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Is bottled water regulated?

Yes. The U.S. Food and Drug Administration (FDA) is responsible for regulating bottled water products that are either imported or sold between states.

Bottled water, one of the most regulated food products, is subject to three levels of regulations and standards: federal, state and industry.

1. Federal Regulations
On a federal level, bottled water is regulated by the Food and Drug Administration (FDA) as a food product to ensure bottled water product safety from production to packaging to consumption.
All bottled water products must comply with FDA’s Quality Standards listed in the Code of Federal Regulations (CFR) including:

• Standards of Quality
• Standards of Identity (such as labeling regulations and standardized terms)
• Good Manufacturing Practices (such as plant construction, sanitary facilities and process controls)
• The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (such as maintaining records and registering bottling and operations/sales facilities with the FDA.)

2. State Standards
In addition to FDA's extensive regulatory requirements, the bottled water industry is subject to state regulatory requirements as well.
A significant responsibility of the states is inspecting, sampling, analyzing and approving sources of water. Under the federal GMPs, only approved sources of water can be used to supply a bottling plant. Although regulations vary from state to state, in general they cover the following:

• State Labeling
• Laboratory Certification
• Quality Standards
• Bottling Plant Permits
• Water Sources
• Product Labeling

Another area in which some states have important responsibilities that complement federal regulation is the certification of testing laboratories. As with any food establishment, the states perform unannounced plant inspections, and some states perform annual inspections.

3. IBWA Standards
Bottled water companies that are members of the International Bottled Water Association (IBWA) must adhere to stringent industry standards. IBWA has established a quality assurance program, a strict set of standards called the Model Code of Practice. In some instances, the IBWA Model Code is stricter than FDA regulations. The IBWA is also active at all levels of the local, state and federal government assisting in the development of such regulations. As a member of the IBWA, we must comply with the following standards:

• Annual, unannounced inspections by third-party auditors
• Audits of all areas of plant production
• Adherence to the Hazard Analysis and Critical Control Points (HACCP) Program
• Compliance audits of federal and state regulations and industry standards

Not only do we comply with bottled water regulations, we take it a step further. We produce high quality bottled water that is crisp, refreshing and tastes great.
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How do I know that my bottled water is safe?

Consumers can trust that bottled water is safe for many reasons. The first is that bottled water is strictly regulated on the federal level by the Food and Drug Administration (FDA) and on the state level by state officials. This ensures that all bottled water sold in the United States meets these stringent standards. In addition, members of the International Bottled Water Association (IBWA), who produce about 85% of the bottled water sold in the United States, must meet strict industry standards established by the association.These standards, contained in the IBWA "Model Code", exceed the FDA regulations currently in place for bottled water. To ensure that all their bottled water is as safe as possible and of the highest quality, all IBWA members use one or more of the following practices: source protection and monitoring, reverse osmosis, distillation, filtration, ozonation and disinfection. According to the US Centers for Disease Control and Prevention(CDC), bottled water has never been responsible for an outbreak of waterborne illness.
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Does bottled water have to be free from contaminants?

Although bottled water products do not have to be 100% free of all contaminants, any contaminants that are present must be below the maximum permitted level established by the FDA or the state. Consumers can contact the bottler directly to obtain a report showing what contaminants, if any, are present in their bottled water product.
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What are the types of contaminants for which bottled water is checked?

• Aesthetic Contaminants (affect the taste, odor, or color of the water)
  

  Inorganic parameters, including iron, manganese, zinc, chloride, sulfate, total dissolved solids, and fluoride

  Physical characteristics, including color, odor, and pH.

• Health-Related Contaminants (a potential health hazard has been established)
  

  Inorganic parameters, including arsenic, barium, beryllium, cadmium, chromium, lead, and mercury, as well as contaminants such as nitrite and nitrate

  Volatile organic chemicals (VOCs), including benzene, trichloroethylene, and tetrachloroethylene (dry cleaning solvents), and trihalomethanes such as chloroform (chlorination by-products)

  Herbicides, pesticides, and PCBs

  Physical characteristics, such as turbidity, and radioactive elements, such as radium and strontium

  Coliform bacteria, which, although not disease-causing themselves, indicate the possibility that other disease-causing bacteria, may be present. Bottled water companies are required to adequately disinfect their water prior to bottling, using an approved process such as ozonation, ultraviolet disinfection, or chlorination.

