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For Business and Industry:
Notice 15-06 - Use of Non-Amenable Animal Tissue in Inspected Products
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- Can you please provide clarification regarding the purpose of FSIS Notice 15-06 "Use of Non-Amenable Animal Tissue in Inspected Products"?
- Can inspected product that includes non-inspected, non-amenable animal tissue as an ingredient still bear the "mark of inspection" on the finished product? Is there a limit on the percent of non-amenable animal tissues that can be added to inspected product?
- How does this affect labeling? Are there any new provisions due to the issuance of this notice?
- Is the establishment required to reassess its HACCP plan when there is a new source of product?
- How will FSIS verify that non-amenable animal tissue is clean and wholesome product according to FSIS Notice 15-06? Can the establishment use a letter of guarantee (e.g. FDA letter of guarantee, Material Specification Data Sheet, etc)?
- If a particular state requires inspection of certain species, or restricts the sale of certain kinds of meat (e.g. wild game), does FSIS need to do something different to coordinate with the state to assure this state law is being complied with, or is labeling as federally inspected and passed product allowed?
- Would this Notice allow establishments to place wild game that was not listed under 9 CFR Part 352 in a labeled box with a U.S. inspected legend?
- Doesn't the phrase "the use of non-amenable animal tissue in official inspected products" have a very broad implication as to what now can be added to U.S. inspected products?
- Is nitrite/nitrate now allowed to be added to non amenable animal tissues?
- Can non-amenable animals, such as bison, deer, or elk, slaughtered and processed under FDA guidelines at an official establishment be sold at retail or wholesale and across state lines?
- Has there been any change in agency policy with regard to ingredients in voluntary (non-amenable) products? Specifically, can state inspected or non-inspected bison be used as an ingredient in product such as ground bison that is provided voluntary inspection service under 9 CFR 352?
- Does Notice 15-06 make custom exempt "amenable species" essentially U.S. inspected?
Q. Can you please provide clarification regarding the purpose of FSIS Notice 15-06 "Use of Non-Amenable Animal Tissue in Inspected Products"?
A. FSIS Notice 15-06 was issued to correct an obsolete policy document, FSIS Notice 14-91, which incorrectly stated that any non-amenable tissues used to make an amenable product must originate from an "approved source" and bear a mark of inspection (federal, state, or foreign government). Based on a re-examination of the statutory basis for the policy on using non-amenable animal products as ingredients, FSIS determined that FSIS Notice 14-91 was incorrect, and that the Agency could not restrict non-amenable animal tissues that enter a plant to only those that had the voluntary mark, a state mark, or foreign mark of inspection.
Nonetheless, the same statutory provisions that applied before FSIS Notice 15-06 was issued apply after its issuance. Establishments must ensure that non-amenable animal tissues are clean, sound, healthful, wholesome, properly identified, and otherwise such as will not result in the product to which they are added being adulterated (9 CFR 318.6(a), 318.1(c), 424.21(a)). Amenable meat and poultry products are adulterated if they are, in whole or in part, the product of an animal which died otherwise than by slaughter (FMIA, PPIA).
Q. Can inspected product that includes non-inspected, non-amenable animal tissue as an ingredient still bear the "mark of inspection" on the finished product? Is there a limit on the percent of non-amenable animal tissues that can be added to inspected product? ?
A. Meat and poultry products containing non-amenable animal tissue ingredients are eligible to bear the marks of inspection, provided that the meat and poultry products are produced in accordance with applicable regulatory requirements and subject to verification by inspection personnel, and that they meet the criteria for amenable products as stated in the FSIS Food Standards and Labeling Policy Book (Aug 2005), below.
There is no general limit on the amount of non-amenable animal tissues that may be used as ingredients in an amenable product. However, products containing relatively small proportions of amenable livestock or poultry ingredients are not amenable to USDA inspection and are not eligible to bear the marks of inspection. Generally, the USDA has determined by policy that the "relatively small proportions" of livestock ingredients are: 3 percent or less raw meat; less than 2 percent cooked meat or other portions of the carcass; or 30 percent or less fat, tallow or meat extract, alone or in combination. In the case of poultry, the "relatively small proportions" are: less than 3 percent raw poultry meat; less than 2 percent cooked poultry meat; less than 10 percent cooked poultry skins, giblets or fat, separately; or less than 10 percent cooked poultry skins, giblets, fat and poultry meat (limited to less than 2 percent) in any combination (refer to 9 CFR Part 381.15(a)). These percentages are computed on the basis of the moist cooked chicken in the ready to serve product when prepared according to the directions on the consumer package. A condition for the application of these exemptions is that any product exempted from USDA jurisdiction cannot be represented as a meat food or poultry product, except as provided in the meat or poultry regulations. A product is deemed as representing a meat food or poultry product if a term representing meat or poultry is used on labeling, e.g., in the product name, without appropriate qualification.
