21CFR129.1

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.1]

[Page 278]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 129.1  Current good manufacturing practice.


    The applicable criteria in part 110 of this chapter, as well as the 
criteria in Secs. 129.20, 129.35, 129.37, 129.40, and 129.80 shall apply 
in determining whether the facilities, methods, practices, and controls 
used in the processing, bottling, holding, and shipping of bottled 
drinking water are in conformance with or are operated or administered 
in conformity with good manufacturing practice to assure that bottled 
drinking water is safe and that it has been processed, bottled, held, 
and transported under sanitary conditions.

21CFR129.3

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.3]

[Page 278-279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 129.3  Definitions.

    For the purposes of this part, the following definitions apply:
    (a) Approved source when used in reference to a plant's product 
water or operations water means a source of water and the water 
therefrom, whether it be from a spring, artesian well, drilled well, 
municipal water supply, or any other source, that has been inspected and 
the water sampled, analyzed, and found to be of a safe and sanitary 
quality according to applicable laws and regulations of State and local 
government agencies having jurisdiction. The presence in the plant of 
current certificates or notifications of approval from the government 
agency or agencies having jurisdiction constitutes approval of the 
source and the water supply.
    (b) Bottled drinking water means all water which is sealed in 
bottles, packages, or other containers and offered for sale for human 
consumption, including bottled mineral water.
    (c) Lot means a collection of primary containers or unit packages of 
the same size, type, and style produced under conditions as nearly 
uniform as possible and designated by a common container code or 
marking.
    (d) Multiservice containers means containers intended for use more 
than one time.
    (e) Nontoxic materials means materials for product water contact 
surfaces utilized in the transporting, processing, storing, and 
packaging of bottled drinking water, which are free of substances which 
may render the water injurious to health or which may adversely affect 
the flavor, color, odor, or bacteriological quality of the water.
    (f) Operations water means water which is delivered under pressure 
to a plant for container washing, hand washing, plant and equipment 
cleanup and for other sanitary purposes.
    (g) Primary container means the immediate container in which the 
product water is packaged.
    (h) Product water means processed water used by a plant for bottled 
drinking water.
    (i) Shall and should. ``Shall'' refers to mandatory requirements and 
``should'' refers to recommended or advisory procedures or equipment.

[[Page 279]]

    (j) Shipping case means a container in which one or more primary 
containers of the product are held.
    (k) Single-service container means a container intended for one time 
usage only.
    (l) Unit package means a standard commercial package of bottled 
drinking water, which may consist of one or more containers.

[42 FR 14355, Mar. 6, 1977, as amended at 44 FR 12175, Mar. 6, 1979]

21CFR129.20

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.20]

[Page 279]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--Table of Contents
 
                   Subpart B--Buildings and Facilities
 
Sec. 129.20  Plant construction and design.


    (a) The bottling room shall be separated from other plant operations 
or storage areas by tight walls, ceilings, and self-closing doors to 
protect against contamination. Conveyor openings shall not exceed the 
size required to permit passage of containers.
    (b) If processing operations are conducted in other than a sealed 
system under pressure, adequate protection shall be provided to preclude 
contamination of the water and the system.
    (c) Adequate ventilation shall be provided to minimize condensation 
in processing rooms, bottling rooms, and in container washing and 
sanitizing areas.
    (d) The washing and sanitizing of containers for bottled drinking 
water shall be performed in an enclosed room. The washing and sanitizing 
operation shall be positioned within the room so as to minimize any 
possible post-sanitizing contamination of the containers before they 
enter the bottling room.
    (e) Rooms in which product water is handled, processed, or held or 
in which containers, utensils, or equipment are washed or held shall not 
open directly into any room used for domestic household purposes.

21CFR129.35

[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.35]

[Page 279-280]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 129--PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER--Table of Contents
 
                   Subpart B--Buildings and Facilities
 
Sec. 129.35  Sanitary facilities.

