Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules 25789

Issued in Kansas City, Missouri, on May 4,

1998.

Marvin R. Nuss,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 98–12383 Filed 5–8–98; 8:45 am]

BILLING CODE 4910–13–U

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.

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-andcomment 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

§ 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
25790 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules

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
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules 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

Type of establishment Standard Industry Classification Codes

Classification of Small EntitiesPercentage of Category

Defined as Small by SBA

No. of Small Establishments Covered by the

Rule

IBWA NA Annual sales below $1 million50% 280

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

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

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-1,028 $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 summarizes the

expected additional costs.
25792 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules

TABLE 4.—ESTIMATED TOTAL COSTS

No. of Small Establishments Covered by the RuleSubtotal 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-1,028 $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 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

Provision

No. of Small

Entities Keeping Records

Annual Frequency

Hours per

Record per

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 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

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’s 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’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.,
Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules 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:
25794 Federal Register / Vol. 63, No. 90 / Monday, May 11, 1998 / Proposed Rules

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. 98–12382 Filed 5–6–98; 3:57 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 98N–0249]

Ear, Nose, and Throat Devices;

Classification of the Nasal Dilator, the

Intranasal Splint, and the Bone Particle

Collector

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

classify the nasal dilator, intranasal

splint, and the bone particle collector

into class I and exempt these devices

from premarket notification procedures.

FDA is also publishing the

recommendations of the Ear, Nose, and

Throat Devices Panel (the panel)

regarding the classification of the

devices. After considering public

comments on the proposed

classifications, FDA will publish a final

regulation classifying the devices. This

action is being taken under the Federal

Food, Drug, and Cosmetic Act (the act),

as amended by the Medical Device

Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (FDAMA).

DATES: Written comments by August 10,

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:

Harry R. Sauberman, Center for Devices

and Radiological Health (HFZ–420),

Food and Drug Administration, 9200

Corporate Blvd, Rockville, MD 20850,

301– 594–2080.

SUPPLEMENTARY INFORMATION:

I. Background

The act, as amended by the 1976

amendments (Pub. L. 94–295), the

SMDA (Pub. L. 101–629), and FDAMA

(Pub. L. 105–115), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval). Under section 513

of the act, devices that were in

commercial distribution before May 28,

1976 (the date of enactment of the

amendments) are classified after FDA

has: (1) Received a recommendation

from a device classification panel (an

FDA advisory committee), (2) published

the panel’s recommendations for

comment, along with a proposed

regulation classifying the device, and (3)

published a final regulation classifying

the device. A device that is first offered

in commercial distribution after May 28,

1976, and which FDA determines to be

substantially equivalent to a device

classified under this scheme, is

classified into the same class as the

device to which it is substantially

equivalent. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

A device that was not in commercial

distribution prior to May 28, 1976, and

that has not been found by FDA to be

substantially equivalent to a legally

marketed predicate device, is classified

automatically by statute (section 513(f)

of the act) into class III without any FDA

rulemaking process.

In the Federal Register of November

6, 1986 (51 FR 40378), FDA published

a final rule classifying ear, nose and

throat devices. At that time, FDA was

not aware that the nasal dilator, the

intranasal splint, and the bone particle

collector were preamendments devices

and inadvertently omitted classifying

them.

II. Device Descriptions

FDA is proposing the following

device descriptions based on the panel’s

recommendations (Ref. 1) and the

agency’s review:

(1) The nasal dilator is a device

intended to provide temporary relief

from breathing difficulties resulting

from structural abnormalities in the

nose. The external nasal dilator is

described as a device constructed from

layers of fabric material with a flat

plastic spring inserted between the

layers, with a skin adhesive applied to

adhere to the skin of the nose. The

device is placed externally on the lower

third of the nose. The external nasal

dilator acts with a pulling force to open

the nares and the nasal valves thereby

decreasing nasal airway resistance and

increasing nasal air flow. The internal

nasal dilator is constructed from metal

or plastic and is placed inside the

nostrils. It acts by pushing the nostrils

open or by gently pressing on the

columella, thereby decreasing nasal

airway resistance and increasing nasal

airflow;

(2) The intranasal splint is a device

intended to minimize bleeding and

edema and to prevent adhesions

between the septum and the nasal

cavity. The intranasal splint is

constructed from plastic, silicone, or

absorbent material and is placed in the

nasal cavity after surgery or trauma; and

(3) The bone particle collector is a

filtering device intended to be inserted

into the suction tube line during the

early stages of otologic surgery to collect

bone particles for future use.

III. Recommendations of the Panel

In a public meeting held on October

25, 1990, the panel made classification

recommendations for the nasal dilator,

the intranasal splint, and the bone

particle collector. The panel

recommended that the devices be

classified in class I (general controls).

No recommendation was made to

exempt these devices.

IV. Summary of the Reasons for the

Recommendations

The panel concluded that the safety

and effectiveness of the nasal dilator,

intranasal splint, and bone particle

collector can be reasonably assured by

general controls. Specifically, the panel

believed that the safety and

effectiveness of the nasal dilator,