9
Animals and Animal Products
2
2017-01-01
2017-01-01
false

PREPARATION AND PROCESSING OPERATIONS
424

PART 424
Animals and Animal Products
FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE
REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT
Pt. 424

PART 424—PREPARATION AND PROCESSING OPERATIONS

Subpart A—General
Sec.
424.1
Purpose and scope.

Subpart C—Food Ingredients and Sources of Radiation
424.21
Use of food ingredients and sources of radiation.
424.22
Certain other permitted uses.
424.23
Prohibited uses.

Authority:
7 U.S.C. 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.

Source:
64 FR 72175, Dec. 23, 1999, unless otherwise noted.

Subpart A—General
§ 424.1
Purpose and scope.
This part of the regulations prescribes rules for the preparation of meat and the processing of poultry products. The rules in this part further the purposes of the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) by, among other things, preventing the adulteration or misbranding of meat and poultry products at official establishments. 9 CFR Chapter III, Subchapter A, Parts 318 and 319, Subpart C of this part, and 21 CFR Chapter I, Subchapter A or Subchapter B, specify rules for the use of certain food ingredients (e.g., food additives and color additives) and sources of radiation that may render meat or poultry products adulterated or misbranded.

Subpart C—Food Ingredients and Sources of Radiation
§ 424.21
Use of food ingredients and sources of radiation.
(a)(1) General. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, part 318 or part 319 of this chapter, or by the Administrator in specific cases.
(2)(i) Poultry products and poultry broth used in the processing of poultry products shall have been processed in the United States only in an official establishment or imported from a foreign country listed in § 381.196(b), and have been inspected and passed in accordance with the regulations. Detached ova and offal shall not be used in the processing of any poultry products, except that poultry feet may be processed for use as human food in a manner approved by the Administrator in specific cases and detached ova may be used in the processing of poultry products if the processor demonstrates that such ova comply with the requirements of the Federal Food, Drug, and Cosmetic Act.
(ii) Liquid, frozen, and dried egg products used in the processing of any poultry product shall have been prepared under inspection and be so marked in accordance with the Egg Products Inspection Act.
(3)(i) Carcasses, parts thereof, and products of cattle, sheep, swine, goats, or equines may be used in the processing of poultry products only if they were prepared in the United States in an official meat packing establishment or imported from a foreign country listed in § 327.2(b), were inspected and passed in accordance with the Federal Meat Inspection Act and the regulations under such Act (subchapter A of this chapter), and are so marked.
(ii) Pork from carcasses or carcass parts used as an ingredient in poultry products that has been found free of trichinae, as described under § 318.10 (a)(2), (e) and (f) of the Federal meat inspection regulations (9 CFR 318.10 (a)(2), (e) and (f)), is not required to be treated for the destruction of trichinae.
(iii) Poultry products containing pork muscle tissue which the Administrator determines at the time the labeling for the product is submitted for approval in accordance with part 381 of the regulations in subchapter A or upon subsequent reevaluation of the product would be prepared in such a manner that the product might be eaten rare or without thorough cooking because of the appearance of the finished product or otherwise, shall be effectively heated, refrigerated, or cured to destroy any possible live trichinae, as prescribed in § 318.10(c) of this chapter, at the official establishment where such products are prepared. In lieu of such treatment of poultry products containing pork, the pork ingredient may be so treated.
(b)(1) Food ingredients and sources of radiation. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR chapter I, subchapter A or subchapter B, shall be listed for such use under this chapter, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter, unless precluded from such use or further restricted in parts 318 or 319, or subparts O and P, of part 381 of this chapter, or unless such use otherwise results in the adulteration or misbranding of meat or poultry products. Food ingredients and sources of radiation listed or approved for use in the production of meat or poultry products in 21 CFR Chapter I, subchapter A or subchapter B, may be listed or approved for such use under this chapter by the Administrator in § 424.21, subject to declaration requirements in parts 316 and 317, or subparts M and N, of part 381 of this chapter.
(2) No food ingredients or sources of radiation may be used in the preparation of any meat or poultry product, for any purpose, unless the use is listed or approved in 21 CFR chapter I as a direct food additive (21 CFR part 172), a secondary direct food additive (21 CFR part 173), indirect food additive (21 CFR parts 174-178), radiation source (21 CFR part 179), an interim-listed direct food additive (21 CFR part 180), a prior-sanctioned substance (21 CFR part 181), a Generally Recognized As Safe (GRAS) substance (21 CFR parts 182 or 184), or by a regulation in this chapter. Part 319 of this chapter also specifies other food ingredients that are acceptable in preparing specified products.
(3) No food ingredient, the intended use of which is to impart color in any meat or poultry product, shall be used unless such use is approved in 21 CFR chapter I as a color additive (21 CFR Parts 73, 74, 81, and 82) or in a regulation in this chapter.
(4) Petitions to amend 21 CFR chapter I to provide for uses of food additives, or other substances or sources of radiation necessary in the preparation of meat or poultry products, or food ingredients used to impart color to product, should be sent to the Food and Drug Administration, in accordance with the provisions of 21 CFR parts 71 or 171, as appropriate.
(5) Inquiries concerning the regulatory status under the Federal Food, Drug, and Cosmetic Act of any articles intended for use as components of, or in contact with, meat or poultry products, may be addressed to the Food and Drug Administration, Center for Food Safety and Applied Nutrition, 200 C Street, SW, Washington, DC 20204, or the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.
(6) Inquiries concerning the use in specific meat or poultry products of substances that are not affirmed by the Food and Drug Administration as Generally Recognized as Safe (GRAS) or otherwise listed in 21 CFR part 182 or part 184, or of food or color additives listed in 21 CFR regulations for general use in foods or for use in meat, or poultry products, generally, including mixtures of such substances or additives, should be addressed to the Department of Agriculture, Food Safety and Inspection Service, Office of Policy, Program Development and Evaluation, Washington, DC 20250-3700.
(c) The food ingredients specified in the following chart are approved for use in the preparation of meat products, provided they are used for the purposes indicated, within the limit of the amounts stated, and under other conditions specified in this part and Part 317 of this chapter. Part 319 of this chapter specifies other food ingredients that are acceptable in preparing specified meat products. This chart also contains food ingredients that are acceptable for use in poultry products, provided they are used for the purpose indicated, within the limits of the amounts stated and under other conditions specified in this part. No meat or poultry product shall bear or contain any food ingredient that would render it adulterated or misbranded, or which is not approved in this part, or by the Administrator in specific cases.
Class of substance | Substance | Purpose | Products | Amount
Acidifiers | Acetic acid | To adjust acidity | Various meat and poultry products ^2 | Sufficient for purpose. ^3
| Citric acid | ......do | ......do | Do.
| Glucono delta-lactone | ......do | ......do | Do.
| Lactic acid | ......do | ......do | Do.
| Phosphoric acid | ......do | ......do | Do.
| Tartaric acid | ......do | ......do | Do.
