[Federal Register: June 9, 2005 (Volume 70, Number 110)]
[Rules and Regulations]
[Page 33694-33701]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn05-6]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 165
[Docket No. 2004N-0416]
Beverages: Bottled Water
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its bottled
water quality standard regulations by revising the existing allowable
level for the contaminant arsenic. As a consequence, bottled water
manufacturers are required to monitor their finished bottled water
products for arsenic at least once each year under the current good
manufacturing practice (CGMP) regulations for bottled water. Bottled
water manufacturers are also required to monitor their source water for
arsenic as often as necessary, but at least once every year unless they
meet the criteria for the source water monitoring exemptions under the
CGMP regulations. This final rule will ensure that the minimum quality
of bottled water, as affected by arsenic, remains comparable with the
quality of public drinking water that meets the Environmental
Protection Agency's (EPA's) standards.
DATES: This rule is effective January 23, 2006. The Director of the
Office of the Federal Register approves the incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in 21 CFR 165.110(b)(4)(iii), as of January 23, 2006.
FOR FURTHER INFORMATION CONTACT: Jennifer A. Burnham, Center for Food
Safety and Applied Nutrition (HFS-306), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2030.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 22, 2001 (66 FR 6976), EPA
published a final rule issuing a National Primary Drinking Water
Regulation (NPDWR) containing a maximum contaminant level (MCL) of 0.01
milligram per liter (mg[sol]L) or 10 parts per billion (ppb) and a
Maximum Contaminant Level Goal (MCLG) of zero for arsenic to address
potential public heath effects from the presence of arsenic in drinking
water. This rulemaking finalized a proposed rule that EPA published in
the Federal Register of June 22, 2000 (65 FR 38888). EPA's effective
date of March 23, 2001, for this rule was temporarily delayed for 60
days to a new effective date of May 22, 2001, in accordance with the
memorandum of January 20, 2001, from the Assistant to the President and
Chief of Staff, entitled ``Regulatory Review Plan'' (66 FR 7702,
January 24, 2001). On May 22, 2001, EPA announced that it would further
delay the effective date for the rule until February 22, 2002, to allow
time to complete a reassessment of the information on which the revised
arsenic standard is based. On February 22, 2002, the arsenic MCL of
0.01 mg[sol]L in public drinking water rule became effective, and water
systems must comply with the new standard for arsenic in public
drinking water by January 23, 2006. On March 25, 2003 (68 FR 14501 at
14503), EPA revised the rule text in its January 2001 final rule that
established the 10 ppb arsenic drinking water standard to express the
standard as 0.010 mg[sol]L, in order to clarify the implementation of
the original rule. EPA made this change in response to a concern raised
by a number of States and other stakeholders that State laws adopting
the Federal arsenic standard as 0.01 mg[sol]L might allow rounding of
monitoring results above 0.01 mg[sol]L so that the effective standard
(in consideration of rounding of results) would be 0.014 mg[sol]L (or
14 ppb), not 0.010 mg[sol]L (10 ppb).
Under section 410(b)(1) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 349(b)(1)), FDA is required to issue a standard of
quality regulation for a contaminant in bottled water not later than
180 days before the effective date of an NPDWR issued by EPA for a
contaminant under section 1412 of the Safe Drinking Water Act (SDWA)
(42 U.S.C. 300g-1), or make a finding that such a regulation is not
necessary to protect the public health because the contaminant is
contained in water in public water systems but not in water used for
bottled water. The effective date for any such standard of quality
regulation is to be the same as the effective date of the NPDWR. In
addition, section 410(b)(2) of the act provides that a quality standard
regulation issued by FDA shall include monitoring requirements that the
agency determines to be appropriate for bottled water. Further, section
410(b)(3) of the act requires a quality standard for a contaminant in
bottled water to be no less stringent than EPA's MCL and no less
protective of the public health than EPA's treatment technique
requirements for the same contaminant.
In accordance with section 410 of the act, FDA published in the
Federal
[[Page 33695]]
Register of December 2, 2004 (69 FR 70082), a proposal to adopt EPA's
MCL for arsenic as an allowable level in the quality standard for
bottled water. In the 2004 proposal, FDA tentatively concluded that the
MCL that EPA had established based on available toxicological
information for arsenic in public drinking water was adequate for the
protection of public health. As a consequence, bottled water
manufacturers would be required to monitor their finished bottled water
products for arsenic at least once each year under the CGMP regulations
for bottled water. Bottled water manufacturers would also be required
to monitor their source water for arsenic as often as necessary, but at
least once every year unless they meet the criteria for the source
water monitoring exemptions under the CGMP regulations. Interested
persons were given until January 31, 2005, to submit comments.
