Processing and bottling of bottled drinking water (21 CFR 129.1-129.80)

368 21 CFR Ch. I (4–1–15 Edition) Pt. 129 long as the shellfish have not been har vested from waters that have been closed to harvesting by an agency of the Federal government. (c) To meet the requirements of para graph (b) of this section, processors who receive shellstock shall accept only shellstock from a harvester that is in compliance with such licensure requirements as may apply to the har vesting of molluscan shellfish or from a processor that is certified by a shell fish control authority, and that has a tag affixed to each container of shellstock. The tag shall bear, at a minimum, the information required in § 1240.60(b) of this chapter. In place of the tag, bulk shellstock shipments may be accompanied by a bill of lading or similar shipping document that con tains the information required in § 1240.60(b) of this chapter. Processors shall maintain records that document that all shellstock have met the re quirements of this section. These records shall document: (1) The date of harvest; (2) The location of harvest by State and site; (3) The quantity and type of shellfish; (4) The date of receipt by the proc essor; and (5) The name of the harvester, the name or registration number of the harvester’s vessel, or an identification number issued to the harvester by the shellfish control authority. (d) To meet the requirements of para graph (b) of this section, processors who receive shucked molluscan shell fish shall accept only containers of shucked molluscan shellfish that bear a label that complies with § 1240.60(c) of this chapter. Processors shall maintain records that document that all shucked molluscan shellfish have met the re quirements of this section. These records shall document: (1) The date of receipt; (2) The quantity and type of shellfish; and (3) The name and certification num ber of the packer or repacker of the product. PART 129—PROCESSING AND BOT TLING OF BOTTLED DRINKING WATER 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. Subpart A—General Provisions § 129.1 Current good manufacturing practice. The applicable criteria in part 110 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 con trols used in the processing, bottling, holding, and shipping of bottled drink ing water are in conformance with or are operated or administered in con formity with good manufacturing prac tice to assure that bottled drinking water is safe and that it has been proc essed, bottled, held, and transported under sanitary conditions. § 129.3 Definitions. For the purposes of this part, the fol lowing definitions apply: (a) Approved source when used in ref erence to a plant’s product water or op erations 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 VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00378 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 369 Food and Drug Administration, HHS § 129.35 found to be of a safe and sanitary qual ity according to applicable laws and regulations of State and local govern ment agencies having jurisdiction. The presence in the plant of current certifi cates or notifications of approval from the government agency or agencies having jurisdiction constitutes ap proval of the source and the water sup ply. (b) Bottled drinking water means all water which is sealed in bottles, pack ages, or other containers and offered for sale for human consumption, in cluding 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 con tainers intended for use more than one time. (e) Nontoxic materials means mate rials for product water contact surfaces utilized in the transporting, proc essing, storing, and packaging of bot tled drinking water, which are free of substances which may render the water injurious to health or which may ad versely 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 im mediate container in which the product water is packaged. (h) Product water means processed water used by a plant for bottled drink ing water. (i) Shall and should. ‘‘Shall’’ refers to mandatory requirements and ‘‘should’’ refers to recommended or advisory pro cedures 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. (l) Unit package means a standard commercial package of bottled drink ing water, which may consist of one or more containers. [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 sepa rated from other plant operations or storage areas by tight walls, ceilings, and self-closing doors to protect against contamination. Conveyor open ings shall not exceed the size required to permit passage of containers. (b) If processing operations are con ducted in other than a sealed system under pressure, adequate protection shall be provided to preclude contami nation of the water and the system. (c) Adequate ventilation shall be pro vided 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-sani tizing 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 house hold 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—(1) Product water. The product water supply for each plant shall be from an approved source properly lo cated, 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 regula tions of the government agency or agencies having jurisdiction. (2) Operations water. If different from the product water supply, the oper ations water supply shall be obtained VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00379 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 370 21 CFR Ch. I (4–1–15 Edition) § 129.35 from an approved source properly lo cated, 