Current good manufacturing practice in manufacturing, packing, or holding human food (21 CFR 110.3-110.110)

216 21 CFR Ch. I (4–1–11 Edition) Pt. 110 level of PCB’s as adulterated in violation of sec. 402 of the act. Subpart C—Regulatory Limits for Added Poisonous or Delete rious Substances [Reserved] Subpart D—Naturally Occurring Posionous or Deleterious Sub stances [Reserved] PART 110—CURRENT GOOD MAN UFACTURING PRACTICE IN MAN UFACTURING, PACKING, OR HOLDING HUMAN FOOD Subpart A—General Provisions Sec. 110.3 Definitions. 110.5 Current good manufacturing practice. 110.10 Personnel. 110.19 Exclusions. Subpart B—Buildings and Facilities 110.20 Plant and grounds. 110.35 Sanitary operations. 110.37 Sanitary facilities and controls. Subpart C—Equipment 110.40 Equipment and utensils. Subpart D [Reserved] Subpart E—Production and Process Controls 110.80 Processes and controls. 110.93 Warehousing and distribution. Subpart F [Reserved] Subpart G—Defect Action Levels 110.110 Natural or unavoidable defects in food for human use that present no health hazard. AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264. SOURCE: 51 FR 24475, June 19, 1986, unless otherwise noted. Subpart A—General Provisions § 110.3 Definitions. The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. The following definitions shall also apply: (a) Acid foods or acidified foods means foods that have an equilibrium pH of 4.6 or below. (b) Adequate means that which is needed to accomplish the intended pur pose in keeping with good public health practice. (c) Batter means a semifluid sub stance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods. (d) Blanching, except for tree nuts and peanuts, means a prepackaging heat treatment of foodstuffs for a suffi cient time and at a sufficient tempera ture to partially or completely inac tivate the naturally occurring enzymes and to effect other physical or bio chemical changes in the food. (e) Critical control point means a point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decompo sition of the final food. (f) Food means food as defined in sec tion 201(f) of the act and includes raw materials and ingredients. (g) Food-contact surfaces are those surfaces that contact human food and those surfaces from which drainage onto the food or onto surfaces that contact the food ordinarily occurs dur ing the normal course of operations. ‘‘Food-contact surfaces’’ includes uten sils and food-contact surfaces of equip ment. (h) Lot means the food produced dur ing a period of time indicated by a spe cific code. (i) Microorganisms means yeasts, molds, bacteria, and viruses and in cludes, but is not limited to, species having public health significance. The term ‘‘undesirable microorganisms’’ in cludes those microorganisms that are of public health significance, that sub ject food to decomposition, that indi cate that food is contaminated with filth, or that otherwise may cause food to be adulterated within the meaning of the act. Occasionally in these regu lations, FDA used the adjective ‘‘mi crobial’’ instead of using an adjectival VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00226 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 217 Food and Drug Administration, HHS § 110.10 phrase containing the word microorga nism. (j) Pest refers to any objectionable animals or insects including, but not limited to, birds, rodents, flies, and lar vae. (k) Plant means the building or facil ity or parts thereof, used for or in con nection with the manufacturing, pack aging, labeling, or holding of human food. (l) Quality control operation means a planned and systematic procedure for taking all actions necessary to prevent food from being adulterated within the meaning of the act. (m) Rework means clean, unadulter ated food that has been removed from processing for reasons other than in sanitary conditions or that has been successfully reconditioned by reproc essing and that is suitable for use as food. (n) Safe-moisture level is a level of moisture low enough to prevent the growth of undesirable microorganisms in the finished product under the in tended conditions of manufacturing, storage, and distribution. The max imum safe moisture level for a food is based on its water activity (aw). An aw will be considered safe for a food if ade quate data are available that dem onstrate that the food at or below the given aw will not support the growth of undesirable microorganisms. (o) Sanitize means to adequately treat food-contact surfaces by a process that is effective in destroying vegetative cells of microorganisms of public health significance, and in substan tially reducing numbers of other unde sirable microorganisms, but without adversely affecting the product or its safety for the consumer. (p) Shall is used to state mandatory requirements. (q) Should is used to state rec ommended or advisory procedures or identify recommended equipment. (r) Water activity (aw) is a measure of the free moisture in a food and is the quotient of the water vapor pressure of the substance divided by the vapor pressure of pure water at the same temperature. § 110.5 Current good manufacturing practice. (a) The criteria and definitions in this part shall apply in determining whether a food is adulterated (1) within the meaning of section 402(a)(3) of the act in that the food has been manufac tured under such conditions that it is unfit for food; or (2) within the mean ing of section 402(a)(4) of the act in that the food has been prepared, packed, or held under insanitary condi tions whereby it may have become con taminated with filth, or whereby it may have been rendered injurious to health. The criteria and definitions in this part also apply in determining whether a food is in violation of sec tion 361 of the Public Health Service Act (42 U.S.C. 264). (b) Food