§ 118.3 Definitions.

For the purposes of this part, the following definitions apply:

(a) "Cacao products" means any form of chocolate, chocolate product, cocoa, or cocoa product. Such foods include but are not limited to cacao nibs, sweet chocolate, milk chocolate, other foods standardized by Part 163 of this chapter, and chocolate sirup. They do not include the raw cacao beans, extracts, flavoring derived from such extracts, and chocolate or cocoa-flavored foods.

(b) "Confectionery" means candy and other food products made with sweeteners, and frequently prepared with colorings, flavorings, milk products, cacao products, nuts, fruits, starches, and other materials. Such foods include but are not limited to frostings, toppings, and cake decorations. They do not include chewing gum, sauces, sirups, jellies, jams, preserves, cakes, or cookies.

(c) "Lot" means a collection of primary containers or units of the same size, type and style, containing finished product produced under conditions as nearly uniform as possible, designated by a common container code or marking, and, in any event no more than a day's production.

(d) "Return" means clean, wholesome product(s) returned to the manufacturer for reprocessing for reasons other than insanitary conditions and which is suitable for use as food.

(e) "Rework" means clean, wholesome product(s) removed from processing for reasons other than insanitary conditions and which is suitable for reprocessing and for use as food.

(f) "Shall" refers to mandatory requirements and “should” refers to recommended or advisory procedures or equipment.

(g) "Waste" means product rejected due to adulteration that renders it unsuitable for use as human food.

Subpart B-Buildings and Facilities § 118.20 Plants and grounds.

Effective measures shall be taken to prevent contamination of products, raw materials, or packaging materials with microorganisms, chemicals, filth,

or other extraneous material. This may be accomplished by separating the following operations by partition, location, air flow, enclosed systems, or other effective means:

(a) Receiving.

(b) Raw material storage.

(c) Cacao bean cleaning, roasting, cooling, cracking, and fanning.

(d) Cacao product milling, pressing, mixing, refining, conching, tempering, and molding.

(e) Pulverizing or separating of cocoa, and other dusty operations.

(f) Cacao product and confectionery processing.

(g) Portable equipment and utensil cleaning and sanitizing.

(h) Packaging and packing. (i) Finished product storage and shipping.

§ 118.35 Sanitation facilities.

(a) Adequate and readily accessible hand washing and sanitizing facilities shall be provided in the plant for employees who may handle unprotected food, unprotected packaging materials, and food-contact surfaces. Such facilities shall be furnished with running water at a suitable temperature for hand washing, effective hand cleaning and sanitizing preparations, sanitary towel service or suitable drying devices, and, where appropriate, refuse receptacles constructed and maintained in a manner to prevent product contamination. These facilities should also be equipped with water control valves so designed and constructed as to prevent recontamination of clean, sanitized hands.

(b) Readily understandable signs directing employees handling unprotected food, unprotected packaging materials, or food-contact surfaces, to wash and sanitize their hands before starting work, after each absence from post of duty, and when their hands may have become soiled or contaminated shall be conspicuously posted in the processing room(s) and in all other areas where employees may handle such materials and surfaces.

(c) Management shall maintain sufficient control to ensure that employees handling unprotected food, unprotected packaging materials, or foodcontact surfaces wash and sanitize

their hands before starting work, after each absence from post of duty, and when their hands may have become soiled or contaminated.

§ 118.37 Sanitary operations.

(a) Cleaning and sanitizing of utensils and equipment shall be carried out in such a manner as to prevent raw material, packaging material, or product contamination.

(b) Food-contact surfaces of equipment used for processing or holding low moisture raw materials or products such as chocolate, fats and oils, liquid nutritive sweeteners, peanut butter, and similar materials which are not conducive to microbial growth shall be maintained in a sanitary condition. When wet cleaning of such equipment may cause conditions conducive to microbial growth, other appropriate cleaning methods shall be utilized to prevent product contamination.

(c) Poisonous or dangerous cleaning compounds, sanitizing agents, and pesticide chemicals shall be applied, stored, and held in such a manner as to prevent food or packaging material contamination. These materials shall be identified and used only in such manner and under such conditions as will be safe for their intended use. Any applicable regulations promulgated by the Environmental Protection Agency for the application, use, or holding of such material shall be followed.

Subpart C-Equipment

§ 118.40 Equipment and procedures.

