Code of Federal Regulations

Title 9: Animals and Animal Products PART 319 - DEFINITIONS AND STANDARDS OF IDENTITY OR COMPOSITION

Subpart E—Sausage Generally: Fresh Sausage

§ 319.140 Sausage.

Except as otherwise provided in this section, or under the Poultry Products Inspection Act with respect to products consisting partly of poultry, sausage is the coarse or finely comminuted meat food product prepared from one or more kinds of meat or meat and meat byproducts, containing various amounts of water as provided for elsewhere in this part, and usually seasoned with condimented proportions of condimental substances, and frequently cured. Certain sausage as provided for elsewhere in this part may contain binders and extenders as provided in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. In addition to the binders and extenders referred to in the preceding sentence, the following two substances may also be used as binders in those sausages in which the use of such class of substances is permitted: pork collagen at up to 3.5% of the product formulation and transglutaminase enzyme at up to 65 ppm of the product formulation. Sausage may not contain phosphates except that phosphates listed in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B may be used in cooked sausage. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of sausage which is not cooked in an amount not to exceed 3 percent of the total ingredients in the formula. Cooked sausages such as Polish sausage, cotto salami, braunschweiger, liver sausage, and similar cooked sausage products may contain no more than 10 percent of added water in the finished product. Sausage may contain Mechanically Separated (Species) used in accordance with §319.6.

§ 319.141 Fresh pork sausage.

“Fresh Pork Sausage” is sausage prepared with fresh pork or frozen pork or both, but not including pork byproducts, and may contain Mechanically Separated (Species) in accordance with §319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

§ 319.142 Fresh beef sausage.

“Fresh Beef Sausage” is sausage prepared with fresh beef or frozen beef, or both, but not including beef byproducts, and may contain Mechanically Separated (Species) used in accordance with §319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 30 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

§ 319.143 Breakfast sausage.

“Breakfast sausage” is sausage prepared with fresh and/or frozen meat; or fresh and/or frozen meat and meat byproducts, and may contain Mechanically Separated (Species) in accordance with §319.6, and may be seasoned with condimental substances as permitted in part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used. Binders or extenders may be added as provided in §319.140 of this part.

§ 319.144 Whole hog sausage.

“Whole Hog Sausage” is sausage prepared with fresh and/or frozen meat from swine in such proportions as are normal to a single animal, and may include any Mechanically Separated (Species) produced from the animal and used in accordance with §319.6, and may be seasoned with condimental substances as permitted under part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

§ 319.145 Italian sausage products.

