ATTACH.1_-_Quality_Assurance_Recommendations_Bottled_Water.pdf

1. In coordination with Public Health Command Region Europe Laboratory Services and the Public Health Command Region Europe Veterinary Services, DLA TROOP SUPPORT EUROPE & AFRICA Food Safety and Quality Assurance recommends these parameters for the quality assurance section of DLA TROOP SUPPORT EUROPE & AFRICA bottled water acquisitions for the AFRICOM, EUCOM and CENTCOM areas of responsibility.

2. REFERENCES:

a. Code of Federal Regulations, Title 21, Volume 2, Parts 129 and 165, 01 April 2014.

b. Bottled Water Laboratory – Auditor Checklist, Appendix.

c. EU Directive 98/ 93/ EC, 14 December 1998.

d. MIL-STD 3006C, 01 June 2008.

e. Worldwide Directory Of Sanitarily Approved Food Establishments For Armed Forces

Procurement, Appendix O - DoD Food Safety and Quality Assurance Action Levels, 19 June 2014.

3. The following parameters must be monitored. See Part 4 for testing frequency.

PARAMETER GROUP TEST

FREQUENCY

FDA LIMITS

in mg/L (ppm) Individual Group Analytes

Inorganic Chemicals (IOCs) Antimony (1) SOURCE: Annually

PRODUCT: Annually 0.006

Arsenic 0.01 Barium 2.0 Beryllium (1) 0.004 Bromate (2) 0.010 Cadmium 0.005 Chlorine (2) 4.0 Chloramine (2) 4.0 Chlorine dioxide (2) 0.8 Chlorite (2) 1.0 Chromium 0.1 Cyanide (1) 0.1 Lead 0.005 Mercury 0.002 Nickel (1) 0.1 Nitrate-N 10.0 Nitrite-N 1.0 Total Nitrate + Nitrite 10.0 Selenium 0.05 Thallium (1) 0.002

Secondary Inorganic Parameters Aluminum SOURCE: Annually

PRODUCT: Annually 0.2

Chloride (3) 250 Copper 1.0 Iron (3) 0.3 Manganese (3) 0.05 Silver 0.1 Sulfate (3) 250 Total Dissolved Solids (TDS) (3) 500 Zinc (3) 5.0

Volatile Organic Chemicals (VOCs) 1,1,1-Trichloroethane SOURCE: Annually

PRODUCT: Annually 0.2

1,1,2-Trichloroethane 0.005 1,1-Dichloroethylene 0.007

Attachment 1

QUALITY ASSURANCE RECOMMENDATIONS FOR BOTTLED WATER DATED 27 APRIL 2015

1,2,4-Trichlorobenzene 0.07 1,2-Dichloroethane 0.005 1,2-Dichloropropane 0.005 Benzene 0.005 Carbon tetrachloride 0.005 cis-1,2-Dichloroethylene 0.07 trans-1,2-Dichloroethylene 0.1 Ethylbenzene 0.7 Methylene chloride (Dichloromethane) 0.005 Monochlorobenzene 0.1 o-Dichlorobenzene 0.6 p-Dichlorobenzene 0.075 Haloacetic Acids (HAA5) (2) 0.06 Styrene 0.1

(1) Included in FDA’s 9 contaminant regulations.

(2) Included in FDA’s Disinfectants / Disinfection By-Products Rule (D/DBP).

(3) Mineral water is exempt from allowable level. The exemptions are aesthetically based allowable levels and do not relate to a health concern.

FDA LIMITS

in mg/L (ppm) Individual Group Analytes

Volatile Organic Chemicals (VOCs) (Continued) Tetrachloroethylene SOURCE: Annually

PRODUCT: Annually 0.005

Toluene 1.0 Trichloroethylene 0.005 Vinyl chloride 0.002 Xylenes (total) 10.0 Total Trihalomethanes (2)(4) 0.08

Semivolatile Organic Chemicals (SVOCs) Benzo(a)pyrene SOURCE: Annually

PRODUCT: Annually 0.0002

Di(2-ethyhexyl)adipate 0.4 Hexachlorobenzene 0.001 Hexachlorocyclopentadiene 0.05 Total Recoverable Phenolics 0.001

Synthetic Organic Chemicals (SOCs) 2,4,5-TP (Silvex) SOURCE: Annually

PRODUCT: Annually 0.05

2,4-D (Dichlorophenoxy acetic acid) 0.07 Alachlor 0.002 Atrazine 0.003 Carbofuran 0.04 Chlordane 0.002 Dalapon 0.2 Dibromochloropropane (DBCP) 0.0002 Dinoseb 0.007 Dioxin (2,3,7,8-Tetrachlorodibenzo-p-dioxin) (1)(5)

SOURCE: Annually PRODUCT: Annually

3x10-8

Diquat (1)(5) 0.02 Endothall (1)(5) 0.1 Endrin SOURCE: Annually

PRODUCT: Annually 0.002

Ethylene dibromide 0.00005 Glyphosate (1)(5) SOURCE: Annually

PRODUCT: Every 3 years 0.7

Heptachlor SOURCE: Annually PRODUCT: Annually

0.0004 Heptachlor epoxide 0.0002 Lindane 0.0002 Methoxychlor 0.04 Oxamyl (vydate) 0.2 Pentachlorophenol 0.001 Picloram 0.5 Polychlorinated biphenyls (PCBs) 0.0005 Simazine 0.004 Toxaphene 0.003

(1) Included in FDA’s 9 contaminant regulations.

