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Questions and Answers
The bottled water industry in Alaska is in its infancy and has great potential for growth. Alaska is blessed with approximately 40 percent of the Nation's fresh water supply. This web page provides answers to some commonly-asked questions about the bottling of water in Alaska and outlines a program designed to enhance the safe and fair development of the bottled water industry.
By definition, bottled water is water that is intended for human consumption and is sealed in bottles or other containers with no added ingredients, except that it may contain safe and suitable anti-microbial agents. Fluoride may be added within the limitations established in the federal Food & Drug Administration (FDA) regulations, 21 C.F.R. 165.110(b)(4)(ii). It also includes bottled water that has been flavored. It does NOT include soft drinks and similar beverages that have the following declarations in the ingredient labeling: water, carbonated water, disinfected water, filtered water, seltzer water, soda water, sparkling water, and tonic water.
DEFINITIONS
Intrastate means within the State of Alaska.
Interstate means outside of the State of Alaska, nationally and/or internationally.
Who are the agencies that regulate the bottling of water in Alaska, and what regulations apply?
- Alaska Department of Natural Resources, Division of Mining and Water Management (ADNR/DMWM): Water-use approvals including water rights and removal of water from hydrological units or water shipped out of state. AS 45.15
- Alaska Department of Fish & Game, Division of Sport Fish (ADFG/DSF): When water use would affect fisheries, wildlife, or other habitat.
- Alaska Department of Environmental Conservation, Drinking Water Program (DEC/DW): Source, treatment, and quality of water to be bottled. 18 AAC 80
- Alaska Department of Environmental Conservation, Environmental Sanitation & Food Safety (DEC/ESFS): Plant design and operation, microbial testing of bottled water, labeling and permitting. 18 AAC 31.740 and 21 C.F.R. 165.110, adopted by reference.
What if I want to distribute the product interstate?
U.S. Food & Drug Administration Title 21, Parts 129 and 165 of the Code of Federal Regulations (21 C.F.R. 129 and 165) apply to bottled water that will be distributed interstate or to intrastate bottlers who use product containers shipped interstate. The FDA enforces these codes.
Is there any agency that could help promote, market or develop this industry?
Alaska Department of Commerce & Economic Development, Division of Trade & Development; U.S. Department of Commerce, Alaska Export Assistance Center.
Who can I contact with these agencies for specific requirements and technical assistance?
See the end of this page for a listing of primary contacts within each agency.
What are the water source and water treatment requirements to bottle water?
If the water to be bottled is from an approved Class-A Public Water System (PWS), the bottler needs to submit plans prepared by a registered engineer to DEC/DW for review and approval of the treatment equipment, methods, piping, etc.
If the water bottler is planning to develop its own water source, then:
- plans prepared by a registered engineer must be submitted to DEC/DW for the source, storage, distribution and treatment system, and
- raw water must be analyzed by a commercial lab for the inorganic, organic, radiological, physical and coliform bacteria contaminants listed in 18 AAC 80.310(1)(A).
Additionally, all bottled water must be disinfected prior to bottling. Disinfection might be the use of ozone, UV light, chlorination, or a heat-treatment process.
What about the bottling plant?
If the product or containers will be shipped interstate, the plant and operation must comply with both 18 AAC 31.740, as well as 21 C.F.R. 129. Plan review is required by DEC prior to construction and operation. Plans need to be to-scale and include specifications for equipment and packaging materials.
What additional testing is required and on what frequency?
Once the water supply system is approved, and analysis of the source water for the contaminants listed above is satisfactory, the source water, bottled water and materials must be tested on a scheduled basis.
