product as determined by the method described in section 18.006 of that edition. Copies of the material incorporated by reference are available from the Division of Food Technology, Bureau of Foods (HFF-210), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, or available for inspection at the Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.

(e) "Hot-process smoked or hot-process smoke-flavored fish" means the finished food prepared by subjecting E forms of smoked fish referred to in paragraphs (a) and (b) of this section to heat as prescribed in § 122.80(d).

300

[42 FR 14352, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19, 1982]

Subpart B-Buildings and Facilities

§ 122.20 Plants and grounds.

(a) Unloading platforms shall be: (1) Made of readily cleanable material.

(2) Equipped with drainage facilities adequate to accommodate all seepage and wash water.

(b) The following processes should be carried out in separate rooms or facilities, and the interior walls separating these processes should extend from floor to ceiling and contain only necessary openings (such as for conveyors and doorways):

(1) Receiving or shipping.
(2) Storage of raw fish.

(3) Presmoking operations (thawing, dressing, brining, etc.).

(4) Drying and smoking.

(c) The following processes shall be carried out in separate room or facilities, and the interior walls separating these processes shall extend from floor to ceiling and contain only necessary openings (such as for conveyors and doorways):

(1) Cooling and packing.
(2) Storage of final product.

(d) The product shall be so processed as to prevent contamination by exposure to areas, utensils, or equipment, involved in earlier processing steps, refuse, or other objectionable areas.

§ 122.35 Sanitary facilities.

(a) Adequate hand-washing and sanitizing facilities shall be located in the processing room(s) or in one area easily accessible from the processing room(s).

(b) Readily understandable signs directing employees to wash and sanitize their hands after each absence from post of duty shall be conspicuously posted in the processing room(s) and elsewhere in the plant as conditions require.

(c) Offal shall be placed in suitable covered containers for removal at least once a day, or more frequently if necessary, or shall be removed by conveyors or chutes. Offal, debris, or refuse from any source whatever shall not be allowed to accumulate in or about the plant.

§ 122.37 Sanitary operations.

(a) Before beginning the day's operation, all utensils and product-contact surfaces of equipment to be used for the day's operation shall be rinsed and sanitized.

(b) Containers used to convey or store fish shall not be nested while they contain fish or otherwise handled during processing or storage in a manner conducive to direct or indirect contamination of their contents.

(c) Cleaning and sanitizing of utensils and portable equipment should be conducted in an area set aside for these purposes and shall be carried out in such a manner as to prevent contamination of the fish or fish prod

(2) An indicating thermometer so installed as to show accurately the temperature within the compartment.

(3) A recording thermometer so installed as to indicate accurately at all times the temperature within the compartment.

(d) Thermometers or other temperature-measuring devices shall have an accuracy of ±2° F.

Subpart D-[Reserved]

Subpart E-Production and Process Controls

§ 122.80

Processes and controls.

(a) Raw materials. (1) Fresh fish received shall be inspected and adequately washed before processing. Only sound, wholesome fish free from adulteration and organoleptically detectable spoilage shall be processed.

(2) Every lot of fish that has been partially processed in another plant, including frozen fish, shall be adequately inspected, and only clean, wholesome fish shall be processed.

(3) Fresh or partially processed fish, except those to be immediately processed, shall be iced or otherwise refrigerated to an internal temperature of 38° F or below upon receipt and shall be maintained at that temperature until the fish are to be processed.

(4) All fish received in a frozen state shall be either thawed promptly and processed, or stored at a temperature that will maintain it in a frozen state.

(b) Defrosting of frozen fish. (1) Defrosting shall be carried out in a sanitary manner and by such methods that the wholesomeness of the fish is not adversely affected. Frozen fish shall be defrosted:

(i) In air at 45° F or below until other than hard frozen; or

(ii) In air so that the temperature in any part of the fish does not exceed 45° F; or

(iii) In a continuous water-overflow thaw tank or spray system in such a manner that the temperature in any part of the fish does not exceed 45° F.

(2) When a thaw tank is used, fish should not remain in the tank longer than one-half hour after they are completely defrosted.

(3) Fish entering the thaw tanks shall be free of exterior packaging material and substantially free of liner material.

(4) After thawing, fish shall be washed thoroughly with a vigorous water spray or a continuous waterflow system.

(c) Presmoking operation. (1) Evisceration of fish shall be performed with minimum disturbance of intestinal tract contents. Removal of viscera shall be complete.

(2) After the evisceration process, the fish (including the body cavity) shall be thoroughly washed with a vigorous water spray or a continuous waterflow system.

