Authority:
21 USC 451-470,601-695,1031-1056;7 USC 450,1901-1906;7 CFR 2.18,2.53.
Those:
61FR 38868, July 25, 1996, unless otherwise noted.
§ 416.1 General Rules.
Any official facility must be properly operated and maintained to avoid unsanitary conditions and to ensure that the product is not adulterated.
[64FR56417, October 20, 1999]
Section 416.2 Business premises and facilities.
(A) soil and pest control.The premises of a facility must be maintained to avoid conditions that could result in unsanitary conditions, product tampering, or interference with inspection by FSIS program personnel. Facilities must have a pest control program in place to prevent pests from harboring and breeding on-site and within the facility. Pest control products used must be safe and effective under the conditions of use and must not be applied or stored in a manner that would adulterate the product or create unsanitary conditions.
(B) Construction.
(1)The premises of the facility, including its structures, rooms and departments, must be of sound construction, maintained in good condition and of sufficient size to allow processing, handling and storage of the product in a manner that does not lead to adulteration or the creation of unsanitary conditions.
(2)Walls, floors, and ceilings within the facility must be made of durable moisture-proof materials and must be cleaned and sanitized as necessary to prevent product tampering or creating unsanitary conditions.
(3)Walls, floors, ceilings, doors, windows, and other external openings must be constructed and maintained to keep out insects such as flies, rats, and mice.
(4)Rooms or compartments in which edible products are processed, handled, or stored shall be separate and separate from rooms or compartments in which inedible products are processed, handled, or stored to the extent necessary to prevent adulteration of the product and the occurrence of products harmful to health. to avoid conditions.
(C) Luz.In the areas where food is processed, handled, stored or examined, there must be lighting of good quality and sufficient intensity to ensure the maintenance of sanitary conditions and non-handling of the product; where equipment and utensils are cleaned; as well as in hand washing areas, changing rooms and changing rooms and toilets.
(D) Ventilation.Adequate ventilation must be provided to control odors, fumes, and condensation to the extent necessary to prevent adulteration of product and the creation of unsanitary conditions.
(mi) Installation.Plumbing systems must be installed and maintained to:
(1)Bring water in sufficient quantities to the required places throughout the facility;
(2)Adequately drain sewage and single-use liquid waste from the facility;
(3)Avoid tampering with products, water supplies, equipment and utensils, and avoid creating insanitary conditions throughout the facility.
(4)Provide adequate floor drainage in all areas where floors are subject to flood cleaning or where normal operations release or discharge water or other liquid waste onto the floor.
(5)Avoid backflow conditions and cross-connections between piping systems that discharge sewage or sewage and piping systems that carry water for product manufacturing. Is
(6)Avoid the accumulation of sewage gases.
(F) sanitation.Wastewater should be discharged to a sewer system separate from all other drains or otherwise disposed of to prevent accumulation of wastewater in areas where product is processed, handled, or stored. If the septic system is a private system that requires a permit from a state or local health authority, the facility must provide FSIS with the permit letter from that authority upon request.
(GRAMS) Water supply and reuse of water, ice and solutions.
(1)A piped water supply that meets national standards for primary drinking water (40 CFR Telephone 141), if necessary, at the appropriate temperature and pressure, in all areas where it is necessary (for product processing, for cleaning rooms and equipment, utensils and packaging materials, for employee bathrooms, etc.). If the facility uses the municipal water supply system, it must submit to FSIS, upon request, a water report issued by the state or local public health department agency that certifies or certifies the potability of the supply water. If the business uses its own well for its water supply, it must submit proof of the potable water quality of the water, renewed at least every six months, to FSIS upon request.
(2)Water, ice, and solutions (such as brine, liquid smoke, or propylene glycol) used to cool or cook ready-to-eat products may be reused for the same purpose as long as they are kept free of pathogenic organisms and fecal coliforms, other physical contaminants. have reduced the chemical and microbiological properties to avoid adulteration of the product.
