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Federal Register: May 11, 1998 (Volume 63, Number 90)
Proposed Rules
Page 25789-25794
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DOCID:fr11my98-18
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 165
Docket No. 98N-0294
Beverages: Bottled Water; Companion Document to Direct Final Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations to lift the stay of the effective date for the
allowable levels in the bottled water quality standard for nine
chemical contaminants, i.e., antimony, beryllium, cyanide, nickel,
thallium, diquat, endothall, glyphosate, and 2,3,7,8-TCDD (dioxin),
that was imposed in a final rule published on March 26, 1996. By
lifting the stay of the effective date, bottled water manufacturers
will be required to monitor source waters and finished bottled water
products at least once a year for these nine chemical contaminants
under the current good manufacturing practice (CGMP) regulations for
bottled water. FDA is required to issue monitoring requirements for the
nine chemical contaminants under the Safe Drinking Water Act Amendments
of 1996 (SDWA Amendments). This proposed rule is a companion to the
direct final rule published elsewhere in this issue of the Federal
Register.
DATES: Submit written comments by July 27, 1998. See section VIII. of
this document for the proposed effective date of a final rule based on
this document.
ADDRESSES: Submit written comments on the companion proposed rule to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-260-0631.
SUPPLEMENTARY INFORMATION:
I. Background
This proposed rule is a companion to the direct final rule
published in the final rules section of this issue of the Federal
Register. The companion proposed rule and the direct final rule are
substantively identical. This companion proposed rule will provide the
procedural framework to finalize the rule in the event the direct final
rule receives significant adverse comment and is withdrawn. The comment
period for the companion proposed rule runs concurrently with the
comment period of the direct final rule. Any comments received under
the companion proposed rule will be treated as comments regarding the
direct final rule. FDA is publishing the direct final rule because the
agency anticipates that it will receive no significant adverse comment.
A detailed discussion of this rule is set forth in section II of the
direct final rule. If no significant adverse comment is received in
response to the direct final rule, no further action will be taken
related to this proposed rule. Instead, FDA will publish a confirmation
notice no later than August 6, 1998. FDA intends the direct final rule
to become effective 180 days after publication of the confirmation
notice. If FDA receives significant adverse comment, the agency will
withdraw the direct final rule. FDA will proceed to respond to all of
the comments received regarding the rule, and, if appropriate, the rule
will be finalized under this companion proposed rule using notice-and-
comment procedure. The comment period for this companion proposed rule
runs concurrently with the comment period for the direct final rule.
Any comments received under this companion proposed rule will also be
considered as comments regarding the direct final rule.
Before the enactment of the SDWA Amendments on August 6, 1996,
section 410 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 349) required that, whenever the Environmental Protection Agency
(EPA) prescribed interim or revised National Primary Drinking Water
Regulations (NPDWR's) under section 1412 of the Public Health Service
Act SDWA (42 U.S.C. 300f through 300j-9)), FDA consult with EPA and
either amend its regulations for bottled drinking water in Sec. 165.110
(21 CFR 165.110) or publish in the Federal Register its reasons for not
making such amendments.
In accordance with section 410 of the act, FDA published in the
Federal Register of March 26, 1996 (61 FR 13258), a final rule
(hereinafter ``the March 1996 final rule'') that amended the quality
standard for bottled water by establishing or revising the allowable
levels for 5 inorganic chemicals (IOC's) and 17 synthetic organic
chemicals (SOC's), including 3 synthetic volatile organic chemicals
(VOC's), 9 pesticide chemicals, and 5 nonpesticide chemicals. This
action was in response to EPA's issuance of NPDWR's consisting of
maximum contaminant levels (MCL's) for the same 5 IOC's and 17 SOC's in
public drinking water (57 FR 31776; July 17, 1992).
However, in the March 1996 final rule, FDA stayed the effective
date for the allowable levels for the five IOC's (antimony, beryllium,
cyanide, nickel, and thallium) and four of the SOC's (diquat,
endothall, glyphosate, and dioxin). This action was in response to
bottled water industry comments (responding to the August 4, 1993
proposal (58 FR 41612)) which asserted that additional monitoring for
these nine chemicals required under the bottled water CGMP regulations
would pose an undue economic burden on bottlers. If the agency had not
stayed the effective date for the allowable levels, the bottled water
CGMP regulations under 21 CFR part 129 (part 129) would have been in
effect for these nine chemical contaminants. The bottle water CGMP
regulations require a minimum yearly monitoring of source water and
finished bottled water products for chemical contaminants for which
allowable levels have been established in the bottled water quality
standard. The comments requested that FDA adopt reduced frequency
monitoring requirements for chemical contaminants that are not likely
to be present in the source water for bottling or in the finished
bottled water products. The comments submitted data that supported the
request that FDA reconsider the current monitoring frequency
requirements for chemical contaminants in the bottled water CGMP
regulations.
