Bottled water is fully regulated by the U.S. Food and Drug Administration (FDA) as a food
product and subject to FDA?s extensive food safety and labeling
requirements. Bottled water is a product that is affected by both general food
as well as bottled water-specific legislation, regulations and standards. The
International Bottled Water Association (IBWA) tracks and takes action on a
number of relevant issues. The goal is to ensure fair and equitable treatment
of bottled water companies and to help the industry continue to deliver safe,
high-quality bottled water products to a thirsty consumer market. In 2001, IBWA
was engaged on both the federal and state legislative fronts, working hard to
represent the bottled water industry and seeking the adoption of sensible,
effective laws and regulations.
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New Bottled Water Regulations
The tragic events of Sept. 11, 2001, have changed many of
the issues confronting the bottled water industry and the food industry
overall. Elected officials and regulators have refocused on the security and
safety of the food supply and infrastructure and are placing greater emphasis
on risk assessments, planning and prevention, and government and industry
response plans. These new initiatives may present challenges and change for the
bottled water industry and others within the food and drinking water
industries.
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Most immediate and significant are new requirements dictated
by the Public Health Security and Bioterrorism Response Act (bioterrorism law)
that was signed into law by President George W. Bush on June 12, 2002. The
provisions of the bioterrorism law address a wide variety of issues. However,
the food provisions including bottled water and to some extent the public water
provisions are of particular interest to the bottled water industry. The key
provisions of interest to bottlers are
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? food
facility registration,
? maintenance
and inspection of records, and
? prior
notice for importation of food products.
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IBWA worked with other members of a broad-based food
industry coalition to provide input to Congress as it considered this
legislation. FDA will be charged with interpretation and enforcement of the new
law and has been authorized to make grants to the states to assist in the
examinations, inspections and investigations. In addition, FDA may award
?food safety grants? to expand participation in programs designed
to enhance food safety.
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Food Facility Registration
Every facility that manufactures, processes, packs or holds
a food for human consumption must be registered with FDA by Dec. 11, 2003. FDA
has until then to promulgate regulations implementing the food facility
registration provisions. However, if it fails to finalize regulations by that
date, the obligation to register is still on the bottler. (See Registration
Requirements sidebar.)
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A registrant must apprise FDA of changes to such information
?in a timely manner.?
A facility includes any factory, warehouse or establishment that
manufactures, processes, packs or holds food for human consumption. A foreign
food facility is a facility that manufactures, processes, packs or holds food
for export to the United States without further processing or packaging outside
the United States. The law specifically excludes farms, restaurants, other
retail food establishments, non-profit food establishments in which food is
prepared for or served directly to the consumer, and fishing vessels not
engaged in processing. Failure to register is a ?prohibited act? under
the Food, Drug and Cosmetic Act. If a foreign facility is not registered, the
food product will be held at the point of entry until the facility registers.
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Specific bottled water issues yet to be resolved include
questions such as, ?Is a pump house, springhouse or water storage
facility classified as a food facility?? A determination whether to
impose user fees is an issue for rulemaking under the expedited rulemaking
provisions of the new law. IBWA will be working with FDA to have these and other
issues clarified.
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Record Maintenance and Inspections
The records access provision of the law expands FDA?s
authority to review records of food producers if the agency has a
?reasonable belief? that the food is adulterated and poses a health
risk to humans. It extends to all records relating to the manufacture,
processing, packing, distribution, receipt, holding or importation of the food,
without regard of the format or the location at which they are held. The new
law mandates that records show from whom a purchase was made and to whom a food
product was sold (one look forward; one look backward). Records must be
maintained for two years and FDA may promulgate implementing regulations by
Dec. 11, 2003. It is a prohibited act to refuse FDA access to and the
opportunity to copy such records.
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Prior Notice of Importation
By Dec. 11, 2003, FDA must promulgate final regulations that
require importers of food products to provide prior notice to FDA. The required
information includes the identity of the article; its manufacturer and shipper;
its grower (if known within the specified notice period); the country of origin
and country from which it is shipped; and the article?s anticipated port
of entry. If FDA does not finalize regulations, the law specifies a minimum of
eight hours and a maximum of five days prior notice. Failure to provide notice
will result in the product being held at the port of entry until notice is
given.
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The new bioterrorism law also may be affected by the
creation of a Department of Homeland Security which, according to the current
configuration of the new department, is to include the Federal Emergency
Management Administration (FEMA). As community water systems develop their risk
assessments and response plans as required under the water provisions of the
new law, they also must identify alternative water sources in the case of a
disaster. This has been the traditional role of FEMA. The responsibilities of
the proposed Department of Homeland Security have yet to be determined.
However, the requirement for community water systems to identify alternative
water sources will be required, regardless. One alternate source is, of course,
bottled water.
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There remain many questions and concerns about the full
impact of the new authority granted to FDA. As the provisions are implemented,
IBWA will be engaged with Congress and FDA to ensure the smooth transition with
the new requirements.
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State Regulatory Update Section
In the state regulatory arena, IBWA?s activity
currently is focused on states undergoing regular review of their bottled water
regulations. With the Texas Department of Health in the midst of revising its
rules related to bottled water, IBWA on April 17, 2002, submitted comments to
the department. Among the recommendations made to the department, IBWA is
requesting the removal of the current requirement for a minimum chlorine
residual of 0.5 mg/L for bulk water hauling from source to the bottling
facility. The State of Texas regulates bottled water under the same authority
as its public water systems and requires each to maintain a residual chlorine
level. However, where public systems must maintain residual chlorine levels
until the point of distribution (e.g., the tap), bottled water producers
currently are required to chlorinate water as it is transported from the source
to the plant. IBWA contends that this source water is an ingredient for bottled
water that will be properly handled at the plant through ozonation or other
protective measures at the plant to help ensure its safety. This makes advance
chlorination of source water in transport an unnecessary and inefficient step.
The department also is being asked to expand its scope of responsibility for
bottled water to encompass the entire process pathway from natural water source
(wellhead or spring) to finished, packaged food product.
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Revised rulemaking also is underway in Massachusetts. On
Feb. 22, 2002, IBWA submitted comments to the Department of Public Health in
response to proposed changes to the bottled water regulations. Of particular
concern, IBWA urged more clarity on the definition of minimal treatment and
testing requirements. It was requested that the source labeling requirement be
deleted, as FDA already has considered and rejected such a proposal as not
being material fact. Regarding a proposal by the state that would require the
printing of a permit number on each bottled water label, IBWA suggested that
the permit numbers expected to be required as part of soon-to-be enacted
federal bioterrorism legislation (HR 3448) be used as a single national permit
number, thus easing labeling requirements for multistate sellers.
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IBWA will continue to work with lawmakers and regulators at
the federal and state levels to help ensure a fair and balanced legislative
environment and the continued protection of bottled water consumers across the
United States.
