Sanitation Performance Standards Compliance Guide Appendices
As stated in the introduction, meat and poultry establishments that follow the guidance in this document, including the past sanitation regulations, can be fairly certain that they are meeting the new sanitation performance standards. Because the past sanitation regulations have been removed from the Code of Federal Regulations, we are presenting them here as a reference only. Compliance with these specific regulations is no longer required. Also, keep in mind that because FSIS has rescinded all of the following regulations requiring prior approval of equipment, blueprints, chemical uses, etc., the mailing addresses listed for applications for prior approval are no longer valid.
The past regulations are preceded by a table showing the correlation between past requirements and the new performance standards.
|SUBJECT||PERFORMANCE STANDARDS||PAST REGULATION(S)|
|General sanitation||§ 416.1||§§ 308.3(a),(g), 308.7, 381.45, 381.57, and all other provisions not listed below.|
|Establishment grounds and pest management||§ 416.2(a)||§§ 308.3 (h), 308.13, 381.49(b), 381.56(a), 381.59, and 381.60.|
|Establishment Construction||§ 416.2(b)||§§ 308.3(e),(f),(h), 381.46, 381.47 and 381.48.|
|Light||§ 416.2(c)||§§ 308.3(b), 381.52(a) and (b).|
|Ventilation||§ 416.2(d)||§§ 308.3(b) and (g), 308.8(b), 381.52(a) and (c).|
|Plumbing||§ 416.2(e)||§§ 308.3(c), 381.47(b), 381.49(a),(b) and (c).|
|Sewage disposal||§ 416.2(f)||§§ 308.4(c) and 381.49(c)(4).|
|Water supply and water, ice, and solution reuse||§ 416.2(g)||§§ 308.3(d), 381.50 and 381.53(k) and FSIS policy.|
|Dressing rooms, lavatories, and toilets||§ 416.2(h)||§§ 308.4(a),(b),(d), 381.47(h), 381.51 and 381.53(c).|
|Equipment and utensils||§ 416.3||§§ 308.5(a) and (g), 308.6, 308.8(c), 308.16, 381.53(a)(1),(f),(g),(h),(i),(j),(k),(l),(m), 381.54, 381.55 and 381.56(b).|
|Food-contact surface cleaning and sanitation||§ 416.4(a)||§§ 308.3(d)(4), 308.7, 308.8(a), 381.57 and 381.58.|
|Non-food-contact surface cleaning and sanitation||§ 416.4(b)||§§ 308.3(d)(4), 308.7, 308.8(a), 381.57 and 381.58.|
|Cleaning compounds and sanitizers||§ 416.4(c)||§ 381.60.|
|Operational sanitation||§ 416.4(d)||§§ 308.3(g), 308.7, 308.8(a), 308.9, 308.10, 308.11, 308.12, 381.47(e), 381.53(d),(e), and (g)(4).|
|Employee hygiene||§ 416.5(a)||§§ 308.8(c),(e), 381.47(i), 381.51(g), 381.61(b),(c), and (d).|
|Employee clothing||§ 416.5(b)||§§ 308.8(d) and 381.61(b).|
|Employee disease||§ 416.5(c)||§§ 308.14 and 381.61(a).|
|Tagging insanitary equipment, rooms, or compartments||§ 416.6||§§ 308.15 and 381.99.|
- Sec. 308.1 Examination and specifications for equipment and sanitation prior to granting inspection.
- 308.2 Drawings and specifications to be furnished in advance of construction.
- 308.3 Establishments; sanitary condition; requirements.
- 308.4 Sanitary facilities and accommodations; specific requirements.
- 308.5 Equipment and utensils to be easily cleaned; those for inedible products to be so marked; evaluation of equipment and utensils; PCB-containing equipment.
- 308.6 Scabbards for knives.
- 308.7 Rooms, compartments, etc., to be clean and sanitary.
- 308.8 Operations, procedures, rooms, clothing, utensils, etc., to be clean and sanitary.
- 308.9 Protective handling of products.
- 308.10 Slack barrels and similar containers and means of conveyance used for product; paper in contact with product.
- 308.11 Burlap wrapping for meat.
- 308.12 Second-hand tubs, barrels, and other containers.
- 308.13 Inedible operating and storage rooms; outer premises, docks, driveways, approaches, pens, alleys, etc.; flybreeding material; other conditions.
- 308.14 Employment of diseased persons.
- 308.15 Tagging insanitary equipment, utensils, rooms or compartments.
- 308.16 Sanitation requirements for electrical stimulating (EST)equipment.
Sec. 308.1 Examination and specifications for equipment and sanitation prior to granting inspection.
Prior to the inauguration of inspection, an examination of the establishment and premises shall be made by a Program employee and the requirements for sanitation and the necessary facilities for inspection shall be specified by him in accordance with the regulations in this part and part 307 of this subchapter.
Sec. 308.2 Drawings and specifications to be furnished in advance of construction.
Drawings and specifications as prescribed in Sec. 304.2 of this subchapter for remodeling any official establishment, or part thereof, and for any new structures to be used in an official establishment, or part thereof, shall be submitted to the Administrator and approval obtained for the plans in advance of construction.
Sec. 308.3 Establishments; sanitary condition; requirements.
- Official establishments shall be maintained in sanitary condition, and to this end the requirements of this section shall be complied with. The provisions of part 416 of this chapter also apply.
- There shall be abundant light, of good quality and well distributed, and sufficient ventilation for all rooms and compartments to insure sanitary condition.
- There shall be an efficient drainage and plumbing system for the establishment and premises, and all drains and gutters shall be properly installed with traps and vents approved by the circuit supervisor.
- The water supply shall be ample, clean, and potable, with adequate facilities for its distribution in the plant and its protection against contamination and pollution. Every establishment shall make known and, whenever required by the circuit supervisor, shall afford opportunity for inspection of the source of its water supply, the storage facilities, and the distribution system. Equipment using potable water shall be so installed as to prevent back-siphonage into the potable water system. Nonpotable water is permitted only in those parts of official establishments where no edible product is handled or prepared, and then only for limited purposes such as on ammonia condensers not connected with the potable water supply, in vapor lines serving inedible product rendering tanks, in connection with equipment used for hashing and washing inedible products preparatory to tanking, and in sewer lines for moving heavy solids in the sewage. Nonpotable water is not permitted for washing floors, areas, or equipment involved in trucking materials to and from edible product departments nor is it permitted in hog scalding vats, dehairing machines, or vapor lines serving edible product rendering equipment, or for cleanup of shackling pens, bleeding areas, or runways within the slaughtering department. In all cases, nonpotable waterlines shall be clearly identified and shall not be cross-connected with the potable water supply unless this is necessary for fire protection and such connection is of a type with an adequate break to assure against accidental contamination, and is approved by local authorities and by the circuit supervisor.
- The circuit supervisor may permit the reuse of water in vapor lines leading from deodorizers used in the preparation of lard and similar edible product and in equipment where such water is used to thermally process canned product packed in hermetically sealed containers, provided:
- The reuse is for the identical original purpose.
- All pipelines, reservoirs, tanks, cooling towers, and like equipment employed in handling the reused water are so constructed and installed so they can be cleaned and drained, and are kept clean.
