[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129]
 
[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.
129.3  Definitions.
 
                   Subpart B--Buildings and Facilities
 
129.20  Plant construction and design.
129.35  Sanitary facilities.
129.37  Sanitary operations.
 
                          Subpart C--Equipment
 
129.40  Equipment and procedures.
 
Subpart D [Reserved]
 
               Subpart E--Production and Process Controls
 
129.80  Processes and controls.
 
    Authority: 21 U.S.C. 342, 348, 371, 374; 42 U.S.C. 264.
 
    Source: 42 FR 14355, Mar. 15, 1977, unless otherwise noted.
 
 
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
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.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
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.
    (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.
 
[[Page 279]]
 
    (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]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
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.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
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).
    (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
 
[[Page 280]]
 
they can document that such reduction is consistent with a State-issued 
waiver under EPA regulations (40 CFR parts 141 and 143).
    (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.
    (iv) 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; 66 FR 16865, Mar. 28, 2001]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.37]
 
[Page 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. 129.37  Sanitary operations.
 
    (a) The product water-contact surfaces of all multiservice 
containers, utensils, pipes, and equipment used in the transportation, 
processing, handling, and storage of product water shall be clean and 
adequately sanitized. All product water-contact surfaces shall be 
inspected by plant personnel as often as necessary to maintain the 
sanitary condition of such surfaces and to assure they are kept free of 
scale, evidence of oxidation, and other residue. The presence of any 
unsanitary condition, scale, residue, or oxidation shall be immediately 
remedied by adequate cleaning and sanitizing of that product water-
contact surface prior to use.
    (b) After cleaning, all multiservice containers, utensils, and 
disassembled piping and equipment shall be transported and stored in 
such a manner as to assure drainage and shall be protected from 
contamination.
    (c) Single-service containers and caps or seals shall be purchased 
and stored in sanitary closures and kept clean therein in a clean, dry 
place until used. Prior to use they shall be examined, and as necessary, 
washed, rinsed, and sanitized and shall be handled in a sanitary manner.
    (d) Filling, capping, closing, sealing, and packaging of containers 
shall be done in a sanitary manner so as to preclude contamination of 
the bottled drinking water.
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.40]
 
[Page 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 C--Equipment
 
Sec. 129.40  Equipment and procedures.
 
 
    (a) Suitability. (1) All plant equipment and utensils shall be 
suitable for their intended use. This includes all collection and 
storage tanks, piping, fittings, connections, bottle washers, fillers, 
cappers, and other equipment which may be used to store, handle, 
process, package, or transport product water.
    (2) All product water contact surfaces shall be constructed of 
nontoxic and nonabsorbant material which can be adequately cleaned and 
sanitized and is in compliance with section 409 of the act.
    (b) Design. Storage tanks shall be of the type that can be closed to 
exclude all foreign matter and shall be adequately vented.
 
Subpart D [Reserved]
 
[[Page 281]]
 
 
 
 
 
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR129.80]
 
[Page 281-282]
 
                        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 E--Production and Process Controls
 
Sec. 129.80  Processes and controls.
 