Based on the information submitted by the comments, FDA stated in
the March 1996 final rule (61 FR 13258 at 13261) that the matter of
reduced frequency of monitoring (less frequently than once per year)
requirements for chemical contaminants that are not likely to be found
in bottled water merited consideration by the agency. FDA also stated,
however, that any revision of the monitoring requirements for chemical
contaminants in bottled water would require an amendment of the bottled
water CGMP regulations in part 129. FDA stated that it intended to
initiate, considering its resources and competing priorities, a
separate rulemaking to address the issue of
Page 25790
circumstances in which reduced frequency of monitoring requirements for
chemical contaminants in bottled water products may be appropriate.
Therefore, FDA stayed the effective date for the nine chemical
contaminants pending completion of a rulemaking to address the issue of
reduced frequency monitoring for chemical contaminants in bottled
water. Although the effect of the stay does not require bottled water
manufacturers to monitor source waters and finished bottled water
products annually for the nine chemical contaminants, FDA advised water
bottlers to ensure through appropriate manufacturing techniques and
sufficient quality control procedures that their bottled water products
are safe with respect to levels of these nine chemical contaminants.
II. Additional Information
For additional information see the corresponding direct final rule
published elsewhere in this issue of the Federal Register. All persons
who wish to submit comments should review the detailed rationale for
these amendments set out in the preamble discussion of the direct final
rule.
A significant adverse comment is one that explains why the rule
would be inappropriate, including challenges to the rule's underlying
premise or approach, or would be ineffective or unacceptable without a
change. A comment recommending a rule change in addition to the rule
will not be considered a significant adverse comment, unless the
comment states why this rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, FDA may adopt as final those parts of the rule
that are not the subject of a significant adverse comment.
III. Proposal to Lift the Stay
Subsequent to the March 1996 final rule, on August 6, 1996, the
SDWA Amendments was enacted. Section 305 of the SDWA Amendments
requires that, for contaminants covered by a standard of quality
regulation issued by FDA before the enactment of the SDWA Amendments
for which an effective date had not been established, FDA issue
monitoring requirements for such contaminants (e.g., the nine chemical
contaminants: Antimony, beryllium, cyanide, nickel, thallium, diquat,
endothall, glyphosate, and dioxin) not later than 2 years after the
date of enactment of the SDWA Amendments. Under this mandate, FDA is
required to issue monitoring requirements for the nine chemical
contaminants for which it stayed the effective date in the March 1996
final rule by August 6, 1998, with an effective date of February 6,
1999. If FDA does not meet this statutory time period, the NPDWR's for
the nine chemical contaminants become applicable to bottled water.
FDA is proposing to lift the stay of the effective date for the
allowable levels for the nine chemical contaminants (antimony,
beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate,
and dioxin) for the following reasons: First, the agency's CGMP
regulations for bottled water, which require that source waters and
finished bottled water products be tested for these nine contaminants
at least once a year, are protective of the public health. The agency
considers at least annual testing, as set forth in its CGMP regulations
in part 129, to be of sufficient frequency, absent circumstances that
may warrant more frequent testing, to ensure that bottled water has
been prepared, packed, or held under sanitary conditions. Second,
Congress mandated, under the SDWA Amendments, that the agency issue
monitoring requirements for the nine chemical contaminants by August 6,
1998. The agency's action to lift the stay is consistent with this
mandate. By lifting the stay of the effective date for the allowable
levels for the nine chemical contaminants in the bottled water quality
standard, bottled water manufacturers will be required to monitor
source waters and finished bottled water products at least once a year
for these nine chemical contaminants under the CGMP provisions in part
129. Third, FDA, in the March 1996 final rule, stated that it intended
to initiate rulemaking to address the issue of whether there are
circumstances in which reduced frequency of monitoring for contaminants
is appropriate. However, such rulemaking would require consideration of
all chemical contaminants, not just the nine chemical contaminants that
are the subject of the stay. FDA is only addressing, in this
rulemaking, the frequency of monitoring for the nine chemical
contaminants that are the subject of the stay. FDA may consider, in a
future rulemaking, the issue of reduced frequency of monitoring in the
context of all chemical contaminants in bottled water subject to the
bottled water CGMP regulations in part 129. Therefore, the agency is,
at this time, electing to lift the stay of the effective date for the
allowable levels in the bottled water quality standard for the nine
chemical contaminants, i.e., antimony, beryllium, cyanide, nickel,
thallium, diquat, endothall, glyphosate, and dioxin, and thereby
require annual testing for these nine contaminants, consistent with the
CGMP requirements for bottled water.
