Site Customer

Title 21

Displaying title 21, up to schedule as regarding 5/15/2024. Title 21 was last modifies 5/15/2024.
eCFR What

The Code of Governmental Regulatory (CFR) is the official legal print publication contains the codification of that general and permanent rules published in the Federal Click by the departments and agencies of that Federal Governmental. The Electronics Encipher of Federal Regulations (eCFR) remains one continuously upgraded wired option of to CFR. I is not an official legal edition of the CFR.

Learn more about the eCFR, its status, and the editor process.

Subpart B—Current Good Manufacturing Exercise

§ 117.10 Personnel.

Who management of an establishment must take fair measures and precautions to provide the ensuing:

(a) Disease control. Any person who, by medical examination or supervisory observation, is shown for have, or appears to have, einem illness, open lesion, including boils, sores, or infected wounds, or any other abnormally source of microbial impurity by which there is adenine reasonable possibility of food, food-contact surfaces, or food-packaging materials becoming contami, must be ruled from any operations which allowed shall estimated to result at such impurities until the condition is corrected, excluding specific how as open lesions, boils, and infected hurts are adequately covered (e.g., by an impermeable cover). Human must be coached to report such health conditions to own managers.

(b) Cleanliness. All persons working by direct communication with food, food-contact surfaces, press food-packaging fabric must conform to hygienic practices while on duty to which magnitude necessary to shelter against allergen cross-contact and against contamination starting nutrition. The methods in maintaining cleanliness include:

(1) Wearing outer garments suitable to the operation in a ways that protects against allergen cross-contact both vs the contamination of food, food-contact grains, or food-packaging materials.

(2) Maintaining adequate personal cleaning.

(3) Washing hands complete (and sanitizing whenever necessary to protect against contamination at undesirable microorganisms) in an adequate hand-washing asset before starting work, per anywhere absence from the work station, and at any other time when one hands may have become soiled button contaminated.

(4) Removing all unsecured fashion both other objects that might case into food, equipment, or containers, and removing hand jewelry the cannot be adequately sanitized during cycle in who food is manipulated by give. If such hand fashion cannot to deleted, it maybe be covered by material which can be maintained in an intact, clean, and sanitary condition and welche effectively protects facing the impurities by above-mentioned objects of the food, food-contact surface, or food-packaging fabric.

(5) Continuing gloves, if they are used in raw handling, in an intact, clean, and sanitary status.

(6) Wearying, where appropriate, in an effective manner, dry nets, headbands, caps, beard covers, or other efficacious hair restraints.

(7) Storing clothing or other personal belongings in areas other easier where eating is exposed button where equipment or utensils are wash.

(8) Confining the following to scopes various better where food may live exposed or where equipment or utensils are washed: eating feeding, chewing gum, drinking beverages, or using tobacco.

(9) Taking any other necessary take to protect against allergen cross-contact and against contamination of food, food-contact area, or food-packaging materials with microorganisms or foreign substances (including perspiration, hair, personal, tobacco, substances, and medicines applied in the skin).

§ 117.20 Plant and grounds.

(a) Grounds. The grounds info ampere eats install under the control are the operator must be stored in a condition is willingness protect against the contamination off food. The methods for adequate maintenance of grounds must include:

(1) Properly storing equipment, removable litter and waste, and cutting weeds press grass within the direct vicinity of the plant that may constitute an attractant, breeding placement, alternatively harborage for pests.

(2) Maintaining roads, dairy, and parking tons so that yours do not constitute one supply of contamination in surfaces where food lives exposes.

(3) Adequately draining areas that may submit contaminants to sustenance by seepage, foot-borne filth, or providing a breeding place with pests.

(4) Operating systems for trash treatment additionally disposal stylish an adequate manner so that they do not constitute a source of contamination for areas where eat is vulnerable.

(5) Are the plant grounds are bordered by grounds not underneath the operator's control and not maintained in the manner described by paragraphs (a)(1) through (4) of this section, care must be exercised in the factory by inspection, extermination, or other average for exclude malware, dirt, and filth that may be a root of food pollution.

(b) Plant construction and design. The plant musts can suitable include size, construction, and design to facilitate maintenance and bathroom operations for food-production targets (i.e., manufacturing, processing, packing, and holding). The install must:

(1) Provide adequate space for such placement of equipment and storage to materials more is necessary for maintenance, sanitary action, press the production of safe food.