II. Comment on the Proposed Rule
FDA received four letters, each containing one or more comments, in
response to the December 2, 2004, proposal. The comments were received
from two trade associations and two consumers. Two letters generally
support the proposal with one containing comments suggesting
modifications to various provisions of the Analysis of Economic Impacts
section. The agency's responses to these suggestions are addressed in
that section. Two letters raised issues that are outside the scope of
this rulemaking (the appropriate agency to regulate bottled water and
EPA's requirements for testing frequency) and therefore are not
addressed here.
III. Conclusion
The agency is adopting the allowable level for arsenic in the
quality standard for bottled water as proposed (69 FR 70082).
Therefore, FDA is establishing in Sec. 165.110(b)(4)(iii)(A) (21 CFR
165.110(b)(4)(iii)(A)), which includes allowable levels for inorganic
substances, an allowable level for arsenic at 0.010 mg[sol]L and
removing the existing entry for arsenic in Sec. 165.110(b)(4)(i)(A).
With respect to analytical methods for the determination of
chemical contaminants, FDA is making the following changes in Sec.
165.110(b)(4)(iii). In the new Sec. 165.110(b)(4)(iii)(E)(14), FDA is
incorporating by reference EPA approved analytical methods (66 FR 6975
at 6988) for determining compliance with the quality standard for
arsenic in bottled water. These methods are contained in the manual
entitled ``Methods for the Determinations of Metals in Environmental
Samples-Supplement 1,'' EPA/600/R-94/111, May 1994, which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. The source for this manual containing the two methods is the
National Technical Information Service (NTIS), PB95-125472, U.S.
Department of Commerce, 5825 Port Royal Rd., Springfield, VA 22161. FDA
believes that these methods are sufficient to use for determining the
level of arsenic in bottled water.
Therefore, upon the effective date of this rule, January 23, 2006,
any bottled water that contains arsenic at a level that exceeds the
applicable allowable level will be deemed misbranded under section
403(h)(1) of the act (21 U.S.C. 343(h)(1)) unless it bears a statement
of substandard quality as provided by Sec. 165.110(c)(3).
IV. Environmental Impact
The agency has previously considered the environmental effects of
this rule as announced in the proposed rule (69 FR 70082, December 2,
2004). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
V. Analysis of Economic Impacts
A. Final Regulatory Impact Analysis
FDA has examined the economic implications of this final rule as
required by 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, public safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as 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 a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. The Office of Management and
Budget (OMB) has determined that this final rule is a significant
regulatory action as defined by Executive Order 12866.
This final regulatory impact analysis revises the analysis set
forth in the proposed rule (69 FR 70082) in response to comments
received. Except as we indicate below, the analysis in this final rule
is the same as the analysis of the proposed rule.
1. Need for Regulation
We did not receive any comments on the discussion of the need for
regulation in the analysis of the proposed rule. To briefly summarize
the discussion in the analysis of the proposed rule, under section 410
of the act, when the Environmental Protection Agency (EPA) issues a
regulation establishing an MCL for a particular contaminant in drinking
water, FDA is required to issue a standard of quality regulation for
that contaminant in bottled water or make a finding that such a
regulation is unnecessary to protect the public health. FDA's quality
standard must also include appropriate monitoring requirements. If FDA
does not issue a quality standard for arsenic in bottled water by 180
days before the effective date of EPA's regulations or make a finding
that such a regulation is not necessary to protect the public health,
then EPA's regulation becomes applicable to bottled water as well as
drinking water.
2. Regulatory Options
We considered five regulatory options in the analysis of the
proposed rule:
Option One--Re-establish a quality standard for arsenic in bottled
water that maintains the current allowable level of 0.05 mg[sol]L.
Option Two--Take no action. Under this option, EPA's regulation on
arsenic in drinking water would become applicable to bottled water.
Option Three--Establish a quality standard for arsenic in bottled
water that adopts EPA's MCL for arsenic in drinking water of 0.010
mg[sol]L. Under this option, bottled water producers would be subject
to CGMP monitoring requirements in 21 CFR 129.35 and 129.80.
Option Four--Establish a quality standard for arsenic in bottled
water that sets the allowable level of arsenic at 0.02 mg[sol]L.
Option Five--Establish a quality standard for arsenic in bottled
water that sets the allowable level of arsenic at 0.005 mg[sol]L.
One comment stated that bottled water should be regulated by EPA,
not FDA. This comment maintained that economies of scale suggest that
EPA should oversee bottled water as well as tap water and that it is
wasteful for us to spend public money to change bottled water
regulations in a way that mirrors EPA's regulations for tap water.
[[Page 33696]]
This option is outside the scope of this rulemaking and would not be
legally feasible at this time. In addition, changing the jurisdiction
of bottled water from FDA to EPA would generate costs in addition to
cost savings. We do not have information suggesting that the net
benefits of this option would be likely to be greater than the net
benefits of the options that we considered in the proposed rule.
