Beverages: Bottled Water; Companion Document to Direct Final Rule

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 98N-0294]

Beverages: Bottled Water; Companion Document to Direct Final Rule

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 lift the stay of the effective date for the

allowable levels in the bottled water quality standard for nine

chemical contaminants, i.e., antimony, beryllium, cyanide, nickel,

thallium, diquat, endothall, glyphosate, and 2,3,7,8-TCDD (dioxin),

that was imposed in a final rule published on March 26, 1996. By

lifting the stay of the effective date, bottled water manufacturers

will be required to monitor source waters and finished bottled water

products at least once a year for these nine chemical contaminants

under the current good manufacturing practice (CGMP) regulations for

bottled water. FDA is required to issue monitoring requirements for the

nine chemical contaminants under the Safe Drinking Water Act Amendments

of 1996 (SDWA Amendments). This proposed rule is a companion to the

direct final rule published elsewhere in this issue of the Federal

Register.

DATES: Submit written comments by July 27, 1998. See section VIII. of

this document for the proposed effective date of a final rule based on

this document.

ADDRESSES: Submit written comments on the companion proposed rule to

the Dockets Management Branch (HFA-305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and

Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St.

SW., Washington, DC 20204, 202-260-0631.

SUPPLEMENTARY INFORMATION:

I. Background

This proposed rule is a companion to the direct final rule

published in the final rules section of this issue of the Federal

Register. The companion proposed rule and the direct final rule are

substantively identical. This companion proposed rule will provide the

procedural framework to finalize the rule in the event the direct final

rule receives significant adverse comment and is withdrawn. The comment

period for the companion proposed rule runs concurrently with the

comment period of the direct final rule. Any comments received under

the companion proposed rule will be treated as comments regarding the

direct final rule. FDA is publishing the direct final rule because the

agency anticipates that it will receive no significant adverse comment.

A detailed discussion of this rule is set forth in section II of the

direct final rule. If no significant adverse comment is received in

response to the direct final rule, no further action will be taken

related to this proposed rule. Instead, FDA will publish a confirmation

notice no later than August 6, 1998. FDA intends the direct final rule

to become effective 180 days after publication of the confirmation

notice. If FDA receives significant adverse comment, the agency will

withdraw the direct final rule. FDA will proceed to respond to all of

the comments received regarding the rule, and, if appropriate, the rule

will be finalized under this companion proposed rule using notice-and-

comment procedure. The comment period for this companion proposed rule

runs concurrently with the comment period for the direct final rule.

Any comments received under this companion proposed rule will also be

considered as comments regarding the direct final rule.

Before the enactment of the SDWA Amendments on August 6, 1996,

section 410 of the Federal Food, Drug, and Cosmetic Act (the act) (21

U.S.C. 349) required that, whenever the Environmental Protection Agency

(EPA) prescribed interim or revised National Primary Drinking Water

Regulations (NPDWR's) under section 1412 of the Public Health Service

Act SDWA (42 U.S.C. 300f through 300j-9)), FDA consult with EPA and

either amend its regulations for bottled drinking water in Sec. 165.110

(21 CFR 165.110) or publish in the Federal Register its reasons for not

making such amendments.

In accordance with section 410 of the act, FDA published in the

Federal Register of March 26, 1996 (61 FR 13258), a final rule

(hereinafter ``the March 1996 final rule'') that amended the quality

standard for bottled water by establishing or revising the allowable

levels for 5 inorganic chemicals (IOC's) and 17 synthetic organic

chemicals (SOC's), including 3 synthetic volatile organic chemicals

(VOC's), 9 pesticide chemicals, and 5 nonpesticide chemicals. This

action was in response to EPA's issuance of NPDWR's consisting of

maximum contaminant levels (MCL's) for the same 5 IOC's and 17 SOC's in

public drinking water (57 FR 31776; July 17, 1992).