(3)Water, ice, and solutions used to cool or wash raw product may be reused for the same purpose provided steps are taken to reduce physical, chemical, and microbiological contamination to prevent product contamination or adulteration. The reuse of what was in contact with the raw product cannot be used in ready-to-eat products.
(4)Purified water, which has never contained human waste and has been treated in an advanced on-site wastewater treatment plant, can be used in the raw product, except for product formulation, and throughout the plant in which both edible and inedible production. areas, provided measures are taken Ensures that this water meets prescribed criteriaParagraph (g)(1)this section. Products, systems, devices, and utensils that come into contact with this water must undergo a separate final rinse with raw water that meets the specified criteria.Paragraph (g)(1)this section.
(5)Any water that has never contained human waste and is free of pathogens can be used in areas with edible and inedible products as long as it does not come into contact with edible products. This recycled water can be used, for example, to move heavy solids, wash the bottom of open pans, or to wash pre-kill areas, livestock pens, trucks, poultry pens, collection aprons, collection room floors, and similar areas within the facility.
(6)Water that does not meet the conditions of useparagraphs (g)(1)through(g)(5)of this section should not be used in areas where edible products are handled or prepared, or in any manner that allows edible products to adulterate or create unsanitary conditions.
(H) Dressing rooms, sinks and bathrooms.
(1)Changing rooms, toilets and urinals must be sufficient, spacious, conveniently located and maintained in a good state of hygiene and in good condition at all times to guarantee the cleanliness of all persons handling a product. They must be separated from the rooms and compartments where the products are processed, stored or handled.
(2)Toilets with hot and cold running water, soap, and towels should be located in or near toilets and urinals and other locations in the facility necessary to ensure cleanliness for all persons handling a product.
(3)Waste containers must be constructed and maintained to protect against insanitary conditions and product adulteration.
[64FR56417, October 20, 1999]
§ 416.3 Devices and installations.
(A)Equipment and utensils used to process or handle edible products or ingredients shall be of a material and construction that will facilitate thorough cleaning and ensure that their use does not cause adulteration of the product during processing, handling, or storage. Equipment and utensils must be kept in hygienic conditions so as not to adulterate the product.
(B)Equipment and devices must not be constructed, arranged, or operated in such a way as to prevent FSIS inspection program personnel from inspecting the equipment or devices for sanitary condition.
(C)Containers used to store non-edible materials must be of such material and construction that their use does not lead to the adulteration of edible products or the creation of unsanitary conditions. These containers must not be used to store edible products and must bear a visible and distinctive mark to identify the permitted uses.
[64FR56417, October 20, 1999]
§ 416.4 Sanitary operations.
(A)All food contact surfaces, including food contact surfaces of utensils and equipment, must be cleaned and sanitized as often as necessary to prevent unsanitary conditions and adulteration of product.
(B)Non-food contact surfaces of equipment, equipment, and utensils used in the operation of the establishment shall be cleaned and sanitized as often as necessary to prevent harmful conditions and product adulteration.
(C)Cleaning agents, disinfectants, processing aids, and other chemicals used by a facility must be safe and effective under the conditions of use. These chemicals must be used, handled, and stored in a manner that does not adulterate the product or create unsanitary conditions. Documentation demonstrating the safe use of a chemical in a food processing environment must be available for review by FSIS inspection program officials.
(D)Product must be protected from tampering during processing, handling, storage, loading and unloading at and during transportation from official facilities.
[64FR56417, October 20, 1999]
§ 416.5 Employee hygiene.
(A) Cleaning.All persons who come in contact with the product, food contact surfaces, and product packaging materials must follow hygienic practices during operations to avoid handling the product and creating unsanitary conditions.
(B) Clothes.Aprons, smocks and other outer garments worn by persons handling the product must be disposable or easy to clean. Clean clothing should be worn at the beginning of each work day and clothing should be changed as often as necessary throughout the day to avoid product tampering and the creation of unsanitary conditions.
(C) disease Control.Anyone who has or appears to have a contagious disease, open lesion, including infected boils, ulcers or sores, or any other abnormal source of microbial contamination, must be excluded from any operation that may result in product adulteration and product manufacturing. unsanitary conditions until the condition is corrected.
