable level of 0.2 mg/L for aluminum in 
bottled water in Sec.  103.35(d)(3)(iv) (recodified as Sec.  
165.110(b)(4)(iii)(D) elsewhere in this issue of the Federal Register).
    In response to the January 5, 1993, proposal, FDA received one 
comment that expressed concern about the proposed allowable level for 
aluminum in bottled water and with exempting aluminum in mineral water 
from the quality standard, because there are some data that suggest 
that there may be a link between aluminum and Alzheimer's Disease and 
other adverse health effects. It recommended that FDA maintain an 
allowable level of 0.2 mg/L for aluminum in all bottled water.
    The agency disagrees with the comment. EPA established a SMCL for 
aluminum to control aesthetic properties of the water (turbidity) and 
not its effect on the body. Aluminum has been found to be neurotoxic 
when injected into the brains of animals and in renal patients dosed 
inappropriately with aluminum salts. However, the current evidence 
suggests that aluminum neither causes Alzheimer's disease nor 
contributes to the expression of Alzheimer's disease (Ref. 1).
    Therefore, the agency tentatively concludes that it is appropriate 
to exempt mineral water from the allowable level of 0.2 mg/L for 
aluminum in Sec.  165.110(b)(4)(iii)(D) because it is an aesthetically-
based (turbidity) allowable level. Accordingly, the agency is proposing 
to add a footnote to the list of allowable levels in Sec.  
165.110(b)(4)(iii)(D) to provide that when water is labeled as 
``mineral water,'' it will be exempt from the allowable level for 
aluminum. FDA is not proposing to include bottled waters that are not 
conspicuously identified with the term ``mineral'' in this exemption 
because consumers will not generally expect to encounter aesthetic 
effects typical of high mineral content waters in these bottled waters 
products. In addition, the agency is not proposing to exempt mineral 
water from the allowable level for turbidity because high turbidity may 
interfere with disinfection and microbiological determinations. This 
exemption parallels the exemptions in Sec.  165.110(b)(3) and 
(b)(4)(i)(A) that FDA is establishing in a final rule published 
elsewhere in this issue of the Federal Register that exempts mineral 
water from certain other aesthetically based allowable levels.

B. Updating References

    In the proposal to establish a standard of identity for bottled 
water (58 FR 393, January 5, 1993), the agency proposed to update the 
methods referenced in Sec. 165.110(b)(2) and (b)(3) for testing water 
for the listed contaminants to the ``Standard Methods for the 
Examination of Water and Wastewater,'' 17th edition (1989). Several 
comments received in response to that proposal stated that 
Sec. 165.110(b)(2) and (b)(3) should be updated and should reference 
``Standard Methods for the Examination of Water and Wastewater,'' 18th 
edition (1992). However, because the agency failed to state in the 
proposal that it intended to update the references to the latest 
edition, the comments' requested change did not fall within the scope 
of that rulemaking, and a separate rulemaking was necessary to effect 
that change.
    Title 1, part 51 of the Code of Federal Regulations (1 CFR part 51) 
requires the filing and updating of material that has 

[[Page 57133]]
been incorporated by reference in the Code of Federal Regulations. The 
purpose of the requirement is to ensure the public availability and 
accuracy of material that has been incorporated from other sources.
    In the Federal Register of October 6, 1993 (58 FR 52042), FDA 
proposed to update the reference in Sec.  165.110(b)(2) to the 18th 
edition. The agency expects to adopt that modification in a final rule 
that will be published in the near future. However, to ensure the 
accuracy of methods for testing bottled water, that are referenced in 
Sec.  165.110(b)(3), FDA is proposing to update them to reference 
``Standard Methods for the Examination of Water and Wastewater,'' 18th 
edition (1992). If subsequent editions of the methods referenced are 
published before the completion of this rulemaking, the agency intends 
to update the references in Sec.  165.110(b)(2) and (b)(3) to reflect 
the most recent edition.

II. Environmental Impact

    -The agency has determined under 21 CFR 25.24(b)(1) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

III. Analysis of Impacts

    FDA has examined the impact of this proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess the 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). According to Executive 
Order 12866, a regulatory action is ``economically significant'' if it 
meets any one of a number of specified conditions, including having an 
annual effect on the economy of $100 million or adversely affecting in 
a material way a sector of the economy, competition, or jobs. A 
regulation is considered ``significant'' under Executive Order 12866 if 
it raises novel legal or policy issues. The Regulatory Flexibility Act 
requires agencies to minimize the economic impact of their regulations 
on small entities. FDA finds that this proposed rule is neither an 
economically significant nor significant regulatory action as defined 
by Executive Order 12866. In compliance with the Regulatory Flexibility 
Act, the agency certifies that the proposed rule will not have a 
significant impact on a substantial number of small entities.
    Updating the references is not expected to significantly affect the 
content of those references or the cost of complying with regulations 
citing those references. FDA requests comments on any costs generated 
by updating the references as proposed.
    Exempting mineral water from the allowable level for aluminum in 
bottled water does not represent a change from the current situation. 
There is currently no limitation on the amount of aluminum in mineral 
water. Similarly, there is no limitation on the amount of aluminum in 
mineral water under this proposal (other than a level that is injurious 
to health). The current situation is the baseline in comparison with 
which costs and benefits of proposed actions are measured. Therefore, 
there are neither costs nor benefits associated with exempting mineral 
water from the allowable level for aluminum in bottled water.

IV. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Humphreys, S., Contaminants, Standards, and Monitoring Branch 
(HFS-308F), Center for Food Safety and Applied Nutrition, Food and Drug 
Administration, memo to Shellee Davis, May 26, 1995.

V. Comments

    Interested persons may, on or before January 29, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 165

    Beverages, Bottled water, Food grades and standards.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 165 be amended as follows:

PART 165--BEVERAGES

    1. The authority citation for 21 CFR part 165 continues to read as 
follows:

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

    2. Section 165.110 is amended by revising the introductory text of 
paragraph (b)(3) and by revising paragraph (b)(4)(iii)(D) to read as 
follows:

Sec. 165.110   Bottled water.

* * * * *
    (b) * * *
    (3) Physical quality. Bottled water shall, when a composite of 
analytical units of equal volume from a sample is examined by the 
method described in applicable sections of ``Standard Methods for the 
Examination of Water and Wastewater,'' 18th ed. (1992), which is 
incorporated by reference (the availability of this incorporation by 
reference is given in paragraph (b)(2) of this section), meet the 
following standards of physical quality:
* * * * *
    (4) * * *
    (iii) * * *
    (D) The allowable levels for certain chemicals for which EPA has 
established secondary maximum contaminant levels in its drinking water 
regulations are as follows:

------------------------------------------------------------------------
                                                        Concentration in
                      Contaminant                        milligrams per 
                                                              liter     
------------------------------------------------------------------------
Aluminum..............................................              0.21
Silver................................................               0.1
------------------------------------------------------------------------
\1\ Mineral water is exempt from the allowable level. The exemption is  
  an aesthetically based allowable level and does not relate to a health
  concern.                                                              

* * * * *

    Dated: November 3, 1995.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 95-27799 Filed 11-7-95; 8:45 am]
BILLING CODE 4160-01-F