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 regula tions of the government agency or agencies having jurisdiction. (3) Product water and operations water from approved sources. (i) Samples of source water from each source in use by the plant are to be taken and ana lyzed by the plant as often as nec essary, but at a minimum frequency of once each year for chemical contami nants and once every 4 years for radio logical contaminants. Additionally, source water obtained from other than a public water system is to be sampled and analyzed for total coliform at least once each week. If any coliform orga nisms are detected, follow-up testing must be conducted to determine wheth er any of the coliform organisms are Escherichia coli. This sampling is in ad dition to any performed by government agencies having jurisdiction. Source water found to contain E. coli is not considered water of a safe, sanitary quality as required for use in bottled water by paragraph (a)(1) of this sec tion. Before a bottler can use source water from a source that has tested positive for E. coli, the bottler must take appropriate measures to rectify or otherwise eliminate the cause of E. coli contamination of that source in a man ner sufficient to prevent its reoccur rence. A source previously found to contain E. coli will be considered nega tive for E. coli after five samples col lected over a 24-hour period from the same sampling site that originally tested positive for E. coli are tested and found to be E. coli negative. Records of approval of the source water by govern ment agencies having jurisdiction, records of sampling and analyses for which the plant is responsible, and records describing corrective measures taken in response to a finding of E. coli 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 § 165.110(b) of this chapter. (iii) Analysis of the sample may be performed for the plant by competent commercial laboratories (e.g., Environ mental 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 certifi cates showing full compliance with all provisions of EPA National Primary and Secondary Drinking Water Regula tions pertaining to chemical contami nants (40 CFR parts 141 and 143), for the testing requirements of § 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 they can document that such reduction is consistent with a State-issued waiv er 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 dis infectant or ozone do not have to test their source water for the residual dis infectants 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. Whenever air under pressure is directed at product water or a product water-contact sur face, it shall be free of oil, dust, rust, excessive moisture, and extraneous ma terials; shall not affect the bacterio logical quality of the water; and should not adversely affect the flavor, color, or odor of the water. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00380 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 371 Food and Drug Administration, HHS § 129.80 (c) Locker and lunchrooms. When em ployee locker and lunchrooms are pro vided, 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; 74 FR 25664, May 29, 2009] § 129.37 Sanitary operations. (a) The product water-contact sur faces of all multiservice containers, utensils, pipes, and equipment used in the transportation, processing, han dling, 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 san itary condition of such surfaces and to assure they are kept free of scale, evi dence of oxidation, and other residue. The presence of any unsanitary condi tion, 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 trans ported and stored in such a manner as to assure drainage and shall be pro tected 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 san itary manner. (d) Filling, capping, closing, sealing, and packaging of containers shall be done in a sanitary manner so as to pre clude contamination of the bottled drinking water. Subpart C—Equipment § 129.40 Equipment and procedures. (a) Suitability. (1) All plant equipment and utensils shall be suitable for their intended use. This includes all collec tion 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 ade quately vented. Subpart D [Reserved] Subpart E—Production and Process Controls § 129.80 Processes and controls. (a) Treatment of product water. All treatment of product water by distilla tion, ion-exchanging, filtration, ultra violet 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 proc esses 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 phys ical inspections of such equipment, conditions found, and the performance and effectiveness of such equipment shall be maintained by the plant. Prod uct water samples shall be taken after processing and prior to bottling by the plant and analyzed as often as is nec essary to assure uniformity and effec tiveness of the processes performed by the plant. The methods of analysis shall be those approved by the govern ment agency or agencies having juris diction. (b) Containers. (1) Multiservice pri mary containers shall be adequately cleaned, sanitized, and inspected just prior to being filled, capped, and sealed. Containers found to be unsani tary or defective by the inspection shall be reprocessed or discarded. All multiservice primary containers shall VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00381 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 372 21 CFR Ch. I (4–1–15 Edition) § 129.80 be washed, rinsed, and sanitized by me chanical washers or by any other meth od giving adequate sanitary results. Mechanical washers shall be inspected as often as is necessary to assure ade quate performance. Records of physical maintenance, inspections and condi tions 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 uti lized by the plant shall be sampled and tested by the plant as often as is nec essary to assure adequate performance in the cleaning and sanitizing oper ations. 