(a) Italian sausage products are cured or uncured sausages containing at least 85 percent meat, or combination of meat and fat, with the total fat content constituting not more than 35 percent of the finished product. Such products shall be prepared in accordance with the provisions of paragraph (a) (1), (2) or (3) of this section, and shall contain salt, pepper, and either fennel or anise, or a combination of fennel and anise. Such products may contain any or all of the optional ingredients listed in paragraph (b) of this section.
(1) “Italian Sausage” shall be prepared with fresh or frozen pork, or pork and pork fat, and may contain Mechanically Separated (Species) in accordance with §319.6.
(2) “Italian Sausage with Beef,” “Italian Sausage with Veal,” or “Italian Sausage with Beef and Veal,” shall be prepared so that fresh or frozen pork constitutes the major portion of the meat content requirement of this paragraph. Mechanically Separated (Species) may be used in accordance with §319.6. When pork muscle tissue is combined with beef or veal, or both, in the preparation of bulk-packed products, or patties, it shall be treated for the destruction of possible live trichinae in accordance with §318.10 of this subchapter.
(3) “Italian Beef Sausage” or “Kosher Italian Beef Sausage” shall be prepared with fresh or frozen beef or beef and beef fat. “Italian Veal Sausage” or “Kosher Italian Veal Sausage” shall be prepared with fresh or frozen veal or veal and veal fat. Mechanically Separated (Species) may be used in accordance with §319.6.
(4) Italian sausage products made in conformance with the provisions of paragraphs (a) (1), (2), and (3) of this section, and with paragraphs (b) and (c) of this section, may contain sodium nitrite or potassium nitrite in amounts not to exceed those allowed in a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B, provided that such products are labeled with the word “cured” in the product name, such as “Cured Italian Sausage.” The word “cured” shall be displayed on the product label in the same size and style of lettering as other words in the product name.
(b) Optional ingredients permitted in Italian sausage products include:
(1) Spices (including paprika) and flavorings.
(2) Water or ice to facilitate chopping or mixing, but not to exceed 3 percent of the total weight of all ingredients including the water.
(3) Red or green peppers, or both.
(4) Dehydrated or fresh onions, garlic, and parsley.
(5) Sugar, dextrose, corn syrup, corn syrup solids, and glucose syrup.
(6) Monosodium glutamate and antioxidants in accordance with the chart of substances a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.
(c) If Italian sausage products are cooked or smoked, determination of compliance with the provisions of paragraphs (a) and (b) of this section shall be based on the uncooked or unsmoked product. The product before cooking or smoking shall contain no more than 3 percent water as specified in paragraph (b)(2) of this section. Product which is cooked shall be labeled with the word “cooked” in the product name, such as “Cooked Italian Sausage” or “Cooked Cured Italian Sausage.” Product which is smoked shall be labeled with the word “smoked” in the product name, such as “Smoked Italian Sausage” or “Smoked Cured Italian Sausage.” The words “cooked” and “smoked” shall be displayed on the product label in the same size and style of lettering as other words in the product name.

Subpart F—Uncooked, Smoked Sausage

§ 319.160 Smoked pork sausage.

“Smoked Pork Sausage” is pork sausage that is smoked with hardwood or other approved nonresinous materials. It may be seasoned with condimental substances as permitted in part 318 of this subchapter. The finished product shall not contain more than 50 percent fat. To facilitate chopping or mixing, water, or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Subpart G—Cooked Sausage

§ 319.180 Frankfurter, frank, furter, hotdog, weiner, vienna, bologna, garlic bologna, knockwurst, and similar products.