(a) Food-contact surfaces shall be corrosion-free and made of nontoxic material that will not crack or disintegrate in normal operation and will withstand the environment of its intended use and the action of food ingredients, cleaning compounds, and sanitizing agents. All food-contact surfaces shall be maintained to prevent product contamination and shall be in compliance with section 409 of the act (21 U.S.C. 348) as it pertains to indirect food additives.

(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to prevent microbiological

of

contamination in places where dirt or organic material might accumulate. (c) Nonfood-contact surfaces equipment shall be so constructed that they can be kept in a clean condition. (d) Regulating and/or recording controls, thermometers, other temperature measuring devices, and temperature recording devices on equipment used to pasteurize raw materials or products shall be accurate and effective for their designated uses. The accuracy of temperature controlling, measuring, and recording devices on equipment used to control or prevent undesirable microbial growth in raw materials or finished products shall be within ±2° F.

(e) Each freezer and cold storage compartment used for storing or holding raw materials or products capable of supporting growth of microorganisms shall be fitted with an indicating thermometer, temperature measuring device, or temperature recording device so installed as to show accurately the temperature within the compartment, and should be fitted with an automatic control for regulating temperature or an automatic alarm system to indicate a significant temperature change in a manual operation.

(f) Cooling tunnels on processing lines shall have access doors or other provisions to permit cleaning of the interior.

Subpart D-[Reserved]

Subpart E-Production and Process Controls

§ 118.80 Processes and controls.

The manufacturer shall employ appropriate quality control procedures and treatments to ensure that raw materials and finished products are wholesome and fit for food, that packaging materials are safe and suitable and that all of the foregoing materials are otherwise in compliance with the Federal Food, Drug, and Cosmetic Act.

(a) Handling of raw materials. (1) Milk and milk products shall have been pasteurized before use, and egg products shall have been pasteurized or otherwise treated to destroy viable

Salmonella microorganisms before use, or these materials (i.e., milk, milk products and egg products) shall be pasteurized or otherwise treated during processing operations to destroy pathogenic microorganisms. The manufacturer shall ensure that gelatin, dried coconut, nuts, and other raw materials susceptible to contamination by pathogenic microorganisms are free of such microorganisms before these materials are incorporated into finished products unless these materials are pasteurized or otherwise treated before or during processing operations to destroy pathogenic microorganisms. Compliance with this requirement may be accomplished by purchasing these materials under a supplier's guarantee or certification, or verified by analyzing these materials for pathogenic microorganisms.

(2) The manufacturer shall ensure that peanuts, Brazil nuts, pistachio nuts, filberts, walnuts, almonds, pecans, corn meal, and other raw materials susceptible to aflatoxin contamination comply with current Food and Drug Administration regulations, guidelines, and action levels for poisonous or deleterious substances

before these materials are incorporated into finished products. Compliance with this requirement may be accomplished by purchasing these materials under a supplier's guarantee or certification, or verified by analyzing these materials for aflatoxins.

(3) The manufacturer shall ensure that nuts, raisins, cacao beans, spices, rework, return, and other raw materials susceptible to infestation or contamination by animals, birds, vermin, microorganisms, or extraneous material comply with current Food and Drug Administration regulations, guidelines, and action levels for natural or unavoidable defects before these materials are incorporated into finished products. Compliance with this requirement may be verified by examining these materials for infestation and contamination.

(b) Storing and holding of raw materials. Raw materials shall be held in containers so designed and constructed as to prevent raw material contamination. Raw materials and packaging materials shall be held at such tem

perature and relative humidity and in such a manner as to prevent their adulteration due to contamination or decomposition.

(1) Materials capable of supporting growth of pathogenic microorganisms shall be stored at a temperature below 40° F or above 140° F, except for such period of time actually required for the processing involved and which does not affect the wholesomeness of the raw materials.

(2) Frozen materials shall be kept frozen and should be stored at a temperature of 0° F or below.

(3) Liquid sugars shall be held in such a manner as to prevent microbial growth or any other direct or indirect contamination. Storage tanks for liquid sugars shall have filtered airintake vents.

(4) Liquid mixtures containing egg products or other perishable materials and capable of supporting growth of pathogenic microorganisms shall be held in such a manner as to preclude the growth of these microorganisms or shall be processed in such a manner as to destroy these microorganisms. This may be accomplished by:

(i) Maintaining the mixtures at a temperature below 40° F after removal from storage and disposing of the unused portion at least every 12 hours during operations and at the end of the day's operation; or

(ii) Maintaining the mixture at a temperature below 50° F after removal from storage and disposing of the unused portion at least every 4 hours during operations and at the end of the day's operation; or

(iii) Pasteurizing or otherwise treating the mixtures during processing operations to destroy pathogenic microorganisms.