Anti-coagulants | Citric acid | To prevent clotting | Fresh blood of livestock | 0.2 percent with or without water. When water is used to make a solution of citric acid added to the blood of livestock, not more than 2 parts of water to 1 part of citric acid shall be used.
| | Sodium citrate | ......do | ......do | Not to exceed 0.5 percent based on the ingoing weight of the product. When water is used to make a solution of sodium citrate added to livestock blood, not more than 2 parts of water to 1 part of sodium citrate shall be used.
Antifoaming agent | Methyl polysilicone | To retard foaming | Soups (meat and poultry) | 10 ppm.
| | ......do | Rendered fats (meat and poultry) | Do.
| | ......do | Curing pickle (meat and poultry) | 50 ppm.
Antimicrobial Agents | Potassium lactate | To inhibit microbial growth | Various meat and poultry products, except infant formulas and infant food | 4.8% by weight of total formulation.
| Sodium diacetate | ......do | ......do | 0.25% by weight of total formulation.
| Sodium lactate | ......do | ......do | 4.8% by weight of total formulation.
| Trisodium phosphate | To reduce microbial levels | Raw, chilled poultry carcasses | 8 to 12 percent; solution to be maintained at 45 °F. to 55 °F. and applied by spraying or dipping carcasses for up to 15 seconds when used in accordance with 21 CFR 182.1778.
Antioxidants and oxygen interceptors | Ascorbyl palmitate | To retard rancidity | Margarine or oleomargarine | 0.02 percent (by wt. of finished product) individually or in combination with other antioxidants approved for use in margarine.
| Ascorbyl stearate
| BHA (butylated hydroxyanisole)
| ......do | Dry sausage | 0.003 based on total weight | 0.006 percent in combination with other anti-oxidants for use in meat.
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat.
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat.
| ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.
| | BHT (butylated hydroxytoluene) | ......do | Dry sausage | 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat.
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat.
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat.
| ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry) based on fat content.
| Dodecyl gallate | ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
| Glycine | ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent 0.02 percent in combination with other anti-oxidants for use in meat.
| Octyl gallate | ......do | Margarine or oleomargarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
| Propyl gallate | ......do | Dry sausage | 0.003 percent based on total weight 0.006 percent in combination with other anti-oxidants for use in meat.
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combination with other anti-oxidants for use in meat.
| | ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combination with other anti-oxidants for use in meat, based on fat content.
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combination with other anti-oxidants for use in meat.
| ......do | Margarine or oleo-margarine | 0.02 percent (by wt. of the finished product) individually or in combination with other antioxidants approved for use in margarine.
| ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).
| Resin guaiac | ......do | Rendered animal fat or a combination of such fat and vegetable fat 0.01 percent | 0.02 percent in combination with other antioxidants for use in meat.
| TBHQ (tertiary butylhydroquinone) | ......do | Dry sausage 0.003 percent based on weight | 0.006 percent in combina-tion only with BHA and/or BHT.
| ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.01 percent | 0.02 percent in combina-tion only with BHA or BHT.
| ......do | Fresh pork, sausage, brown and serve sausages, fresh Italian sausage products, pregrilled beef patties, fresh sausage made from beef or beef and pork, cooked or raw pizza topping and cooked or raw meatballs | 0.01 percent based on fat content | 0.02 percent in combin-ation only with BHA and/ or BHT, based on fat content.
| ......do | Dried meats | 0.01 percent based on total weight | 0.01 percent in combina-tion only with BHA and/or BHT.
| | ......do | Margarine or oleo-margarine | 0.02 percent alone or in combination only with BHA and/or BHT, based on oil or fat content.
| | ......do | Various poultry products | 0.01 percent based on fat content (0.02 percent in combination only with BHA and/or BHT, based on fat content).
| Tocopherols | ......do | Rendered animal fat or a combination of such fat and vegetable fat | 0.03 percent. A 30 percent concentration of tocopherols in vegetable oils shall be used when added as an antioxidant to products designated as “lard” or “rendered pork fat.”
| | | ......do | Dry sausage, semidry sausage, dried meats, uncooked or cooked fresh sausage made with beef and/or pork, uncooked or cooked Italian sausage products, uncooked or cooked meatballs, uncooked or cooked meat pizza toppings, brown and serve sausages, pregrilled beef patties, and restructured meats | Not to exceed 0.03 percent based on fat content. Not used in combination with other antioxidants.
| | ......do | Various poultry products | 0.03 percent based on fat content (0.02 percent in combination with any other antioxidant for use in poultry, except TBHQ, based on fat content).
Artificial Sweeteners | Saccharin | To sweeten product | Bacon | 0.01 percent.
Binders and Extenders | Agar-agar | To stabilize and thicken | Thermally processed canned and jellied meat food products | 0.25 percent of finished product.
| Algin | To extend and stabilize product | Breading mix; sauces (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| A mixture of sodium alginate, calcium carbonate and calcium lactate/lactic acid (or glucono delta lactone) | To bind meat pieces | Restructured meat food products | Sodium alginate not to exceed 1.0 percent; calcium carbonate not to exceed 0.2 percent; and lactic acid/calcium lactate (or glucono delta-lactone) not to exceed 0.3 percent of product formulation. Added mixture may not exceed 1.5 percent of product at formulation. Mixture ingredients must be added dry.
| A mixture of sodium alginate, calcium carbonate, lactic acid, and calcium lactate | To bind poultry pieces | Ground and formed raw or cooked poultry pieces | Sodium alginate not more than 0.8 percent, calcium carbonate not more than 0.15 percent; lactic acid and calcium lactate, in combination, not more than 0.6 percent of product formulation. Added mixture may not exceed 1.55 percent of product at formulation. The mixture must be added in dry form.
| Bread | To bind and extend product | Bockwurst | 3.5 percent individually or collectively with other binders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat.
| | ......do | Spaghetti with meat balls and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders for use in meat.
| Carboxymethyl cellulose (cellulose gum) | To extend and stabilize product | Baked pies (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| Carrageenan | To extend and stabilize product | Breading mix; sauces (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| | | To prevent purging of brine solution | Cured pork products as provided in 9 CFR 319.104(d) | Not to exceed 1.5 percent of product formulation; permitted in combination only with soy protein concentrate, combination not to exceed 1.5 percent of product formulation; in accordance with 21 CFR 172.620, 172.623, and 172.626.
| Carrageenan, Locust bean gum, and Xanthan gum blend | ......do | ......do | In combination, not to exceed 0.5 percent of formulation; not permitted in combination with other binders approved for use in cured pork products; in accordance with 21 CFR 172.620, 172.623, 172.626, 184.1343, and 172.695.
| Cereal | To bind and extend product | Sausages as provided in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat.
| Dried milk | ......do | Sausages as provided for in 9 CFR Part 319 | 3.5 percent individually or collectively with other binders for use in meat
| Dried skim milk, calcium reduced | ......do | Sausages as provided in 9 CFR 9 CFR Part 319 | Do.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat.
| Enzyme (rennet) treated with calcium reduced dried skim milk and calcium lactate | ......do | Sausages as provided for in 9 CFR Part 319 | 3.5 percent total finished product (calcium lactate required at rate of 10 percent of binder.)
| | ......do | Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 10 percent of binder).
