Guidance Document

Guidance Document

MEMBER COMMUNICATIONS GUIDANCE FOR THE

FDA DISINFECTANT/DISINFECTION BYPRODUCTS DIRECT FINAL RULE

December 22, 2001

 

About this Paper

The purpose of this paper is to provide IBWA members with a brief resource when addressing issues related to the FDA/EPA Disinfectant/Disinfection Byproducts (D/DBP) Rule, including the resulting bromate Standard of Quality (SOQ) of 10 parts-per-billion (ppb). This paper provides you with a brief background on the issue, sample Question and Answers, issue talking points, a general position statement currently being used by IBWA and a more detailed background document addressing ozonation and a multi-barrier approach.

These resources have been provided to give you guidance if you are asked questions about the FDA D/DBP Rule and bromate, in particular. It is important that the industry speak with one voice, utilizing the messages provided below. For consistency, it is highly recommended that all inquiries that do not relate to your specific product or situation be referred to the IBWA staff.

IBWA is addressing this issue as just one more rule/new standards in a comprehensive set of standards designed to help ensure consumers enjoy safe, high quality bottled water products. There are no immediate adverse health affects from drinking bottled water, produced either before or after the Rule’s compliance date and there is no looming health threat faced by bottled water consumers.

 

Background and Key Facts

The bromide ion is a natural and harmless element found in some bottled water source waters that, when exposed to the disinfection process of ozonation, may form a byproduct called bromate. Not all source waters for bottled and other water contain the bromide ion and, therefore, will not undergo conversion to bromate when ozonated. As important, not all finished waters contain bromate, even if the source water contained the bromide ion.

The level of bromate that may form in water depends on the concentration of bromide in the source water, the amount of ozone contact time, and a variety of water chemistry factors including pH, organic material, hardness and alkalinity.

Ozonation is one aspect of a multi-barrier approach used to help ensure the safety and quality of bottled water products. Ozonation is often preferred over chlorination to disinfect water because it does not leave a residual taste, color or odor in the water. While chlorination is primarily used for disinfection in public water systems in the U.S., a number of U.S. public water systems use ozone. Ozonation has been used extensively for public water utilities in Europe for many years.

In the early 1990’s, the U.S. Environmental Protection Agency (EPA) began to look at the health effects of byproducts formed by drinking water disinfection methods including chlorine and ozone. In December 1998, EPA issued a new rule for “Disinfectants and Disinfectant Byproducts (D/DBPs).” That rule contained a new standard of 10 parts-per-billion (ppb) for bromate with a compliance date of January 1, 2002 for large municipal systems and January 1, 2004 for smaller systems. There is no actual evidence that exposure to bromate in drinking water presents a health risk to humans. Because of the very conservative way EPA conducted its risk evaluation for bromate, there may be no actual health risk to humans from bromate in drinking water. Although EPA has estimated a cancer potency value for bromate, the health protective methods used to determine cancer potency mean that the true risk is likely to be lower than predicted and could even be zero (0). There are no studies indicating that ingestion of bromate in water has caused adverse health effects in humans.

By law, the FDA must adopt standards for bottled water comparable to EPA’s standards within 180 days after EPA’s rules take effect. On March 28, 2001, FDA published in the Federal Register a D/DBP Direct Final Rule with standards analogous to the EPA rule and standards and with a compliance date of January 1, 2002.

In anticipation of that rule, IBWA amended the IBWA Model Code to require member bottlers to begin monitoring for bromide in source waters in 2001 and was further amended to require compliance with a 10 ppb bromate standard starting January 1, 2002. In developing its new rule, FDA indicated that it does not want to increase the risks due to reduced or new disinfection levels or actions in its effort to reduce bromate levels. The Centers for Disease Control and Prevention (CDC) has never confirmed an outbreak of water-borne illness or disease in the United States due to bottled water.

QUESTIONS AND ANSWERS

The FDA D/DBP Direct Final Rule and Bromate

Answers You Can Use With Inquiries


What are the new rules and when do they take effect?