 
    (a) Treatment of product water. All treatment of product water by 
distillation, ion-exchanging, filtration, ultraviolet treatment, reverse 
osmosis, carbonation, mineral addition, or any other process shall be 
done in a manner so as to be effective in accomplishing its intended 
purpose and in accordance with section 409 of the Federal Food, Drug, 
and Cosmetic Act. All such processes shall be performed in and by 
equipment and with substances which will not adulterate the bottled 
product. A record of the type and date of physical inspections of such 
equipment, conditions found, and the performance and effectiveness of 
such equipment shall be maintained by the plant. Product water samples 
shall be taken after processing and prior to bottling by the plant and 
analyzed as often as is necessary to assure uniformity and effectiveness 
of the processes performed by the plant. The methods of analysis shall 
be those approved by the government agency or agencies having 
jurisdiction.
    (b) Containers. (1) Multiservice primary containers shall be 
adequately cleaned, sanitized, and inspected just prior to being filled, 
capped, and sealed. Containers found to be unsanitary or defective by 
the inspection shall be reprocessed or discarded. All multiservice 
primary containers shall be washed, rinsed, and sanitized by mechanical 
washers or by any other method giving adequate sanitary results. 
Mechanical washers shall be inspected as often as is necessary to assure 
adequate performance. Records of physical maintenance, inspections and 
conditions found, and performance of the mechanical washer shall be 
maintained by the plant.
    (2) Multiservice shipping cases shall be maintained in such 
condition as to assure they will not contaminate the primary container 
or the product water. Adequate dry or wet cleaning procedures shall be 
performed as often as necessary to maintain the cases in satisfactory 
condition.
    (c) Cleaning and sanitizing solutions. Cleaning and sanitizing 
solutions utilized by the plant shall be sampled and tested by the plant 
as often as is necessary to assure adequate performance in the cleaning 
and sanitizing operations. Records of these tests shall be maintained by 
the plant.
    (d) Sanitizing operations. Sanitizing operations, including those 
performed by chemical means or by any other means such as circulation of 
live steam or hot water, shall be adequate to effect sanitization of the 
intended product water-contact surfaces and any other critical area. The 
plant should maintain a record of the intensity of the sanitizing agent 
and the time duration that the agent was in contact with the surface 
being sanitized. The following times and intensities shall be considered 
a minimum:
    (1) Steam in enclosed system: At least 170  deg.F for at least 15 
minutes or at least 200  deg.F for at least 5 minutes.
    (2) Hot water in enclosed system: At least 170  deg.F for at least 
15 minutes or at least 200  deg.F for at least 5 minutes.
    (3) Chemical sanitizers shall be equivalent in bactericidal action 
to a 2-minute exposure of 50 parts per million of available chlorine at 
57  deg.F when used as an immersion or circulating solution. Chemical 
sanitizers applied as a spray or fog shall have as a minimum 100 parts 
per million of available chlorine at 57  deg.F or its equivalent in 
bactericidal action.
    (4) 0.1 part per million ozone water solution in an enclosed system 
for at least 5 minutes.
    (5) When containers are sanitized using a substance other than one 
provided for in Sec. 178.1010 of this chapter, such substance shall be 
removed from the surface of the container by a rinsing procedure. The 
final rinse, prior to filling the container with product water, shall be 
performed with a disinfected water rinse free of pathogenic bacteria or 
by an additional sanitizing procedure equivalent in bactericidal action 
to that required in paragraph (d)(3) of this section.
    (e) Unit package production code. Each unit package from a batch or 
segment of a continuous production run of bottled drinking water shall 
be identified by a production code. The production code shall identify a 
particular batch or segment of a continuous production
 
[[Page 282]]
 
run and the day produced. The plant shall record and maintain 
information as to the kind of product, volume produced, date produced, 
lot code used, and the distribution of the finished product to wholesale 
and retail outlets.
    (f) Filling, capping, or sealing. During the process of filling, 
capping or sealing either single-service or multiservice containers, the 
performance of the filler, capper or sealer shall be monitored and the 
filled containers visually or electronically inspected to assure they 
are sound, properly capped or sealed, and coded and labeled. Containers 
which are not satisfactory shall be reprocessed or rejected. Only 
nontoxic containers and closures shall be used. All containers and 
closures shall be sampled and inspected to ascertain that they are free 
from contamination. At least once each 3 months, a bacteriological swab 
and/or rinse count should be made from at least four containers and 
closures selected just prior to filling and sealing. 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. All 
samples shall be free of coliform organisms. The procedure and apparatus 
for these bacteriological tests shall be in conformance with those 
recognized by the government agency or agencies having jurisdiction. 
Tests shall be performed either by qualified plant personnel or a 
competent commercial laboratory.
    (g) Compliance procedures. A quality standard for bottled drinking 
water is established in Sec. 165.110(b) of this chapter. To assure that 
the plant's production of bottled drinking water complies with the 
applicable standards, laws, and regulations of the government agency or 
agencies having jurisdiction, the plant will analyze product samples as 
follows:
    (1) For bacteriological purposes, take and analyze at least once a 
week a representative sample from a batch or segment of a continuous 
production run for each type of bottled drinking water produced during a 
day's production. The representative sample shall consist of primary 
containers of product or unit packages of product.
    (2) For chemical, physical, and radiological purposes, take and 
analyze at least annually a representative sample from a batch or 
segment of a continuous production run for each type of bottled drinking 
water produced during a day's production. The representtive sample(s) 
consists of primary containers of product of unit packages of product.
    (3) Analyze such samples by methods approved by the government 
agency or agencies having jurisdiction. The plant shall maintain records 
of date of sampling, type of product sampled, production code, and 
results of the analysis.
    (h) Record retention. All records required by Secs. 129.1, 129.20, 
129.35, 129.37, 129.40, and 129.80 shall be maintained at the plant for 
not less than 2 years. Plants shall also retain, on file at the plant, 
current certificates or notifications of approval issued by the 
government agency or agencies approving the plant's source and supply of 
product water and operations water. All required documents shall be 
available for official review at reasonable times.
 
[42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar, 6, 1979; 60 
FR 57124, Nov. 13, 1995]