(c) Processing operations. (1) Frozen egg products shall be defrosted in a sanitary manner and by such methods that their wholesomeness is not adversely affected. This may be accomplished by defrosting at a temperature of 40° F or below, or by defrosting at a temperature above 40° F for a period of time not exceeding 24 hours: Provided, That the temperature in any part of the defrosted liquid does not exceed 50° F.

(2) Processes intended to pasteurize or otherwise treat materials to destroy pathogenic microorganisms shall be scientifically determined to be adequate under the conditions of manufacture for a given product to ensure destruction of such microorganisms.

(3) Rework and return shall be considered as raw materials. They shall be held in properly identified containers in a manner to prevent product contamination.

(4) Waste shall not contribute to direct or indirect product contamination. This may be accomplished by holding the waste in properly identified containers and removing it from the processing area daily.

(5) Effective measures shall be taken to prevent cross contamination between raw materials and finished products or between refuse and these materials. When any of these materials are unprotected they shall not be handled simultaneously in a receiving, loading, or shipping area. Raw materials and products transported by conveyor shall be protected against contamination from extraneous material.

(6) Equipment, containers, and utensils used to convey, process, hold or store raw materials or products shall be handled during processing or storage in such a manner as to prevent raw material or product contamination.

(7) Effective measures shall be taken to prevent the inclusion of metal or other extraneous material in finished products. This may be accomplished by using suitable equipment such as sieves, magnets, electronic metal detectors, or by other effective means.

(8) Effective measures shall be taken to remove extraneous material from molding starch before it is reused in molding operations. This may be accomplished by passing the starch through a sieve and a metal trap or by otherwise treating it to remove extraneous material.

(9) The cooling and winnowing of roasted cacao beans and the processing and storage of cacao nibs shall be carried out in such a manner as to prevent product contamination.

(10) Cacao bean shell, dust, and other residue particles resulting from cracking operations shall be handled

and held in such a manner as to prevent product contamination.

(11) Adulterated materials shall be disposed of in such a manner as to prevent raw material, rework, return, or finished product contamination, or shall be reconditioned, if feasible, and then reexamined and found to be wholesome before being incorporated into finished products.

(d) Coding. Permanently legible code marks shall be placed at a readily visible location on each shipping container or they shall be placed on each finished product package delivered or displayed to retail purchasers and be visible on the unopened package. The code marks may be placed in both locations if desired by the manufacturer. Such marks shall identify at least the plant where packed and the product lot or packaging lot.

60-052 0-80--9

§ 122.1 Current good manufacturing practice.

(a) The criteria in Part 110 of this chapter shall apply in determining whether the facilities, methods, practices, and controls used for the manufacture, processing, packing, or holding of fish and seafood products are in conformance with and are operated or administered in conformity with good manufacturing practice to produce, under sanitary conditions, food for human consumption.

(b) The criteria in this part set forth additional requirements for the hotprocess smoked or hot-process smokeflavored fish industry.

§ 122.3 Definitions.

For the purposes of this part, the following definitions apply:

(a) "Smoked fish" means any fish that is prepared by treating it with salt (sodium chloride) and then subjecting it to the direct action of smoke from burning wood, sawdust, or similar material.

(b) "Smoke-flavored fish” means any fish that is prepared by treating it with salt (sodium chloride) and then imparting to it the flavor of smoke by other than the direct action of smoke. This paragraph does not alter the labeling requirements under § 101.22 of this chapter.

(c) "Loin muscle" means the longitudinal quarter of the great lateral muscle freed from skin, scales, visible blood clots, bones, gills, and viscera and from the nonstriated part of such muscle, which part is known anatomically as the median superficial muscle.

(d) "Water phase salt" means the percent salt (sodium chloride) in the finished product as determined by the method described in sections 18.009 and 18.010 of the "Official Methods of Analysis of the Association of Agricultural Chemists," 10th edition, page 273 (1965), multiplied by 100 and divided by the percent salt (sodium chloride) plus the percent moisture in the finished product as determined by the method described in section 18.006 of said edition.

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

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