- Approval for the reuse of water other than as specified in paragraph (d)(2) of this section or in Sec. 318.305(h) shall be obtained from the Administrator in specific cases.
- An ample supply of water at not less than 180 deg.F. shall be furnished and used for the cleaning of inspection equipment and other equipment, floors, and walls which are subject to contamination by the dressing or handling of diseased carcasses, their viscera, and other parts. Whenever necessary to determine compliance with this requirement, conveniently located thermometers shall be installed by the operator of the official establishment to show the temperature of the water at the point of use.
- Hot water for cleaning rooms and equipment other than those mentioned in paragraph (d)(4) of this section shall be delivered under pressure to sufficient convenient outlets and shall be of such temperature as to accomplish a thorough cleanup.
- The floors, walls, ceilings, partitions, posts, doors, and other parts of all structures shall be of such materials, construction, and finish as will make them susceptible of being readily and thoroughly cleaned. The floors shall be kept watertight. The rooms and compartments used for edible product shall be separate and distinct from those used for inedible product.
- Rails should be located and passageway space provided so that exposed product does not come in contact with posts, walls, and other fixed parts of the building, or with barrels, boxes, and other containers trafficked through holding and operating areas. Exposed product shall not be placed or stored beneath carcasses in coolers or holding areas.
- The rooms and compartments in which any product is prepared or handled shall be free from dust and from odors from dressing and toilet rooms, catch basins, hide cellars, casing rooms, inedible tank and fertilizer rooms, and livestock pens.
- Every practicable precaution shall be taken to exclude flies, rats, mice, and other vermin from official establishments. The use of poisons for any purpose in rooms or compartments where any unpacked product is stored or handled is forbidden, except under such restrictions and precautions as are prescribed by the regulations in this part or by the circuit supervisor in specific cases. The use of insecticides, rodenticides, and similar pest control substances in hide cellars, inedible product departments, outbuildings, or similar places, or in storerooms containing canned or tierced products is not forbidden but only those approved by the Administrator may be used.1 So- called rat viruses shall not be used in any part of an establishment or the premises thereof.
- Dogs and cats shall be excluded from the interior of official establishments; however, dogs may be permitted on the outer premises for guard purposes.
1A list of approved pest control substances is available upon request to the Scientific Services, Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
Sec. 308.4 Sanitary facilities and accommodations; specific requirements.
Adequate sanitary facilities and accommodations shall be furnished by every official establishment. Of these, the following are specifically required:
- Dressing rooms, toilet rooms, and urinals shall be sufficient in number, ample in size, and conveniently located. The rooms shall be provided with facilities to provide abundant light of good quality and well distributed. They shall be properly ventilated, and meet all requirements of the regulations in this part as to sanitary construction and equipment. They shall be separate from the rooms and compartments in which products are prepared, stored, or handled. Where both sexes are employed, separate facilities shall be provided.
- Acceptable lavatories, including running hot and cold water, soap, and towels, shall be placed in or near toilet and urinal rooms and also at such other places in the establishment as may be essential to assure cleanliness of all persons handling any product.
- Toilet soil lines shall be separate from house drainage lines to a point outside the building and drainage from toilet bowls and urinals shall not be discharged into a grease catch basin.
- Properly located facilities shall be provided for cleansing and disinfecting utensils and hands of all persons handling any product.
Sec. 308.5 Equipment and utensils to be easily cleaned; those for inedible products to be so marked; evaluation of equipment and utensils; PCB-containing equipment.
- Equipment and utensils used for preparing or otherwise handling any edible product or ingredient thereof in any official establishment shall be of such material and construction as, in the judgment of the Administrator, will facilitate their thorough cleaning and insure cleanliness in the preparation and handling of all edible products and otherwise avoid adulteration and misbranding of such products. In addition to these requirements, equipment and utensils shall not in any way interfere with or impede inspection procedures. Receptacles used for handling inedible material shall be of such material and construction that, in the judgment of the Administrator, their use will not result in adulteration of any edible product or in insanitary conditions at the establishment, and they shall bear conspicuous and distinctive marking to identify them as only for such use and shall not be used for handling any edible product.
- When equipment or utensils for use in preparing or handling product are proposed for use in an official establishment, the operator of the establishment shall so notify the Administrator, and thereafter shall submit to the Administrator such information as the Administrator specifies in each case as necessary to determine whether the equipment or utensils meet the criteria specified in paragraph (a) of this section. The required information shall include, but may not be limited to, assembly type drawings and a list showing the materials of which parts are made. The Administrator will evaluate the model of equipment or utensil and determine whether it is acceptable for its proposed use under the criteria set forth in paragraph (a) of this section.
- The Administrator will, from time to time, prepare a listing by name and model number of equipment and utensils that have been evaluated and found to be acceptable for their proposed use in accordance with this section. A copy of such listing can be obtained from Technical Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
- The Administrator may disapprove for use in official establishments particular models of equipment or utensils that he finds do not meet the requirements of paragraph (a) of this section or that he cannot evaluate because of lack of sufficient information. Further, he may prescribe such conditions for the use of particular models of equipment or utensils, either on a trial or permanent basis, as he finds necessary to prevent adulteration or misbranding of product.
- Nothing in this section shall affect the authority of Program inspectors to reject specific equipment or utensils under Sec. 308.15 of the regulations in this subchapter.
- Before approval of any model or specific item of equipment or utensil is finally denied, or is granted only with conditions, the applicant shall be given notice and opportunity to present his views to the Administrator. If the applicant does not accept the Administrator's determination, a hearing in accordance with the applicable rules of practice will be held to resolve such dispute. This shall not preclude rejection of the equipment or utensils under Sec. 308.15 or this section pending the outcome of the presentation of views or hearing.
- New or replacement equipment or machinery (including any replacement parts) brought onto the premises of any official establishment shall not contain liquid polychlorinated biphenyls (PCBs) in concentrations above 50 parts per million by weight of the liquid medium. This provision applies to both food processing and nonfood processing equipment and machinery, and any replacement parts for such equipment and machinery. Totally enclosed capacitors containing less than 3 pounds of PCBs are exempted from this prohibition.
Sec. 308.6 Scabbards for knives.
Scabbards and similar devices for the temporary retention of knives, steels, triers, etc., by workers and others at official establishments shall be constructed of rust-resisting metal or other impervious material, shall be of a type that may be readily cleaned, and shall be kept clean.
Sec. 308.7 Rooms, compartments, etc., to be clean and sanitary.
Rooms, compartments, places, equipment, and utensils used for preparing, storing, or otherwise handling any product, and all other parts of the establishment, shall be kept clean and in sanitary condition. There shall be no handling or storing of materials which create an objectionable condition in rooms, compartments, or places where any product is prepared, stored, or otherwise handled.
Sec. 308.8 Operations, procedures, rooms, clothing, utensils, etc., to be clean and sanitary.
- Operations and procedures involving the preparation, storing, or handling of any product shall be strictly in accord with clean and sanitary methods.