[64FR56417, October 20, 1999]
§ 416.6 Identification of unsanitary equipment, utensils, rooms or compartments.
If an FSIS program employee determines that any equipment, paraphernalia, room, or compartment in an official facility is unsanitary or that its use may result in product tampering, they must issue a "U.S. Reject." Equipment, utensils, rooms or compartments so marked shall not be used until accepted. Only an FSIS program employee can issue a "Rejected US."
[64FR56417, October 20, 1999]
§ 416.11 General Rules.
Each official facility shall develop, implement, and maintain written sanitation standard operating procedures (sanitation SOPs) in accordance with the requirements of this part.
§ 416.12 Development of plumbing POP.
(A)Hygiene SOPs must describe all procedures that an official facility performs daily before and during operations to prevent direct contamination or adulteration of products.
(B)Hygiene SOPs must be signed and dated by the person with general authority on site or by a senior official at the facility. This signature will signify that the facility implements the Hygiene SOPs as directed and maintains the Hygiene SOPs in accordance with the requirements of this part. Hygiene SOPs must be signed and dated after initial implementation of the Hygiene SOPs and after changes to the Hygiene SOPs.
(C)The procedures in the hygiene SOPs that must be carried out before the operation must be identified as such and at least refer to the cleaning of the food contact surfaces of the facilities, equipment and utensils.
(D)Hygiene SOPs must indicate the frequency with which each hygiene SOP procedure must be performed and identify the facility personnel responsible for implementing and maintaining those procedures.
§ 416.13 SOP implementation.
(A)Each official facility must perform pre-operational procedures at the POPs for sanitation facilities before starting operations.
(B)Each official body must carry out all the other procedures in the sanitary POPs with the specified frequencies.
(C)Each official body must monitor the implementation of the Hygiene SOP procedures on a daily basis.
§ 416.14 Maintenance of hygiene SOPs.
Each official facility should routinely evaluate the effectiveness of hygiene SOPs and their procedures in preventing direct contamination or adulteration of product and revise them as necessary to keep them effective and current with changes in the facility. equipment, facilities, operations or personnel.
§ 416.15 Corrective actions.
(A)Any official entity shall take appropriate corrective action when the entity or FSIS determines that the entity's hygiene SOPs or procedures, or the implementation or maintenance of hygiene SOPs, may not have prevented direct contamination or adulteration of the products).
(B)Corrective actions include procedures to ensure proper disposal of products that may be contaminated, to restore sanitary conditions, and to prevent recurrence of direct contamination or adulteration of products, including appropriate reassessment and modification of hygiene POPs. and the procedures specified therein or appropriate improvements in the performance of hygiene POPs or the procedures specified therein.
[61FR 38868, July 25, 1996, as amended62 FR26219, May 13, 1997]
Section 416.16 Recordkeeping Obligations.
(A)Each official body should keep sufficient daily records to document the implementation and monitoring of hygiene SOPs and any corrective actions taken. Facility employees identified in the Hygiene SOPs as being responsible for implementing and following the procedures specified in the Hygiene SOPs must certify these records with their initials and date.
(B)The records required by this Part may be maintained on computers provided the facility implements appropriate controls to ensure the integrity of the electronic data.
(C)Records required by this part shall be retained for a minimum of 6 months and made available to FSIS. All such records must be retained at the official facility for 48 hours after completion, after which they may be retained off-site as long as such records can be made available to FSIS within 24 hours of the request.
§ 416.17 Agency review.
FSIS will review the adequacy and effectiveness of the hygiene SOPs and the procedures set forth in them, and determine if they meet the requirements of this part. This exam may include:
(A)review of hygiene SOPs;
(B)Review daily logs documenting the implementation of the Hygiene SOPs and the procedures set forth therein, and any corrective actions taken or required;
(C)Observe directly the implementation of hygiene SOPs and the procedures set forth therein, and any corrective actions taken or expected; Is
(D)Direct observation or tests to assess the sanitary conditions of the establishment.