Appendix 3.
FDA's Activities Related to Water

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), food means articles used for food or drink by man or other animals and components of such articles. By this definition, water is considered a food and is subject to the provisions of the FD&C Act. The FDA’s regulatory activities to ensure the safety of the U.S. food supply as it relates to water follow.

• Water Used in Food Processing. When water enters a food manufacturing establishment, the FDA has jurisdiction for regulation of that water when it is to be used in the processing of food. The FDA’s current good manufacturing practice (CGMP) regulations for manufacturing, packing, or holding human foods require use of safe and sanitary water for food processing. Use of safe and sanitary water for seafood processing at manufacturing plants, at docks, and on ships is of particular importance to ensure the safety of seafood products. All substances added to water after entering a food processing establishment are subject to FDA’s food additive regulations under the FD&C Act.
  
• Bottled Drinking Water. The FDA’s quality standard regulations for bottled water establish maximum allowable levels for contaminants (physical, chemical, radiological, and microbiological) in bottled water products, including mineral water. The FDA’s CGMP regulations for processing and bottling of bottled drinking water require safe and sanitary conditions during the manufacture, packing, and holding of bottled water products; approval of source waters for bottling; and monitoring for contaminants to ensure that water is safe and to ensure compliance with the bottled water quality standard.
  
  The FDA has established an identity standard for bottled water that includes definitions for various types of bottled water (e.g., artesian water, ground water, mineral water, purified water, sparkling bottled water, spring water, sterile water, well water). The identity standard for bottled water also requires any declared bottled water ingredient (e.g., mineral, well, artesian, spring, or purified) in a multicomponent food to meet FDA’s definitions for those types of water and the bottle water quality standard regulations.
  
• Retail Foods. The FDA’s Model Code provides guidance and recommendations to State and local officials regarding safe handling of foods (including the use of water) at the retail level, such as food service establishments (e.g., restaurants), institutions (e.g., nursing homes), and grocery stores.
  
• Harvest Water for Seafood. The FDA, in cooperation with the Interstate Shellfish Sanitation Conference, establishes public health controls for incorporation into the National Shellfish Sanitation Program (NSSP) Manuals of Operation. These manuals provide guidance to States and industry concerning the sanitary control of the molluscan shellfish industry.
  
  Included in these guidelines are specific requirements for the classification of shellfish growing waters to ensure that shellfish are harvested only from unpolluted areas where they will not pose a health hazard to consumers who often eat them raw or partially cooked. In accordance with NSSP requirements, waters which demonstrate unacceptable bacteriological quality, and may therefore be contaminated with pathogenic microorganisms, are closed to the harvesting of shellfish.
  
  The FDA provides guidance to the States for closing of waters under State jurisdiction for finfish harvesting when finfish are found to contain levels of chemical contaminants that exceed FDA action levels. In addition, the FDA works closely with the National Marine Fisheries Service (NMFS), which oversees Federal waters, to determine the safety of those waters for finfish harvesting.
  
  The FDA monitors chemical spills and dump sites. For example, samples have been taken from the Boston Harbor area for radionuclide examination after nuclear waste dump sites were found in the area. The area is closed by the NMFS to commercial fishing as a result of cooperative efforts between that agency and FDA.
  
• Interstate Conveyance Sanitation. Under the Public Health Service Act, the FDA regulates potable water, including water for ice, and water for other uses on conveyances (planes, trains, and ships) that are in interstate traffic.
  
  The FDA approves watering points for potable water for drinking and culinary purposes on conveyances to ensure that the potable water supply meets EPA’s Primary Drinking Water Regulations.
  
  The FDA regulates water for other uses (e.g., wash water, swimming pool water) and equipment and facilities (e.g., potable water systems, drinking fountains and coolers, water storage containers, toilets and lavatories) on conveyances to ensure safe and sanitary use of water.