Revid 11/03 Drinking Water Quality Standards
Edstrom Industries
819 Bakke Ave.
Waterford, Wisconsin 53185
4230-MI4171
© Copyright 2003 Edstrom Industries, Inc.
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we assume no responsibility for errors or omissions, nor do we assume liability for damages to your system resulting from the u of the information in this manual. Informa-tion in this document is subject to change without notice and does not reprent a commitment on the part of Edstrom Industries.
Edstrom Industries, Inc.
819 Bakke Avenue
Waterford, WI 53185-5913
(262) 534-5181
(800) 558-5913
(262) 534-5184 – FAX
Drinking Water Quality Standards Over the years, many animal facility managers have called Edstrom Industries to ask "What are the stan-dards for laboratory animal drinking water?", “What bacterial level is acceptable?", and “What should we test water for?” They are looking for something
more specific than the general statement in the 1996 revi-sion of The Guide for the Care and U of Laboratory Animals, which states:
“Ordinarily animals should have continuous access to fresh, po-
table, uncontaminated drinking water, according to their
particular requirements. Water quality and the definition of pota-
养鱼经ble water can vary with locality (Homberger and others 1993).
Periodic monitoring for pH, hardness, and microbial or chemical
contamination might be necessary to ensure that water quality is
acceptable, particularly for u in studies in which normal com-
ponents of water in a given locality can influence the results
obtained. Water can be treated or purified to minimize or elimi-
nate contamination when protocols require highly purified water.
The lection of water treatments should be carefully considered
becau many forms of water treatment have the potential to cau
physiologic alterations, changes in microflora, or effects on ex-
perimental results (Fidler 1977; Hall and others 1980; Hermann
and others 1982; Homberger and others 1993). For example,
chlorination of the water supply can be uful for some species but
toxic to others (such as aquatic species).
For a more specific water quality standard, we recommend the following:
1. Meet Environmental Protection Agency (EPA) standards. It makes n to interpret “potable,
uncontaminated” water as water meeting the EPA’s Primary (health-related) Drinking Water
一创Standards for human consumption.
2. Set limits and test for contaminants of concern to your facility’s rearch studies. Examples:
For toxicological studies, test for any interfering chemical contaminants in drinking water. For
immune-compromid animals, t tighter limits on bacterial contaminants.
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3. Learn from limits t by other facilities and organizations. Some animal facilities have t
their own microbial water quality goals (e the Microbiological Survey of Drinking Water Sys-
tems – Edstrom document). To learn about bacterial quality levels achievable in piped water
systems, refer to the United States Pharmacopeia (USP) standards for pharmaceutical water.
4. Monitor the purification process if purified water is specified. Water purification (usually by
rever osmosis) will remove contaminants from water and will provide a standardized water
quality safeguarded against upts in the local tap water supply. Monitor the purification process, usually by testing conductivity or percent rejection.
At the Charles River Symposium in 1980, Gordon Newell suggested that the laboratory animal industry should consider a cooperative effort “to establish water quality standards before any regulatory agency steps in and dictates water quality rules.” This has yet to be done.
The purpo of this document is to recommend animal drinking water quality standards bad on EPA standards, standards for pharmaceutical waters, and on what some of the more proactive facilities have done in their organizations. Edstrom Industries hopes this document will help facility managers in tting their own water quality standards. We welcome input and suggestions from the laboratory animal re-arch community! If you have any suggestions or questions, plea call Edstrom Industries at 1-800-558-5913 or nd e-mail to
Drinking Water Quality Standards
EPA Drinking Water Standards
Most facilities interpret the “potable, uncontaminated” water requirement for ordinary animals as water that meets, at a minimum, the EPA drinking water standards for human consumption. What are the EPA standards?
The EPA is responsible for the National Primary Drinking Water Regulations, which are health-related standards that establish the Maximum Contaminant Levels (MCLs). MCLs are the maximum permissible level of a contaminant in water delivered to urs of a public water system. MCLs are en-forceable under the Safe Drinking Water Act. The EPA has also t unenforceable Maximum Contaminant Level Goals (MCLGs) at levels where no known or anticipated adver effects on health occur and that allow an adequate margin of safety. The enforceable MCL is t as clo to the MCLG as reasonable, taking into consideration the costs and treatment techniques available to public water systems. Health advisories provide information on contaminants that can cau human health effects and are known or anticipated to be in drinking water. Health advisories are guidance values bad on non-cancer health effects for different durations of exposure (e.g., one-day, ten-day, longer-term, and lifetime).