Q. How does this affect labeling? Are there any new provisions due to the issuance of this notice?
A. FSIS Notice 15-06 does not change FSIS labeling policy. All federally inspected products must be accurately labeled. All ingredients must be declared by a common or usual name in labeling. In addition, if any non-amenable animal tissues are included, product names will be required to declare the species of non-amenable animal tissue ingredients, in accordance with FSIS labeling policy (e.g., "ground beef with kangaroo").
Q. Is the establishment required to reassess its HACCP plan when there is a new source of product?
A. Issuance of FSIS Notice 15-06 does not automatically require HACCP plan reassessment.
However, when there is a new source of product the establishment would need to reassess its HACCP plan. The establishment is required to comply with all the requirements in 9 CFR 417, including section 417.4(a)(3), which requires reassessment of the HACCP plan when changes occur that could affect the hazard analysis or alter the HACCP plan.
Q. How will FSIS verify that non-amenable animal tissue is clean and wholesome product according to FSIS Notice 15-06? Can the establishment use a letter of guarantee (e.g. FDA letter of guarantee, Material Specification Data Sheet, etc)?
A. FSIS does not have specific requirements regarding how an establishment should ensure that non-amenable animal tissues are suitable for use as ingredients in FSIS-inspected meat and poultry products. However, official establishments are required to comply with all the requirements in 9 CFR 417, including 417.2 (a), which requires that the establishment conduct a hazard analysis to determine what food safety hazards are reasonably likely to occur. The hazard analysis shall include food safety hazards that could occur before, during, or after entry into the establishment. An establishment must consider the use of ingredients as part of its hazard analysis.
An establishment may choose to demonstrate the safety and suitability of non-amenable ingredients through documentation such as letters of guarantee, manufacturer specification data sheets, or other documents related to the harvest or processing of non-amenable animal tissues. Such documentation may be used to support an establishment's hazard analysis and to ensure that such ingredients meet the requirements of 9 CFR 318.1(c), 318.6(a), and 424.21(a). Establishments are expected to demonstrate that non-amenable animal tissues to be used as ingredients in FSIS-inspected products were prepared and handled in accordance with the requirements of FDA, or other appropriate federal, state, or local regulatory authority, and are clean, sound, healthful, properly identified, and wholesome.
Because of the vast array of possible non-amenable animal ingredients, and the variety of sources for those ingredients, it is not possible to specify how an establishment might choose to ensure the safety and wholesomeness of those ingredients.
FSIS inspectors also verify that non-amenable animal tissue ingredients are acceptable for the purpose intended; that they are clean, sound, healthful, wholesome, and properly identified when used as an ingredient in FSIS inspected and passed meat and poultry products as is the practice for all ingredients used in amenable product. For example inspectors may:
- Organoleptically inspect non-amenable tissue.
- Review documentation supporting the soundness of the non-amenable tissue such as letters of guarantee, Material Specification Data Sheets, certification of commercial and legal harvest, or other documents provided by the establishment.
Q. If a particular state requires inspection of certain species, or restricts the sale of certain kinds of meat (e.g. wild game), does FSIS need to do something different to coordinate with the state to assure this state law is being complied with, or is labeling as federally inspected and passed product allowed?
A. No. State and local laws have no bearing on whether non-amenable animal tissues may be used as ingredients in amenable products. FSIS inspected and passed product is eligible for sale in commerce. Notice 15-06 did not change any FSIS regulation, and FSIS is not responsible for enforcing the laws of a particular State or local jurisdiction
Q. Would this Notice allow establishments to place wild game that was not listed under 9 CFR Part 352 in a labeled box with a U.S. inspected legend?
A. No. Individually packaged wild game products may not be placed in a box that has the federal marks of inspection as they are not federally inspected. However, wild game animals that are harvested with the intention for use in human food, even if not listed as exotic animals in the regulations for voluntary inspection (e.g. alligator, kangaroo, etc.) may be used as ingredients in inspected products. These ingredients must be clean, sound, healthful, wholesome, properly identified, and otherwise such as will not result in the product to which they are added being adulterated.
