> January 31, 2005

[VIA EMAIL]{.underline}

Documents Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Arsenic SOQ for Bottled Water - Docket No. 2004N-0416

Dear Sir or Madam:

The International Bottled Water Association (IBWA)[^1] appreciates the
opportunity to submit comments to the U.S. Food and Drug Administration
(FDA) on the proposed regulations concerning a standard of quality (SOQ)
for arsenic in bottled water. IBWA has been urging FDA to promulgate
such a standard for three years and supports the proposed FDA SOQ for
arsenic of 10 parts per billion (ppb) in bottled water.

IBWA is dedicated to helping ensure the safety and quality of bottled
water. The IBWA Model Code establishes standards of quality and
manufacturing practices that are, in some cases, more stringent than FDA
standards. As a condition of membership, bottlers must comply with these
requirements and are inspected annually by an independent third-party
firm. IBWA established an SOQ within the Model Code for arsenic in
bottled water at 10 ppb in 2002, and IBWA members have been meeting this
standard since that time. The experience of IBWA and its members is the
basis for these comments on the proposed regulation by FDA.

**Summary of IBWA Comments**

-   IBWA supports FDA's proposed standard of quality for arsenic of 10
    ppb in bottled water;

-   IBWA urges FDA to issue a final regulation and not allow the
    "hammer" provision to become effective under section 410 of the
    Federal Food, Drug, and Cosmetic Act (FFDCA);

-   FDA should correct certain statements in the economic analysis and
    state clearly that, even if the "hammer" provision should become
    effective, that FDA (and not the Environmental Protection Agency)
    exercises regulatory responsibility over bottled water; and

-   IBWA endorses FDA's position that any final rule based on this
    proposal would preempt states from administering different
    requirements.

IBWA also is providing detailed technical information, as requested in
FDA's economic analysis, to assist FDA in promulgating a final rule with
as accurate economic information as possible.

**I. IBWA Supports an FDA Arsenic Standard of Quality for Bottled
Water**

FDA has requested comments on its analysis and five regulatory options
for establishing an SOQ for arsenic in bottled water. IBWA is providing
such comments below.

IBWA supports option number three, which is to establish the same SOQ
for arsenic in bottled water, as the U. S. Environmental Protection
Agency's (EPA) maximum contaminant level (MCL) of 10 ppb, and subject
bottlers to the monitoring requirements of 21 C.F.R. §129.35 and 21
C.F.R. §129.80. By adopting this option, FDA will incorporate arsenic
into the FDA regulatory framework for bottled water as a food product
and will promote uniform standards between Federal and state agencies.

**II. Economic Impact - FDA Assumptions for all Options**

**[IBWA Comments]{.underline}**

IBWA concurs with FDA's assumption that 370 bottled water manufacturers
and facilities will be impacted by the proposed regulation. Currently,
IBWA has approximately 270 bottled water plants and 180 firms within the
bottler membership base. These firms represent the vast majority of
bottled water companies in the United States. As indicated above, these
firms already comply with IBWA's Model Code SOQ of 10 ppb for arsenic
and the establishment by FDA of a bottled water quality standard at this
level will not have any material impact on these firms.

IBWA suggests, however, that the consumer value of bottled water as
indicated in the FDA analysis may change if a bottler must produce a
purified water (as the only treatment option available to them), rather
than a natural water in order to be compliant with a new standard of
below 10 ppb. By purifying the water through the use of reverse osmosis,
for example, the standard of identity for the bottled water, such as
"spring water," will change. This could have an adverse impact on sales
to those consumers who prefer natural water. Although many options
remain for these consumers, they may be limited in their choice of home
or office delivery company. It is difficult for IBWA to provide a
numeric value to the impact of such a change on a bottler. However, it
is more likely to affect small bottlers because of their limited options
and distribution area.