covered by specific current good manufacturing practice regula tions also is subject to the require ments of those regulations. § 110.10 Personnel. The plant management shall take all reasonable measures and precautions to ensure the following: (a) Disease control. Any person who, by medical examination or supervisory observation, is shown to have, or ap pears to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food-contact surfaces, or food packaging materials becoming con taminated, shall be excluded from any operations which may be expected to result in such contamination until the condition is corrected. Personnel shall be instructed to report such health conditions to their supervisors. (b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienic practices while on duty to the extent necessary to protect against contamination of food. The methods for maintaining cleanliness include, but are not limited to: (1) Wearing outer garments suitable to the operation in a manner that pro tects against the contamination of food, food-contact surfaces, or food packaging materials. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00227 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 218 21 CFR Ch. I (4–1–11 Edition) § 110.19 (2) Maintaining adequate personal cleanliness. (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesir able microorganisms) in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when the hands may have become soiled or contaminated. (4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or containers, and re moving hand jewelry that cannot be adequately sanitized during periods in which food is manipulated by hand. If such hand jewelry cannot be removed, it may be covered by material which can be maintained in an intact, clean, and sanitary condition and which effec tively protects against the contamina tion by these objects of the food, food contact surfaces, or food-packaging materials. (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition. The gloves should be of an impermeable material. (6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers, or other effective hair restraints. (7) Storing clothing or other personal belongings in areas other than where food is exposed or where equipment or utensils are washed. (8) Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco. (9) Taking any other necessary pre cautions to protect against contamina tion of food, food-contact surfaces, or food-packaging materials with micro organisms or foreign substances includ ing, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin. (c) Education and training. Personnel responsible for identifying sanitation failures or food contamination should have a background of education or ex perience, or a combination thereof, to provide a level of competency nec essary for production of clean and safe food. Food handlers and supervisors should receive appropriate training in proper food handling techniques and food-protection principles and should be informed of the danger of poor per sonal hygiene and insanitary practices. (d) Supervision. Responsibility for as suring compliance by all personnel with all requirements of this part shall be clearly assigned to competent super visory personnel. [51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989] § 110.19 Exclusions. (a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, stor age, or distribution of one or more ‘‘raw agricultural commodities,’’ as de fined in section 201(r) of the act, which are ordinarily cleaned, prepared, treat ed, or otherwise processed before being marketed to the consuming public. (b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations. Subpart B—Buildings and Facilities § 110.20 Plant and grounds. (a) Grounds. The grounds about a food plant under the control of the operator shall be kept in a condition that will protect against the contamination of food. The methods for adequate main tenance of grounds include, but are not limited to: (1) Properly storing equipment, re moving litter and waste, and cutting weeds or grass within the immediate vicinity of the plant buildings or struc tures that may constitute an attract ant, breeding place, or harborage for pests. (2) Maintaining roads, yards, and parking lots so that they do not con stitute a source of contamination in areas where food is exposed. (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne filth, or pro viding a breeding place for pests. (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00228 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 219 Food and Drug Administration, HHS § 110.35 If the plant grounds are bordered by grounds not under the operator’s con trol and not maintained in the manner described in paragraph (a) (1) through (3) of this section, care shall be exer cised in the plant by inspection, exter mination, or other means to exclude pests, dirt, and filth that may be a source of food contamination. (b) Plant construction and design. Plant buildings and structures shall be suitable in size, construction, and de sign to facilitate maintenance and san itary operations for food-manufac turing purposes. The plant and facili ties shall: (1) Provide sufficient space for such placement of equipment and storage of materials as is necessary for the main tenance of sanitary operations and the production of safe food. (2) Permit the taking of proper pre cautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganisms, chemicals, filth, or other extraneous material. The po tential for contamination may be re duced by adequate food safety controls and operating practices or effective de sign, including the separation of oper ations in which contamination is likely to occur, by one or more of the fol lowing means: location, time, parti tion, air flow, enclosed systems, or