- Rooms and compartments in which inspections are made and those in which livestock are slaughtered or any product is prepared shall be kept sufficiently free of steam and vapors to enable Program employees to make inspections and to insure clean operations. The walls, ceilings, and overhead structure of rooms and compartments in which product is prepared, handled, or stored shall be kept reasonably free from moisture to prevent dripping and contamination of product.
- Butchers and others who dress or handle diseased carcasses or parts shall, before handling or dressing other carcasses or parts, cleanse their hands with liquid soap and hot water, and rinse them in clean water. Implements used in dressing diseased carcasses shall be thoroughly cleansed with hot water having a minimum temperature of 180 deg.F. or in a disinfectant approved by the Administrator,2 followed by rinsing in clean water. The employees of the establishment who handle any product shall keep their hands clean, and in all cases after visiting the toilet rooms or urinals shall wash their hands before handling any product or implements used in the preparation of product.
- Aprons, frocks, and other outer clothing worn by persons who handle any product shall be of material that is readily cleansed. Clean garments shall be worn at the start of each working day and the garments shall be changed during the day when required by the inspector in charge.
- Such practices as spitting on whetstones; spitting on the floor; placing skewers, tags, or knives in the mouth; inflating lungs or casings with air from the mouth; or testing with air from the mouth such receptacles as tierces, kegs, or casks, containing or intended as containers of any product, are prohibited. Only mechanical means may be used for such testing. Care shall be taken to prevent the contamination of product with perspiration, hair, cosmetics, medications, and similar substances.
- Equipment or substances which generate gases or odors shall not be used in official establishments except as permitted by the regulations in this part or by the circuit supervisor in specific cases in which he determines that such use will not result in adulteration of any product.
2A list of approved disinfectants is available upon request to the Scientific Services, Meat and Poultry Inspection, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
Sec. 308.9 Protective handling of products.
Products shall be protected from contamination from any source such as dust, dirt, or insects during storage, loading, or unloading at and transportation from official establishments.
Sec. 308.10 Slack barrels and similar containers and means of conveyance used for product; paper in contact with product.
- When necessary to avoid contamination of product with wood splinters or similar contaminants, slack barrels and similar containers and the cargo space of trucks, railroad cars, or other means of conveyance shall be lined with suitable material of good quality before packing.
- Slack barrels and similar containers and trucks, railroad cars, and other means of conveyance in which any product is transported shall be kept in a clean and sanitary condition.
- Paper used for covering or lining slack barrels and similar containers and the cargo space of trucks, railroad cars, or other means of conveyance shall be of a kind which does not tear during use but remains intact when moistened by the product and does not disintegrate.
Sec. 308.11 Burlap wrapping for meat.
Since burlap used without any other material as a wrapping for meat deposits lint on the meat and does not sufficiently protect it from outside contamination, the use of burlap as a wrapping for meat will not be permitted unless the meat is first wrapped with a good grade of paper or cloth of a kind which will prevent contamination with lint or other foreign matter.
Sec. 308.12 Second-hand tubs, barrels, and other containers.
Second-hand tubs, barrels, and boxes intended for use as containers of any product shall be inspected when received at the official establishment and before they are cleaned. Those showing evidence of misuse rendering them unfit to serve as containers for food products shall be rejected. The use of those showing no evidence of previous misuse may be allowed after they have been thoroughly and properly cleaned. Steaming, after thorough scrubbing and rinsing, is essential to cleaning tubs and barrels.
Sec. 308.13 Inedible operating and storage rooms; outer premises, docks, driveways, approaches, pens, alleys, etc.; flybreeding material; other conditions.
All operating and storage rooms and departments of official establishments used for inedible materials shall be maintained in acceptably clean condition. The outer premises of every official establishment, including docks and areas where cars and vehicles are loaded, and the driveways, approaches, yards, pens, and alleys, shall be properly paved and drained and kept in clean and orderly condition. All catch basins on the premises shall be of such construction and location and shall be given such attention as will insure their being kept in acceptable condition as regards odors and cleanliness. Catch basins shall not be located in departments where any product is prepared, handled, or stored. The accumulation on the premises of official establishments of any material in which flies may breed, such as hog hair, bones, paunch contents, or manure, is forbidden. No other conditions that may result in adulteration of product or interfere with inspection shall be allowed in any official establishment or on its premises.
Sec. 308.14 Employment of diseased persons.
No operator of an official establishment or other person preparing product in an official establishment shall employ, in any department where any product is handled or prepared, any person showing evidence of a communicable disease in a transmissible stage, or known to be a carrier of such a disease, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiological contaminants.
Sec. 308.15 Tagging insanitary equipment, utensils, rooms or compartments.
When, in the opinion of a Program employee, any equipment, utensil, room, or compartment at an official establishment is unclean or its use would be in violation of any of the regulations in this subchapter, he will attach a ``U.S. Rejected'' tag thereto. No equipment, utensil, room, or compartment so tagged shall again be used until made acceptable. Such tag so attached shall not be removed by anyone other than a Program employee.
Sec. 308.16 Sanitation requirements for electrical stimulating (EST) equipment.
- Hide-on stimulation. Automatic and manually operated equipment may be used to apply electrical stimulation to the hide-on surface of slaughtered carcasses provided no opening cuts other than the stick wound or foot removal have been made in the carcass. If the hide is penetrated by electrodes, the penetrated tissue shall be trimmed. Disinfection of electrodes between each hide-on carcass stimulation is not necessary.
- Hide-off stimulation. (1) Automatic or manually operated equipment may be used to apply electrical stimulation to carcasses after complete hide removal. Partially skinned carcasses shall not be stimulated.
- If stimulation is applied before the carcass has been inspected, the carcass contact surfaces of the equipment shall be disinfected with a disinfectant approved by the Administrator3 before stimulation of the next carcass. In the event that carcass contact surfaces of the equipment cannot be cleaned and disinfected between carcass stimulations, those surfaces shall be immediately removed from contact with the exposed carcass and cleaned and disinfected before carcass contact is resumed.
- If stimulation is applied after the carcass has been inspected, carcass contact surfaces of the equipment need not be disinfected with a disinfectant approved by the Administrator before stimulation of the next carcass. Carcass contact surfaces shall be maintained in a clean and sanitary condition.
- Preventing product contamination. Carcass contamination of edible tissue by stomach contents, feces and/or urine is unacceptable. To prevent such occurrences, any of the following optional procedures may be used before stimulation to prevent this contamination:
- Leave the sphincter muscles intact;
- Cut the rectum and the urethra free from surrounding tissue and securely tie each off;
- Partially open the mid-line and/or saw the brisket to reduce pressure on the visceral organs; or
- Any other pressure-relieving or discharge-restricting alternative acceptable to the Administrator. Alternatives should be presented in writing, through the inspector-in-charge, to the Program for approval.
- Cleaning. All equipment must be thoroughly cleaned at least daily.
3 A list of approved disinfectants is available upon request from the Facilities, Equipment and Sanitation Division, Technical Services, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
Sec. 381.45 Minimum standards for sanitation, facilities, and operating procedures in official establishments.
The provisions of Secs. 381.46 and 381.61, inclusive, and part 416 of this chapter shall apply with respect to all official establishments.
Sec. 381.46 Buildings.
- General. The buildings shall be of sound construction and kept in good repair.
- Outside openings.