### 

### 

### III. Option One -- Re-establish a quality standard for bottled water at 0.05 mg/L

**[IBWA Comments]{.underline}**

The current FDA SOQ for arsenic in bottled water is 10 ppb. This
standard is based is based on the existing EPA MCL of 50 ppb for public
drinking water. The EPA has determined that the current arsenic MCL of
50 ppb for public water systems, based on the risk assessments in the
public literature, should be lowered to be, in the EPA's opinion, more
protective of human health. Section 410 of the FFDCA mandates that FDA
establish SOQ's for bottled water, that are no less protective of public
health than the EPA's National Primary Drinking Water standards. EPA's
lowering of the MCL for arsenic in drinking water is based on EPA's
evaluation of the risks to human health. If FDA were to maintain the
current 50 ppb standard for bottled water, it may not provide an equal
or greater protection of public health than the new EPA public drinking
water MCL for arsenic of 10 ppb.

**[IBWA Position]{.underline}**

Therefore, IBWA opposes option one. If FDA were to re-establish a
quality standard of 50 ppb of arsenic in bottled water, such a standard
may not be as protective of public health as the public drinking water
standard as required under Section 410 of the FFDCA.

**IV. *Option Two -- Take No Action***

**[IBWA Comments]{.underline}**

As set forth in the proposed regulation, FDA's inaction would trigger
Section 410 of FFDCA. Since the enactment of that provision in 1996 on
this issue, the trigger has been activated only once, in August of
1998.[^2] FDA allowed the "hammer" (the provision of the section that
provides for the application of the EPA MCL's to bottled water)[^3] for
nine contaminants, specifically, antimony, beryllium, cyanide, nickel,
thallium, diquat, endothall, glyphosate, and 2,3,7,8--TCDD (dioxin).
Based on the confusion experienced by bottlers with the regulatory
quality monitoring requirements for these nine contaminants, IBWA
strongly urges FDA to promulgate a final rule in a timely manner, so
that the "hammer" provision will not be invoked for arsenic.

Accordingly, IBWA urges FDA to take whatever steps are necessary to
ensure that a final rule is published by July 23, 2005, so that the
"hammer" does not fall. Even though IBWA supports an SOQ for arsenic in
bottled water of 10 ppb, the same level as in EPA's final MCL
regulation, the inconsistency and confusion to the bottled water
industry of implementing EPA's monitoring requirements -- which were
designed for municipal water supplies and not for bottled water
companies -- is substantial and without any commensurate public health
benefit. Moreover, the EPA monitoring requirements are often
supplemented by state requirements, and state waivers for bottled water
companies are seldom granted.

These differences emanate from the different nature of municipal water
systems compared to bottled water companies. For example, EPA monitoring
requirements vary according to the size of the population serviced by a
particular water source, a framework totally inapplicable to bottled
water distribution methods. Moreover, EPA's monitoring requirements are
based on testing a single point in the distribution of municipal water,
whereas bottled water companies test their products at two completely
different points in the distribution chain -- at the source and again
after final production at the bottling facility.

It is precisely for this reason that FDA developed a framework for
monitoring bottled water that is designed specifically for this
industry, and which the agency has already determined is fully adequate
(indeed, preferable) for protecting public health. By issuing a final
regulation, FDA would allow bottled water companies to simply
incorporate testing for arsenic into their existing monitoring
schedules, rather than create different schedules, thereby greatly
simplifying implementation by the industry. This is especially so where,
as here, a large portion of the industry has already adopted FDA's
testing regimens voluntarily to ensure that arsenic levels do not exceed
10 ppb. IBWA, therefore, strongly opposes Option Two. Additional
technical comments follow.

## 

## Cases of Cancer Avoided

*Risk and Valuation of Risk*

As stated earlier, IBWA has required, as a condition for membership, a
maximum level of arsenic of 10 ppb for at least three (3) years and the
Association represents the vast majority of bottled water producers.
California's Department of Health Services established an SOQ for
arsenic in bottled water of 10 ppb in 2000. In addition, approximately
25% of the bottled water sold in the United States is purified water,
which is largely produced through the use of reverse osmosis that
removes a substantial amount of components such as arsenic from the
final product. Therefore, because of reverse osmosis and the fact that
many natural waters do not contain arsenic, the vast majority of the
volume of bottled water sold in the United States [already]{.underline}
meets or exceeds the proposed regulation, given that the large and
medium size bottled water producers of "natural waters" belong to IBWA
or sell in California.[^4] Thus, any potential health benefits that
would be derived from lowering the SOQ for arsenic to 10 ppb may have
already been realized.