| Enzyme (rennet) treated with sodium caseinate and calcium lactate | ......do | Imitation sausages; nonspecific loaves; soups, stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5 (calcium lactate required at a rate of 25 percent of binder).
| Food starch modified | To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation in “Ham Water Added” and “Ham with Natural Juices” products; not to exceed 3.5 percent of product formulation in “Ham and Water Product—X percent of Weight is Added Ingredients” products; permitted in combination only with soy protein concentrate, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in accordance with 21 CFR 172.892.
| | Gelatin | To bind and extend product | Various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| Gums, vegetable | ......do | Egg roll (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| Isolated soy protein | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 2 percent.
| | ......do | Imitation sausages; nonspecific loaves; soups; stews (meat only) and various poultry products | Sufficient for purpose in accordance with 21 CFR 172.5.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat.
| | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat.
| | To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation, not permitted in combination with other binders approved for use in cured pork products.
| Methyl cellulose | To extend and stabilize product (also carrier) | Meat and vegetable patties; various poultry products | 0.15 percent.
| Sodium caseinate | To bind and extend product | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 182.1748 and 21 CFR 172.5.
| | ......do | Sausages as provided for in 9 CFR Part 319 | 2 percent in accordance with 21 CFR 182.1748.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748.
| | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat in accordance with 21 CFR 182.1748.
| | To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 2 percent of product formulation; not permitted in combination with other binders approved for use in cured pork products, in accordance with 21 CFR 182.1748.
| | To bind and extend product | Various poultry products | 3 percent in cooked product, 2 percent in raw product, in accordance with 21 CFR 172.5 and 182.1748.
| Soy flour | ......do | Sausages as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat.
| | Soy protein concentrate | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat.
| | To prevent purging of brine solution | Cured pork products as provided for in 9 CFR 319.104(d) | Not to exceed 3.5 percent of product formulation; permitted in combination only with modified food starch, with combination of modified food starch at 3 percent of product formulation and soy protein concentrate at 0.5 percent of product formulation; in combination only with carrageenan, combination not to exceed 1.5 percent of product formulation.
| Starchy vegetable flour | To bind and extend product | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat.
| Tapioca dextrin | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
| | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1277.
| | ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1277.
| Vegetable starch | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders and extenders for use in meat.
| Wheat gluten | To bind and extend product | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322.
| | ......do | Chili con carne, chili con carne with beans | 8 percent individually or collectively with other binders for use in meat, in accordance with 21 CFR 184.1322.
| | | ......do | Spaghetti with meatballs and sauce, spaghetti with meat and sauce and similar products | 12 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1322.
| | ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1322.
| Whey, Dry or dried | To bind or thicken | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | 8 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Various poultry products | Sufficient for purpose in accordance with 21 CFR 184.1322.
| Whey, Reduced lactose | To bind or thicken | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 172.5.
| | ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat.
| Whey, Reduced minerals | ......do | Sausage as provided for in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat.
| | ......do | Imitation sausages, nonspecific loaves, soups, stews (meat only) | Sufficient for purpose in accordance with 21 CFR 172.5.
| | ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat.
| Whey protein concentrate | ......do | Sausage as provided in 9 CFR Part 319, bockwurst | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c.
| | ......do | Imitation sausages, nonspecific loaves, soups, stews | Sufficient for purpose in accordance with 21 CFR 184.1979c.
| | ......do | Chili con carne, chili con carne with beans, pork or beef with barbecue sauce | 8 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c
| | To bind meat pieces | Restructured meat food products, whole muscle meat cuts | 3.5 percent individually or collectively with other binders and extenders for use in meat, in accordance with 21 CFR 184.1979c.
| | Xanthan gum | To maintain: uniform viscosity; suspension of particulate matter, emulsion stability; freeze-thaw stability | Meat sauces, gravies or sauces and meats, canned or frozen and/or refrigerated meat salads, canned or frozen meat stews, canned chili or chili with beans, pizza topping mixes and batter or breading mixes | Sufficient for purpose in accordance with 21 CFR 172.5.
| | ......do | Various poultry products, except uncooked products or sausages or other products with a moisture limitation established by Subpart P of Part 381 | Sufficient for purpose
Bleaching Agent | Hydrogen peroxide | To remove color | Tripe (substance must be removed from product by rinsing with clear water) | Sufficient for purpose.
Catalysts (substances must be eliminated during process) | Nickel | To accelerate chemical reaction | Rendered animal fats or a combination of such fats and vegetable fats | Do.
| Sodium amide | Rearrangement of fatty acid radicals | ......do | Do.
| Sodium methoxide | ......do | ......do
Chilling Media | Salt (NaCl) | To aid in chilling | Raw poultry products | 700 lbs. to 10,000 gallons of water.
Coloring Agents (artificial) | Coal tar dyes (FD&C certified) | To color products | Various poultry products | Sufficient for purpose.
| Color additives listed in 21 CFR Part 74, Subpart A of Part 82, Subpart B (operator must furnish evidence to inspector in charge that color additive has been certified for use in connection with foods by the Food and Drug Administration) | To color casings or rendered fats; marking and branding product | Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) | Sufficient for purpose (may be mixed with approved natural coloring matters or harmless inert material such as common salt and sugar).
| Titanium oxide | To whiten | Canned ham salad spread and creamed-type canned meat products. Poultry salads and poultry spreads | 0.5 percent.
Coloring Agents (natural) | Alkanet, annatto, carotene, cochineal, green chlorophyll, saffron and tumeric | To color casings or rendered fats; marking and branding product | Sausage casings, oleomargarine, shortening, marking or branding ink on product (meat only) | Sufficient for purpose (may be mixed with approved artificial dyes or harmless inert material such as common salt and sugar).
| Annatto, carotene | To color products | Various poultry products | Sufficient for purpose.
Curing accelerators (must be used only in combination with curing agents) | Ascorbic acid | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products | 75 oz to 100 gal pickle at 10 percent pump level; 3/4 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
| | Citric acid or sodium citrate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products | May be used in cured meat products or in 10 percent solution used to spray surfaces of cured meat cuts prior to packaging to replace up to 50 percent of the ascorbic acid, erythorbic acid, sodium ascorbate, or sodium erythorbate that is used. May be used in cured poultry products to replace 50 percent of the ascorbic acid or sodium ascorbate that is used.
| Erythorbic acid | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured poultry, cured comminuted poultry and meat food products | 75 oz to 100 gal pickle at 10 percent pump level; 3/4 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
| Fumaric acid | ......do | Cured, comminuted meat, poultry or meat and poultry products | 0.065 percent (or 1 oz to 100 lb) of the weight of the meat, poultry or the meat or poultry byproducts before processing.
| Glucono delta lactone | ......do | Cured, comminuted meat or meat food product | 8 oz to each 100 lb of meat or meat byproduct.
| | ......do | Genoa salami | 16 oz to 100 lb of meat (1.0 percent).
| Sodium acid pyrophosphate | ......do | Frankfurters, wieners, vienna, bologna, garlic bologna, knockwurst and similar products | Not to exceed alone or in combination with other curing accelerators for use in meat the following: 8 oz in 100 lb of meat, or meat and meat byproducts, content of the formula; nor 0.5 percent in the finished product.