- The doors, windows, skylights, and other outside openings of the plant, except in receiving rooms and feeding rooms, shall be protected by properly fitted screens or other suitable devices against the entrance of flies and other insects.
- Outside doors, except in receiving rooms and feeding rooms, shall be so hung as to be close fitting when closed. Doors shall be provided with self-closing devices where necessary to prevent the entry of vermin into processing and storage rooms.
Sec. 381.47 Rooms and compartments.
- General. Rooms or compartments used for edible poultry products shall be separate and distinct from inedible products departments and from rooms where live poultry is held or slaughtered. Separate rooms shall be provided when required for conducting processing operations in a sanitary manner; and all rooms shall be of sufficient size to permit the installation of the necessary equipment for processing operations and the conduct of such operations in a sanitary manner.
- Refuse rooms. A separate refuse room, or other equally adequate facilities, shall be provided in official establishments where accumulations of refuse occur. Refuse rooms shall be entirely separate from other rooms in the establishment, have tight-fitting doors, be properly ventilated, and have adequate drainage and cleanup facilities, and the floors and walls to a height of 6 feet above the floor shall be impervious to moisture, and walls above that height, and ceilings shall be moisture resistant.
- Rooms for holding carcasses for further inspection. Rooms or other acceptable facilities in which carcasses or parts thereof are held for further inspection shall be in such numbers and such locations as the needs of the inspection in the establishment may require. These rooms or facilities shall be equipped with hasps for locking.
- Coolers and freezers. Coolers and freezers shall be of such size and capacity as are required for compliance with the provisions set forth in Sec. 381.66. Freezing rooms, other than those for plate freezers or liquid freezing, shall have forced air circulation, and freezers and coolers shall be equipped with floor racks, pallets or other means which will assure that the poultry products will not be adulterated.
- Rooms for mechanical deboning of raw poultry. Rooms or compartments where mechanical equipment for deboning of raw poultry is operated shall be maintained at 50 deg.F. or less.
- Storage and supply rooms. The storage and supply rooms shall be kept in good repair, dry, orderly, and sanitary.
- Boiler room. The boiler room shall be a separate room where necessary to prevent dirt and objectionable odors entering from it into any room where dressed poultry or other poultry products are processed, otherwise handled, or stored.
- Toilet rooms. Toilet rooms, opening directly into rooms where poultry products are exposed shall have self-closing doors and shall be ventilated to the outside of the building.
- Lunch rooms. Lunches and snacks shall not be eaten in processing, packing, or supply rooms. If needed, separate rooms or areas shall be provided in establishment where employees eat their lunches.
Sec. 381.48 Floors, walls, ceilings, etc.
- Floors. All floors in rooms where exposed poultry products are processed or handled shall be constructed of, or finished with, materials impervious to moisture, so they can be readily and thoroughly cleaned. The floors in killing, ice cooling, ice packing, eviscerating, cooking, boning, and cannery rooms shall be graded for complete runoff with no standing water.
- Walls, posts, partitions, doors. All walls, posts, partitions, and doors in rooms where exposed poultry products are processed or otherwise handled shall be smooth and constructed of materials impervious to moisture to a height of 6 feet above the floor to enable thorough cleaning. All surfaces above this height must be smooth and finished with moisture-resistant material.
- Ceilings. Ceilings must be moisture resistant in rooms where exposed poultry products are processed or otherwise handled, and finished and sealed to prevent collection of dirt or dust that might sift through from the floor above or fall from collecting surfaces on equipment or exposed poultry product.
Sec. 381.49 Drainage and plumbing.
- General. There shall be an efficient draining and plumbing system for the plant and premises.
- Outside premises. The drainage system must permit the quick runoff of all water from buildings, and of surface water around the official establishment and on the premises; and all such water shall be disposed of in such a manner as to avoid the development of insanitary conditions at the establishment.
- Drainage of sewage and plant wastes. (1) All drains and gutters shall be properly installed with approved traps and vents. The sewer system shall have adequate slope and capacity to remove readily all waste from the various processing operations and to minimize or, if possible, prevent stoppage and surcharging of the system. When the sewage disposal system is a private system which is required to be approved by a State or local health authority, the applicant shall furnish the Administrator a letter from the proper health authority indicating that the sewage disposal system is acceptable to such authority
- Interceptor traps which are connected with the sewer system shall be suitably located, and not near any edible poultry products department or in any area where edible poultry products are unloaded from or loaded into any means of conveyance. To facilitate cleaning, such traps shall have inclined bottoms and be provided with suitable covers.
- Each floor drain shall be equipped with a deep seal trap, and the plumbing shall be installed so as to prevent sewage from backing up and flooding the floor, except that floor drains in areas not regularly washed down will be acceptable without deep seal traps: Provided, That such drains are connected to secondary drainage systems discharging into a safe sink or basin (air gap) that is properly trapped and vented: And provided further, That such drains accomplish the objectives and intent of this paragraph.
- Toilet soil lines shall be separate from house drainage lines to a point outside the buildings unless an automatic backwater check valve is installed to prevent backflow. Drainage from toilet bowls and urinals shall not be discharged into a grease catch basin, nor shall such drainage be permitted to enter the sewer lines at a point where there might be a possibility of such drainage backing up and flooding the floor of the building.
Sec. 381.50 Water supply.
- General: Except as provided in paragraph (e) of this section, the water supply shall be ample, clean, and potable with adequate pressure and facilities for its distribution in the official establishment and its protection against contamination and pollution. A water report, issued under the authority of the State health agency, certifying to the potability of the water supply, shall be obtained by the applicant and furnished to the Administrator whenever such report is required by the Administrator in specific cases.
- An adequate supply of hot water to enable proper cleaning shall be available.
- Hose connections with steam and water mixing valves or hot water hose connections shall be provided at convenient locations throughout the plant for cleaning purposes.
- The refuse rooms shall be provided with adequate facilities for washing refuse cans and other equipment in the rooms.
- Nonpotable water is permitted only in those parts of official establishments where no poultry product is processed or otherwise handled and then only for limited purposes such as on condensers not connected with the potable water supply, in vapor lines serving inedible product rendering tanks, and in sewer lines for moving heavy solids in the sewage. Nonpotable water is not permitted for washing floors, areas, or equipment, nor is it permitted in boilers, scalders, chill vats, or icemaking machines. In all cases, nonpotable water lines shall be clearly identified and shall not be cross connected with the potable water supply unless this is necessary for fire protection. Any such connection must have an adequate break to assure against accidental contamination, and must be approved by local authorities and by the Administrator. Any untested water supply in an official establishment shall be treated as a nonpotable supply.
- The circuit supervisor may permit the reuse of water in equipment where such water is used to thermally process canned product packed in hermetically sealed containers, provided:
- The reuse is for the identical original purpose.
Sec. 381.51 Lavatories, toilets, and other sanitary facilities.
- Modern lavatory and toilet accommodations and properly located facilities for cleaning utensils and hands shall be provided.
- Adequate lavatory and toilet accommodations, including but not being limited to, running hot and cold water, soap, or other acceptable agents (in sanitary dispensers), toilet tissue, and towels or other acceptable facilities for drying hands, shall be provided. Lavatories shall be in or near toilet and locker rooms and also at other places in the plant as may be essential to the cleanliness of all personnel handling poultry products.