## Costs

## Abatement

IBWA concurs with FDA's assessment on the costs for abatement of bottled
water that exceeds the proposed new SOQ. Those using community water
systems that currently exceed 10 ppb may be using processing techniques
to meet the "purified water" standard of identity, such as reverse
osmosis or membrane filtration or de-ionization that would remove
substantial amounts of arsenic. Thus, there may not be a need for
additional abatement costs for these firms.

Abatement becomes more complicated for those firms that bottle a natural
water with naturally occurring arsenic content above the proposed
quality standard. The methods available to them may not be all 13
identified by the EPA. Because of commercial and regulatory restraints
on the ability to selectively remove undesirable elements and still
maintain the standard of identity for a natural water, the actual costs
for these firms could be substantially more than the average of the EPA
identified treatment methods.

Additionally, it appears that the cost of abatement techniques is not
proportionally related to the amount of arsenic removed, thus making
achievement of a reduction from 10 ppb to 5 ppb for example, more
expensive than the removal from 15 ppb to 10 ppb.

# Testing

The result of the "hammer" provision becoming effective in the case of
regulation of the nine contaminants has been to create confusion by
applying a significantly different regulatory monitoring scheme for
these substances than for other FDA- regulated parameters, as well as
lack of clarity for enforcement purposes. Based on this experience, IBWA
believes some of the cost savings calculated in the analysis of this
option will not be forthcoming and are thus overstated. The problems are
essentially two-fold:

1.  The FDA regulatory framework for bottled water requires annual
    testing for contaminants, while the EPA has a multi-year schedule
    that may vary according to system size, water source, and
    detections, and many states also have established their own
    schedules;

2.  There is minimal opportunity to obtain waivers for reduced testing
    by bottled water companies for a number of reasons.

Currently bottlers provide annually the appropriate samples to a
competent laboratory to have their bottled water tested for the spectrum
of regulated parameters. The records are maintained for inspection for
two years and are often sent to the appropriate state regulators. The
proposed regulation would add arsenic to the existing battery of tests
on bottled water. There would be no additional burden to track the
frequency by which bottlers must add arsenic to their annual tests under
current FDA regulations. In addition, bottlers would not be required to
add tests for those states that regulate bottled water as a food product
and require annualized testing for bottled water as part of their
regulatory scheme.

EPA's regulatory framework for arsenic, on the other hand, is on a
multi-year periodic schedule that would require community water systems
to test for arsenic once every three years for groundwater sources and
annually for surface water sources.

Although it would seem to result in cost savings to bottlers, these
state regulatory requirements often mitigate any savings, particularly
for bottlers that operate in multiple states. Waivers have seldom been
granted to bottlers because of a variety of factors. One principal
reason is the distribution of bottled water as compared with community
water systems. If a bottler obtains a waiver from one state, it will not
automatically transfer to other states, in which the bottler may do
business where a different monitoring schedule may be required. This is
a substantial consideration, given the cost of application for a waiver.
Thus, waivers may be of only a very limited benefit to the bottled water
producers. IBWA is not aware of any bottlers being granted nine-year
waivers in any state for any contaminant. In addition, many states that
regulate bottled water as a food product do not offer waivers to
bottlers. The waiver system is often viewed by these states as too
expensive for the state to develop and administer. California and
Massachusetts are the only two states that regulate bottled water as
food product and that have developed a waiver system for bottled water.

Community water systems do not generally encounter these commercial
challenges with waivers or in their ability to obtain these state
waivers through the regulatory framework of the state agencies. Thus, it
is highly unlikely that there will be the estimated savings from the
elimination of between 163 and 745 tests per year due to waivers and
extensions.