| Sodium ascorbate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food product, cured comminuted poultry or poultry products | 87.5 oz to 100 gal pickle at 10 percent pump level; 7/8 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product).
| Sodium erythorbate | To accelerate color fixing or preserve color during storage | Cured pork and beef cuts, cured comminuted meat food products, cured comminuted poultry or poultry products | 87.5 oz to 100 gal pickle at 10 percent pump level; 7/8 oz to 100 lb meat, meat byproduct or poultry product; 10 percent solution to surfaces of cured meat cuts or poultry products prior to packaging. (The use of such solution shall not result in the addition of a significant amount of moisture to the product.)
| Curing Agents | Sodium or potassium nitrate | Source of nitrite | Cured meat products other than bacon. Nitrates may not be used in baby, junior, and toddler foods. Cured, comminuted poultry or poultry products | 7 lb to 100 gal pickle; 31/2 oz to 100 lb meat or poultry product (dry cure); 23/4 oz to 100 lb chopped meat or poultry.
| Sodium or potassium nitrite (supplies of sodium nitrite and potassium nitrite and mixtures containing them must be kept under the care of a responsible employee of the establishment. The specific nitrite content of such supplies must be known and clearly marked accordingly) | To fix color | Cured meat and poultry products. Nitrites may not be used in baby, junior, or toddler foods | 2 lb to 100 gal pickle at 10 percent pump level; 1 oz to 100 lb meat or poultry product (dry cure); 1/4 oz to 100 lb chopped meat, meat byproduct or poultry product. The use of nitrites, nitrates or combination shall not result in more than 200 ppm of nitrite, calculated as sodium nitrite in finished product, except that nitrites may be used in bacon only in accordance with paragraph (b) of this section.
Denuding Agents (may be used in combination. Must be removed from tripe by rinsing with potable water.) | Lime (calcium oxide, calcium hydroxide) | To denude mucous membranes | Tripe | Sufficient for purpose.
| Sodium carbonate | ......do | ......do | Do.
| Sodium citrate | ......do | ......do | Do.
| Sodium gluconate | ......do | ......do | Do.
| Sodium hydroxide | ......do | ......do | Do.
| Sodium persulfate | ......do | ......do | Do.
| Sodium silicates (ortho, meta, and sesqui) | ......do | ......do | Do.
| Trisodium phosphate | ......do | ......do | Do.
Emulsifying Agents | Actylated monoglycerides | To emulsify product | Shortening and various poultry products | Sufficient for purpose.
| Diacetyl tartaric acid esters of mono-and diglycerides | ......do | ......do | Do.
| Glycerol-lacto stearate, oleate, or palmitate | ......do | ......do | Do.
| Lecithin | To emulsify product (also as an antioxidant) | Oleomargarine, shortening, various meat and poultry products | 0.5 percent in oleomargarine, use in other products—sufficient amount for emulsification.
| Mono and diglycerides (glycerol palmitate, etc.) | To emulsify product | Rendered animal fat or a combination of such fat with vegetable fat; oleomargarine | Sufficient for purpose in lard and shortening; 0.5 percent in oleomargarine.
| | ......do | Various poultry products | Sufficient for purpose.
| Mono and diglycerides of fatty acids esterified with any of the following acids: acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and calcium salts; the sodium sulfoacetate derivatives of these mono and diglycerides | ......do | Margarine or oleomargarine | 0.5 percent.
| | Polyglycerol esters of fatty acids (polyglycerol esters of fatty acids are restricted to those up to and including the decaglycerol esters and otherwise meeting the requirements of § 172.854(a) of the Food Additive Regulations) | ......do | Rendered animal fat or a combination of such fat with vegetable fat when use is not precluded by standards of identity of composition; oleomargarine | Sufficient for purpose for rendered animal fat or combination with vegetable fat; 0.5 percent for oleomargarine.
| Polysorbate 60 (polyoxyethylene (20) sorbitan monostearate) | ......do | Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Rendered poultry fat or a combination of such fat with vegetable fat | 1 percent when used alone. If used with polysorbate 80 the combined total shall not exceed 1 percent.
| Polysorbate 80 (polyoxyethylene (20) sorbitan monooleate) | ......do | Shortening for use in nonstandardized baked goods, baking mixes, icings, fillings, and toppings and in the frying of foods (meat only). Various poultry products | 1 percent when used alone. If used with polysorbate 60 the combined total shall not exceed 1 percent.
| 1,2-propylene glycol esters of fatty acids | ......do | Margarine or oleomargarine | 2.0 percent.
| Propylene glycol mono and diesters of fats and fatty acids | ......do | Rendered animal or poultry fat or a combination of such fat with vegetable fat | Sufficient for purpose.
| Stearyl-2-lactylic acid | ......do | Shortening to be used for cake icings and fillings (meat only) | 3.0 percent.
| Stearyl monoglyceridyl citrate | ......do | Shortening | Sufficient for purpose
Film Forming Agents | A mixture consisting of water, sodium alginate, calcium chloride, sodium carboxymethyl-cellulose, and corn syrup solids | To reduce cooler shrinkage and help protect surface | Freshly dressed meat carcasses. Such carcasses must bear a statement “Protected with a film of water, corn syrup solids, sodium alginate, calcium chloride and sodium carboxymethyl-cellulose.” | Formulation may not exceed 1.5 percent of hot carcass weight when applied. Chilled weight may not exceed hot weight.
Flavoring Agents; Protectors and Developers | Artificial smoke flavoring | To flavor product | Various (meat and poultry) ^2 | Sufficient for purpose.
| Autolyzed yeast extract | ......do | ......do | Do.
| Benzoic acid (sodium, potassium and calcium salts) | To retard flavor reversion | Margarine or oleomargarine | 0.1 percent individually, or if used in combination with other flavoring agents for use in meat or with sorbic acid and its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
| Calcium lactate | To protect flavor | Cooked semi-dry and dry products including sausage, imitation sausage, and nonspecific meat food sticks | 0.6 percent in product formulation.
| Citric acid | ......do | Various poultry products | Sufficient for purpose.
| | Flavoring | Chili con carne | Do.
| | Corn syrup solids; corn syrup; glucose syrup | To flavor product | Various poultry products, sausage, hamburger, meat loaf, luncheon meat, chopped or pressed ham | Do.
| Dextrose | ......do | Sausage, ham and cured products | Do.
| Diacetyl | ......do | Oleomargarine | Do.
| Disodium guanylate | ......do | Various meat and poultry products. ^2
| Disodium inosinate | ......do | ......do | Do.
| Harmless bacteria starters of the acidophilus type, lactic acid starter or culture of Pediococcus cerevisiae | To develop flavor | Dry sausage, pork roll, thuringer, lebanon bologna, cervelat, and salami | 0.5 percent.
| Harmless lactic acid producing bacteria | To prevent the growth of Clostridium botulinum | Bacon | Sufficient for purpose.
| Hydrolyzed plant protein | To flavor product | Various meat and poultry products. ^2 | Do.
| Isopropyl citrate | To protect flavor | Oleomargarine | 0.02 percent.