In the early 1990’s, the U.S. Environmental Protection Agency (EPA) began to look at the health effects of byproducts formed by drinking water disinfection methods including chlorine and ozone. In December 1998, EPA issued a new rule for “Disinfectants and Disinfectant Byproducts (D/DBPs).” That rule contained standards for disinfection byproducts from both chlorination and ozonation.

By law, the FDA must adopt standards for bottled water comparable to EPA’s standards within 180 days after EPA’s rules take effect. On March 28, 2001, FDA published in the Federal Register a D/DBP Direct Final Rule with standards analogous to the EPA rule and standards with a compliance date of January 1, 2002. The FDA rule applies to bottled water produced and bottled on or after January 1, 2002.

In particular, EPA set a standard for bromate of 10 ppb for public water systems and requires large public water systems to be in compliance by January 1, 2002 and small municipal utilities to be in compliance by January 2004 which is most relevant to bottled water. FDA adopted a similar standard for bottled water.

In anticipation of that rule, IBWA amended the IBWA Model Code to require member bottlers to begin monitoring for bromide (a naturally occurring element) in source waters in 2001 and further amended the IBWA Model Code to require member compliance with a 10 ppb bromate standard starting January 1, 2002.

FDA has indicated that it does not want to increase the risk of illness due to reduced or new disinfection levels. The Centers for Disease Control and Prevention (CDC) has never confirmed an outbreak of water-borne illness or disease in the United States from bottled water.

 

What is bromate? How may it get in my water?

Bromate may be formed when the bromide ion, a harmless, naturally occurring element found in some source waters, is ozonated, an FDA approved disinfection process. Not all source waters for bottled water contain the bromide ion and, therefore, will not undergo conversion to bromate when ozonated. As important, not all finished waters contain bromate, even if the source water contained the bromide ion. The level of bromate that may form in water depends on the concentration of bromide in the source water, the amount of contact time during ozonation, and a variety of water chemistry factors including pH, organic material, hardness and alkalinity.

 

What are the health effects?

There is no actual evidence that exposure to bromate in drinking water presents a health risk to humans. Because of the very conservative way EPA conducted its risk evaluation for bromate, there may be no actual health risk to humans from bromate in drinking water.

 

Is it unsafe to drink water containing bromate?

No. Although EPA has estimated a cancer potency value for bromate, the health protective methods used to determine cancer potency mean that the true risk is likely to be lower than predicted and could even be zero (0). There are no studies indicating that bromate in drinking water has caused adverse health effects in humans.


Why hasn’t bromate been regulated earlier?

Prior to 1996, the U.S. Environmental Protection Agency (EPA) and U.S. Food and Drug Administration (FDA) did not consider the presence of bromate in drinking water to be a public health issue, and as a result neither agency set a standard for the amount of bromate in drinking water. In the early 1990’s, EPA began to look at the effects of all disinfection byproducts, (DBPs) including chlorination and ozonation. The EPA began its research into the potential effects of DBPs upon promulgation of the Information Collection Rule in 1996. The rule mandated that the agency review present methods of disinfection and any byproducts formed. In particular, the technology and analytical methodology for detecting bromate in water at low concentration levels did not exist and was not available to testing laboratories until 1997. In 1998, following its initial research, EPA issued standards for a number of DBPs, including bromate.


Should I stop drinking water with bromate?

Consumers should not be alarmed about the presence of bromate in water. If the presence of bromate were an imminent health risk, EPA would not have allowed public water systems up to five years to meet the new standards. As well, FDA would have moved much more quickly to adopt a bromate standard for bottled water, had there been any immediate risk of adverse health affects. Further, both EPA and FDA have set bromate standards for public drinking water and bottled water, respectively, and the benefits of water consumption outweigh the minimal – possibly zero – risk of consuming water that adheres to the bromate and other standards.


How will the industry meet the DBP standards and reduce bromate?

Bottlers that must do so are likely to employ a variety of methods to meet the standards due to the fact that each situation is unique. The industry, through the International Bottled Water Association (IBWA) is reviewing a number of approaches designed to reduce or eliminate bromate in water and at the same time maintaining the current high levels of protection while maintaining the natural characteristics of the water.

