and Drug Administration, HHS § 110.3

level of PCB’s as adulterated in violation of in this part. The following definitions sec. 402 of the act. shall also apply: (a) Acid or acidified foods means Subpart C—Regulatory Limits for foods that have an equilibrium pH of Added Poisonous or Delete- 4.6 or below. rious Substances [Reserved] (b) Adequate means that which is needed to accomplish the intended pur- Subpart D—Naturally Occurring pose in keeping with good public health Posionous or Deleterious Sub- practice. stances [Reserved] (c) Batter means a semifluid sub- stance, usually composed of flour and other ingredients, into which principal PART 110—CURRENT GOOD MAN- components of food are dipped or with UFACTURING PRACTICE IN MAN- which they are coated, or which may UFACTURING, PACKING, OR be used directly to form bakery foods. HOLDING HUMAN FOOD (d) Blanching, except for tree nuts and peanuts, means a prepackaging Subpart A—General Provisions heat treatment of foodstuffs for a suffi- Sec. cient time and at a sufficient tempera- 110.3 Definitions. ture to partially or completely inac- 110.5 Current good manufacturing practice. tivate the naturally occurring enzymes 110.10 Personnel. and to effect other physical or bio- 110.19 Exclusions. chemical changes in the food. (e) means a point Subpart B—Buildings and Facilities in a food process where there is a high 110.20 Plant and grounds. probability that improper control may 110.35 Sanitary operations. cause, allow, or contribute to a hazard 110.37 Sanitary facilities and controls. or to filth in the final food or decompo- sition of the final food. Subpart C—Equipment (f) Food means food as defined in sec- 110.40 Equipment and utensils. tion 201(f) of the act and includes raw materials and ingredients. Subpart D [Reserved] (g) Food-contact surfaces are those surfaces that contact human food and Subpart E—Production and Process those surfaces from which drainage Controls onto the food or onto surfaces that contact the food ordinarily occurs dur- 110.80 Processes and controls. 110.93 Warehousing and distribution. ing the normal course of operations. ‘‘Food-contact surfaces’’ includes uten- Subpart F [Reserved] sils and food-contact surfaces of equip- ment. Subpart G—Defect Action Levels (h) Lot means the food produced dur- ing a period of time indicated by a spe- 110.110 Natural or unavoidable defects in food for human use that present no cific code. health hazard. (i) means yeasts, molds, bacteria, and viruses and in- AUTHORITY: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264. cludes, but is not limited to, species having public health significance. The SOURCE: 51 FR 22475, June 19, 1986, unless term ‘‘undesirable microorganisms’’ in- otherwise noted. cludes those microorganisms that are of public health significance, that sub- Subpart A—General Provisions ject food to decomposition, that indi- cate that food is contaminated with § 110.3 Definitions. filth, or that otherwise may cause food The definitions and interpretations to be adulterated within the meaning of terms in section 201 of the Federal of the act. Occasionally in these regu- Food, Drug, and Cosmetic Act (the act) lations, FDA used the adjective ‘‘mi- are applicable to such terms when used crobial’’ instead of using an adjectival

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phrase containing the word microorga- § 110.5 Current good manufacturing nism. practice. (j) Pest refers to any objectionable (a) The criteria and definitions in animals or insects including, but not this part shall apply in determining limited to, birds, rodents, flies, and lar- whether a food is adulterated (1) within vae. the meaning of section 402(a)(3) of the (k) Plant means the building or facil- act in that the food has been manufac- ity or parts thereof, used for or in con- tured under such conditions that it is nection with the manufacturing, pack- unfit for food; or (2) within the mean- aging, labeling, or holding of human ing of section 402(a)(4) of the act in food. that the food has been prepared, (l) Quality control operation means a packed, or held under insanitary condi- tions whereby it may have become con- planned and systematic procedure for taminated with filth, or whereby it taking all actions necessary to prevent may have been rendered injurious to food from being adulterated within the health. The criteria and definitions in meaning of the act. this part also apply in determining (m) Rework means clean, unadulter- whether a food is in violation of sec- ated food that has been removed from tion 361 of the Public Health Service processing for reasons other than in- Act (42 U.S.C. 264). sanitary conditions or that has been (b) Food covered by specific current successfully reconditioned by reproc- good manufacturing practice regula- essing and that is suitable for use as tions also is subject to the require- food. ments of those regulations. (n) Safe-moisture level is a level of moisture low enough to prevent the § 110.10 Personnel. growth of undesirable microorganisms The plant management shall take all in the finished product under the in- reasonable measures and precautions tended conditions of manufacturing, to ensure the following: storage, and distribution. The max- (a) Disease control. Any person who, imum safe moisture level for a food is by medical examination or supervisory observation, is shown to have, or ap- based on its water activity (a ). An a w w pears to have, an illness, open lesion, will be considered safe for a food if ade- including boils, sores, or infected quate data are available that dem- wounds, or any other