(a) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages are comminuted, semisolid sausages prepared from one or more kinds of raw skeletal muscle meat or raw skeletal muscle meat and raw or cooked poultry meat, and seasoned and cured, using one or more of the curing agents in accordance with a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. They may or may not be smoked. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing or to dissolve the curing ingredients but the sausage shall contain no more than 40 percent of a combination of fat and added water. These sausage products may contain only phosphates approved under part 318 of this chapter. Such products may contain raw or cooked poultry meat and/or Mechanically Separated (Kind of Poultry) without skin and without kidneys and sex glands used in accordance with §381.174, not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and Mechanically Separated (Species) used in accordance with §319.6. Such poultry meat ingredients shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of §381.118 of this chapter.
(b) Frankfurter, frank, furter, hot-dog, wiener, vienna, bologna, garlic bologna, knockwurst and similar cooked sausages that are labeled with the phrase “with byproducts” or “with variety meats” in the product name are comminuted, semisolid sausages consisting of not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts, or not less than 15 percent of one or more kinds of raw skeletal muscle meat with raw meat byproducts and raw or cooked poultry products; and seasoned and cured, using one or more of the curing ingredients in accordance with a regulation permitting that use in this subchapter or in 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B. They may or may not be smoked. Partially defatted pork fatty tissue or partially defatted beef fatty tissue, or a combination of both, may be used in an amount not exceeding 15 percent of the meat and meat byproducts or meat, meat byproducts, and poultry products ingredients. The finished products shall not contain more than 30 percent fat. Water or ice, or both, may be used to facilitate chopping or mixing to dissolve the curing and seasoning ingredients, the sausage shall contain no more than 40 percent of a combination of fat and added water. These sausage products may contain only phosphates approved under part 318 of this chapter. These sausage products may contain poultry products and/or Mechanically Separated (Kind of Poultry) used in accordance with §381.174, individually or in combination, not in excess of 15 percent of the total ingredients, excluding water, in the sausage, and may contain Mechanically Separated (Species) used in accordance with §319.6. Such poultry products shall not contain kidneys or sex glands. The amount of poultry skin present in the sausage must not exceed the natural proportion of skin present on the whole carcass of the kind of poultry used in the sausage, as specified in §381.117(d) of this chapter. The poultry products used in the sausage shall be designated in the ingredient statement on the label of such sausage in accordance with the provisions of §381.118 of this chapter. Meat byproducts used in the sausage shall be designated individually in the ingredient statement on the label for such sausage in accordance with §317.2 of this chapter.
(c) A cooked sausage as defined in paragraph (a) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst. When such sausage products are prepared with meat from a single species of cattle, sheep, swine, or goats they shall be labeled with the term designating the particular species in conjunction with the generic name, e.g., “Beef Frankfurter,” and when such sausage products are prepared in part with Mechanically Separated (Species) in accordance with §319.6, they shall be labeled in accordance with §317.2(j)(13) of this subchapter.
(d) A cooked sausage as defined in paragraph (b) of this section shall be labeled by its generic name, e.g., frankfurter, frank, furter, hotdog, wiener, vienna, bologna, garlic bologna, or knockwurst, in conjunction with the phrase “with byproducts” or “with variety meats” with such supplemental phrase shown in a prominent manner directly contiguous to the generic name and in the same color on an identical background.
(e) Binders and extenders as provided in §319.140 of this part may be used in cooked sausage that otherwise comply with paragraph (a) or (b) of this section. When any such substance is added to these products, the substance shall be declared in the ingredients statement by its common or usual name in order of predominance.
(f) Cooked sausages shall not be labeled with terms such as “All Meat” or “All (Species),” or otherwise to indicate they do not contain nonmeat ingredients or are prepared only from meat.
(g) For the purposes of this section: Poultry meat means deboned chicken meat or turkey meat, or both, without skin or added fat; poultry products mean chicken or turkey, or chicken meat or turkey meat as defined in §381.118 of this chapter, or poultry byproducts as defined in §381.1 of this chapter; and meat byproducts (or variety meats), mean pork stomachs or snouts; beef, veal, lamb, or goat tripe; beef, veal, lamb, goat, or pork hearts, tongues, fat, lips, weasands, and spleens; and partially defatted pork fatty tissue, or partially defatted beef fatty tissue.

§ 319.181 Cheesefurters and similar products.

“Cheesefurters” and similar products are products in casings which resemble frankfurters except that they contain sufficient cheese to give definite characteristics to the finished article. They may contain binders and extenders as provided in §318.7(c)(4) of this subchapter. Limits on use as provided in §318.7 are intended to be exclusive of the cheese constituent. When any such substance is added to these products, the substance shall be designated in the ingredients statement by its common or usual name in order of predominance. These products shall contain no more than 40 percent of a combination of fat and added water, and no more than 30 percent fat and shall comply with the other provisions for cooked sausages that are in this subchapter.

§ 319.182 Braunschweiger and liver sausage or liverwurst.

(a) “Braunschweiger” is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 percent pork, beef, and/or veal livers computed on the weight of the fresh livers. It may also contain pork and/or beef fat. Mechanically Separated (Species) may be used in accordance with §319.6. Binders and extenders may be used as permitted in §319.140. The product may have a smoked taste characteristic, which may be imparted by use of smoked meats, smoke flavoring or smoking. If prepared from components of a single species, the product name may reflect the species, e.g., “Beef Braunschweiger.” Braunschweiger may also be labeled as any of the following: “Braunschweiger—A Liver Sausage,” “Braunschweiger—A Liverwurst,” or “Braunschweiger (Liver Sausage)” or “Braunschweiger (Liverwurst).”
(b) “Liver Sausage” or “Liverwurst” is a cooked sausage made from fresh, cured, and/or frozen pork, beef, and/or veal and at least 30 percent pork, beef, veal, sheep, and/or goat livers computed on the weight of the fresh livers. It may also contain pork and/or beef byproducts. Mechanically Separated (Species) may be used in accordance with §319.6. Binders and extenders maybe used as permitted in §319.140. If prepared from components of a Single species, the product name may reflect that species, e.g., “Pork Liver Sausage.”

