Federal Register: May 11, 1998 (Volume 63, Number 90)
Rules and Regulations
Page 25764-25769
From the Federal Register Online via GPO Access wais.access.gpo.gov
DOCID:fr11my98-4
 
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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
 
AGENCY: Food and Drug Administration, HHS.
 
ACTION: Direct final rule.
 
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to lift the stay of the effective date for the allowable
levels in the bottled water quality standard for nine chemical
contaminants, i.e., antimony, beryllium, cyanide, nickel, thallium,
diquat, endothall, glyphosate, and 2,3,7,8-TCDD (dioxin), that was
imposed in a final rule published on March 26, 1996. By lifting the
stay of the effective date, bottled water manufacturers will be
required to monitor source waters and finished bottled water products
at least once a year for these nine chemical contaminants under the
current good manufacturing practice (CGMP) regulations for bottled
water. FDA is required to issue monitoring requirements for the nine
chemical contaminants under the Safe Drinking Water Act Amendments of
1996 (SDWA Amendments). FDA is using direct final rulemaking for this
action because the agency expects that there will be no significant
adverse comment on the rule. Elsewhere in this issue of the Federal
Register, FDA is publishing a companion proposed rule under FDA's usual
procedure for notice-and-comment rulemaking to provide a procedural
framework to finalize the rule in the event the agency receives
significant adverse comments and withdraws this direct final rule. The
companion proposed rule and direct final rule are substantively
identical.
 
DATES: The regulation is effective November 9, 1998. Submit written
comments by July 27, 1998. If no timely significant adverse comments
are received, the agency will publish a notice in the Federal Register
no later than August 6, 1998, confirming the effective date of the
direct final rule. If timely significant adverse comments are received,
the agency will publish a notice of significant adverse comment in the
Federal Register withdrawing this direct final rule no later than
August 6, 1998.
 
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
 
FOR FURTHER INFORMATION CONTACT: Henry Kim, Center for Food Safety and
Applied Nutrition (HFS-306), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, 202-260-0631.
SUPPLEMENTARY INFORMATION:
 
I. Background
 
    Before the enactment of the SDWA Amendments on August 6, 1996,
section 410 of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 349) required that, whenever the Environmental Protection Agency
(EPA) prescribed interim or revised National Primary Drinking Water
Regulations (NPDWR's) under section 1412 of the Public Health Service
Act (SDWA) (42 U.S.C. 300f through 300j-9)), FDA consult with EPA and
either amend its regulations for bottled drinking water in Sec. 165.110
(21 CFR 165.110) or publish in the Federal Register its reasons for not
making such amendments.
    In accordance with section 410 of the act, FDA published in the
Federal Register of March 26, 1996 (61 FR 13258), a final rule
(hereinafter ``the March 1996 final rule'') that amended the quality
standard for bottled water by establishing or revising the allowable
levels for 5 inorganic chemicals (IOC's) and 17 synthetic organic
chemicals (SOC's), including 3 synthetic volatile organic chemicals
(VOC's), 9 pesticide chemicals, and 5 nonpesticide chemicals. This
action was in response to EPA's issuance of NPDWR's consisting of
maximum contaminant levels (MCL's) for the same 5 IOC's and 17 SOC's in
public drinking water (see 57 FR 31776, July 17, 1992).
    However, in the March 1996 final rule, FDA stayed the effective
date for the allowable levels for the five IOC's (antimony, beryllium,
cyanide, nickel, and thallium) and four of the SOC's (diquat,
endothall, glyphosate, and dioxin). This action was in response to
bottled water industry comments (responding to the August 4, 1993,
proposal (58 FR 41612)) which asserted that additional monitoring for
these nine chemicals required under the bottled water CGMP regulations
would pose an undue economic burden on bottlers. If the agency had not
stayed the effective date for the allowable levels,
 
Page 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
 
Page 25766
 
the nine chemical contaminants in the bottled water quality standard,
bottled water manufacturers will be required to monitor source waters
and finished bottled water products at least once a year for these nine
chemical contaminants under the CGMP provisions in part 129. Third, in
the March 1996 final rule, FDA stated that it intended to initiate
rulemaking to address the issue of whether there are circumstances in
which reduced frequency of monitoring for contaminants is appropriate.
However, such rulemaking would require consideration of all chemical
contaminants, not just the nine chemical contaminants that are the
subject of the stay. FDA is only addressing, in this rulemaking, the
frequency of monitoring for the nine chemical contaminants that are the
subject of the stay. FDA may consider, in a future rulemaking, the
issue of reduced frequency of monitoring in the context of all chemical
contaminants in bottled water subject to the bottled water CGMP
regulations (part 129). Therefore, the agency is, at this time,
electing to lift the stay of the effective date for the allowable
levels in the bottled water quality standard for the nine chemical
contaminants, i.e., antimony, beryllium, cyanide, nickel, thallium,
diquat, endothall, glyphosate, and dioxin, and thereby require annual
testing for these nine contaminants, consistent with the CGMP
requirements for bottled water.
 