However, in the March 1996 final rule, FDA stayed the effective

date for the allowable levels for the five IOC's (antimony, beryllium,

cyanide, nickel, and thallium) and four of the SOC's (diquat,

endothall, glyphosate, and dioxin). This action was in response to

bottled water industry comments (responding to the August 4, 1993

proposal (58 FR 41612)) which asserted that additional monitoring for

these nine chemicals required under the bottled water CGMP regulations

would pose an undue economic burden on bottlers. If the agency had not

stayed the effective date for the allowable levels, the bottled water

CGMP regulations under 21 CFR part 129 (part 129) would have been in

effect for these nine chemical contaminants. The bottle water CGMP

regulations require a minimum yearly monitoring of source water and

finished bottled water products for chemical contaminants for which

allowable levels have been established in the bottled water quality

standard. The comments requested that FDA adopt reduced frequency

monitoring requirements for chemical contaminants that are not likely

to be present in the source water for bottling or in the finished

bottled water products. The comments submitted data that supported the

request that FDA reconsider the current monitoring frequency

requirements for chemical contaminants in the bottled water CGMP

regulations.

Based on the information submitted by the comments, FDA stated in

the March 1996 final rule (61 FR 13258 at 13261) that the matter of

reduced frequency of monitoring (less frequently than once per year)

requirements for chemical contaminants that are not likely to be found

in bottled water merited consideration by the agency. FDA also stated,

however, that any revision of the monitoring requirements for chemical

contaminants in bottled water would require an amendment of the bottled

water CGMP regulations in part 129. FDA stated that it intended to

initiate, considering its resources and competing priorities, a

separate rulemaking to address the issue of

[[Page 25790]]

circumstances in which reduced frequency of monitoring requirements for

chemical contaminants in bottled water products may be appropriate.

Therefore, FDA stayed the effective date for the nine chemical

contaminants pending completion of a rulemaking to address the issue of

reduced frequency monitoring for chemical contaminants in bottled

water. Although the effect of the stay does not require bottled water

manufacturers to monitor source waters and finished bottled water

products annually for the nine chemical contaminants, FDA advised water

bottlers to ensure through appropriate manufacturing techniques and

sufficient quality control procedures that their bottled water products

are safe with respect to levels of these nine chemical contaminants.

II. Additional Information

For additional information see the corresponding direct final rule

published elsewhere in this issue of the Federal Register. All persons

who wish to submit comments should review the detailed rationale for

these amendments set out in the preamble discussion of the direct final

rule.

A significant adverse comment is one that explains why the rule

would be inappropriate, including challenges to the rule's underlying

premise or approach, or would be ineffective or unacceptable without a

change. A comment recommending a rule change in addition to the rule

will not be considered a significant adverse comment, unless the

comment states why this rule would be ineffective without the

additional change. In addition, if a significant adverse comment

applies to part of a rule and that part can be severed from the

remainder of the rule, FDA may adopt as final those parts of the rule

that are not the subject of a significant adverse comment.

III. Proposal to Lift the Stay

Subsequent to the March 1996 final rule, on August 6, 1996, the

SDWA Amendments was enacted. Section 305 of the SDWA Amendments

requires that, for contaminants covered by a standard of quality

regulation issued by FDA before the enactment of the SDWA Amendments

for which an effective date had not been established, FDA issue

monitoring requirements for such contaminants (e.g., the nine chemical

contaminants: Antimony, beryllium, cyanide, nickel, thallium, diquat,

endothall, glyphosate, and dioxin) not later than 2 years after the

date of enactment of the SDWA Amendments. Under this mandate, FDA is

required to issue monitoring requirements for the nine chemical

contaminants for which it stayed the effective date in the March 1996

final rule by August 6, 1998, with an effective date of February 6,

1999. If FDA does not meet this statutory time period, the NPDWR's for

the nine chemical contaminants become applicable to bottled water.