other effective means. (3) Permit the taking of proper pre cautions to protect food in outdoor bulk fermentation vessels by any effec tive means, including: (i) Using protective coverings. (ii) Controlling areas over and around the vessels to eliminate harborages for pests. (iii) Checking on a regular basis for pests and pest infestation. (iv) Skimming the fermentation ves sels, as necessary. (4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned and kept clean and kept in good repair; that drip or con densate from fixtures, ducts and pipes does not contaminate food, food-con tact surfaces, or food-packaging mate rials; and that aisles or working spaces are provided between equipment and walls and are adequately unobstructed and of adequate width to permit em ployees to perform their duties and to protect against contaminating food or food-contact surfaces with clothing or personal contact. (5) Provide adequate lighting in hand-washing areas, dressing and lock er rooms, and toilet rooms and in all areas where food is examined, proc essed, or stored and where equipment or utensils are cleaned; and provide safety-type light bulbs, fixtures, sky lights, or other glass suspended over exposed food in any step of preparation or otherwise protect against food con tamination in case of glass breakage. (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including steam and nox ious fumes) in areas where they may contaminate food; and locate and oper ate fans and other air-blowing equip ment in a manner that minimizes the potential for contaminating food, food packaging materials, and food-contact surfaces. (7) Provide, where necessary, ade quate screening or other protection against pests. § 110.35 Sanitary operations. (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the mean ing of the act. Cleaning and sanitizing of utensils and equipment shall be con ducted in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials. (b) Substances used in cleaning and sanitizing; storage of toxic materials. (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be free from undesir able microorganisms and shall be safe and adequate under the conditions of use. Compliance with this requirement may be verified by any effective means including purchase of these substances under a supplier’s guarantee or certifi cation, or examination of these sub stances for contamination. Only the following toxic materials may be used or stored in a plant where food is proc essed or exposed: VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00229 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 220 21 CFR Ch. I (4–1–11 Edition) § 110.37 (i) Those required to maintain clean and sanitary conditions; (ii) Those necessary for use in labora tory testing procedures; (iii) Those necessary for plant and equipment maintenance and operation; and (iv) Those necessary for use in the plant’s operations. (2) Toxic cleaning compounds, sani tizing agents, and pesticide chemicals shall be identified, held, and stored in a manner that protects against contami nation of food, food-contact surfaces, or food-packaging materials. All rel evant regulations promulgated by other Federal, State, and local govern ment agencies for the application, use, or holding of these products should be followed. (c) Pest control. No pests shall be al lowed in any area of a food plant. Guard or guide dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in con tamination of food, food-contact sur faces, or food-packaging materials. Ef fective measures shall be taken to ex clude pests from the processing areas and to protect against the contamina tion of food on the premises by pests. The use of insecticides or rodenticides is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-pack aging materials. (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as fre quently as necessary to protect against contamination of food. (1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, sanitary condi tion at the time of use. When the sur faces are wet-cleaned, they shall, when necessary, be sanitized and thoroughly dried before subsequent use. (2) In wet processing, when cleaning is necessary to protect against the in troduction of microorganisms into food, all food-contact surfaces shall be cleaned and sanitized before use and after any interruption during which the food-contact surfaces may have be come contaminated. Where equipment and utensils are used in a continuous production operation, the utensils and food-contact surfaces of the equipment shall be cleaned and sanitized as nec essary. (3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned as fre quently as necessary to protect against contamination of food. (4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper towels) should be stored in appropriate containers and shall be handled, dispensed, used, and disposed of in a manner that protects against contamination of food or food contact surfaces. (5) Sanitizing agents shall be ade quate and safe under conditions of use. Any facility, procedure, or machine is acceptable for cleaning and sanitizing equipment and utensils if it is estab lished that the facility, procedure, or machine will routinely render equip ment and utensils clean and provide adequate cleaning and sanitizing treat ment. (e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized portable equipment with food-contact surfaces and utensils should be stored in a location and man ner that protects food-contact surfaces from contamination. [51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989] § 110.37 Sanitary facilities and con trols. Each plant shall be equipped with adequate sanitary facilities and accom modations including, but not limited to: (a) Water supply. The water supply shall be sufficient for the operations intended and