abnormal source onstrate that the food at or below the of microbial contamination by which given aw will not support the growth of there is a reasonable possibility of undesirable microorganisms. food, food-contact surfaces, or food- (o) Sanitize means to adequately treat packaging materials becoming con- food-contact surfaces by a process that taminated, shall be excluded from any is effective in destroying vegetative operations which may be expected to cells of microorganisms of public result in such contamination until the health significance, and in substan- condition is corrected. Personnel shall tially reducing numbers of other unde- be instructed to report such health sirable microorganisms, but without conditions to their supervisors. adversely affecting the product or its (b) Cleanliness. All persons working in safety for the consumer. direct contact with food, food-contact (p) Shall is used to state mandatory surfaces, and food-packaging materials requirements. shall conform to hygienic practices (q) Should is used to state rec- while on duty to the extent necessary to protect against contamination of ommended or advisory procedures or food. The methods for maintaining identify recommended equipment. cleanliness include, but are not limited (r) Water activity (aw) is a measure of to: the free moisture in a food and is the (1) Wearing outer garments suitable quotient of the water of to the operation in a manner that pro- the substance divided by the vapor tects against the contamination of pressure of pure water at the same food, food-contact surfaces, or food- temperature. packaging materials.

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(2) Maintaining adequate personal should receive appropriate training in cleanliness. proper food handling techniques and (3) Washing hands thoroughly (and food-protection principles and should sanitizing if necessary to protect be informed of the danger of poor per- against contamination with undesir- sonal hygiene and insanitary practices. able microorganisms) in an adequate (d) Supervision. Responsibility for as- hand-washing facility before starting suring compliance by all personnel work, after each absence from the work with all requirements of this part shall station, and at any other time when be clearly assigned to competent super- the hands may have become soiled or visory personnel. contaminated. (4) Removing all unsecured jewelry [51 FR 22475, June 19, 1986, as amended at 54 and other objects that might fall into FR 24892, June 12, 1989] food, equipment, or containers, and re- § 110.19 Exclusions. moving hand jewelry that cannot be adequately sanitized during periods in (a) The following operations are not which food is manipulated by hand. If subject to this part: Establishments such hand jewelry cannot be removed, engaged solely in the harvesting, stor- it may be covered by material which age, or distribution of one or more can be maintained in an intact, clean, ‘‘raw agricultural commodities,’’ as de- and sanitary condition and which effec- fined in section 201(r) of the act, which tively protects against the contamina- are ordinarily cleaned, prepared, treat- tion by these objects of the food, food- ed, or otherwise processed before being contact surfaces, or food-packaging marketed to the consuming public. materials. (b) FDA, however, will issue special (5) Maintaining gloves, if they are regulations if it is necessary to cover used in food handling, in an intact, these excluded operations. clean, and sanitary condition. The gloves should be of an impermeable Subpart B—Buildings and Facilities material. (6) Wearing, where appropriate, in an § 110.20 Plant and grounds. effective manner, hair nets, headbands, caps, beard covers, or other effective (a) Grounds. The grounds about a food hair restraints. plant under the control of the operator (7) Storing clothing or other personal shall be kept in a condition that will belongings in areas other than where protect against the contamination of food is exposed or where equipment or food. The methods for adequate main- utensils are washed. tenance of grounds include, but are not (8) Confining the following to areas limited to: other than where food may be exposed (1) Properly storing equipment, re- or where equipment or utensils are moving litter and waste, and cutting washed: eating food, chewing gum, weeds or grass within the immediate drinking beverages, or using tobacco. vicinity of the plant buildings or struc- (9) Taking any other necessary pre- tures that may constitute an attract- cautions to protect against contamina- ant, breeding place, or harborage for tion of food, food-contact surfaces, or pests. food-packaging materials with micro- (2) Maintaining roads, yards, and organisms or foreign substances includ- parking lots so that they do not con- ing, but not limited to, perspiration, stitute a source of contamination in hair, cosmetics, tobacco, chemicals, areas where food is exposed. and medicines applied to the skin. (3) Adequately draining areas that (c) Education and training. Personnel may contribute contamination to food responsible for identifying sanitation by seepage, foot-borne filth, or pro- failures or food contamination should viding a breeding place for pests. have a background of education or ex- (4) Operating systems for waste perience, or a combination thereof, to treatment and disposal in an adequate provide a level of competency nec- manner so that they do not constitute essary for production of clean and safe a source of contamination in areas food. Food handlers and supervisors where food is exposed.