These approaches include trying to eliminate bromide in the water source, altering the ozonation process, and identifying and/or enhancing other technologies and approaches other than ozonation. These include micro and nano-filtration, ultraviolet light, application of plant zoning principles, enhanced maintenance and cleaning/sanitizing operations, further attention to personal hygiene, personnel training, control procedures, and corrective actions.


Why doesn’t the bottled water industry simply stop using ozone for disinfection and do something else?

While some bottlers are choosing to eliminate the use of ozonation, others are able to adjust processes and control use of ozonation in concert with other steps to continue to provide a safe, high quality bottled water product. For those bottlers that continue to utilize ozonation, they are able to do so for several reasons. First, not all source waters contain the bromide ion and will not undergo conversion to bromate when ozonated. Since ozonation remains an effective disinfection method, bottlers are likely to continue to use this method. Second, ozonation may be managed or used in concert with other processes to help ensure that bromate is contained within allowable limits, or does not form at all. As important, not all finished waters contain bromate, even if the source water contained the bromide ion.

Ozonation is a proven means of disinfecting bottled water in the United States and has been used safely for over 30 years and is an important measure for some bottlers as part of the bottled water industry’s multi-barrier approach, which helps assure safe, high quality bottled water products. The U.S. Food and Drug Administration (FDA), which regulates bottled water as a packaged food product, lists ozonation as Generally Recognized As Safe (GRAS) as a disinfection method for foods, including bottled water, when used in conformity with FDA regulations. Moreover, ozonation has been widely used as a disinfection method in European public water systems for nearly 70 years and has come into use in many public water systems in the United States.

The bottled water industry uses ozonation as a treatment method because of its effectiveness and safety as a disinfectant. Ozonation is capable of disinfecting water at a faster rate than chlorine and, once it passes through water, ozone undergoes a complete conversion to oxygen within a few hours. And since it leaves no residual in the container, there is no detectable taste in the water. Other commonly used disinfectants such as chlorine and iodine leave a residual taste that many consumers find objectionable. Chlorine and iodine also react with other elements in the water that may form undesirable byproducts.

What are the health risks of water containing more than 10 ppb of bromate?

Consumers should not be alarmed about the presence of bromate in water. If the presence of bromate were an imminent health risk, EPA would not have allowed public water systems up to five years to meet the new standards. As well, FDA would have moved much more quickly to adopt a bromate standard for bottled water, had there been any immediate risk of adverse health affects. Further, both EPA and FDA have set bromate standards for public drinking water and bottled water, respectively, and the benefits of water consumption outweigh the minimal – possibly zero – risk of consuming water that adheres to the bromate and other standards.

The EPA risk assessment is not based on probable or likely risk, but based on a worst-case scenario.

Is there a risk of drinking water containing even 1 ppb or any bromate below the 10 ppb standard?

Consumers should not be alarmed about the presence of bromate in water. If the presence of bromate were an imminent health risk, EPA would not have allowed public water systems up to five years to meet the new standards. As well, FDA would have moved much more quickly to adopt a bromate standard for bottled water, had there been any immediate risk of adverse health affects. Further, both EPA and FDA have set bromate standards for public drinking water and bottled water, respectively, and the benefits of water consumption outweigh the minimal – possibly zero – risk of consuming water that adheres to the bromate and other standards.

The EPA risk assessment is not based on probable or likely risk, but based on a worst-case scenario.

I thought bottled water was supposed to be pure and, at the least, could not possibly have adverse health affects. If there is any question as to its safety, why should I pay for this product?

Bottled water sold in the United States must meet very strict standards for quality and safety, standards that have undergone intensive research, testing and analysis. Bottled water is a product that is subject to great care and technologies to help ensure a consistently safe, high quality product. Producing such a product that meets stringent federal, state and industry standards requires significant capital investment and utilization of people, technology and equipment to bring this high quality, safe product to consumers.

If my bottled water was so pristine and pure, why did the company have to “disinfect” it and, by doing so, add contaminants or carcinogens?

Disinfection and sanitization are used to help further ensure high bottled water quality. Although bottled water plants must follow general food Good Manufacturing Practices (GMPs) and bottled water-specific GMPs, bottlers employ all known technological measures and take advantage of every precaution to ensure the safety and quality of the finished bottled water product.