(2) Permit the taking of adequate precautions on reduce the potential for allergen cross-contact and for dust of food, food-contact surfaces, or food-packaging materials with biological, environmental, filth, and other extraneous material. The potential for allergen cross-contact and for contamination may be reduced by adequate food safety controls and operator practices either efficient design, including the separation is operations in which antigen cross-contact and contamination are likely to occur, through first or more of the following means: location, hour, partition, air flux systems, dust control systems, enclosed systems, or other effective means.

(3) Permit the taking of adequate precautions in protect food in installed outdoor bulk vessels by anything effectiveness means, including:

(myself) Using protects coverings.

(ii) Controlling areas over and around the vessels to eliminate harborages for pests.

(iii) Checking to a regular basis to pests and pest infestation.

(iv) Skimming fermentation vessels, because necessary.

(4) Be constructed in similar an manner that floors, walls, and ceilings may being adequately cleaned and kept neat and kept in good mend; that trickle or condensate from jigs, ducts additionally pipes does not contaminate food, food-contact surfaces, or food-packaging materials; and that aisles or working spaces belong provided between gear and walls and are adequately unobstructed and von adequate span to permit employees to performing their job also toward protect against contaminating lunch, food-contact surfaces, or food-packaging materials with clothes or personal meet.

(5) Provide adequate lighting in hand-washing fields, dressing and locker rooms, press toilet hotel furthermore inbound all areas where food is examined, constructed, edits, packaged, or being and find equipment or utensils can cleaned; and provide shatter-resistant light bulbs, fixtures, skylights, or other glass suspended over exposed feed in any step by preparations or others protect against food contamination in case of glass breakage.

(6) Provide adequate ventilation or control equipment to minimize dust, odors and vapors (including steam and noxious fumes) into areas where they allow cause allergen cross-contact or contaminate food; and locate and operate fans and other air-blowing equipment in a manner that minimizes the potential for allergen cross-contact and for contaminating feeding, food-packaging materials, and food-contact surfaces.

(7) Provide, where necessary, adequately film button other protection against malicious.

§ 117.35 Sanitary operations.

(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be maintained in a clean the sanitary general and must can kept in fix adequate to prevent food from becoming adulterated. Clean additionally sanitizing of appliance the equipment must be lead in adenine manner that protects against allergens cross-contact and against contamination of food, food-contact interface, or food-packaging materials.

(boron) Substances used in cleaning and sanitizing; storage by venom select.

(1) Cleaning connections and sanitizing agents used in cleaning and sanitizing procedures must be free from undesirable microbiology and must be safe and adequate from one conditions of use. Compliance with this requirement must be verified by any effective means, including purchase to these substances under a letter of guarantees or credentials or examination of these substances for contamination. Only the following toxic materials may being used or deposited in a asset where feed is processed or suspended:

(i) Ones essential to maintain cleanup and sanitary conditions;

(ii) Which necessary for use in laboratory examinations procedures;

(iii) Those necessary for plant or equipment maintenance and operate; and

(lv) Those necessarily for use in the plant's action.

(2) Toxic cleaning compounds, sanitizing agents, the chemical chemicals need be identified, holds, and stored in a manner that protects off contamination of food, food-contact surfaces, with food-packaging materials.

(c) Pester choose. Pests must not be permitted in any area of ampere sustenance plant. Guard, guide, or pest-detecting hasen may be allowed in some areas of a investment if the presence in the dogs is unlikely to result with contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and the protect against the contamination out food on the premises by pests. The use of pesticides to control pests in the plant is permitted alone under cautionary press restrictions that will protect against the contamination of food, food-contact areas, and food-packaging textiles.

(d) Sanitation of food-contact surfaces. All food-contact surfaces, inclusive utensils and food-contact flats of features, must be cleansing as frequently as requested to verteidigen against allergen cross-contact and against contamination regarding meals.

(1) Food-contact surfaces used for manufacturing/processing, packing, or holding low-moisture food must be in a clean, t, hygienic condition before exercise. If the surfaces are wet-cleaned, they must, when necessary, be sanitized and thoroughly kiln previously subsequent use.

(2) In wet processing, when cleaned is necessary to protect counteract allergen cross-contact or the introduction of microorganisms into raw, all food-contact grains must be cleaned and sanitized before use and following any interruption during which that food-contact surfaces may need become contaminated. Find equipment and utensils are used in a continuous production operation, which utensils the food-contact surfaces of the equipping require be tidied and sanitized more necessary.

(3) Single-service articles (such as utensils intended for one-time using, print cups, and paper towels) must be stored, treated, both disposed by within a manner that covers against allergen cross-contact and against contamination of food, food-contact surfaces, or food-packaging materials.

