Attachment 3 - Quality Assurance Requirements.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, 3 November 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.

QUALITY ASSURANCE REQUIREMENTS FOR BOTTLED WATER

DATED 3 December 2020

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 8 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 8 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 coliforms / 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))

E. coli: Not detected in 100 ml.

Total coliforms: <1 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)

8 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.