In addition, the potential for a delay in the monitoring requirement and
thus savings in testing costs is unlikely to be realized for those
bottlers that operate in states that regulate bottled water as a food
product. Therefore, the monitoring costs under Option Two are not likely
to be any lower than under Option Three.

## Administrative Costs

As discussed earlier in these comments, states that regulate bottled
water as a food product will likely incorporate the new SOQ for arsenic
in bottled water as part of their state's regulatory scheme, and develop
a separate monitoring schedule for arsenic just because the "hammer"
provision has fallen at the federal level. Our experience with the nine
contaminants confirms this assumption. There are 28 states that license
bottled water facilities. These states will incur additional expense in
promulgating new regulations incorporating the new SOQ, which as
indicated in the proposed rule, is a one-time expense.

## Public Notification

FDA's brief discussion in the economic analysis concerning public
notification contains two important errors concerning the "hammer"
provision (in section 410 of the Act) that need to be corrected in the
final rule.

The first, and more narrow of the two, is the assumption in the economic
analysis that, if the "hammer" provision were to become effective, the
public notification requirement in EPA's regulations would apply to
bottled water companies. In fact, under the feasibility study mandated
by the 1996 Amendments to the Safe Drinking Water Act, FDA made a
determination that such public notifications were not practical for
bottled water companies.[^5] Accordingly, in FDA's economic analysis
accompanying its final rule, the agency should omit any discussion of
public notification requirements except to note their non-applicability
to bottled water companies.

The second, and more fundamental point, is the impression given in this
section of FDA's economic analysis that, if the "hammer" provision were
to become effective, bottled water companies would somehow fall under
the jurisdiction of EPA. (Specifically, the economic analysis stated:
"It is not clear how EPA would adapt these regulations to bottled water
establishments ...." \[emphasis added\]). This is simply incorrect.
Under section 410 of the Act, should the "hammer" fall, the Secretary of
Health and Human Services (and, by delegation, the FDA) retains full
jurisdiction over and responsibility for the regulation of bottled
water. What would happen, should the "hammer" fall, would be that the
MCL and the monitoring requirements contained in the EPA regulation
would become the FDA SOQ regulation for bottled water by operation of
law. As such, the MCL and monitoring requirements contained in the EPA
regulation would become the SOQ and monitoring requirements enforced by
FDA for arsenic in bottled water. The key point here is that it would be
the FDA, not the EPA, as the responsible agency for enforcing these
requirements.

FDA has already taken this position in a parallel proceeding. In a
*Federal Register* notice dated August 6, 1998, FDA needed to address
the consequences of the "hammer" falling with regard to an SOQ
regulation for nine chemical contaminants.[^6] In addressing the legal
applicability of EPA's monitoring requirements, FDA stated that the EPA
monitoring requirements "shall be considered, under section 410(b)(4)(A)
of the \[Food, Drug, and Cosmetic\] act, to be the SOQ regulation for
bottled water."

IBWA believes that the continued legal authority of FDA for bottled
water, should the "hammer" become effective, to be a central point of
FDA's jurisdiction over bottled water. The agency should be sure to
clarify this point in the preamble to the final rule. IBWA has every
reason to believe that FDA is in agreement with this position, and
simply requests that the agency to state this explicitly.

**[IBWA Position]{.underline}**

IBWA opposes inaction by FDA in promulgating an SOQ for arsenic in
bottled water and allowing the provisions of Section 410 be triggered
for all of the reasons outlined above in these comments.

**V. *Option Three -- Establish a Quality Standard of 10 ppb for Arsenic
in Bottled Water***

**[IBWA Comments]{.underline}**

IBWA agrees with FDA's assessment that establishing an SOQ for arsenic
in bottled water that sets the allowable level of arsenic at 0.010 mg/l
is the appropriate course of regulation. Further, IBWA concurs with
FDA's analysis that the MCL for arsenic of 0.010 mg/L established by EPA
for public water systems, as an SOQ level for bottled water, is adequate
for the protection of public health. Adoption of the 0.010 mg/L standard
will ensure that the quality of bottled water is equivalent to the
quality of public drinking water that meets EPA standards.

