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Food > Meat and Poultry Products > Manual of Procedures > Chapter 11  

Annex Y

 Guidance for Operators submitting Protocols to CFIA and for the
Veterinarian-in-Charge (VIC) for evaluating protocols
submitted by operators for CFIA acceptance
:

1. Ensure that the applicable product(s) are covered by the revised US moisture retention requirements (see Annex Y-1). The US has posted explanatory information for their moisture retention requirements at:

http://www.fsis.usda.gov/oppde/rdad/frpubs/docs_97-054F.htm

FSIS Notice 22-01, (see Annex Y-2), question VII, as posted on the aforementioned URL, indicates the following:

"A. Pre-evisceration and evisceration processes not subject to the retained water regulation include:

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

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

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

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

A.5. Washing beef heads with water.

B. Post-evisceration processes subject to the retained water requirements include:

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

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

B.3. Post chill spraying of meat and poultry carcasses or parts with water or an antimicrobial solution.

B.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.

B.5. Water or ice chilling of poultry carcasses or giblets with or without an antimicrobial.

B.6. Spraying byproducts with an antimicrobial after they have been converted from their natural state to an edible state, e.g. hearts, livers, tongues, cheeks, salivary glands, spleens, pancreases, chitterlings, stomachs, ears, and tails.

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

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

B.9. Thawing of meat, byproducts, poultry, or giblets in water."

2. Ensure that all elements required by the US regulations have been included in the proposed protocol (complete the checklist issued by USDA for this purpose and as contained in Attachment 1)

3. Contents of the proposed protocol. Compare to the example protocols as developed by USDA and as included in Attachment 2 (steer/heifer) and 3 (young chicken).

4. Variable factors. For red meat and poultry, if no moisture retention occurs, then only one test, comprised of the standard procedure, is required. If moisture retention occurs, e.g. cheek meat or poultry carcasses chilled by immersion in water, then refer to the example protocols developed by USDA and as included in Attachment 2 (steer/heifer) and 3 (young chicken).

5. Testing methodology - sample size. For red meat, accept if the total number of carcasses (divided into several groups as specified in the example protocol) is equal to or greater than that specified in section 4.10.1(4)(c), chapter 4, of this manual. For poultry, accept if the total number of carcasses (divided up into several groups as specified in the example protocol) is equal to or greater than 50 carcasses as specified in section 4.10.1(6)(c), chapter 4, of the Meat Hygiene Manual of Procedures (MOP).

6. Pathogen reduction measurement. USDA has informed CFIA verbally that US industry is not performing salmonella testing as part of validating proposed protocol(s). Rather, USDA continues to collect sample carcasses for salmonella testing as per their standard procedure. Suggest that after all the tests have been completed (one for each combination of factors), that a series of 51 sample carcasses be tested for salmonella with the chilling system operating according to the revised chilling procedure as based on the variable factors corresponding to the lowest level of moisture retention.

7. The protocol should be copied to your Area Red Meat Program or Poultry Inspection Program Specialist for their input if the VIC has any questions concerning the adequacy of the proposed protocol or if the level of moisture retention is above 0% for the product.

8. The VIC (or the Area Program specialist if the level of moisture retention is above 0%) should Issue an official letter on behalf of CFIA indicating objection or no objection to the proposed protocol (refer to the templates developed by USDA and as amended for use by CFIA and included in Attachments 4 (no objection) and 5 (objection).


 

Guidance for Operators Validating Protocols Accepted by CFIA
and for the Veterinarian-in-Charge (VIC) for
Determining If Moisture Retention has been Minimized
Consistent With and Food Safety Requirements

1. Parameters. Ensure that each set of variable factors is tested according to the procedures contained in the protocol accepted by CFIA.

2. Observations, records. Critical operating parameters of the chilling system should be documented on specified forms as indicated in the CFIA accepted protocol for each test; e.g. sampling time and location, "green" and final weight for each sample carcass, transit/chilling time, air or water temperature, revolutions per minute for paddle chillers, cycle time and spraying time for spray chilling systems, surface and/or internal temperature of carcasses, etc.

For poultry, form AGR 4673 should be completed if the operator desires to establish a new chilling procedure suitable for both domestic and exported poultry products.

3. Minimizing moisture retention. Confirm that there is zero net moisture absorption and retention ("green" weight after evisceration but before contact with water post evisceration compared to product final weight as packaged). If not, copy the protocol to the Area Program Specialist for their assessment if the moisture retention has been minimized.

The operator may appeal decisions by the area program specialist to the applicable program Chief at CFIA headquarters.

4. CFIA oversight during experimentation as described in the CFIA accepted protocol. Activities should include review and analysis of data and observation of processes (minimum bi-weekly) carried out by the operator as part of the experimentation. These activities will be performed at the discretion of the VIC using a checklist designed to verify that the protocols are being followed (copy included in Attachment 6).

5. Food safety. Compliance with the US Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) requirements should be considered as satisfying food safety requirements. Salmonella and E. coli samples should be collected during operations consistent with variables corresponding to the lowest moisture retention. Test results should be assessed for compliance with the PR/HACCP requirements as listed in the US section of chapter 11 of this manual.

6. Labelling. Examples of acceptable labels for exported raw single ingredient meat (including poultry) products are posted at the following URL:

http://www.fsis.usda.gov/oppde/rdad/frpubs/docs_97-054F.htm

Labels may be accepted by the VIC. The VIC should continue refer labels to the area program specialist(s) for advice and/or a decision as appropriate. The operator may appeal rejected labels to the labelling section at the Food of Animal Origin Division.

 


 

ATTACHMENT 1

Proposed Moisture Retention Protocol
Elements Checklist

1. Purpose statement: The primary purpose of the protocol should be clearly and succinctly stated.

2. Type of washing and chilling system used should be carefully described.

3. Configuration and any modifications of the chiller system components, including the number and type of chillers in a series and arrangements of the chilling system components, and the number of evisceration lines feeding into a chiller system should be carefully described.

4. Special features in the chilling process should be described, including antimicrobial treatments, length and speed of the dripping line.

5. Variable factors that affect water absorption and retention, such as time in the chiller water, water temperature, agitation, and other factors must be described.

6. Standards to be met by the chilling system must be described.

7. Testing methods used, both for measuring water absorption and retention and for sampling and testing product for pathogen reductions at various chilling equipment settings and chilling time-and-temperature combinations, should be described. The number of samples, type of samples, sampling time period, and type of testing or measurement should be included.

8. The protocol should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.

9. Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.

 


 

ATTACHMENT 2

 

Protocol for Evaluating Retained Water
in the Following Single Ingredient Red Meat Product:
Steer/Heifer Carcasses

 

Note:

 

The following is an example protocol and should not to be used verbatim. Because each establishment is unique, each establishment should design their protocol to reflect the individual characteristics of their operations.

 

1.0 Purpose Statement

1.1 The purpose of this protocol is to determine the amount of water absorption and retention in Steer/Heifer carcasses that is unavoidable while achieving the regulatory pathogen reduction performance standard for Salmonella (as set forth in the PR/HACCP regulations – 9 CFR 310.25(b).

 

2.0 Type of washing and chilling system

2.1 The facility slaughter/dressing line utilizes a final carcass washer at the end of the dressing procedures. This is followed by a carcass rinses that includes the antimicrobial intervention (*insert example)prior to entry into the carcass cooler. The carcass cooler is maintained around 34 °F.

 

3.0 Configuration and modification of the chiller system components

3.1 The establishment uses a carcass water spray system in the carcass cooler to chill carcasses rapidly. The carcass water spray system consists of intermittent sprays of water during the carcass cooling process.