(3) All fish shall be dry-salted at a temperature not to exceed 38° F throughout the fish, or shall be brined in such a manner that the temperature of the fish and the brine:

(i) Does not exceed 60° F at the start of brining, and

(ii) If between 38° F and 50° F at the start of brining, is continuously lowered to 38° F or below within 12 hours, and

(iii) If between 50° F and 60° F at the start of brining, is continuously lowered to 50° F or below within 2 hours and to 38° F or below within the following 10 hours, and

(iv) Does not rise above 38° F after reaching that temperature or below either prior to or during the brining operation.

(4) Hot-process smoked or hot-process smoke-flavored fish shall be brined in such a manner that the final salt (sodium chloride) content of the loin muscle of the finished product, expressed as percent in the water phase of the loin muscle, shall not be less than:

(i) 3.5 percent if heat-processed as prescribed under paragraph (d)(2)(i) of this section; or

(ii) 5.0 percent if heat-processed as prescribed under paragraph (d)(2)(ii) of this section.

(5) Fish shall be rinsed with fresh water after brining.

(d) Heating, cooking, smoking operation. (1) A point-sensitive, continuous temperature-recording device shall be used to monitor both the internal temperature of the fish and the ambient

temperature within the oven. Each recording-device record shall be identified as to the specific oven load and date processed.

(2) Hot-process smoked or hot-process smoke-flavored fish shall be heated by a controlled heat process that provides a monitoring system positioned in as many strategic locations in the oven as necessary to assure a continuous temperature throughout each fish of:

(i) Not less than 180° F for a minimum of 30 minutes for hot-process smoked or hot-process smoke-flavored fish which have been brined to contain 3.5 percent water phase salt in the finished product as prescribed in paragraph (c)(4)(i) of this section, except that smoked chub containing sodium nitrite as provided for in § 172.177 of this chapter shall be processed in accordance with that section; or

(ii) Not less than 150° F for a minimum of 30 minutes for hot-process smoked or hot-process smoke-flavored fish which have been brined to contain 5.0 percent water phase salt in the finished product as prescribed in paragraph (c)(4)(ii) of this section.

(e) Packing. (1) The finished product shall be handled only with clean, sanitized hands, gloves, or utensils.

(2) Manual manipulation of the finished product shall be kept to a mini

mum.

(3) The finished product shall be cooled to a temperature of 50° F or below within 3 hours after cooking and further cooled to a temperature of 38° F or below within 12 hours after cooking, and this temperature shall be maintained during all subsequent storage and distribution.

(4) The shipping containers, retail packages, and shipping records shall indicate by appropriate labeling the perishable nature of the product and shall specify that the product shall be shipped, stored, and/or held for sale at 38° F or below until consumed.

(5) Permanently legible code marks shall be placed on the outer layer of every finished product package and master carton. Such marks shall identify at least the plant where packed, the date of packing, and the oven load. Records shall be so maintained as to provide positive identification (1) of

the process procedures used for the manufacture of hot-process smoked or hot-process smoke-flavored fish and (ii) of the distribution of the finished product.

(f) Testing. (1) Microbiological examination of in-line and finished product samples should be conducted with sufficient frequency to assure that processing steps and sanitary procedures are adequate.

(2) The finished product shall be analyzed chemically with sufficient frequency to assure that the required salinity is obtained in every fish and that other chemical additives are present at authorized levels.

§ 123.20 Plants and grounds.

(a) Unloading platforms shall be: (1) Made of a readily cleanable material.

(2) Equipped with drainage facilities adequate to accommodate all seepage and wash water.

(b) The product shall be so processed as to prevent contamination by exposure to areas involved in earlier processing steps, refuse, or other objectionable areas.

§ 123.35 Sanitary facilities and controls.

(a) Adequate hand-washing and sanitizing facilities shall be located in the processing area, easily accessible from the peeling and subsequent processing operations.

(b) Readily understandable signs directing employees handling shrimp to wash and sanitize their hands after each absence from post of duty shall be conspicuously posted in the peeling and subsequent processing areas and elsewhere in the plant as conditions require.

(c) Offal, debris, or refuse from any source whatsoever shall not be allowed to accumulate. Offal shall be placed in suitable, covered containers and shall be removed not less than once daily or

shall be continuously removed by flumes, conveyors, or chutes.

§ 123.37 Sanitary operations.

(a) Batter application equipment, except that prescribed under § 123.80(d)(3), shall be flushed and sanitized at least every 4 hours during plant operations. All batter application equipment shall be cleaned and sanitized at the end of the day's operation.