FDA maintains, and IBWA concurs, that adopting EPA's MCL as the SOQ
level for bottled water appears to generate higher net health benefits
than either maintaining the current allowable level of 0.05 mg/L or
taking no action and allowing EPA's regulation to become applicable to
bottled water.

## Costs

As discussed under Option Two, there are likely to be very little
differences in costs to bottlers for testing between Options Two and
Three.

Option Three provides the most consistent and least burdensome
alternative outlined in the proposed regulation. Adoption of the
proposed 0.010 mg/L level for arsenic into the quality standards for
bottled water will not change current procedures for the vast majority
of the bottlers. Those bottlers who are not members of IBWA that will
have to develop abatement methods to meet the standard will incur costs
regardless of whether Option Two or Three or Five are promulgated.
Option Three will also provide states with the simple method for
harmonizing their regulations with FDA regulations for arsenic in
bottled water.

**[IBWA Position]{.underline}**

IBWA strongly supports FDA's proposed SOQ regulation of 10 ppb for
arsenic in bottled water, and urges the Agency to promulgate the final
regulation before the "hammer" provision deadline of July 23, 2005.

**VI. *Option Four -- Establish a Quality Standard of 20 ppb for Arsenic
in Bottled Water***

**[IBWA Comments]{.underline}**

*[Benefits]{.underline}*

Although evolving scientific understanding of the risks posed by
ingestion of arsenic in drinking water suggests that a higher level of
arsenic may be safer than previously thought, FDA is required to
regulate bottled water no less stringently than public drinking water as
discussed under Option One above. An SOQ of 20 ppb for arsenic in
bottled water may not be as protective of public health or as stringent
as the standard for public drinking water.

*[Costs]{.underline}*

IBWA concurs with FDA's analysis of the potential costs incurred under
this option.

**[IBWA Position]{.underline}**

IBWA, therefore, does not support a standard of quality of 20 ppb for
arsenic in bottled water.

**VII. *Option Five - Establish a Quality Standard of 5 ppb for Arsenic
in Bottled Water***

**[IBWA Comments]{.underline}**

*[Benefits]{.underline}*

IBWA agrees with FDA's assessment that establishing an SOQ for arsenic
in bottled water that sets the allowable level of arsenic at 0.005 mg/l
(5 ppb) is not appropriate. As summarized below, a review of the science
and new research available on arsenic in the United States suggests that
a 0.010 ppb SOQ for arsenic in bottled water is fully protective of the
public health.

Reports by independent, expert panels, including the National Academies
of Science (NAS), the National Drinking Water Advisory Council, and the
EPA Science Advisory Board confirmed arsenic as a
[suspected]{.underline} carcinogen. However:

-   These studies did not confirm a mode of action.

-   The levels identified in these reports as actionable for arsenic in
    drinking water varied among the expert panels.

On behalf of EPA, health risk issues with arsenic in drinking water were
examined the by National Academy of Sciences (NAS) in two studies,
including *Arsenic in Drinking Water* published 1999 and then again in
*Arsenic in Drinking Water: 2001 Update* published September 2001. In
its 2001 report, the NAS expert panel examined four additional
epidemiological studies published after the 1999 report was issued. The
expert panel concluded that the science on arsenic suggests it does not
cause bladder or lung cancer at concentrations up to 50 ppb in drinking
water.

In addition to conclusions reached by the NAS, in the 2001 report,
experts have expressed concerns with existing epidemiological studies
that have associated arsenic in drinking water with cancer and the
conclusions drawn from them. Specifically**:**

-   Where arsenic ingestion from drinking water has been was associated
    with cancer --in Taiwan and Chile\--residents had been exposed to
    much higher levels than in U.S. drinking water.

