Source: https://fontiswater.com/water-quality/
Timestamp: 2020-07-12 02:59:20
Document Index: 780196825

Matched Legal Cases: ['art 165', '§ 165', 'art 129', '§ 349', '§ 343', '§ 374', 'art 110']

Water Quality | Fontis Water
Bottled water is fully regulated as a food product by the FDA under the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) and several sections of Title 21 of the Code of Federal Regulations (CFR). Standard of Identity: 21 CFR, Part 165, provides uniform definitions for the following bottled water classifications: bottled, drinking, artesian, ground, distilled, deionized, reverse osmosis, mineral, purified, sparkling, spring, sterile and well. A bottled water product must bear the appropriate name on its label as reflected in the applicable Standard of Identity definition or it may be deemed misbranded under the Federal Food, Drug, and Cosmetic Act. Standard of Quality: 21 CFR § 165 also contains the Standard of Quality for bottled water. This regulation establishes limits for microbiological, physical, chemical, and radiological substances for both source water and finished bottled water products. Federal testing frequency and parameters are specified in 21 CFR, Part 129, as part of the Good Manufacturing Practices (GMP) for bottled water. Bottled water is one of few food products with its own specific GMPs. FDA has established standards for more than 75 substances pursuant to the Standard of Quality for bottled water. Substandard bottled water must be clearly labeled with the appropriate statements regarding non-compliance (e.g., “This product contains excessive amounts of iron.”). The product will otherwise be considered misbranded and possibly adulterated. The Hammer Provision of 1996, 21 USC § 349: The Hammer Provision of the Federal Food, Drug, and Cosmetic Act provides that the Secretary of Health and Human Services shall consult with the Administrator of the Environmental Protection Agency (EPA) in regard to any EPA-proposed changes to the national primary drinking water regulations for public water supplies. Within 180 days of the effective date of such regulations, the Secretary must either promulgate amendments to the regulations applicable to bottled drinking water or publish in the Federal Register reasons for not making such amendments. The standards of quality issued for bottled water by FDA must be as stringent as those adopted by EPA for tap water. Amendments to the FFDCA Made by the Nutrition Labeling and Education Act (NLEA): Enacted in 1990 and resulting in FDA’s promulgation of final regulations in 1993, the NLEA amended the Federal Food, Drug, and Cosmetic Act by requiring packaged food products to disclose the exact nutritional content of the product by way of a uniform “nutrition facts” panel. For bottled water, the obligation to provide nutrition information arises when an express or implied nutritional claim is made [21 USC § 343 (g)]. Nutritional labeling is also required when nutritional ingredients are added. The essential nutrients and the order in which they must appear are: total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium and iron. Misbranding: Food misbranding is regulated under Section 403 of the Act. The Act requires a bottled water product to include on its label the correct standard of identity (i.e., bottled water, mineral water, spring water, etc.), the name and place of business of the manufacturer, and a statement of the net quantity of contents. Additional misbranding (labeling) regulations specific to bottled water include:
FDA Enforcement: The following tools are available to FDA in its enforcement of bottled water regulations: Pursuant to section 704 of the Act (21 USC § 374), FDA may inspect any food manufacturing facility, including a bottled water plant. In the event a product is deemed misbranded or adulterated, FDA generally seeks voluntary compliance through the use of warning letters and requests for voluntary recalls. If the company declines to comply with applicable requirements or declines to take action to correct the violation, FDA may take either civil and/or criminal action. FDA may seek action from the U.S. Department of Justice in the form of a civil seizure or an injunction against the products and/or company involved. Depending on the circumstances, a criminal prosecution may also be warranted. FDA may also use its authority to warn the public (e.g., press releases). Good Manufacturing Practices (GMPs): 21 CFR, Part 110, contains FDA regulations relating to GMPs for all food production facilities. These regulations address:
State governments use one of the following approaches in their regulation of bottled water: Federal/FDA Model: Under the Federal/FDA Model, used in the majority of states, bottled water is treated solely as a food product and subject to the FDA’s extensive food safety and labeling requirements. Bottled water is treated in the same manner as all other packaged food products by the state and, therefore, is subject to the same requirements. Bottled water may also be required to meet certain state-specific labeling and/or quality standards. Environmental Model: Under the Environmental Model, bottled water is regulated by a particular state’s environmental protection or natural resources department, comparable to that of the EPA. This regulation, used to some degree in six states, begins at the source of withdrawal and usually includes inspection, sampling, analysis and approval of water sources. Withdrawals are generally treated in the same manner as municipal water sources, thus subject to state regulations similar to the Safe Drinking Water Act, 42 USC 300(f). Combination: In a majority of jurisdictions, bottled water is regulated in a manner combining the Federal/FDA and Environmental Models. The withdrawal of water at the source is regulated by an EPA-type agency, while bottled water, once packaged, is treated like a traditional food product and regulated accordingly. Some states also take responsibility in the certification of testing laboratories. Unannounced inspections are among the steps that some states take to ensure quality in the testing process.
The bottled water industry also employs additional measures to help ensure the safety and quality of its product beginning with the source on through to packaging. Bottler members of the International Bottled Water Association (IBWA) must adhere to the IBWA Model Code, which requires members to undergo an annual, unannounced plant inspection. These inspections are conducted by an independent third-party organization and assess compliance with all applicable regulations. The major areas covered by the IBWA annual inspections are: plant construction and design, sanitary facilities and controls, sanitary operations, equipment and procedures, process and controls, and personnel. IBWA bottler members must also develop a Hazard Analysis and Critical Control Points (HACCP) program for each of their facilities to be in compliance with the IBWA Model Code. The HACCP program requirement further ensures food safety and security within the production facility. The IBWA Model Code (available at www.bottledwater.org ) is, in several cases, more stringent than state and federal regulations and has been adopted by more than a dozen states as their standard for regulation of bottled water.