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USDA/FSIS Perspective on Retained Water

USDA/FSIS Perspective on Retained Water. DANIEL L. ENGELJOHN Director RDDS (Regulations and Directives Development Staff) OPPDE (Office of Policy, Program Development, and Evaluation) FSIS (Food Safety and Inspection Service) USDA (United States Department of Agriculture)

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USDA/FSIS Perspective on Retained Water

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  1. USDA/FSIS Perspective onRetained Water DANIEL L. ENGELJOHN Director RDDS (Regulations and Directives Development Staff) OPPDE (Office of Policy, Program Development, and Evaluation) FSIS (Food Safety and Inspection Service) USDA (United States Department of Agriculture) 300-12th St., S.W., Rm. #112, Washington, DC 20250-3700 Office: 202-720-5627; Fax: 202-690-0486; daniel.engeljohn@usda.gov Web-based Policy Documents http://www.fsis.usda.gov/OPPDE/rdad/publications.htm

  2. USDA/FSIS Perspective onRetained Water FSIS Responsibility • Public health regulatory agency within USDA • Ensure that the commercial supply of meat, poultry, and processed egg products in the United States is safe, wholesome, and accurately labeled • Federal Meat Inspection Act (FMIA) • Poultry Products Inspection Act (PPIA) • Egg Products Inspection Act (EPIA)

  3. Final Rule: 66 FR 1750, 1/9/01 USDA/FSIS Perspective onRetained Water • Effective January 9, 2002 • Comments on guidance due April 9, 2001 • Early implementation provisions identified • Changes to existing regulations: • 9 CFR 381.1 • 9 CFR 381.65 • 9 CFR 381.66 • New 9 CFR 441.10

  4. Preamble Overview (pages 1750-1751) USDA/FSIS Perspective onRetained Water • Background • FMIA and PPIA adulteration and misbranding provisions • “…any substance has been added …to increase its bulk or weight….” (adulteration)“…its labeling is false or misleading….” (misbranding) • Federal court set aside the regulatory limits on retained water in poultry products • Label disclosure determined to be necessary • Proposed rule on September 11, 1998 (63 FR 48963)

  5. Preamble Overview (page 1752) Continued USDA/FSIS Perspective onRetained Water • 252 comments received • 24 % meat industry • 67 % poultry industry • 8 % other (individuals, consumers, weights/measures, European interests) • Except for 40 degree chilling of poultry, FSIS views equity issues resolved • FSIS expects to address the 40 degree issue in a separate, but priority, rulemaking this year

  6. Preamble Overview (pages 1752-1753) Continued USDA/FSIS Perspective onRetained Water • Rule addresses single ingredient raw meat and poultry: • Carcasses, parts, offal, and organs -- whether meat or poultry • Concerned with post-evisceration water retention-- whether meat or poultry • FSIS recognizes that immersion chilling is effective in removing carcass heat, but products will retain water • Retained water from any source must be accounted for

  7. Preamble Overview (pages 1753-1754) Continued USDA/FSIS Perspective onRetained Water • Establishments can be exempted from 40 degree chilling to meet objectives of data collection protocols--pre-implementation • Retained water is limited to the amount that is unavoidable to achieve a food safety objective • Retained water is not viewed by FSIS as an ingredient • Injected and cured products are outside the scope of this rulemaking

  8. Preamble Overview (page 1755) Continued USDA/FSIS Perspective onRetained Water • FSIS noted: • “… it could determine that some water retention is necessary, is unavoidable, and would not need to be disclosed. However, those circumstances have not been established in this rulemaking.” • Protocol Issues: • Establishments have the burden of identifying what they have to do to meet the food safety requirements and to minimize retained water

  9. Preamble Overview (page 1755) Continued USDA/FSIS Perspective onRetained Water • Protocol Issues Continued: • Agency will not pre-approve protocols but will review and identify objections within 30 days, if any • Retained water labels are generically approved • Labeling claims regarding safety may be reviewed on a case-by-case basis • FSIS will issue draft pre-implementation policy immediately and finalize within next few weeks • Establishments can use any substantiated in-plant procedure

