Medicated Feeds Under the Microscope

• Licensing
• Verifying Equipment Accuracy
• Safety
• Recordkeeping

New legislation promoting safe production and handling of medicated livestock feeds will help alleviate the growing public concern over food safety.

In the winter of 2000, the Canadian Food Inspection Agency (CFIA) first introduced the Regulations Respecting the Making of Medicated Feed, which fall under the authority of the federal Health of Animals Act. Based on HACCP principles, the proposed regulations will require licensing and increased control measures by anyone mixing medicated animal feeds in Canada. This initiative shows a strengthened commitment to animal health and human safety by putting in place proactive controls aimed at reducing errors in the food production chain. The legislation will also help to facilitate trace-backs in the event of a possible contamination.

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Licensing

According to the regulations, a medicated feed is meant for consumption by an animal that is intended to be used as food for humans or that produces food for them, and has a medicating ingredient mixed into it. A medicating ingredient is a substance with a drug identification number (DIN) that is used to prevent or treat animal disease, to promote growth, or to affect an animal's body structure or functioning. By definition, dietary supplements such as vitamins, minerals, amino acids and enzymes will be excluded. Medicated feed production for fur-bearing species such as mink and fox will only be controlled by the standards of the Feeds Act, unless the premises is also used to make medicated feeds for food-producing animals.

Both commercial and farm-based operations mixing medicated feeds are considered manufacturers and will need to be licensed. In each case, it is the operator of the establishment that will require a license. The operator is the person responsible for the operation of the facility and its workers. Medicated feed ingredients and medicated feeds needing further mixing can only be sold to licensed operators.

To obtain a license, medicated feed manufacturers apply in writing to the CFIA. The application must include the results of mixer efficiency tests, scale and metering device verification tests, and drug concentration tests from representative feed samples. If the drug levels are out of tolerance, records of investigations into the sources of error and corrective actions taken must also be included. If the application is approved and the facility passes an inspection by the CFIA, a license will be granted for three years.

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Verifying Equipment Accuracy

Licensed feed manufacturers will have to prove that their equipment functions properly. This is achieved through regular testing of mixing and weighing equipment. The details for conducting the tests will be described in the Manual of Procedures that will accompany the regulations.

Mixer Performance Testing
It is essential that medications get mixed evenly throughout feed so that animals receive the correct dosage. In order to show that a mixer is working properly, nine or more feed samples containing a measurable test substance are collected from the mixer at the time of installation and at least once per year afterwards. This is known as mixer performance testing. The test substance, such as sodium, is added to the feed in amounts similar to the levels of medication normally used. After mixing, the samples are collected and sent to a laboratory accredited by the Standards Council of Canada. Upon request, the lab measures the levels of test substance in each of the samples, and determines the degree of difference among them. The amount of variation across the samples is indicated by a statistical measure known as the coefficient of variation (CV). The lower the CV, the more uniform the mix. The regulations limit the coefficient of variation in feed samples, depending on the concentration of medicating ingredient used. The CV must be no greater than 5% for concentrated drug premixes, 10% for micro or macro premixes and supplements, and 15% for complete feeds and total mixed rations. Licensed manufacturers must have written procedures describing mixer performance testing protocol. Farmers may be able to save costs by asking that mixer performance testing be done by the company that installs any new mixing equipment.

Scale and Metering Device Verification
The ability to measure ingredients accurately is critical to producing safe and effective medicated feeds. Scales and metering devices must be appropriate for the range of weights or volumes they are being used to measure. In addition, regular calibration and maintenance of equipment are essential for ensuring continuing accuracy. Licensed mixers must have written directions describing the calibration of scales and metering devices. To verify measuring equipment accuracy, testing must be carried out at the time of installation and no less than once per year afterwards. This can be done either by a scale company or independently, using a set of test weights. The testing procedure and record sheets will be included in the Manual of Procedures.

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Safety

A series of handling and manufacturing practices ensuring feed safety are also outlined in the legislation. All medicating ingredients and medicated feeds must be received, handled and stored in a way that preserves their potency. To prevent contamination, the regulations require that manufacturers practise sequential production, unless all equipment coming into contact with the feed is cleaned or flushed using validated cleaning procedures between batches. Acceptable sequencing, cleaning and flushing techniques will be described in detail in the Manual of Procedures. The regulations further specify appropriate methods for dealing with the materials recovered after flushing and cleaning. Licensed operators must have written procedures describing sequencing, flushing and cleaning of medicated feed manufacturing equipment as well as evidence supporting the effectiveness of the cleaning procedures used.

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Recordkeeping

In addition to the written procedures describing testing, handling and manufacturing protocol, medicated feed manufacturers will be asked to document certain activities. Records must be maintained for three years. The Manual of Procedures requires the use of a daily production log for each piece of cross-utilised equipment used in making medicated feeds. This log should track the manufacturing dates, feed names (in order) and amounts coming in contact with the equipment, plus any safety precautions (such as cleaning or flushing) taken between feed batches. Records of equipment calibration, clean out, maintenance, repair and testing are also required. These should include dates and details of each procedure. Along with written directions for dealing with non-compliant feed samples, licensed manufacturers should also keep records of investigations into the sources of error and of any corrective actions taken. For those who sell medicated feed, an individual lot number must identify each lot of feed. Distribution records are also required in this case.

The CFIA is currently discussing the requirement for a daily medication inventory that was originally described in the regulations. The inventory's purpose is to reconcile the theoretical amount of each medicating ingredient added to feeds with the actual amount used. Keeping such an inventory would have much the same effect as balancing a chequebook. The particulars of the daily inventory requirement will be included in the final version of the Manual of Procedures to be completed in September.

The regulations are scheduled to be phased in over a two-year period, with a possible start date as early as this fall. The regulations will apply to commercial feed mills first, followed by on-farm operations using concentrated drug sources fourteen months later. On-farm operations using non-concentrated medication sources would be the last to require licenses, beginning eighteen months from the start of implementation. Comments on the proposed Manual of Procedures will be accepted until September 6, 2002, at which point the final version will be produced. Official comments should be directed to Ms. Linda Morrison, National Manager of the CFIA's Feed Section.

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