the edible product departments, the operations incident to the manufacture of the uninspected article will be subject to the same sanitary requirements that apply to all operations in edible product departments. The manufacture of the uninspected article shall be limited to those hours during which the establishment operates under inspectional supervision; and there shall be no handling, other than receiving at the official establishment, of any of the product ingredient of the uninspected article, other than during the regular hours of inspection. The materials used in the manufacture of the uninspected article shall not be used so as to interfere with the inspection of edible product or the maintenance of sanitary conditions in the department or render any edible product adulterated. The meat, meat byproducts, and meat food product ingredients of the uninspected article may be admitted into any edible products department of an official establishment only if they are U.S. Inspected and Passed. Products within § 314.11 of this subchapter or parts of carcasses of kinds not permitted under the regulations in this subchapter to be prepared for human food (e.g., lungs or intestines), which are produced at any official establishment, may be brought into the inedible products department of any official establishment for use in uninspected articles under this section. The uninspected article may be stored in, and distributed from, edible product departments: Provided, That adequate facilities are furnished, there is no interference with the maintenance of sanitary conditions, and such article is properly identified.

(b) When dog food or similar uninspected article is manufactured in a part of an official establishment other than an edible product department, the area in which the article is manufactured shall be separated from edible product departments in the manner required for separation between edible product departments and inedible product departments. Sufficient space must be allotted and adequate equipment provided so that the manufacture of the uninspected article does not interfere with the proper functioning of the other operations at

the establishment. Except as provided in § 314.11 of this subchapter, nothing in this paragraph shall be construed as permitting any deviation from the requirement that dead animals, condemned products, and similar materials of whatever origin, must be placed in the inedible product rendering equipment, and without undue delay. The manufacture of the uninspected article must be such as not to interfere with the maintenance of general sanitary conditions on the premises, and it shall be subject to inspectional supervision similar to that exercised over other inedible product departments. There shall be no movement of any product from an inedible product department to any edible product department. Trucks, barrels, and other equipment shall be cleaned before being returned to edible product departments from inedible product departments. Unoffensive material prepared outside edible product departments may be stored in, and distributed from, edible product departments only if packaged in clean, properly identified, sealed containers.

(c) Animal food shall be distinguished from articles of human food, so as to avoid distribution of such animal food as human food. To accomplish this, such animal food shall be labeled or otherwise identified in accordance with § 325.11(d) of this subchapter.

[35 FR 15586, Oct. 3, 1970, as amended at 36 FR 11639, June 17, 1971; 53 FR 24679, June 30, 1988]

§ 318.13 Mixtures containing product but not amenable to the Act.

Mixtures containing product but not classed as a meat food product under the Act shall not bear the inspection legend or any abbreviation or representation thereof unless manufactured under the food inspection service provided for in part 350 of subchapter B of this chapter. When such mixtures are manufactured in any part of an official establishment, the sanitation of that part of the establishment shall be supervised by Program employees, and the manufacture of such mixtures shall not cause any deviation from the requirement of § 318.1.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 29215, Oct. 23, 1973]

§ 318.14 Adulteration of product by polluted water; procedure for handling.

(a) In the event there is polluted water (including but not limited to flood water) in an official establishment, all products and ingredients for use in the preparation of such products that have been rendered adulterated by the water shall be condemned.

(b) After the polluted water has receded from an official establishment, all walls, ceilings, posts, and floors of the rooms and compartments involved, including the equipment therein,

shall, under the supervision of an inspector, be cleaned thoroughly by the official establishment personnel. An adequate supply of hot water under pressure is essential to make such cleaning effective. After cleaning, a solution of sodium hypochlorite containing approximately one-half of 1 percent available chlorine (5,000 p/m) or other equivalent disinfectant approved by the Administrator' shall be applied to the surface of the rooms and equipment and rinsed with potable water before use.

(c) Hermetically sealed containers of product which have been contaminated by polluted water shall be examined promptly by the official establishment under supervision of an inspector and rehandled as follows:

(1) Separate and condemn all product in damaged or extensively rusted containers.

(2) Remove paper labels and wash the remaining containers in warm soapy water, using a brush where necessary to remove rust or other foreign material. Disinfect these containers by either of the following methods:

(i) Immerse in a solution of sodium hypochlorite containing not less than 100 p/m of available chlorine or other equivalent disinfectant approved by the Administrator,1 rinse in potable water, and dry thoroughly; or

'A list of approved disinfectants is available upon request to Scientific Services, Meat and Poultry Inspection Program, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, D.C. 20250.

(ii) Immerse in 212° F. water, bring temperature of the water back to 212° F. and maintain the temperature at 212° F. for 5 minutes, then remove containers from water and cool them to 95° F. and dry thoroughly.