IV. Environmental Impact
The agency has determined under 21 CFR 25.32(a) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Analysis of Economic Impacts
A. Benefit-Cost Analysis
FDA has examined the impacts of this proposed rule under Executive
Order 12866. Executive Order 12866 directs agencies to assess the costs
and benefits of available regulatory alternatives and, when regulation
is necessary, to select regulatory approaches that maximize net
benefits (including potential economic, environmental, public health
and safety effects; distributive impacts; and equity). According to
Executive Order 12866, a regulatory action is ``significant'' if it
meets any one of a number of specified conditions, including having an
annual effect on the economy of $100 million, adversely affecting in a
material way a sector of the economy, competition, or jobs, or if it
raises novel legal or policy issues. FDA finds that this proposed rule
is not a significant regulatory action as defined by Executive Order
12866. In addition, it has been determined that this proposed rule is
not a major rule for the purpose of congressional review. For the
purpose of Congressional review, a major rule is one which is likely to
cause an annual effect on the economy of $100 million; a major increase
in costs or prices; significant effects on competition, employment,
productivity, or innovation; or significant effects on the ability of
U.S.-based enterprises to compete with foreign-based enterprises in
domestic or export markets.
B. Initial Regulatory Flexibility Analysis
FDA has examined the impact of the rule as required by the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). If a rule has a
significant economic impact on a substantial number of small entities,
the RFA requires agencies to analyze options that would minimize the
economic impact of that rule on small entities. The agency acknowledges
that the proposed rule may have a significant economic impact on a
Page 25791
substantial number of small entities. If the agency receives any
significant adverse comments to the direct final rule, the agency will
withdraw the direct final rule and proceed with the rulemaking based on
this proposed rule. In the context of the rulemaking based on this
proposed rule, the agency will consider comments to the initial
regulatory flexibility analysis.
1. Objectives
The RFA requires a succinct statement of the purpose and objectives
of any rule that may have a significant economic impact on a
substantial number of small entities. The agency is taking this action
to lift the stay for nine chemical contaminants under a congressional
mandate, under the SDWA Amendments, that FDA issue monitoring
requirements for these nine chemical contaminants in bottled water.
Lifting the stay of the effective date for the allowable levels in the
bottled water quality standard for the nine chemical contaminants
(antimony, beryllium, cyanide, nickel, thallium, diquat, endothall,
glyphosate, and dioxin) protects the public health. By lifting the
stay, bottled water manufacturers will be required to monitor source
waters and finished bottled water products at least once a year for the
nine chemical contaminants under the bottled water CGMP regulations in
part 129. The agency considers at least annual testing, as set forth in
its CGMP regulations, to be of sufficient frequency, absent
circumstances that may warrant more frequent testing, to ensure that
bottled water has been prepared, packed, or held under sanitary
conditions.
2. Description of Small Business and the Number of Small Businesses
Affected
The RFA requires a description of small businesses used in the
analysis and an estimate of the number of small businesses affected, if
such estimate is available. Table 1 describes small businesses affected
and estimates the number of small businesses affected by the rule. The
agency combined the Small Business Administration (SBA) definition of a
small business as an upper bound of the total number in the analysis
with data from Duns Market Identifiers (DMI) on the number of plants
using SIC 2086. FDA has used the International Bottled Water
Association (IBWA) estimate as a lower bound of the number of small
entities in the industry. According to DMI, there are a total of 1,567
establishments in the industry group of which 66 percent of the
entities (1,028 firms) have fewer than 500 employees. According to
IBWA, there are approximately 560 member firms, of which 50 percent or
280 firms have annual sales below $1 million.
Table 1.--Approximate Number of Small Entities Covered by This Rule
----------------------------------------------------------------------------------------------------------------
Percentage of No. of Small
Type of establishment Standard Industry Classification of Category Defined as Establishments
Classification Codes Small Entities Small by SBA Covered by the Rule
----------------------------------------------------------------------------------------------------------------
IBWA NA Annual sales below $1 50% 280
million
DMI 2,086 Less than 500 66% 1,028
employees
----------------------------------------------------------------------------------------------------------------
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 Percent Water
Establishments From Subtotal Annual
Covered by the Cost per Sample Nonmunicipal Cost
Rule Sources
------------------------------------------------------------------------
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 Average Number Subtotal Annual
Covered by the Cost per Sample of Products Cost
Rule
------------------------------------------------------------------------
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.