For bottled water produced and shipped intrastate (DEC requirements):
a. Source water from a municipal supply or another approved Class A public water supply: coliform analysis of the water to be bottled once a month at a certified lab coliform analysis of each container type of bottled water once a month at a certified lab
b. Source water from an approved Class A public water supply operated at the plant: coliform analysis of the water to be bottled once a month at a certified lab coliform analysis of each container type of bottled water once a month at a certified lab routine Class A sampling in accordance with 18 AAC 80.310 (1)(A)
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For bottled water shipped interstate (FDA requirements):
a. Source water from a municipal water supply or another Class A public water supply: routine Class A sampling in accordance with AAC 80.310(1)(A).
b. Bottled water: annual testing for chemical contaminants listed in 21 C.F.R. 165. coliform analysis weekly.
c. Empty containers and closures: quarterly testing for microbiological contaminants.
If we want to conduct microbial tests in house, do we need to have a certified lab, or are there any test kits that are approved?
FDA will allow the use of microbial water testing methods listed under Standard Methods for the Examination of Water and Wastewater, Edition #19. These methods include specific presence/absence test. The firm will need to have procedures for handling positive samples using a presence/absence test. These could include reprocessing the water, discarding the water, or submitting a check sample to a certified lab for quantitative analysis to ensure it is under the standard.
DEC will also propose revisions to current bottled-water regulations to allow the use of these methods. DEC is also willing to provide scheduled training to bottled water operators in these methodologies at its Food Safety Laboratory in Palmer.
What information is required on the label, and are there any size requirements?
Labels must be printed legibly in type of sufficient size and prominence to be easily read under normal conditions of sale and display. Required labeling information must be:
- on the main part of the label in a color that contrasts with its background; and
- in English, except that duplicate labeling in other languages is allowed.
Labels must include:
- the name of the product or the name under which a standard of identity has been adopted in 18 AAC 31.740 or 21 C.F.R. 165;
- name and address of the manufacturer or distributor;
- net contents of the product in terms of weight or measure;
- common and usual name of each ingredient in order of preponderance by weight;
- production code for product shipped intrastate; and
- statement of substandard quality if the microbial, physical, chemical or radiological quality is below that prescribed in 21 C.F.R. 165 (b) (2) - (b) (5).
What options do I have for what I can call the bottled water?
Bottled water can only be called "bottled water" or "drinking water" if it meets one of the standard definitions in 21 C.F.R. 165 for "artesian water," "ground water," "mineral water," "purified water," "sparkling bottled water," "spring water," "sterile water," or "well water."
Bottled water from a municipal or community water system must be clearly labeled as "from a community water system'" or, alternatively, "from a municipal source" as appropriate, on the principal display panel, unless it is processed sufficiently to be labeled as "distilled" or "purified" water in accordance with the United States Pharmacopeia.
In Alaska, bottled water may be labeled as "glacier water" if it is either the runoff directly from the natural melting of a glacier or water obtained from the melting of glacier ice at a bottled water operation.
It seems that there are a lot of products labeled "glacier water" or something similar, both in Alaska and in the Lower 48. What gives?
The 1997 revision to the Alaska Food Code, 18 AAC 31, does have a definition for "glacier water." Bottled water produced and marketed within Alaska may be labeled as "glacier water" if it meets the definition in the code.
FDA regulations do not currently have a definition for "glacier water." Therefore, bottled water marketed interstate that is labeled as "glacier water" would be in violation of the Food and Drug Administration regulations, 21 C.F.R. 165, as well as the truth in labeling requirements of the Food, Drug and Cosmetic Act.
Well, what's the State and FDA doing to enforce this requirement?
Due to staffing levels, federal inspectors direct their enforcement efforts on testing and labeling issues that might impact health, as opposed to labeling that is fraudulent and misleading. However they are aware of the labeling problems and controversy and do follow up on complaints and labeling violations that are discovered during routine inspections of bottled water plants.
Since the State has adopted the standard definitions in 21 C.F.R. 165, and both agencies regulate most of the bottled water plants in Alaska, DEC and FDA need to work together on issues and violations.
It seems that Alaska has the largest portion of glaciers in the nation, and if there should be a marketing advantage in the correct use of this terminology, it would be Alaska's advantage. What can we do to enhance the marketability of Alaska waters and level the playing field?