(b) Breading application equipment and utensils, excluding holding tanks and pneumatic systems, shall be thoroughly cleaned and sanitized at the end of the day's operation.

(c) All utensils used in processing and product-contact surfaces of equipment shall be thoroughly cleaned and sanitized at least every 4 hours during operation; however, this shall not apply to equipment for which other specific minimum cleaning times are established or to freezing equipment.

(d) Before beginning the day's operation, all utensils and product-contact surfaces of equipment, except for those prescribed under paragraph (b) of this section, shall be rinsed and sanitized.

(e) Containers used to convey or store food shall not be handled in a manner conducive to direct or indirect contamination of the contents.

Subpart C-Equipment

§ 123.40 Equipment and procedures.

(a) All food-contact surfaces (tanks, belts, tables, flumes, utensils, and other equipment) shall be of metal or other readily cleanable materials.

(b) All seams shall be smoothly soldered, welded, or bonded to prevent accumulation of shrimp, shrimp material, and debris.

(c) Each freezer and cold storage compartment used for raw materials, materials in process, or finished products shall be fitted with at least the following:

(1) An automatic control for regulating temperature, or an automatic alarm system to indicate a significant temperature change in a manual operation.

(2) An indicating thermometer so installed as to show accurately the temperature within the compartment.

(3) A recording thermometer so installed as to indicate accurately at all times the temperature within the compartment.

(d) Thermometers or other temperature measuring devices shall have an accuracy of ±2° F.

Subpart D-[Reserved]

Subpart E-Production and Process Controls

§ 123.80

Processes and controls.

(a) Raw materials. (1) Fresh shrimp shall be adequately washed, inspected, and culled to remove shrimp that are filthy, putrid, or decomposed, and to remove all nonshrimp material.

(2) Every lot of shrimp that has been partially processed in another plant, including frozen shrimp, shall be inspected, and only cleaned, wholesome shrimp shall be processed.

(3) Fresh or partially processed shrimp shall be iced or otherwise refrigerated to maintain the shrimp at a temperature of 40° F or below until they are to be processed.

(4) Frozen shrimp shall be stored at a temperature of 0° F or below.

(5) Ingredients capable of supporting rapid bacterial growth shall be examined to assure that only clean, wholesome materials are used in production.

(b) Defrosting of frozen shrimp. (1) Defrosting shall be carried out in a sanitary manner and by such methods that the wholesomeness of the shrimp is not adversely affected; for example, in air at 45° F or below until other than hard frozen or in a continuous waterflow thaw tank or spray system.

(2) When a thaw tank is used, shrimp should not remain in the tank any longer than one-half hour after they are thawed.

(3) Shrimp entering the thaw tank should be free of exterior packaging material and substantially free of liner material.

(4) On removal from the thaw tank, shrimp shall be washed with a vigorous water spray.

(c) Peeling operation. (1) Shrimp shall be peeled into flumes that immediately transport the meat portion from the machines or peeling tables, except that shrimp may be peeled into seamless containers if the peeled meats are not held in such containers for more than 20 minutes before being flumed or conveyed from peeling tables. If shrimp are peeled into such containers, the containers shall be cleaned and sanitized as often as necessary to maintain them in a sanitary condition, but in no case less frequently than every 3 hours. Whenever a peeler is absent from his post of duty, the container used by such peeler shall be cleaned and sanitized before peeling is resumed.

(2) Sanitary drainage shall be provided to remove liquid waste from the peeling tables.

(3) Peeled shrimp being transported from one building of the plant to another shall be properly iced or refrigerated, covered, and protected.

(d) Batter and breading operation. (1) Shrimp shall be washed with a lowvelocity spray or in unrecirculated flowing water at 50° F or below just prior to the initial batter or breading application, whichever comes first, except in those instances where a predust application is included in the process.

(2) In removing the batter or breading mixes or other dry ingredients from multiwalled bags:

(i) The outer layer of the bag shall first be removed.

(ii) The bag shall be slit in the exposed area and the contents removed without contact with the seam ends or closures.

(iii) If the entire contents are not removed at one time, the remainder shall be protected against contamination.

(3) Batter in enclosed equipment that assures a batter temperature of not more than 40° F shall be disposed of at the end of each work day, but under no circumstances less often than every 12 hours.

(4) Batter, except for that prescribed under paragraph (d)(3) of this section, shall be maintained at a temperature of 50° F or below and shall be disposed of at least every 4 hours during oper