As well, a small percentage of bottled water is sourced from municipal systems. Disinfection/sanitization is a key part of the additional care given to further purify these waters using methods dictated in a multi -barrier approach to render a finished bottled water product that is distinctly different from the original tap water source.

Is tap water safer?

No. Tap water is required by EPA to comply with the same bromate standard of 10 ppb. In addition, tap water is required to meet a host of other standards tied to disinfection byproducts that result from the use of chlorine for disinfection as well as standards for other contaminants.

How long has the industry known about bromate?

EPA issued its bromate standards for tap water in 1998 with compliance dates of January 1, 2002 for large municipal utilities and January 1, 2004 for smaller utilities. IBWA has anticipated that bottlers would be required to meet the 10 ppb standard on the earlier date and has taken actions to help ensure compliance once the regulations took affect. In fact, IBWA amended the IBWA Model Code to require members to monitor source waters for bromide starting in 2001 and will make further changes to the IBWA Model Code to include a 10 ppb standard for bromate in concert with the FDA regulations starting January 1, 2002.

In short, we haven’t waited to take action. Since it was determined that DBPs, including bromate could be accurately measured, IBWA and its bottler members have aggressively addressed the issue with a review, and examination of all steps in the bottled water process, from source to finished product, to enable the continued provision of safe, high quality bottled water.

Is processed water safer than natural or spring water?

No. All bottled water sold in the United States must meet stringent FDA/federal and state quality and safety standards. In addition, IBWA members must adhere to the IBWA Model Code, a set of strict standards and processes that, in some cases, are more stringent than FDA and state regulations. Consumers can get an IBWA member brand list by calling 1-800-WATER11 or logging on to the IBWA web site at www.bottledwater.org.

How extensive is bromate in bottled water?

IBWA does not maintain data on individual bottlers and only tracks compliance with FDA, IBWA and state regulations. Compliance is verified through FDA and state bottled water plant inspections and the unannounced plant inspections conducted as a requirement of the IBWA Model Code. Again, not all source waters contain bromide and therefore are not affected by bromate, and many finished products do not contain bromate. Compliance with bromate, and all other standards, are both an FDA requirement and a requirement for IBWA membership in good standing.

How can I tell which brand is safer?

Bottled water that meets FDA standards is considered safe for human consumption. Further, IBWA members must adhere to the IBWA Model Code, a set of strict standards and processes that, in some cases, are more stringent than FDA and state regulations. Consumers can get an IBWA member brand list by calling 1-800-WATER11 or logging on to the IBWA web site at www.bottledwater.org.

How much water can I safely drink?

Consumers should feel comfortable drinking as much water as they please. The EPA standard for bromate was based on worst-case, and very conservative assumptions. Because of the very conservative way EPA conducted its risk evaluation for bromate, there may be no actual risk – even zero (0) – from 10 ppb of bromate in drinking water.

Why doesn’t EPA regulate bottled water?

FDA has regulated bottled water since 1938 as a packaged food product because it is produced specifically and only for human consumption. Because of this, the product and the processes used to guide the water from its source to the packaged finished product must meet or surpass food standards. These standards also apply to the container, cap, closure and the equipment and plants where bottled water is packaged. EPA regulates tap water and, even though the tap water may have many industrial, residential, commercial and personal uses, it must be potable and meet standards as dictated by the EPA Maximum Contaminant Levels (MCL).

How is bottled water regulated?

Bottled water is a highly regulated product, subject to federal, state, and industry standards. Bottled water is regulated as a food product by FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA). This includes packaged water sold in smaller containers at retail outlets as well as larger containers (e.g., three and five gallon) distributed to the home and office markets.

Bottled water is subject to FDA’s extensive food safety and labeling requirements, and water is subject to FDA’s:

    • food adulteration and misbranding provisions;
    • nutritional labeling provisions;
    • general Good Manufacturing Practices (GMPs);
    • bottled water GMPs;
    • the bottled water standard of identity; and
    • the bottled water standard of quality (which is as stringent as EPA’s standards for public water systems).