- Adequate lockers or other facilities, shall be provided for employees' wearing apparel, and for the storing and changing of clothing. Wearing apparel shall not be stored in rooms where processing operations are conducted.
- Suitable containers shall be provided for the temporary storage of soiled linen, coats, aprons, and other items of employees' uniforms or work clothing.
- Sufficient containers of metal or other acceptable impervious material shall be provided for used towels and other wastes.
- An adequate number of hand washing facilities shall be provided in areas where poultry products are prepared. Hand washing facilities accepted in accordance with the procedures set forth in Sec. 381.53 may be used in such areas, provided that if hand-activated facilities are used, the hand-contact element must be rinsed automatically with a sufficient volume of water to remove all fat, tissue, debris, and other extraneous material from the hand contact element after each use. Both hot and cold running water shall be available at each inspection station on the eviscerating line and shall be delivered through a suitable mixing device controlled by the inspector. Alternatively, water for hand washing shall be delivered to such inspection stations at a minimum temperature of 65 deg.F.
- Durable signs shall be posted conspicuously in each toilet room and locker room directing employees to wash their hands before returning to work.
- Adequate toilet facilities shall be provided and the following formula shall serve as a basis for determining the number of toilet bowls required:
Number of persons of same sex
Minimum number of facilities
l to 9 1 l0 to 24 2 25 to 49 3 50 to 74 4 75 to l00 5 Over l00 1 for each additional 30 persons
Where 10 or more are employed, urinals may be substituted for the toilet bowls specified in the foregoing formula, except that the number of toilet bowls in such cases may not be reduced to less than two-thirds of the number specified. Two feet of trough urinal shall be considered as equivalent to one individual urinal.
- Suitable sanitary drinking water facilities shall be provided.
- All toilets, lavatories, and other sanitary facilities shall be kept clean and in good repair.
Sec. 381.52 Lighting and ventilation.
- There shall be ample light, either natural or artificial or both, of good quality and well distributed, and sufficient ventilation for all rooms and compartments to insure sanitary conditions.
- All rooms in which poultry is killed, eviscerated, or otherwise processed shall have at least 30 foot-candles of light intensity on all working surfaces, except that at the inspection stations such light intensity shall be of 50 foot-candles. In all other rooms there shall be provided at least 5 foot-candles of light intensity when measured at a distance of 30 inches from the floor.
- All rooms shall be adequately ventilated to eliminate objectionable odors and minimize moisture condensation.
Sec. 381.53 Equipment and utensils.
- Equipment and utensils used for processing or otherwise handling any edible poultry product or ingredient thereof, in any official establishment shall comply with any applicable provisions of paragraphs (c) through (m) of this section and otherwise shall be of such material and construction as, in the judgment of the Administrator, will facilitate their thorough cleaning and insure cleanliness in the preparation and handling of all edible poultry products and avoid adulteration and misbranding of such products. In addition to these requirements, equipment and utensils shall not in any way interfere with or impede inspection procedures. Receptacles used for handling inedible products shall be of such material and construction that, in the judgment of the Administrator, their use will not result in adulteration of any edible product or in unsanitary conditions at the establishment, and they shall bear conspicuous and distinctive marking to identify them as only for such use and shall not be used for handling any edible poultry products.
- When equipment or utensils for use in preparing or handling product are proposed for use in an official establishment, the operator of the establishment shall so notify the Administrator, and thereafter shall submit to the Administrator such information as the Administrator specifies in each case as necessary to determine whether the equipment or utensils meet the criteria specified in paragraph (a)(1) of this section. The required information shall include, but may not be limited to, assembly type drawings and a list showing the materials of which parts are made. The Administrator will evaluate the model of equipment or utensil and determine whether it is acceptable for its proposed use under the criteria set forth in paragraph (a)(1) of this section.
- The Administrator will, from time to time, prepare a listing by name and model number of equipment and utensils that have been evaluated and found to be acceptable for their proposed use in accordance with this section. A copy of such listing can be obtained from Technical Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
- The Administrator may disapprove for use in official establishments particular models of equipment or utensils that he finds do not meet the requirements of paragraph (a)(1) of this section, or that he cannot evaluate because of lack of sufficient information. Further, he may prescribe such conditions for the use of particular models of equipment or utensils, either on a trial or permanent basis, as he finds necessary to prevent adulteration or misbranding of product.
- Nothing in this section shall affect the authority of Inspection Service inspectors to reject specific equipment or utensils under Sec. 381.99 of the regulations in this subchapter.
- Before approval of any model or specific item of equipment or utensil is finally denied, or is granted only with conditions, the applicant shall be given notice and opportunity to present his views to the Administrator. If the applicant does not accept the Administrator's determination, a hearing in accordance with the applicable rules of practice will be held to resolve such dispute. This shall not preclude rejection of the equipment or utensils under Sec. 381.99 or this section pending the outcome of the presentation of views or hearing.
- Refuse containers. Leakproof refuse containers with covers shall be provided, except that perforated containers may be used for the temporary collection of feathers and such containers need not be covered.
- Scalding equipment. (1) Scalding tanks shall be constructed and installed so as to prevent contamination of potable water lines and to permit water to enter continuously at a rate which will result in a sanitary scalding operation. The rate of flow necessary to maintain a sanitary scalding operation will be determined on such factors as the class of poultry and the number of birds per minute going into the scalding tank. It shall be the responsibility of the inspector in charge to establish a minimum rate of flow for each scalding tank in each official establishment.
- The overflow outlets in scalding equipment shall be of sufficient size to permit feathers and water to be carried off.
- The overflow, drawoff valves, and sediment basin drain shall discharge into a floor or valley drain, or onto the floor in proximity to a floor or valley drain.
- Wax finishing. When wax dipping is used, metal troughs shall be provided to catch the wax removed from the dipped poultry. Acceptable facilities and methods shall be employed in reclaiming the wax.
- Ice shovels. Ice shovels shall be smooth surfaced and entirely constructed of rustproof, impervious material.
- Conveyors used in the preparation of ready-to-cook poultry shall be of metal or other acceptable material and of such construction as to permit easy identification of the viscera with their carcass and so designed as will present each carcass or all parts thereof in a way that will permit adequate and efficient inspection.
- Overhead conveyors shall be so constructed and maintained that they will not allow grease, oil, or dirt to accumulate on the drop chain or shackle, which shall be of noncorrosive metal.
- Nonmetallic belt-type conveyors used in moving poultry products shall be of waterproof composition.
- When eviscerated on a conveyor, each carcass shall be suspended and a trough or other acceptable facilities for maintaining proper sanitation shall be provided beneath the conveyor. Such troughs or other facilities shall be flushed or cleaned in an acceptable manner and shall extend beneath the conveyor at all places where processing operations are conducted from the point where the carcass is opened to the point where the viscera have been completely removed.
- Chilling and thawing tanks. Chilling and thawing tanks shall be constructed of metal or other suitable material impervious to moisture and shall be of sanitary construction with edges rolled outward. Where mechanical devices are not used for removing carcasses from the chilling or thawing tanks, the tanks shall be of a size that will enable employees to remove poultry without entering the tanks.