shall be derived from an adequate source. Any water that con tacts food or food-contact surfaces shall be safe and of adequate sanitary quality. Running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. (b) Plumbing. Plumbing shall be of adequate size and design and ade quately installed and maintained to: VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00230 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 221 Food and Drug Administration, HHS § 110.40 (1) Carry sufficient quantities of water to required locations throughout the plant. (2) Properly convey sewage and liquid disposable waste from the plant. (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition. (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleaning or where normal operations release or discharge water or other liquid waste on the floor. (5) Provide that there is not backflow from, or cross-connection between, pip ing systems that discharge waste water or sewage and piping systems that carry water for food or food manufac turing. (c) Sewage disposal. Sewage disposal shall be made into an adequate sewer age system or disposed of through other adequate means. (d) Toilet facilities. Each plant shall provide its employees with adequate, readily accessible toilet facilities. Compliance with this requirement may be accomplished by: (1) Maintaining the facilities in a sanitary condition. (2) Keeping the facilities in good re pair at all times. (3) Providing self-closing doors. (4) Providing doors that do not open into areas where food is exposed to air borne contamination, except where al ternate means have been taken to pro tect against such contamination (such as double doors or positive air-flow sys tems). (e) Hand-washing facilities. Hand washing facilities shall be adequate and convenient and be furnished with running water at a suitable tempera ture. Compliance with this require ment may be accomplished by pro viding: (1) Hand-washing and, where appro priate, hand-sanitizing facilities at each location in the plant where good sanitary practices require employees to wash and/or sanitize their hands. (2) Effective hand-cleaning and sani tizing preparations. (3) Sanitary towel service or suitable drying devices. (4) Devices or fixtures, such as water control valves, so designed and con structed to protect against recontami nation of clean, sanitized hands. (5) Readily understandable signs di recting employees handling unproteced food, unprotected food-packaging ma terials, of food-contact surfaces to wash and, where appropriate, sanitize their hands before they start work, after each absence from post of duty, and when their hands may have become soiled or contaminated. These signs may be posted in the processing room(s) and in all other areas where employees may handle such food, ma terials, or surfaces. (6) Refuse receptacles that are con structed and maintained in a manner that protects against contamination of food. (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an at tractant and harborage or breeding place for pests, and protect against contamination of food, food-contact surfaces, water supplies, and ground surfaces. Subpart C—Equipment § 110.40 Equipment and utensils. (a) All plant equipment and utensils shall be so designed and of such mate rial and workmanship as to be ade quately cleanable, and shall be prop erly maintained. The design, construc tion, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other con taminants. All equipment should be so installed and maintained as to facili tate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and de signed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning com pounds and sanitizing agents. Food contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indi rect food additives. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00231 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 222 21 CFR Ch. I (4–1–11 Edition) § 110.80 (b) Seams on food-contact surfaces shall be smoothly bonded or main tained so as to minimize accumulation of food particles, dirt, and organic mat ter and thus minimize the opportunity for growth of microorganisms. (c) Equipment that is in the manu facturing or food-handling area and that does not come into contact with food shall be so constructed that it can be kept in a clean condition. (d) Holding, conveying, and manufac turing systems, including gravimetric, pneumatic, closed, and automated sys tems, shall be of a design and construc tion that enables them to be main tained in an appropriate sanitary con dition. (e) Each freezer and cold storage compartment used to store and hold food capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature measuring device, or temperature-re cording device so installed as to show the temperature accurately within the compartment, and should be fitted with an automatic control for regu lating temperature or with an auto matic alarm system to indicate a sig nificant temperature change in a man ual operation. (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activ ity, or other conditions that control or prevent the growth of undesirable microorganisms in food shall be accu rate and adequately maintained, and adequate in number for their des ignated uses. (g) Compressed air or other gases me chanically introduced into food or used to clean food-contact surfaces or equip ment shall be treated in such a way that food is not contaminated with un lawful indirect food additives. Subpart D [Reserved] Subpart E—Production and Process Controls § 110.80 Processes and controls. All operations in the receiving, in specting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles. Appropriate quality control operations shall be employed to ensure that food is suitable for human con sumption and that food-packaging ma