in the New Millennium
By Kristin Saltzgiver and Barbara
Bottled water is regulated by the U.S. Food and Drug Administration
(FDA) as a food product. The FDA regulations for bottled water include
the Good Manufacturing Practices (GMPs) to be employed at bottling plants,
labeling requirements, "Standard of Identity" and the "Standard
of Quality," which all bottled water must meet. This article reviews
the current FDA requirements and speculates on coming changes in the years
2001 and beyond for each of these areas.
The GMPs currently established for bottled water include FDA Title 21
CFR Parts 110 and 129-with CFR standing for Code of Federal Regulations.
The GMPs include requirements for buildings and facilities, equipment,
processes and controls, warehousing and distribution. The current GMPs
for bottled water depend on spot-checks of manufacturing condition and
random sampling of final product to ensure product safety. State and national
bottled water associations and the FDA have been promoting movement from
traditional GMPs to a HAACP based approached for product safety.
HAACPHazard Analysis and Critical
Control Pointwas originally developed for the National Aeronautics
and Space Administration (NASA) 30 years ago. HAACP takes a more proactive
approach than traditional GMPs by focusing on preventing hazards that
could cause food-borne illnesses through application of science-based
control from raw material to final product. The U.S. Department of Agriculture
and FDA have established HACCP requirements for the seafood, meat and
poultry industries and are implementing HACCP for fruit and vegetable
juice production. The FDA intends to implement HACCP for all food commodities,
including bottled water.
The International Bottled Water Association
(IBWA) has presented training seminars for the last two years regarding
the design and development of HAACP plans for bottled water plants. IBWA
anticipates full implementation of the HACCP system over the next two
years. For more information, see: "Water Matters: HACCP and The Bottled
Water Industry-Taking the Final Steps," WC&P, October 1999; and
"HACCP 9000: International Standard Attracts Bottler's Attention,"
WC&P, February 1997.
Current FDA label requirements for the industry include principal display
panel declarations (such as the type of water and product size), nutrition
labels for products making health claims and ingredient lists if minerals
are added. Consumer groups and some government legislators have been advocating
that bottled water should be providing more information regarding product
quality and contents to consumers.
On Feb. 22 the FDA published a "Draft
Study Report on Feasibility of Appropriate Methods of Informing Customers
of the Contents of Bottled Water." This feasibility study was mandated
in the Safe Drinking Water Act (SDWA) Reauthorization of 1996, which established
requirements for public water supplies (PWSs) to notify customers on an
annual basis of water quality, methods of treatment and USEPA violations
which the PWS may have received in the previous year. These notices were
to be in the form of Consumer Confidence Reports (CCRs). The FDA concluded
that while it's neither feasible nor appropriate to place all CCR information
on a label, there was validity in a combination approach in which certain
individual bits of information (i.e., water source, suitability for consumption
by immunocompromised individuals or fluoride levels) would appear on the
label. And other CCR-type information would be available to customers
through contact with the company by mail or through its website.
The FDA is currently receiving comments
on the draft study proposals. The IBWA, while opposed to additional labeling
requirements, has urged members to place bottler and/or distributor contact
information on the bottle. It also recommends members develop a "bottled
water quality report" containing information on source of the water,
process techniques utilized and annual finished product test results for
distribution to consumers upon request. The FDA has already missed the
statutory deadline for the final report-February 1999. The final study
is not expected until later in 2000 or early 2001.
Standards of quality
The Standards of Quality (SOQs) will change in the years 2001 and beyond
This is due, in part, to more attention given to drinking water by the
media and film industry over the last few years. Movies like Erin Brokovich
and A Civil Action along with news stories of deaths caused by
contaminated drinking water supplies have brought drinking water quality
issues to the public podium. In addition to increased public awareness
of drinking water quality, new methods are being established enabling
laboratories to test for contaminants at lower levels than ever. As a
result, we can expect to see a barrage of USEPA regulations establishing
new contaminants to be monitored and lower MCLs for existing contaminants-that
the FDA will likely add for bottled water.