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How does bottled water differ from tap water?

The source, taste, and treatment methods used are some of the principle differences between bottled water and tap water.

Municipalities and private water utilities most often use chlorine to disinfect tap water, which can leave an aftertaste and lead to the development of chlorination byproducts. Many bottled water producers use ozone or ultraviolet disinfection instead.
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What is the difference between Spring and Purified Water?

In the bottled water industry, the two most common types of water are spring water and purified water. Because the average consumer doesn't fully understand the differences, they're often left wondering which of the two products to buy when confronted with the choice. Since most consumers are unaware of the specific treatment guidelines behind each type of water, they generally make their selection based on their perceived preference for spring versus purified water on brand name or price.

The FDA classifies bottled water according to its origin.

Purified Water Specifications

Bottled water that has been treated by distillation, reverse osmosis, or other suitable process and that meets the definition of "purified water" in the U.S. Pharmacopoeia can be labeled as "purified water." This water may be sources from spring or municipal systems.

Spring Water Specifications

Spring water must be derived from an underground formation from which water flows naturally to the earth's surface. Spring water must be collected only at the spring or through a borehole tapping the underground formation feeding the spring. If some external force is used to collect the water through a borehole, the water must have the same composition and quality as the water that naturally flows to the surface.

According to the labeling guidelines set by the Food and Drug Administration (FDA), spring water must come from a pure, natural source and cannot have minerals added or taken away. This means that to label and sell bottled water as spring water, the water can be filtered (but only to a certain level) and disinfected by ozone or ultraviolet (UV) light. At the source or in the bottling plant, the spring water is first filtered to remove physical particles. This step acts as the first barrier against possible biological contaminants such as bacteria, viruses or cysts. In order to ensure a bacteria-free environment, the bottler typically provides a second barrier, which is a disinfection step that uses ozone and/or UV light. This multi-barrier approach ensures that no contamination can make its way to the water at the time of bottling.

When bottled water was first introduced, disinfection steps weren't always practiced. Rather, bottlers would rely on filtration and good sanitary techniques to purify the water and protect against biological re-growth in the bottles. While these steps were adequate, they didn't always provide a multi-barrier approach to eliminate pathogens from the water. As better filtration and disinfection practices emerged, significant biological control was demonstrated. These measures were reviewed and adopted as a standard practice by the International Bottled Water Association (IBWA) through its Model Code.
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How long can I store bottled water?

The FDA has not established a shelf life for Bottled Water. Creekside Springs recommends a two-year shelf life and prints an expiration date on all products. It should be kept in a dry place, out of direct sunlight. It is also necessary to keep it away from toxic chemicals, such as cleaning agents, solvents, or gasoline. Do not store bottled water in your garage.
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What is the concern over Bromides?

Bromide ion is a naturally-occurring salt present in some spring water sources, which may be influenced by saltwater intrusion or certain formations that may leach out bromide ion. The presence of bromide ion isn't an issue in purified water since reverse osmosis is used as the filtration step, removing the bromide ion prior to the disinfection step.

In spring water plants, where bromate levels may be high, using ozone has raised concerns for bottlers, since ozone can facilitate conversion of bromide ion into bromate, a suspected carcinogen. Because of this, bromate is now limited to a maximum contaminant level (MCL) of less than 10 micrograms per liter by the U.S. Environmental Protection Agency.

While bromide isn't found in every water source, its presence cannot be overlooked. In situations where it's present, decisions need to be made. Bottlers first need to determine if the water source is still viable as a spring water source, or if it should be abandoned. This is a difficult decision because spring water sources are limited in number and cannot be recreated. If bromide is present and ozone is being used for disinfection, bottlers need to be aware of the amount of ozone they apply and how accurately they can control the ozone dosage to minimize the conversion rates of bromide to bromate. If the ozone level or contact time with the water is too great, the bottler runs the risk of exceeding the bromate MCL.

Fortunately, there are some tools that Creekside Springs employs to help keep bromate formation under control. To start, the ozone level is carefully measured by using dissolved ozone monitors. Accurately measuring dissolved ozone in the water before it reaches the bottle allows control loops between the ozone generator and monitor, resulting in consistent levels and helping to minimize the amount of bromate conversion possible in bottled water.
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What if I am unsure which contaminants are in my water?