- Tables. Inspection, eviscerating, and cutting tables shall be made of metal or other acceptable material, have coved corners, and be constructed and placed so as to permit thorough cleaning.
- Plants lacking conveyors. In plants where no conveyors are used, each carcass shall be eviscerated in an individual metal tray of seamless construction or in a tray of other acceptable material and construction.
- Water spray washing equipment. Water spray washing equipment with sufficient water pressure to thoroughly and efficiently wash carcasses shall be used for washing carcasses inside and out.
- Offal receptacles. Watertight receptacles constructed of metal or other acceptable impervious material shall be used for entrails and other waste resulting from preparation of eviscerated poultry.
- Receptacles for condemned carcasses. Watertight receptacles for holding or handling condemned carcasses or parts of carcasses shall be so constructed as to be readily and thoroughly cleaned; such receptacles shall be marked in a conspicuous manner with the words ``U.S. Condemned'' in letters not less than 2 inches high and when required by the inspector in charge, shall be equipped with facilities for locking and sealing.
Sec. 381.54 Accessibility of equipment.
- General. All equipment shall be placed so as to be readily accessible for all processing and cleaning operations.
- Mechanical pickers. When mechanical pickers are used, they shall be installed so as to be accessible for thorough cleaning and removal of the accumulation of feathers.
Sec. 381.55 Restrictions on use of equipment and utensils.
Equipment and utensils used in the official establishment shall not be used outside the official establishment, except under conditions prescribed or approved by the Administrator in specific cases. Equipment used in the preparation of any article (including, but not limited to, animal food), from inedible material shall not be used outside of the inedible products department except under such conditions as may be prescribed or approved by the Administrator in specific cases.
Sec. 381.56 Maintenance of sanitary conditions and precautions against contamination of poultry products; PCB-containing equipment.
- The premises of the official establishment shall be kept free from refuse, waste materials, and all other sources of odors and conditions that may result in adulteration of the poultry products handled at the establishment.
- New or replacement equipment or machinery (including any replacement parts) brought onto the premises of any official establishment shall not contain liquid polychlorinated biphenyls (PCBs) in concentrations above 50 parts per million by weight of the liquid medium. This provision applies to both food processing and nonfood processing equipment and machinery, and any replacement parts for such equipment and machinery, totally enclosed capacitors containing less than 3 pounds of PCBs are exempted from this prohibition.
Sec. 381.57 Cleaning of rooms and compartments.
Rooms, compartments, and other parts of the official establishment shall be kept clean and in sanitary condition and good repair.
Sec. 381.58 Cleaning of equipment and utensils.
- Equipment and utensils used for processing or otherwise handling any poultry or poultry product shall be kept clean, sanitary, and in good repair.
- Batteries and dropping pans shall be cleaned regularly and the manure removed from the official establishment daily.
- Scalding tanks shall be completely emptied and thoroughly cleaned as often as may be necessary, but not less frequently than once a day when in use.
- All equipment and utensils used in the killing, roughing, and pinning rooms shall be thoroughly washed and cleaned at least once daily when in use.
- The chilling and packing room and equipment and utensils used therein shall be maintained in a clean and sanitary condition.
- Chilling or thawing tanks shall be emptied after each use. They shall be thoroughly cleaned at least once daily when in use, except that when the same poultry is held therein in excess of 24 hours, the tanks shall be thoroughly cleaned after the poultry is removed therefrom and prior to reuse.
- Conveyor trays or belts which come in contact with raw poultry products shall be completely washed and sanitized after each use.
- Tables, shelves, bins, trays, pans, knives, and all other tools and equipment used in the processing of poultry products shall, after cleaning, be drained on racks and trays and pans shall not be nested.
Sec. 381.59 Vermin.
Every practicable precaution shall be taken to exclude flies, rats, mice, and other vermin from the official establishment. Dogs, cats, and other pets shall be excluded from rooms where dressed poultry or other poultry products are processed, handled, or stored.
Sec. 381.60 Use of compounds.
Germicides, insecticides, rodenticides, detergents, or wetting agents or other similar compounds may be used in an official establishment only if they will not deleteriously affect the poultry or poultry products therein and have been approved by the Administrator. Such compounds shall be used only in a manner satisfactory to the Administrator. Such compounds shall be approved, for the purpose of the Act only upon application and in accordance with the following procedure:
- The manufacturer or user of the compound, or any other interested person, shall submit to the Administrator the following data:
- The formula of the compound, listing each ingredient and the percentage of each ingredient in terms of weight or liquid measure, if the product is a liquid, and in terms of weight, if it is solid or semisolid, viscous, or a mixture of liquid and solids. The ingredients must be stated in terms of the well-known common names of the ingredients or if an ingredient has no common name, the correct chemical name. However, in the case of any compound subject to the Federal Insecticide, Fungicide, and Rodenticide Act, a statement of the composition of the compound as required for registration under that Act shall be submitted in lieu of the data otherwise required by this subparagraph.
- A certification by the applicant that the compound as it is proposed to be used in the official establishment will not deleteriously affect the poultry or poultry products therein. The certification shall include the conditions under which the particular compound is believed to be satisfactory for use and the precautions, if any, necessary in the use of such compound for the purpose intended in poultry processing establishments.
- As a prerequisite for approval, any compound which is required to be registered under the provisions of the Federal Insecticide, Fungicide, and Rodenticide Act shall be registered and comply with the provisions of that Act. The applicant shall furnish the registration number assigned under the aforesaid Act along with two copies of the label being currently used on the product.
- A small sample of the compound (4 to 6 ounces) shall be submitted with the request for approval of its use in poultry processing establishments.
- The Administrator will either approve or disapprove the use of a particular compound after a careful evaluation of the data submitted pursuant to paragraph (a) of this section and consideration of any other information that is available pertaining to the compound under consideration.
- The Inspection Service is authorized to draw samples of any compound used in any official establishment and make analyses of such compound to determine if the compound conforms to that originally approved and if it is satisfactory for use in official establishments under this section. Whenever the Administrator has reason to believe that a compound may have a deleterious effect on poultry or poultry products, the approval of the particular compound may be suspended, and in such case the processor shall be given an opportunity to show that the compound does not have such effect. After such opportunity has been afforded to the processor, the Administrator shall make a determination as to the effect of the compound on poultry and poultry products and withdraw or reinstate the approval of the compound accordingly. Use of the compound shall not be permitted during the period of suspension.
Sec. 381.61 Cleanliness and hygiene of official establishment personnel.
- No official establishment shall employ, in any department where any poultry product is processed or otherwise handled, any person showing evidence of a communicable disease in a transmissible stage or known to be a carrier of such disease, or while affected with boils, sores, infected wounds, or other abnormal sources of microbiological contaminants.
- All persons coming in contact with exposed poultry products, or poultry products handling equipment shall wear clean garments and suitable head coverings to prevent hair from falling into poultry products; and shall keep their hands and fingernails clean at all times while thus engaged.
- Every person shall wash his hands thoroughly after each use of toilet or change of garments before returning to duties that require the handling of dressed poultry or other poultry products or containers thereof, or poultry product handling equipment.