 

 

4.0 Special features in the chilling process:

4.1 Chlorine is added to the carcass water spray as an antimicrobial intervention at 20-50 PPM. The carcasses freely drain before exiting the carcass cooler and prior to further processing in the establishment or prior to shipping.

 

5.0 Variable factors that affect water absorption and retention

5.1 The final carcass wash cabinet consists of a number of spray nozzles at a selected pressure at selected spray directions by the establishment. The final carcass wash water is the normal ambient water temperature from the municipality or of the well water. The number and size of spray nozzles, direction of nozzles, water pressure, and the length of time in the final wash cabinet may be changed depending upon the size of the carcasses, season of the year, and changes in the dressing procedures. The carcasses are in the chiller system (cooler)usually from 18 to 24 hours. The carcass cooler temperature is usually maintained around 34 °F. The temperature of the water in the carcass water spray is the normal ambient water temperature from the municipality or of the well water. The frequency and length of intermittent sprays of water per bay during the carcass cooling, the carcass cooler temperature and the drain time from the last spray prior to exiting the cooler may be varied.

 

6.0 Standards to be met by the chilling system:

6.1 The current FSIS Salmonella pathogen reduction performance standards, as set forth in the PR/HACCP final rule, will be met.

 

7.0 Testing methodology

7.1 Water absorption and retention

7.1.1 Samples will be collected immediately prior to the final carcass wash on the slaughter/dressing line to determine the "green"weight of the carcasses.

7.1.1.1. *(insert number)random carcasses will be tagged and weighed in *(insert number) groups of *(insert number) carcasses. The *(insert number)groups will be distributed evenly throughout the production period (beginning, middle, and end)with the production period being defined as sanitation to sanitation.

7.1.2 Samples will be collected from carcasses at point exiting the cooler.

7.1.2.1 The tagged carcasses from 7.1.1.1 will be weighed immediately prior to further processing or shipping.

7.1.2.2 These post-cooler weights will be compared to the pre-final carcass wash weights to determine the retained water gained using a mathematical difference calculation (cooler exit weight minus "green" weight [pre-final carcass wash weight ])as a percentage.

7.2 Pathogen reduction measurement

7.2.1 *(insert number)groups of *(insert number)carcasses will be randomly selected post-cooler from the same lots as those tested in Section 7.1.The *(insert number)groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.2.1.1 The percent salmonella positive rate will be determined using the post-cooler carcass swabs salmonella performance standard methodology.

7.3 Evaluation of cooler factors

7.3.1 The frequency and length of intermittent carcass sprays per cooler bay

7.3.1.1 Three frequency and length of sprays will be evaluated.

7.3.1.1.1 Fifteen minute interval: Spray for 1 minute, spray off for 14 minutes.

7.3.1.1.2 Thirty minute interval: spray for 3 minutes, spray off for 27 minutes.

7.3.1.1.3 Sixty minute interval: spray for 3 minutes, spray off for 57 minutes.

7.3.2 The carcass cooler temperature will remain around 34 ° F..

7.3.3 The drain time from the last carcass spray until exit

7.3.3.1 Two drain times will be evaluated.

7.3.3.1.1 Four (4) hours after last spray

7.3.3.1.2 Six (6) hours after last spray

7.3.4 Study design

7.3.4.1 A three-by-two factorial table will be used to evaluate the effect of these cooler factor settings on the percent moisture retention (Section 7.1)and on the pathogen reduction measurements (Section 7.2).

7.3.4.2 Each of the six cooler setting combinations will be evaluated for three processing periods (defined as sanitation to sanitation). Each processing period will be considered a replicate.

 

8.0 Evaluation and Reporting of Data

8.1 The results achieved from the three replicates per cooler setting combination will be

averaged and reported as the final result for each cooler setting combination.

8.1.1 Carcass weight differences will be determined using a mathematical difference

calculation (cooler exit weight minus "green"weight)for each carcass group resulting in recorded weight difference results. The weight difference obtained per carcass group will be divided by the "green" weight per carcass group to determine the %moisture retention cooler exit per group. The results will be averaged to obtain the estimated average % moisture retention at point of cooler exit.

8.1.2 The salmonella data will be reported as the number of positive samples/number of samples tested x 100 (%positive).

 

9.0 Explanation of how the conclusions will be determined.

9.1 Conclusions will be determined by comparing the baseline pathogen reduction levels achieved pre-protocol implementation with the post-protocol implementation pathogen reduction results. This comparison will be evaluated according to the specifications detailed in section 6.1.

9.2 The amount of moisture retention that is unavoidable to achieve the above food safety criteria will be reported.

 

(*)Each establishment should insert statistically significant and verifiable information that reflects their unique operations.

 


 

ATTACHMENT 3

Protocol for Evaluating Retained Water
in the Following Single Ingredient Poultry Product:
Young Chicken Carcasses

 

 

Note:

The following is an example protocol and should not to be used verbatim. Because each establishment is unique, each establishment should design their protocol to reflect the individual characteristics of their operations.

 

1.0 Purpose Statement

1.1 The purpose of this protocol is to determine the amount of water absorption and retention in young chicken carcasses that is unavoidable while achieving the regulatory pathogen reduction performance standard for Salmonella (as set forth in the PR/HACCP regulations – 9 CFR 381.94(b) and the time/temperature requirements set forth in 9 CFR 381.66.

 

 

2.0 Type of washing and chilling system

2.1 The facility evisceration lines utilize a series of two pre-chiller external sprays, one inside-outside bird washer, immediately followed by the trisodium phosphate antimicrobial system. This is followed by a 60 second drip period prior to entering the cold-water chiller. The chiller is a Stork Gamco model RS-6 which uses a drag-through type mechanism to transport the birds through the chiller. It has a prechiller section which receives water from the main body of the chiller. Chilled water from the fresh and recirculated sources is added.

 

 

3.0 Configuration and modification of the chiller system components

3.1 The prechiller length is 50 feet with a dwell time of 20 minutes. The main chiller length is 100 feet with a dwell time of 45 minutes. The number of evisceration lines feeding into the chiller system is 2.

 

 

4.0 Special features in the chilling process:

4.1 The chiller uses chlorine as an antimicrobial at 20 PPM. After existing the chiller system the birds are placed on a drip line that is 100 feet in length and drains the whole carcasses for 5 minutes before reaching whole carcass packaging.

 

 

5.0 Variable factors that affect water absorption and retention

5.1 The scalding temperature used is approximately 138° F. The birds are in the chiller system for 65 minutes. The water temperature of the pre-chiller is 65 degrees Fahrenheit. The water temperature in the main chiller is 36 degrees Fahrenheit. The chiller uses air type agitation.

 

 

6.0 Standards to be met by the chilling system:

6.1 The current FSIS Salmonella pathogen reduction performance standards, as set forth in the PR/HACCP final rule, will be met.

 

 

7.0 Testing methodology

7.1 Water absorption and retention

7.1.1 Samples will be collected immediately prior to the two pre-chiller rinses on the evisceration line.

7.1.1.1 *(insert number) random A-grade carcasses will be tagged and weighed in *(insert number) groups of *(insert number) carcasses. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.1.2 Samples will be collected from carcasses at point of packaging.

7.1.2.1 The tagged carcasses from 7.1.1.1 will be weighed immediately prior to packaging.

7.1.2.2 These postchiller weights will be compared to the pre-chiller weights to determine the retained water gained using a mathematical difference calculation (prepackaging weight minus pre-chiller weight) as a percentage.