Nine stayed parameters
Antimony, beryllium, cyanide, nickel, thallium, diquat, endothall, glyphosate,
and 2,3,7,8-TCDD (dioxin) are to be included in bottled water analysis.
The FDA has announced monitoring for these previously stayed parameters
will be required as the SDWA outlined. While the FDA still hasn't released
its guidance document, it has indicated the following schedule in meetings
with IBWA staff.
In the first monitoring period (prior to
February 2002), bottlers are required to perform four consecutive quarters
of analysis for glyphosate, endothall, diquat, and 2,3,7,8-TCDD (Dioxin)
on finished products. After the initial four quarters have been completed,
bottlers may be able to reduce testing to annually if no detections are
found. Antimony, beryllium, cyanide, nickel and thallium are to be tested
The IBWA has revised its "Model Code"
to include the monitoring schedule outlined above with the exception that
the association mandates the quarterly testing be completed by December
Disinfection By-Products (DBPs) are formed when disinfectants such as
chlorine or ozone react with natural organic and inorganic matter. Toxicology
studies have shown some DBPs to be carcinogenic and/or cause adverse reproductive
or developmental effects in laboratory animals. Stage 1 of the Disinfectant
and Disinfection By-Product Rule (D/DBP) updates the 1979 regulations
for total trihalomethanes (TTHMs) as well as established maximum contaminant
level goals (MCLGs) and maximum contaminant levels (MCLs) for haloacetic
acids, chlorite and bromate (see Table 1).
Large surface water systems are required to comply with the Stage 1 D/DBP
Rule by December 2001. Groundwater systems and small surface water systems
must comply with the State 1 D/DBP Rule by December 2003. The FDA is mandated
by a hammer clause in 1996 SDWA Amendments to evaluate and establish monitoring
requirements for these parameters for bottled water by August 2001.
The SDWA Amendments also require the USEPA to revise the Unregulated Contaminant
Monitoring Rule (UCMR). Data generated by the new UCMR is to be used to
evaluate and prioritize contaminants being considered for possible new
drinking water standards. The UCMR monitoring list (see Table
2) contains 36 contaminants divided into three lists. The USEPA
has utilized this tiered approach to maximize capability to monitor up
to the statutory limit of 30 contaminant in any five-year monitoring cycle.
As contaminants are found to occur in public water systems, the agency
may move them up to a higher priority list.
List 1 contains 12 contaminants for which
3,600 public water supplies will begin monitoring in 2001. List 2 contains
16 contaminants for which analytical methods are under development and
for which current USEPA data show less frequency of occurrence. Monitoring
for these parameters will occur at 300 randomly selected public water
supplies after additional rulemaking and analytical development. List
3 contains contaminants, which are newly emerged as drinking water concerns.
In most cases, these contaminants have methods in the early state of development.
List 3 contaminant monitoring will be performed only after future rulemaking
and method development and will occur among 200 public water supplies
determined by the agency to be most vulnerable.
The USEPA is proposing new regulations to reduce public health risks from
radon based on a two-tier system. The proposed radon standard offers states
two options. Those who choose to develop enhanced state programs to address
the health risks from radon in indoor air would need to reduce radon levels
in drinking water to 4,000 picocuries per liter (pCi/L). PWSs in states
choosing not to develop an indoor air program-known as a multi-media
mitigation or MMM programwould be required to either reduce radon
in drinking water to 300 pCi/L or develop individual local MMM programs
and meet the greater 4,000 pCi/L level.
The AWWA has opposed these standards for
radon, as has the IBWA. While previous studies by the IBWA indicate radon
isn't an issue in bottled water finished products due to it's extremely
short half life, it remains unclear how the FDA would potentially interpret
and apply these standards to bottled water sources and products.
