Spotlight: BOTTLED WATER


Regulatory Update:

Go to: Bottled Water—Market Overview

FDA Rules
in the New Millennium
By Kristin Saltzgiver and Barbara Marteney

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.

GMPs
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.

HAACP—Hazard Analysis and Critical Control Point—was 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.

Labeling requirements
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 (see www.bottledwater.org/public/ibwp_facts_reg.htm). 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 annually.

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 2001.

Disinfection By-Products
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.

Unregulated contaminants
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.

Radon
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 program—would 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
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).

Conclusion
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.

References
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 1999, pp18-19.

5. International Bottled Water Association, "Model Bottled Water Regulation," IBWA, Alexandria, Va., (revised) November 1999.

6. U.S. Environmental Protection Agency, "Stage 1 Disinfectants and Disinfection Byproducts Rule," USEPA 814-F-98-010, 1998.

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 815-F-00-012, 2000.

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: food-bev@watercheck.com

Table 1. MCLGs and MCLs for Stage 1 D/DBP Rule
Disinfection By-Products

 MCLG (mg/L)

 MCL (mg/L)
 TTHMs:1

 N/A

 0.08
  Chloroform

0.0 

0.08
  Bromodichloromethane

0.0

0.08
  Dibromochloromethane

0.06

0.08
Bromoform

0.0

0.08
HAA52:2

N/A

0.06
 Monochloroacetic Acid

0.06 
 Dichloroacetic Acid

0.0

0.06
Trichloroacetic Acid

0.3

0.06 
 Monobromoacetic Acid

Dibromoacetic Acid

Chlorite

0.8

1.00
Bromate

0.0

0.01
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
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.
2,4-dinitrotoluene
2,5-dinitrotoluene
DCPA mono acid
DCPA di acid
4,4-DDE
EPTC
Molinate
MTBE
Nitrobenzene
Terbacil
Acetochlor
Perchlorate
Diuron
Linuron
Prometon
2,4,6-trichlorophenol
2,4-dichlorophenol
2,4-dinitrophenol
2-methyl-1-phenol
Alachlor ESA
1,2-diphenylhydrazine
Diazinon
Disulfoton
Fonofos
Terbufos
Aeromonas hydrophila
Polonium-210
RDX
Algae and toxins
Echoviruses
Coxsackieviruses
Helicobacter pylori
Microsporidia
Caliciviruses
Adenoviruses
Lead-210
SOURCE: USEPA

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