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If the plant grounds are bordered by ployees to perform their duties and to grounds not under the operator’s con- protect against contaminating food or trol and not maintained in the manner food-contact surfaces with clothing or described in paragraph (a) (1) through personal contact. (3) of this section, care shall be exer- (5) Provide adequate lighting in cised in the plant by inspection, exter- hand-washing areas, dressing and lock- mination, or other means to exclude er rooms, and toilet rooms and in all pests, dirt, and filth that may be a areas where food is examined, proc- source of food contamination. essed, or stored and where equipment (b) Plant construction and design. or utensils are cleaned; and provide Plant buildings and structures shall be safety-type light bulbs, fixtures, sky- suitable in size, construction, and de- lights, or other glass suspended over sign to facilitate maintenance and san- exposed food in any step of preparation itary operations for food-manufac- or otherwise protect against food con- turing purposes. The plant and facili- tamination in case of glass breakage. ties shall: (6) Provide adequate ventilation or (1) Provide sufficient space for such control equipment to minimize odors placement of equipment and storage of and vapors (including steam and nox- materials as is necessary for the main- ious fumes) in areas where they may tenance of sanitary operations and the contaminate food; and locate and oper- production of safe food. ate fans and other air-blowing equip- (2) Permit the taking of proper pre- ment in a manner that minimizes the cautions to reduce the potential for potential for contaminating food, food- contamination of food, food-contact packaging materials, and food-contact surfaces, or food-packaging materials surfaces. with microorganisms, chemicals, filth, (7) Provide, where necessary, ade- or other extraneous material. The po- quate screening or other protection tential for contamination may be re- against pests. duced by adequate controls and operating practices or effective de- § 110.35 Sanitary operations. sign, including the separation of oper- ations in which contamination is likely (a) General maintenance. Buildings, to occur, by one or more of the fol- fixtures, and other physical facilities lowing means: location, time, parti- of the plant shall be maintained in a tion, air flow, enclosed systems, or sanitary condition and shall be kept in other effective means. repair sufficient to prevent food from (3) Permit the taking of proper pre- becoming adulterated within the mean- cautions to protect food in outdoor ing of the act. Cleaning and sanitizing bulk fermentation vessels by any effec- of utensils and equipment shall be con- tive means, including: ducted in a manner that protects (i) Using protective coverings. against contamination of food, food- (ii) Controlling areas over and around contact surfaces, or food-packaging the vessels to eliminate harborages for materials. pests. (b) Substances used in cleaning and (iii) Checking on a regular basis for sanitizing; storage of toxic materials. (1) pests and pest infestation. Cleaning compounds and sanitizing (iv) Skimming the fermentation ves- agents used in cleaning and sanitizing sels, as necessary. procedures shall be free from undesir- (4) Be constructed in such a manner able microorganisms and shall be safe that floors, walls, and ceilings may be and adequate under the conditions of adequately cleaned and kept clean and use. Compliance with this requirement kept in good repair; that drip or con- may be verified by any effective means densate from fixtures, ducts and pipes including purchase of these substances does not contaminate food, food-con- under a supplier’s guarantee or certifi- tact surfaces, or food-packaging mate- cation, or examination of these sub- rials; and that aisles or working spaces stances for contamination. Only the are provided between equipment and following toxic materials may be used walls and are adequately unobstructed or stored in a plant where food is proc- and of adequate width to permit em- essed or exposed:

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(i) Those required to maintain clean production operation, the utensils and and sanitary conditions; food-contact surfaces of the equipment (ii) Those necessary for use in labora- shall be cleaned and sanitized as nec- tory testing procedures; essary. (iii) Those necessary for plant and (3) Non-food-contact surfaces of equipment maintenance and operation; equipment used in the operation of and food plants should be cleaned as fre- (iv) Those necessary for use in the quently as necessary to protect against plant’s operations. contamination of food. (2) Toxic cleaning compounds, sani- (4) Single-service articles (such as tizing agents, and pesticide chemicals utensils intended for one-time use, shall be identified, held, and stored in a paper cups, and paper towels) should be manner that protects against contami- stored in appropriate containers and nation of food, food-contact surfaces, shall be handled, dispensed, used, and or food-packaging materials. All rel- disposed of in a manner that protects evant regulations promulgated by against contamination of food or food- other Federal, State, and local govern- contact surfaces. ment agencies for the application, use, (5) Sanitizing agents shall be ade- or holding of these products should be quate