FDA is proposing to lift the stay of the effective date for the

allowable levels for the nine chemical contaminants (antimony,

beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate,

and dioxin) for the following reasons: First, the agency's CGMP

regulations for bottled water, which require that source waters and

finished bottled water products be tested for these nine contaminants

at least once a year, are protective of the public health. The agency

considers at least annual testing, as set forth in its CGMP regulations

in part 129, to be of sufficient frequency, absent circumstances that

may warrant more frequent testing, to ensure that bottled water has

been prepared, packed, or held under sanitary conditions. Second,

Congress mandated, under the SDWA Amendments, that the agency issue

monitoring requirements for the nine chemical contaminants by August 6,

1998. The agency's action to lift the stay is consistent with this

mandate. By lifting the stay of the effective date for the allowable

levels for the nine chemical contaminants in the bottled water quality

standard, bottled water manufacturers will be required to monitor

source waters and finished bottled water products at least once a year

for these nine chemical contaminants under the CGMP provisions in part

129. Third, FDA, in the March 1996 final rule, stated that it intended

to initiate rulemaking to address the issue of whether there are

circumstances in which reduced frequency of monitoring for contaminants

is appropriate. However, such rulemaking would require consideration of

all chemical contaminants, not just the nine chemical contaminants that

are the subject of the stay. FDA is only addressing, in this

rulemaking, the frequency of monitoring for the nine chemical

contaminants that are the subject of the stay. FDA may consider, in a

future rulemaking, the issue of reduced frequency of monitoring in the

context of all chemical contaminants in bottled water subject to the

bottled water CGMP regulations in part 129. Therefore, the agency is,

at this time, electing to lift the stay of the effective date for the

allowable levels in the bottled water quality standard for the nine

chemical contaminants, i.e., antimony, beryllium, cyanide, nickel,

thallium, diquat, endothall, glyphosate, and dioxin, and thereby

require annual testing for these nine contaminants, consistent with the

CGMP requirements for bottled water.

IV. Environmental Impact

The agency has determined under 21 CFR 25.32(a) 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.

V. Analysis of Economic Impacts

A. Benefit-Cost Analysis

FDA has examined the impacts of this proposed rule under Executive

Order 12866. 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 effects; distributive impacts; and equity). According to

Executive Order 12866, a regulatory action is ``significant'' if it

meets any one of a number of specified conditions, including having an

annual effect on the economy of $100 million, adversely affecting in a

material way a sector of the economy, competition, or jobs, or if it

raises novel legal or policy issues. FDA finds that this proposed rule

is not a significant regulatory action as defined by Executive Order

12866. In addition, it has been determined that this proposed rule is

not a major rule for the purpose of congressional review. For the

purpose of Congressional review, a major rule is one which is likely to

cause an annual effect on the economy of $100 million; a major increase

in costs or prices; significant effects on competition, employment,

productivity, or innovation; or significant effects on the ability of

U.S.-based enterprises to compete with foreign-based enterprises in

domestic or export markets.

B. Initial Regulatory Flexibility Analysis

FDA has examined the impact of the rule as required by the

Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). If a rule has a

significant economic impact on a substantial number of small entities,

the RFA requires agencies to analyze options that would minimize the

economic impact of that rule on small entities. The agency acknowledges

that the proposed rule may have a significant economic impact on a

[[Page 25791]]

substantial number of small entities. If the agency receives any

significant adverse comments to the direct final rule, the agency will

withdraw the direct final rule and proceed with the rulemaking based on

this proposed rule. In the context of the rulemaking based on this

proposed rule, the agency will consider comments to the initial

regulatory flexibility analysis.

1. Objectives

The RFA requires a succinct statement of the purpose and objectives

of any rule that may have a significant economic impact on a

substantial number of small entities. The agency is taking this action

to lift the stay for nine chemical contaminants under a congressional

mandate, under the SDWA Amendments, that FDA issue monitoring

requirements for these nine chemical contaminants in bottled water.

Lifting the stay of the effective date for the allowable levels in the

bottled water quality standard for the nine chemical contaminants

(antimony, beryllium, cyanide, nickel, thallium, diquat, endothall,

glyphosate, and dioxin) protects the public health. By lifting the

stay, bottled water manufacturers will be required to monitor source

waters and finished bottled water products at least once a year for the

nine chemical contaminants under the bottled water CGMP regulations in

part 129. The agency considers at least annual testing, as set forth in

its CGMP regulations, to be of sufficient frequency, absent

circumstances that may warrant more frequent testing, to ensure that

bottled water has been prepared, packed, or held under sanitary

conditions.

2. Description of Small Business and the Number of Small Businesses

Affected

The RFA requires a description of small businesses used in the

analysis and an estimate of the number of small businesses affected, if

such estimate is available. Table 1 describes small businesses affected

and estimates the number of small businesses affected by the rule. The

agency combined the Small Business Administration (SBA) definition of a

small business as an upper bound of the total number in the analysis

with data from Duns Market Identifiers (DMI) on the number of plants

using SIC 2086. FDA has used the International Bottled Water

Association (IBWA) estimate as a lower bound of the number of small

entities in the industry. According to DMI, there are a total of 1,567

establishments in the industry group of which 66 percent of the

entities (1,028 firms) have fewer than 500 employees. According to

IBWA, there are approximately 560 member firms, of which 50 percent or

280 firms have annual sales below $1 million.