Therefore, we have not addressed this option in this analysis.
3. General Comments
(Comment 1) One comment argued that some bottled water
establishments may need to purify their water using reverse osmosis or
other methods in order to meet an allowable level of 0.010 mg[sol]L.
This comment suggested that these establishments would need to change
the identification of their products from ``spring water'' to
``purified water.'' The comment noted that this could lead to a loss of
utility for consumers who prefer spring water if they have limited
choices for home or office water delivery and can no longer obtain
spring water from other establishments. Finally, the comment noted that
this change in how consumers value bottled water could reduce sales for
the establishments producing that water, although the comment noted
that that it was unable to estimate this cost.
(Response) The comment is correct that if bottled water
establishments need to adopt treatment methods that require them to
change the identity of their product, (e.g., from ``spring water'' to
``purified water'') then some consumers might place a lower value on
that water. If some consumers choose not to continue to consume the
water after the identity change, then some bottled water establishments
could face a decline in sales and profits. We would classify any loss
of profit from shifts in consumer demand as a distributive impact
rather than a social cost because the sales and profit losses for some
firms would be offset by countervailing sales and profit increases for
other firms. The comment did not provide sufficient information to
estimate the loss in consumer utility or the distributive impact on
industry. Although the comment only discussed this effect in relation
to an allowable level of 0.010 mg[sol]L (corresponding to Options 2 and
3), the same effect might also be relevant to any reduction in the
current allowable level of 0.05 mg[sol]L, including reductions to
allowable levels of 0.02 mg[sol]L (Option 4) and 0.005 mg[sol]L (Option
5). The likelihood of this effect would be greater the lower the
allowable level. Thus, this effect would be largest under Option 5 and
smallest under Option 4.
(Comment 2) One comment suggested that our estimate of the benefits
of specifying a maximum arsenic level of 0.005 mg[sol]L was too high
because EPA based their benefit estimate on a flawed interpretation of
the available data, and we based our benefit estimate on EPA's benefit
estimate. This comment cited a report issued by the National Academy of
Sciences (NAS) that the comment claimed concluded that arsenic does not
cause bladder or lung cancer at levels up to 0.05 mg[sol]L (50 ppb) in
drinking water (Ref. 1). Although the comment made this point in
relation to our benefit estimates for Option 5 (allowable level of
0.005 mg[sol]L), it is also relevant to our benefit estimates for
Options 2 and 3 (allowable level of 0.01 mg[sol]L) and Option 4
(allowable level of 0.02 mg[sol]L). The comment also argued that EPA
based its risk assessment on extrapolating cancer risks from relatively
high levels of arsenic investigated in some epidemiological studies to
the relatively low levels that EPA considered when setting an MCL for
arsenic. According to the comment, the NAS study highlighted the
uncertainty associated with this extrapolation and also suggested there
might be a threshold below which arsenic in water would not increase
the risk of cancer at all. The comment noted that EPA reviewed this
study prior to issuing a regulation establishing a MCL of 0.01mg[sol]L.
Finally, the comment cited an article that was published after EPA's
regulation that reportedly found no association between bladder cancer
and arsenic in drinking water at a level of 0.10 mg[sol]L and another
article that ostensibly made a similar point.
(Response) The 2001 NAS study concluded that arsenic in drinking
water increases the risk of bladder or lung cancer at concentrations at
least as low as 0.003 mg[sol]L (Ref. 2). Although the study noted that
a threshold was theoretically possible, it noted that there was no
experimental data to identify a threshold and concluded that any
threshold was likely to occur below concentrations that are relevant to
the U.S. population (Ref. 3). The study did note that there was
insufficient mode-of-action data on arsenic to provide a biological
basis for using either a linear or nonlinear extrapolation to estimate
low dose health risks and that the choice of extrapolation method was,
in part, a policy decision (Ref. 4). However, the study supported the
use of a linear extrapolation in conjunction with a discussion of the
uncertainties associated with that approach (Ref. 5). EPA acknowledged
uncertainty about the impact of reducing arsenic to the levels under
consideration in this rule and carried out a sensitivity analysis to
reflect that uncertainty. The range of potential benefits that we
estimated in the proposed rule reflects that uncertainty. However, EPA
could not have considered the two articles cited in the comment that
were published after the publication of the regulation. One of these
articles found no increase in the risk of bladder cancer from arsenic
in drinking water at levels up to 0.1 mg[sol]L (Ref. 6). The other
article found no increase in the risk of death from bladder cancer from
arsenic in drinking water at concentrations between 0.003 mg[sol]L and
0.06 mg[sol]L (Ref. 7). We based our benefit estimates on reductions of
bladder cancer and lung cancer. EPA's estimated health benefit from
reductions in bladder cancer were approximately 30 percent of the total
health benefits from reductions in both bladder and lung cancer.