and safe under conditions of use. followed. Any facility, procedure, or machine is (c) Pest control. No pests shall be al- acceptable for cleaning and sanitizing lowed in any area of a food plant. equipment and utensils if it is estab- Guard or guide dogs may be allowed in lished that the facility, procedure, or some areas of a plant if the presence of machine will routinely render equip- the dogs is unlikely to result in con- ment and utensils clean and provide tamination of food, food-contact sur- adequate cleaning and sanitizing treat- faces, or food-packaging materials. Ef- ment. fective measures shall be taken to ex- (e) Storage and handling of cleaned clude pests from the processing areas portable equipment and utensils. Cleaned and to protect against the contamina- and sanitized portable equipment with tion of food on the premises by pests. food-contact surfaces and utensils The use of insecticides or rodenticides should be stored in a location and man- is permitted only under precautions ner that protects food-contact surfaces and restrictions that will protect from contamination. against the contamination of food, [51 FR 22475, June 19, 1986, as amended at 54 food-contact surfaces, and food-pack- FR 24892, June 12, 1989] aging materials. (d) Sanitation of food-contact surfaces. § 110.37 Sanitary facilities and con- All food-contact surfaces, including trols. utensils and food-contact surfaces of Each plant shall be equipped with equipment, shall be cleaned as fre- adequate sanitary facilities and accom- quently as necessary to protect against modations including, but not limited contamination of food. to: (1) Food-contact surfaces used for (a) Water supply. The water supply manufacturing or holding low-moisture shall be sufficient for the operations food shall be in a dry, sanitary condi- intended and shall be derived from an tion at the time of use. When the sur- adequate source. Any water that con- faces are wet-cleaned, they shall, when tacts food or food-contact surfaces necessary, be sanitized and thoroughly shall be safe and of adequate sanitary dried before subsequent use. quality. Running water at a suitable (2) In wet processing, when cleaning temperature, and under pressure as is necessary to protect against the in- needed, shall be provided in all areas troduction of microorganisms into where required for the processing of food, all food-contact surfaces shall be food, for the cleaning of equipment, cleaned and sanitized before use and utensils, and food-packaging materials, after any interruption during which or for employee sanitary facilities. the food-contact surfaces may have be- (b) Plumbing. Plumbing shall be of come contaminated. Where equipment adequate size and design and ade- and utensils are used in a continuous quately installed and maintained to:

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(1) Carry sufficient quantities of structed to protect against recontami- water to required locations throughout nation of clean, sanitized hands. the plant. (5) Readily understandable signs di- (2) Properly convey sewage and liquid recting employees handling unproteced disposable waste from the plant. food, unprotected food-packaging ma- (3) Avoid constituting a source of terials, of food-contact surfaces to contamination to food, water supplies, wash and, where appropriate, sanitize equipment, or utensils or creating an their hands before they start work, unsanitary condition. after each absence from post of duty, (4) Provide adequate floor drainage in and when their hands may have become all areas where floors are subject to soiled or contaminated. These signs flooding-type cleaning or where normal may be posted in the processing operations release or discharge water room(s) and in all other areas where or other liquid waste on the floor. employees may handle such food, ma- (5) Provide that there is not backflow terials, or surfaces. from, or cross-connection between, pip- (6) Refuse receptacles that are con- ing systems that discharge waste water or sewage and piping systems that structed and maintained in a manner carry water for food or food manufac- that protects against contamination of turing. food. (c) Sewage disposal. Sewage disposal (f) Rubbish and offal disposal. Rubbish shall be made into an adequate sewer- and any offal shall be so conveyed, age system or disposed of through stored, and disposed of as to minimize other adequate means. the development of odor, minimize the (d) Toilet facilities. Each plant shall potential for the waste becoming an at- provide its employees with adequate, tractant and harborage or breeding readily accessible toilet facilities. place for pests, and protect against Compliance with this requirement may contamination of food, food-contact be accomplished by: surfaces, water supplies, and ground (1) Maintaining the facilities in a surfaces. sanitary condition. (2) Keeping the facilities in good re- Subpart C—Equipment pair at all times. (3) Providing self-closing doors. § 110.40 Equipment and utensils. (4) Providing doors that do not open (a) All plant equipment and utensils into areas where food is exposed to air- shall be so designed and of such mate- borne contamination, except where al- rial and workmanship as to be ade- ternate means have been taken to pro- quately cleanable, and shall be prop- tect against such contamination (such as double doors or positive air-flow sys- erly maintained. The design, construc- tems). tion, and