Table 1.--Approximate Number of Small Entities Covered by This Rule

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Percentage of No. of Small

Type of establishment Standard Industry Classification of Category Defined as Establishments

Classification Codes Small Entities Small by SBA Covered by the Rule

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IBWA NA Annual sales below $1 50% 280

million

DMI 2,086 Less than 500 66% 1,028

employees

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3. Description of the Economic Impact on Small Entities.

a. Estimated costs for testing source waters. The estimated costs

for testing source waters are the estimated total additional costs the

small entity would incur to monitor source waters for the nine chemical

contaminants annually. Table 2 summarizes the expected additional

costs. As discussed in the March 1996 final rule (61 FR 13258 at

13263), additional cost per sample is estimated to be $1,290, and an

estimated 50 percent of source waters are from municipal sources that

do not require testing.

Table 2.--Estimated Subtotal Costs for Testing Source Waters

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No. of Small Percent Water

Establishments From Subtotal Annual

Covered by the Cost per Sample Nonmunicipal Cost

Rule Sources

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Lower bound-280 $1,290 50% $180,600

Upper bound-1,028 $1,290 50% $663,060

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b. Estimated costs for testing finished bottle water products. The

estimated costs for testing are the estimated total additional costs

the small entity would incur to monitor finished bottled water products

for the nine chemical contaminants annually. Table 3 summarizes the

expected costs. As discussed in the March 1996 final rule (61 FR 13258

at 13263), additional cost per sample is estimated to be $1,290.

Table 3.--Estimated Subtotal Costs for Testing Finished Bottle Water

Products

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No. of Small

Establishments Average Number Subtotal Annual

Covered by the Cost per Sample of Products Cost

Rule

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Lower bound-280 $1,290 2 $722,400

Upper bound-1,028 $1,290 2 $2,652,240

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c. Estimated total costs for testing source waters and finished

bottled water products. The estimated total testing costs are the sum

of estimated costs to monitor source waters and finished bottled water

products . The agency estimates that the lower bound cost is $900,000

and the upper bound cost is $3 million. Table 4 summarizes the expected

additional costs.

[[Page 25792]]

Table 4.--Estimated Total Costs

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No. of Small Subtotal Costs

Establishments Subtotal Costs for Testing Total Testing

Covered by the for Testing Finished Bottled Costs1

Rule Source Waters Water Products

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Lower bound-280 $180,600 $722,400 $900,000

Upper bound-1,028 $660,060 $2,652,240 $3,000,000

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\1\ Total Testing Costs are rounded to the nearest significant digit.

d. Professional skills required for compliance. The RFA requires a

description of the professional skills necessary for the preparation of

a report or record. This rule does not require professional skills for

the preparation of a report or record. Any sampling of source water or

finished bottled water product for analysis of chemical contaminants

can be carried out by trained plant personnel who can ship such samples

to a testing laboratory for analysis. Other trained skills would also

include recording and maintaining the test result records at the plant

for a minimum of 2 years.

e. Recordkeeping requirements. The RFA requires a description of

the recordkeeping requirements of the rule. Table 5 shows the

provisions for making and maintaining records by small businesses, the

number of small businesses affected, the annual frequency of making

each record, the amount of time needed for making each record, and the

total number of hours for each provision in the first year and then in

subsequent years.

Table 5.--Small Business Recordkeeping Requirements

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No. of Small

Entities Annual Hours per Total Hours, Total Hours,

Provision Keeping Frequency Record per First Year Subsequent

Records Small Entity Years

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Monitoring SOP 280 1 10 2,800 2,800

Monitoring SOP 1,028 1 10 10,280 10,280

Validation 280 1 5 1,400 1,400

Validation 1,028 1 5 5,140 5,140

Record maintenance 280 1 5 1,400 1,400

Record maintenance 1,028 1 5 5,140 5,140

Totals-lower bound 280 1 20 5,600 5,600

Totals-upper bound 1,028 1 20 20,560 20,560

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4. Minimizing the Burden to Small Entities

