PART 129—PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER Authority: 21 U.S.C. 342, 348, 350k, 371, 374, 42 U.S.C. 264. Source: 42 FR 14355, Mar. 15, 1977, unless otherwise noted. Subpart A—General Provisions § 129.1 Current good manufacturing practice. The applicable criteria in parts 110 and 117 of this chapter, as well as the criteria in §§ 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. [80 FR 56167, Sept. 17, 2015] § 129.3 Definitions. For the purposes of this part, the following definitions apply: (a) Approved source (b) Bottled drinking water (c) Lot (d) Multiservice containers (e) Nontoxic materials (f) Operations water (g) Primary container (h) Product water (i) Shall and should. (j) Shipping case (k) Single-service container (l) Unit package [42 FR 14355, Mar. 6, 1977, as amended at 44 FR 12175, Mar. 6, 1979] Subpart B—Buildings and Facilities § 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. § 129.35 Sanitary facilities. Each plant shall provide adequate sanitary facilities including, but not limited to, the following: (a) Product water and operations water Product water. (2) Operations water. (3) Product water and operations water from approved sources. Escherichia coli. E. coli E. coli E. coli E. coli E. coli E. coli E. coli E. coli (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 § 165.110(b) of this chapter. (iii) Analysis of the sample may be performed for the plant by competent commercial laboratories ( e.g., E. coli, (4) Source water testing exemptions. (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) 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 § 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 § 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 (§ 165.110(b) of this chapter) and section 402(a)(1) and (a)(3) of the Federal Food, Drug, and Cosmetic Act dealing with adulterated foods. (b) Air under pressure. (c) Locker and 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; 74 FR 25664, May 29, 2009; 86 FR 68831, Dec. 3, 2021] § 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. Subpart C—Equipment § 129.40 Equipment and procedures. (a) Suitability. (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. Subpart D [Reserved] Subpart E—Production and Process Controls § 129.80 Processes and controls. (a) Treatment of product water. (b) Containers. (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. (d) Sanitizing operations. (1) Steam in enclosed system: At least 170 °F for at least 15 minutes or at least 200 °F for at least 5 minutes. (2) Hot water in enclosed system: At least 170 °F for at least 15 minutes or at least 200 °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 °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 °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 § 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. (f) Filling, capping, or sealing. (g) Compliance procedures. (1) For bacteriological purposes, take and analyze at least once a week for total coliform 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. If any coliform organisms are detected, follow-up testing must be conducted to determine whether any of the coliform organisms are E. coli. (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 representative 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. [42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979; 60 FR 57124, Nov. 13, 1995; 74 FR 25665, May 29, 2009]