Beverages: Bottled Water

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 98N-0294]

Beverages: Bottled Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending 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). FDA is using direct final rulemaking for this

action because the agency expects that there will be no significant

adverse comment on the rule. Elsewhere in this issue of the Federal

Register, FDA is publishing a companion proposed rule under FDA's usual

procedure for notice-and-comment rulemaking to provide a procedural

framework to finalize the rule in the event the agency receives

significant adverse comments and withdraws this direct final rule. The

companion proposed rule and direct final rule are substantively

identical.

DATES: The regulation is effective November 9, 1998. Submit written

comments by July 27, 1998. If no timely significant adverse comments

are received, the agency will publish a notice in the Federal Register

no later than August 6, 1998, confirming the effective date of the

direct final rule. If timely significant adverse comments are received,

the agency will publish a notice of significant adverse comment in the

Federal Register withdrawing this direct final rule no later than

August 6, 1998.

ADDRESSES: Submit written comments 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

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 (see 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,

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the bottled water CGMP regulations under part 129 (21 CFR part 129)

would have been in effect for these nine chemical contaminants. The

bottled 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 (part 129). FDA stated that it intended to

initiate, considering its resources and competing priorities, a

separate rulemaking to address the issue of 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. Direct Final Rulemaking

FDA has determined that the subjects of this rulemaking are

suitable for a direct final rule. The actions taken should be

noncontroversial and the agency does not anticipate receiving any

significant adverse comments.

FDA is lifting the stay for the nine chemical contaminants for

which the agency stayed the effective date in the March 1996 final

rule. By lifting the stay, the bottled water CGMP requirements for

annual testing for the nine chemical contaminants will become

effective. This action will 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 receive significant adverse comment on or before

July 27, 1998, the agency will publish a notice in the Federal Register

no later than August 6, 1998, confirming the effective date of the

direct final rule. The agency intends to make the direct final rule

effective 180 days after publication of the confirmation notice in the

Federal Register.

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. In determining whether a significant adverse comment is

sufficient to terminate a direct final rulemaking, FDA will consider

whether the comment raises an issue serious enough to warrant a

substantive response in a notice-and-comment process. Comments that are

frivolous, insubstantial, or outside the scope of the rule will not be

considered adverse under this procedure. 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. If timely significant adverse comments are received, the

agency will publish a notice of significant adverse comment in the

Federal Register withdrawing this direct final rule no later than

August 6, 1998.

The companion proposed rule, which is substantively identical to

the direct final rule, provides a procedural framework within which the

rule may be finalized in the event the direct final rule is withdrawn

because of significant adverse comment. The comment period for the

direct final rule runs concurrently with that of the companion proposed

rule. Any comments received under the companion proposed rule will be

treated as comments regarding the direct final rule. Likewise,

significant adverse comments submitted to the direct final rule will be

considered as comments to the companion proposed rule and the agency

will consider such comments in developing a final rule. FDA will not

provide additional opportunity for comment on the companion proposed

rule. A full description of FDA's policy on direct final rule

procedures may be found in a guidance document published in the Federal

Register of November 21, 1997 (62 FR 62466).

III. Action to Lift the Stay

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

SDWA Amendments were 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.

For the reasons set forth in this document, FDA is lifting 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). 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

[[Page 25766]]

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, in

the March 1996 final rule, FDA 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 (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 direct final rule under

Executive Order 12866. 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). 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 direct final rule is not a significant regulatory

action as defined by Executive Order 12866. In addition, it has been

determined that this direct final 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. Final 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 direct final rule may have a significant economic impact on a

substantial number of small entities. The agency is not, in this

analysis, addressing comments received in response to an initial

regulatory flexibility analysis. The nature of the direct final rule

provides for a companion proposed rule published at the same time as

the direct final rule. An initial regulatory flexibility analysis is

contained in the companion proposed rule. The agency is publishing the

direct final rule because the agency does not anticipate any

significant adverse comment. Should the agency receive any significant

adverse comment in response to the direct final rule, the agency will

withdraw the direct final rule and use the companion proposed rule in

developing a final rule.

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 of this document 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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Standard Industry Classification of Small Percentage of Category No. of Small Establishments

Type of Establishment Classification Codes Entities Defined as Small by SBA Covered by the Rule

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IBWA NA Annual Sales below $1million 50% 280

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

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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 of this document 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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Percent Water from

No. of Small Establishments Covered by the Rule Cost per Sample Nonmunicipal Subtotal Annual

Sources Cost

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

Upper Bound-1028 $1,290 50% $663,060

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b. Estimated costs for testing finished bottled 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 of this document

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 Bottled Water Products

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Average Number of Subtotal Annual

No. of Small Establishments Covered by the Rule Cost per Sample Products Cost

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

Upper Bound-1028 $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 of this document

summarizes the expected additional costs.

Table 4.--Estimated Total Costs

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Subtotal Costs for

Subtotal Costs for Testing Finished Total Testing

No. of Small Establishments Covered by the Rule Testing Source Bottled Water Costs\1\

Waters Products

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

Upper Bound-1028 $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 of this document

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.

[[Page 25768]]

Table 5.--Small Business Recordkeeping Requirements

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No. of Small

Provision Entities Keeping Annual Frequency Hours per Record Total Hours, First Total Hours,

Records per Small Entity Year Subsequent 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 1028 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 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 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,

without 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., 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, or

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 below in section V.B.3.d 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

[[Page 25769]]

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 section V.B.4.b 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 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 direct final rule on small

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

preamble, constitutes RFA.

C. Unfunded Mandates Reform Act of 1995

FDA has examined the impacts of this direct final 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 one year.

VI. Paperwork Reduction Act of 1995

FDA concludes that this direct final 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 direct final rule. 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 the direct final rule effective 180 days

after the publication of the confirmation notice in the Federal

Register. The agency is providing a 180 day effective date 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, 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

165 is amended as follows:

PART 165--BEVERAGES

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

follows:

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. 98-12381 Filed 5-6-98; 3:57 pm]

BILLING CODE 4160-01-F