IV. Environmental Impact
 
    The agency has determined under 21 CFR 25.32(a) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
 
V. Analysis of Economic Impacts
 
A. Benefit-Cost Analysis
 
    FDA has examined the impacts of this direct final rule under
Executive Order 12866. Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). According to Executive Order 12866, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million, adversely affecting in a material way a sector of the economy,
competition, or jobs, or if it raises novel legal or policy issues. FDA
finds that this direct final rule is not a significant regulatory
action as defined by Executive Order 12866. In addition, it has been
determined that this direct final rule is not a major rule for the
purpose of Congressional review. For the purpose of Congressional
review, a major rule is one which is likely to cause an annual effect
on the economy of $100 million; a major increase in costs or prices;
significant effects on competition, employment, productivity, or
innovation; or significant effects on the ability of U.S.-based
enterprises to compete with foreign-based enterprises in domestic or
export markets.
 
B. Final Regulatory Flexibility Analysis
 
    FDA has examined the impact of the rule as required by the
Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612). If a rule has a
significant economic impact on a substantial number of small entities,
the RFA requires agencies to analyze options that would minimize the
economic impact of that rule on small entities. The agency acknowledges
that the direct final rule may have a significant economic impact on a
substantial number of small entities. The agency is not, in this
analysis, addressing comments received in response to an initial
regulatory flexibility analysis. The nature of the direct final rule
provides for a companion proposed rule published at the same time as
the direct final rule. An initial regulatory flexibility analysis is
contained in the companion proposed rule. The agency is publishing the
direct final rule because the agency does not anticipate any
significant adverse comment. Should the agency receive any significant
adverse comment in response to the direct final rule, the agency will
withdraw the direct final rule and use the companion proposed rule in
developing a final rule.
1. Objectives
    The RFA requires a succinct statement of the purpose and objectives
of any rule that may have a significant economic impact on a
substantial number of small entities. The agency is taking this action
to lift the stay for nine chemical contaminants under a Congressional
mandate, under the SDWA Amendments, that FDA issue monitoring
requirements for these nine chemical contaminants in bottled water.
Lifting the stay of the effective date for the allowable levels in the
bottled water quality standard for the nine chemical contaminants
(antimony, beryllium, cyanide, nickel, thallium, diquat, endothall,
glyphosate, and dioxin) protects the public health. By lifting the
stay, bottled water manufacturers will be required to monitor source
waters and finished bottled water products at least once a year for the
nine chemical contaminants under the bottled water CGMP regulations in
part 129. The agency considers at least annual testing, as set forth in
its CGMP regulations, to be of sufficient frequency, absent
circumstances that may warrant more frequent testing, to ensure that
bottled water has been prepared, packed, or held under sanitary
conditions.
2. Description of Small Business and the Number of Small Businesses
Affected
    The RFA requires a description of small businesses used in the
analysis and an estimate of the number of small businesses affected, if
such estimate is available. Table 1 of this document describes small
businesses affected and estimates the number of small businesses
affected by the rule. The agency combined the Small Business
Administration (SBA) definition of a small business as an upper bound
of the total number in the analysis with data from Duns Market
Identifiers (DMI) on the number of plants using SIC 2086. FDA has used
the International Bottled Water Association (IBWA) estimate as a lower
bound of the number of small entities in the industry. According to
DMI, there are a total of 1,567 establishments in the industry group of
which 66 percent of the entities (1,028 firms) have fewer than 500
employees. According to IBWA, there are approximately 560 member firms,
of which 50 percent or 280 firms have annual sales below $1 million.
 