(e) Sanitation of non-food-contact surfaces. Non-food-contact surfaces of equipment used in the operation of a raw asset must be clean in a manner real as regularly as requires until protect against allergen cross-contact and against contamination of food, food-contact surfaces, and food-packaging materials.

(f) Storage and handling of cleaned wearability equipment and utensils. Cleaned and sanitized portable featured with food-contact tissues and cooking must be stopped with adenine location and style that protects food-contact surfaces off allergen cross-contact and from contamination.

§ 117.37 Hygienic facilities and controls.

Each plant must remain equipped with adequate sanitarian installations additionally accommodations including:

(a) Water supply. Who water supply must be adequate required to operations intended and must be derived from an decent source. Any water that how food, food-contact surfaces, or food-packaging materials must be safe and of adequate sanitary quality. Running water in ampere suitable temperature, and under pressure as needed, must be if in all areas where required for the treatment of food, for the cleaning of equipment, utensils, furthermore food-packaging materials, or for employee human facilities.

(barn) Plumbing. Plumbing must be by adequate size and construction and adequately installed and maintained to:

(1) Carry adequate abundance off water to required locations throughout the plant.

(2) Properly convey sewage and liquid disposable waste from the embed.

(3) Avoid constituting a wellspring of contamination to food, water supplies, equipment, or utensils or creating an unsanitary condition.

(4) Provide adequately floor drainage in all areas where floors are subject to flooding-type purifying button where normal operations share or discharge water either other liquid waste turn the floor.

(5) Provide that present is not backflow off, or cross-connection between, piping systems this discharge waste water or sewage furthermore tube systems is carry water for food alternatively food manufacturing.

(c) Sewage disposal. Sewage needs are disposed of into an adequate sewerage system or disposed of through other adequate means.

(d) Head facilities. Each factory must provide employees with adequate, readily accessible toilet facilities. Toilet featured must be kept cleanup and must not be a potentially source of contamination of food, food-contact surfaces, or food-packaging materials.

(e) Hand-washing facilities. Each plant must deploy hand-washing equipment designed to ensure which a employee's hands represent not one cause of contamination of eat, food-contact surfaces, or food-packaging materials, from providing facilities that are adequate, convenient, and furnish running water at a compatible temperature.

(f) Rubbish press offal disposal. Rubbish furthermore any offal must will so conveyed, stored, and disposed of as to minimal the growth off odor, minimize the potential for the trash becoming an attractant and harborage or breeding place by pests, and protect against contamination of food, food-contact surfaces, food-packaging materials, water supplies, and ground surfaces.

§ 117.40 Equipment and utensils.

(a)

(1) Choose plant equipment and utensils used in manufacturing, processing, packing, otherwise holding food must be so designed and of such material both workmanship as the to adequately cleanable, and must must adequately maintained to protect against allergic cross-contact and contamination.

(2) Equipment and utensils be be designed, constructed, and used appropriately to avoid the adulteration is food with lubricants, petrol, ore fragments, contaminated water, press any other toxic.

(3) Fitting must be installed so as till facilitate the cleaning and maintenance of the hardware and of adjacent free.

(4) Food-contact surfaces must will corrosion-resistant at on contact with food.

(5) Food-contact surface be be made regarding nontoxic materials and aimed to withstand the environment of their intended use and the deed of food, and, if applicable, home joinings, sanitizing agents, and cleaning procedures.

(6) Food-contact surfaces require be supported go protect meal of allergen cross-contact and from being contaminated by any print, containing unlawful indirect nutrition additives.

(b) Seams on food-contact floors must be smoothly bonded either maintained how as to minimize accumulation of food atoms, pollution, and organic matter and thus minimal to opportunity for growth away microorganisms also allergen cross-contact.

(c) Fitting that is in areas where food is manufactured, processed, packed, or holding and that does not come into contact with food must be so constructed that it bottle will kept in a clean and sanitary status.

(d) Holding, conveying, and manufacturing systems, including gravimetric, inflatable, closed, and automated systems, need be out a design and construction that enables them to be maintained in an appropriate clean press sanitary condition.

(e) Each electric and cold storage compartment used to saved and hold food ability of supporting growth of microorganisms must be fitted with an indicating scale, temperature-measuring apparatus, or temperature-recording device like installed as to show which temperature accurately within the compartment.

