May 20, 2003

Bottled Water and the FDA Standards of Quality

The true driving force behind the addition of parameters to the FDA SOQs is the U.S. Environmental Protection Agency's Safe Drinking Water Act.

Bottled water is classified as a food product and regulated
by the U.S. Food and Drug Administration (FDA). The FDA has regulations that

* What
bottled water can be called (Standards of Identity),

* How
bottled water can be produced (Good Manufacturing Practices),

* What
can and cannot be on the label (labeling requirements), and

* The
contaminants for which bottled water must be tested along with the allowable
limits for each (Standards of Quality).

This article will focus on the last item, the Standards of
Quality (SOQs). Bottlers may feel that every time they turn around they have to
do more testing, especially over the last few years. To a point, those feelings
are valid. In 2002, bottlers were required by FDA to add an analysis for the
disinfectants and disinfection byproducts (chlorine, chloramine, chlorine
dioxide, HAAs, bromate and chlorite) to their annual tests. In addition, the
FDA recently announced that it plans to add uranium to the list of required
parameters effective in December 2003.

The fact that bottlers are having to test for more now than
they did a couple of years ago won't be much of a surprise to anyone in the
industry. The driving forces behind why more testing continues to be added,
however, often are misguided. Many bottlers speculate that the FDA is being
lobbied to add requirements; others simply blame the bureaucrats at the FDA. In
reality, the true driving force behind the addition of parameters to the FDA
SOQs is the U.S. Environmental Protection Agency's Safe Drinking Water Act

Originally passed in 1974 and amended in 1996, the SDWA is
the federal law that allows the EPA to set National Primary Drinking Water
Standards (NPDWSs). The EPA goes through an extensive and ongoing process to
determine which contaminants should be regulated and at what level. The EPA
promulgates standards for those contaminants that have demonstrated occurrences
at levels that pose a potential health risk. These standards are developed with
the goal of ensuring that public water supplies are safe to drink, but they
also directly impact the FDA SOQs.

In order to ensure that bottled water is regulated at least
as stringently as public water systems, the 1996 SDWA amendments included a
"hammer clause." This clause states that when EPA promulgates interim
or revised NPDWS regulations, the FDA has 180 days to either promulgate
amendments to regulations establishing an SOQ for bottled water or publish
reasons for not making such amendments. If FDA fails to promulgate rules within
the specified time period, the EPA NPDWS regulations become the SOQs for
bottled water.

Normally, when the FDA promulgates a rule for addition of a
new standard within the time frame allowed, the SOQ is equivalent to that of
the EPA maximum contaminant level. However, FDA usually substitutes the
complicated monitoring program applied to public water supplies of waivers,
system size schedule tiers and reduced monitoring programs with a simple annual
requirement for sources and products. The disinfectants and disinfection
byproducts are an example of FDA promulgating its own rules for parameters
added by the EPA to the NPDWS within the allowable time frame as described
above. As a result of these additions, bottlers were required, as of January
2003, to be in compliance with the SOQ and begin annual testing of all products
and some sources for HAAs, bromate, chlorite, TTHMs, chlorine, chloramine and
chlorine dioxide.

In contrast, what often is referred to as the "nine stayed
parameters" is a prime example of the repercussions when the FDA cannot
fully promulgate an SOQ and monitoring frequency within statutory requirements.
On the last day of the 180 day period, the FDA issued notice that they were
unable to promulgate rules regarding the monitoring for the synthetic organic
compounds (SOCs)--glyphosate, endothall, diquat and 2,3,7,8-tcdd dioxin--that
were included in the "nine stayed parameters." Therefore, the
monitoring frequency for these parameters would be the same as specified in the
NPDWS regulations.

Unfortunately, the NPDWS regulations for these contaminants
contain many options based on state plans for implementation and system
classifications determined by source types and population served. For example,
some states were allowed to present data to EPA and obtain statewide waivers
for some or all of these parameters so that public water systems in the state
don't have to test for them. In addition, the NPDWSs have two different sets of
monitoring schemes: one for large systems serving a more than 10,000 population
and one for small systems serving less than 10,000.

This raised a couple of questions.

* How
do in-state waiver programs apply?

* Is
bottled water a large system or a small system?

The answers to these questions determine how frequently
testing is to be required. Unfortunately, there are no answers to these
questions, and the FDA has been unable to finalize the guidance document it
promised in 1998 to help give clarification to these issues.

Without the guidance from FDA, industry and regulators were
left to speculate what the correct interpretation of monitoring frequency was.
The International Bottled Water Association adhered to virtually a literal
interpretation, which required finished product water to be testing for the
SOCs--glyphosate, endothall, diquat and 2,3,7,8-tcdd dioxin--for four
consecutive quarters during the first three-year monitoring period and annually
thereafter, as well as annual source testing. Regulators for the states of
Georgia, Massachusetts and California determined that, until advised otherwise
by FDA, they would require these four parameters annually on source and product
and not require any quarterly testing.

The majority of state regulators took a stance that they
will require additional testing when FDA advises them of how frequently that
testing should be performed. In short, failure of FDA to fully promulgate both
the SOQ and the monitoring frequency prior to the statutory deadline resulted
in tremendous confusion as bottlers, state regulators and the FDA seem unsure
as to what is required to be in compliance.

While the nine-stayed parameters outcome was not a desirable
one, several lessons were learned.

needs encouragement to address the industry issues within statutory deadlines.

* FDA's
many priorities may not always allow sufficient resources to devise alternative
monitoring schedules to the present annual requirements within the statutory
time frame.

* If
the industry submits "adverse comments" to a direct final rule of
adding NPDWS parameters to the FDA SOQs, FDA most likely will let the hammer

* The
hammer falling results in confusion between the industry and regulators and,
depending on regulation interpretation, may significantly increase testing

* It
benefits the industry to be proactive in tracking potential NPDWS add-ons and
to have strong communication with FDA prior to FDA issuing the draft rules.

In conclusion, future years most likely will bring
additional testing requirements as the EPA adds parameters to the NPDWS's
forcing FDA to attempt to draft rules as well. While there is not much that the
industry can do to prevent new parameters from being added, it can be proactive
by learning about upcoming changes and preparing for their impact.

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