- First, involved agencies, with your input, could draft revisions to the definition of glacier water that provide a little more flexibility but still is not false or misleading.
- Secondly, involved agencies, with your input, could propose a definition for a "glacier blend" or "glacially influenced water" that would provide many additional sources but not be false or misleading.
- Thirdly, agencies and industry could petition the Food & Drug Administration to amend 21 C.F.R. 165 to include our proposed standards of identity for "glacier water" and "glacier blend" or "glacially influenced." As long as it is based on science and has the backing of the Alaska industry, and perhaps the congressional delegation, the FDA would likely put it out for public comment.
- Lastly, we encourage the industry to form an Alaskan Association of Water Bottlers to promote the development of this industry within Alaska and the marketing of products nationally and internationally.
The FDA and the State held an industry meeting in December of 1997. Proposed revisions to the definition of "glacier water" were presented at this meeting. Following the Public Notice of proposed revisions to the food code, the State will petition the FDA to amend 21 C.F.R. 165 to include these revised definitions.
What are your proposed revisions regarding glacier water?
No changes are proposed to the current definition of glacier in 18 AAC 31.990 which reads as follows: "glacier means a large body of ice moving slowly down a slope or valley spreading outward on a land surface; glacier does not include a snow field or a frozen or ice covered stream, river, spring, or other water body."
Proposed revisions to "glacier water" are:
- water obtained from the melting of glacier ice at a bottled water operation;
- the runoff directly from the natural melting of a glacier; or
- water gathered from a glacial stream, prior to any other non glacial stream influences.
How about "glacier blend," or "glacially influenced?"
"Glacier blend," or "glacially influenced" is proposed to read either:
- water from a first-, second-, or third-order stream which has other watershed influences, or
- water drawn from a catchment connected to a first-, second-, or third-order stream which has other watershed influences.
What do you mean by first-, second- or third-order stream?
Stream order is a technique to describe a drainage basin on the basis of the types of tributaries that join to form the basin. A first-order stream is a small, unbranched tributary. A second-order stream has only first-order tributaries. A third-order stream has only first- and second-order tributaries.
Agency Listing
Alaska Department of Environmental Conservation
Drinking Water Program
555 Cordova
Anchorage, Ak 99501-2617
(907) 269-7696; FAX (907) 269-7655
Ron Klein, Program Manager
Food Safety and Sanitation Program
555 Cordova Street
Anchorage, AK 99501
(907) 269 - 7583; FAX (907) 269-7510
Alaska Department of Fish & Game
Christopher Estes
Statewide Instream Flow Coordinator
ADF&G, Div of Sport Fish/RTS
333 Raspberry Road
Anchorage, AK 99518-1579
(907) 267-2142; FAX (907) 267-2422
Email Address: cestes@fishgame.state.ak.us
Alaska Department of Natural Resources
Gary Prokosch, Section Chief
ADNR, Div of Mining & Water Management
3601 C Street, Suite 800
Anchorage, AK 99503-5935
(907) 269-8645; FAX (907) 562-1384
Email Address: gary_prokosch@dnr.state.ak.us
Alaska Department of Commerce & Economic Development
Division of Trade & Development
Nancy Babcock, Trade Specialist
3601 C Street Ste 700
Anchorage, AK 99503
(907) 269-8110; FAX (907) 269-8125
Email Address: nancy_babcock@commerce.state.ak.us
U.S. Food & Drug Administration
Wayne Larson, Investigator
Email Address: larsonw@pa66.par.ora.fda.gov
Jim Vik, Investigator
Email Address: vikj@par66.par.ora.fda.gov
Anchorage Residential Post
222 W 7th/ Federal Building # 25
Anchorage, AK 99513
(907) 271-5018; FAX (907) 271-5018
US Department of Commerce
Chuck Becker, Director
Alaska Export Assistance Center
3601 C Street, Suite 700
Anchorage, AK 99503
(907) 271-6237; FAX (907) 271-6242
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