7.2 Pathogen reduction measurement

7.2.1 *(insert number) groups of *(insert number) carcasses will be randomly selected post-chiller from the same flocks as those tested in Section 7.1. The *(insert number) groups will be distributed evenly throughout the production period (beginning, middle, and end) with the production period being defined as sanitation to sanitation.

7.2.1.1 The percent salmonella positive rate will be determined using the post-chiller carcass rinse salmonella performance standard methodology.

7.3 Evaluation of chiller factors

7.3.1 Water temperature

7.3.1.1 Two chiller settings will be evaluated.

7.3.1.1.1 Temperature setting of 36°F

7.3.1.1.2 Temperature setting of 39°F

7.3.2 Air agitation

7.3.2.1 Two chiller settings will be evaluated.

7.3.2.1.1 Air agitation setting of 80 RPM

7.3.2.1.2 Air agitation setting of 40 RPM

7.3.3 Study design

7.3.3.1 A two-by-two factorial table will be used to evaluate the effect of these chiller settings on the percent moisture retention (Section 7.1) and on the pathogen reduction measurements (Section 7.2).

7.3.3.2 Each of the four chiller setting combinations will be evaluated for three processing periods (defined as sanitation to sanitation). Each processing period will be considered a replicate.

 

 

8.0 Evaluation and Reporting of Data

8.1 The results achieved from the three replicates per chiller setting combination will be averaged and reported as the final result for each chiller setting combination.

8.1.1 Carcass weight differences will be determined using a mathematical difference calculation (prepackaging weight minus pre-chiller weight) for each carcass group resulting in recorded weight difference results. The weight difference obtained per carcass group will be divided by the pre-chiller wash weight per carcass group to determine the % moisture retention prepackaging per group. The results will be averaged to obtain the estimated average % moisture retention at point of packaging.

8.1.2 The salmonella data will be reported as the number of positive samples/number of samples tested x 100 (% positive).

 

 

9.0 Explanation of how the conclusions will be determined

9.1 Conclusions will be determined by comparing the baseline pathogen reduction levels achieved pre-protocol implementation with the post-protocol implementation pathogen reduction results. This comparison will be evaluated according to the specifications detailed in section 6.1.

9.2 The amount of moisture retention that is unavoidable to achieve the above food safety criteria will be reported.

 

(*) Each establishment should insert statistically significant and verifiable information that reflects their unique operations.

 


 

ATTACHMENT 4

 

 

Sample No Objection Letter

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, Province 00000

Dear Mr. Doe:

I have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, I have no objection to the written protocol. Please be advised that this protocol must be maintained on file and available to the Canadian Food Inspection Agency (CFIA). Any revisions to this protocol must be submitted to this office for review.

Sincerely,

 

 

VIC,
Generic Establishment
Anywhere Lane
Anywhere City,

 

cc:

Area Program Specialist
Inspection Manager

 


 

ATTACHMENT 5

 

Sample Objection Letter

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, State 00000

Dear Mr. Doe:

I have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, the following checked items have not been included and must be submitted with a revised protocol:

1.__________ Purpose statement.
2.__________ Type of washing and chilling system used.
3.__________ Configuration and any modifications of the chiller system components.
4.__________ Special features in the chilling process.
5.__________ Description of variable factors in the chilling system.
6.__________ Standards to be met by the chilling system.
7.__________ Testing methods to be employed.
8.__________ Reporting of data and evaluation of results. Should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.
9.__________ Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.

If you have any further questions, please contact me.

Sincerely,

 

VIC,
Generic Establishment
Anywhere Lane
Anywhere City,

cc:

Area Program Specialist
Inspection Manager

 


 

ATTACHMENT 6

 

Retained Moisture Checklist for VICs

 

Establishment Name:

Establishment Number:

1. Product covered by the establishment’s protocol:_________________________________________.

2. Date of CFIA no-objection letter that applies to the protocol:_________________________________.

3. Indicate where product sampling occurs during the sampling and analysis to determine post-evisceration and retained water:

___________________________________________________________________________.

4. Date of bi-weekly check to verify that establishment is following the protocol:_________________________.

5. At the end of the experimentation period:

a. Retained moisture for the product described in 1 above:_________________

b. Check to indicate that you have examined all labels relating to the product described in 1. above and that they have been approved:__________________.


Annex Y-1

Federal Register: January 9, 2001 (Volume 66, Number 6)] [Rules and Regulations] [Page 1749-1772] 9 CFR Parts 381 and 441 [Docket No. 97-054F] RIN 0583-AC26 as amended by Federal Register: April 17, 2001 (Volume 66, Number 74) [Rules and Regulations] [Page 19713-19714] 9 CFR Parts 381 and 441 [DOCID:fr17ap01-1]

 

Retained Water in Raw Meat and Poultry Products; Poultry Chilling Requirements

Food Safety and Inspection Service, USDA.
ACTION: Final rule plus final rule correction.

SUMMARY: The Food Safety and Inspection Service (FSIS) is issuing regulations to limit the amount of water retained by raw, single- ingredient, meat and poultry products as a result of post-evisceration processing, such as carcass washing and chilling. Raw livestock and poultry carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses and parts is an inevitable consequence of the process used to meet applicable food safety requirements. In addition, the establishment will be required to disclose on the labelling of the meat or poultry products the maximum percentage of retained water in the raw product. The required labelling statement will help consumers of raw meat and poultry products to make informed purchasing decisions. Establishments having data demonstrating that there is no retained water in their products can choose not to label the products with the retained-water statement or to make a no-retained-water claim on the product label. FSIS is also revising the poultry chilling regulations to improve consistency with the Pathogen Reduction/Hazard Analysis and Critical Control Points (PR/HACCP) regulations, eliminate "command-and-control'' features, and reflect current technological capabilities and good manufacturing practices.

Federal Register: January 10, 2002 (Volume 67, Number 7) [Rules and Regulations]
[Page 1277-1281] 9 CFR Parts 381 and 441 [Docket No. 01-046N] RIN 0583-AC87

 

Retained Water in Raw Meat and Poultry Products: Suspension of Regulation

SUMMARY: The Food Safety and Inspection Service (FSIS) is suspending until January 9, 2003, regulations that limit water retained by raw meat and poultry products from post-evisceration processing to the amount that is unavoidable in meeting applicable food safety requirements and that require labelling for the amount of water retained. The original effective date of these final regulations was January 9, 2002. FSIS is taking this action in response to a petition from four trade associations representing the meat and poultry industries. The petitioners requested the effective date be extended

until August, 2004. However, FSIS has decided that a one-year suspension of the regulation will allow the meat and poultry industry sufficient time to complete necessary experimentation, including microbial testing and chilling system trials under FSIS-accepted data collection protocols; to fine-tune and stabilize newly adjusted processes; and to conduct regular measurements of retained water at packaging. Suspension of the regulation also will provide members of the meat and poultry industry sufficient time to order new supplies of labels with statements reflecting the amount of retained water in their raw products.

The final rule promulgating the retained water regulations also made numerous technical amendments in the sections of the poultry products inspection regulations that concern poultry chilling practices. The effective date of these amendments will remain January 9, 2002.

DATES: The effective date of the amendments of 9 CFR 381.65 and 381.66 published January 9, 2001 (66 FR 1750), as corrected by the Federal Register notice published April 17, 2001, at 66 FR 19713-19714, is and remains January 9, 2002. 9 CFR part 441 is suspended from January 9, 2002, until January 9, 2003.