National Secondary Drinking Water Standards
National Secondary Drinking Water Standards are unenforceable federal guidelines regarding
taste, odor, color, and certain other aesthetic characteristics of water. The EPA recommends them to states as reasonable goals, but federal law does not require water systems to comply with them. The
EPA drinking water standards are listed in Table 1. For the most recent regulations, you can order a free copy of Drinking Water Regulations and Health Advisories from the safe drinking water hotline.
Safe Drinking Water Hotline
(800)-426-4791
Monday through Friday, 9:00 AM to 5:30 PM EST
USP (United States Pharmacopeia) Specifications
It is uful to learn about pharmaceutical water standards to e what can be applied to animal drinking water. This is especially true for bacterial contaminants. It is impossible to achieve absolutely sterile wa-ter in any piped water system, but automated watering systems can (with appropriate design and operation) achieve the quality of USP Purified Water and can approach USP Water for Injection.
What is the USP?
The United States Pharmacopeia Convention is a private, not-for-profit organization that ts
standards for drugs, devices and diagnostics. It publishes two compendia (summary documents).
The US Pharmacopeia (USP) contains standards for drug products. The National Formulary (NF) ts standards for drug excipients (inert substances ud as carriers or dilutants).
Legal Status
The standards listed in the “monograph” ction of the USP are legally enforceable by the FDA.
The “General Information” ction is not enforceable by the FDA.
Drinking Water Quality Standards
USP Waters
The USP monograph lists two waters that are prepared in bulk form: Purified Water (PW), often called USP Purified Water to distinguish it from other purified waters, and Water for Injection (WFI).
USP Purified Water (PW)
Purified Water is described in the USP 23 monograph as follows:
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“Purified Water is water obtained by distillation, ion-exchange
treatment, rever osmosis, or other suitable process. It is pre-
怎么样炖羊肉pared from water complying with the regulations of the U.S.
Environmental Protection Agency (EPA) with respect to drinking
water. It contains no added substances.”
Microbial Quality
Regarding the bacteriological purity of PW, the monograph (legally enforceable ction) states only that PW must comply with the EPA regulations for drinking water. The EPA regulations only specify limits for coliform bacteria. In the informational ction of the USP 23, which deals with action guidelines for the microbial control of ingredient water, it says:
拖拉机规则“A total microbial (aerobic) count that may be ud for source
drinking water is 500 colony-forming units (cfu) per mL. A gen-
eral guideline for Purified Water may be 100 cfu/mL.”
The numbers for cfu/mL are only advisory guidelines that reprent recommended alert/action limits, not reject levels. The informational ction also suggests that the microbial action limits
for PW should be bad on the intended u of the water and the nature of the product being
made. It recognizes that microbial limits for PW require being defined on a ca-by-ca basis.
USP 23 Supplement 5, effective since November 1996, specifies the method for total bacteria
counts. It states “Heterotrophic Plate Count of a 1-mL sample, using Plate Count Agar at an incu-bation temperature of 30 to 35°C for a 48-hour period (minimum).” There is some controversy
(Collentro 1996) becau this method will underestimate “starved” bacteria in high-purity water.
Chemical Quality
Effective November 15, 1996, the former inorganic chemistry tests (for calcium, sulfate, chloride, ammonia, and carbon dioxide) were replaced with a three-stage conductivity test. The conductiv-ity limit is pH-dependent but, for example, at pH 7.0, conductivity should be less than 5.8
microSiemen/cm (µS/cm). The former test for oxidizable substances was replaced with a Total城南旧事摘抄
Organic Carbon (TOC) limit of 0.05 mg/L. TOC is an indirect measure of organic molecules pre-nt in water measured as carbon. The new tests allow continuous in-line monitoring of water
using instrumentation rather than lab work.
Water for Injection (WFI)
The USP 23 monograph states:
“Water for Injection (WFI) is water purified by distillation or re-
ver osmosis.”百度歌曲