The bottled water industry is further regulated on two additional levels: state and industry trade association. Many states maintain their own bottled water standards at least equivalent in stringency to those of FDA. In addition, members of the International Bottled Water Association (IBWA) are required to undergo an unannounced third party annual plant inspection and product analysis to assure compliance with IBWA standards that are more stringent than FDA requirements. In addition, products imported from outside the U.S. must meet all U.S. regulations in addition to standards established by the exporting country.

FDA regulations, combined with state and industry standards, offer consumers assurance that the bottled water they purchase is stringently regulated, tested, and of the highest quality. The IBWA has been a long-standing proponent of additional federal regulations for bottled water, and is active at all levels of local, state, and federal government assisting in the development of such regulations.

What is IBWA?

The International Bottled Water Association (IBWA) is the authoritative source of information about all types of bottled waters. Founded in 1958, IBWA member companies account for more than 80 percent of all bottled water sales in the U.S. IBWA’s membership includes U.S. and international bottlers, distributors and suppliers. IBWA is committed to working with state and federal governments, in concert with the IBWA Model Code, to set stringent bottled water standards for safe, high quality products. Consumers can contact IBWA at 1-800-WATER-11 or log onto IBWA’s web site (www.bottledwater.org) for more information about bottled water and a list of members’ brands.

 

D/DBP RULE TALKING POINTS

Talking Points to be Used with Interviews

 

About EPA and FDA Rules

Key Point: The industry is working closely with the government to make sure that the safety and quality of bottled water is maintained.

    • The International Bottled Water Association (IBWA) asked FDA to move forward with the rulemaking on disinfectant byproducts (bromate in particular) and has established a task force to work with the Agency. The FDA has been reviewing the EPA rulemaking and issued a disinfectant byproduct rule on March 28, 2001with standards analogous to the EPA rule and standards and with a compliance date of January 1, 2002.
    • The 1998 EPA rule applies to public water utilities and provides three years (December 2002) for large water systems and five years (December 2004) for smaller public utilities and groundwater systems to come into compliance with the new standards. By law, FDA must adopt standards for bottled water comparable to EPA’s standards within 180 days after EPA’s rules take effect. The industry anticipates that FDA will issue a standard of quality for bromate of 10ppb (identical to EPA’s rule) and require compliance beginning January 2002 (identical to EPA’s earlier compliance date.)
    • The FDA has indicated that it does not want to increase the risk of illness due to reduced or new disinfection levels or actions in its effort to reduce disinfection byproduct levels. To date, The Centers for Disease Control and Prevention (CDC) has never confirmed an outbreak of water-borne disease in the United States from bottled water in large part due to the quality of disinfection.

 

About Bromate In Drinking Water

Key Point: Not all bottled water contains bromate.

    • For drinking water, bromate may be formed as a byproduct of ozone disinfection when bromide, a naturally occurring substance in some water sources, is present.
    • Bromate can be present both in public water supplies as well as some bottled water.
    • Not all water sources contain bromide and therefore are not affected by bromate.

 

About Ozonation

Key Point: Ozonation has been recognized as safe by the government, has been used extensively throughout the world, and provides unique benefits to bottled water.

    • Ozonation is used as an alternative to chlorine to disinfect water because it does not leave a residual taste, color or odor in the water and completely dissipates. Chlorination, an alternative to ozone, also forms byproducts similar in effect to bromate, which are regulated by EPA.
    • Ozone has been used extensively for public water utilities in Europe for many years.
    • In 1975, based on its review of the health and safety literature, the U.S. Food and Drug Administration (FDA) issued a rule stating that ozonation was Generally Recognized As Safe (GRAS) for use in bottled water.
    • Because of its qualities, ozonation has been the primary method of disinfection for the bottled water industry. For many bottlers, ozonation makes the product safe for consumers without altering the organic or natural essence of the water.

 

About Health Effects

Key Point: While EPA has identified bromate as a concern, it is not an imminent health threat.