| Malt syrup | To flavor product | Cured meat products | 2.5 percent.
| | ......do | Various poultry products | Sufficient for purpose.
| Milk protein hydrolysate | ......do | Various meat and poultry products. ^2 | Do.
| Monoammonium glutamate | ......do | ......do | Do.
| Monosodium glutamate | ......do | ......do | Do.
| Potassium lactate | ......do | Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. ^2 | Not to exceed 2 percent of formulation; in accordance with 21 CFR 184.1639.
| Smoke flavoring | To flavor product | Various meat and poultry products | Sufficient for purpose.
| Sodium acetate | To flavor products | Various meat and poultry products | Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1721.
| Sodium diacetate | ......do | ......do | Not to exceed 0.25% of formulate in accordance with 21 CFR 184.1754.
| Sodium lactate | ......do | Various meat and meat food products, poultry and poultry food products, except infant formula and infant food. ^2 | Not to exceed 2 percent of formulation in accordance with 21 CFR 184.1768.
| Sodium sulfoacetate derivative of mono and diglycerids | ......do | Various meat and poultry products. ^2 | 0.5 percent.
| Sodium tripolyphosphate | To help protect flavor | “Fresh Beef,” ^2 “Beef for further cooking, “Cooked Beef,” Beef Patties, Meat Loaves, Meat Toppings, and similar products derived from pork, lamb, veal, mutton, and goat meat which are cooked or frozen after processing | 0.5 percent of total product.
| Sodium tripolyphosphate and sodium mixtures, metaphosphate, insoluble; and sodium polyphosphates, glassy | ......do | ......do | Do.
| | Sorbitol | To flavor, to facilitate the removal of casings from product, and to reduce caramelization and charring | Cooked sausage labeled frankfurter, frank, furter, wiener, and knockwurst; cured pork and pork products, as provided for in 9 CFR Part 319 | Not to exceed 2 percent of the weight of the formula excluding the formula weight of water or ice, when used in accordance with 21 CFR 184.1835.
| Starter distillate | To help protect flavor | Oleomargarine | Sufficient for purpose.
| Stearyl citrate | ......do | ......do | 0.15 percent.
| Sugars (sucrose and dextrose) | To flavor product | Various meat and poultry products | Sufficient for purpose.
Gases | Carbon dioxide liquid | Contact freezing | Various poultry products | Do.
| Carbon dioxide solid (dry ice) | To cool product | Chopping of meat, packing of product | Sufficient for purpose.
| | To cool product or facilitate chopping or packaging | Various poultry products | Do.
| Nitrogen | To exclude oxygen from sealed containers | Various meat and poultry products | Do.
| Nitrogen, liquid | Contact freezant | ......do | Do.
Hog Scald Agents (must be removed by subsequent cleaning operations) | Caustic soda | To remove hair | Hog carcasses | Sufficient for purpose.
| Dicotyl sodium sulfosuccinate | ......do | ......do | Do.
| Dimethylpolysiloxane | ......do | ......do | Do.
| Disodium-calcium ethylenediaminetetra-acetate | ......do | ......do | Do.
| Disodium phosphate | ......do | ......do | Do.
| Ethylenediaminetetra-acetic acid (sodium salts) | ......do | ......do | Do.
| Lime (calcium oxide, calcium hydroxide) | ......do | ......do | Do.
| Potassium hydroxide | | | Do.
| Propylene glycol | ......do | ......do | Do.
| Soap (prepared by the reaction of calcium, potassium, or sodium with rosin or fatty acids of natural fats and oils) | ......do | ......do | Do.
| Sodium acid pyrophosphate | ......do | ......do | Do.
| Sodium carbonate | ......do | ......do | Do.
| Sodium dodecylbenzene sulfonate | ......do | ......do | Do.
| Sodium gluconate | ......do | ......do | Do.
| Sodium hexametaphosphate | ......do | ......do | Do.
| Sodium lauryl sulfate | ......do | ......do | Do.
| Sodium mono and dimethylnaphthalene sulfonate (molecular weight 245-260) | ......do | ......do | Do.
| | Sodium n-alkylbenzene sulfonate (alkyl group predominantly C12 and C13 and not less than 95 percent C10 and C16) | ......do | ......do | Do.
| Sodium pyrophosphate | ......do | ......do | Do.
| Sodium silicates (ortho, meta, and sesqui) | ......do | ......do | Do.
| Sodium sulfate | ......do | ......do | Do.
| Sodium tripolyphosphate | ......do | ......do | Do.
| Sucrose | ......do | ......do | Do.
| Triethanolamine dodecylbenzene sulfonate | ......do | ......do | Do.
| Trisodium phosphate | ......do | ......do | Do.
Miscellaneous | Adipic acid | To acidify | Margarine or oleomargarine | Sufficient for purpose.
| Ascorbic acid, erythorbic acid, citric acid, sodium ascorbate and sodium citrate, singly or in combination | To delay discoloration | Fresh beef cuts, fresh lamb cuts, and fresh pork cuts | Not to exceed, singly or in combination, 500 ppm or 1.8 mg/sq inch of product surface of ascorbic acid (in accordance with 21 CFR 182.3013), erythorbic acid (in accordance with 21 CFR 182.3041), or sodium ascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or 0.9 mg/sq inch of product surface of citric acid (in accordance with 21 CFR 182.6033), or sodium citrate (in accordance with 21 CFR 182.6751).
| Calcium disodium, EDTA (calcium disodium ethylene-diaminetetraacetate | To preserve product and to protect flavor | Margarine or oleomargarine | 75 ppm by weight of the finished oleomargarine or margarine.
| Calcium propionate | To retard mold growth | Pizza crust | 0.32 percent alone or in combination based on weight of the flour brace used.
| | ......do | Fresh pie dough (poultry only) | 0.3 percent of calcium propionate or sodium propionate alone, or in combination, based on weight of flour used.
| Citric acid | To preserve cured color during storage | Cured pork cuts | Not to exceed 30 percent in water solution used to spray surfaces of cured cuts, prior to packaging, in accordance with 21 CFR 184.1033. (The use of such solution shall not result in the addition of a significant amount of moisture to the product and shall be applied only once to product).
| Citric acid (sodium and potassium salts) | To acidify | Margarine and oleomargarine | Sufficient for purpose.
| d- and dl-alpha-tocopherol | To inhibit nitrosamine formation | Pump-cured bacon | 500 ppm; by injection or surface application.
| | Dipotassium phosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
| Disodium phosphate | ......do | ......do | Do.
| Glycerine | Humectant | Shelf stable meat snacks | Not to exceed 2 percent of the formulation weight of the product in accordance with 21 CFR 182.1320.
| Hydrochloric acid | To acidify | Margarine or oleomargarine | Sufficient for purpose.
| Lactic acid (sodium and potassium salts) | ......do | ......do | Do.
| L-Tartaric acid (sodium and sodium potassium salts) | ......do | ......do | Do.
| Monopotassium phosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
| Monosodium phosphate | ......do | ......do | Do.
| Phosphoric acid | To acidify | Margarine or oleomargarine | Sufficient for purpose.