  10. Preamble Overview (page 1755) Continued USDA/FSIS Perspective onRetained Water • Protocol Issues Continued: • The FSIS “30-day” review will focus on protocol elements via a checklist • Salmonella pathogen reduction regulatory performance standards must be met; FSIS expects to immediately provide Salmonella data for non-regulatory performance standards, if baseline data available; if Salmonella baseline data is not available, establishments can use other food safety process controls

  11. Preamble Overview (page 1756) Continued USDA/FSIS Perspective onRetained Water • Retained Water Relationship to HACCP: • Unavoidable retained water must be associated with a food safety objective -- generally the Salmonella performance standard; the Salmonella pathogen reduction performance standard is directly tied to HACCP; thus, there is a relationship between retained water and HACCP • FSIS has no expectations regarding whether establishments will add a CCP or critical limits to HACCP plans

  12. Preamble Overview (pages 1756-1757) Continued USDA/FSIS Perspective onRetained Water • Labeling Issues: • Minimization of retained water prevents adulteration; labeling the amount of retained water prevents misbranding • At this time, single-ingredient raw meat and poultry products (including ground meat and poultry) are not required to bear nutrition labeling • Nutrition labeling, if finalized for these products, will not replace the need for retained water labeling • Labeling statement must be contiguous to the product name or elsewhere on the principal display panel of the label

  13. Preamble Overview (pages 1756-1757) Continued USDA/FSIS Perspective onRetained Water • Labeling Issues Continued: • All product in commerce must be accurately labeled regarding retained water • Importing countries that do not require retained water to be identified can provide documentation allowing non-labeled product into their country • The one-year effective date will allow time for experimentation and finalization of procedures, and labeling modifications

  14. Preamble Overview (page 1757) Continued USDA/FSIS Perspective onRetained Water • Labeling IssuesContinued: • FSIS national reference database on the natural moisture content of raw products in the various meat and poultry product classes • The effective date of 1/9/02 is real • FSIS does not expect to initiate sampling and analyses to establish a database due to resource issues • FSIS expects to aggregate industry data, make it available to industry, and use it as a national baseline

  15. Preamble Overview (pages 1757-1758) Continued USDA/FSIS Perspective onRetained Water • Labeling Issues Continued: • FSIS expects that the 20 % variation from the labeled statement to be reasonable unless presented with contrary data (not in preamble) • The statement should be scientifically substantiated, addressing seasonal, product, and processing variation • Establishments need to account for distribution changes in retained water (e.g., dry-tare/wet-tare issues)

  16. Preamble Overview (pages 1758-1759) Continued USDA/FSIS Perspective onRetained Water • Cost Issues: • FSIS expects establishments to have on-going verification to ensure accuracy of labeling • Measuring Retained Water: • Establishments can use any supportable methodology; FSIS will use method in Appendix A • FSIS believes naturally occurring moisture should be accounted for after evisceration but before any other process that may cause water retention to occur (clarification to the preamble)

  17. Preamble Overview (page 1759) Continued USDA/FSIS Perspective onRetained Water • Measuring Retained WaterContinued: • After the effective date, FSIS will concentrate its verification efforts in the market place • FSIS will rely upon the dry-oven methodology (Appendix A) but likely will review in-plant documentation if the results do not reasonably support the labeling statement • Offal products are subject to this rulemaking regardless of past policy documents; such documents will be revised or cancelled

  18. Preamble Overview (pages 1759-1761) Continued USDA/FSIS Perspective onRetained Water • Consumer Issues; Court Case; Effect on Pathogens; Inconsistency in Proposed Rule; Time and Flexibility for Final Rule Implementation: • Discussed at length in preamble

