Food > Meat and Poultry Products > Manual of Procedures > Chapter 4

ANNEX K - CHAPTER 4

Tracking Sheet - Option Used For the Control of E. Coli O157:H7 in Dry And Semi-dry Fermented Sausage

Instructions:

Complete a copy of part I of this form for each dry or semi-dry meat sausage made at the facility.

If the formulation/manufacturing processes is being changed as a result of the new requirements, a new label registration will be required. In this case, complete a copy of part II of this form as well; AND

Attach a copy of the registered label and detailed (stamped copy) formulation/processing information which was provided to the labels section at the time of label registration.

The material must be reviewed by the inspector in charge of the establishment and thereafter sent to the Area Program Manager, Meat Hygiene.

PART I - to be completed individually for each dry or semi-dry meat sausage made at the facility 1. Product name:
2. Label Registration Number:
3. Option/process controls currently used for the Control of E. coli O157:H7:
Option #			Details regarding the Option
1			Time x Internal Temp. combination is : [ ] ° C / [ ] ° F X [ ] Minutes
2			Check off the process method which you are using under this option;
[]	Fermentation chamber temperature			pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)
	°F	°C
[]	70	21		>/- 5.0	</- 55 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
[]	90	32		</- 4.6	</- 55 mm	HOLD @ 90°F for >/- 6 days
[]	90	32		</- 4.6	</- 55 mm	HEAT (1hr @ 110°F then 6 hrs @ 125°F)
[]	90	32		</- 4.6	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)
[]	90	32		>/- 5.0	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)
[]	96	36		</- 5.0	</- 55 mm	HEAT (128°F internal product temperature x 60 minutes) and DRY (at 55°F and 65% Relative Humidity to a Moisture Protein Ration of </- 1.6:1)
[]	110	43		</- 4.6	</- 55 mm	HOLD @ 110°F for >/- 4 days
[]	110	43		</- 4.6	56 to 105 mm	HOLD @ 110°F for >/- 4 days
[]	110	43		>/-5.0	56 to 105 mm	HOLD @ 110°F for >/- 7 days
3			End Product Testing - 30 samples from each lot of finished product must be tested for at least E. coli O157:H7 and Salmonella
What laboratory is being used: What is the official laboratory method used:
4			Check off the process method which you are using under this option
[]	Fermentation chamber temperature			pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)
	°F	°C
[]	70	21		>/- 5.0	56 to 105 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
[]	90	32		</- 4.6	56 to 105 mm	HOLD @ 90°F for 7 days then dry
[]	90	32		>/- 5.0	56 to 105 mm	HOLD @ 90°F for 7 days then dry
[]	110	43		>/- 5.0	</- 55 mm	HOLD @ 110°F for 7 days then dry
[]	110	43		>/- 5.0	56 to 105 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
Under this option 15 samples of raw batter must be tested for each lot What laboratory is being used: What is the official laboratory method used:
5			Outside validation by a 3^rd party
When/where was the validation test conducted?
Have the testing results been accepted by the Food of Animal Origin Division and/or Food borne Pathogens Unit? YES [ ] NO [ ] (Until the results are forwarded and accepted, the operator cannot use them to justify manufacturing product under either Option 2 or 4)
What is the D reduction achieved?
If the reduction is less than 5D, 15 samples of raw batter must be tested for each lot; What laboratory is being used: What is the official laboratory method used:

PART II - To be completed if a change to the process is being made and the label is being re-submitted in order to register the new process.

1. Product name:

2. Previous Label Registration Number:

Date of label (re)submission:

Which option is being proposed for the control of E. coli O157:H7 (indicate the option on the label submission request as well. Ensure that you also provide the following information for the option which you have selected.)
Option #			Details regarding the Option
1			Time x Internal Temp. combination is : ° C / ° F X Minutes
2			Check off the process method which you are using under this option;
[]	Fermentation chamber temperature			pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)
	°F	°C
[]	70	21		>/- 5.0	</- 55 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
[]	90	32		</- 4.6	</- 55 mm	HOLD @ 90°F for >/-6 days
[]	90	32		</- 4.6	</- 55 mm	HEAT (1hr @ 110°F then 6 hrs @ 125°F)
[]	90	32		</- 4.6	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)
[]	90	32		>/- 5.0	56 to 105 mm	HEAT (1hr @100°, 1hr @110°F, 1hr @120°F, then 7hrs @ 125°F)
[]	96	36		</- 5.0	</- 55 mm	HEAT (128°F internal product temperature x 60 minutes) and DRY (at 55°F and 65% Relative Humidity to a Moisture Protein Ration of </- 1.6:1)
[]	110	43		</- 4.6	</- 55 mm	HOLD @ 110°F for >/- 4 days
[]	110	43		</- 4.6	56 to 105 mm	HOLD @ 110°F for >/- 4 days
[]	110	43		>/- 5.0	56 to 105 mm	HOLD @ 110°F for >/- 7 days
3				End Product Testing - 30 samples from each lot of finished product must be tested for at least E. coli O157:H7 and Salmonella
What laboratory is being used: What is the official laboratory method used:

4			Check off the process method which you are using under this option
[]	Fermentation chamber temperature		pH at the end of fermentation process	Casing diameter	Subsequent process (dry, hold or cook)
	°F	°C
[]	70	21	>/- 5.0	56 to 105 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
[]	90	32	</- 4.6	56 to 105 mm	HOLD @ 90°F for 7 days then dry
[]	90	32	>/- 5.0	56 to 105 mm	HOLD @ 90°F for 7 days then dry
[]	110	43	>/- 5.0	</- 55 mm	HOLD @ 110°F for 7 days then dry
[]	110	43	>/- 5.0	56 to 105 mm	HEAT (1hr @ 110°F and 6 hrs @ 125°F)
Under this option 15 samples of raw batter must be tested for each lot What laboratory is being used: What is the official laboratory method used:
5			Outside validation
When/where was the validation test conducted?
Have the testing results been accepted by the Food of Animal Origin Division and/or Food borne Pathogens Unit? YES [ ] NO [ ] (Until the results are forwarded and accepted, the operator cannot use them to justify manufacturing product under either Option 2 or 4)
What is the D reduction achieved?
If the reduction is less than 5D, 15 samples of raw batter must be tested for each lot; What laboratory is being used: What is the official laboratory method used:

[ 4.1 | 4.2 | 4.3 | 4.4 | 4.5 | 4.6 | 4.7 | 4.8 | 4.9 | 4.10 | 4.11 | 4.12
Annex A | Annex B | Annex C | Annex E | Annex F | Annex G | Annex H
Annex I | Annex J | Annex K | Annex L | Annex M | Annex N | Annex O | Annex P ]