25764 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations

depository institution shall be deemed

to be a deposit by a trustee of trust funds

of which the noteholders or

bondholders are pro rata beneficiaries,

and the beneficial interest of each

noteholder or bondholder in the deposit

shall be separately insured up to

$100,000.

(d) Definition of ‘‘political

subdivision’’. The term ‘‘political

subdivision’’ includes drainage,

irrigation, navigation, improvement,

levee, sanitary, school or power

districts, and bridge or port authorities

and other special districts created by

state statute or compacts between the

states. It also includes any subdivision

of a public unit mentioned in

paragraphs (a)(2), (a)(3) and (a)(4) of this

section or any principal department of

such public unit:

(1) The creation of which subdivision

or department has been expressly

authorized by the law of such public

unit;

(2) To which some functions of

government have been delegated by

such law; and

(3) Which is empowered to exercise

exclusive control over funds for its

exclusive use.

§ 330.16 Effective dates.

(a) Prior effective dates. Former

§§ 330.1(j), 330.10(a), 330.12(c),

330.12(d)(3) and 330.13 (see 12 CFR part

330, as revised January 1, 1998) became

effective on December 19, 1993.

(b) Time deposits. Except with respect

to the provisions in former § 330.12 (a)

and (b) (see 12 CFR part 330, as revised

January 1, l998) and current § 330.14(a)

and (b), any time deposits made before

December 19, 1991 that do not mature

until after December 19, 1993, shall be

subject to the rules as they existed on

the date the deposits were made. Any

time deposits made after December 19,

1991 but before December 19, 1993,

shall be subject to the rules as they

existed on the date the deposits were

made. Any rollover or renewal of such

time deposits prior to December 19,

1993 shall subject those deposits to the

rules in effect on the date of such

rollover or renewal. With respect to time

deposits which mature only after a

prescribed notice period, the provisions

of this part shall be effective on the

earliest possible maturity date after June

24, 1993 assuming (solely for purposes

of this section) that notice had been

given on that date.

By order of the Board of Directors.

Dated at Washington, D.C., this 28th day of

April, 1998.

Federal Deposit Insurance Corporation.

Robert E. Feldman,

Executive Secretary.

[FR Doc. 98–11987 Filed 5–8–98; 8:45 am]

BILLING CODE 6714–01–P

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.

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-andcomment 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

§ 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,
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations 25765

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
25766 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations

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

Type of EstablishmentStandard Industry Classification Codes Classification of Small Entities Percentage of Category Defined as Small by SBANo. of Small Establishments

Covered by the Rule

IBWA NA Annual Sales below $1million 50% 280
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations 25767

TABLE 1.—APPROXIMATE NUMBER OF SMALL ENTITIES COVERED BY THIS RULE—Continued

Type of EstablishmentStandard Industry Classification Codes Classification of Small Entities Percentage of Category Defined as Small by SBANo. of Small Establishments

Covered by the Rule

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

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

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

Percent Water from

Nonmunicipal

Sources

Subtotal Annual

Cost

Lower Bound–280 $1,290 50% $180,600

Upper Bound–1028 $1,290 50% $663,060

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

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

Products

Subtotal Annual

Cost

Lower Bound–280 $1,290 2 $722,400

Upper Bound–1028 $1,290 2 $2,652,240

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

No. of Small Establishments Covered by the Rule

Subtotal Costs for

Testing Source Waters

Subtotal Costs for

Testing Finished

Bottled Water Products

Total Testing Costs1

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

Upper Bound–1028 $660,060 $2,652,240 $3,000,000

1Total 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.
25768 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations

TABLE 5.—SMALL BUSINESS RECORDKEEPING REQUIREMENTS

Provision No. of Small Entities

Keeping Records Annual Frequency Hours per Recordper Small Entity

Total Hours, First

Year

Total Hours, Subsequent Years

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

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 § 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 Stateissued 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
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 /Rules and Regulations 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.

§ 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

DEPARTMENT OF JUSTICE

Parole Commission

28 CFR Part 2

Paroling, Recommitting, and

Supervising Federal Prisoners:

Expedited Revocation Procedure for

Parole Violators

AGENCY: Parole Commission, Justice.

ACTION: Final rule.

SUMMARY: The U.S. Parole Commission

is adding to its regulations a provision

whereby certain parolees who have been

arrested and charged with violations of

parole (or who are serving new

sentences for crimes committed while

on parole) may consent to revocation of

parole upon the acceptance of a

sanction within the applicable guideline

range. The purpose of this procedure is

to avoid the need for holding parole

violators in local jails for revocation

hearings, and to save the Parole

Commission the time and expense of

conducting hearings when an

appropriate sanction can be imposed

with the consent of the offender.

DATES: Effective June 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Pamela A. Posch, Office of General