Page 25792
Table 4.--Estimated Total Costs
------------------------------------------------------------------------
No. of Small Subtotal Costs
Establishments Subtotal Costs for Testing Total Testing
Covered by the for Testing Finished Bottled Costs<SUP>1
Rule Source Waters Water Products
------------------------------------------------------------------------
Lower bound-280 $180,600 $722,400 $900,000
Upper bound-1,028 $660,060 $2,652,240 $3,000,000
------------------------------------------------------------------------
\1\ Total Testing Costs are rounded to the nearest significant digit.
d. Professional skills required for compliance. The RFA requires a
description of the professional skills necessary for the preparation of
a report or record. This rule does not require professional skills for
the preparation of a report or record. Any sampling of source water or
finished bottled water product for analysis of chemical contaminants
can be carried out by trained plant personnel who can ship such samples
to a testing laboratory for analysis. Other trained skills would also
include recording and maintaining the test result records at the plant
for a minimum of 2 years.
e. Recordkeeping requirements. The RFA requires a description of
the recordkeeping requirements of the rule. Table 5 shows the
provisions for making and maintaining records by small businesses, the
number of small businesses affected, the annual frequency of making
each record, the amount of time needed for making each record, and the
total number of hours for each provision in the first year and then in
subsequent years.
Table 5.--Small Business Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
No. of Small
Entities Annual Hours per Total Hours, Total Hours,
Provision Keeping Frequency Record per First Year Subsequent
Records Small Entity 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
Sec. 165.110. Under the NPDWR's, EPA's base monitoring requirements for
ground water testing are once every 3 years for testing inorganic
chemicals (e.g., antimony, beryllium, cyanide, nickel, and thallium),
and four successive quarters every 3 years for ground water testing for
synthetic organic chemicals (e.g., diquat, endothall, glyphosate, and
dioxin). Under part 129, FDA requires at least annual testing for both
the inorganic and synthetic organic chemicals. Therefore, the frequency
of testing requirements under EPA's NPDWR's for public drinking water
and FDA's frequency of testing requirements for bottled water differ.
Moreover, the regulatory scheme under EPA's regulations for public
drinking water contemplates State coordination, including the use of
state-issued waivers in certain situations. EPA regulations address
treated ground and surface water testing, whereas FDA's regulations
address source water (which in most cases involves testing of untreated
ground water) and finished bottled water product testing. Source water
testing provides a preliminary review of the safety and quality of the
water source that a water bottler intends to manufacture into a bottled
water product. FDA considers source water testing to be as important as
finished bottled water product testing because the safety and quality
of the source water, determined by source water testing, will affect
the treatment necessary to produce a finished bottled water product
that complies with the bottled water quality standard. However, if
EPA's regulatory scheme for public drinking water would need to be
considered for the nine chemical contaminants that are the subject of
this rule for bottled water, it is unclear whether only finished
bottled water product testing for these nine chemical contaminants, in
lieu of source water testing, would be applicable. Furthermore, EPA's
monitoring requirements are designed to address water that is provided
to customers through municipal water distribution systems while FDA's
requirements address water that is produced to be sold to consumers in
discrete units. Some differences between these two sets of monitoring
requirements exist (e.g.,
Page 25793
criteria for determining when a system (or bottler) is not in
compliance), because they address two fundamentally different
production circumstances. FDA believes that its regulations for bottled
water, which are designed to ensure that bottled water is prepared,
packed, and held under sanitary conditions, should apply to the testing
for these nine chemical contaminants in bottled water rather than
having such contaminants subject to a regulatory scheme established for
public drinking water.
Furthermore, the extent to which FDA would consider certain aspects
of EPA's regulatory scheme for public drinking water as ``monitoring
requirements'' is not clear. FDA has not had to apply EPA's regulations
for public drinking water to bottled water under the bottled water
quality standard regulations. Therefore, if FDA did not lift the stay
and issue monitoring requirements under the agency's CGMP requirements
in part 129 for these nine chemical contaminants, the application of
section 410(b)(4)(A) of the act would create uncertainty for industry
and regulators. The practical effect of the application of section
410(b)(4)(A) of the act may be additional burdens on small businesses
if such businesses must adhere to two regulatory schemes for testing of
their bottled water products rather than one comprehensive scheme for
all bottled water testing. As stated earlier, FDA's CGMP requirements
are protective of the public health and the application of these CGMP
requirements to all bottled water would not result in uncertainty to
industry and regulators. As discussed in option d of this section of
this document, FDA believes that retaining the applicability of its
CGMP requirements to all bottled water, with further evaluation of
reduced frequency of testing in the context of all chemical
contaminants in a future rulemaking, would be less confusing to small
entities. Therefore, FDA believes that lifting the stay would be
beneficial to the public.
