[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)]
[Proposed Rules]
[Pages 25789-25794]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12382]


=======================================================================
-----------------------------------------------------------------------

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-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