use of equipment and utensils (e) Hand-washing facilities. Hand- shall preclude the adulteration of food washing facilities shall be adequate with lubricants, fuel, metal fragments, and convenient and be furnished with contaminated water, or any other con- running water at a suitable tempera- taminants. All equipment should be so ture. Compliance with this require- installed and maintained as to facili- ment may be accomplished by pro- tate the cleaning of the equipment and viding: of all adjacent spaces. Food-contact (1) Hand-washing and, where appro- surfaces shall be corrosion-resistant priate, hand-sanitizing facilities at when in contact with food. They shall each location in the plant where good be made of nontoxic materials and de- sanitary practices require employees signed to withstand the environment of to wash and/or sanitize their hands. their intended use and the action of (2) Effective hand-cleaning and sani- food, and, if applicable, cleaning com- tizing preparations. pounds and sanitizing agents. Food- (3) Sanitary towel service or suitable contact surfaces shall be maintained to drying devices. protect food from being contaminated (4) Devices or fixtures, such as water by any source, including unlawful indi- control valves, so designed and con- rect food additives.

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(b) Seams on food-contact surfaces principles. Appropriate quality control shall be smoothly bonded or main- operations shall be employed to ensure tained so as to minimize accumulation that food is suitable for human con- of food particles, dirt, and organic mat- sumption and that food-packaging ma- ter and thus minimize the opportunity terials are safe and suitable. Overall for growth of microorganisms. sanitation of the plant shall be under (c) Equipment that is in the manu- the supervision of one or more com- facturing or food-handling area and petent individuals assigned responsi- that does not come into contact with bility for this function. All reasonable food shall be so constructed that it can precautions shall be taken to ensure be kept in a clean condition. that production procedures do not con- (d) Holding, conveying, and manufac- tribute contamination from any turing systems, including gravimetric, source. Chemical, microbial, or extra- pneumatic, closed, and automated sys- neous-material testing procedures tems, shall be of a design and construc- shall be used where necessary to iden- tion that enables them to be main- tify sanitation failures or possible food tained in an appropriate sanitary con- dition. contamination. All food that has be- (e) Each freezer and cold storage come contaminated to the extent that compartment used to store and hold it is adulterated within the meaning of food capable of supporting growth of the act shall be rejected, or if permis- microorganisms shall be fitted with an sible, treated or processed to eliminate indicating thermometer, temperature- the contamination. measuring device, or temperature-re- (a) Raw materials and other ingredi- cording device so installed as to show ents. (1) Raw materials and other ingre- the temperature accurately within the dients shall be inspected and seg- compartment, and should be fitted regated or otherwise handled as nec- with an automatic control for regu- essary to ascertain that they are clean lating temperature or with an auto- and suitable for processing into food matic alarm system to indicate a sig- and shall be stored under conditions nificant temperature change in a man- that will protect against contamina- ual operation. tion and minimize deterioration. Raw (f) Instruments and controls used for materials shall be washed or cleaned as measuring, regulating, or recording necessary to remove soil or other con- temperatures, pH, acidity, water activ- tamination. Water used for washing, ity, or other conditions that control or rinsing, or conveying food shall be safe prevent the growth of undesirable and of adequate sanitary quality. microorganisms in food shall be accu- Water may be reused for washing, rins- rate and adequately maintained, and ing, or conveying food if it does not in- adequate in number for their des- crease the level of contamination of ignated uses. the food. Containers and carriers of (g) Compressed air or other gases me- raw materials should be inspected on chanically introduced into food or used receipt to ensure that their condition to clean food-contact surfaces or equip- has not contributed to the contamina- ment shall be treated in such a way tion or deterioration of food. that food is not contaminated with un- (2) Raw materials and other ingredi- lawful indirect food additives. ents shall either not contain levels of microorganisms that may produce food Subpart D [Reserved] poisoning or other disease in humans, or they shall be pasteurized or other- Subpart E—Production and wise treated during manufacturing op- Process Controls erations so that they no longer contain levels that would cause the product to § 110.80 Processes and controls. be adulterated within the meaning of All operations in the receiving, in- the act. Compliance with this require- specting, transporting, segregating, ment may be verified by any effective preparing, manufacturing, packaging, means, including purchasing raw mate- and storing of food shall be conducted rials and other ingredients under a sup- in accordance with adequate sanitation plier’s guarantee or certification.