Subpart K—Luncheon Meat, Loaves and Jellied Products

§ 319.260 Luncheon meat.

“Luncheon Meat” is a cured, cooked meat food product made from comminuted meat. Mechanically Separated (Species) may be used in accordance with §319.6. To facilitate chopping or mixing or to dissolve the usual curing ingredients, water or ice may be used in the preparation of luncheon meat in an amount not to exceed 3 percent of the total ingredients.

§ 319.261 Meat loaf.

“Meat Loaf” is a cooked meat food product in loaf form made from comminuted meat. Mechanically Separated (Species) may be used in accordance with §319.6. To facilitate chopping or mixing, water or ice may be used in an amount not to exceed 3 percent of the total ingredients used.

Subpart L—Meat Specialties, Puddings and Nonspecific Loaves

§ 319.280 Scrapple.

“Scrapple” shall contain not less than 40 percent meat and/or meat byproducts computed on the basis of the fresh weight, exclusive of bone. Mechanically Separated (Species) may be used in accordance with §319.6. The meal or flour used may be derived from grain and/or soybeans.

§ 319.281 Bockwurst.

(a) Bockwurst is an uncured, comminuted meat food product which may or may not be cooked. It contains meat, milk or water or a combination thereof, eggs, vegetables, and any of the optional ingredients listed in paragraph (b) of this section; and is prepared in accordance with the provisions of paragraphs (a)(1), (2), (3), and (4) of this section.
(1) Meat shall constitute not less than 70 percent of the total weight of the product and shall consist of pork or a mixture of pork and veal, pork and beef, or pork, veal, and beef. Such meat shall be fresh or fresh frozen meat. Pork may be omitted when the specie or species of meat used in the product is identified in the product name (e.g., Veal Bockwurst, Beef Bockwurst, or Beef and Veal Bockwurst). Mechanically Separated (Species) may be used in accordance with §319.6.
(2) The “milk” may be fresh whole milk, dried milk, nonfat dry milk, calcium reduced dried skim milk, enzyme (rennet) treated calcium reduced dried skim milk and calcium lactate, or any combination thereof.
(3) “Eggs” refer to whole eggs that are fresh, frozen, or dried.
(4) “Vegetables” refer to onions, chives, parsley, and leeks, alone or in any combination.
(b) Bockwurst may contain one or more of the following optional ingredients:
(1) Pork fat.
(2) Celery, fresh or dehydrated.
(3) Spices, flavorings.
(4) Salt.
(5) Egg whites, fresh, frozen, or dried.
(6) Corn syrup solids, corn syrup, or glucose syrup with a maximum limit of 2 percent individually or collectively, calculated on a dry basis. The maximum quantities of such ingredients shall be computed on the basis of the total weight of the ingredients.
(7) Autolyzed yeast extract, hydrolyzed plant protein, milk protein hydrolysate, and monosodium glutamate.
(8) Sugars (sucrose and dextrose).
(9) Binders and extenders may be added as provided in §318.7(c)(4) of this subchapter. When any such substance is added to bockwurst, the substance shall be designated in the ingredients statement by its common or usual name in order of predominance.
(c) If bockwurst is cooked or partially cooked, the composition of the raw mix from which it is prepared shall be used in determining whether it meets the requirements of this section.
Our Note: Certain subparts for example I - Semi-dry Fermented Sausages and J-Dry Fermented Sausages are listed as “reserved.” The reference to the regulations being “reserved” is that these sections are reserved if FSIS decided to conduct rulemaking to create regulations for these products. The regulations would be placed in these sections.