-   NAS, and subsequently the EPA, used (by default) a linear
    relationship to extrapolate cancer risk from much higher levels of
    arsenic found in Taiwanese studies to the low levels of concern for
    regulatory interest. NAS conceded a linear dose-response curve may
    not be correct:

> \"Despite the extensive research on modes of action of arsenic, the
> experimental evidence does not allow confidence in distinguishing
> between various shapes (sublinear, linear or supralinear) of the
> dose-response curve for tumorigenisis at low doses. Therefore the
> choice of model to extrapolate human epidemiological data from the
> observed range (100-2000 ug/l (ppb)) to the range of regulatory
> interest (3-50 ug/l (ppb)) cannot be made solely on a mechanistic
> basis." (see \"Summary and Conclusions\" in both 1999 and 2001
> reports)

-   Additionally, NAS stated:

> \"An important and controversial issue is whether the existing mode of
> action data provide suitable evidence to demonstrate that arsenic acts
> as a threshold type carcinogen in humans exposed to arsenic in
> drinking water. A sublinear response might imply the existence below
> which there is no biologically relevant response\".

-   NAS also stated that:

> "inferring the shape of the dose-response curve in mechanistic
> studies cannot be done with any confidence." (page 119, 2001 report)

After receiving the NAS 2001 Update report, EPA conducted additional
scientific review of 10 ppb level after publication (January 2001) of
its arsenic final rule. After conducting this review, EPA affirmed the
10 ppb standard (October 2001).

New research on arsenic in drinking water also suggests that arsenic may
not be as harmful as previously thought. For example, a recent paper in
American Journal of Epidemiology by Steinmaus[^7], et al. reviewed
epidemiological data from 6 counties in California and Nevada, where
residents drank water with arsenic at 100 ppb.

-   The researchers found no association between bladder cancer risk and
    the high level (100 ppb) of arsenic exposure.

-   The researchers concluded that there are no increased risks for
    arsenic intakes greater then 80 ug/day and that the risks are below
    predictions based on the Taiwanese studies.

The principal author of this study (Steinmaus) is a lead researcher at
the University of California\--Berkeley's Arsenic Health Effects
Research Program. The study was conducted by the same group of
researchers who previously favored the EPA's decision to lower the
arsenic MCL to 10 ppb in drinking water.

These conclusions are similar to those in another recent study by Lamm.
et al. entitled "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."[^8] In conjunction with the research by
Steinmaus, these studies suggest that EPA's current risk assessment for
arsenic is based on a flawed interpretation of data from Taiwan (as
complied by Wu et al.) that over predicts the cancer risk for arsenic in
drinking water in the United States.

*[Costs]{.underline}*

IBWA concurs with FDA's method of cost analysis for lowering the quality
standard to 5 ppb for arsenic in bottled water. However, there may also
be an undetermined number of additional firms that will need to employ
abatement methodologies to be compliant with the new standard. Thus,
there is likely to be an increase in the total number of firms, above
the estimate under Option Two of 20 firms that will be impacted.

**[IBWA Position]{.underline}**

IBWA agrees with FDA's assessment that establishing an SOQ for arsenic
in bottled water at 0.005 mg/l (5 ppb) is not appropriate. As discussed
above, the science does not indicate a consensus on the potential
benefit, and the increase in costs to the industry is unknown, but could
be substantial.

**VIII. *Small Entity Analysis***

**[IBWA Comments]{.underline}**

As discussed above under Option Two, the vast majority of bottlers of
all sizes already comply with a quality standard of 10 ppb for arsenic
in bottled water. Bottlers that do not do not comply are not members of
IBWA and are most likely small bottlers. The large firms that produce
"natural waters" belong to IBWA and would comply with a 10 ppb standard.
Therefore, FDA's analysis that the impact will fall to small firms is
probably accurate.

IBWA would not support a separate quality standard for arsenic in
bottled water for small firms. Such a standard would be difficult to
communicate to consumers and provide less protection to them than a
uniform standard of 10 ppb. In order to mitigate the abatement cost
impact to these firms, FDA may consider a scalable implementation date
for small firms. This could be similar to the recently published
regulations on records maintenance and inspections under the
Bioterrorism Act. However, legal restraints under Section 410 of the
FFDCA may preclude such an option.