| Potassium bicarbonate | To alkalize | Margarine or oleomargarine | Sufficient for purpose.
| Potassium carbonate | ......do | ......do | Do.
| Potassium pyrophosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
| Potassium sorbate | To retard mold growth | Dry sausage | 10 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
| Potassium tripolyphosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations | 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry food products, 0.5 percent of total product.
| Propyl paraben (propyl p-hydroxy-benzoate) | To retard mold growth | Dry sausage | 3.5 percent in water solution may be applied to casings after stuffing or casings may be dipped in solution prior to stuffing.
| Silicon dioxide | Processing aid/dispersant | Tocopherol containing bacon curing mixes | At level not to exceed 4.0 percent in the dry mix.
| | Sodium acid pyrophosphate | To decrease the amount of cooked out juices | Meat food products except where other prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations. | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
| Sodium bicarbonate | To neutralize excess acidity, cleaning vegetables | Rendered fats, soups, curing pickle (meat and poultry) | Sufficient for purpose.
| | To alkalize | Margarine or oleomargarine | Do.
| Sodium carbonate | ......do | ......do | Do.
| Sodium citrate buffered with citric acid to a pH of 5.6 | To inhibit the growth of micro-organisms and retain product flavor during storage | Cured and uncured, processed whole muscle meat and poultry food products, e.g., ham, chicken breasts | Not to exceed 1.3 percent of the formulation weight of the product in accordance with 21 CFR 184.1751.
| Sodium hydroxide | To alkalize | Margarine or oleomargarine | Sufficient for purpose.
| | To decrease the amount of cooked out juices | Poultry food products containing phosphates | May be used only in combination with phosphate in a ratio not to exceed one part sodium hydroxide to four parts phosphate.
| | ......do | Meat food products containing phosphates | May be used only in combination with phosphates in a ratio not to exceed one part sodium hydroxide to four parts phosphate; the combination shall not exceed 5 percent in pickle at 10 percent pump level; 0.5 percent in product.
| Sodium metaphosphate, insoluble | ......do | Meat food products except where other prohibited by the meat inspection regulations, and poultry food products except where otherwise prohibited by the poultry products inspection regulations | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
| Sodium polyphosphate, glassy | ......do | ......do | Do.
| Sodium proprionate | To retard mold growth | Pizza crust | 0.32 percent alone or in combination based on weight of the flour brace used.
| | ......do | Fresh pie dough (poultry only) | 0.3 percent of calcium proprionate or sodium proprionate alone, or in combination, based on weight of flour used.
| Sodium pryophosphate | To decrease the amount of cooked out juices | Meat food products except where otherwise prohibited by the meat inspection regulations and poultry food products except where otherwise prohibited by the poultry products inspection regulations | For meat food products, 5 percent of phosphate in pickle at 10 percent pump level; 0.5 percent of phosphate in meat food product (only clear solution may be injected into meat food product). For poultry products, 0.5 percent of total product.
| Sodium tripolyphosphate | ......do | ......do | Do.
| | Sorbic acid (sodium, potassium, and calcium salts) | To preserve product and to retard mold growth | Margarine or oleomargarine | 0.1 percent individually, or if used in combination or with benzoic acid or its salts, 0.2 percent (expressed as the acids in the wt. of the finished foods).
| Tricalcium phosphate | To preserve product color during dehydration process | Mechanically deboned chicken to be dehydrated | Not to exceed 2 percent of the weight of the mechanically deboned chicken prior to dehydration, in accordance with 21 CFR 182.1217.
Poultry scald agents (must be removed by subsequent cleaning operations) | Alpha-hydro-omega-hydroxy-poly (oxyethylene) poly (oxypropylene) (minimum 15 moles) poly (oxyethylene) block copolymer (poloxamer) | To remove feathers | Poultry carcasses | Not to exceed 0.05 percent by weight in scald water.
| Dimethylpolysiloxane | ......do | ......do | Sufficient for purpose.
| Dioctyl sodium sulfosuccinate | ......do | ......do | Do.
| Dipotassium phosphate | ......do | ......do | Do.
| Ethylenediaminetetra-acetic acid (sodium salts) | ......do | ......do | Do.
| Lime (calcium oxide, calcium hydroxide) | ......do | ......do | Do.
| Polyoxyethylene (20) sorbitan monooleate | ......do | ......do | Not to exceed 0.0175 percent in scald water.
| Potassium hydroxide | ......do | ......do | Sufficient for purpose.
| Propylene glycol | ......do | ......do | Do.
| Sodium acid phosphate | ......do | ......do | Do.
| Sodium acid pyrophosphate | ......do | ......do | Do.
| Sodium bicarbonate | ......do | ......do | Do.
| Sodium carbonate | ......do | ......do | Do.
| Sodium dodecylbenzene-sulfonate | ......do | ......do | Do.
| Sodium-2-ethylhexyl sulfate | ......do | ......do | Do.
| Sodium hexametaphosphate | ......do | ......do | Do.
| Sodium hydroxide | ......do | ......do | Do.
| Sodium lauryl sulfate | ......do | ......do | Do.
| Sodium phosphate (mono-, di-, tribasic) | ......do | ......do | Do.
| Sodium pyrophosphate | ......do | ......do | Do.
| Sodium sesquicarbonate | ......do | ......do | Do.
| Sodium sulfate | ......do | ......do | Do.
| Sodium tripolyphosphate | ......do | ......do | Do.
| Tetrasodium pyrophosphate | ......do | ......do | Do.
| Proteolytic Enzymes | Aspergillus flavus oryzae group | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
| Aspergillus oryzae | ......do | ......do | Do.
| Bromelin | ......do | ......do | Do.
| Ficin | ......do | ......do | Do.
| Papain | ......do | ......do | Do.
Refining Agents (must be eliminated during process of manufacturing) | Acetic acid | To separate fatty acids and glycerol | Rendered fats (meat only) | Sufficient for purpose.
| Bicarbonate of soda | ......do | ......do | Do.
| Carbon (purified charcoal) | To aid in refining of animal fats | ......do | Do.
| Caustic soda (sodium hydroxide) | To refine fats | ......do | Do.
| Diatomaceous earth; Fuller's earth | ......do | ......do | Do.
| Sodium carbonate | ......do | ......do | Do.
| Tannic acid | ......do | ......do | Do.
Rendering agents | Tricalcium phosphate | To aid rendering | Animal fats | Do.
| Trisodium phosphate | ......do | ......do | Do.
Synergists (used in combination with antioxidants) | Citric acid | To increase effectiveness of antioxidants | Any meat product permitted to contain antioxidants as provided for in this part | Not to exceed 0.01 percent based on fat content.
| | ......do | Poultry fats | 0.01 percent alone or in combination with antioxidants in poultry fats.
| Malic acid | ......do | Lard and shortening | 0.01 percent based on total weight in combination with antioxidants for use in meat products only.
| | ......do | Poultry fats | 0.01 percent alone or in combination with antioxidants in poultry fats.
| Monoglyceride citrate | ......do | Lard, shortening, fresh pork sausage, dried meats and poultry fats | 0.02 percent.
| Monoisopropyl citrate | ......do | Lard, shortening, oleomargarine, fresh pork sausage, dried meats | Do.
| | ......do | Poultry fats | 0.01 percent poultry fats.
| Phosphoric acid | ......do | Lard, shortening, and poultry fats | 0.01 percent.
