1. PURPOSE
   This Directive provides instructions to inspection program personnel on the procedures for conducting inspection activities concerning the consumer protection standards for retained water in raw meat and poultry products. (NOTE: THIS DIRECTIVE IS NOT EFFECTIVE UNTIL JANUARY 9, 2003).
2. [Reserved]
3. [Reserved]
4. REFERENCES
   9 CFR Section 441.10
5. BACKGROUND
   1. Raw, single-ingredient meat and poultry products that retain water as the result of post-evisceration processing in excess of naturally occurring moisture are subject to the retained water regulations. Section 9 CFR 441.10, which becomes effective January 9, 2003, allows for retained water in raw livestock and poultry carcasses and parts only to the extent that it is an unavoidable consequence of a process used to meet applicable food safety requirements. The amount of water retained in the product in excess of naturally occurring moisture must be prominently declared on the label. Any establishment that uses a post-evisceration process that results in water retention in a raw livestock or poultry carcass or part must maintain on file a written data-collection protocol in accordance with 9 CFR 441.10 (c)(1). Establishments’ protocols and procedures are to be available to FSIS. An establishment does not have to maintain a protocol on file if it has data or information that clearly demonstrate that its products do not retain water as a result of the process, e.g. spraying boneless meat with antimicrobials where the end product does not retain water from the antimicrobial application process.

   2. Establishments may include a no-retained-water statement on the label whe n product has not been exposed to a post-evisceration process that adds water, or the establishment has data or information that establishes that the process does not add water to the product.

   3. FSIS does not require official establishments to use any specific method to make a retained water determination. The method chosen in calculating water absorption and retention, however, should be reproducible and verifiable. For example, an establishment may use physical water pick-up tests, weighing carcasses post- evisceration, before the use of water directly contacting product, and again just prior to final packaging and labeling. Likewise, an establishment may develop its protocol based on laboratory analysis for naturally occurring and total water content of carcasses before and after the application of water for food safety purposes.

   4. In-plant inspection program personnel who have questions about the validity of the method being used by an establishment should consult the Technical Service Center (TSC).

6. POST-EVISCERATION PROCESS
   1. The following are examples of post evisceration processes involving the use of water that would subject products to the requirements of 9 CFR 441.10 (Retained Water):

      1. Post-evisceration washing of livestock and poultry carcasses with hot water, cold water, or an antimicrobial, including on-line reprocessing systems.

      2. Livestock carcass spray chilling with or without an antimicrobial.

      3. Water or ice chilling of poultry carcasses or giblets with or without an antimicrobial.

      4. Water or ice chilling with or without an antimicrobial used to remove heat from parts: hearts, kidneys, livers, tongues, cheeks, salivary glands, spleens, pancreases, ears, tails, or head meat trimmings, including head meat, cheek meat, or tongue meat.

      5. Post chill spraying of meat and poultry carcasses or parts, with water or an antimicrobial solution.

      6. Spraying byproducts (e.g. hearts, livers, tongues, cheeks, salivary glands, spleens, pancreases, chitterlings, stomachs, ears, and tails) with an antimicrobial after they have been converted from their natural state to an edible state (e.g., after the lining has been removed from tripe, and the tripe has been cleaned).

      7. Spraying bones with an antimicrobial used for advanced meat recovery systems or for mechanical deboning.

      8. Spraying meat trimmings, including head meat, cheek meat, or tongue meat, with an antimicrobial solution.

   2. The following are examples of post evisceration processes involving the use of water that would not subject products to 9 CFR 441.10.

      1. Flushing stomachs, small intestines, large intestines, rectum, braided marrow gut, and chitterlings to remove digestive tract contents.

      2. Scalding of pork stomachs, pork tongues, and beef lips, intestines, and stomachs.

      3. Flushing the gizzard with water to remove digestive tract contents.

      4. Washing with water to remove excess blood, e.g. washing hearts, livers, brains, and tendons.

      5. Washing beef heads with water.

         Note: On a case-by-case basis, the Inspector-in-Charge (IIC), in consultation with his or her supervisor and the TSC, will evaluate other post evisceration processes involving the use of water to determine whether the resulting products are subject to 9 CFR 441.10.