***Federalism***

**[IBWA Comments]{.underline}**

IBWA supports the conclusion in FDA's analysis with regard to Federal
preemption and its compliance with Executive Order 13132 - -
specifically, that any final regulation establishing an SOQ for bottled
water would preempt state requirements that are not identical to it.

Express preemption for FDA's standards of identity is established by
Section 403A of the Federal Food, Drug, and Cosmetic Act (FDCA), as
follows:[^9]

> "\[n\]o 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... that is not identical to such standard of identity...."
> 21 U.S.C. § 343-1(a)(1).

The plain language of this controlling federal statute demonstrates that
any state requirements in conflict with a standard of identity are
preempted.

Using the authority granted by the FFDCA, FDA promulgated a standard of
identity for bottled water.[^10] The standard of identity for bottled
water includes a number of quality standards. Under the standard of
identity, bottled water must meet these quality standards or be labeled
as substandard.[^11] The quality standards include numerous
microbiological, physical, chemical and radiological limits.

FDA has long interpreted Section 403A of the FFDCA as applying to
standards of quality in conjunction with the standard of identity for
bottled water.[^12] FDA stated in the 1993 final rule on State petitions
requesting exemption from Federal preemption that "\[u\]nder section
403A(a)(1) of the act, a State may not establish or continue in effect a
standard of identity, *quality*, or fill for a food that is the subject
of a standard of identity under section 401 of the act that is not
identical to the Federal standard (emphasis added)."[^13] Therefore,
states may not establish differing standards of quality, such as
establishing requirements for arsenic levels that are inconsistent with
the federal requirement.

FDA reiterated the preemptive nature of Section 403A in a September 4,
2003, letter to Maine Attorney General Steven Rowe on labeling and
standards of identity. In this letter, FDA stated that the newly enacted
Maine labeling requirement to identify water sources on bottled water
labels was preempted by FDA regulations. The letter cites several
passages from the 1993 proposed rule for bottled water, notably that FDA
"concluded that the different State requirements for labeling and
testing bottled water impose a significant burden on interstate
commerce."[^14] FDA found that a "uniform Federal definition will ensure
that consumers will be able to purchase bottled water products that are
informatively and consistently labeled throughout the country" and that
"such a standard will preempt any State standards that are not identical
to it."[^15]

In the 1995 final rule on bottled water, FDA acknowledged that some
State laws will be preempted by Federal regulations.[^16] However, FDA
notes that one of the goals of the national uniformity provisions was to
give that industry some relief from State requirements that interfere
with their ability to market products in all 50 States in an efficient
and cost effective manner.[^17] "... Congress decided that even though
Federal requirements may preempt more restrictive State requirements in
certain instances, the net benefits from national uniformity in these
aspects outweigh the loss in consumer protection that may occur as a
result."[^18]

Several court cases have also addressed similar questions of preemption
relating to food labeling. The U.S. Supreme Court left no doubt that
federal regulations preempt inconsistent state or local standards or
practices in the area of food labeling. In Jones v. Rath Packing Co.,
for example, the Court held that federal law requiring the recognition
of moisture loss in determining net weight compliance preempted
California law and county enforcement practice to the contrary.[^19] As
the Court explained, "Congressional enactments that do not exclude all
state legislation in the same field nevertheless override state laws
with which they conflict."[^20]

In a more recent case, the Southern District of New York found Congress
expressly preempted any state or local package weight labeling
requirements that differ from those imposed by federal statute and
regulation such as Section 403A.[^21] The court noted:

> "\[n\]o State...may directly or indirectly establish under any
> authority or continue in effect as to any food in interstate commerce
> -- (2) any requirement for the labeling of food of the type required
> by section...343(e)... of this title that is not identical to the
> requirement of such section." 21 U.S.C. § 343-1(a)(2).

The Court overturned local inspection practices and enforcement schemes
that conflicted with federal food labeling law based, in part, on the
express preemption provision in Section 403A.