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

1. The authority citation for part 381 continues to read as follows: Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 2.18, 2.53

2. Paragraph (b) of Sec. 381.1 is amended by revising the definition of Ready-to-cook poultry to read as follows:

Sec. 381.1 Definitions. * * * * *

(b) * * * Ready-to-cook poultry. "Ready-to-cook poultry'' means any slaughtered poultry free from protruding pinfeathers and vestigial feathers (hair or down), from which the head, feet, crop, oil gland, trachea, esophagus, entrails, and lungs have been removed, and from which the mature reproductive organs and kidneys may have been removed, and with or without the giblets, and which is suitable for cooking without need of further processing. Ready-to-cook poultry also means any cut-up or disjointed portion of poultry or other parts of poultry, such as reproductive organs, head, or feet that are suitable for cooking without need of further processing. * * * * *

3. Section 381.65 is revised to read as follows:

Sec. 381.65 Operations and procedures, generally.

(a) Operations and procedures involving the processing, other handling, or storing of any poultry product must be strictly in accord with clean and sanitary practices and must be conducted in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry products that are not adulterated.

(b) Poultry must be slaughtered in accordance with good commercial practices in a manner that will result in thorough bleeding of the carcasses and ensure that breathing has stopped prior to scalding. Blood from the killing operation must be confined to a relatively small area.

(c) When thawing frozen ready-to-cook poultry in water, the establishment must use methods that prevent adulteration of, or net weight gain by, the poultry.

(d) The water used in washing the poultry must be permitted to drain freely from the body cavity.

(e) Poultry carcasses contaminated with visible fecal material shall be prevented from entering the chilling tank.

(f) Detached ova may be collected for human food and handled only in accordance with 9 CFR 590.440 and may leave the establishment only to be moved to an official egg product processing plant for processing. Ova from condemned carcasses must be condemned and treated as required in Sec. 381.95.

4. Section 381.66 is amended by revising paragraphs (a), (c), and (d) and removing paragraph (f)(6), to read as follows:

Sec. 381.66 Temperatures and chilling and freezing procedures.

(a) General. Temperatures and procedures that are necessary for chilling and freezing ready-to-cook poultry, including all edible portions thereof, must be in accordance with operating procedures that ensure the prompt removal of the animal heat, preserve the condition and wholesomeness of the poultry, and assure that the products are not adulterated. * * * * *

(c) Ice and water chilling.

(1) Only ice produced from potable water may be used for ice and water chilling, except that the water and ice used for chilling may be reused in accordance with Sec. 416.2(g).

(2) (i) Poultry chilling equipment must be operated in a manner consistent with meeting the applicable pathogen reduction performance standards for raw poultry products as set forth in Sec. 381.94 and the provisions of the establishment's HACCP plan.

(ii) Major portions of poultry carcasses, as defined in Sec. 381.170(b)(22), may be chilled in water and ice.

(3) Previously chilled poultry carcasses and major portions must be maintained constantly at 40 deg.F or below until removed from the vats or tanks for immediate packaging. Such products may be removed from the vats or tanks prior to being cooled to 40 deg.F or below, for freezing or cooling in the official establishment. Such products must not be packed until after they have been chilled to 40 deg.F or below, except when the packaging will be followed immediately by freezing at the official establishment.

(4) Giblets must be chilled to 40 deg.F or below within 2 hours from the time they are removed from the inedible viscera, except that when they are cooled with the carcass, the requirements of paragraph (b)(2) of this section must apply. Any of the acceptable methods of chilling the poultry carcass may be followed in cooling giblets.

(d) Water absorption and retention.

(1) Poultry washing, chilling, and draining practices and procedures must be such as will minimize water absorption and retention at time of packaging.

(2) The establishment must provide scales, weights, identification devices, and other supplies necessary to conduct water tests. * * * * * (f) * * * (6) [Removed]

5. A new Part 441 is added to subchapter E to read as follows:

PART 441--CONSUMER PROTECTION STANDARDS: RAW PRODUCTS

Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906; 7 CFR 2.18, 2.53. Sec. 441.10 Retained water.

(a) Raw livestock and poultry carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates to FSIS, with data collected in accordance with a written protocol, that any water retained in the carcasses or parts is an unavoidable consequence of the process used to meet applicable food safety requirements.

(b) Raw livestock and poultry carcasses and parts that retain water from post-evisceration processing and that are sold, transported, offered for sale or transportation, or received for transportation, in commerce, must bear a statement on the label in prominent letters and contiguous to the product name or elsewhere on the principal display panel of the label stating the maximum percentage of water that may be retained (e.g., ``up to X% retained water,'' ``less than X% retained water,'' ``up to X% water added from processing''). The percent water statement need not accompany the product name on other parts of the label. Raw livestock and poultry carcasses and parts that retain no water may bear a statement that no water is retained.

(c) (1) An establishment subject to paragraph (a) of this section must maintain on file and available to FSIS its written data-collection protocol. The protocol must explain how data will be collected and used to demonstrate the amount of retained water in the product covered by the protocol that is an unavoidable consequence of the process used to meet specified food safety requirements.

(2) The establishment must notify FSIS as soon as it has a new or revised protocol available for review by the Agency. Within 30 days after receipt of this notification, FSIS may object to or require the establishment to make changes in the protocol.

(d) Expected elements of a protocol for gathering water retention data:

(1) Purpose statement. The primary purpose of the protocol should be to determine the amount or percentage of water absorption and retention that is unavoidable using a particular chilling system while achieving the regulatory pathogen reduction performance standard for Salmonella as set forth in the PR/HACCP regulations (9 CFR 310.25(b), 381.94(b)) and the time/temperature requirements set forth in 9 CFR 381.66. Additional purposes that could be included are determining chilling system efficiency and evaluating product quality.

(2) Type of washing and chilling system used by the establishment. Any post-evisceration washing or chilling processes that affect water retention levels in and microbial loads on raw products should be described. For poultry establishments, the main chiller types, identified by the mechanism used to transport the birds through the chiller or to agitate the water in the chiller, are the drag-through, the screw type, and the rocker-arm type.

(3) Configuration and any modifications of the chiller system components. A description of chiller-system configurations and modifications should be provided. The description should include the number and type of chillers in a series and arrangements of chilling system components, and the number of evisceration lines feeding into a chiller system. If there is a pre-chilling step in the process, its purpose and the type of equipment used should be accurately described. Any mechanical or design changes made to the chilling equipment should be described.

(4) Special features in the chilling process. Any special features in the chilling process, such as antimicrobial treatments, should be described. Also, the length and velocity of the dripping line should be described, as well as the total time allowed for dripping. Any special apparatus, such as a mechanism for squeezing excessive water from chilled birds, should be explained.

(5) Description of variable factors in the chilling system. The protocol should describe variable factors that affect water absorption and retention. In poultry processing, such factors are typically considered to be the time in chiller water, the water temperature, and agitation. The protocol should consider air agitation, where applicable. Additional factors that may affect water absorption and retention are scalding temperature and the pressure or amount of buffeting applied to birds by feather removal machinery, and the resultant loosening of the skin. Another factor that should be considered is the method used to open the bird for evisceration.

(6) Standards to be met by the chilling system. For example, the chilling system may be designed simply to achieve a reduction in temperature of ready-to-cook poultry to less than 40 deg. F within the time limit specified by the regulations, or in less time. As to the standard for pathogen minimization, the Salmonella pathogen reduction standards, as set forth in the PR/HACCP final rule, have been suggested. Although there is not yet an applicable Salmonella standard for turkeys, establishments are free to adopt practicable criteria for use in gathering data on turkeys under the protocols here suggested. Additional microbiological targets, such as E. coli or Campylobacter levels, or reductions in numbers of other microorganisms, may also be used.