    • In the early-mid 1990’s the U.S. Environmental Protection Agency (EPA) looked at the health effects of byproducts formed by drinking water disinfection utilizing chlorine and ozone. In December 1998, EPA issued a new rule for “Disinfectants and Disinfectant Byproducts (D/DBPs).” That rule contained a new standard of 10 parts per billion (ppb) for bromate based on EPA’s concern that long-term exposure to bromate could have adverse health effects, primarily various types of cancer.
    • EPA concluded that a 10 ppb standard protects both adults and children from long-term exposure to bromate. Specifically, EPA concluded that a person drinking two liters (over one-half gallon) of water containing 10 ppb of bromate per day for an entire life would be safe.
    • There are no studies indicating that bromate in water (or other foods) has caused chronic health effects in humans.
    • While EPA has identified bromate as a concern that needs to be addressed by all aspects of the drinking water industry, there is no cause for alarm. EPA would not have allowed water systems up to five years to meet the new standard if it believed the public faced an imminent health threat.

 

The Industry Is Already Taking Action

Key Point: The industry is already taking action to meet the new government standard.

    • · EPA issued its bromate standards for tap water in 1998 with compliance dates of 2002 for large municipal utilities and 2004 for smaller utilities. IBWA has anticipated that bottlers would be required to meet the 10 ppb standard on the earlier date and has taken actions to help ensure compliance once the regulations took affect. In fact, IBWA amended the IBWA Model Code to require monitoring source waters for bromide starting in 2001 and requires member companies to meet a 10 ppb for bromate starting in January 2002. In addition, IBWA formed a Bromate Action Task Force to help develop technical solutions to bromate formation and work with FDA and state governments. In short, the industry has not waited to take action.

 

About How Companies Will Meet the New Rules

Key Point: Companies will employ many different ways to comply with the new standard because each situation is unique.

    • Because each situation is unique, companies are likely, when necessary, to employ many different methods to meet the new standards. For example, many source waters do not contain bromide and therefore no action will need to be taken. Others may simply need to adjust ozonation levels, while others may change processes to eliminate the use of ozonation altogether or even change source waters.

 

IBWA STANDBY POSITION STATEMENT ON BROMATE

IBWA MODEL CODE FOR QUALITY ANTICIPATES

PROPOSED FDA ACTION, ADOPTS BROMATE STANDARD

The International Bottled Water Association (IBWA) has adopted a Standard of Quality (SOQ) of 10 parts-per-billion (ppb) for bromate as part of the IBWA Model Code. IBWA members will be required to comply with the new standard starting January 2002. In advance of the standard’s effective date, the IBWA Model Code required member bottlers to implement monitoring and control procedures to determine if bromide is present in source water as well as bromate in the finished product. Bottled water companies that are IBWA members will be required to meet or surpass this standard.

The U.S. Food and Drug Administration (FDA), which regulates bottled water as a packaged food product, has established a regulation that includes a SOQ of 10 ppb for bromate in bottled water consistent with that established by IBWA for its members and the U.S. Environmental Protection Agency (EPA) for municipal water. EPA’s rule requires large municipal drinking water systems to be in compliance by January 2002 and smaller municipal systems to comply by January 2004. The FDA rules will require bottlers to be in compliance starting January 1 2002. IBWA last year asked FDA to move forward expeditiously with a rulemaking on bromate.

Bromate may be formed, under certain conditions, when bromide, a natural and harmless compound found in some source waters, is subjected to the FDA-accepted oxidizing disinfectant ozone. Many finished bottled water products do not contain bromate or contain such low levels that they are not impacted by the new standard.

IBWA has been working with member companies whose source water may contain natural bromides to help ensure the standard is met or exceeded. Where deemed necessary, a variety of methods are likely to be employed to meet the new standard including: controlling disinfection methods; modifying processing and/or quality control measures; or modifying disinfection methods and sanitation practices.

To achieve FDA and IBWA Model Code standards, IBWA member bottlers employ a multi-barrier approach to help assure safe, high quality bottled water products. A multi-barrier approach may include two or more of the following: source protection, source monitoring, reverse osmosis, distillation, micron filtration, ultraviolet (UV) light, and ozonation, which FDA considers Generally Recognized As Safe (GRAS) for bottled water when used in conformity with FDA regulations.