If you are on a municipal water system, contact your water utility and ask for a copy of their Annual Water Quality Report (also called a Consumer Confidence Report). If you are on a private well, contact your local health department and ask for a list of the typical well water contaminants in your area. Another option is to contact an independent laboratory to have your drinking water tested. Your local or state health department can provide you with the names of laboratories accredited by your state to analyze drinking water.
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Where can I get additional information on the health effects of contaminants that may be harmful to me?

You can contact your local health department, your personal physician, or the EPA Safe Drinking Water Hotline at 1-800-426-4791.
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Does the EPA regulate both health and aesthetic contaminants?

For health effects contaminants, the U.S. EPA establishes Maximum Contaminant Levels (MCLs) for those known to cause, or suspected of causing, health problems. The MCL defines the highest concentration allowed in public water supplies.

For aesthetic contaminants, the water may be safe to drink, but not very pleasant because of an undesirable taste, odor, or color. Some water may also stain clothes and fixtures, corrode plumbing, or form a scale and film. Secondary Maximum Contaminant Levels (SMCLs) are usually recommended by the EPA for these aesthetic water quality factors. SMCLs are useful guides for evaluating the suitability of water for drinking, bathing, clothes washing, cooking, and other domestic uses.
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Are there other organizations that may have information?

The EPA Safe Drinking Water Hotline (1-800-426-4791) has information on how to get involved with drinking water protection, as well as information on the EPA Drinking Water Maximum Contaminant Levels. Your local health department or state agency dealing with drinking water may also have information regarding the water and contaminants in your area.
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What is BPA and how does it relate to polycarbonate bottles?

Polycarbonate is traditionally used in the manufacture of returnable 5 and 3 gallon bottles as well as refillable personal water bottles and baby bottles.

Bisphenol A (BPA) is an industrial chemical used primarily to make polycarbonate plastic and epoxy resins – both of which are used in countless applications that make our lives easier, healthier and safer, each and every day. www.bisphenol-a.org is a comprehensive resource for environmental, health and safety information about bisphenol A.

Recent media stories and a statement issued by the National Toxicology Program (NTP) have raised questions about the safety of polycarbonate plastic bottles due to the presence of a substance known as bisphenol A (BPA). The IBWA recently responded:

• Bottled water is comprehensively regulated as a food product by the U.S. Food and Drug Administration (FDA). Plastic food and beverage containers, including polycarbonate plastic made with BPA, must meet or exceed all FDA requirements. FDA clears all food-contact plastics for their intended use based on migration and safety data. The clearance process includes stringent requirements for estimating the levels at which such materials may transfer to the diet. FDA's safety criteria require extensive toxicity testing for any substance that may be ingested at more than negligible levels. This means FDA has affirmatively determined that, when cleared plastics are used as intended in food-contact applications, the nature and amount of substances that may migrate, if any, are safe.
• Polycarbonate plastic has been the material of choice for food and beverage product containers for nearly 50 years because it is lightweight, highly shatter-resistant, and transparent. During that time, many studies have been conducted to assess the potential for trace levels of BPA to migrate from polycarbonate bottles into foods or beverages. The conclusions from those studies and comprehensive safety evaluations by government bodies worldwide are that polycarbonate bottles are safe for consumer use.
• The April 14, 2008 NTP Draft Brief on BPA confirms that there are no serious or high level concerns for adverse effects of BPA on human reproduction and development. Steven G. Hentges, Ph.D., of the American Chemistry Council’s Polycarbonate/BPA Global Group, states that the “findings in NTP’s draft report provide reassurance that consumers can continue to use products made from bisphenol A. Importantly, this conclusion has been affirmed by scientific and government bodies worldwide.”
• The NTP Draft Brief confirms that human exposure to BPA is extremely low and noted no direct evidence in humans that exposure to BPA adversely affects reproduction or development. The limited evidence for effects in laboratory animals at low doses primarily highlights opportunities for additional research to better understand whether these findings are of any significance to human health.
• For more information on this issue, visit the American Chemistry Council’s website at www.factsonplastic.com or www.bisphenol-a.org

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What is Cryptosporidium ?