- The use of tobacco in any form, the eating of food, or any other personal habit which may result in adulteration of any poultry product shall not be permitted in any room where exposed dressed poultry or other poultry products are being processed or otherwise handled.
- Establishments are responsible for ensuring the safety and efficacy of nonfood compounds and proprietary substances.
- Nonfood compounds and proprietary substances should not adulterate meat or poultry;
- Should not create or lead to inspection interference;
- Should not create or lead to conditions of insanitation;
- Should be safe and effective under the conditions of use;
- Should be identified, and stored in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
- Product labeling from suppliers should clearly provide identity of product, the address of manufacturer or supplier, and intended use.
- All working and storage containers of nonfood compounds and proprietary substances should be clearly and individually identified with the product name or common name of the material.
- Materials that are: known human carcinogens; mutagens or teratogens classified as hazardous substances; heavy metals; or hazardous compounds classified as extremely or super toxic, should not be allowed in the plants unless it is established that the substance will not become a component of edible product according to the levels exempted under the threshold of regulation process indicated in Title 21 CFR Section 170.39.
Cleaners are used frequently throughout the plant both in processing and non-processing areas. They are needed to maintain sanitary conditions to assure an environment conducive to the production of safe, wholesome, unadulterated food product. Examples of cleaners and their previous numerical designations from the discontinued List of Proprietary Substances and Nonfood Compounds follow.
- Formerly "A1" Compounds for use as general cleaning agents on all surfaces, or for use with steam or mechanical cleaning devices in all departments.
- Formerly "A2" Compounds for use only in soak tanks or with steam or mechanical cleaning devices in all departments.
- Formerly "A3" Acid cleaners for use in all departments.
- Formerly "A4" Floor and wall cleaners for use in all departments.
- Formerly "A5" Floor and wall cleaners for subfreezing temperatures.
- Formerly "A6" Scouring cleaners.
- Formerly "A8" Degreasers or carbon removers for food cooking or smoking equipment, utensils, or other associated surfaces.
- Formerly "K1" Cleaning and/or degreasing solvents for use in nonprocessing areas.
- Cleaners should be formulated to be safe and appropriate for the intended use.
- Cleaners should not contain undesirable microorganisms.
- Cleaners should be formulated so that rinsing will be sufficient to ensure effective removal of cleaning solution from food contact surfaces and removal of residual odors from food processing areas.
- Use of special purpose cleaners classified as hazardous materials should be limited to the amount and frequency only sufficient for the required effect. Personnel protection provisions and precautions to prevent food and food contact surfaces from contamination and residuals should be specified; use should be in accordance with manufacturer's labeling instructions and precautions.
- Use of hazardous substances containing fluorine compounds, such as hydrofluoric acid, hydrofluosilic acid, or ammonium bifluoride, to remove siliceous scale deposits or for similar cleaning purposes should be in accordance with provisions for the special purpose cleaners classified as hazardous materials. Each use should be documented and the substance should not be stored within the plant. Hydrofluoric acid is extremely irritating and corrosive to the skin and mucous membranes. The acid and it salts are highly toxic and may cause death or permanent injury after very limited exposure to small quantities.
- Cleaners consisting primarily of hydrocarbon, chlorinated hydrocarbon or other water immiscible solvents should be limited to use in non-processing areas. Treated food processing equipment and utensils should be washed and thoroughly rinsed with potable water before being returned to a processing area.
- Cleaners formulated to provide very low freezing points such as alcohol or glycol based compounds are appropriate for use on surfaces that do not contact food in areas with subfreezing temperatures. The cleaning solution and solubilized soil should be effectively removed by wiping, wet vacuuming, or other appropriate means.
- Boric acid and salts thereof should be limited to 90% of a cleaner in association with strong acids, strong alkalis, soaps or synthetic detergents.
- General use cleaners as supplied should not have an expected human single oral LD50 of <10mg/kg.
- Labeling should include appropriate use directions.
- Laundry compounds should be formulated so that rinsing instructions will be sufficient to prevent food contamination or inspection interference, and to ensure effective removal of laundry agents from food contact articles, e.g. carcass shrouds.
Hand Care Treatments:
- Formerly "E1" Handwashing compounds for use in all departments.
- Formerly "E2" Handwashing and sanitizing compounds.
- Formerly "E3" Hand sanitizing compounds.
- Formerly "E4" Hand creams, lotions, and cleaners.
- Hand care products formulated with chlorhexidene gluconate and intended to be used as an antimicrobial hand cleaner or hand sanitizer/dip in food handling and processing are considered a "drug" and possibly "new drugs" under the Federal Food, Drug, and Cosmetic Act (FFDCA). These products are subject to registration by the Food and Drug Administration (FDA), OTC Drug Compliance Branch before they can be marketed and used. Establishments should keep registrations on file for review by FSIS inspection personnel.
- Hand care treatments intended for use as a "barrier" or "shield" to prevent or mitigate human disease by protecting skin from exposure to toxic chemicals and/or pathogenic microorganisms are considered "drugs" and "new drugs," under the FFDCA. These products are subject to registration by the FDA before they can be marketed and used. Establishments should keep registrations on file for review by FSIS inspection personnel.
- Hand treatments intended to remain on the hands of food handlers should be formulated in compliance with appropriate food additive regulations, Title 21 of the Code of Federal Regulations (CFR) Section 178.1010, or appropriate GRAS materials.
- Hand sanitizer solutions should be kept clean and maintained at a germicidal equivalence of at least 50 ppm available chlorine as hypochlorite at 20° C (68° F) for one minute.
- Precautions should be taken to ensure hand care stations do not cause direct or indirect contamination of food or food contact surfaces with hand care substances. Therefore, FSIS recommends that only liquid hand cleaners and sanitizers be used in areas where food and food contact surfaces are exposed.
- Hand treatments not formulated in compliance with appropriate food additive regulations should be:
- thoroughly removed from the hands by rinsing in clean potable water, or
- separated from contact with food by the use of gloves that are an effective barrier to migration of the nonfood substance to edible product.
Sanitizers and Disinfectants:
- Formerly "D1" Antimicrobial agents always requiring a rinse.
- Formerly "D2" Sanitizers for all surfaces not always requiring a rinse.
- Chemical sanitizers and other chemical antimicrobials used on food contact surfaces must comply with the 21, CFR Section 178.1010 or appropriate food additive regulations.
- Chemicals used to sanitize food contact surfaces and utensils must comply with 21 CFR 178.1010.
- Sanitizers should only be applied to cleaned surfaces. Sanitized food contact equipment and utensils must be adequately drained, in accordance with 21 CFR 178.1010(a), sufficient to prevent food adulteration.
- EPA registered antimicrobials must include labeling instructions stating that they are appropriate for use in food establishments. Establishments should keep registration documentation on file for review by FSIS inspection personnel.
- Chemical germicides established as meeting efficacy requirements of EPA as both a hospital level disinfectant and a tuberculocide are appropriate for use to decontaminate implements provided:
- Food contact surfaces are subsequently washed and rinsed;
- Appropriate preventative actions are taken to protect edible products and food packaging materials;
- Labeled use directions specify minimum contact time required to meet both registered kill levels.