Q. Doesn't the phrase "the use of non-amenable animal tissue in official inspected products" have a very broad implication as to what now can be added to U.S. inspected products?
A. The policy expressed in Notice 15-06 does allow establishments more flexibility in the sources of non-amenable animal tissue for use in inspected products. Such ingredients are not limited to only the three "approved source" specified in the obsolete FSIS Notice 14-91. However, such ingredients are still required to be clean, sound, healthful, wholesome, and otherwise such as will not result in the product being adulterated in accordance with 9 CFR 318.6(a).
Q. Is nitrite/nitrate now allowed to be added to non amenable animal tissues?
A. Sodium nitrite and nitrate are listed as approved prior-sanctioned food ingredients in FDA's regulations based on their documented use for curing "meat," as meat was defined by the FMIA prior to September 1958. Prior to September 1958, "meat" was defined as being from cattle, sheep, swine, goats, and equines. Therefore, because bison, buffalo, antelope, or other species of animal for human food use was not included in the definition of meat prior to September 1958, nitrite/nitrate cannot be used to formulate products prepared solely from non-amenable species. Thus, there is no change in the regulations on the use of nitrite/nitrate as ingredients.
Q. Can non-amenable animals, such as bison, deer, or elk, slaughtered and processed under FDA guidelines at an official establishment be sold at retail or wholesale and across state lines?
A. Yes, provided the establishment maintains separation between amenable and non-amenable products sufficient to prevent contamination or adulteration of amenable products. Alternatively, the animals defined in 9 CFR 352.1 as "exotic animals" may be slaughtered and processed under voluntary inspection service according to the regulations in 9 CFR 352.
If establishments wish to slaughter and process non-amenable animals under FDA jurisdiction, the facilities are advised to contact the appropriate FDA field office to learn about what actions they should take.
Q. Has there been any change in agency policy with regard to ingredients in voluntary (non-amenable) products? Specifically, can state inspected or non-inspected bison be used as an ingredient in product such as ground bison that is provided voluntary inspection service under 9 CFR 352?
A. No, FSIS Notice 15-06 did not change any Agency policy with regard to ingredients used in product that is produced under Federal voluntary inspection. Products of exotic animals (e.g. bison) may be produced from animals slaughtered and processed under USDA voluntary inspection as set out in 9 CFR 352. These products may not contain ingredients of the same type of animal unless those ingredients were also produced under voluntary inspection and bear the USDA triangular mark of inspection. It would be misleading for such products to bear the mark. Products produced under voluntary inspection could, however, include non-amenable animal tissues from other types of exotic animals without a mark of inspection, provided that these ingredients are clean, sound, healthful, properly identified, and will not result in adulteration of products.
For example, ground bison produced under FSIS voluntary inspection bearing the triangular mark of inspection can contain only FSIS inspected bison and may not contain bison inspected under a state or foreign government program. However, ground bison with elk could contain elk that did not bear a mark of inspection, provided it is clean, sound, healthful, properly identified, and will not result in adulteration of products.
Q. Does Notice 15-06 make custom exempt "amenable species" essentially U.S. inspected?
A. No, FSIS Notice 15-06 does not change the FMIA, PPIA, or any regulation. Livestock and poultry meat products produced as custom exempt cannot be used as ingredients in inspected and passed product. USDA inspected products may not include meat from amenable species unless it bears the USDA mark of inspection (circle brand) (9 CFR 318.1(a), 381.145(a)). Products produced under custom exemption cannot be used as ingredients in USDA inspected items.
Q. Does this Notice make custom exempt "wild game" products amenable and therefore U.S. inspected?
A. No, FSIS Notice 15-06 does not change the FMIA, PPIA, or any regulation. Wild game, game birds, migratory water fowl, and rabbit cannot be custom exempt from the provisions of the FMIA or PPIA as they are not subject to the FMIA or PPIA. Wild game products are not amenable to inspection.
Q. If a hunter takes his deer to a federally inspected establishment, can the establishment add inspected pork to the sausage mix, produce deer hotdogs under USDA inspection, properly label the ingredients with the inspection legend, and market them for sale to the public?
A. No. There must be assurance that animal tissues, whether from amenable or non-amenable animals, are clean, sound, healthful, and wholesome if they are to be used in product that is to receive the mark of inspection. Such assurance is generally not possible with an animal killed by hunting. There simply is not sufficient knowledge about the animal necessary to make a finding that the meat from the animal is not adulterated.
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Last Modified: May 25, 2006 |
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