The RFA requires an evaluation of any regulatory alternatives that

would minimize the costs to small entities. There are four alternatives

that the agency has considered to provide regulatory relief for small

entities. First, FDA considered the option of not lifting the stay of

the effective date for the allowable levels in the bottled water

quality standard for the nine chemical contaminants. Second, FDA

considered the option of exempting small entities from the requirements

of this rule. Third, FDA considered lengthening the compliance period

for small entities. Fourth, FDA considered reducing the testing

frequency.

a. Not lifting the stay. By convention, the option of taking no

action is the baseline in comparison with the evaluation of the other

options. Taking no action in this case means not lifting the stay of

the effective date for the allowable levels in the bottled water

quality standard for the nine chemical contaminants. By not lifting the

stay, FDA would not meet the statutory mandate provided in the SDWA

Amendments that requires the agency to issue monitoring requirements

for the nine chemical contaminants by August 6, 1998. If FDA does not

issue monitoring requirements by August 6, 1998, the NPDWR's for public

drinking water for these nine contaminants would be considered to be

the standard of quality regulations for bottled water under

Sec. 165.110. Under the NPDWR's, EPA's base monitoring requirements for

ground water testing are once every 3 years for testing inorganic

chemicals (e.g., antimony, beryllium, cyanide, nickel, and thallium),

and four successive quarters every 3 years for ground water testing for

synthetic organic chemicals (e.g., diquat, endothall, glyphosate, and

dioxin). Under part 129, FDA requires at least annual testing for both

the inorganic and synthetic organic chemicals. Therefore, the frequency

of testing requirements under EPA's NPDWR's for public drinking water

and FDA's frequency of testing requirements for bottled water differ.

Moreover, the regulatory scheme under EPA's regulations for public

drinking water contemplates State coordination, including the use of

state-issued waivers in certain situations. EPA regulations address

treated ground and surface water testing, whereas FDA's regulations

address source water (which in most cases involves testing of untreated

ground water) and finished bottled water product testing. Source water

testing provides a preliminary review of the safety and quality of the

water source that a water bottler intends to manufacture into a bottled

water product. FDA considers source water testing to be as important as

finished bottled water product testing because the safety and quality

of the source water, determined by source water testing, will affect

the treatment necessary to produce a finished bottled water product

that complies with the bottled water quality standard. However, if

EPA's regulatory scheme for public drinking water would need to be

considered for the nine chemical contaminants that are the subject of

this rule for bottled water, it is unclear whether only finished

bottled water product testing for these nine chemical contaminants, in

lieu of source water testing, would be applicable. Furthermore, EPA's

monitoring requirements are designed to address water that is provided

to customers through municipal water distribution systems while FDA's

requirements address water that is produced to be sold to consumers in

discrete units. Some differences between these two sets of monitoring

requirements exist (e.g.,

[[Page 25793]]

criteria for determining when a system (or bottler) is not in

compliance), because they address two fundamentally different

production circumstances. FDA believes that its regulations for bottled

water, which are designed to ensure that bottled water is prepared,

packed, and held under sanitary conditions, should apply to the testing

for these nine chemical contaminants in bottled water rather than

having such contaminants subject to a regulatory scheme established for

public drinking water.

Furthermore, the extent to which FDA would consider certain aspects

of EPA's regulatory scheme for public drinking water as ``monitoring

requirements'' is not clear. FDA has not had to apply EPA's regulations

for public drinking water to bottled water under the bottled water

quality standard regulations. Therefore, if FDA did not lift the stay

and issue monitoring requirements under the agency's CGMP requirements

in part 129 for these nine chemical contaminants, the application of

section 410(b)(4)(A) of the act would create uncertainty for industry

and regulators. The practical effect of the application of section

410(b)(4)(A) of the act may be additional burdens on small businesses

if such businesses must adhere to two regulatory schemes for testing of

their bottled water products rather than one comprehensive scheme for

all bottled water testing. As stated earlier, FDA's CGMP requirements

are protective of the public health and the application of these CGMP

requirements to all bottled water would not result in uncertainty to

industry and regulators. As discussed in option d of this section of

this document, FDA believes that retaining the applicability of its

CGMP requirements to all bottled water, with further evaluation of

reduced frequency of testing in the context of all chemical

contaminants in a future rulemaking, would be less confusing to small

entities. Therefore, FDA believes that lifting the stay would be

beneficial to the public.