Tenderizing agents | Aspergillus flavus oryzae group | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
| Aspergillus oryzae | ......do | ......do | Not more than 3 percent of a 0.8 molar solution.
| Bromelin | ......do | ......do | Do.
| Calcium chloride | ......do | ......do | Do.
| Magnesium chloride | ......do | ......do | Do.
| | Papain | To soften tissue | Raw poultry muscle tissue of hen, cock, mature turkey, mature duck, mature goose, and mature guinea, and raw meat cuts | Solutions consisting of water and approved proteolytic enzyme applied or injected into raw meat or poultry tissue shall not result in a gain of more than 3 percent above the weight of the untreated product.
| Potassium chloride | ......do | ......do | Not more than 3 percent of a 2.0 molar solution.
| Potassium, magnesium or calcium chloride | ......do | ......do | A solution of approved inorganic chlorides injected into or applied to raw meats or poultry cuts shall not result in a gain of more than 3 percent above the weight of the untreated product.
^1 [Reserved]
^2 Information as to the specific products for which use of this additive is approved may be obtained upon inquiry addressed to the Labeling and Additives Policy Division, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250.
^3 Provided that its use is functional and suitable for the product and it is permitted for use at the lowest level necessary to accomplish the desired technical effect as determined in specific cases prior to label approval under part 412 of this chapter.
^4 Special labeling requirements are prescribed in 381.120 for raw poultry chilled in a medium with more than 70 lbs. of salt to 10,000 gals. of water.
[64 FR 72175, Dec. 23, 1999, as amended at 65 FR 3123, Jan. 20, 2000; 65 FR 34391, May 30, 2000; 78 FR 66839, Nov. 7, 2013]
§ 424.22
Certain other permitted uses.
(a) Under appropriate declaration as required in parts 316 and 317 of this chapter, the following substances may be added to meat:
(1) General. Common salt, approved sugars (sucrose, cane or beet sugar), maple sugar, dextrose, invert sugar, honey, corn syrup solids (corn syrup, glucose syrup and fructose), wood smoke, vinegar, flavorings, spices, sodium nitrate, sodium nitrite, potassium nitrate, potassium nitrite, and other food and color additives specified in the chart in paragraph (c) of this section may be added to meat under conditions, if any, specified in this part or in part 317 of this chapter.
(2) Artificial flavorings. Other harmless artificial flavorings may be added to meat, with the approval of the Administrator in specific cases.
(3) Coloring matter and dyes. Coloring matter and dyes, other than those specified in a regulation permitting that use in this chapter or in 21 CFR Chapter I, Subchapter A and Subchapter B, may be applied to meat mixed with rendered fat, applied to natural and artificial casings, and applied to such casings enclosing products, if approved by the Administrator in specific cases. When any coloring matter or dye is applied to casings, there shall be no penetration of coloring into the product.
(b) Use of nitrite and sodium ascorbate or sodium erythorbate (isoascorbate) in bacon—(1) Pumped bacon. With respect to bacon injected with curing ingredients and massaged bacon, sodium nitrite shall be used at 120 parts per million (ppm) ingoing or an equivalent amount of potassium nitrite shall be used (148 ppm ingoing); and 550 ppm of sodium ascorbate or sodium erythorbate (isoascorbate) shall be used. Sodium ascorbate or sodium erythorbate have a molecular weight of approximately 198. Hydrated forms of these substances shall be adjusted to attain the equivalent of 550 ppm of sodium ascorbate or sodium erythorbate.
(i) The Department shall collect samples of pumped bacon from producing plants and analyze them for the level of nitrosamines by the Thermal Energy Analyzer (TEA). In the event that a TEA analysis indicates that a confirmable level of nitrosamines might be present, additional samples shall be collected and analyzed by gas chromatography. Presumptive positive results must be confirmed by mass spectrometry before being considered positive. If during the interval required for the Department to analyze the confirmatory samples by gas chromatography and mass spectrometry, changes are made in processing procedures which are expected to result in no confirmable levels of nitrosamines in pumped bacon produced by these new procedures, an establishment may submit samples to USDA for analysis upon prior notification and arrangements with USDA. If, however, an establishment furnishes USDA with laboratory results from testing five consecutive lots of pumped bacon produced under the new procedures and the testing is performed by the USDA methodology and procedures, those results will be utilized in making the determination concerning the product produced under the new procedures. Should the results of these tests reveal that confirmable levels of nitrosamines are not indicated in any of the five consecutive lots, the confirmation analysis by USDA shall be terminated and the establishment shall revert to normal monitoring status. In the event the test results continue to indicate nitrosamines, however, USDA shall proceed in its confirmation analysis on the original samples taken for confirmation. If any one of the original samples collected by USDA for confirmation is found to contain confirmable levels of nitrosamines, all pumped bacon in the producing establishment and all future production will be retained. The Department shall sample and analyze such retained pumped bacon for nitrosamines on a lot by lot basis. A production lot shall be that pumped bacon produced by the establishment in any single shift. Samples from any lot of pumped bacon under retention found to contain nitrosamines at a confirmable level shall cause the lot of pumped bacon to be disposed of in a manner to ensure it will not form nitrosamines when cooked. Such disposal may include incorporation of the uncooked pumped bacon as an ingredient of another meat provided it is processed for eating without further preparation in a manner to preclude the formation of nitrosamines. Bacon subsequently produced shall not be retained because of nitrosamines if the operator of the establishment makes adjustments in the processing of the product and laboratory results obtained by TEA analysis of samples from five consecutive normal sized lots of pumped bacon indicates that the product being produced contains no confirmable levels of nitrosamines. These tests from five consecutive normal sized lots of pumped bacon shall be conducted by the Department. However, if the establishment furnishes the Department with the results of tests conducted under the methodology and procedures used by the Department, such test results will be utilized in making the determination concerning the nitrosamine content of the product. All tests of pumped bacon for nitrosamines under this paragraph (b)(1)(i) shall be made on pumped bacon cooked at 340 degrees F. for 3 minutes on each side. In order to determine that no confirmable levels of nitrosamines are present in a sample tested, the testing must be performed by methodology and procedures that would detect the presence of any nitrosamines at 10 ppb.
(ii) Notwithstanding the provisions of paragraph (b)(1)(i) of this section, sodium nitrite may be used at:
(A) 100 ppm ingoing (potassium nitrite at 123 ppm ingoing); and 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate) shall be used; or
(B) A predetermined level between 40 and 80 ppm (potassium nitrite at a level between 49 and 99 ppm); 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate); and additional sucrose or other similar fermentable carbohydrate at a minimum of 0.7 percent and an inoculum of lactic acid producing bacteria such as Pediococcus acetolactii or other bacteria demonstrated to be equally effective in preventing the production of botulinum toxin at a level sufficient for the purpose of preventing the production of botulinum toxin.
