Update on Proposed Medicated Feed Regulations

In February of 2000, the Canadian Food Inspection Agency (CFIA) proposed new regulations, under the authority of the Health of Animals Act - Regulations Respecting the Making of Medicated Feed, that will require licensing and upgraded control measures for manufacturers of medicated animal feeds in Canada. Since that time, CFIA has consulted with stakeholders, established a Manual of Procedures to explain and detail the regulations, and carried out both a pre-pilot project on 14 Ontario farms and a pilot project on 16 farms across Canada.

What is a medicating ingredient?

• a substance intended for use in the prevention or treatment of disease in livestock
• a substance, other than a feed, intended to affect the structure or any function of the body of livestock, and that has an assigned drug identification (DIN) number under the Food and Drugs Act

Who will need a licence?

All commercial and on-farm manufacturers of medicated feeds will require a licence under the new regulations. Every person who wishes to make medicated feed in an operation must have a valid licence. Only licensed medicated feed manufacturers will be able to buy medicated feeds/ingredients that require further mixing. Without a licence, feed manufacturers will only be able to manufacture non-medicated feeds or purchase and use finished medicated feeds that do not require further mixing prior to being fed to livestock.

What are the licence requirements?

An application for a licence to make medicated feed must be submitted to CFIA, along with the following:

• results of verification tests for metering devices, scales, and mixers used
• results of all tests for concentration of medicating ingredients in representative samples of manufactured feed
  An inspection will be conducted, by a CFIA inspector, to verify results and assess the establishment's ability to meet the requirements of the regulations. The licence will be valid for 3 years.

What control measures must be in place for making medicated feed?

The regulations will establish a minimum set of mandatory control measures that will require:

• all scales and metering devices must demonstrate accuracy - checked once/year
• written procedures for calibration of scales and metering devices
• verification of mixer accuracy at least once/year
• written procedures on how mixers are maintained
• proper storage of medicating ingredients
• written manufacturing procedures on sequential production, cleaning and flushing
• written procedures for determining correct levels of medication
• recorded inventories of medication purchased, quantities used daily and in what quantity of feed
• analyses of feed samples - at least 4 samples/year
• appropriate records kept for at least 3 years
  

What will acceptable parameters around mixing be?

The proposed coefficient of variation for mixers has been set at:

• 5% for premixes
• 10% for supplements
• 15% for complete feeds

What is a coefficient of variation?

Coefficient of variation (CV) is a common statistical measure used in describing the amount of variation in a population. It is a simple calculation based on the mean (average) and the standard deviation (SD). Standard deviation is a measure of how similar the samples are, so if all the values are nearly the same, the SD will be low. The lower the CV, the more uniformity is achieved. To illustrate, here is an example used in determining appropriate feed mixing times:

A producer would like to establish the appropriate mix time for a particular ration. The target inclusion rate of salt in the ration is 0.5%. She adds the salt to the mixer with the other ingredients and starts her timer. She takes 10 random samples of the mixed ration after 10 minutes, then restarts the mixer and repeats the sampling at 15 minutes. Here are her results:

Source: Behnke, K.C. 1990. Your goal: A uniform mix. National Hog Farmer. Pages 18 - 36. Fall, 1990

In this case, the target CV is less than 10%. Based on the results of this test, the producer knows that mixing for 10 minutes is not satisfactory. At 15 minutes, the CV is less than 10% so the producer knows that the mix is reasonably uniform..

Remaining Issues

While CFIA and the stakeholder groups have made good progress in developing the Manual of Procedures, there are still a number of key outstanding issues, including:

• will CFIA recognize on-farm quality assurance programs, like CQA™?
• although there will be no cost recovery by CFIA for licencing or inspection, how much will it cost for testing of samples?
• will on-farm manufacturers need to keep daily inventory records?

When will the regulations take effect?

The regulations are scheduled to be phased in over a period of 2 years, starting with commercial manufacturers. Licencing of on-farm manufacturers would follow in a year or year and a half. There have been several delays in implementing these regulations however they are still in process. At this point it is expected that, when finalized, the regulations would be republished in Canada Gazette 1 with an allotted comment period before moving to final publication and implementation. No target date has currently been set.

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