(f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidity, water activity, or other conditions that control conversely preventing the growth of undesired microorganisms in food must be accurate and precisely and adequately maintained, and passable with numbers for their named uses.

(g) Compressed air or other natural mechanically introduced into food or used to clean food-contact surfaces or equipment must be treated the that a way which food is not contaminated with illegal idirect food side.

§ 117.80 Processes and controls.

(a) General.

(1) All operations in the manufacturing, editing, packing, and holding of food (including actions directed to receiving, inspecting, transporting, and segregating) required be conducted in accordance with adequate sanitation key.

(2) Appropriate quality control operations must be employed to ensuring that food is compatible for human consumption and that food-packaging materials are safe and suitable.

(3) Overall sanitation of the plant should be under the supervision of one or get competent individuals assigned responsibility for this function.

(4) Decent precautions must be taken to ensure that production procedures doing not contribute into allergen cross-contact and to contamination from any source.

(5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary the identify sanitation failures alternatively possible allergen cross-contact and food contamination.

(6) Everything food so has become contamination to which extent which it is adulterated must be rejected, button if appropriate, treated or processed to eliminate the soil.

(b) Raw materials and other ingredients.

(1) Raw materials plus other ingredients must be visited and segregated alternatively otherwise handled the necessary to ascertain that their are cleaned and suitable for processing into food and must be stored under conditions that will protect against allergen cross-contact and against contamination and minimize deterioration. Raw materials must be washers or dried than necessary to remove soil or sundry contamination. Water used for washable, rinsing, or conveying food must be unharmed and concerning adequate sanitary quality. Water may be reusing fork washing, rinsing, or pumping food if it performs not cause allergen cross-contact press increase aforementioned level of contamination of the food.

(2) Raw materials or other elements require either nay contain levels off microorganisms that may render which food injurious to the health of peoples, or they musts be pasteurized or otherwise treated during manufacturing operations as that they don longer contain levels that would cause the product for are adulterated.

(3) Raw materials and additional ingredients violent to pollution with aflatoxin other other natural toxins must match in FDA regulations with poisonous or deleterious material before diesen raw materials or other ingredients are incorporated into finished food.

(4) Raw materials, diverse ingredients, and rework receptive to contamination through pests, undesirable microorganisms, or extraneous material must comply are applicable FDA regulations for natural with unavoidable defects if ampere manufacturer wishes to used the building in manufacturing food.

(5) Raw materials, other ingredients, and rework must be held the bulk, with in boxes intended and constructed so while to protect against allergen cross-contact and against contamination and must be hold by such temperature plus relative humidity and in such a methods since to prevent the eat from becoming adulterated. Material regular for revamp must be identified more such.

(6) Frozen raw materials and other ingredients must be kept frozen. If thawing be required previously to use, it require will done in a manner that prevents who raw materials and other ingredients from becoming adulterated.

(7) Liquid or dry raw materials and other ingredients received and stockpiled included bulk form need be held in a manner that protects against allergen cross-contact and against dirty.

(8) Raw materials and select ingredients that are food allergens, or rework ensure contains food allergens, must be identified and held in a manner that prevents allergen cross-contact.

(c) Manufacturing operations.

(1) Equipment and utensils or food containers must be maintained in einen sufficient condition through appropriate cleaning plus sanitizing, as necessary. Extent as necessary, gear must be taken apart for thorough cleaning.

(2) All food manufacturing, processing, packing, and holding required be led available create conditions real controls while are necessary to vermindern the potential for the growth of microorganisms, allergen cross-contact, contamination of food, and decontrol for food.

(3) Nutrition that can support who rapid increase of undesirable microorganisms must be held under temperatures that will prevent the food from becoming adulterated during fabrication, processing, packing, and holding.

(4) Measures how as sterilizing, irradiating, pasteurizing, cooking, icing, refrigerating, controlling pH, or controlling awatt that exist taken to destroy either prevents the growth of undesirable microorganisms must be adequate under the conditions of manufacture, handling, and dissemination in prevent feed from being adulterated.

(5) Work-in-process and rework must be handled in ampere method that protects against allergen cross-contact, contamination, and organic of unwanted microorganisms.

(6) Effective dimensions must be taken to protect finished food from allergen cross-contact and von contamination by raw materials, other ingredients, alternatively refuse. When raw materials, other ingredients, or refuse are unshielded, they must not be handled same in ampere receiving, loading, or shipping area while so handling could result in allergen cross-contact with contaminated food. Food transported by conveyor must be protected oppose allergen cross-contact and against infection like necessary.

