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food and drug branch (fdb)

Food Safety Programā€‹ā€‹

ā€‹Bottled Water and Vended Water Source ā€‹ā€‹and Product Water Analysis

Physical

Group: PhysicalMaximumā€‹
Color
15 units*
OdorThreshold odor number 3*
Turbidity5 units
Total Dissolved Solids (TDS)500.0 mg/L*

*mineral water is exempt from allowable limit.ā€‹

Chemical

Group II: Chemical Substance 1Maximum (mg/L)
Aluminum0.2
Antimony0.006
Arsenic0.010
Barium2
Beryllium0.004
Cadmium0.005
Chloride250
Chromium0.1
Copper1.0
Cyanide0.2
Fluoridesee 21 CFR 165.110(b)(4)(ii)
Iron0.3
Lead0.005
Manganese0.05
Mercury0.002
Nickel0.1
Nitrate10 (as nitrogen)
Nitrite1 (as nitrogen)
Total Nitrate & Nitrite10 (as nitrogen)
Phenols0.001
Selenium0.05
Silver0.1
Sulfate250.0
Thallium0.002
Zinc5.0

Chemical, Continued

Group III: Chemical Substance 2 (Volatile Organic Chemicals)Maximum (mg/Lā€‹)
Benzene (71-43-2)0.005
Carbon Tetrachloride (56-23-5)
0.005
o-Dichlorobenzene (95-50-1)0.6
p-Dichlorobenzene (106-46-7)0.075
1,2-Dichloroethane (107-06-2)0.005
1,1-Dichloroethylene (75-35-4)0.007
cis-1,2-Dichloroethylene(156-59-2)0.07
trans-1,2-Dichloroethylene(156-60-5)0.1
Dichloromethane (75-09-2)0.005
1,2-Dichloropropane (78-87-5)0.005
Ethylbenzene (100-41-4)0.7
Monochlorobenzene (108-90-7)0.1
Styrene (100-42-5)0.1
Tetrachloroethylene (127-18-4)0.005
Toluene (108-88-3)1
1,2,4-Trichlorobenzene (120-82-1)
0.07
1,1,1-Trichloroethane (71-55-6)0.20
1,1,2-Trichloroethane (79-00-5)0.005
Trichloroethylene (79-01-6)0.005
Vinyl chloride (75-01-4)
0.002
Xylenes (330-20-7)10
Total Trihalomethanes (TTHMs)a0.01


Group IV: Chemical Substance 3 (Nonā€Volatile Synthetic Organic Chemicals)Maximum (mg/L)
Alachlor (15972-60-8)0.002
Atrazine (1912-24-9)0.003
Benzo(a)pyrene (50-32-8)0.0002
Carbofuran (1563-66-2)0.04
Chlordane (57-74-9)0.002
Dalapon (75-99-0)0.2
1,2-Dibromo-3-chloropropane (DBCP) (96-12-8)0.0002
2, 4-D (94-75-7)0.07
Di(2-ethylhexyl)adipate(103-23-1)0.4
Di(2-ethylhexyl)phthalate(117-81-7)0.006
Dinoseb (88-85-7)0.007
Diquat (85-00-7)0.02
Endothall (145-73-3)0.1
Endrin (72-20-8)0.002
Ethylene Dibromide (EDB)(106-93-4)0.00005
Glyphosate (1071-53-6)0.7
Heptachlor (76-44-8)0.0004
Heptachlor Epoxide (1024-57-3)0.0002
Hexachlorobenzene (118-74-4)0.001
Hexachlorocyclopentadiene(77-47-4)0.05
Lindane (58-89-9)0.0002
Methoxychlor (72-43-5)0.04
Oxamyl (23135-22-0)0.2
Pentachlorophenol (87-86-5)
0.001
PCB's (as decachlorobiphenyls)(1336-36-3)0.0005
Picloram (1918-02-1)0.5
Simazine (122-34-9)0.004
2,3,7,8-TCDD (Dioxin)(1746-01-6)3 x 10-8
Toxaphene (8001-35-2)0.003
2, 4, 5-TP (Silvex)(93-72-1)0.05

Radiological

ā€‹Group V: RadioactivityMaximum
Combined Radium-226 and Radium-228 b5 pCi/L
Gross Alpha particle activity (including Radium-226, but excluding Radon and Uranium)15 pCi/L
Gross Beta particle activity
50 pCi/L
Uranium c30 Āµg/L

Bacteriological

ā€‹Group VI: Bacteriological, Total ColiformsMaximum (Coliform organisms)**
Multiple Tube Fermentation Method2.2 MPN /100 mL
Membrane Filter Method4.0 /100 mL

** see 21 CFR 165.110(b)(2)(i) for more detailsā€‹

Disinfectants and Disinfection Byproductsdā€‹

ā€‹ā€‹Group VII: Disinfection byproducts (DBPs)Maximum (mg/L)
Bromate
0.010
Chlorite1.0
Haloacetic acids (five)(HAA5)0.060

Group VII: Residual disinfectantsMaximum (mg/L)
Chloramine (as Cl2)4.0
Chlorine (as Cl2)
4.0
Chlorine dioxide (as ClO2)0.8

Analyses Requirements and Testing Frequencies

All testing must be done by laboratories certified by the California Environmental Laboratory Accreditation Program (ELAP) or the United States Environmental Protection Agency (USEPA). Analyses must be conducted in accordance with 21CFR 165.110(b) and using the methods specified in applicable sections of ''Standard Methods for the Examination of Water and Wastewater,'' published by the American Public Health Association.

GroupType of AnalysisFrequency of Testing
Group IPhysicalAnnually
Group IIChemicalAnnually
Group IIIVolatile Organic ChemicalsAnnually
Group IVNon-Volatile Synthetic Organic ChemicalsAnnually
Group VIIResidual disinfectants & DBPsAnnually
Group VRadioactivitySource Water- Every 4 years Bottled Water- Every Year
Group VIBacteriologicalVended Water- Every 6 months Bottled Water- Weekly

Notes:

ā€‹a Total Trihalomethanes (TTHM) is the sum of trichloromethane (chloroform), dibromochloromethane (chlorodibromomethane), bromodichloromethane (dichlorobromomethane), and tribromomethane (bromoform). TTHM shall not exceed 0.01mg/L (10 ppb) pursuant to H&SC 111080(b).

b If Gross Alpha particle activity is less than 5pCi/L you may determine only Radium-228 instead of combined Radium-226 and Radium-228.

c If Gross Alpha particle activity is less than 15pCi/L, Uranium does not have to be determined.

d Firms that do not use a public water system as the source of their water and whose source water has not been treated with a chlorine-based disinfectant or ozone, do not have to test their source water for residual disinfectants and DBPs. Firms that do not use a public water system as the source of their water but whose source water has been treated with a chlorine-based disinfectant or ozone, must test their source water for the residual disinfectants and DBPs in accordance with 21CFR 129.35(a)(4)(iii) and 66 FR 16865, Mar. 28, 2001. There are no exemptions from this testing requirement for product (bottled) water.

References

Code of Federal Regulations, Title 21, sections 129.1 to 129.80, and 165.110(b). The California Health and Safety Code, sections 111070 to 111195.

The California Code of Regulations, Title 22, Sections 64421 to 64449.ā€‹ā€‹

Food and Drug Branch

1-800-495-3232

FDBfood@cdph.ca.gov

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