DANIEL L' ENGELJOHN

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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 [phone]
• daniel.engeljohn_at_usda.gov
• Web-based Policy Documents
• http//www.fsis.usda.gov/OPPDE/rdad/publications.h
  tm

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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)

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USDA/FSIS Perspective onRetained Water
Final Rule 66 FR 1750, 1/9/01

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1750-1751)

• 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)

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1752) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1752-1753) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1753-1754) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1755) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1755) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1755) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1756) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1756-1757) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1756-1757) Continued

• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1757) Continued

• Labeling Issues Continued
• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1757-1758) Continued

• 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)

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1758-1759) Continued

• 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)

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1759) Continued

• Measuring Retained Water Continued
• 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1759-1761) Continued

• Consumer Issues Court Case Effect on Pathogens
  Inconsistency in Proposed Rule Time and
  Flexibility for Final Rule Implementation
• Discussed at length in preamble

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USDA/FSIS Perspective onRetained Water
Preamble Overview (page 1762) Continued

• 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 SOPs 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

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USDA/FSIS Perspective onRetained Water
Preamble Overview (pages 1762-1763) Continued

• Technical Changes Continued
• 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

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USDA/FSIS Perspective onRetained Water
Reg Text Overview (pages 1770-1771)

• 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

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USDA/FSIS Perspective onRetained Water
Reg Text Overview (page 1771)

• 381.65 Operations and Procedures Continued
• 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

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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

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Reg Text Overview (page 1771)
USDA/FSIS Perspective onRetained Water

• 381.66 Temperatures and Chilling and Freezing
  Continued
• 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

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Reg Text Overview (page 1771)
USDA/FSIS Perspective onRetained Water

• 381.66 Temperatures and Chilling and Freezing
  Continued
• 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

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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

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Reg Text Overview (page 1771)
USDA/FSIS Perspective onRetained Water

• New 441.10 Retained Water Continued
• (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

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Reg Text Overview (pages 1771-1772)
USDA/FSIS Perspective onRetained Water

• New 441.10 Retained Water Continued
• (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

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Reg Text Overview (page 1772)
USDA/FSIS Perspective onRetained Water

• New 441.10 Retained Water Continued
• Appendix A Method for Determining Moisture
• Oven drying procedure