(3) After handling as described in paragraph (c)(2) of this section, the containers may be relacquered, if necessary, and then relabeled with approved labels applicable to the product therein.

(4) The identity of the canned product shall be maintained throughout all stages of the rehandling operations to insure correct labeling of the contain

ers.

[35 FR 15586, Oct. 3, 1970, as amended at 38 FR 34455, Dec. 14, 1973]

§ 318.15 Tagging chemicals, preservatives, cereals, spices, etc., "U.S. retained."

When any chemical, preservative, cereal, spice, or other substance is intended for use in an official establishment, it shall be examined by a Program employee and if found to be unfit or otherwise unacceptable for the use intended, or if final decision regarding acceptance is deferred pending laboratory or other examination, the employee shall attach a "U.S. retained" tag to the substance or container thereof. The substance SO tagged shall be kept separate from other substances as the circuit supervisor may require and shall not be used until the tag is removed, and such removal shall be made only by a Program employee after a finding that the substance can be accepted, or, in the case of an unacceptable substance, when it is removed from the establishment.

§ 318.16 Pesticide chemicals and other residues in products.

(a) Nonmeat ingredients. Residues of pesticide chemicals, food additives and color additives or other substances in or on ingredients (other than meat, meat byproducts, and meat food products) used in the formulation of products shall not exceed the levels permitted under the Federal Food, Drug, and Cosmetic Act, and such nonmeat ingredients must otherwise be in compli

ance with the requirements under that Act.

(b) Products, and meat, meat byproduct, or other meat food product ingredients. Products, and products used as ingredients of products, shall not bear or contain any pesticide chemical, food additives, or color additive residue in excess of the level permitted under the Federal Food, Drug, and Cosmetic Act and the regulations in this subchapter, or any other substance that is prohibited by such regulations or that otherwise makes the products adulterated.

(c) Standards and procedures. Instructions specifying the standards and procedures for determining when ingredients of finished products are in compliance with this section shall be issued to the inspectors by the Administrator. Copies of such instructions will be made available to interested persons upon request made to the Administrator.

(b) Cooked beef, including sectioned and formed roasts and chunked and formed roasts, and cooked corned beef shall be moist cooked throughout the process or, in the case of roast beef or corned beef to be roasted, cooked as provided in paragraph (c) of this sec tion. The moist cooking may be accomplished by (1) placing the meat in a sealed, moisture impermeable bag, removing the excess air, and cooking, (2) completely immersing the meat, unbagged, in water throughout the entire cooking process, or (3) using a sealed oven or steam injection to raise the relative humidity above 90 percent throughout the cooking process.

(c) Roast beef or corned beef to be roasted shall be cooked by one of the following methods:

(1) Heating roasts of 10 pounds or more in an oven maintained at 250° F (121° C) or higher throughout the process;

(2) Heating roasts of any size to a minimum internal temperature of 145° F (62.8° C) in an oven maintained at any temperature if the relative humid ity of the oven is maintained either by continuously introducing steam for 50 percent of the cooking time or by use of a sealed oven for over 50 percent of the cooking time, or if the relative hu midity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour; or

(3) Heating roasts of any size in an oven maintained at any temperature that will satisfy the internal temperature and time requirements of paragraph (a) of this section if the relative humidity of the oven is maintained at 90 percent or above for at least 25 percent of the total cooking time, but in no case less than 1 hour.

The

relative humidity may be achieved by use of steam injection or by sealed ovens capable of producing and maintaining the required relative humidity.

(d)(1) Except as provided in paragraph (d)(2) of this section, establishments producing cooked beef, roast beef, or cooked corned beef shall have sufficient monitoring equipment, including recording devices, to assure that the time (within 1 minute), the temperature (within 1° F), and relative humidity (within 5 percent) limits of these processes are being met. Data from the recording devices shall be made available to a program employee upon request.

(2) In lieu of recording devices, establishments may propose in the written procedures prescribed in paragraph (f) of this section, an alternative means of providing inspection personnel with evidence that finished product has been prepared in compliance with the humidity requirements of paragraphs (b) and (c) of this section, and the 145° F (62.8° C) temperature requirements of paragraph (a) of this section.

(e) Each package of finished product shall be plainly and permanently marked on the immediate container with the date of production either in code or with the calendar date.

(f) In order to assure that cooked beef, roast beef, and cooked corned beef are handled, processed, and stored under sanitary conditions, the establishment shall submit a set of written procedures through the inspector-in-charge for approval by the Regional Director. The written procedures shall include the following information:

(1) The temperature to which raw frozen product is thawed and the time required.

(2) The lot identification procedure for lots of product during processing.

(3) The storage time and temperature combinations which the establishment intends to use before cooking, the cooking time and temperature the establishment intends to use, and the time, if any, the establishment intends to wait after cooking and before cooling.