Cryptosporidium is a waterborne parasite that lives in animals and can be passed into the water through their waste. Cryptosporidium oocysts from animal wastes have been found in rivers, streams, lakes, reservoirs and many other types of surface water.
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How do I know that Cryptosporidium is not in my bottled water?

Bottled water companies are required to use approved sources. There are two types of sources from which bottled water can be drawn: the first type is natural sources (i.e. springs and wells). By law, these sources must be protected from surface intrusion and other environmental influences. This requirement ensures that surface water contaminants such as Cryptosporidium and Giardia are not present.
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How do I know that Per- and Polyfluoroalkyl Substances (PFAS) are not in my bottled water?

Currently, there is no U.S. Food and Drug Administration (FDA) Standard of Quality for per- and polyfluoroalkyl substances (PFAS) in bottled water. However, although not mandated by law, as of January 1, 2019, IBWA requires its members to test for PFAS in all the products they sell. IBWA members have always been committed to providing the highest quality bottled water products to their customers.

Testing for PFAS provides consumers, local and state governments, and disaster relief personnel further assurance that bottled water is a safe and convenient product for every day use and in times of need when tap water is compromised. Many of IBWA member companies, at the suggestion of IBWA, began testing for PFAS several years ago.

IBWA continually monitors emerging contaminants as they apply to both FDA regulations for bottled water and U.S. Environmental Protection Agency (EPA) standards for tap water. As such, IBWA has been following the PFAS issue very closely.

For more information on FDA’s research and investigation of PFAS in foods and beverages: See “Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys”: https://www.fda.gov/news-events/press-announcements/statement-fdas- scientific-work-understand-and-polyfluoroalkyl-substances-pfas-food-and-findings

First data review under new IBWA PFAS Monitoring Program

IBWA established the following operational control limits (OCL) for PFAS in member company bottled water products:

• IBWA’s OCLs for PFAS are substantially below the EPA’s health advisory level of 70 parts per trillion (ppt).
• Processes and practices used in producing bottled water, such as source protection, reverse osmosis, and carbon filtration greatly reduce the likelihood that PFAS would be found in bottled water. If it is, IBWA members have access to association-supplied guidance materials for monitoring and controlling PFAS levels in bottled water.

IBWA is currently conducting its first data review under the association’s new PFAS Monitoring Program, which requires testing of IBWA member bottled water for 14 PFAS compounds using EPA Method 537.

The first summary results are as follows:

• 100% of samples were below the EPA 70 ppt health advisory level
• 97.3% of samples were below the detection limit of 2 ppt (non-detect)

EPA and State Action on PFAS

The EPA has established a “Drinking Water Health Advisory Level” for PFOA and PFOS of 70 ppt in public drinking water (i.e., tap water). Public water systems that are contaminated with more than 70 ppt must notify their customers and provide an alternate source of drinking water.

To date, bottled water has been a primary alternative source for safe drinking water when tap water has been contaminated with PFAS. EPA will eventually establish a maximum contaminant level (MCL) for PFAS in tap water, but several states are regulating now, or are planning to regulate soon, these substances in public drinking water. Those states include the following:

• New Jersey has finalized new standards and monitoring requirements for perfluorononanoic acid (PFNA) for public water systems in the state. Additional new standards for PFOA and PFOS will be effective in 2020. The new standards also require bottle water companies to monitor for these substances.
• California, New York, and Massachusetts are looking at regulating PFAS at very low levels (<20 ppt).
• Massachusetts has established a list of bottled waters that contain <70 ppt of PFAS, similar to their list of bottled waters with 1 parts per billion (ppb) or less of perchlorate. This helps consumers find alternative sources of drinking water if their tap water is contaminated with PFAS.
• Other states are regulating various PFAS contaminants or have established PFAS data reporting programs, and that data may be posted online.

PFAS Background

PFAS are a group of man-made chemicals that includes PFOA, PFOS, GenX, and many other chemicals. PFAS have been manufactured and used in a variety of industries around the globe, including in the United States, since the 1940s (not bottled water companies). PFOA and PFOS have been the most extensively produced and studied of these chemicals.