Therefore, we have reduced the lower bound of our estimated range of
benefits to reflect the possibility that none of the options under
consideration reduce the risk of bladder cancer.
4. Option One--Re-establish a Quality Standard for Arsenic in Bottled
Water That Maintains the Current Allowable Level of 0.05 Mg/L
We used this option as the baseline in the analysis of the proposed
rule. We did not receive any comments on the use of this option as the
baseline. We did receive one comment that noted that an allowable level
of 0.05 mg[sol]L might not lead to the same health benefits as an
allowable level of 0.01 mg[sol]L. This observation is consistent with
the analysis of the proposed rule in which we attributed health
benefits to moving from the baseline to an allowable level of 0.01
mg[sol]L.
5. Option Two--Take No Action
Benefits of option two.
(Comment 3) One comment from a trade group that stated it
represented 270 bottled water establishments argued that we may have
overestimated the benefits of taking no action and allowing EPA's
regulations governing arsenic in drinking water to become applicable to
bottled water. The trade group that submitted this comment stated that
it has required its members to meet a maximum arsenic level of 0.010
mg[sol]L (10 ppb) since 2002 as a condition of membership. The comment
also noted that California's Department of Health Services established
a standard of quality specifying an allowable level of 0.01 mg[sol]L
(10 ppb) for arsenic in bottled water in 2000. This comment argued that
most medium and
[[Page 33697]]
large bottled water establishments of ``natural water'' belong to this
trade group or sell water in California. Finally, the comment noted
that approximately 25 percent of the bottled water sold in the United
States is ``purified water'' and that most purified water is produced
using the reverse osmosis method, which removes a substantial amount of
any existing arsenic from the final product. The comment concluded that
the vast majority of bottled water sold in the United States already
meets an allowable level of 0.010 mg[sol]L and that any potential
health benefits from revising the allowable level of arsenic from 0.05
mg[sol]L to 0.01 mg[sol]L may have already been realized.
(Response) In the analysis of the proposed rule, we based our
benefit estimates on EPA's analysis of its drinking water regulations.
EPA's analysis found that 5.3 percent of the ground water sources used
by community water systems failed to meet a maximum arsenic level of
0.010 mg[sol]L. We used the same percentage as the percentage of
bottled water establishments that would fail to meet that level of
arsenic. Thus, our benefit estimate accounted for the fact that the
vast majority of bottled water establishments use water that already
meets a maximum arsenic level of 0.010 mg[sol]L. The 270 establishments
that this comment stated belonged to the trade group in question
represent 73 percent of the 370 establishments that we identified in
the analysis of the proposed rule. Thus, the information provided by
the comment is consistent with the 5.3 percent estimate.
Abatement.
(Comment 4) One comment argued that some bottled water
establishments might not be able to choose some of the 13 abatement
methods that EPA discussed in their analysis. The comment noted that we
used the average cost of these abatement methods in our analysis.
According to this comment, establishments that bottle natural water
containing naturally occurring arsenic may face abatement costs
substantially higher than the average of the 13 methods discussed in
the EPA report because of the commercial and financial restraints on
their ability to selectively remove arsenic while maintaining the
standard of identity for natural water. The comment also noted that
abatement costs would depend on the initial level of arsenic found in
the water (e.g., reductions from 0.03 mg[sol]L to 0.01 mg[sol]L is more
expensive than reductions from 0.02 mg[sol]L to 0.01 mg[sol]L).
(Response) We acknowledged in the analysis of the proposed rule
that some bottled water establishments might be unable to use some of
the 13 potential abatement methods EPA discussed in their analysis. Our
rationale for using the average cost of those methods was that some
establishments might be able to use the less expensive methods while
other establishments might need to use the more expensive methods.
Using average cost is appropriate in this context because we are
estimating total costs rather than the costs that any particular
facility might face. The comment did not provide sufficient information
to revise this approach. EPA's cost estimates, on which we based our
cost estimates, accounted for the fact that abatement costs depend on
the initial level of arsenic in the water.
Testing.
(Comment 5) One comment argued that we overstated the potential
benefit from reduced testing costs under this option and suggested that
this option would probably not reduce testing costs at all. This
comment noted that we estimated that adopting this option would
eliminate between 163 and 745 tests per year. The comment said that
such a reduction is highly unlikely because bottled water
establishments that sell bottled water in more than one State might
need to apply for waivers for each State in which they sell their
product but may be unable or unwilling to pay for multiple waivers. The
comment also noted that some States regulate bottled water as a food
product and require annual testing for contaminants including arsenic.