(C) The Department shall collect samples of bacon from establishments producing under paragraph (b)(1)(ii) of this section and analyze them for the level of nitrosamines. Samples shall be randomly selected throughout the production of a lot. The actual sampling plans and methods of analysis that are used will result in approximately the same likelihood as under paragraph (b)(1)(i) of this section of having a presumptive positive result when the true mean level of nitrosamines in a production lot is 10 ppb. In the event of a presumptive positive result, the establishment shall become subject to the provisions of paragraph (b)(1)(i) of this section.
(2) Immersion cured bacon. Immersion cured bacon may be placed in a brine solution containing salt, nitrite and flavoring material or in a container with salt, nitrite and flavoring material. Sodium nitrite shall not exceed 120 ppm ingoing or an equivalent amount of potassium nitrite (148 ppm ingoing) based on the actual or estimated skin-free green weight of the bacon bellies.
(3) Bacon made with dry curing materials. With respect to bacon made with dry curing materials, the product shall be cured by applying a premeasured amount of cure mixture to the bacon belly surfaces, completely covering the surfaces. Sodium nitrite shall not exceed 200 ppm ingoing or an equivalent amount of potassium nitrite (246 ppm ingoing) in dry cured bacon based on the actual or estimated skin-free green weight of the bacon belly.
(c) Irradiation of meat food and poultry products.
(1) General requirements. Meat food and poultry products may be treated to reduce foodborne pathogens and to extend product shelf-life by the use of sources of ionizing radiation as identified in 21 CFR 179.26(a). Official establishments must irradiate meat food and poultry products in accordance with 21 CFR 179.26(b), the Hazard Analysis and Critical Control Point (HACCP) system requirements in part 417 of this chapter, and the provisions of this section.
(2) Dosimetry. Official establishments that irradiate meat food and poultry products must have the following procedures in place:
(i) Laboratory operation procedures for determining the absorbed dose value from the dosimeter.
(ii) Calibration criteria for verifying the accuracy and consistency of any means of measurement (e.g., time clocks and weight scales).
(iii) Calibration and accountability criteria for verifying the traceability and accuracy of dosimeters for the intended purpose, and the verification of calibration at least every 12 months. To confirm traceability, establishments must relate, through documentation, the end point measurement of a dosimeter to recognized standards.
(iv) Procedures for ensuring that the product unit is dose mapped to identify the regions of minimum and maximum absorbed dose and such regions are consistent from one product unit to another of like product.
(v) Procedures for accounting for the total absorbed dose received by the product unit (e.g., partial applications of the absorbed dose within one production lot).
(vi) Procedures for verifying routine dosimetry, i.e., assuring each production lot receives the total absorbed dose. Establishments may either position one dosimeter at the regions of minimum and maximum absorbed dose (or at one region verified to represent such) on at least the first, middle, and last product unit in each production lot or use statistically based validation and dose mapping to determine the number and placement of dosimeters in each production lot.
(vii) Procedures for verifying the relationship of absorbed dose as measured by the dosimeter to time exposure of the product unit to the radiation source.
(viii) Procedures for verifying the integrity of the radiation source and processing procedure. Aside from expected and verified radiation source activity decay for radionuclide sources, the radiation source or processing procedure must not be altered, modified, replenished, or adjusted without repeating dose mapping of product units to redefine the regions of minimum and maximum absorbed dose.
(3) Documentation. Official establishments that irradiate meat food or poultry products must have the following documentation on premises, available to FSIS:
(i) Documentation that the irradiation facility is licensed or possesses gamma radiation sources registered with the Nuclear Regulatory Commission (NRC) or the appropriate State government acting under authority granted by the NRC.
(ii) Documentation that the machine radiation source irradiation facility is registered with the appropriate State government, if applicable.
(iii) Documentation that a worker safety program addressing OSHA regulations (29 CFR chapter XVII) is in place.
(iv) Citations or other documents that relate to incidences in which the establishment was found not to comply with Federal or State agency requirements for irradiation facilities.
(v) A certification by the operator that the irradiation facility personnel will only operate under supervision of a person who has successfully completed a course of instruction for operators of food irradiation facilities.
(vi) A certification by the operator that the key irradiation personnel, who monitor or control daily operations, have been trained in food technology, irradiation processing, and radiation health and safety.
(vii) Guarantees from the suppliers of all food-contact packaging materials that may be subject to irradiation that those materials comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
(4) Labeling. (i) The labels on packages of meat food and poultry products irradiated in their entirety, in conformance with this section and with 21 CFR 179.26(a) and (b), must bear the logo shown at the end of this paragraph. Unless the word “Irradiated” is part of the product name, labels also must bear a statement such as “Treated with radiation” or “Treated by irradiation.” The logo must be placed in conjunction with the required statement, if the statement is used. The statement is not required to be more prominent than the declaration of ingredients required under § 317.2(c)(2) of this chapter.
(ii) For meat food or poultry products that have been irradiated in their entirety, but that are not sold in packages, the required logo must be displayed to the purchaser with either the labeling of the bulk container plainly in view or a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. In either case, the information must be prominently and conspicuously displayed to purchasers. Unless the word “Irradiated” is part of the product name, the labeling counter sign, card, or other device also must bear a statement such as “Treated with radiation” or “Treated by irradiation.” The logo must be placed in conjunction with the required statement, if the statement is used.
(iii) The inclusion of an irradiated meat food or poultry product ingredient in any multi-ingredient meat food or poultry product must be reflected in the ingredient statement on the finished product labeling.
(iv) Optional labeling statements about the purpose for radiation processing may be included on the product label in addition to the stated requirements elsewhere in this section, provided that such statements are not false or misleading. Statements that there has been a specific reduction in microbial pathogens must be substantiated by processing documentation.
[64 FR 72175, Dec. 23, 1999, as amended at 64 FR 72165, Dec. 23, 1999; 65 FR 34391, May 30, 2000; 78 FR 66839, Nov. 7, 2013]
§ 424.23
Prohibited uses.
(a) Substances that conceal damage or inferiority or make products appear better or of greater value. No substance may be used in or on any meat if it conceals damage or inferiority or makes the product appear to be better or of greater value than it is. Therefore:
(1) Paprika or oleoresin paprika may not be used in or on fresh meat, such as steaks, or comminuted fresh meat, such as chopped and formed steaks or patties; or in any other meat consisting of fresh meat (with or without seasoning).
(2) Paprika or oleoresin paprika may be used in or on chorizo sausage and other meat in which paprika or oleoresin paprika is permitted as an ingredient in a standard of identity or composition in part 319 of this subchapter.
(3) Sorbic acid, calcium sorbate, sodium sorbate, and other salts of sorbic acid shall not be used in cooked sausages or any other meat; sulfurous acid and salts of sulfurous acid shall not be used in or on any meat; and niacin or nicotinamide shall not be used in or on fresh meat product; except that potassium sorbate, propylparaben (propyl p-hydroxybenzoate), and calcium propionate, may be used in or on any product, only as provided in 9 CFR Chapter III.
(b) Nitrates. Nitrates shall not be used in curing bacon.
[64 FR 72175, Dec. 23, 1999, as amended at 78 FR 14640, Mar. 7, 2013]