                                           Table 1.--Approximate Number of Small Entities Covered by this Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                        Standard Industry          Classification of Small       Percentage of Category      No. of Small Establishments
      Type of Establishment           Classification Codes                Entities               Defined as Small by SBA         Covered by the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
IBWA                                                        NA  Annual Sales below $1million                           50%                           280
 
Page 25767
 
 
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
----------------------------------------------------------------------------------------------------------------
                                                                          Percent Water from
   No. of Small Establishments Covered by the Rule      Cost per Sample      Nonmunicipal       Subtotal Annual
                                                                                Sources              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
----------------------------------------------------------------------------------------------------------------
                                                                           Average Number of    Subtotal Annual
   No. of Small Establishments Covered by the Rule      Cost per Sample        Products              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
----------------------------------------------------------------------------------------------------------------
                                                                          Subtotal Costs for
                                                      Subtotal Costs for   Testing Finished      Total Testing
   No. of Small Establishments Covered by the Rule      Testing Source       Bottled Water         Costs\1\
                                                            Waters             Products
----------------------------------------------------------------------------------------------------------------
Lower Bound-280                                          $180,600            $722,400            $900,000
Upper Bound-1028                                         $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 of this document
shows the provisions for making and maintaining records by small
businesses, the number of small businesses affected, the annual
frequency of making each record, the amount of time needed for making
each record, and the total number of hours for each provision in the
first year and then in subsequent years.
 
Page 25768
 
 
 
                               Table 5.--Small Business Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
                 No. of Small
  Provision    Entities Keeping    Annual Frequency    Hours per Record   Total Hours, First     Total Hours,
                    Records                            per Small Entity          Year          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
Sec. 165.110. Under the NPDWR's, EPA's base monitoring requirements for
ground water testing are once every 3 years for testing inorganic
chemicals (e.g., antimony, beryllium, cyanide, nickel, and thallium),
and four successive quarters every 3 years for ground water testing for
synthetic organic chemicals (e.g., diquat, endothall, glyphosate, and
dioxin). Under part 129, FDA requires at least annual testing for both
the inorganic and synthetic organic chemicals. Therefore, the frequency
of testing requirements under EPA's NPDWR's for public drinking water
and FDA's frequency of testing requirements for bottled water differ.
    Moreover, the regulatory scheme under EPA regulations for public
drinking water contemplates State coordination, including the use of
State-issued waivers in certain situations. EPA regulations address
treated ground and surface water testing, whereas FDA regulations
address source water (which in most cases involves testing of untreated
ground water) and finished bottled water product testing. Source water
testing provides a preliminary review of the safety and quality of the
water source that a water bottler intends to manufacture into a bottled
water product. FDA considers source water testing to be as important as
finished bottled water product testing because the safety and quality
of the source water, determined by source water testing, will affect
the treatment necessary to produce a finished bottled water product
that complies with the bottled water quality standard. However, if
EPA's regulatory scheme for public drinking water would need to be
considered for the nine chemical contaminants that are the subject of
this rule for bottled water, it is unclear whether only finished
bottled water product testing for these nine chemical contaminants,
without source water testing, would be applicable.
    Furthermore, EPA's monitoring requirements are designed to address
water that is provided to customers through municipal water
distribution systems while FDA's requirements address water that is
produced to be sold to consumers in discrete units. Some differences
between these two sets of monitoring requirements exist (e.g., criteria
for determining when a system (or bottler) is not in compliance),
because they address two fundamentally different production
circumstances. FDA believes that its regulations for bottled water,
which are designed to ensure that bottled water is prepared, packed, or
held under sanitary conditions, should apply to the testing for these
nine chemical contaminants in bottled water rather than having such
contaminants subject to a regulatory scheme established for public
drinking water.
    Furthermore, the extent to which FDA would consider certain aspects
of EPA's regulatory scheme for public drinking water as ``monitoring
requirements'' is not clear. FDA has not had to apply EPA's regulations
for public drinking water to bottled water under the bottled water
quality standard regulations. Therefore, if FDA did not lift the stay
and issue monitoring requirements under the agency's CGMP requirements
in part 129 for these nine chemical contaminants, the application of
section 410(b)(4)(A) of the act would create uncertainty for industry
and regulators. The practical effect of the application of section
410(b)(4)(A) of the act may be additional burdens on small businesses
if such businesses must adhere to two regulatory schemes for testing of
their bottled water products rather than one comprehensive scheme for
all bottled water testing. As stated earlier, FDA's CGMP requirements
are protective of the public health and the application of these CGMP
requirements to all bottled water would not result in uncertainty to
industry and regulators. As discussed below in section V.B.3.d of this
document, FDA believes that retaining the applicability of its CGMP
requirements to all bottled water, with further evaluation of reduced
frequency of testing in the context of all chemical contaminants in a
future rulemaking, would be less confusing to small entities.
Therefore, FDA believes that lifting the stay would be beneficial to
the public.
    b. Exempt small entities. One alternative for alleviating the
burden for small entities would be to exempt them from the testing
requirements of this rule. Although, this option would eliminate the
cost of testing on small firms, it may also result in a decrease in the
potential public health benefits of the rule. Small entities comprise a
large part of the affected industry and
 