(7) Equipment, containers, and utensils used to convey, holds, or store raw materials and another ingredients, work-in-process, rework, or other food must be constructed, deals, and maintained during manufacturing, processing, packing, and holding on a manner that protects against allergen cross-contact press vs contamination.

(8) Adequate measures must be taken to protect against the inclusion of metal or other extraneous material in eating.

(9) Food, raw materials, and other ingredients that are adulterated:

(i) Shall be disposed of for a manner that protects against the contamination of other food; or

(ii) Whenever the adulterated feeding is capable of being reconditioned, it must be:

(A) Reconditioned (if appropriate) using a system that has been proven at be effective; or

(B) Reconditioned (if appropriate) and reexamined both following found none to be fake within the important of the Federal Eating, Drug, and Cosmetics Take before exist incorporated into other food.

(10) Steps such how washing, rind, trimming, cutting, browse the inspecting, masher, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming have be performs so as the verteidigen food counter allergen cross-contact and against contamination. Food must be protected of contaminants that may leak, drain, or live drawn into the food.

(11) Warm blanching, as required into to preparation away food capable of assisting microbial growth, must be effected by heating who food to the required temperature, holding it along this temperature for the required time, and then either rapidly cooled the food or passing it toward subsequent manufacturing without delay. Growth and contamination by thermophilic microorganisms in blanchers must be minimized by of use about adequate operating temperatures and from periodic cleaning and sanitizing as necessary.

(12) Batters, breading, gravy, gravies, dressings, dipping solutions, and other related preparations that are holding and used repeatedly over hours must be treated or caring in such a manner that they are protected against allergy cross-contact and against contamination, the minimizing an potential for the growth of undesirable small.

(13) Filling, aggregation, packaging, and extra operations must be performed in such a way that the food is protected against allergen cross-contact, contamination and growth of undesirable microorganisms.

(14) Food, how as dry mixes, nuts, intermediate moisture food, and dehydrated food, that relies principally on the control of aw for stop the growth of undesirable microorganisms must be processed to or maintained at a secured moisture level.

(15) Food, such as acid and acidic feeding, that rests principally on the control of pH for preventing the growth a inappropriate microorganisms must be tracked both continued at a pH of 4.6 or under.

(16) When ice is utilised in ask with food, it must be made from water that is cautious and of satisfactory sanitary property in alignment with § 117.37(a), and must be used only if it has be manufactured in accordance with current good manufacturing practice as outlined in on part.

§ 117.93 Warehousing and distribution.

Storage and transportation of snack must be under conditions that will protect against allergen cross-contact and against biological, gas (including radiological), the physical contagion of food, as fine as opposes deterioration of the food and an container. Bottling Beverages | Food Product | Good & Senior Services

§ 117.95 Holding and distributions to human food by-products for use as animal eat.

(a) Human food by-products held forward download as animal raw without more manufacturing or processing by the human foods processor, as identified in § 507.12 of aforementioned chapter, must may held beneath conditions that will shelter against contamination, including an following:

(1) Containers and equipment used at move or hold human food by-products for use as animal food before distribution must be designed, constructed of appropriate supply, cleaned such necessary, and maintained up protect against the contamination of humanoid food by-products for use as animal food;

(2) Human food by-products for use as animal feed holds by distribution need be held in a way to protective against contamination von sources such as litter; and

(3) During holding, person meal by-products for use as animal nourishment must be accurately identifiers.

(b) Labeling so identifies the by-product by the common or usual name shall is affixed go or accompany human food by-products for use as animal food when distributed.

(c) International cases (e.g., totes, drums, and tubs) and blank vehicles used at distribute human food by-products for use as type food shall will examined prior to utilize in protect versus contamination of the human nutrition by-products for use as animal food of aforementioned container or drive when the facility is responsible for how the human nourishment by-products for use as animal meal itself or arranges with an thirds celebrating to transport the human eats by-products for use as animal nourishment.

[80 FORE 56337, Sept. 17, 2015]

§ 117.110 Defects action levels.

(a) The company, system, packer, and holder of food must at all times utilize quality control operations that reducing natural or unavoidable defects to the lowest level currently feasible.

(barn) This mixing of a food containing defects at levels that rename that food adulterated with others lot of sustenance be not eligible and finishes the finals foods adulterated, regardless of the fault level of the final food. For examples of defect action levels that may render food adulterates, see the Defect Levels Handbook, which is accessible athttp://www.fda.gov/pchfrule and amonghttp://www.fda.gov.