(4) If a code, instead of the calendar date, is used on the immediate container of the finished product, its meaning shall also be included.

(5) Any other critical control points in the procedures which could affect the safety of the product.

(6) In lieu of recording devices, the alternate means permitted by § 318.17(d)(2) of providing evidence to inspection personnel that the finished product will be prepared in compliance with temperature or humidity requirements.

(7) Any other alternate procedure used that is permitted in this section.

(g) The establishment shall maintain records and reports which document the time, temperature, and humidity at which any cooked beef, roast beef, or cooked corned beef is cooked and cooled at the establishment. Such records shall be kept by the establishment for 6 months or for such further period as the Administrator may require for purposes of any investigation or litigation under the Act, by written notice to the person required to keep such records. Such records shall be made available to the inspector or any duly authorized representative of the Secretary upon request.

(h) The handling and processing of cooked beef, roast beef, and cooked corned beef before, during, and after cooking shall be such as to prevent the finished product from being adulterated. As a minimum, they shall be controled as follows:

(1) The establishment shall notify the inspector-in-charge which processing procedure will be used on each lot, including time and temperature.

(2) In order to assure uniform heat penetration and consequent adequate cooking of each piece of beef, individual pieces of raw product in any one lot shall either not vary in weight by more than 2 pounds or not vary in thickness by more than 2 inches at the thickest part. Alternate methods of assuring uniform heat penetration may be submitted in writing for approval to the Regional Director.

(3) A water-based solution that is used for injecting or immersing the meat shall be refrigerated to 50° F (10° C) or lower from the time it contacts

the meat, and shall be filtered each time it is recirculated or reused.

(4) A nonmeat ingredient, including the water-based solution in (h)(3) above, which has contacted meat shall be discarded at the end of that day's production unless it is in continuous contact with one batch of product.

(5) Product prepared for cooking shall be entered into the cooking cycle within 2 hours of completion of precooking preparation, or be placed immediately in a cooler at a temperature of 40° F (4.4° C) or lower.

(6) The time and temperature requirements shall be met before any product in the lot is removed from the cooking units. Unless otherwise specified in the written procedures approved in accordance with paragraph (f) of this section, the heat source shall not be shut off until these requirements are met.

(7) Other than incidental contact caused by water currents during immersion cooking or cooling, product shall be placed so that it does not touch or overlap other products. This provision does not apply to product that is stirred or agitated to assure uniform heat transfer.

(8) Temperature sensing devices shall be so placed that they monitor product in the coldest part of the cooking unit; and when an oven temperature is required by paragraph (c) of this section, the oven temperature shall also be monitored in the coldest part of the cooking unit.

(9) If a humidity sensing device is required in an oven, it shall be placed so that it measures humidity in either the oven chamber or at the exit vent. (10) Chilling shall begin within 90 minutes after the cooking cycle is completed.

(i) All product shall be chilled from 120° F (48.8° C) to 55° F (12.7° C) in no more than 6 hours.

(ii) Chilling shall continue and the product shall not be packed for shipment until it has reached 40° F (4.4° C).

(11) Any establishment that has experienced a cooking process deviation during preparation of product may either reprocess the product completely, continue the heating to 145° F (62.8° C), or contact the Regional Di

rector for a review of the process schedule for adequacy and, if needed, for a cooking schedule to finish that one batch of product.

(12) An establishment that has experienced a cooling deviation after the product has been cooked shall contact the Regional Director to determine the disposition of that retained product.

(i) Cooked beef, roast beef, and cooked corned beef shall be so handled as to assure that the product is not recontaminated by direct contact with raw product. To prevent direct contamination of the cooked product, establishments shall:

(1) Physically separate areas where raw product is handled from areas where exposed cooked product is handled, using a solid impervious floor to ceiling wall; or

(2) Handle raw and exposed cooked product at different times, with a cleaning of the entire area after the raw material handling is completed and prior to the handling of cooked product in that area; or

(3) Submit a written procedure for approval through the inspector-incharge to the Circuit Supervisor detailing the steps to be taken which would avoid recontamination of cooked product by raw product during processing.

(j) To prevent indirect contamination of cooked product:

(1) Any work surface, machine, or tool which contacts raw product shall be thoroughly cleaned and sanitized with a solution germicidally equivalent to 50 ppm chlorine before it contacts cooked product;

(2) Employees shall wash their hands and sanitize them with a solution germicidally equivalent to 50 ppm chlorine whenever they enter the heat processed product area or before preparing to handle cooked product, and as frequently as necessary during operations to avoid product contamination; and

(3) Outer garments, including aprons, smocks, and gloves, shall be especially identified as restricted for use in cooked product areas only, changed at least daily, and hung in a designated location when the employee leaves the area.