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(3) Raw materials and other ingredi- shall be taken apart for thorough ents susceptible to contamination with cleaning. aflatoxin or other natural toxins shall (2) All food manufacturing, including comply with current Food and Drug packaging and storage, shall be con- Administration regulations and action ducted under such conditions and con- levels for poisonous or deleterious sub- trols as are necessary to minimize the stances before these materials or ingre- potential for the growth of microorga- dients are incorporated into finished nisms, or for the contamination of food. Compliance with this require- food. One way to comply with this re- ment may be accomplished by pur- quirement is careful monitoring of chasing raw materials and other ingre- physical factors such as time, tempera- dients under a supplier’s guarantee or ture, , aw, pH, pressure, flow certification, or may be verified by rate, and manufacturing operations analyzing these materials and ingredi- such as freezing, dehydration, heat ents for aflatoxins and other natural processing, acidification, and refrigera- toxins. tion to ensure that mechanical break- (4) Raw materials, other ingredients, downs, time delays, temperature fluc- and rework susceptible to contamina- tuations, and other factors do not con- tion with pests, undesirable microorga- tribute to the decomposition or con- nisms, or extraneous material shall tamination of food. comply with applicable Food and Drug (3) Food that can support the rapid Administration regulations and defect growth of undesirable microorganisms, action levels for natural or unavoidable particularly those of public health sig- defects if a manufacturer wishes to use nificance, shall be held in a manner the materials in manufacturing food. that prevents the food from becoming Compliance with this requirement may adulterated within the meaning of the be verified by any effective means, in- act. Compliance with this requirement cluding purchasing the materials under may be accomplished by any effective a supplier’s guarantee or certification, means, including: or examination of these materials for (i) Maintaining refrigerated foods at ° ° contamination. 45 F (7.2 C) or below as appropriate for the particular food involved. (5) Raw materials, other ingredients, (ii) Maintaining frozen foods in a fro- and rework shall be held in bulk, or in zen state. containers designed and constructed so (iii) Maintaining hot foods at 140 °F as to protect against contamination (60 °C) or above. and shall be held at such temperature (iv) Heat treating acid or acidified and relative humidity and in such a foods to destroy mesophilic microorga- manner as to prevent the food from be- nisms when those foods are to be held coming adulterated within the mean- in hermetically sealed containers at ing of the act. Material scheduled for ambient temperatures. rework shall be identified as such. (4) Measures such as sterilizing, irra- (6) Frozen raw materials and other diating, pasteurizing, freezing, refrig- ingredients shall be kept frozen. If erating, controlling pH or controlling thawing is required prior to use, it aw that are taken to destroy or prevent shall be done in a manner that pre- the growth of undesirable microorga- vents the raw materials and other in- nisms, particularly those of public gredients from becoming adulterated health significance, shall be adequate within the meaning of the act. under the conditions of manufacture, (7) Liquid or dry raw materials and handling, and distribution to prevent other ingredients received and stored food from being adulterated within the in bulk form shall be held in a manner meaning of the act. that protects against contamination. (5) Work-in-process shall be handled (b) Manufacturing operations. (1) in a manner that protects against con- Equipment and utensils and finished tamination. food containers shall be maintained in (6) Effective measures shall be taken an acceptable condition through appro- to protect finished food from contami- priate cleaning and sanitizing, as nec- nation by raw materials, other ingredi- essary. Insofar as necessary, equipment ents, or refuse. When raw materials,

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other ingredients, or refuse are unpro- passing it to subsequent manufacturing tected, they shall not be handled si- without delay. Thermophilic growth multaneously in a receiving, loading, and contamination in blanchers should or shipping area if that handling could be minimized by the use of adequate result in contaminated food. Food operating temperatures and by periodic transported by conveyor shall be pro- cleaning. Where the blanched food is tected against contamination as nec- washed prior to filling, water used essary. shall be safe and of adequate sanitary (7) Equipment, containers, and uten- quality. sils used to convey, hold, or store raw (12) Batters, breading, sauces, gra- materials, work-in-process, rework, or vies, dressings, and other similar prep- food shall be constructed, handled, and arations shall be treated or maintained maintained during manufacturing or in such a manner that they are pro- storage in a manner that protects tected against contamination. Compli- against contamination. ance with this requirement may be ac- (8) Effective