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 ef fect sanitization of the intended prod uct water-contact surfaces and any other critical area. The plant should maintain a record of the intensity of the sanitizing agent and the time dura tion that the agent was in contact with the surface being sanitized. The fol lowing times and intensities shall be considered a minimum: (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 solu tion. Chemical sanitizers applied as a spray or fog shall have as a minimum 100 parts per million of available chlo rine at 57 °F or its equivalent in bac tericidal 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 pro vided for in § 178.1010 of this chapter, such substance shall be removed from the surface of the container by a rins ing procedure. The final rinse, prior to filling the container with product water, shall be performed with a dis infected 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 bot tled drinking water shall be identified by a production code. The production code shall identify a particular batch or segment of a continuous production run and the day produced. The plant shall record and maintain information as to the kind of product, volume pro duced, 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 seal ing either single-service or multi service 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. Con tainers 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 as certain that they are free from con tamination. At least once each 3 months, a bacteriological swab and/or rinse count should be made from at least four containers and closures se lected 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 orga nisms. 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 per formed either by qualified plant per sonnel or a competent commercial lab oratory. VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00382 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 373 Food and Drug Administration, HHS § 130.3 (g) Compliance procedures. A quality standard for bottled drinking water is established in § 165.110(b) of this chap ter. To assure that the plant’s produc tion 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 for total coliform a representative sample from a batch or segment of a contin uous production run for each type of bottled drinking water produced during a day’s production. The representative sample shall consist of primary con tainers 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 radio logical purposes, take and analyze at least annually a representative sample from a batch or segment of a contin uous production run for each type of bottled drinking water produced during a day’s production. The representtive sample(s) consists of primary con tainers 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 sam pling, type of product sampled, produc tion code, and results of the analysis. (h) Record retention. All records re quired by §§ 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 notifica tions of approval issued by the govern ment agency or agencies approving the plant’s source and supply of product water and operations water. All re quired 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; 74 FR 25665, May 29, 2009] PART 130—FOOD STANDARDS: GENERAL Subpart A—General Provisions Sec. 130.3 Definitions and interpretations. 130.5 Procedure for establishing a food standard. 130.6 Review of Codex Alimentarius food standards. 130.8 Conformity to definitions and stand ards of identity. 130.9 Sulfites in standardized food. 130.10 Requirements for foods named by use of a nutrient content claim and a stand ardized term. 130.11 Label designations of ingredients for standardized foods. 130.12 General methods for water capacity and fill of containers. 130.14 General statements of substandard quality and substandard fill of container. 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of defini tions and standards of identity. Subpart B—Food Additives in Standardized Foods 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established. AUTHORITY: 21 U.S.C. 321, 336, 341, 343, 371. Subpart A—General Provisions § 130.3 Definitions and interpretations. (a) The definitions and interpreta tions of terms contained in section 201 of the act shall be applicable also to such terms when used in regulations promulgated under the act. (b) If a regulation prescribing a defi nition and standard of identity for a food has been promulgated under sec tion 401 of the act and the name there in specified for the food is used in any other regulation under section 401 or any other provision of the act, such name means the food which conforms to such definition and standard, except as otherwise specifically provided in such other regulation. (c) No provision of any regulation prescribing a definition and standard of identity or standard of quality or fill of container under section 401 of the act shall be construed as in any way affect ing the concurrent applicability of the general provisions of the act and the VerDate Sep<11>2014 16:02 Jun 05, 2015 Jkt 235071 PO 00000 Frm 00383 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B