Arsenic is currently regulated with an MCL of .050 mg/L, or 50 parts per
billion (ppb), by the USEPA and FDA. Long term exposure of low doses of
arsenic has been linked to cancer as well as other non-cancer effects
such as cardiovascular disease, diabetes and anemia. The USEPA has proposed
lowering the arsenic MCL to .005 mg/L (5 ppb). The USEPA is required by
the SDWA Amendments to promulgate a final rule by Jan. 1, 2001. A lawsuit
brought by the Natural Resources Defense Council seeks to hold the agency
to that schedule, while water utilities have been pressing Congress to
extend the deadline to one-year after final comments were to be submitted-Sept.
20, 2000-to properly consider alternative proposals. Those include a staggered
implementation timeframe in which the first phase would lower the MCL
to 0.02 mg/L (20 ppb).
The new millennium is likely to bring many changes in FDA bottled water
regulations, labeling requirements, GMPs and standards of quality that
bottled water must meet. As we strive to speculate regulatory impact for
the years to come, there'll always be new issues to face with the changing
focus of the public, media and government agencies. Bottlers and bottled
water companies will be tasked with monitoring the regulation in the pipelines
and assessing their impact to the industry.
1. International Bottled Water
Association, "Bottled Water Questions and Answers Brochure,"
IBWA, Alexandria, Va.
2. Hirst, Bob, "IBWA HAACP Workshop PowerPoint Presentation Slides,"
IBWA, Alexandria, Va.
3. International Bottled Water Association,
"Plant Technical Manual" Revised 12/95
Federal Register, February 22, 2000, Vol. 65, No. 35, PP 8718-8722.
3. Hirst, Bob, "Comments on FDA Draft
Feasibility Study" IBWA, Alexandria, Va., March 24, 2000.
4. Marteney, Barbara, and Kristin Saltzgiver,
"Update: FDA Bottled Water Regulations," Aqua News, Fall
5. International Bottled Water Association,
"Model Bottled Water Regulation," IBWA, Alexandria, Va., (revised)
6. U.S. Environmental Protection Agency,
"Stage 1 Disinfectants and Disinfection Byproducts Rule," USEPA
7. U.S. Environmental Protection Agency,
"Final Revisions to the Unregulated Contaminant Monitoring Regulation
Fact Sheet," USEPA 815-F-99-005, 1999.
8. U.S. Environmental Protection Agency,
"Consumer Fact Sheet: Proposed Radon in Drinking Water Rule,"
USEPA 815-F-99-009, 1999.
9. U.S. Environmental Protection Agency,
"Proposed Revision to Arsenic Drinking Water Standard," USEPA
About the authors
Kristin M. Saltzgiver is the
beverage market manager for National Testing Laboratories Ltd., of Cleveland.
Her department coordinates annual testing for over 250 beverage plants
worldwide. She's a member of the IBWA Government Relations and Technical
Committees and has authored numerous articles regarding state, federal
and international bottled water regulations.
Barbara L. Marteney, beverage accounts
manager with National Testing Laboratories since 1994, specializes in
consulting with bottled water companies regarding testing requirements.
She's the company representative to the Northeast Bottled Water Association.
She has authored numerous articles in industry publications and given
presentations on bottled water testing requirements.
Saltzgiver and Marteney can be reached
at (800) 458-3330 or email: firstname.lastname@example.org
| Table 1. MCLGs and MCLs for
Stage 1 D/DBP Rule
| Disinfection By-Products
| Trichloroacetic Acid
| Dibromoacetic Acid
| 1. 1998 Final Rule
for Disinfectants and Disnfection By-Products: The limit for total
trihalomethanes is 0.08 mg/L.
| 2. 1998 Final
Rule for Disinfectants and Disinfection By-Products: The total for
five haloacetic acids is 0.06 mg/L.
| SOURCE: USEPA
| Table 2. UCMR Monitoring
| List 1: Assessment monitoring of contaminants
with available methods.
|| List 2: Screening survey of contaminants projected
to have methods by date of program implementation.
|| List 3: Pre-screen testing of contaminants needing
research on methods.
DCPA mono acid
DCPA di acid
| Algae and toxins
| SOURCE: USEPA
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