measures shall be taken complished by any effective means, in- to protect against the inclusion of cluding one or more of the following: metal or other extraneous material in (i) Using ingredients free of contami- food. Compliance with this require- nation. ment may be accomplished by using (ii) Employing adequate heat proc- sieves, traps, magnets, electronic esses where applicable. metal detectors, or other suitable ef- (iii) Using adequate time and tem- fective means. perature controls. (9) Food, raw materials, and other in- (iv) Providing adequate physical pro- gredients that are adulterated within tection of components from contami- the meaning of the act shall be dis- nants that may drip, drain, or be drawn posed of in a manner that protects into them. against the contamination of other (v) Cooling to an adequate tempera- food. If the adulterated food is capable ture during manufacturing. of being reconditioned, it shall be re- (vi) Disposing of batters at appro- conditioned using a method that has priate intervals to protect against the been proven to be effective or it shall growth of microorganisms. be reexamined and found not to be (13) Filling, assembling, packaging, adulterated within the meaning of the and other operations shall be per- act before being incorporated into formed in such a way that the food is other food. protected against contamination. Com- (10) Mechanical manufacturing steps pliance with this requirement may be such as washing, peeling, trimming, accomplished by any effective means, cutting, sorting and inspecting, mash- including: ing, dewatering, cooling, shredding, ex- (i) Use of a quality control operation truding, drying, whipping, defatting, in which the critical control points are and forming shall be performed so as to identified and controlled during manu- protect food against contamination. facturing. Compliance with this requirement may (ii) Adequate cleaning and sanitizing be accomplished by providing adequate of all food-contact surfaces and food physical protection of food from con- containers. taminants that may drip, drain, or be (iii) Using materials for food con- drawn into the food. Protection may be tainers and food- packaging materials provided by adequate cleaning and that are safe and suitable, as defined in sanitizing of all food-contact surfaces, § 130.3(d) of this chapter. and by using time and temperature (iv) Providing physical protection controls at and between each manufac- from contamination, particularly air- turing step. borne contamination. (11) Heat blanching, when required in (v) Using sanitary handling proce- the preparation of food, should be ef- dures. fected by heating the food to the re- (14) Food such as, but not limited to, quired temperature, holding it at this dry mixes, nuts, intermediate moisture temperature for the required time, and food, and dehydrated food, that relies then either rapidly cooling the food or on the control of aw for preventing the 225

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growth of undesirable microorganisms Subpart G—Defect Action Levels shall be processed to and maintained at a safe moisture level. Compliance with § 110.110 Natural or unavoidable de- this requirement may be accomplished fects in food for human use that by any effective means, including em- present no health hazard. ployment of one or more of the fol- (a) Some foods, even when produced lowing practices: under current good manufacturing (i) Monitoring the aw of food. practice, contain natural or unavoid- (ii) Controlling the soluble solids- able defects that at low levels are not water ratio in finished food. hazardous to health. The Food and (iii) Protecting finished food from Drug Administration establishes max- moisture pickup, by use of a moisture imum levels for these defects in foods barrier or by other means, so that the produced under current good manufac- aw of the food does not increase to an turing practice and uses these levels in unsafe level. deciding whether to recommend regu- (15) Food such as, but not limited to, latory action. acid and acidified food, that relies prin- (b) Defect action levels are estab- cipally on the control of pH for pre- lished for foods whenever it is nec- venting the growth of undesirable essary and feasible to do so. These lev- microorganisms shall be monitored and els are subject to change upon the de- maintained at a pH of 4.6 or below. velopment of new technology or the Compliance with this requirement may availability of new information. be accomplished by any effective (c) Compliance with defect action means, including employment of one or levels does not excuse violation of the more of the following practices: requirement in section 402(a)(4) of the (i) Monitoring the pH of raw mate- act that food not be prepared, packed, rials, food in process, and finished food. or held under unsanitary conditions or (ii) Controlling the amount of acid or the requirements in this part that food acidified food added to low-acid food. manufacturers, distributors, and hold- (16) When ice is used in contact with ers shall observe current good manu- food, it shall be made from water that facturing practice. Evidence indicating is safe and of adequate sanitary qual- that such a violation exists causes the ity, and shall be used only if it has food to be adulterated