The comment said that only two of the States that regulate bottled
water as food offer testing waivers for bottled water. In addition, the
authors of the comment noted that they were unaware of any State
granting a bottled water establishment a 9-year waiver for any
contaminant. The comment claimed that adopting EPA's testing schedule
for arsenic could result in additional tests because EPA's testing
schedule would not coincide with States' testing schedules. Finally,
the comment noted that the delay in testing requirements that we
discussed in the analysis of the proposed rule would probably not
affect bottled water establishments that operate in States that
regulate bottled water as a food.
(Response) In the analysis of the proposed rule, we assumed that
between 0 and 90 percent of bottled water establishments might operate
under a waiver in any given year. The low end of this range is
consistent with the comment's assertion that few bottled water
establishments would be able or willing to obtain waivers. The comment
provided some reasons why the upper bound of 90 percent may be
unrealistically high, but it did not provide an alternative upper bound
estimate. The comment also did not provide sufficient information to
estimate any additional testing that the comment claimed could be
required under this option because of discrepancies between EPA's
testing schedule and States' testing schedules, or the additional cost
of tracking EPA's testing schedule if it differs from States' testing
schedules, or the proper adjustment for the start of our testing
requirements to account for the fact that some establishments must test
annually because of State regulations. In the analysis of the proposed
rule, we estimated that the change in testing costs generated by this
option would round to $0 million per year. Attempting to further refine
this estimate to account for these factors would have little effect on
the overall results.
(Comment 6) One comment argued that we failed to include some of
the costs associated with testing requirements under this option. This
comment noted that we previously allowed EPA regulations on maximum
levels for nine other contaminants in drinking water to become
effective for bottled water. The nine contaminants were antimony,
beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate,
and 2,3,7,8-TCDD (dioxin). The comment argued that implementing EPA
testing requirements for these contaminants created confusion and
inconsistencies because EPA designed their testing requirements for
municipal water systems rather than for bottled water establishments.
The comment suggested that this experience showed that implementing EPA
testing requirements for arsenic would also create confusion about
testing requirements for bottled water establishments.
(Response) We are not addressing previous actions regarding the
nine contaminants in this analysis. However, experiences generated by
past actions may be relevant to this analysis. In this case, the
comment claims that past experience suggests that adapting EPA's
testing requirements for bottled water establishments could create some
initial confusion. However, the comment did not provide sufficient
information to allow us to quantify this cost. Therefore, we have added
this cost as an unquantified cost.
Administrative costs.
We did not receive any significant comments on this section.
[[Page 33698]]
Public notification.
(Comment 7) One comment noted that we said that under this option
(i.e., if we take no action and EPA's regulations are applied to
bottled water establishments according to section 410 of the act) EPA's
requirement that community water systems prepare and distribute public
notifications of water analyses might apply to bottled water
establishments, but we were unsure how EPA would apply or adapt these
public notification requirements to bottled water establishments. The
comment argued that if we take no action, then EPA's public
notification requirements for community water systems would not become
applicable to bottled water establishments and that the only change in
our current regulations would be that EPA's MCL for arsenic and testing
requirements would replace the existing maximum arsenic level and
testing requirements. In addition, the comment noted that bottled water
would remain under our jurisdiction.
(Response) If we take no action, then EPA's NPDWR for arsenic in
public drinking becomes applicable to bottled water. In addition to
MCLs and monitoring requirements, EPA's NPDWRs (40 CFR part 141)
contain other requirements such as analytical requirements (e.g., use
of certified labs), reporting (e.g., test results submitted to the
states), public notification (e.g., consumer confidence reports), and
recordkeeping (chemical test results to be kept for at least 10 years).
As such, EPA's public notification requirements would be applicable to
bottled water. However, we agree with the comment that bottled water
would remain under our jurisdiction and that we would be responsible
for enforcing EPA's public notification requirements for bottled water
establishments.
Total costs and benefits of option two.
Based on the analysis of the proposed rule and the preceding
discussion, we estimate that taking no action and allowing EPA's NPDWR
for arsenic to become applicable to bottled water would generate
quantified benefits of $6 to $36 million per year (revised from $9 to
$36 million per year in the analysis of the proposed rule), quantified
costs of $11 to $15 million in the first year and $7 to $11 million in
every year after the first year, plus any costs associated with public
notification requirements, any costs associated with potential
confusion associated with adapting EPA's testing requirements and any
loss of consumer utility associated with product identity changes. This
option could also cause some firms that produce bottled spring water to
lose profits and firms producing competing products to increase
profits.
6. Option Three--Establish a Quality Standard for Arsenic in Bottled
Water That Adopts EPA's MCL for Arsenic in Drinking Water of 0.010 Mg/L
(Comment 8) One comment noted that one advantage of this option is
that the vast majority of bottled water establishments would not need
to change their current testing procedures and States could easily
harmonize their regulations with FDA regulations.
