2007 Town Hall Presentation for the Proposed
Medicated Feed Regulations

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Agenda Overview

• Importance and Relevance of the Issue and International Feed Safety Initiatives
• Overview of Proposed Medicated Feed Regulations
• Integrated Regulatory Approach
• Providing Input to the Regulatory Process

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Medicated Feed Regulations - Steering Group Members

Industry Stakeholders

ANAC-Kathleen Sullivan, Julie Latremouille (Feed)
CAHI- Jean Szkotnicki, Dr. Gail Pauling (Pharmaceutical)
CCA- Rob McNabb (Beef Cattle)
CFC- Steven Leech (Meat Chickens)
CMC- Parthiban Muthukumarasamy (Meat Industry)
CPC- Catherine Scovil (Swine)
CTMA- Colleen McElwain (Turkeys)
DFC- Réjean Bouchard (Dairy Cattle)

Government Stakeholders

CFIA- Paul Mayers, Linda Morrison
HC- Dr.Rajinder Sharma
PHAC- Richard Reid-Smith (Public Health)

Medicated Feed Regulations - Stakeholder Group Members

Additional Technical Experts - Industry

ANAC-Dr.Maurice Smith, Peter Vingerhoeds, John Osbourne, John Rheaume, Nathalie Frenette
CCA- Terry Grajczyk
CPC- Casey Smit, Jasper Vanderbas, Jerry Gelderman
DFC- Ron Versteeg

Additional Technical Experts - Government

CFIA- Judy Thompson, Allen Good, David Johnson, Pascal Bouchard, Kimberly Redden
HC- Aimé Kombe

Importance and Relevance of the Issue

Outline

• Current Regulatory Environment
• Current Situation
• Drivers for Change – Regulatory Evolution
• Maintaining Consumer Confidence

Current Regulatory Environment

CFIA and Health Canada share responsibility

Health Canada - Food and Drug Act

• Evaluate and approve medications for use in feed
• Evaluations consider:
  • effectiveness of the medication at preventing or treating specific disease conditions
  • safety of the medication to treated animals
  • potential safety implications on human food products derived from treated animals
• Consider antimicrobial resistance impact
  • lead on Antimicrobial Resistance Surveillance

CFIA - Feeds Act

• Maintain and publish the Compendium of Medicating Ingredient Brochures (CMIB), a listing of drug sources approved by Health Canada
• Monitor use of medication in feeds through facility inspections and product sampling
• Limited control on how feeds are manufactured
• Contribute to Health Canada's Antimicrobial Resistance Surveillance
• To be in compliance, feeds must meet standards for drug content and freedom from drug residues
  • verify that medicated feeds are within regulatory tolerance of guaranteed amount ±20-25%
  • blanket zero tolerance for residues resulting from carryover between batches
• Product-based approach - compliance verified by sampling and analysis of feeds after manufacture
• Reactive approach only detects problems after manufacturing errors have been made

Current situation

• Medications are available to feed manufacturers with limited controls
  • "Over the counter" per CMIB (except in Québec)
  • By veterinary prescription for levels and animal species outside those approved by Health Canada in CMIB
• Regulatory authority is focused at the product level with limited authority related to process controls

Drivers for change

• Current product-based approach has not been effective in minimizing over/under medication and carryover
  • Feeds that are under-medicated may prove ineffective at preventing or treating the disease
  • Feeds that are over-medicated may result in residues in foods of animal origin
  • Under-medicated feeds may contribute to the emergence of antibiotic resistant bacteria in animals
• Without process controls, issues may not be identified until after the feed has been consumed
• Need for prevention or mitigation of anti-microbial resistant bacteria (super bugs)
• Canadian and international consumers demand safe food
• Detection of residues of veterinary drugs in food has resulted in border closures

Status quo - Public Health Risks

• Medication residues in animal tissues can cause allergic reactions in some consumers
  • Sulfamethazine residues in BBQ pigs
• Residues in feed can cause residues in meat, milk, eggs
  • Ionophores found > 30% of eggs tested contained a residue
• Contribution to the development of antimicrobial resistance

Status quo - Animal Health Risks

• Under-medicated feeds may be ineffective in treating animal disease
• Residues in feed can harm other sensitive livestock species
  • Monensin residues in horse feeds

Status quo - Trade Risks

• Residues in feed can cause residues in meat, milk, eggs
  • EU Audit highlighted weaknesses in Canadian system
  • Sulfamethazine and tetracycline residues in exported pork
• Other countries moving forward to adopt progressive approaches

Summary

• Canada has taken significant measures to advance its food safety priorities
• Improved feed safety is the logical next step
• Proposed regulations are HACCP-based GMPs for the manufacture of medicated feed

International Feed Safety Initiatives

Outline

• Codex Code of Good Animal Feeding
  • What's in the Code?
• How feed is regulated internationally
  • Current requirements for medicated feed
• Summary
• Questions and clarification