(7) Testing methods to be employed. The protocol should detail the testing methods to be used both for measuring water absorption and retention and for sampling and testing product for pathogen reductions. The protocol should call for water retention and pathogen reduction tests at various chilling equipment settings and chilling time-and- temperature combinations. The method to be used in calculating water absorption and retention should be reproducible and statistically verifiable. With respect to the pathogen-reduction aspect of the testing, FSIS recommends the methods used for E. coli and Salmonella testing under the PR/HACCP regulations. The number of samples, the type of samples, the sampling time period, and the type of testing or measurement should be included in the protocol.

(8) Reporting of data and evaluation of results. The protocol should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.

(9) Conclusions. The protocol should provide for a statement of what the data obtained demonstrate and what conclusions were reached.

Done at Washington, DC: January 3, 2001. Thomas J. Billy, Administrator.

Note: Appendix A will not be codified in Title 9 of the Code of Federal Regulations.

 


Appendix A

Method for Determining Moisture in Meat and Meat Products and Poultry Products

A. Introduction Theory:

In this determination, a weighed sample is heated, cooled, and then re-weighed. The loss in weight is calculated as moisture content.

B. Equipment Apparatus:

a. Covered aluminum dish. At least 50 mm. diameter and not greater than 40 mm. deep, containing a paddle.

b. Mechanical convection oven, preferably one equipped with a booster heater.

c. Food chopper with plate openings \1/8\" (3 mm.), or Robot Coupe or equivalent food processor.

C. [Reserved.]

D. [Reserved.]

E. Sample Preparation Procedure for Fresh Meat or Poultry For accurate and reliable measurement, the raw meat or poultry sample should be finely ground to a homogeneous consistency.

F. Analytical Procedure

a. Accurately weigh sample (representing approximately 2 g. of dry material) into an aluminum dish.

i. Weigh the sample as rapidly as possible to minimize loss of moisture.

ii. The weight of the pan should include the paddle, which is used in spreading the sample across the bottom of the pan, thereby presenting a greater sample surface area, which is beneficial to moisture removal.

iii. If the sample is relatively dry when received, a small quantity of distilled water may be added to the pan only after the sample weight is obtained.

This quantity of water will be helpful in spreading the sample across the bottom of the pan, and will introduce no error since it will be evaporated when the sample is oven-dried.

b. Dry, with cover removed, for 16-18 hours at 100-102 deg.C, or for 4 hours at 125 deg.C in mechanical convection oven. Do not overload the drying oven or sample may be insufficiently dried and give low results. Drying time will start when the original temperature has been reached. Use the oven's booster heater, if the oven is so equipped, to minimize this recovery time.

 

G. Calculations

1. Procedure

Percent = [100 (B - C)] / A

A = sample weight
B = weight of dish + sample before drying
C = weight of dish + sample after drying

Note: If laboratory is not air-conditioned, and humidity is high, dishes should be desiccated before the initial and final weighings.

Reference:

Official Methods of Analysis of the Association of Official Analytical Chemists, 16th Edition, 950.46.


Annex Y-2

UNITED STATES DEPARTMENT OF AGRICULTURE
FOOD SAFETY AND INSPECTION SERVICE
WASHINGTON, DC

FSIS NOTICE, 22-01, 6/29/01

 

PROCEDURES FOR FSIS PERSONNEL DURING PRE-IMPLEMENTATION PERIOD FOR "RETAINED WATER IN RAW MEAT AND POULTRY PRODUCTS; POULTRY CHILLING REQUIREMENTS"

I. What is the purpose of this notice ?

This Notice provides instructions to Food Safety and Inspection Service (FSIS) personnel on their responsibilities and activities during the pre-implementation period for the January 9, 2001, final rule "Retained Water in Raw Meat and Poultry Products; Poultry Chilling Requirements." The final rule is effective January 9, 2002.

II. What is the policy underlying this notice ?

A. Under the final rule, raw, single ingredient meat and poultry carcasses and parts will not be permitted to retain water resulting from post-evisceration processing unless the establishment preparing those carcasses and parts demonstrates, with data collected in accordance with a written protocol, that any water retained in the carcasses and parts is an inevitable consequence of the process used to meet applicable food safety requirements.

B. Additionally, the establishment will be required to disclose on the labelling of the meat and poultry products the maximum percentage of retained water in the raw product. Establishments having data or information to demonstrate that their products do not contain retained water will not be required to label the products and could include a no-retained-water statement on the label.

C. FSIS believes that, particularly during the pre-implementation period, most activity relating to the final rule will be occurring in poultry establishments because the conventional chilling method is a water bath. However, the regulatory requirements apply equally to meat products that are subjected to post-evisceration processes that result in water retention.

III. What is the pre-implementation period and how will FSIS procedures change during this period ?

A. The pre-implementation period began when the final rule was published, January 9, 2001, and will end when the final rule becomes effective, January 9, 2002.

B. FSIS personnel will respond to the publication of the final rule by terminating any activities they have performed to verify that establishments are meeting regulatory requirements that were removed from the regulations. For example:

1. Requirements prescribing how to thaw frozen poultry and drain ready-to-cook poultry, 381.65(i).

2. Requirements on how establishments can chill parts of carcasses, 381.65(k)(1).

3. Requirements related to harvesting detached ova, 381.65(q).

4. The requirement that establishments must file a description of chilling and freezing procedure with the Inspector-In-Charge (IIC), 381.66(a).

5. The prescriptive requirements for water reconditioning systems for poultry chillers, 381.66(a).

C. The final rule also removed the requirements that the establishment submit written notice of any adjustments to washing, chilling, and draining methods before any changes are made and provide FSIS with data showing that the adjustments are effective in meeting existing water limits.

IV. Are there any exceptions to this change in procedures ?

If an establishment has included one of these deleted regulatory requirements as part of its Sanitation Standard Operating Procedures (SSOPs) or Hazard Analysis and Critical Control Point (HACCP) system, it is subject to verification unless and until the establishment performs a reassessment and decides to change the features of its system.

V. Do FSIS personnel still have to follow up on Noncompliance Records (NRs) that have been written since January 9, 2001 ?

If NRs have been written since January 9, 2001, based on requirements that are no longer part of the regulations and listed above, the NRs should be withdrawn and the records corrected.

VI. What activities should establishments be carrying out during this period ?

A. The final rule specifies that establishments need data to support their label declarations. Collection and analysis of relevant data is an activity that establishments may perform during the pre-implementation period. This set of activities, called pre-implementation experimentation, includes the submission of a protocol to FSIS for review by the Technology Program Development Staff (TPDS):

by mail to:

USDA/FSIS/OPPDE/TPDS
300 Twelfth Street, SW
Washington, DC 20250

or by facsimile to: (202) 205-0080

or by e-mail to: http://www.tpds.protocols@usda.gov/

B. New 9 CFR 441.10(d) lists the elements to be included in the protocol. Attachment 1 of this Notice is the checklist that TPDS will use in reviewing protocols. FSIS will notify establishments about the outcome of the review no more than 30 days after the Agency receives the protocol. Attachments 2 and 3 are samples of the letters that will be sent. FSIS encourages establishments to send completed protocols that will minimize FSIS review time.

C. The pre-implementation experimentation period for an establishment will begin when the establishment receives a message that FSIS does not object to the protocol. Such a notification will be supplied to Field Operations (FO), including the IIC, who will then assume leadership for the Agency in observing establishment data collection and analysis as described in the establishment’s protocol. The IIC will have a checklist (Attachment 7) to use to report his or her observations to OPPDE.

