Medication sequencing guideline for management of drug carryover

Printable Medication sequencing guideline for management of drug carryover (PDF - 926 kb)

Purpose

Some feed manufacturing facilities use medications (drugs) in the production of feed products. This document describes the policy the Canadian Food Inspection Agency (CFIA) will use to determine if these facilities have developed and are using the necessary procedures and controls intended to mitigate the risks associated with the use of medications in their facility, such as the carryover of medications between feed batches.

Applicability and scope

Facilities manufacturing or handling livestock feeds, and medicating ingredients or medicated feeds.

Regulatory requirements

In Canada, the use of drugs in livestock feeds is regulated under two sets of legislation: the Food and Drugs Act and Food and Drug Regulations, which are administered by Health Canada's Veterinary Drugs Directorate, and the Feeds Act and Feeds Regulations, which are administered by the CFIA. Livestock is defined as cattle, sheep, horses, chickens, turkeys, geese, ducks, swine, rabbits, fish, mink and foxes.

The Compendium of Medicated Ingredient Brochures (CMIB) is a listing of drug premixes that have been approved and assigned a Drug Identification Number (DIN) by Health Canada. These premixes can be used without veterinary oversight in livestock feeds, as long as they are used in accordance with the CMIB (e.g., for the approved species, at the approved level).

Desired outcome

Control and management of medication residues in feeds that are not intended to contain them contributes to safe feed, prudent use of medications, as well as food safety. This includes controls to ensure the appropriate dosage of the correct medications in medicated livestock feeds and to control cross-contamination with medicated feeds with other feeds.

Cross-contamination of feeds occurs when substances, including medications which according to the formulation are not intentionally included in the feed, have been carried over from previous use of the same equipment. This carryover can be minimized through the use of effective equipment and good manufacturing practices, but cannot be completely eliminated without physical cleaning of the equipment.

If carryover is not properly managed, cross-contamination with medicated feeds can:

• harm species that are sensitive to the drug residues they consume
• contribute to antimicrobial resistance
• lead to drug residues in food products

The CFIA recognizes that the prevention of comingling or cross-contamination of feeds with medications through the use of dedicated equipment, or equipment cleanout, is not always practical. The Agency also considers the risk associated with unintentional medication residues acceptable in cases where there is no negative impact on animal or human health.

Considering these factors, the CFIA has developed guidelines to permit the production of medicated and non-medicated feeds in cross-utilized equipment, where feeds containing medications are followed only by feeds intended to contain those same medications, or by feeds where residual levels of the carryover medications present an acceptable risk. The CFIA's assessment of acceptable production sequences involving medications considers whether the medication residue(s) are appropriate for the species and class of animal affected.

Medication sequencing guideline for management of drug carryover

The Medication Sequencing Guideline for Management of Drug Carryover is used by CFIA inspection staff to assess the acceptability of feed production sequences involving medications. The guideline considers whether the medication residue(s) is (are) appropriate for the species and class of animal feed affected. It provides a listing of each approved drug, and identifies the types of feed (by species and class of animals) in which it is acceptable to have residual levels of that drug.

With a few exceptions, the information in the guideline reflects the intended uses detailed in the CMIB. The most notable set of exceptions are the result of a joint project between the CFIA and Health Canada designed to quantify the risks associated with carryover of individual drug residues, and to identify flexibilities or restrictions for production sequences where appropriate.

In cases where the order of feed production through common equipment occurs in an acceptable sequence, specific cleanout of the equipment is not required. In cases where the feed cannot be manufactured in an acceptable production order, the equipment involved must be cleaned (by flushing or other physical cleanout) using validated procedures. Information regarding acceptable procedures for validating equipment cleanout is available in Acceptable Validation Testing Procedures for Equipment Clean-out Procedures.

Associated documents

The following documents are used in association with the Medicated Sequencing Guideline for Management of Drug Carryover:

• Feeds Act and Regulations
• Feed Compliance Verification System Procedural Manual
• Compendium of Medicated Ingredient Brochures
• Veterinary Prescription Checklist
• Regulatory Guidance documents
• Validation Studies for Modification of Sequencing Guidelines
• Measurement of Feed Carryover Level; and
• Acceptable Validation Testing Procedures for Equipment Clean-out Procedures

Medication sequencing guideline for management of drug carryover

For use by CFIA inspection staff as a guide in assessing the adequacy of written clean out procedures for cross-utilized equipment used to manufacture and handle medicated feeds containing different medications or medicated and non-medicated feeds in commercial feed mills, feed retail outlets and on-farm feed mills. This document is a risk management tool used by CFIA inspection staff as a guide in verifying compliance with domestic requirements under the Feeds Act and Regulations associated with managing drug residue cross-contamination (14 (b) 19(1)(j)&(k)). Sequencing requirements related to other programs for such things as export (for example the Canadian Ractopamine-Free Pork Certification Program) or private certification are not included in this guide and may be more stringent.

For the most part, these guidelines reflect the intended uses detailed in the Compendium of Medicating Ingredient Brochures (CMIB) which are based on the submissions from the drug companies to Health Canada for approval, with the following exceptions:

1. Concerns related to residues of sulfamethazine in barbecue hogs has limited sequencing as a viable drug management strategy in commercial feed mills and feed retail outlets for this medication to swine starter rations (swine < 20 kg) with labelled withdrawal times of at least 7 days. For on-farm situations, greater sequencing flexibility remains as the livestock producer will have access to information on the feeding practices for the animals on the farm and be able to determine whether a residue might be present in animals receiving feeds that contain residual levels of sulfamethazine.
2. Health Canada and the CFIA are conducting a joint Drug Carryover Risk Project to evaluate the risks associated with carryover drug residues for both approved and unapproved uses in order to provide additional guidance on management strategies supporting the development of production sequences that will result in the manufacture of feeds that do not negatively impact on either animal or human health. This version of the Medication Sequencing Guideline includes the results of evaluations to date, e.g., where scientifically justified, carryover levels of medications such as chlortetracycline hydrochloride, lasalocid sodium, and lincomycin are now considered acceptable in certain additional species or production classes of animal for which the drug is not approved in the CMIB. Updates to the Medication Sequencing Guideline will continue to be made as the evaluation of additional drugs is completed.
3. In the absence of safety evaluations, Emergency Drugs Release (EDRs) can only be sequenced when both feeds contain the same medications stipulated on the EDR.

Remarks

1. This guide requires that inspection staff consider concentration of medications in feeds when assessing sequencing procedures to verify that carryover does not result in the feeds (unintentionally) containing treatment levels of medications (for example, a complete feed might safely follow a medicated complete feed but it may not be safe for that same complete feed to follow a medicated premix or other medicated feed containing high concentrations of the same drug).
2. Market Ready is defined as follows:
   • for feeds manufactured in commercial feed mills - feeds labelled for consumption by finishing animals, growing swine, laying hens and lactating animals producing milk intended for human consumption or where the labelling does not specify the stage of production (e.g. swine ration).
   • for feeds manufactured on-farm feeds intended for feeding to animals that produce food for human consumption (meat, milk, eggs) within the withdrawal period for the drug being fed. Special caution needs to be used when culling sows or selecting BBQ hogs, etc. to make sure that animals that have consumed a feed containing a medication that has a withdrawal period are fed non-medicated feed for a period equal to the withdrawal period for that medication prior to being shipped.