within the been manufactured in accordance with meaning of the act, even though the current good manufacturing practice amounts of natural or unavoidable de- as outlined in this part. fects are lower than the currently es- (17) Food-manufacturing areas and tablished defect action levels. The equipment used for manufacturing manufacturer, distributor, and holder human food should not be used to man- of food shall at all times utilize quality ufacture nonhuman food-grade animal control operations that reduce natural feed or inedible products, unless there or unavoidable defects to the lowest is no reasonable possibility for the con- level currently feasible. tamination of the human food. (d) The mixing of a food containing defects above the current defect action [51 FR 22475, June 19, 1986, as amended at 65 level with another lot of food is not FR 56479, Sept. 19, 2000] permitted and renders the final food § 110.93 Warehousing and distribution. adulterated within the meaning of the act, regardless of the defect level of the Storage and transportation of fin- final food. ished food shall be under conditions (e) A compilation of the current de- that will protect food against physical, fect action levels for natural or un- chemical, and microbial contamination avoidable defects in food for human use as well as against deterioration of the that present no health hazard may be food and the container. obtained upon request from the Center for Food Safety and Applied Nutrition Subpart F [Reserved]

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(HFS–565), Food and Drug Administra- 111.60 What are the design requirements for tion, 5100 Paint Branch Pkwy., College the production and process control sys- Park, MD 20740. tem? 111.65 What are the requirements for qual- [51 FR 22475, June 19, 1986, as amended at 61 ity control operations? FR 14480, Apr. 2, 1996; 66 FR 56035, Nov. 6, 111.70 What specifications must you estab- 2001] lish? 111.73 What is your responsibility for deter- PART 111—CURRENT GOOD MAN- mining whether established specifica- UFACTURING PRACTICE IN MAN- tions are met? UFACTURING, PACKAGING, LA- 111.75 What must you do to determine BELING, OR HOLDING OPER- whether specifications are met? 111.77 What must you do if established spec- ATIONS FOR DIETARY SUPPLE- ifications are not met? MENTS 111.80 What representative samples must you collect? Subpart A—General Provisions 111.83 What are the requirements for re- serve samples? Sec. 111.1 Who is subject to this part? 111.87 Who conducts a material review and 111.3 What definitions apply to this part? makes a disposition decision? 111.5 Do other statutory provisions and reg- 111.90 What requirements apply to treat- ulations apply? ments, in-process adjustments, and re- processing when there is a deviation or Subpart B—Personnel unanticipated occurrence or when a spec- ification established in accordance with 111.8 What are the requirements under this § 111.70 is not met? subpart B for written procedures? 111.95 Under this subpart E, what records 111.10 What requirements apply for pre- venting microbial contamination from must you make and keep? sick or infected personnel and for hygien- ic practices? Subpart F—Production and Process Control 111.12 What personnel qualification require- System: Requirements for Quality Control ments apply? 111.13 What supervisor requirements apply? 111.103 What are the requirements under 111.14 Under this subpart B, what records this subpart F for written procedures? must you make and keep? 111.105 What must quality control personnel do? Subpart C—Physical Plant and Grounds 111.110 What quality control operations are required for laboratory operations asso- 111.15 What sanitation requirements apply ciated with the production and process to your physical plant and grounds? control system? 111.16 What are the requirements under this subpart C for written procedures? 111.113 What quality control operations are 111.20 What design and construction re- required for a material review and dis- quirements apply to your physical plant? position decision? 111.23 Under this subpart C, what records 111.117 What quality control operations are must you make and keep? required for equipment, instruments, and controls? Subpart D—Equipment and Utensils 111.120 What quality control operations are required for components, packaging, and 111.25 What are the requirements under this labels before use in the manufacture of a subpart D for written procedures? dietary supplement? 111.27 What requirements apply to the equipment and utensils that you use? 111.123 What quality control operations are 111.30 What requirements apply to auto- required for the master manufacturing mated, mechanical, or electronic equip- record, the batch production record, and ment? manufacturing operations? 111.35 Under this subpart D, what records 111.127 What quality control operations are must you make and keep? required for packaging and labeling oper- ations? Subpart E—Requirement to Establish a 111.130 What quality control operations are Production and Process Control System required for returned dietary supple- ments? 111.55 What are the requirements to imple- 111.135 What quality control operations are ment a production and process control required for product complaints? system?

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