VII. What is the purpose of data collection and analysis during the pre-implementation period ?

A. Data collection and analysis during this period will provide important information on two items:

1. The establishment will determine the naturally occurring water in the raw materials it uses, at minimum on a whole-bird basis; and

2. The establishment will determine the minimum amount, if any, of retained water in its products (single ingredient raw meat and poultry) leaving the establishment as a result of the processes used to meet applicable food safety requirements.

VIII. Where will the naturally occurring moisture be measured?

In both poultry and red-meat plants, the naturally occurring moisture should be measured after evisceration and before any processes that could add water have been applied to the carcasses. In poultry plants, this point may be after viscera and crop removal.

A. Pre-evisceration and evisceration processes not subject to the retained water regulation include:

1. Flushing with water of 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 stomach.

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

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

5. Washing beef heads with water.

B. Post-evisceration processes subject to the retained water requirements include:

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

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

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

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 of meat trimmings.

9. Thawing of meat, byproducts, poultry, or giblets in water.

IX. Will FSIS review the data collected and analysed by the establishment ?

The IIC will periodically review data for naturally occurring water and for percent of retained water. The IIC will report on the checklist the naturally occurring moisture by class of product; OPPDE will review and analyse these levels.

X. Can the establishment have more than one level of naturally occurring water for a product ?

Yes. An establishment is permitted to have more than one level of naturally occurring water if necessary to account for seasonal variability. Ultimately, labelling may need to reflect any differing levels.

XI. Will the establishment be permitted to vary parameters of its process during the pre-implementation period?

During the pre-implementation experimentation period, the establishment may vary the parameters of its processes that could affect water retention levels, such as time in the chiller or degree of cooling achieved, as long as the general performance standard in 9 CFR 381.66(a) and the Salmonella performance standards in 9 CFR 310.25(b) and 381.94(b) are met. FSIS intends to remove the prescriptive time and temperature requirements now in 9 CFR 381.66(b). FSIS understands that these requirements severely constrain the possibilities for experimentation in poultry processing. Given this fact, using the authority of 9 CFR 381.3(b), the Agency has determined that, for the purposes of pre-implementation experimentation, the specific time/temperature requirements in 9 CFR 381.66(b) will not be enforced. However, during any pre-implementation experimentation, the establishment must meet applicable food safety requirements. FSIS considers the Salmonella performance standards to be the applicable food safety requirements for products for which they now exist.

XII. Can an establishment conduct pre-implementation experimentation even if it has failed Salmonella verification sets?

FSIS will continue its verification testing for Salmonella during the pre-implementation period. To avoid any difficulties that could jeopardize establishment HACCP systems, FSIS advises that pre-implementation experimentation should not begin if an establishment has one or two consecutive Salmonella verification set failures.

XIII. The final rule states that, because Salmonella performance standards are not yet applicable to turkeys, establishments may adopt practicable criteria for gathering data on turkeys. How will turkey data collection be judged?

A. FSIS has not amended its regulations to establish a pathogen reduction Salmonella performance standard for turkey carcasses. The Agency has, however, completed data collection and analysis for this class of poultry using the same techniques that it used to establish other Salmonella performance standards. The Agency has determined what parameters (n and c) it will propose as the Salmonella performance standard for these products. The intended turkey carcass performance standard is included as Attachment 4. FSIS will consider protocols from establishments that produce turkey carcasses that include other microbiological targets. Agency decisions about the acceptability of such alternative organisms will be based on FSIS expert judgment about whether there is an indicator organism relationship between the alternative organism and Salmonella.

B. FSIS has begun taking sponge samples from the back and thigh of turkey carcasses and will share results with establishments as feedback on whether their processes are meeting probable food safety standards. However, the Agency will not enforce those standards under §381.94(b).

XIV. What activities will FSIS carry out during the pre-implementation period ?

A. FSIS in-plant activities during pre-implementation experimentation will consist of review and analysis of data and observation of processes carried out by the plant as part of its pre-implementation experimentation. These activities will be performed at the discretion of the IIC using a checklist designed to verify that the protocols are being followed (Attachment 7).

B. On rare occasions during pre-implementation experimentation, and at randomly selected establishments, FSIS may choose to take one or more product samples for laboratory analysis. The purpose of any such sampling would be to practice the sample preparation. This product sample will be taken at the point where naturally occurring water is being measured. The sample will be taken according to the sampling procedures described in Attachment 5 and FSIS will employ the laboratory analysis method described in Appendix A to the final rule. Any such sampling will be directed, and in-plant personnel will receive appropriate instructions. FSIS will share laboratory results with the establishment from which such sample was taken.

XV. When will pre-implementation experimentation be concluded ?

Pre-implementation experimentation will be concluded when an establishment begins labelling its products in conformity with the regulatory requirements of this final rule. In no case can this be later than January 9, 2002.

XVI. How will FSIS develop a national baseline for naturally occurring water in poultry, given that Handbook 8 and its successor cannot be used ?

A. The preamble to the final rule suggested that FSIS will conduct a baseline study to establish the naturally occurring moisture expected in various classes of poultry products. The Agency’s current thinking, however, is that FSIS’ scarce resources should not be diverted from food safety verifications to this purpose, and that such a baseline may be developed from establishment data. Each establishment producing product subject to this final rule needs to know what the level of naturally occurring water in its raw materials is in order to have data to support its labelling decisions. FSIS believes that the establishment data on naturally occurring moisture can serve as the establishment baseline, and that groups of establishment results could be aggregated and analysed to provide a national baseline.

B. National baseline data would be expressed as a range and would be necessary only if establishment baselines for naturally occurring moisture in a particular class of product revealed, on analysis, wide and unexpected variability. FSIS would establish a national baseline in order to be sure that consumers were not being misled by labelling requirements and policies. If this situation arises, FSIS will notify affected stakeholders and establish a date when use of the national baseline will begin.

C. FSIS believes that, for any particular class of poultry products, establishment baselines (or, alternatively, a national baseline) would be necessary for whole birds only. Computations from whole-bird levels and known ratios could support other levels for parts. At the request of Agriculture Marketing Service, FSIS is revising the poultry classes in its regulations to better reflect current market practices; this proposed rule will include the usual comment period. However, FSIS will use the poultry market classes in this proposed rule to establish market classes for various poultry products. These market classes are described in Attachment 6.

XVII. How does FSIS plan to determine the moisture content of poultry products ?

FSIS will sample tissue from poultry thighs and use the known ratio of the moisture content of the thigh to that of the whole bird to compute the moisture content of the whole bird.

A. Where will the Agency get the data necessary to compute the ratio? FSIS will compute thigh-to-whole-bird moisture content ratios using data in USDA’s Nutrient DataBase for Standard Reference (the former Handbook 8).

B. How will the Agency compute the moisture content for a whole bird? FSIS will analyse the moisture content of a thigh sample and divide the result by the known thigh-to-whole-bird moisture content ratio.

XVIII. Can an establishment follow a similar procedure ?

Yes, an establishment may follow the same procedure on a routine basis after the establishment has determined the level of naturally occurring moisture in whole birds.

XIX. What principles govern the labelling of products that are subject to the retained-water final rule?

A. The final rule applies to raw, single-ingredient, whole, ground, or cut-up meat or poultry products that retain water that has been used in post-evisceration processing to meet applicable food safety requirements. The final rule does not change existing labelling requirements or policies. However, the rule does require labelling declaring any water retained by carcasses and parts of carcasses resulting from post-evisceration processing that was done to meet applicable food safety requirements. Any water retained over 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% retained water," or "contains X% retained water" for single-ingredient raw product.

B. The generic labelling regulations §317.5 and §381.133 apply to retained-water products as they do to other single-ingredient products. This means that most labels for these products can be generically approved because the retained water statement is not considered to be a claim.