(2) Included in FDA’s Disinfectants / Disinfection By-Products Rule (D/DBP).

(4) No SOQs or MCLs established for individual trihalomethane contaminants. The sum of the 4 THMs (Bromodichloromethane, Chlorodibromomethane, Chloroform, Bromoform) is regulated as total trihalomethanes (TTHMs).

(5) FDA requires that the four synthetic organic chemicals (SOC) listed must be tested quarterly for four consecutive quarters for each type of finished bottled water (e.g., spring, purified, etc.). If none of the SOCs are detected, then once every three years for each type of finished product. If SOCs are detected, maintain monitoring for four consecutive quarters in each three-year period. New products and new companies must do an initial round of quarterly monitoring in the first year of operation.

FDA LIMITS

in mg/L (ppm) Individual Group Analytes

Microbiological Contaminants Total coliform SOURCE: at least once each week (21 CFR 129.35(a)(3)(i))

If positive for total coliform, follow-up testing required to determine presence of E. coli.

PRODUCT: at least once each week (21 CFR §129.80(g)(1))

MPN: <2.2 organisms per 100 ml. (6) MF: <4 CFU per 100 ml;

Arithmetic mean shall not exceed 1 coliform organism per 100 mL. (6)

Escherichia coli (E. coli) SOURCE: If coliform is detected, follow-up testing must be conducted to determine if coliform is E.

coli.

(21 CFR §129.35(a)(3)(i))

None detected. If detected, source water not of a safe, sanitary quality.

PRODUCT: If coliform is detected, follow-up testing must be conducted to determine if coliform is E.

coli.

None detected. If detected, product is deemed adulterated.

(6) The analytical methods listed by FDA for total coliform analysis in 21 CFR §165.110(b)(2), multiple tube fermentation/most probable number (MPN) and membrane filtration (MF), are cited as methods to determine compliance with FDA’s bottled water microbiological standards of quality. The standards of quality for total coliform, therefore, apply when those specific methods are employed to test a bottled water product for compliance. For routine daily and weekly testing, bottlers are free to use any approved analytical methodology that is considered to be “equivalent” to the two methods listed in the FDA bottled water total coliform standard of quality. Such methods would include methods published in Standard Methods for the Examination of Water and Wastewater. Standard Methods also includes methods also approved by the U.S. Environmental Protection Agency for analysis of drinking water. Standard Methods and USEPA-approved methods include many commercially available test methods such as membrane filtration (MF) and “presence/absence” (P/A) methods, including but not limited to “Colilert.”

(7) If the gross beta particle activity exceeds 50 pCi/L, an analysis of the sample must be performed to identify the major radioactive constituents present.

FDA LIMITS

Radiological Contaminants Gross Alpha Particle Radioactivity SOURCE: Every 4 years

PRODUCT: Annually 15 pCi/L

Gross Beta Particle and Photon Radioactivity (7)

50 pCi/L

Radium 226/228 (combined) SOURCE: Every 4 years PRODUCT: Annually

5 pCi/L

Uranium SOURCE: Every 4 years PRODUCT: Annually

0.030

Water Properties Color SOURCE: Annually

PRODUCT: Annually 15 Units

Turbidity 5.0 NTU (nephelometric turbidity unit) Odor 3 T.O.N. (Threshold Odor Number)

FDA LIMITS

Individual Group Analytes Microbiological Contaminants Totals coliform CONTAINERS AND

CLOSURES: at least once each 3 months a bacterial swab and/or rinse count made from at least four containers and closures prior to filling and sealing.

(21 CFR 129.35(a)(3)(i))

All samples shall be free of coliforms.

No more than one of the four samples may exceed more than one bacteria per milliliter of capacity or one colony per square centimeter of surface area.

* U.S. Army veterinary auditors will collect samples to test all parameter categories of finished bottled water products, including pesticide screening, at their initial audit. Annually, they will review all laboratory testing provided by the facility. During this review the bottled water laboratory audit checklist will be completed.

* U.S. Army veterinary auditors will collect samples to test all parameter categories of finished bottled water products, including pesticide screening, at their initial audit. Annually, they will review all laboratory testing provided by the facilit...