(Response) This option would maintain current testing requirements
and would therefore probably not disrupt existing testing schedules or
otherwise create confusion about monitoring requirements. We did not
attribute these costs to this option in the analysis of the proposed
rule.
7. Option Four--Establish a Quality Standard for Arsenic in Bottled
Water That Sets the Allowable Level of Arsenic at 0.02 Mg/L
We did not receive any significant comments on this section.
8. Option Five--Establish a Quality Standard for Arsenic in Bottled
Water but That Sets the Allowable Level of Arsenic at 0.005 Mg/L
Benefits.
We discussed the only comment that we received on the benefits of
this option (that some bottled water establishments may need to purify
their water and change the identification of their products from
``spring water'' to ``purified water'' to meet this requirement) in the
preceding section entitled General Comments because that comment was
relevant to all of the options.
Cost.
(Comment 9) One comment noted that this option would affect more
establishments than would Option 2 because this option involves a lower
allowable level for arsenic. The comment suggested that this would
generate a further increase in costs that is unknown but could be
substantial.
(Response) We estimated the costs of this option by adjusting our
cost estimate for Option 2 upward by 232 percent based on the change in
EPA's estimate of overall abatement costs associated with MCLs of 0.005
mg[sol]L and 0.01 mg[sol]L. EPA's cost estimate accounted for the fact
that a MCL of 0.005 mg[sol]L would affect more community water systems
than would a MCL of 0.01 mg[sol]L. Thus, our estimate already
indirectly accounted for an increase in the number of affected
establishments under this option.
Summary of benefits and costs for regulatory options.
We present a summary of our revised cost and benefit estimates in
table 1 of this document. Option 3 (adopting EPA's allowable arsenic
level) appears likely to generate higher net benefits than either
maintaining the current allowable level of arsenic in bottled water of
0.05 mg[sol]L or taking no action and allowing EPA's NPDWR for arsenic
to become applicable to bottled water. The estimated net benefits of
adopting an allowable level of 0.010 mg[sol]L overlap significantly
with the estimated net benefits of adopting an allowable level of 0.005
mg[sol]L. The lower end of the range of potential net benefits is
substantially higher for 0.010 mg[sol]L, but the higher end of the
range is substantially higher for 0.005 mg[sol]L.
Table 1.--Summary of Costs and Benefits ($ millions)
------------------------------------------------------------------------
Option Cost Benefit Net Benefit
------------------------------------------------------------------------
Option 1- Baseline Baseline Baseline
Maintain
0.05
mg[sol]L
------------------------------------------------------------------------
[[Page 33699]]
Option 2- $11 to $15 in $6 to $36 plus -$9 to $25 plus
Take no first year, $7 unquantified unquantified
action to $11 every health benefits benefits minus
year after first unquantified costs
year, plus in first year, -$5
public to $29 plus
notification unquantified
costs, any costs benefits minus
associated with unquantified costs
potential in subsequent
confusion years
associated with
adapting EPA
testing
requirements,
and any loss of
consumer utility
associated with
product identity
changes
------------------------------------------------------------------------
Option 3- $7 to $11, plus $6 to $36 plus -$5 to $29 plus
Adopt 0.010 any loss of unquantified unquantified
mg[sol]L consumer utility health benefits benefits minus
associated with unquantified costs
product identity
changes
------------------------------------------------------------------------
Option 4- $3 to $4, plus $3 to $14 plus -$1 to $10 plus
Adopt 0.02 any loss of unquantified unquantified
mg[sol]L consumer utility benefits benefits minus
associated with unquantified costs
product identity
changes
------------------------------------------------------------------------
Option 5- $17 to $26, plus $9 to $64 plus -$17 to $47 plus
Adopt 0.005 any loss of unquantified unquantified
mg[sol]L consumer utility benefits benefits minus
associated with unquantified costs
product identity
changes
------------------------------------------------------------------------
B. Small Entity Analysis
We have examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires us to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. We find that this rule would have a significant
economic impact on a substantial number of small entities.
In the analysis of the proposed rule, we discussed allowing small
firms to produce bottled water containing a higher level of arsenic
than larger firms as one possible approach to reducing the burden on
small firms.
(Comment 10) One comment argued that such an approach would provide
less protection to consumers and would be difficult to communicate to
consumers. The comment suggested that we instead consider delaying the
effective date of the rule for small businesses.