terials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more com petent individuals assigned responsi bility for this function. All reasonable precautions shall be taken to ensure that production procedures do not con tribute contamination from any source. Chemical, microbial, or extra neous-material testing procedures shall be used where necessary to iden tify sanitation failures or possible food contamination. All food that has be come contaminated to the extent that it is adulterated within the meaning of the act shall be rejected, or if permis sible, treated or processed to eliminate the contamination. (a) Raw materials and other ingredi ents. (1) Raw materials and other ingre dients shall be inspected and seg regated or otherwise handled as nec essary to ascertain that they are clean and suitable for processing into food and shall be stored under conditions that will protect against contamina tion and minimize deterioration. Raw materials shall be washed or cleaned as necessary to remove soil or other con tamination. Water used for washing, rinsing, or conveying food shall be safe and of adequate sanitary quality. Water may be reused for washing, rins ing, or conveying food if it does not in crease the level of contamination of the food. Containers and carriers of raw materials should be inspected on receipt to ensure that their condition has not contributed to the contamina tion or deterioration of food. (2) Raw materials and other ingredi ents shall either not contain levels of microorganisms that may produce food poisoning or other disease in humans, or they shall be pasteurized or other wise treated during manufacturing op erations so that they no longer contain levels that would cause the product to be adulterated within the meaning of the act. Compliance with this require ment may be verified by any effective means, including purchasing raw mate rials and other ingredients under a sup plier’s guarantee or certification. VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00232 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 223 Food and Drug Administration, HHS § 110.80 (3) Raw materials and other ingredi ents susceptible to contamination with aflatoxin or other natural toxins shall comply with current Food and Drug Administration regulations and action levels for poisonous or deleterious sub stances before these materials or ingre dients are incorporated into finished food. Compliance with this require ment may be accomplished by pur chasing raw materials and other ingre dients under a supplier’s guarantee or certification, or may be verified by analyzing these materials and ingredi ents for aflatoxins and other natural toxins. (4) Raw materials, other ingredients, and rework susceptible to contamina tion with pests, undesirable microorga nisms, or extraneous material shall comply with applicable Food and Drug Administration regulations and defect action levels for natural or unavoidable defects if a manufacturer wishes to use the materials in manufacturing food. Compliance with this requirement may be verified by any effective means, in cluding purchasing the materials under a supplier’s guarantee or certification, or examination of these materials for contamination. (5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed and constructed so as to protect against contamination and shall be held at such temperature and relative humidity and in such a manner as to prevent the food from be coming adulterated within the mean ing of the act. Material scheduled for rework shall be identified as such. (6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior to use, it shall be done in a manner that pre vents the raw materials and other in gredients from becoming adulterated within the meaning of the act. (7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be held in a manner that protects against contamination. (b) Manufacturing operations. (1) Equipment and utensils and finished food containers shall be maintained in an acceptable condition through appro priate cleaning and sanitizing, as nec essary. Insofar as necessary, equipment shall be taken apart for thorough cleaning. (2) All food manufacturing, including packaging and storage, shall be con ducted under such conditions and con trols as are necessary to minimize the potential for the growth of microorga nisms, or for the contamination of food. One way to comply with this re quirement is careful monitoring of physical factors such as time, tempera ture, humidity, aw, pH, pressure, flow rate, and manufacturing operations such as freezing, dehydration, heat processing, acidification, and refrigera tion to ensure that mechanical break downs, time delays, temperature fluc tuations, and other factors do not con tribute to the decomposition or con tamination of food. (3) Food that can support the rapid growth of undesirable microorganisms, particularly those of public health sig nificance, shall be held in a manner that prevents the food from becoming adulterated within the meaning of the act. Compliance with this requirement may be accomplished by any effective means, including: (i) Maintaining refrigerated foods at 45 °F (7.2 °C) or below as appropriate for the particular food involved. (ii) Maintaining frozen foods in a fro zen state. (iii) Maintaining hot foods at 140 °F (60 °C) or above. (iv) Heat treating acid or acidified foods to destroy mesophilic microorga nisms when those foods are to be held in hermetically sealed containers at ambient temperatures. (4) Measures such as sterilizing, irra diating, pasteurizing, freezing, refrig erating, controlling pH or controlling aw that are taken to destroy or prevent the growth of undesirable microorga nisms, particularly those of public health significance, shall be adequate under the conditions of manufacture, handling, and distribution