Animal Agriculture Position Paper on
Proposed Medicated Feed Regulations

Submitted on behalf of:
Dairy Farmers of Ontario
Ontario Sheep Marketing Agency
Ontario Cattlemen's Association
Ontario Veal Association

Background:

On February 5, 2000, the Federal Government published proposed regulations regarding the manufacturing of medicated feeds. The intent of these draft regulations is ensure animal feeds containing medications are manufactured and mixed in a safe and responsible manner.

The regulations will apply equally to farm-based and commercial feed manufacturing situations, and will require commercial mills as well as farms to be licensed. To obtain a licence, producers and feed mills will need to submit an application form, along with appropriate documentation, to the Canadian Food Inspection Agency (CFIA). An on-site inspection will occur to ensure that the regulations will be adhered to before a licence is issued. Regulations cover sample testing, calibration and record keeping requirements once a licence is obtained.

The original date for implementation of these regulations in commercial feed mills was originally to be April 1, 2002. However, development of a protocol that is acceptable to both government and industry has become a challenge, and as a result, delayed implementation. The addition of on-farm mixing increases the complexity of implementation.

Animal Agriculture Reaction to Medicated Feed Regulations:

Commodity groups support the proper use and handling of all medications including those used in feed. As an important element of food safety, antimicrobial resistance is a prominent concern of food animal agriculture. However, commodity groups feel that CFIA’s food safety objectives could be better addressed through commodity On-Farm Food Safety Programs and feed mill HACCP programs. These programs cover concerns about the handling of medication in all forms, including feed additives. On-Farm Food Safety Programs encourage the implementation of Best Management Practices (BMP’s) and use a holistic approach to mitigate food safety risks on farm. Many of the commodity On-Farm Food Safety Programs already have extensive medicated feed components, including record keeping requirements to ensure animal feeds containing medications are manufactured and mixed in a safe and responsible manner. A consistent approach to food safety could be maintained by managing on-farm mixing of medicated feeds through such programs. Current On-Farm Food Safety programs aim to build food safety awareness on-farm. As the programs evolve, there will be increased expectations that require producers to adjust their practices accordingly to meet the needs of consumers. Incorporating medicated feeds in these types of programs allows changes to be made to ensure practices include the most up to date science and technology.

The commodities listed above have reviewed the four modules presented by CFIA. While we accept the need to prevent cross-contamination while handling, mixing or manufacturing animal feed, commodity groups feel the proposed regulations may not be the most practical way to achieve food safety improvements. Animal agriculture is concerned after reading the four modules that the regulations are onerous, labour intensive, and cost prohibitive. Extreme care must be taken so that the regulations allow feed mills and producers to be sustainable and globally competitive. Time, cost and ease of meeting all aspects of the proposed regulations must be considered prior to implementation. Some specific comments and concerns are outlined below:

• Commodities recognize the importance and support the concept of scale calibration on an annual basis, as a minimum requirement.
• Mixer verification, while important, is only effective if proper mixing times are observed for each batch of medicated feed. In most cases, feed mixers are not used to mix supplements and grain on farm. Due to such differences in mixing equipment from feed mills, standardized verification could be difficult to enforce on all applications. In addition, testing samples is expensive and could be biased unless taken properly.
• Inventory reconciliation is viewed as an important consideration when handling concentrated medications. However, commodities request that farms using diluted premixes or supplements containing medications be exempt from this documenting procedure. Instead, proper record keeping systems showing the amount of medicated premix or supplement used in each batch of medicated feed should be maintained.
• Clean out procedures have been identified as a key concern by the feed industry. Animal commodity groups echo their opinions with regard to time, storage, and costs associated with the module requirements.
• There is no infrastructure in place to test the number of samples that will be generated under the current proposal. Laboratory expansions will occur if there is a need. However, before this happens, one must consider the actual benefit and accuracy of periodic testing of feed samples. HACCP based programs have been developed to address potential problems and not react to errors after they occur. HACCP does not guarantee food safety, but demonstrates due diligence in its process. Feed sample testing is reactionary and as such does not provide constant feedback as does a HACCP system.