(Response) We acknowledged the impact on benefits that would occur
if we allowed small firms to produce bottled water containing a higher
level of arsenic than larger firms in the analysis of the proposed
rule. We did not discuss the difficulty of communicating the existence
of different maximum arsenic levels to consumers. However, this cost is
not an additional cost but an alternative to the health costs that we
discussed in the Small Entity Analysis section of the proposed rule. If
we successfully communicated the existence of different arsenic levels
to consumers, then consumers would presumably choose bottled water with
lower levels of arsenic, and we would not expect to see a decline in
health benefits. We do not have sufficient information to evaluate the
cost or effectiveness of educating consumers on different arsenic
levels as an alternative or partial alternative to the health costs of
allowing small firms to produce bottled water containing more arsenic
than bottled water produced by larger firms. Delaying the effective
date for small firms would delay the onset of abatement costs but would
not otherwise reduce those costs. Delaying costs would reduce the
present value of those costs due to discounting. However, delaying the
effective date would also delay the onset of the corresponding health
benefits.
(Comment 11) One comment argued that some bottled water
establishments may need to purify their water using reverse osmosis or
other methods in order to meet a maximum arsenic level of 0.010
mg[sol]L. This comment suggested that some of these methods would
require those establishments to change the identification of their
products from ``spring water'' to ``purified water.'' The comment noted
that this might change how consumers value the water and could reduce
sales for the firms producing that water. The comment noted that it was
unable to estimate this cost. We discussed this comment in the
preceding impact analysis of this document. However, this comment is
also relevant to this section because it noted that any loss of profit
was more likely to affect smaller firms than larger firms because
smaller bottlers have more limited treatment options and distribution
areas.
(Response) The comment is correct that any changes in product
identity that might take place if bottled water establishments found it
necessary to adopt certain treatment methods might lead to changes in
how consumers value the water and could reduce sales and profits for
some small firms. The comment did not provide sufficient information to
estimate this potential impact on small firms.
VI. Paperwork Reduction Act
FDA concludes that this final rule contains no collections of
information. Therefore, clearance by OMB under the Paperwork Reduction
Act of 1995 is not required.
VII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
has a pre-emptive effect on State law. Section 4(a) of the Executive
Order requires agencies to
``construe * * * a Federal Statute to preempt State law only
where the statute contains an express preemption provision, or there
is some other clear evidence that the Congress intended preemption
of State law, or where the exercise of State authority conflicts
with the exercise of Federal authority under the Federal statute.''
Section 403A(a)(1) provides that
``no State or political subdivision of a State may directly or
indirectly establish under any authority or continue in effect as to
any food in interstate commerce-(1) any requirement for a food which
is the subject of a standard of identity established under section
401 that is not identical to such
[[Page 33700]]
standard of identity or that is not identical to the requirement of
section 403(g) * * *.''
FDA has interpreted this provision to apply to standards of quality (21
CFR 100.1(c)(4)). Although this rule has pre-emptive effect in that it
would preclude States from issuing requirements for arsenic levels in
bottled water that are not identical to the allowable level for arsenic
as set forth in this rule, this pre-emptive effect is consistent with
what Congress set forth in section 403A of the act.
Section 4(c) of the Executive Order further requires that ``any
regulatory preemption of State law shall be restricted to the minimum
level necessary'' to achieve the regulatory objective. Under section
410 of the act, not later than 180 days before the effective date of an
NPDWR issued by EPA for a contaminant under section 1412 of the SDWA
(42 U.S.C. 300g-1), FDA is required to issue a standard of quality
regulation for that contaminant in bottled water or make a finding that
such a regulation is not necessary to protect the public health because
the contaminant is contained in water in public water systems but not
in water used for bottled water. Further, section 410(b)(3) of the act
requires a quality standard for a contaminant in bottled water to be no
less stringent than EPA's MCL and no less protective of the public
health than EPA's treatment techniques required for the same
contaminant. FDA has determined that the MCL for arsenic that EPA
established for public drinking water is appropriate as a standard of
quality for bottled water, and is issuing this final regulation
consistent with section 410 of the act.
Further, section 4(e) of the Executive order provides that ``when
an agency proposes to act through adjudication or rulemaking to preempt
State law, the agency shall provide all affected State and local
officials notice and an opportunity for appropriate participation in
the proceedings.'' Given the statutory framework of section 410 of the
act for bottled water, EPA's issuance of an MCL for arsenic in public
drinking water provided notice of possible FDA action for a standard of
quality for arsenic in bottled water. FDA did not receive any
correspondence from State and local officials regarding an arsenic
standard for bottled water subsequent to EPA's NPDWR on the MCL for
arsenic or in response to FDA's proposed rule (69 FR 70082, December 2,
2004) to adopt EPA's MCL for arsenic as an allowable level in the
quality standard for bottled water. Moreover, FDA is not aware of any
States that have requirements for arsenic in bottled water that would
be affected by FDA's decision to establish a bottled water quality
standard for arsenic that is consistent with EPA's standard for public
drinking water. For the reasons set forth previously in this document,
the agency believes that it has complied with all of the applicable
requirements under the Executive order.