Both chemicals are very persistent in the environment and in the human body—meaning they don’t break down and can accumulate over time. There is evidence that exposure to PFAS can lead to adverse human health effects.

PFAS can be found in the following:

• Food packaged in PFAS-containing materials, processed with equipment that used PFAS, or grown in PFAS-contaminated soil or water.
• Commercial household products, including stain- and water-repellent fabrics, nonstick products (e.g., Teflon), polishes, waxes, paints, cleaning products, and fire-fighting foams (a major source of groundwater contamination at airports and military bases where firefighting training occurs).
• Workplaces that use PFAS, including production facilities or industries (e.g., chrome plating, electronics manufacturing, or oil recovery).
• Tap water, typically localized and associated with a specific facility (e.g., manufacturer, landfill, wastewater treatment plant, firefighter training facility).
• Living organisms, including fish, animals, and humans, where PFAS can build up and persist over time.

CLICK HERE to download a PDF of this statement.

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Where does your spring water come from?

Creekside Springs’ spring water comes from our own protected springs located in Columbiana County, OH. Our springs have been inspected by the National Sanitation Foundation (NSF) and exceed their standards. Our springs have been certified by the IBWA and the State of Ohio to be a true natural spring, not a well or borehole as used by many others.
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What is the IBWA?

The International Bottled Water Association (IBWA) is the trade association representing the bottled water industry. Founded in 1958, IBWA's member companies produce and distribute 85 percent of the bottled water sold in the United States. Their membership includes more than 1,200 U.S.-based and international bottlers, distributors and suppliers.
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What is the Global Food Safety Institute (GFSI)?

The Global Food Safety Initiative (GFSI) is a collaboration between some of the world's leading food safety experts from retailer, manufacturer and food service companies, as well as service providers associated with the food supply chain. It is coordinated by The Consumer Goods Forum, the only independent global network for consumer goods retailers and manufacturers worldwide. It serves the CEOs and senior management of nearly 400 members, in over 150 countries.

In May 2000, following a number of food safety scares, a group of international retailer CEOs identified the need to enhance food safety, ensure consumer protection and to strengthen consumer confidence. They launched the Global Food Safety Initiative which sets requirements for food safety schemes through a benchmarking process in order to improve cost efficiency throughout the food supply chain.
For more information on GFSI certification, please visit www.mygfsi.com.
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What is SQF and why is it important?

The SQF (Safe Quality Food) Program is a leading, global food safety and quality certification program and management system, designed to meet the needs of buyers and suppliers worldwide. The Program provides independent certification that a supplier's food safety and quality management system complies with international and domestic food safety regulations. This enables suppliers to assure their customers that food has been produced, processed, prepared and handled according to the highest possible standards, at all levels of the supply chain.

Both Creekside manufacturing plants have now received SQF Level 3 Certification:  Salineville, OH and Ambridge, PA.  In order to receive SQF certification, each of these plants was audited to reassure customers that the product has been produced, processed, prepared and handled according to internationally-recognized quality standards.

The total certification process took about 18 months.  Achieving Level 3 SQF Certification fits our organization’s commitment to produce quality products and assure customer and consumer confidence.

SQF is designed as a food safety program, but it also covers product quality, a feature that is unique to a certification program of this type. Assuring consistent quality and meeting buyer specifications are important aspects of the buyer-supplier relationship.

SQF certification is supported by an increasing number of U.S. and international retailers and foodservice providers who express a preference for suppliers who implement HACCP-based (Hazard Analysis Critical Control Point) food safety and quality management systems.

For more information on SQF certification, please visit www.nsf.com/business/sqf.
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Can you manufacture products that meet kosher certification?

Yes.  When requested, Creekside Springs has included the OU (Orthodox Union) kosher certification symbol on the labels of certified products.

For over 80 years, the Orthodox Union has maintained the highest standard of kosher certification. Today, the OU supervises more than 400,000 products, making it the world’s most recognized and most trusted kosher symbol.

The OU rigorously monitors all aspects of production. It supervises the process by which the water is processed, examines the ingredients regularly inspects the processing facilities to make sure that its standards are met.

All Creekside Springs facilities are inspected regularly for kosher certification by the Orthodox Union.

For more information on OU certification, please visit www.oukosher.org.
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