Area of Reference
Batching Tolerances
CVS Task(s)
1109 and 1108
Effective Date
January 11, 2010
Excerpt from Task Standard (Task 1109) Prior to January 11, 2010
- Mixing records shows that each batch/lot of feed has been produced in accordance with the formula
- Acceptable tolerance for medicating ingredients and/or feeds containing medicating ingredients is ± 5% of the intended amounts per batch (product control action required)
- Acceptable tolerances for non-medicating ingredients is ± 10% of the intended amounts per lot (Refer to the policy entitled "Application of Tolerances for Assessing Feed Verification Task 1109" for additional instruction related to this standard)
- Actual batch sizes are within ± 5% of the intended or theoretical batch sizes for medicated feeds
- Mixing records indicate the name and actual weight of each ingredient used in the manufacture of the feed OR the facility has written procedures that clearly describe the system (e.g., initials, check marks) used to determine whether the amount of:
- each medicating ingredient in a specific batch of feed is within acceptable tolerances and
- each non-medicating ingredient in a specific lot of feed is within acceptable tolerances
Analysis
Section 14 (b) of the Feeds Regulations requires that medicated feeds contain the level of medication identified in the CMIB or on a veterinary prescription while Section 20 requires that a feed has the chemical composition to ensure it is efficacious for its intended use.
Section 171(1) of the Health of Animals Regulations requires that feed manufacturers maintain records including:
- the formula for the animal food, including the name and weight of each ingredient used for each lot of the animal food; and
- a mixing sheet that shows that each lot of the animal food has been produced in accordance with the formula
As some manufacturers find it difficult to maintain mixing sheets for each feed, the CFIA has developed an inspection protocol that allows for check off systems provided they are properly documented to meet the intent of the Health of Animals Regulations requirement for recordkeeping. To ensure consistent compliance assessments are made by inspection staff, standards for the check off system were developed and included in the verification task procedures for Task 1109 as identified above.
Decision
- There are two inspection tasks that assess the compliance of the mixing formula and the mixing sheet; one with respect to the requirements of the Health of Animals Regulations (Task 1108 for commercial mills) and the other with respect to the requirements of the Feeds Regulations (Task 1109 for commercial mills). Since April 1, 2009 all the requirements related to batching tolerances have been included in Task 1109.
- Given the explicit requirement for mixing formula and mixing sheet pursuant to the Health of Animals Regulations, compliance assessment with regards to check-off systems will be moved to Task 1108.
- Task 1108 will be revised to incorporate the requirement that the manufacturer either (a) has a mixing sheet for each feed manufactured or (b) has a properly documented check off system that meets the CFIA standards for batch size and inclusion rates for medicating and non-medicating ingredients, i.e.:
- Actual batch size for medicated feeds within 5% of theoretical batch size
- Actual inclusion rate/batch for medicating ingredients within 5% of theoretical amount
- Actual inclusion rate/lot for non-medicating ingredients within 10% of theoretical amount
- Task 1109 will continue to include an assessment of the actual versus theoretical inclusion rate of medicating ingredients and the deviation in total batch size for mills which have a mixing sheet for every feed the manufacture. With respect to the levels of medicating ingredients, the batching tolerances remain as they are for all medicated feeds, i.e.:
- Actual batch size for medicated feeds within 5% of theoretical batch size
- Actual inclusion rate/batch for medicating ingredients within 5% of theoretical amount
- Where the CARs related to this issue remain in effect (e.g., issues associates with the batching tolerances for medicating ingredients), the facility must develop and implement effective corrective actions to address the non-compliance identified on the CAR
- Facilities that use a check off system rather than maintaining mixing sheets for each feed manufactured will be subject to revised standards for check off systems in Task 1108 at the time of next inspection.
Review Decision made by
CFIA Issue Resolution Working Group
December 17, 2009