to prevent food from being adulterated within the meaning of the act. (5) Work-in-process shall be handled in a manner that protects against con tamination. (6) Effective measures shall be taken to protect finished food from contami nation by raw materials, other ingredi ents, or refuse. When raw materials, VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00233 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 224 21 CFR Ch. I (4–1–11 Edition) § 110.80 other ingredients, or refuse are unpro tected, they shall not be handled si multaneously in a receiving, loading, or shipping area if that handling could result in contaminated food. Food transported by conveyor shall be pro tected against contamination as nec essary. (7) Equipment, containers, and uten sils used to convey, hold, or store raw materials, work-in-process, rework, or food shall be constructed, handled, and maintained during manufacturing or storage in a manner that protects against contamination. (8) Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food. Compliance with this require ment may be accomplished by using sieves, traps, magnets, electronic metal detectors, or other suitable ef fective means. (9) Food, raw materials, and other in gredients that are adulterated within the meaning of the act shall be dis posed of in a manner that protects against the contamination of other food. If the adulterated food is capable of being reconditioned, it shall be re conditioned using a method that has been proven to be effective or it shall be reexamined and found not to be adulterated within the meaning of the act before being incorporated into other food. (10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mash ing, dewatering, cooling, shredding, ex truding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from con taminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufac turing step. (11) Heat blanching, when required in the preparation of food, should be ef fected by heating the food to the re quired temperature, holding it at this temperature for the required time, and then either rapidly cooling the food or passing it to subsequent manufacturing without delay. Thermophilic growth and contamination in blanchers should be minimized by the use of adequate operating temperatures and by periodic cleaning. Where the blanched food is washed prior to filling, water used shall be safe and of adequate sanitary quality. (12) Batters, breading, sauces, gra vies, dressings, and other similar prep arations shall be treated or maintained in such a manner that they are pro tected against contamination. Compli ance with this requirement may be ac complished by any effective means, in cluding one or more of the following: (i) Using ingredients free of contami nation. (ii) Employing adequate heat proc esses where applicable. (iii) Using adequate time and tem perature controls. (iv) Providing adequate physical pro tection of components from contami nants that may drip, drain, or be drawn into them. (v) Cooling to an adequate tempera ture during manufacturing. (vi) Disposing of batters at appro priate intervals to protect against the growth of microorganisms. (13) Filling, assembling, packaging, and other operations shall be per formed in such a way that the food is protected against contamination. Com pliance with this requirement may be accomplished by any effective means, including: (i) Use of a quality control operation in which the critical control points are identified and controlled during manu facturing. (ii) Adequate cleaning and sanitizing of all food-contact surfaces and food containers. (iii) Using materials for food con tainers and food- packaging materials that are safe and suitable, as defined in § 130.3(d) of this chapter. (iv) Providing physical protection from contamination, particularly air borne contamination. (v) Using sanitary handling proce dures. (14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies on the control of aw for preventing the VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00234 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 225 Food and Drug Administration, HHS § 110.110 growth of undesirable microorganisms shall be processed to and maintained at a safe moisture level. Compliance with this requirement may be accomplished by any effective means, including em ployment of one or more of the fol lowing practices: (i) Monitoring the aw of food. (ii) Controlling the soluble solids water ratio in finished food. (iii) Protecting finished food from moisture pickup, by use of a moisture barrier or by other means, so that the aw of the food does not increase to an unsafe level. (15) Food such as, but not limited to, acid and acidified food, that relies prin cipally on the control of pH for pre venting the growth of undesirable microorganisms shall be monitored and maintained at a pH of 4.6 or below. Compliance with this requirement may be accomplished by any effective means, including employment of one or more of the following practices: (i) Monitoring the pH of raw mate rials, food in process, and finished food. (ii) Controlling the amount of acid or acidified food added to low-acid food. (16) When ice is used in contact with food, it shall be made from water that is safe and of adequate sanitary qual ity, and shall be used only if it has been manufactured in accordance with current good manufacturing practice as outlined in this part. (17) Food-manufacturing areas and equipment used for manufacturing human food should not be used to man ufacture nonhuman food-grade animal feed or inedible products, unless there is no reasonable possibility for the con tamination of the human food. [51 FR 24475, June 19, 1986, as amended at 65 FR 56479, Sept. 19, 2000] § 110.93 Warehousing and distribution. Storage and transportation of fin ished food