In conclusion, FDA has determined that the pre-emptive effects of
the final rule are consistent with Executive Order 13132.
VIII. References
The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. Arsenic in Drinking Water: 2001 Update, National Academy
Press, Washington, DC, 2001, available on the Internet at http://www.nap.edu/books/0309076293/html/
.
2. Ibid., p. 13.
3. Ibid., pp. 6-7, 11.
4. Ibid., pp. 6, 11.
5. Ibid., p. 11.
6. Steinmaus, C., Yuan, Y., Bates, M.N., et al., 2003, ``Case-
Control Study of Bladder Cancer and Drinking Water Arsenic in the
Western United States,'' American Journal of Epidemiology,
158(12):1193-1201.
7. Lamm, S., Engel, A., Kruse, M., et al., 2004, ``Arsenic in
Drinking Water and Bladder Cancer Mortality in the United States: An
Analysis Based on 133 U.S. Counties and 30 Years of Observation,''
Journal of Occupational and Environmental Medicine, 46(3):298-306.
List of Subjects in 21 CFR Part 165
Beverages, Bottled water, Food grades and standards, Incorporation
by reference.
0
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
0
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.
0
2. Section 165.110 is amended by removing the entry for ``Arsenic'' in
the table in paragraph (b)(4)(i)(A), by revising paragraph
(b)(4)(iii)(A) and the introductory text of paragraph (b)(4)(iii)(E),
and by adding paragraph (b)(4)(iii)(E)(14) as follows:
Sec. 165.110 Bottled water.
* * * * *
(b) * * *
(4) * * *
(iii) * * *
(A) The allowable levels for inorganic substances are as follows:
----------------------------------------------------------------------------------------------------------------
Contaminant Concentration in milligrams per liter (or as specified)
----------------------------------------------------------------------------------------------------------------
Arsenic.............................................. 0.010
Antimony............................................. .006
Barium............................................... 2
Beryllium............................................ 0.004
Cadmium.............................................. 0.005
Chromium............................................. 0.1
Copper............................................... 1.0
Cyanide.............................................. 0.2
Lead................................................. 0.005
Mercury.............................................. 0.002
Nickel............................................... 0.1
Nitrate.............................................. 10 (as nitrogen)
Nitrite.............................................. 1 (as nitrogen)
Total Nitrate and Nitrite............................ 10 (as nitrogen)
Selenium............................................. 0.05
Thallium............................................. 0.002
----------------------------------------------------------------------------------------------------------------
[[Page 33701]]
* * * * *
(E) Analyses to determine compliance with the requirements of
paragraph (b)(4)(iii)(A) of this section shall be conducted in
accordance with an applicable method and applicable revisions to the
methods listed in paragraphs (b)(4)(iii)(E)(1) through
(b)(4)(iii)(E)(14) of this section and described, unless otherwise
noted, in ``Methods for Chemical Analysis of Water and Wastes,'' U.S.
EPA Environmental Monitoring and Support Laboratory (EMSL), Cincinnati,
OH 45258 (EPA-600/4-79-020), March 1983, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
of this publication are available from the National Technical
Information Service (NTIS), U.S. Department of Commerce, 5825 Port
Royal Rd., Springfield, VA 22161, or may be examined at the Center for
Food Safety and Applied Nutrition's Library, Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at
the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.
* * * * *
(14) Arsenic shall be measured using the following methods:
(i) Method 200.8--``Determination of Trace Elements in Waters and
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Revision 5.4,
which is incorporated by reference in accordance with 5 U.S.C. 552(a)
and 1 CFR part 51. Method 200.8 is contained in the manual entitled
``Methods for the Determination of Metals in Environmental Samples--
Supplement 1,'' EPA/600/R-94/111, May 1994. Copies of this publication
are available from the National Technical Information Service (NTIS),
PB95-125472, U.S. Department of Commerce, 5825 Port Royal Rd.,
Springfield, VA 22161, or may be examined at the Center for Food Safety
and Applied Nutrition's Library, Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.
(ii) Method 200.9--``Determination of Trace Elements by Stabilized
Temperature Graphite Furnace Atomic Absorption,'' Revision 2.2, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Method 200.9 is contained in the manual entitled ``Methods
for the Determination of Metals in Environmental Samples--Supplement
1,'' EPA/600/R-94/111, May 1994. The availability of this incorporation
by reference is given in paragraph (b)(4)(iii)(E)(14)(i) of this
section.
* * * * *
Dated: May 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11406 Filed 6-8-05; 8:45 am]
BILLING CODE 4160-01-S