The International Bottled Water Association (IBWA) is the authoritative source of information about all types of bottled waters. Founded in 1958, IBWA member companies account for more than 80 percent of all bottled water sales in the U.S. IBWA’s membership includes U.S. and international bottlers, distributors and suppliers. IBWA is committed to working with state and federal governments, in concert with the IBWA Model Code, to set stringent bottled water standards for safe, high quality products. Consumers can contact IBWA at 1-800-WATER-11 or log onto IBWA’s web site (www.bottledwater.org) for more information about bottled water and a list of members’ brands.

 

CONTACT:

Stephen R. Kay, IBWA Vice President, Communications (703-683-5213)

# # #

IBWA BACKGROUND STATEMENT

BOTTLED WATER SAFETY, QUALITY AND DISINFECTION

 

The International Bottled Water Association (IBWA) has adopted a maximum standard of 10 ppb for bromate as part of the IBWA Model Code for Quality. IBWA members are required to be in compliance with the new standard starting January 1, 2002. The U.S. Food and Drug Administration (FDA) has published a regulation that includes a Standard of Quality (SOQ) of 10 parts per billion (ppb) for bromate in bottled water, which is consistent with standards established by the U.S. Environmental Protection Agency (EPA) for municipal water.

Bottled water is a packaged food product that is fully regulated by FDA and state authorities and is subject to comprehensive production, safety and quality regulations.

Bromate may be formed when the bromide ion, a naturally occurring compound found in some source water, is subjected to FDA-approved oxidizing disinfection methods such as ozonation, which has been used for more than 30 years. Not all source waters contain the bromide ion and, therefore are not subject to bromate conversion.

The IBWA Model Code helps assure consumers that IBWA member bottlers follow a set of quality standards and good manufacturing practices from the water source to the finished product. The IBWA Model Code is currently used by 16 states as the basis for state regulation of bottled water quality. More than 89 substances are routinely tested for in bottled water as part of the IBWA Model Code. In addition to the standards, members of the IBWA undergo unannounced annual inspections of their bottling plants by an independent, third party organization. In some cases, standards found in the IBWA Model Code are more stringent than those set by FDA, EPA and state authorities.

Because each situation is different, a variety of methods are likely to be employed by bottlers to meet the new standard, including: reducing and controlling disinfectant levels; modifying processing and/or quality control measures; changing disinfection methods; and changing source waters. The bottled water industry employs a multi-barrier approach to help assure product safety and quality. A multi-barrier approach may include two or more of the following: source protection, source monitoring, reverse osmosis, distillation, micron filtration, ozonation and ultraviolet (UV) light.

Ozonation has been given GRAS (Generally Recognized As Safe) status by the FDA for food products, including bottled water. It has been safely and effectively used in the United States for both bottled and tap water for more than 30 years and in Europe for nearly 70 years.

EPA, in conjunction with the Safe Drinking Water Act of 1991 recognized ozone as more powerful and faster for disinfection than other methods. Ozonation is extremely efficient as a bactericide, killing even chlorine-resistant Cryptosporidium. Once ozone passes through water, it undergoes a complete conversion to oxygen within a few hours.

The FDA’s adoption of the SOQ for bromate is equivalent to the Maximum Contaminant Levels (MCL’s) set by the Environmental Protection Agency (EPA) for regulation of tap water. The EPA established a bromate MCL of 10 ppb for tap water with a compliance date of January 1, 2002 for large municipal systems and January 1, 2004 for small municipal systems.

There is no actual evidence that exposure to bromate in drinking water presents a health risk to humans. Because of the very conservative way EPA conducted its risk evaluation for bromate, there may be no actual health risk to humans from bromate in drinking water. Although EPA has estimated a cancer potency value for bromate, the health protective methods used to determine cancer potency mean that the true risk is likely to be lower than predicted and could even be zero (0). There are no studies indicating that ingestion of bromate in water has caused adverse health effects in humans. Adverse health effects reported in animal studies occurred at levels greater than 10,000 ppb.

 

CONTACT:

Stephen R. Kay, IBWA Vice President, Communications (703-683-5213)

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