shall be under conditions that will protect food against physical, chemical, and microbial contamination as well as against deterioration of the food and the container. Subpart F [Reserved] Subpart G—Defect Action Levels § 110.110 Natural or unavoidable de fects in food for human use that present no health hazard. (a) Some foods, even when produced under current good manufacturing practice, contain natural or unavoid able defects that at low levels are not hazardous to health. The Food and Drug Administration establishes max imum levels for these defects in foods produced under current good manufac turing practice and uses these levels in deciding whether to recommend regu latory action. (b) Defect action levels are estab lished for foods whenever it is nec essary and feasible to do so. These lev els are subject to change upon the de velopment of new technology or the availability of new information. (c) Compliance with defect action levels does not excuse violation of the requirement in section 402(a)(4) of the act that food not be prepared, packed, or held under unsanitary conditions or the requirements in this part that food manufacturers, distributors, and hold ers shall observe current good manu facturing practice. Evidence indicating that such a violation exists causes the food to be adulterated within the meaning of the act, even though the amounts of natural or unavoidable de fects are lower than the currently es tablished defect action levels. The manufacturer, distributor, and holder of food shall at all times utilize quality control operations that reduce natural or unavoidable defects to the lowest level currently feasible. (d) The mixing of a food containing defects above the current defect action level with another lot of food is not permitted and renders the final food adulterated within the meaning of the act, regardless of the defect level of the final food. (e) A compilation of the current de fect action levels for natural or un avoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00235 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R 226 21 CFR Ch. I (4–1–11 Edition) Pt. 111 (HFS–565), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, MD 20740. [51 FR 24475, June 19, 1986, as amended at 61 FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] PART 111—CURRENT GOOD MAN UFACTURING PRACTICE IN MAN UFACTURING, PACKAGING, LA BELING, OR HOLDING OPER ATIONS FOR DIETARY SUPPLE MENTS Subpart A—General Provisions Sec. 111.1 Who is subject to this part? 111.3 What definitions apply to this part? 111.5 Do other statutory provisions and reg ulations apply? Subpart B—Personnel 111.8 What are the requirements under this subpart B for written procedures? 111.10 What requirements apply for pre venting microbial contamination from sick or infected personnel and for hygien ic practices? 111.12 What personnel qualification require ments apply? 111.13 What supervisor requirements apply? 111.14 Under this subpart B, what records must you make and keep? Subpart C—Physical Plant and Grounds 111.15 What sanitation requirements apply to your physical plant and grounds? 111.16 What are the requirements under this subpart C for written procedures? 111.20 What design and construction re quirements apply to your physical plant? 111.23 Under this subpart C, what records must you make and keep? Subpart D—Equipment and Utensils 111.25 What are the requirements under this subpart D for written procedures? 111.27 What requirements apply to the equipment and utensils that you use? 111.30 What requirements apply to auto mated, mechanical, or electronic equip ment? 111.35 Under this subpart D, what records must you make and keep? Subpart E—Requirement to Establish a Production and Process Control System 111.55 What are the requirements to imple ment a production and process control system? 111.60 What are the design requirements for the production and process control sys tem? 111.65 What are the requirements for qual ity control operations? 111.70 What specifications must you estab lish? 111.73 What is your responsibility for deter mining whether established specifica tions are met? 111.75 What must you do to determine whether specifications are met? 111.77 What must you do if established spec ifications are not met? 111.80 What representative samples must you collect? 111.83 What are the requirements for re serve samples? 111.87 Who conducts a material review and makes a disposition decision? 111.90 What requirements apply to treat ments, in-process adjustments, and re processing when there is a deviation or unanticipated occurrence or when a spec ification established in accordance with § 111.70 is not met? 111.95 Under this subpart E, what records must you make and keep? Subpart F—Production and Process Control System: Requirements for Quality Control 111.103 What are the requirements under this subpart F for written procedures? 111.105 What must quality control personnel do? 111.110 What quality control operations are required for laboratory operations asso ciated with the production and process control system? 111.113 What quality control operations are required for a material review and dis position decision? 111.117 What quality control operations are required for equipment, instruments, and controls? 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement? 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations? 111.127 What quality control operations are required for packaging and labeling oper ations? 111.130 What quality control operations are required for returned dietary supple ments? 111.135 What quality control operations are required for product complaints? VerDate Mar<15>2010 13:44 Apr 26, 2011 Jkt 223066 PO 00000 Frm 00236 Fmt 8010 Sfmt 8010 Y:\SGML\223066.XXX 223066W R e ie r A vi le s o n D S K G B L S 3 C 1 P R O D w ith C F R