- Antimicrobial solutions should be kept free of contamination and maintain effectiveness under intended conditions of use.
- Chemical sanitizers should be EPA registered for sanitizing food contact surfaces or otherwise established to provide germicidal efficacy yielding a 5-log10 reduction of representative disease microorganisms of public health importance.
- Chemical sanitization of food contact surfaces should ensure exposure times of at least 10 seconds for chlorine solutions or at least 30 seconds for other chemical sanitizer solutions, or according to EPA registered use directions for food contact surfaces.
- A chlorine sanitizing solution should have a minimum temperature based on the concentration and pH of the solution as listed in the following chart; or as specified under EPA registered label use instructions.
|pH of 10 or less
° C(° F)
|pH of 8 or less
° C(° F)
Insecticides, Rodenticides, and similar Pesticides:
- Formerly "F1" Nonresidual pesticides.
- Formerly "F2" Residual pesticides.
- Formerly "F3" Rodenticides for controlled use only.
- Formerly "F4" Fumigants for controlled use only.
- Formerly "F5" Fumigants for controlled use only.
These products are toxic by design, in varying degrees, and should be applied and stored in such a manner as to prevent adulteration of food product, and contamination of food contact equipment and packaging material. All containers used to store, dilute, dispense, or transport pesticides should be clearly labeled. Re-use of containers for other purposes are prevented by destruction of container or other means sufficient to render containers unfit for reuse.
- Pesticides must be EPA registered with labeling instructions and precautions pertinent to its use in food establishments.
- Restricted-use pesticides must be used only under the control of certified applicators (as defined in 7 USC 136 (e)).
- Pesticides must be used in accordance with specific registered label uses and precautions and should not be applied during establishment production hours.
- Dry bait rodenticides should be secured in tamper-resistant stations.
- Powdered or granular insecticides should be colored distinctly (traditionally, blue or green) to distinguish pesticide from edible substances, unless provided in labeled dispenser containers.
- To minimize the possibility of undetected contamination of food products, all liquid baits, and dry baits in which the inert ingredients consist mainly of meal or floor, should be distinctly colored. Where inert ingredients consist mainly of whole or cracked grain, or flour or meal pressed into cakes or pellets that do not have characteristics of food products, no addition of color is necessary.
- Pesticidal tracking materials should not be used in a food establishment. The concern here is that product contact surfaces, utensils, linens, and direct contact packaging materials may become contaminated through transfer of tracking material from pests.
- Nonpesticidal tracking materials should have a distinct color (traditionally blue or green) to distinguish it from edible substances, and may not contaminate food equipment, utensils, linens, and single-service and single-use articles.
- Treated areas should be sufficiently ventilated. Facilities, equipment, utensils, etc. should be thoroughly washed after pesticide application.
- Pest control programs and treatments should be recorded with details sufficient to document compliance with appropriate requirements and provide trace back capability in the event of accidental contamination's.
- Formerly "G1" General potable water treatment compounds.
- Formerly "G2" Phosphate potable water treatment compounds.
- Formerly "G3" Silicate potable water treatment compounds.
- Formerly "G4" Chlorine potable water treatment compounds.
- Formerly "G5" Cooling and retort water treatment compounds.
- Formerly "G6" Compounds for treating boilers, steam lines, where the steam produced may contact edible products and/ or cooling systems where the treated water may not contact edible products.
- Formerly "G7" Compounds for treating boilers, steam lines, and/or cooling systems where neither the treated water nor the steam produced may contact edible products. This does not include compounds added to water used to cook and cool containers of meat and poultry products.
- Boiler water treatments where the steam may contact food must be formulated in compliance with 21 CFR, Section 173.310.
- Ion-exchange resins used for water purification must be formulated in compliance with 21 CFR, Section 173.25.
- Additives used in water in which fruits and vegetables are washed must be formulated in compliance with CFR 21, Section 173.315 and defoamers found in 21 CFR, Section 173.340(a)(2).
- Additives used in water for preflushing of animal casings must be GRAS.
- Processing additives are appropriate for use provided that the quantities of these compounds are controlled, monitored and limited to the amount sufficient for the purpose of such use.
- Processing additives for potable water treatments should be composed of appropriate substances which are prior sanctioned by FDA or GRAS and limited to the following:
- In potable water, phosphate should not exceed 10ppm, silicate should not exceed 10ppm, and chlorine should not exceed 5ppm.
- In other processing applications, chlorine should not exceed 50ppm in carcass wash and 20ppm on trimmed or reprocessed poultry carcasses.
- Compounds containing the sodium or potassium salts of nitrate, sulfite, bisulfite or metabisulfite should be decharacterized so their effect on the heme pigments in meat products is prevented. Decharacterization may be achieved by the addition of colorant to prevent mishandling or by other means such as creation of a basic environment to prevent the formation of acid species of these additives.
- Additives containing nitrite, borate, and nitrate containing treatments for nonprocessing water should be colored distinctly (traditionally, blue or green) to avoid accidental misuse.
- Formerly "H1" Lubricants with incidental contact.
- Formerly "H2" Lubricants with no contact.
- Formerly "H3" Soluble oils.
- Lubricants intended for incidental food contact must comply with 21 CFR, Section 178.3570.
- Lubricants used on food contact surfaces should have appropriate food additive status:
- formulated from an edible oil ( for example: an over the counter food grade oil such as corn oil, olive oil, or canola oil to name a few).
- mineral oil complying with 21 CFR, Section 172.878
- or substances which are GRAS.
- Lubricants should be limited to the amount sufficient for the technical purpose.
- Lubricants should be applied to food contact equipment, which requires lubrication, in a manner that does not contaminate food contact surfaces.
- Formerly "J1" Absorbents or antislip agents for spot application to floors.
Anti-slip compounds are intended for spot application to floors and are limited to the floor area where the hazard exists. They may be used provided their use does not result in dusting, tracking, or other objectionable conditions. These compounds should not be used as a substitute for good sanitation and should be removed as part of the routine floor cleaning operation in accordance with the plants SSOP.
- Anti-slip compounds should be adequate to correct temporary hazardous conditions
- should not promote microbial growth or attract or harbor pests
- should be composed of inert material so that any contact with food results only in surface contamination that is easily identified and removable
Letters of Guaranty
Documentation substantiating compound safety and efficacy, such as letters of assurance, are appropriate for all chemical compounds that are used in the areas of food processing, handling, and storage, and that do not otherwise require declaration on food labeling under Title 7 (part 59) and title 9 (parts 317 and 381). A letter of assurance should contain the following:
- Name and address of supplier.
- Brand name, code or other designation which uniquely identifies the compound. Identification should ensure that the specific chemical ingredients of the compound are traceable in the event of food contamination.
- The letter shall state that the material will be safe and effective under the intended conditions of use and will not adulterate food product.
- The letter should specify the applicable limits, if appropriate, under intended conditions of use.
- Signature of an official of the supplying firm.
A supplier's letter of assurance may be limited to a specific shipment, in which case it would be attached to the invoice, or it may be a continuing letter of assurance that need not accompany each shipment. New formulations, or changes in labeling involving product identification or usage, should be accompanied by new letters of assurance.