C. Retained water in single-ingredient raw product has no effect on standards of identity, composition, or labelling of multi-ingredient product. For example, a multi-ingredient sausage or fresh sausage containing meat from carcasses, parts, or trimmings containing retained water does not need to reflect this retained water on the label because the sausage is not a single ingredient product. Also, this retained water is not counted as part of the 3 percent to facilitate chopping and mixing (§319.140 and §319.141) or as part of the water in an ingredient statement. A multi-ingredient product that is made from raw product containing retained water may be subject to a maximum limit for water in the finished product. For example, cooked sausages such as Polish sausage, cotto salami, and similar sausages may contain no more than 10 percent added water, even if they are made with single-ingredient raw meat containing retained water; the 10% cannot be exceeded regardless of the source of the water.

D. Retained water in raw single-ingredient meat and poultry products may have an effect on standards of identity, composition, or labelling when such product is used to produce another raw single-ingredient meat product that has an added water limitation. For example, when beef trimmings that have been sprayed with chilled water so they contain 5% retained moisture are used to make a single ingredient raw ground product, like ground beef or hamburger, the resulting product must be labeled to declare any retained water above naturally occurring water.

The retained water may be the result of spraying trimmings prior to grinding or spraying the ground product to meet food safety requirements. Also, single-ingredient ground poultry produced from poultry containing 5% retained water would be required to be labeled to declare any retained water above naturally occurring water.

XX. Do antimicrobial solutions used to meet applicable food safety requirements need to be declared on the label when processing results in retained water ?

A. Solutions containing chlorine dioxide or acidified sodium chlorite used to treat carcasses or parts are secondary direct additives, according to Food and Drug Administration (FDA) regulations (21 CFR 173). FSIS considers these secondary direct additives to be processing aids: they do not need to be declared on the label when they are used as permitted in 21 CFR 173 in pre-chill and chilling operations. However, they may not be present in the finished product or may be present at such low levels that they have no continuing functional effect.

B. FSIS has permitted the use of food grade organic acids as processing aids (secondary food additive) for spraying meat or poultry carcass and parts. They may be used in pre-chill spraying and in chilling systems with no labelling requirement. FSIS allows the use of trisodium phosphate during pre-chill on beef carcasses, pre- and post-chill on poultry carcasses, in poultry chilling systems, and post-chill on poultry parts, with no labelling requirement. Food grade organic acids and trisodium phosphate used to treat carcass, split carcasses, or parts are generally recognized as safe (21 CFR 184 and 21 CFR 182.1778) as direct additives and are generally permitted in products as an ingredient at the levels that occur when used in accordance with good manufacturing practices.

For example, citric acid is a generally recognized as safe (GRAS) substance and, when used in accordance with §184.1(b)(1), may be used in food with no limitations other that current good manufacturing practices.

XXI. Is there a size requirement for the prominent lettering in the retained-water statement ?

There is no letter size requirement for the percent-retained-water statement. Prominence is determined by several factors, including size of lettering in the statement compared with other lettering on the label, location of the statement, and color contrast between the lettering and the background.

XXII. Does retained-water product that is shipped for further processing have to bear a retained-water statement?

All raw, single-ingredient product with water retained as a result of post-evisceration processing used to meet a food safety standard must be labeled to reflect that fact.

XXIII. Can products with different retained water levels ever bear the same retained-water labelling statement ?

Yes. The retained-water statement can reflect the maximum percentage retained water of any of the products. For example, two products, each with different retained water levels, prepared by two different establishments owned by the same company, may be labeled, "less than X% retained water" or "contains up to X% retained water." Also, a package of mixed parts, each with different water retention levels, may bear such a statement, or the parts may be listed with separate retained-water statements.

XXIV. How does FSIS plan to verify the retained-water final rule after January 9, 2002 ?

A. As indicated in the preamble to the final rule, FSIS intends to conduct marketplace sampling as a major means of verifying compliance with the retained water requirements. It is expected that at regular, although as yet undefined intervals, FSIS will sample, in the marketplace, labeled products that have been produced in establishments and secure laboratory analysis to determine whether they are misbranded. Inspection program personnel, including compliance officers, will receive specific sampling instructions, as appropriate.

B. The standard against which retained moisture in a given product will be judged will be computed by adding the establishment baseline level of naturally occurring water in the raw material (unless a national baseline established by FSIS is in effect) to the labeled level of retained water, if any, and a factor to account for reasonable variability.

Current thinking is to allow a 20% variation from the stated maximum retained moisture on any one market sample. This is consistent with the variation allowed for nutritional labelling and seems to be appropriate. When an FSIS sample result exceeds the stated maximum retained moisture stated on the product label by more than 20%, the plant will be notified of the FSIS results.

C. FSIS expects that most samples will be found to comply with regulatory requirements. However, if a sample from an establishment is found to be out of compliance, FSIS will seek additional data from various sources, including in-plant personnel, establishment records, the establishment’s analysis in support of the label declaration, and product samples, to determine the course of action.

D. FSIS inspection program personnel who, through analysis of data, believe that establishments may be systematically adulterating and misbranding their products, may submit their analytic information through supervisory channels, and FSIS may determine that special sampling is desirable.

E. FSIS does not plan to use a method of analysis different from the one described in Appendix A unless and until there are data that definitively establish the relationship between that method and an alternative. If such data become available and FSIS or others are then able to use alternative methods, the Agency will make the information publicly available and establish an effective date for use of the alternatives.

XXV. Who should one contact for further information about pre-implementation activities?

Contact Dr. Arshad Hussain, Director, Inspection and Enforcement Standards Development Staff, OPPDE, FSIS, USDA, Room 202 Annex, Washington, DC 20250.

Phone: 202-720-3219
Fax: 202-690-0824
e-mail: arshad.hussain@usda.gov

/s/
Philip S. Derfler

Deputy Administrator
Office of Policy, Program Development and Evaluation
USDA/FSIS

 

NOTICE EXPIRES: 7/01/02


ATTACHMENT 1

 

Protocol Elements Checklist

1. Purpose statement: The primary purpose of the protocol should be clearly and succinctly stated.

2. Type of washing and chilling system used should be carefully described.

3. Configuration and any modifications of the chiller system components, including the number and type of chillers in a series and arrangements of the chilling system components, and the number of evisceration lines feeding into a chiller system should be carefully described.

4. Special features in the chilling process should be described, including antimicrobial treatments, length and speed of the dripping line.

5. Variable factors that affect water absorption and retention, such as time in the chiller water, water temperature, agitation, and other factors must be described.

6. Standards to be met by the chilling system must be described.

7. Testing methods used, both for measuring water absorption and retention and for sampling and testing product for pathogen reductions at various chilling equipment settings and chilling time-and-temperature combinations, should be described. The number of samples, type of samples, sampling time period, and type of testing or measurement should be included.

8. The protocol should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.

9. Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.


 

ATTACHMENT 2

Sample No Objection Letter

 

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, State 00000

Dear Mr. Doe:

We have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, we have no objection to the written protocol. Please be advised that this protocol must be maintained on file and available to the Food Safety and Inspection Service (FSIS). Any revisions to this protocol must be submitted to this office for review.

Sincerely,

 

Charles Edwards
Director
Technology Program Development Staff
Office of Policy, Program Development, and Evaluation

cc:

Technical Service Center
District Office
IIC


ATTACHMENT 3

 

Sample Objection Letter

 

Mr. John Doe
Quality Assurance Manager
Generic Establishment
Anywhere Lane
Anywhere City, State 00000

Dear Mr. Doe:

We have received and reviewed your written protocol determining the amount of water absorption and retention that is an unavoidable consequence of your process used to meet food safety requirements.