Page 25769
 
exempting them would affect the testing requirements for a large
segment of the bottled water products on the market. Such products
would not be subject to a certain frequency of testing that provides
adequate assurance that such products manufactured by small businesses
are as protective of the public health as those that have undergone the
testing requirements for these nine contaminants under part 129.
Therefore, exempting small businesses would reduce the potential public
health benefits of lifting the stay.
    c. Extend compliance period. FDA considered an extended compliance
period. Lengthening the compliance period would provide regulatory
relief to small entities because it would reduce the present value of
the costs of testing. However, as stated in section V.B.4.b of this
document, because small entities comprise a large part of the affected
industry, longer compliance periods would delay any potential public
health benefits of the rule. For example, if a small business had an
excess level of one of the nine chemical contaminants in its bottled
water product, it would not be aware of the potential public health
problem as a result of the specific contaminant because the small
business would not be testing during the longer compliance period.
Therefore, the agency has concluded that lifting the stay is more
protective of the public health.
    d. Reduced testing frequency. Another alternative for alleviating
the burden for small entities would be to reduce the testing frequency
for certain chemical contaminants, including the nine chemical
contaminants that are the subject of this rule. The agency believes
that, in considering the issue of reduced frequency of testing, it
needs to do so in the context of all chemical contaminants, not just
the nine that are the subject of this rule. Reduced frequency of
testing may include an entirely different scheme that may include
waivers for certain chemical contaminants. The contemplation of such a
scheme is better addressed in a context that includes consideration of
all chemical contaminants, rather than considering and implementing a
different regulatory scheme for only the nine chemical contaminants.
Moreover, Congress mandated that the agency issue monitoring
requirements for these nine chemical contaminants by August 6, 1998.
Because the scope of this rule is limited to these nine chemical
contaminants, and the agency does not have sufficient time to enlarge
the scope of this rulemaking to the issue of reduced frequency of
testing for all chemical contaminants, the agency is not pursuing this
alternative in this rulemaking. However, the agency plans to consider
the issue of reduced frequency of monitoring for all chemical
contaminants in bottled water in a future rule.
5. Summary
    FDA has examined the impact of the direct final rule on small
businesses in accordance with RFA. This analysis, together with the
preamble, constitutes RFA.
 
C. Unfunded Mandates Reform Act of 1995
 
    FDA has examined the impacts of this direct final rule under the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). This rule
does not require a written statement under section 202(a) of the UMRA
because it does not impose a mandate that results in an expenditure of
$100 million (adjusted annually for inflation) or more by State, local,
and tribal governments in the aggregate, or by the private sector, in
any one year.
 
VI. Paperwork Reduction Act of 1995
 
    FDA concludes that this direct final rule contains no collections
of information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.
 
VII. Comments
 
    Interested persons may, on or before July 27, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this direct final rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
 
VIII. Effective Date
 
    The agency intends to make the direct final rule effective 180 days
after the publication of the confirmation notice in the Federal
Register. The agency is providing a 180 day effective date to permit
affected firms adequate time to take appropriate steps to bring their
product into compliance with the standard imposed by the new rule.
 
List of Subjects in 21 CFR Part 165
 
    Beverages, Bottled water, Food grades and standards, Incorporation
by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
165 is amended as follows:
 
PART 165--BEVERAGES
 
    1. The authority citation for 21 CFR part 165 continues to read as
follows:
 
    Authority: 21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.
 
Sec. 165.110  Amended
 
    2. Section 165.110 Bottled water is amended in the table in
paragraph (b)(4)(iii)(A) by removing the superscript ``1'' after the
entries for ``Antimony,'' ``Beryllium,'' ``Cyanide,'' ``Nickel,'' and
``Thallium,'' and by removing the footnote to the table; in the table
in paragraph (b)(4)(iii)(C) by removing the superscript ``1'' after the
entries for ``Diquat,'' ``Endothall,'' ``Glyphosate,'' and ``2,3,7,8-
TCDD (Dioxin),'' and by removing the footnote to the table; and by
removing the note that follows paragraph (b)(4)(iii)(G)(3)(iv).
 
    Dated: May 5, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
FR Doc. 98-12381 Filed 5-6-98; 3:57 pm
BILLING CODE 4160-01-F