    Each plant shall provide adequate sanitary facilities including, but 
not limited to, the following:
    (a) Product water and operations water--(1) Product water. The 
product water supply for each plant shall be from an approved source 
properly located, protected, and operated and shall be easily 
accessible, adequate, and of a safe, sanitary quality which shall be in 
conformance at all times with the applicable laws and regulations of the 
government agency or agencies having jurisdiction.
    (2) Operations water. If different from the product water supply, 
the operations water supply shall be obtained from an approved source 
properly located, protected, and operated and shall be easily 
accessible, adequate, and of a safe, sanitary quality which shall be in 
conformance at all times with the applicable laws and regulations of the 
government agency or agencies having jurisdiction.
    (3) Product water and operations water from approved sources. (i) 
Samples of source water are to be taken and analyzed by the plant as 
often as necessary, but at a minimum frequency of once each year for 
chemical contaminants and once every 4 years for radiological 
contaminants. Additionally, source water obtained from other than a 
public water system is to be sampled and analyzed for microbiological 
contaminants at least once each week. This sampling is in addition to 
any performed by govermnnt agencies having jusisdiction. Records of 
approval of the source water by government agencies having jusisdiction 
and of sampling and analyses for which the plant is responsible are to 
be maintained on file at the plant.
    (ii) Test and sample methods shall be those recognized and approved 
by the government agency or agencies having jurisdiction over the 
approval of the water source, and shall be consistent with the minimum 
requirements set forth in Sec. 165.110(b) of this chapter.
    (iii) Analysis of the sample may be performed for the plant by 
competent commercial laboratories (e.g., Environmental Protection Agency 
(EPA) and State-certified laboratories).
    (4) Source water testing exemptions. (i) Firms that use a public 
water system for source water may substitute public water system testing 
results, or certificates showing full compliance with all provisions of 
EPA National Primary and Secondary Drinking Water Regulations pertaining 
to chemical contaminants (40 CFR parts 141 and 143), for the testing 
requirements of Sec. 129.35(a)(3).

[[Page 280]]

    (ii) Firms that do not use a public water system as the source of 
their water may reduce the frequency of their testing of that source, as 
well as the number of chemical contaminants for which they test the 
source water, if they can document that such reduction is consistent 
with a State-issued waiver under EPA regulations (40 CFR parts 141 and 
143).
    (iii) The finished bottled water must comply with bottled water 
quality standards (21 CFR 165.110(b)) and section 402(a)(1) of the act 
dealing with adulterated foods.
    (b) Air under pressure. Whenever air under pressure is directed at 
product water or a product water-contact surface, it shall be free of 
oil, dust, rust, excessive moisture, and extraneous materials; shall not 
affect the bacteriological quality of the water; and should not 
adversely affect the flavor, color, or odor of the water.
    (c) Locker and lunchrooms. When employee locker and lunchrooms are 
provided, they shall be separate from plant operations and storage areas 
and shall be equipped with self-closing doors. The rooms shall be 
maintained in a clean and sanitary condition and refuse containers 
should be provided. Packaging or wrapping material or other processing 
supplies shall not be stored in locker or lunchrooms.

[42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60 
FR 57123, Nov. 13, 1995]

    Effective Date Note: At 66 FR 16865, Mar. 28, 2001, Sec. 129.35 was 
amended by redesignating paragraph (a)(4)(iii) as paragraph (a)(4)(iv) 
and by adding new paragraph (a)(4)(iii), effective Jan. 1, 2002. For the 
convenience of the user, the added text is set forth as follows:

Sec. 129.35  Sanitary facilities.

                                * * * * *

    (a)  *    *    *
    (4)  *    *    *
    (iii) 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 
the residual disinfectants and DBP's listed in 
Sec. 165.110(b)(4)(iii)(H) of this chapter. 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 the DBP's listed 
in Sec. 165.110(b)(4)(iii)(H) that are likely to result from such 
treatment.

                                * * * * *

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