# Presentation: 667531

## 
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 

**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 **

**USDA/FSIS Perspective on****Retained Water**

## Public health regulatory agency within USDA

**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)**

_***FSIS Responsibility***_

## 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**** **

_***Final Rule:***__***  66 FR 1750, 1/9/01***_

## 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)**

_***Preamble Overview (pages 1750-1751)***__*** ***_

## 252 comments received

**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**

_***Preamble Overview (page 1752)***_
_***Continued***__*** ***_

## 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**

_***Preamble Overview (pages 1752-1753)***_
_***Continued***__*** ***_

## Preamble Overview (pages 1753-1754)

**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**** **

_***Preamble Overview (pages 1753-1754)***_
_***Continued***__*** ***_

## FSIS noted: 

**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**

_***Preamble Overview (page 1755)***_
_***Continued***__*** ***_

## Protocol Issues 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**

_***Preamble Overview (page 1755)***_
_***Continued***__*** ***_

## Protocol Issues 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 **

_***Preamble Overview (page 1755)***_
_***Continued***__*** ***_

## Retained Water Relationship to HACCP: 

**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**

_***Preamble Overview (page 1756)***_
_***Continued***__*** ***_

## Labeling Issues: 

**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**

_***Preamble Overview (pages 1756-1757)***_
_***Continued***__*** ***_

## Labeling Issues 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 **

_***Preamble Overview (pages 1756-1757)***_
_***Continued***__*** ***_

## Labeling Issues 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**

_***Preamble Overview (page 1757)***_
_***Continued***__*** ***_

## Labeling Issues 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)**

_***Preamble Overview (pages 1757-1758)***_
_***Continued***__*** ***_

## Cost Issues: 

**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)**

_***Preamble Overview (pages 1758-1759)***_
_***Continued***__*** ***_

## Measuring Retained Water 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**

_***Preamble Overview (page 1759)***_
_***Continued***__*** ***_

## Consumer Issues; Court Case; Effect on Pathogens; Inconsistency in Proposed Rule; Time and Flexibility for Final Rule Implementation: 

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

_***Preamble Overview (pages 1759-1761)***_
_***Continued***__*** ***_

## Technical Changes: 

**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**

_***Preamble Overview (page 1762)***_
_***Continued***__*** ***_

## Technical Changes 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**

_***Preamble Overview (pages 1762-1763)***_
_***Continued ***_

## 381.1 Definitions 

**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  **

_***Reg Text Overview (pages 1770-1771)***_

## 381.65 Operations and Procedures Continued 

**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**

_***Reg Text Overview (page 1771)***_

## 381.66 Temperatures and Chilling and Freezing 

**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**

_***Reg Text Overview (page 1771)***_

## 381.66 Temperatures and Chilling and Freezing Continued 

**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**

_***Reg Text Overview (page 1771)***_

## 381.66 Temperatures and Chilling and Freezing Continued 

**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**

_***Reg Text Overview (page 1771)***_

## New 441.10  Retained 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**

_***Reg Text Overview (page 1771)***_

## New 441.10  Retained Water Continued 

**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**

_***Reg Text Overview (page 1771)***_

## New 441.10  Retained Water Continued 

**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**

_***Reg Text Overview (pages 1771-1772)***_

## New 441.10  Retained Water Continued

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

_***Reg Text Overview (page 1772)***_