§ 319.106 “Country Ham,” “Country Style Ham,” “Dry Cured Ham,” “Country Pork Shoulder,” “Country Style Pork Shoulder,” and “Dry Cured Pork Shoulder.”

(a) “Country Ham,” “Country Style Ham,” or “Dry Cured Ham,” and “Country Pork Shoulder,” “Country Style Pork Shoulder,” or “Dry Cured Pork Shoulder.” are the uncooked, cured, dried, smoked or unsmoked meat food products made respectively from a single piece of meat conforming to the definition of “ham,” as specified in §317.8(b)(13) of this subchapter, or from a single piece of meat from a pork shoulder. They are prepared in accordance with paragraph (c) of this section by the dry application of salt (NaCl), or by the dry application of salt (NaCl) and one or more of the optional ingredients as specified in paragraph (d) of this section. They may not be injected with curing solutions nor placed in curing solutions.
(b) The product must be treated for the destruction of possible live trichinae in accordance with such methods as may be approved by the Administrator upon request in specific instances and none of the provisions of this standard can be interpreted as discharging trichinae treatment requirements.
(c)(1) The entire exterior of the ham or pork shoulder shall be coated by the dry application of salt or by the dry application of salt combined with other ingredients as permitted in paragraph (d) of this section.
2) Additional salt, or salt mixed with other permitted ingredients, may be reapplied to the product as necessary to insure complete penetration.
(3) When sodium or potassium nitrate, or sodium or potassium nitrite, or a combination thereof, is used, the application of salt shall be in sufficient quantity to insure that the finished product has an internal salt content of at least 4 percent.
(4) When no sodium nitrate, potassium nitrate, sodium nitrite, potassium nitrite or a combination thereof is used, the application of salt shall be in sufficient quantity to insure that the finished product has a brine concentration of not less than 10 percent or a water activity of not more than 0.92.
(5) For hams or pork shoulders labeled “country” or “country style,” the combined period for curing and salt equalization shall not be less than 45 days for hams, and shall not be less than 25 days for pork shoulders; the total time for curing salt equalization, and drying shall not be less than 70 days for hams, and shall not be less than 50 days for pork shoulders. During the drying and smoking period, the internal temperature of the product must not exceed 95 °F., provided that such temperature requirement shall not apply to product dried or smoked under natural climatic conditions.
(6) For hams or pork shoulders labeled “dry cured,” the combined period for curing and salt equalization shall not be less than 45 days for hams, and shall not be less than 25 days for pork shoulders; and the total time for curing, salt equalization, and drying shall not be less than 55 days for hams and shall not be less than 40 days for pork shoulders.
(7) The weight of the finished hams and pork shoulders covered in this section shall be at least 18 percent less than the fresh uncured weight of the article.
(d) The optional ingredients for products covered in this section are:
(1) Nutritive sweeteners, spices, seasonings and flavorings.
(2) Sodium or potassium nitrate and sodium or potassium nitrite if used as prescribed in this section and in accordance with a regulation permitting that use in this subchapter or 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or Subchapter B.

Bacon Ingredient Limits

Pumped and/or Massaged Bacon (rind-off): An amount of 120 ppm sodium nitrite (or 148 ppm potassium nitrite), ingoing, is required in pumped and/or massaged bacon, except that 100 ppm sodium nitrite (or 123 ppm potassium nitrite) is permitted with an appropiate partial quality control, and except that 40 - 80 ppm sodium nitrite (or 49 - 99 ppm potassium nitrite) is permitted if sugar and a lactic acid starter culture is used. 550 ppm sodium ascorbate or sodium erythorbate (isoascorbate), ingoing, is required in pumped and massaged bacon, in addition to any prescribed amount of nitrite.
Immersion Cured Bacon (rind-off): A maximum of 120 ppm of nitrite or equivalent of potassium nitrite (148 ppm) can be used in immersion cured bacon.