Based on the information and data submitted, the following checked items have not been included and must be submitted with a revised protocol:

1.__________ Purpose statement.

2.__________ Type of washing and chilling system used.

3.__________ Configuration and any modifications of the chiller system components.

4.__________ Special features in the chilling process.

5.__________ Description of variable factors in the chilling system.

6.__________ Standards to be met by the chilling system.

7.__________ Testing methods to be employed.

8.__________ Reporting of data and evaluation of results. Should explain how data obtained are to be reported and summarized. The criteria for evaluating the results and the basis for conclusions to be drawn should be explained.

9.__________ Conclusions. The protocol should provide for a statement of what the data obtained demonstrated and what conclusions were reached.

If you have any further questions, please contact me at (202) 205-0675.

Sincerely,

Charles Edwards

 

Director
Technology Program Development Staff
Office of Policy, Program Development, and Evaluation


ATTACHMENT 4

 

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

TABLE 2. - SALMONELLA PERFORMANCE STANDARDSa

Class of Product

Performance Standard
(percent positive for
Salmonella)

Number of samples tested
(n)b

Maximum number of
positives to achieve Standard (c)b

Young chicken carcasses c

20.0%

51

12

Ground chicken

44.6%

53

26

Ground turkey

49.9%

53

29

Young turkey carcasses

19.6%

56

13

Goose carcasses

13.7%

54

9

 

a. Performance Standards are FSIS’s calculation of the national prevalence of Salmonella on the indicated raw products based on data developed by FSIS in its nationwide microbiological baseline data collection programs and surveys. Copies of Reports on FSIS's Nationwide Microbiological Data Collection Programs and Nationwide Microbiological Surveys used in determining the prevalence of Salmonella on raw products are available in the FSIS Docket Room.

 

b. The values for Salmonella n and c are the criteria for evaluating sample results to determine whether an establishment is meeting the standard. The number of samples n was selected to be greater than 50 so as to measure establishment performance over a minimum period of time. The n and c are selected so that an establishment has an 80% chance of passing when operating at the standard level. Because (n, c) must be integers, exact probabilities of 80% cannot be expected.

 

c. Young chicken carcasses processed under Chinese Buddhist, Chinese Confucian, and kosher noneviscerated exemptions are exempt from the young chicken Salmonella performance standards.


ATTACHMENT 5

 

Sampling Procedure for Retained Water Determination (Poultry)

1. Take a randomly selected sample from a whole-carcass bird. The sample will include a complete thigh, including the bone, muscle, and skin, with associated fat.

2. After removal from the carcass, immediately place the sample in an impermeable container and seal the container to prevent the loss of any water.

3. Keep the sample under refrigeration until it is shipped.

4. Complete the FSIS form submitted with the FSIS-generated request for sampling.

5. It is recommended that samples not be shipped over a weekend.


 

ATTACHMENT 6

 

PART 381 -- POULTRY PRODUCTS INSPECTION REGULATIONS

1. The authority citation for part 381 continues to read as follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450; 21 U.S.C. 451-470; 7 CFR 2.18, 2.53.

2. Section 381.170 would be amended by revising paragraph (a) to read as follows:

§ 381.170 Standards for kinds and classes, and for cuts of raw poultry.

(a) The following standards specify the various classes of the specified kinds of poultry, and the requirements for each class:

(1) Chickens--

(i) Rock Cornish game hen or Cornish game hen. A "Rock Cornish game hen" or "Cornish game hen" is a young immature chicken (usually less than 5 weeks of age), of either sex, with a ready-to-cook carcass weight of not more than 2 pounds.

(ii) Broiler or fryer. A "broiler" or "fryer" is a young chicken (usually less than 10 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and flexible breastbone cartilage.

(iii) Roaster or roasting chicken. A "roaster" or "roasting chicken" is a young chicken (usually less than 12 weeks of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is somewhat less flexible than that of a broiler or fryer.

(iv) Capon. A "capon" is a surgically neutered male chicken (usually less than 4 months of age) that is tender-meated with soft, pliable, smooth-textured skin.

(v) Hen, fowl, baking chicken, or stewing chicken. A "hen," "fowl," "baking chicken," or "stewing chicken" is an adult female chicken (usually more than 10 months of age) with meat less tender than that of a roaster or roasting chicken and with a nonflexible breastbone tip.

(vi) Cock or rooster. A "cock" or "rooster" is an adult male chicken with coarse skin, toughened and darkened meat, and a nonflexible breastbone tip.

(2) Turkeys--

(i) Fryer-roaster turkey. A "fryer-roaster turkey" is a young immature turkey (usually less than 12 weeks of age), of either sex, that is tender-meated and with soft, pliable, smooth-textured skin, and flexible breastbone cartilage.

(ii) Young turkey. A "young turkey" is a turkey (usually less than 6 months of age), of either sex, that is tender-meated with soft, pliable, smooth-textured skin and breastbone cartilage that is less flexible than that of a fryer-roaster turkey.

(iii) Yearling turkey. A "yearling turkey" is a fully matured turkey (usually less than 15 months of age), of either sex, that is reasonably tender-meated with reasonably smooth-textured skin. (iv) Mature or old (hen or tom) turkey. A "mature turkey" or "old turkey" is an adult turkey (usually more than 15 months of age), of either sex, with coarse skin and toughened flesh. Sex designation is optional.

(3) Ducks--

(i) Duckling. A "duckling" is a young duck (usually less than 8 weeks of age), of either sex, that is tender-meated and has a soft bill and soft windpipe.

(ii) Roaster duck. A "roaster duck" is a young duck (usually less than 16 weeks of age), of either sex, that is tender-meated and has a bill that is not completely hardened and a windpipe that is easily dented.

(iii) Mature duck or old duck. A "mature duck" or an "old duck" is an adult duck (usually more than 6 months of age), of either sex, with toughened flesh, a hardened bill, and a hardened windpipe.

(4) Geese--

(i) Young goose. A "young goose" is an immature goose, of either sex, that is tender-meated and has a windpipe that is easily dented.

(ii) Mature goose or old goose. A "mature goose" or "old goose" is an adult goose, of either sex, that has toughened flesh and a hardened windpipe.

(5) Guineas--

(i) Young guinea. A "young guinea" is an immature guinea, of either sex, that is tender-meated and has a flexible breastbone cartilage.

(ii) Mature guinea or old guinea. A "mature guinea" or "old guinea" is an adult guinea, of either sex, that has toughened flesh and a nonflexible breastbone.


ATTACHMENT 7

 

Retained Moisture Checklist for IICs

Establishment Name:

Establishment Number:

1. Product covered by the establishment’s protocol:_________________________________________.

2. Date of FSIS no-objection letter that applies to the protocol:_________________________________.

3. Indicate where product sampling occurs during the sampling and analysis to determine post-evisceration naturally occurring and retained water:

___________________________________________________________________________.

4. Date of bi-weekly check to verify that establishment is following the protocol:_________________________.

5. At the end of the experimentation period:

a. Naturally occurring moisture for the product sampled at the point described in 3. above:___________________________.

b. Retained moisture for the product described in 1 above:_________________

c. Check to indicate that you have examined all labels relating to the product described in 1. above and that they have been approved:__________________.


Annex C | Annex D | Annex D-1 | Annex E | Annex J (PDF) | Annex K (PDF) | Annex L | Annex M | Annex Q |
Annex R | Annex S | Annex T | Annex U | Annex W | Annex W-1 | Annex W-1 | Annex X | Annex Y |
Annex Z | Annex Z-1 | Annex Z-2 |



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