  19. Preamble Overview (page 1762) Continued USDA/FSIS Perspective onRetained Water • Technical Changes: • The qualifier “mature” restored in the definition of “ready-to-cook” poultry (regarding removal of kidneys with cadmium) • Typographical errors corrected • Removed paragraph (b) of 9 CFR 381.65 (duplicative of Sanitation SOP’s and HACCP) • Removed 9 CFR 381.65(d) as redundant with the new 9 CFR 441.10 (regarding draining) • Removed 9 CFR 381.66(d)(8) regarding notification of inspector of changes

  20. Preamble Overview (pages 1762-1763) Continued USDA/FSIS Perspective onRetained Water • Technical ChangesContinued: • Modified 9 CFR 381.66(c)(2)(i) regarding design requirements of chiller • Modified 9 CFR 381.66(c)(2)(ii) regarding the prohibition to chill in water individual parts from salvage operations • International Trade • Discussed at length in preamble

  21. Reg Text Overview (pages 1770-1771) USDA/FSIS Perspective onRetained Water • 381.1 Definitions • Ready-to-cook revised to state “mature reproductive organs and kidneys may have been removed • 381.65 Operations and Procedures • Old (c) now new (b): Thorough bleeding, breathing stopped before scalding, and blood confined to small area

  22. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • 381.65 Operations and ProceduresContinued • Old (d) -- kidney removal -- and (f)-(g) removed; old (h) modified as new (c): Thawing my method to prevent adulteration or net weight gain • Old (e) accidentally removed fecal contamination prior to entering chiller: Will soon be added back in a technical amendment; meanwhile, new (d): Water for washing must drain freely • Old (q)(1) and (2) condensed and new (e): Harvesting ova

  23. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • 381.66 Temperatures and Chilling and Freezing • Old (a) modified to remove filing description of chilling and freezing procedures with the inspector • Old (b)(1) and (2) remain, for now • Old (c) modified: • New (c)(1) requires potable water to be used • New (c)(2)(i) requires operation of chilling equipment in a manner to meet pathogen reduction performance standards (9 CFR 381.94) and of HACCP plan

  24. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • 381.66 Temperatures and Chilling and FreezingContinued • Old (c) modified (continued): • New (c)(2)(ii) requires major portions of poultry carcasses may be chilled in water and ice • New (c)(3) requires previously chilled poultry to be maintained at 40 degrees Fahrenheit or below until packaged • New (c)(4) requires giblets to be chilled to 40 degrees Fahrenheit or below within 2 hours, except if cooled with the carcass

  25. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • 381.66 Temperatures and Chilling and FreezingContinued • Old (d) modified to minimize water absorption and retention in (1) and to provide scales, weights, and other supplies necessary to conduct water tests in (2) • Old (e) remains: Air chilling • Old (f) regarding freezing remains except that (6) is removed: Equipment construction and compounds used in immersion or spray freezing

  26. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • New 441.10 Retained Water • (a) Livestock and poultry carcasses and parts cannot retain water from post-evisceration processing unless: • The establishment demonstrates with data collected according to a written protocol that retained water is an unavoidable consequence used to meet applicable food safety requirements

  27. Reg Text Overview (page 1771) USDA/FSIS Perspective onRetained Water • New 441.10 Retained WaterContinued • (b) Product in commerce must bear a label statement: • In prominent letters • Contiguous to product name or elsewhere on PDP • State the maximum percentage of retained water • If no retained water, statement can state this • (c)(1) Maintain file available to FSIS regarding retained water protocol • (c)(2) Notification of FSIS of protocol review; FSIS will respond within 30 days

  28. Reg Text Overview (pages 1771-1772) USDA/FSIS Perspective onRetained Water • New 441.10 Retained WaterContinued • (d) Protocol elements • (1) Purpose • (2) Type of washing and chilling system • (3) Configuration of chilling system • (4) Special features in the chilling system • (5) Description of variable factors in chilling system • (6) Standards to be met by the chilling system • (7) Testing methods to be employed • (8) Reporting of data • (9) Conclusions

  29. Reg Text Overview (page 1772) USDA/FSIS Perspective onRetained Water • New 441.10 Retained WaterContinued • Appendix A: Method for Determining Moisture • Oven drying procedure

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