b. Exempt small entities. One alternative for alleviating the

burden for small entities would be to exempt them from the testing

requirements of this rule. Although, this option would eliminate the

cost of testing on small firms, it may also result in a decrease in the

potential public health benefits of the rule. Small entities comprise a

large part of the affected industry and exempting them would affect the

testing requirements for a large segment of the bottled water products

on the market. Such products would not be subject to a certain

frequency of testing that provides adequate assurance that such

products manufactured by small businesses are as protective of the

public health as those that have undergone the testing requirements for

these nine contaminants under part 129. Therefore, exempting small

businesses would reduce the potential public health benefits of lifting

the stay.

c. Extend compliance period. FDA considered an extended compliance

period. Lengthening the compliance period would provide regulatory

relief to small entities because it would reduce the present value of

the costs of testing. However, as stated in option b of section V.B.4.c

of this document, because small entities comprise a large part of the

affected industry, longer compliance periods would delay any potential

public health benefits of the rule. For example, if a small business

had an excess level of one of the nine chemical contaminants in its

bottled water product, it would not be aware of the potential public

health problem as a result of the specific contaminant because the

small business would not be testing during the longer compliance

period. Therefore, the agency has concluded that the lifting the stay

is more protective of the public health.

d. Reduced testing frequency Another alternative for alleviating

the burden for small entities would be to reduce the testing frequency

for certain chemical contaminants, including the nine chemical

contaminants that are the subject of this rule. The agency believes

that, in considering the issue of reduced frequency of testing, it

needs to do so in the context of all chemical contaminants, not just

the nine that are the subject of this rule. Reduced frequency of

testing may include an entirely different scheme that may include

waivers for certain chemical contaminants. The contemplation of such a

scheme is better addressed in a context that includes consideration of

all chemical contaminants, rather than considering and implementing a

different regulatory scheme for only the nine chemical contaminants.

Moreover, Congress mandated that the agency issue monitoring

requirements for these nine chemical contaminants by August 6, 1998.

Because the scope of this rule is limited to these nine chemical

contaminants, and the agency does not have sufficient time to enlarge

the scope of this rulemaking to the issue of reduced frequency of

testing for all chemical contaminants, the agency is not pursuing this

alternative in this rulemaking. However, the agency plans to consider

the issue of reduced frequency of monitoring for all chemical

contaminants in bottled water in a future rule.

5. Summary

FDA has examined the impact of the proposed rule on small

businesses in accordance with the RFA. This analysis, together with the

preamble, constitutes the RFA.

C. Unfunded Mandates Reform Act of 1995

FDA has examined the impacts of this proposed rule under the

Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule

does not require a written statement under section 202(a) of the UMRA

because it does not impose a mandate that results in an expenditure of

$100 million (adjusted annually for inflation) or more by State, local,

and tribal governments in the aggregate, or by the private sector, in

any 1 year.

VI. Paperwork Reduction Act of 1995

FDA tentatively concludes that this companion proposed rule

contains no collections of information. Therefore, clearance by the

Office of Management and Budget under the Paperwork Reduction Act of

1995 is not required.

VII. Comments

Interested persons may, on or before July 27, 1998, 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.

VIII. Effective Date

The agency intends to make any final rule based on this proposal

effective 180 days following the date of publication of the final rule

in the Federal Register. The agency is providing this time period to

permit affected firms adequate time to take appropriate steps to bring

their product into compliance with the standard imposed by the new

rule.

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:

[[Page 25794]]

Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

Sec. 165.110 [Amended]

2. Section 165.110 Bottled water is amended in the table in

paragraph (b)(4)(iii)(A) by removing the superscript ``1'' after the

entries for ``Antimony,'' ``Beryllium,'' ``Cyanide,'' ``Nickel,'' and

``Thallium,'' and by removing the footnote to the table; in the table

in paragraph (b)(4)(iii)(C) by removing the superscript ``1'' after the

entries for ``Diquat,'' ``Endothall,'' ``Glyphosate,'' and ``2,3,7,8-

TCDD (Dioxin),'' and by removing the footnote to the table; and by

removing the note that follows paragraph (b)(4)(iii)(G)(3)(iv).

Dated: May 5, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-12382 Filed 5-6-98; 3:57 pm]

BILLING CODE 4160-01-F