b. Exempt small entities. One alternative for alleviating the
burden for small entities would be to exempt them from the testing
requirements of this rule. Although, this option would eliminate the
cost of testing on small firms, it may also result in a decrease in the
potential public health benefits of the rule. Small entities comprise a
large part of the affected industry and exempting them would affect the
testing requirements for a large segment of the bottled water products
on the market. Such products would not be subject to a certain
frequency of testing that provides adequate assurance that such
products manufactured by small businesses are as protective of the
public health as those that have undergone the testing requirements for
these nine contaminants under part 129. Therefore, exempting small
businesses would reduce the potential public health benefits of lifting
the stay.
c. Extend compliance period. FDA considered an extended compliance
period. Lengthening the compliance period would provide regulatory
relief to small entities because it would reduce the present value of
the costs of testing. However, as stated in option b of section V.B.4.c
of this document, because small entities comprise a large part of the
affected industry, longer compliance periods would delay any potential
public health benefits of the rule. For example, if a small business
had an excess level of one of the nine chemical contaminants in its
bottled water product, it would not be aware of the potential public
health problem as a result of the specific contaminant because the
small business would not be testing during the longer compliance
period. Therefore, the agency has concluded that the lifting the stay
is more protective of the public health.
d. Reduced testing frequency Another alternative for alleviating
the burden for small entities would be to reduce the testing frequency
for certain chemical contaminants, including the nine chemical
contaminants that are the subject of this rule. The agency believes
that, in considering the issue of reduced frequency of testing, it
needs to do so in the context of all chemical contaminants, not just
the nine that are the subject of this rule. Reduced frequency of
testing may include an entirely different scheme that may include
waivers for certain chemical contaminants. The contemplation of such a
scheme is better addressed in a context that includes consideration of
all chemical contaminants, rather than considering and implementing a
different regulatory scheme for only the nine chemical contaminants.
Moreover, Congress mandated that the agency issue monitoring
requirements for these nine chemical contaminants by August 6, 1998.
Because the scope of this rule is limited to these nine chemical
contaminants, and the agency does not have sufficient time to enlarge
the scope of this rulemaking to the issue of reduced frequency of
testing for all chemical contaminants, the agency is not pursuing this
alternative in this rulemaking. However, the agency plans to consider
the issue of reduced frequency of monitoring for all chemical
contaminants in bottled water in a future rule.
5. Summary
FDA has examined the impact of the proposed rule on small
businesses in accordance with the RFA. This analysis, together with the
preamble, constitutes the RFA.
C. Unfunded Mandates Reform Act of 1995
FDA has examined the impacts of this proposed rule under the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule
does not require a written statement under section 202(a) of the UMRA
because it does not impose a mandate that results in an expenditure of
$100 million (adjusted annually for inflation) or more by State, local,
and tribal governments in the aggregate, or by the private sector, in
any 1 year.
VI. Paperwork Reduction Act of 1995
FDA tentatively concludes that this companion proposed rule
contains no collections of information. Therefore, clearance by the
Office of Management and Budget under the Paperwork Reduction Act of
1995 is not required.
VII. Comments
Interested persons may, on or before July 27, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
VIII. Effective Date
The agency intends to make any final rule based on this proposal
effective 180 days following the date of publication of the final rule
in the Federal Register. The agency is providing this time period to
permit affected firms adequate time to take appropriate steps to bring
their product into compliance with the standard imposed by the new
rule.
List of Subjects in 21 CFR Part 165
Beverages, Bottled water, Food grades and standards.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 165 be amended as follows:
PART 165--BEVERAGES
1. The authority citation for 21 CFR part 165 continues to read as
follows:
Page 25794
Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.
Sec. 165.110 Amended
2. Section 165.110 Bottled water is amended in the table in
paragraph (b)(4)(iii)(A) by removing the superscript ``1'' after the
entries for ``Antimony,'' ``Beryllium,'' ``Cyanide,'' ``Nickel,'' and
``Thallium,'' and by removing the footnote to the table; in the table
in paragraph (b)(4)(iii)(C) by removing the superscript ``1'' after the
entries for ``Diquat,'' ``Endothall,'' ``Glyphosate,'' and ``2,3,7,8-
TCDD (Dioxin),'' and by removing the footnote to the table; and by
removing the note that follows paragraph (b)(4)(iii)(G)(3)(iv).
Dated: May 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
FR Doc. 98-12382 Filed 5-6-98; 3:57 pm
BILLING CODE 4160-01-F