IBWA fully supports FDA's conclusion regarding the preemptive effect of
any final rule based on its proposal to amend the bottled water quality
standards. The establishment of an SOQ provides all consumers with the
same protection and consistency, regardless of the state in which they
reside. The proposed regulation, if finalized, would allow consumers
from every State to purchase bottled water with the full assurance that
it complies with the quality standard for arsenic at the highly
protective level of 10 ppb, the same level that EPA requires for
municipal water.

**[Conclusion]{.underline}**

IBWA urges FDA to finalize the proposed regulation for a quality
standard of 10 ppb for arsenic in bottled water in a timely manner, so
that the "hammer" provisions of Section 410 of the FFDCA are not
triggered. IBWA has attempted to offer constructive input on the
analysis by FDA of the five options proffered in the proposed rule. They
are not intended to delay or adversely impact the timely promulgation of
a final rule.

IBWA appreciates the opportunity to comment on the proposed regulation.
If there is additional information IBWA can provide, please do not
hesitate to contact Patrick Donoho, IBWA Vice President of Government
Relations, at (703) 647-4608 or me at (703) 647-4605.

> Sincerely,
>
> Joseph Doss
>
> President

[^1]: IBWA is the trade association representing all segments of the
    bottled water industry. Founded in 1958, IBWA member companies
    includes U.S. and international bottlers, distributors and
    suppliers. IBWA is committed to working with the U.S. Food and Drug
    Administration (FDA), which regulates bottled water as a packaged
    food product, and state governments to set stringent standards for
    safe, high quality bottled water products. In addition to FDA and
    state regulations, the Association requires member bottlers to
    adhere to the IBWA Model Code, which mandates additional standards
    and practices that in some cases are more stringent than federal and
    state regulations. A key feature of the IBWA Model Code is an
    annual, unannounced plant inspection by an independent, third-party
    organization.

[^2]: 63 Fed. Reg. 42199

[^3]: 21 U.S.C. § 349 (b)(4)(B)

[^4]: The term "natural waters" refers to standards of identity for:
    artesian, mineral, sparkling, spring, and well waters.

[^5]: 65 Fed. Reg. 51833-51839

[^6]: 63 Fed. Reg. 42199

[^7]: Steinmaus, C., Yuan, Y., Bates, M.N., Smith, A.H. 2003.
    Case-control study of bladder cancer and drinking water arsenic in
    the Western United States. Am. J. Epidem. 158(12):1193-1201*.*

[^8]: Lamm, S., Engle, A., Kruse, M., Feinleib, M., Byrd, d., Lai, S.,
    Wilson, R. 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. J. Occup. Environ. Med.
    46(3):298-306.

[^9]: 21 U.S.C. § 343.

[^10]: 21 U.S.C. § 341 & 21 C.F.R. § 165.110.

[^11]: 21 C.F.R. § 165.110(c).

[^12]: 21 C.F.R. § 100.1(c)(4). *See also, Jones v. Rath Packing Co.,*
    430 U.S. 519, 526 (1997)("Federal preemption inquiry requires us to
    consider the relationship between state and federal laws as they are
    interpreted and applied, not merely as they are written").

[^13]: "State Petitions Requesting Exemption from Federal Preemption,"
    58 Fed. Reg. 2462, 2463 (January 6, 1993).

[^14]: "Beverages: Bottled Water -- Proposed Rule," 58 Fed. Reg. 393,
    395 (January 5, 1993).

[^15]: *Id.*

[^16]: "Beverages: Bottled Water -- Final Rule," 60 Fed. Reg. 57076
    (November 13, 1995).

[^17]: 60 Fed. Reg. 57,076 at 57, 120 (citing statement of Rep. Madigan,
    136 Congressional Record H12954 (October 26, 1990).

[^18]: *Id.*

[^19]: 430 U.S. 519 (1977).

[^20]: *Id*. at 525-526.

[^21]: *Kraft v. Rockland County Dept. of Weights and Measures*, 2003 WL
    554796 (S.D.N.Y. Feb. 26, 2003).