Attachment_3_-_Quality_Assurance_Requirements_01FEB2018.pdf

1. In coordination with Public Health Command Europe Laboratory Services and the Public Health Command Europe Veterinary Services Division (PHCE VSD), 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

b. Code of Federal Regulations, Title 40, Volume 25, Parts 141 and 143

c. Bottled Water Laboratory – Auditor Checklist, Appendix B

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

e. MIL-STD 3006C, 01 June 2008

f. International Bottled Water Associate, Bottled Water Code of Practice

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

Procurement, Appendix O - DoD Food Safety and Quality Assurance Action Levels, 19 Aug 2016.

3. The following parameters must be monitored.

ATTACHMENT NO. 3

QUALITY ASSURANCE REQUIREMENTS FOR BOTTLED WATER

DATED 01 February 2018

Bottled Water Monitoring Parameters

MONITORING PARAMETER GROUP MONITORING

FREQUENCY

FDA Standard of Quality (SOQ) Limits in mg/L (ppm) except as noted. Individual Group Analytes

Inorganic Chemicals (IOCs) ANNUALLY Antimony (1) ANNUALLY

(Product and Source)

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, Total 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 ANNUALLY Aluminum ANNUALLY

0.2 Chloride (5) 250 Copper 1.0 Iron (5) 0.3 Manganese (5) 0.05 Silver 0.1 Sulfate (5) 250 Total Dissolved Solids (TDS) (5) 500 Zinc (5) 5.0

Volatile Organic Chemicals (VOCs) ANNUALLY 1,1,1-Trichloroethane ANNUALLY

0.2 1,1,2-Trichloroethane 0.005 1,1-Dichloroethylene 0.007 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

MONITORING PARAMETER GROUP MONITORING

mg/L (ppm) except as noted. Individual Group Analytes

Volatile Organic Chemicals (VOCs) (Continued) ANNUALLY Tetrachloroethylene ANNUALLY

0.005 Toluene 1.0 Trichloroethylene 0.005 Vinyl chloride 0.002 Xylenes (total) 10.0 Total Trihalomethanes (2)(7) 0.08

Semivolatile Organic Chemicals (SVOCs) ANNUALLY Benzo(a)pyrene ANNUALLY

0.0002 Di(2-ethyhexyl)adipate 0.4 Di(2-ethyhexyl)phthalate 0.006 Hexachlorobenzene 0.001 Hexachlorocyclopentadiene 0.05

Synthetic Organic Chemicals (SOCs) ANNUALLY 2,4,5-TP (Silvex) 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)(8)(7)

Product: Every 3 years Source: Annually

3x10-8

Diquat (1)(8)(7) 0.02 Endothall (1)(8)(7) 0.1 Endrin ANNUALLY

0.002 Ethylene dibromide 0.00005

Glyphosate(1)(8)(7) Product: Every 3 years Source: Annually

0.7

Heptachlor 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 D/DBP rule.

(3) SOQ dependent upon temperature and other factors. Bottled water to which no fluoride is added shall not contain fluoride in excess of

1.4 milligrams per liter.

(4) SMCL = Secondary maximum contaminant level. SMCLs are guidelines established by the USEPA for use in evaluating aesthetic, non-health-related properties in water. SMCLs are not enforceable for public water systems.

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

(6) If total chromium results are <0.005 mg/l (5 ug/l), then monitoring for hexavalent chromium is waived.

(7) No SOQs or MCLs established for individual trihalomethane contaminants. The sum of the 4 THMs is regulated as total trihalomethanes

(TTHMs).

(8) 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.

(9) If the gross beta particle activity exceeds 50 pCi/1, an analysis of the sample must be performed to identify the major radioactive constituents present. Compliance (with § 141.16) may be assumed without further analysis if the average annual concentration of gross beta particle activity is less than 50 pCi/1 and if the average annual concentrations of tritium and strontium–90 are less than those listed in table A, Provided, That if both radionuclides are present the sum of their annual dose equivalents to bone marrow shall not exceed 4 millirem/year. Consult with your testing laboratory for more information.

(10) The Code of Practice guideline for pH in purified water is 5.0-7.0 (see Appendix B for definition and requirements for purified water). The guideline for source water and other product waters is 6.5-8.5. NOTE: This guideline is not enforceable.

MONITORING PARAMETER GROUP

MONITORING

mg/L (ppm) except as noted.

Individual Group Analytes

Additional Regulated Contaminants ANNUALLY

Phenols (Total Recoverable Phenolics) ANNUALLY

0.001 1,1,2,2-Tetrachloroethane NA

Microbiological Contaminants Total coliform / E. coli SOURCE: at least once each week (21 CFR §129.35(a)(3)) PRODUCT: at least once each week (21 CFR §129.35(g)(1))

MPN: <2.2

Organisms per 100 ml.

MF: <4 CFU per 100 ml.

Radiological Contaminants SEE BELOW Gross Alpha Particle Radioactivity SOURCE: Every 4 years

PRODUCT: Annually 15 pCi/L

Gross Beta Particle and Photon Radioactivity (9) 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 ANNUALLY Color ANNUALLY

15 Units Turbidity 5.0 NTU 'pH (10) NA Odor 3 T.O.N.