7. VERIFICATION PROCEDURES
   1. When directed by PBIS -generated procedure 04B04, the IIC will verify the establishment’s compliance with the other consumer protection (OCP) requirements of 9 CFR 441.10 by reviewing and analyzing the establishment’s data and by observing the processes carried out by the establishment. The IIC will:

      1. verify that the establishment has on file and available to FSIS its written data - collection protocol (9 CFR 441.10(c)(1)) or data that demonstrate that the process does not result in retained water in excess of naturally occurring moisture; and

      2. review all changes or revisions to an existing protocol. An IIC should inform an establishment that it should notify him or her whenever it has a new protocol, has made changes to an existing protocol, or has changed its processing procedures in a manner that would require a new or revised protocol.
          
         Note: Establishments that develop new protocols or revise existing protocols should submit the new or revised protocol to FSIS for review by the Technology Program Development Staff (TPDS) of the Office of Policy and Program Development (OPPD):

         by mail to:
         
         USDA/FSIS/OPPD/TPDS
         1400 Independence Ave., SW Room 405
         Cotton Annex Washington, DC 20250;
         
         or by fax to: (202) 205-0080;
         or by e-mail to: tpds.protocols@usda.gov

         9 CFR 441.10(d) lists the elements to be included in the protocol. FSIS will notify establishments of the outcome of the review in no more than 30 days after the Agency receives the protocol with either a no-objection letter, or a letter listing the Agency’s objections to the submitted protocol. Establishments may choose to implement a new or revised protocol and use a label reflecting the new percentage water gain before receiving FSIS notification of the review outcome. If the FSIS protocol review identified objections or requires changes to the submitted protocol, the establishment will be expected to modify the protocol, and if necessary, the retained water statement.

      3. Verify that the establishment is following its protocol, and that the protocol reflects the actual processing system in use.

      4. Calculate the total retained water in the product using establishment data to verify that the percent retained water declared on the label is supported by the data generated by the protocol. The percent retained water should be within the sampling variability or the allowed labeling variation. That is, continuing measurements of actual retained water demonstrate that it is within 20 percent of the declared retained water level for the product.

   2. Inspection program personnel are to document non-compliances on a Non- Compliance Record (NR), FSIS Form 5400-4, if:

      1. the establishment has a product covered by 9 CFR 441.10 without a protocol or data or information that clearly demonstrate that the product does not retain water as a result of a given process;

      2. the establishment is not following the written protocol;

      3. the retained water declared on the label is less than the level actually retained in the product as determined using the protocol, considering the allowable and appropriate variation; or

      4. the establishment records are incomplete and do not allow for the verification of the accuracy of the retained water label declaration.
         
         Note: IICs who, based on observation or data analysis and actual calc ulations, have reason to believe that an establishment may be systematically adulterating or misbranding its products should submit their information through supervisory channels to the district office. The District Manager will determine the course of action to take.)

8. LABELING REQUIREMENTS
   1. Inspection program personnel are to verify that the labeling of raw single- ingredient products accurately declares any water retained by carcasses or parts of carcasses resulting from post-evisceration processing that was done to meet applicable food safety requirements. Carcasses or parts of carcasses may be whole, cut-up, or ground. Refer to attachment 1 and 2 for additional labeling questions and answers and examples of products. Some labeling principles are:

      1. Any water retained besides naturally occurring moisture in such products must be reflected in a prominent statement on the principal display panel of the product label, e.g., up to X percent retained water, or may contain up to X percent absorbed water.

      2. The generic labeling regulations 9 CFR 317.5 and 9 CFR 381.133 and the nutrition labeling regulations in Part 317 Subpart B and Part 381 Subpart N apply to retained water products as they apply to other single-ingredient products.

      3. The permitted labeling variation is 20 percent from the declared amount within the retained water statement.

   2. Multi-ingredient product labeling is not affected by retained water in a meat or poultry component. Thus, retained water is not an ingredient, and the retained water statement on meat or poultry components is not an ingredient declaration. Refer to attachment 2 for multi-ingredient product examples.

      1. Any retained water in raw meat or poultry items used as ingredients would not be declared on the labeling of multi-ingredient products, e.g., raw or cooked sausage, pre-basted turkeys, or deli meats.

      2. Retained water has no effect on the declared amount of flavor solution in basted, marinated, injected, tumbled, etc. products.

      3. Standards of identity or composition are not affected by the retained water rule.

9. IMPORT PRODUCT
   Import raw single ingredient meat and poultry products that bear an X percent retained water statement, or a statement declaring no retained water, may be sampled periodically during port-of-entry reinspection to verify labeling claims. Exporting country inspection systems are responsible for performing functions equivalent to those set forth in this Directive and for certifying that products for export to the United States meet FSIS import requirements. FSIS will verify the equivalence of exporting country water retention regulatory programs during annual on-site audits.

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