Concerns and Questions with Proposed Regulations:

1. Ionophores are not used in human medicine. At label doses, these compounds have zero withdrawal time in meat. Including ionophores in the Medicated Feed Regulations suggests that animal health is included in the regulatory intent in addition to food safety. Animals fed a ration with ionophores below the label recommendation would receive no benefit. Animals that are fed a ration in which ionophores exceed the label dose will likewise receive no additional benefit, and may show signs of toxicity. Producers therefore have an economic interest in ensuring the prescribed amount of ionophores is administered. Supplements containing ionophores are used in beef, dairy, veal, swine, goats, and poultry. In most instances, these would be the only medicated feeds mixed on-farm. If ionophores are excluded from the regulations, the number of farms having to meet medicated feed mixing requirements would be reduced by approximately two thirds.
Animal agriculture commodity groups strongly feel ionophores should not be included in this legislation.

2. Most On-Farm Food Safety programs address on-farm feed mixing. Commodity groups feel that the intent of the regulations could be achieved by addressing all on-farm feed mixing through On-Farm Food Safety programs. Programs could be adapted to ensure all food safety aspects of the Medicated Feed Regulations are covered. Enforcing compliance through the threat of losing, or not achieving, validation may prove a better tool than using government time and resources to ensure compliance.
Commodity groups feel that the intent of these regulations could be dealt with more effectively through On-Farm Food Safety Programs.

3. Commodity groups are concerned about the costs of administration and implementation of the regulations. There is concern that commodity groups or individual producers would be forced to cover these costs. In particular, if the enforcement of these regulations was incorporated into commodity On-Farm Food Safety Audits, the licensing and administration costs would be downloaded to commodity groups or producers. These proposed regulations address public concerns and as such, costs must be borne by society.
Commodity groups feel that CFIA should be responsible for all administrative and licensing costs.

4. Testing of feed samples must be done annually according to the proposed regulations. Commodity groups are concerned with the logistics of this requirement. Concerns include the accuracy of test results, whether there are sufficient certified labs available to perform this testing, cost of the testing, as well as extension personnel available to help interpret tests. Estimates for testing feed samples range from $200. to $300. per sample. Four samples per year present significant costs to farmers.
All aspects of sample testing including accuracy, cost, laboratory availability and extension must be considered prior to implementing regulations.

5. There are extensive record keeping requirements for these regulations. Although some records may be necessary, excessive paperwork will hinder a producer’s ability to carry out normal farm practices. In particular, inventory reconciliation is too onerous. The intent is to ensure that producers mix the proper amount of medicated feed. Given that monitoring of records will not be done (who has the time or resources?), is it allowable to just record the weight of medication added to each ration as opposed to reconciliation records for each medicated feed production period?
Record requirements must be concise and practical for producers.

6. The issue of enforcement is not clear. Commodity groups are concerned with the logistics of enforcing annual testing. There is a need to describe the enforcement protocols as well as implications of non-compliance.
Commodity groups cannot comment on enforcement or non-compliance penalties without further information.

7. Clean out procedures are complex and questionable in their application. Costs associated with these procedures will compromise the viability of feed plants, not to mention farms, due to both time required to flush and storage requirements of flush material. Maximum Residue Limits must be established for each medication used in feed.
Procedures must not be implemented that will compromise international competitiveness.

8. Feed mills, farms using concentrated drug sources, and farms using diluted medications will all receive the same license. At present, the difference in the licenses will be the timing of their implementation. Commodity groups question the need to regulate farms that mix dilute premixes or supplements. The risk of a medication error is reduced, but admittedly not removed under this option.
The risk is reduced when using dilute premixes or supplements as opposed to concentrated drugs. Farmers using dilute premixes or supplements should either be exempted from the regulations or at the very least, face less rigid requirements than feed mills and farmers using concentrated medications.

9. It is understood that funding for this initiative will come from the Agricultural Policy Framework. Accountability to Canada’s taxpayers must be a consideration before embarking on a program that will have little impact on the safety of food originating from Canadian livestock. By introducing this legislation, it appears that On-Farm Food Safety programs initiated by livestock commodities are being dismissed as ineffective.
What message is the Federal Government sending to consumers by overriding commodity-driven On-Farm Food Safety Programs?

10. CFIA recently acknowledged that medication residues will be present in feed, no matter how diligent the sequencing and flushing process. Pharmaceutical companies and Health Canada must work together to establish Maximum Residue Levels for medications in feeds.
Determination of these residue levels must be established before proceeding with implementation plans.