Codex Code of Good Animal Feeding - Overview

• Provides guidance on how countries should establish a feed safety system
• Objective is safety of food (of animal origin) for human consumption
• Achieved by adherence to good manufacturing practices (GMPs) throughout the manufacture and distribution of animal feeds and feed ingredients, and good animal feeding practice on farm
• Applies to both commercial and on-farm feed production

Codex Code of Good Animal Feeding – Key Elements

Feed ingredients

• Obtain from safe sources
• Conduct risk analysis of feed ingredients
• Risk-based monitoring (inspection, sampling and analysis)

Feed labelling

• Clear and informative
• Define how to handle, store and use feeds or feed ingredients

Traceability

• Records regarding the production, distribution and use of feeds or feed ingredients
• Records to facilitate timely and effective withdrawal or recall of products if required
• Operator informs competent authorities (in Canada, CFIA) when feed safety issues are identified
• CFIA informs trading partners for products traded internationally

Inspection and Control Procedures

• Industry controls and compliance to required standards for production, storage and transport
• Risk-based official regulatory programs verify that feeds or feed ingredients are produced, distributed and used safely
• Inspection and control procedures (inspection, sampling and analysis) used to verify that feeds or feed ingredients meet requirements

Feed Additives and Veterinary Drugs

• Assessed for safety
• Used as approved by the competent authorities
• Received, handled and stored to maintain their integrity and to minimise misuse or unsafe contamination
• Feeds containing feed additives or veterinary drugs used in accordance with clearly defined instructions for use

Production, processing, storage, transport and distribution of feeds and feed ingredients

• Operators follow GMPs and HACCP principles to control hazards that may affect food safety
• Each participant responsible for activities under their direct control, including compliance with any applicable statutory requirements

Codex Code of Good Animal Feeding – GMPs and HACCP Controls

Equipment Performance and Maintenance

All scales and metering devices

• appropriate for the range of weights and volumes measured
• tested regularly for accuracy

All mixers

• appropriate for the range of weights or volumes mixed
• capable of manufacturing homogeneous feeds
• tested regularly to verify their performance

Manufacturing Controls

Manufacturing procedures used to avoid cross-contamination between batches of feed and feed ingredients containing restricted or otherwise potentially harmful materials

• certain animal by-product meals
• veterinary drugs

Procedures also used to minimise cross-contamination between medicated and non-medicated feed and other incompatible feed

Recalls

• Records and other information maintained on the identity and distribution of feeds and feed ingredients
  • support rapid removal from the market of feeds considered to pose a threat to consumers' health
  • permit identification of animals exposed to the affected feed or feed ingredient

Feeding

• Correct feed is fed to the right animal group
• Directions for use are followed
• Animals receiving medicated feed identified and withholding period (if any) is met

International Feed Regulations - Two Exporting Countries

• United States
• European Union

United States - Current Regulatory Requirements

21CFR 225 Current Good Manufacturing Practice For Medicated Feeds

• Apply to all facilities that manufacture medicated feeds
• When Regulations are not followed the feed is considered adulterated
• Risk-based approach to requirements
  • Stricter controls for facilities using higher risk products including a requirement for facility licensing

Key Manufacturing Controls

Scales and Metering Devices

• Suitable and tested annually

Mixer Performance

• Suitable and capable of making a uniform mix
• Mixer performance tested

Sampling for Guaranteed Concentration

• Licensed mills only
• Three (3) samples/drug/year

Sequencing/Equipment Cleanout

• Prevents unsafe contamination

Drug Inventory

• Daily for each drug used

European Union Current Regulatory Requirements

Regulation 183/2005 EC

• All commercial and on-farm feed manufacturers (mixing medicated feeds) must establish and implement a fully documented HACCP system
• Mandatory facility registration for all
• Inform authorities if feeds could impact on animal or human health or the environment
• Very closely aligned with Codex (incorporated by reference)
• Imports only from "approved" facilities maintained by countries from which imports are permitted
• Requirements apply equally to exported products

Medicated Feed Manufacturing Facilities

Fully documented HACCP system

• Buildings and equipment
• Personnel - training and supervision
• Production – written procedures, records
• Quality control – CCP, lab analysis
• Storage and transport – mixed feeds stored separately from feed ingredient
• Recall/traceability

Documentation and Record keeping

• Written procedures
• Documents to support traceability for feeds in the manufacturing stream
• Distribution records for finished feeds
• Complaint file
• No specific record retention period identified

Key Manufacturing Controls

Scales and Metering Devices

• Suitable and tested regularly

Mixer Performance

• Suitable and capable of making a uniform mix
• Mixer performance demonstrated

End-product Testing

Sequencing/Equipment Cleanout

What is required in Canada?

• A federal regulatory system for feed that is in line with international standards (including Codex) to manage the use of medications in feed
  • Better protect human health and maintain consumer confidence
  • Support more prudent drug use
  • Improve overall management of medications in feed
  • Positively impact on AMR
  • Ensure continued access to veterinary drugs

Overview of Proposed Medicated Feed Regulations

Outline

• Introduction
• Consultative stakeholder process
• Progress on 6-Step Strategic Plan
  • Regulatory framework
  • Risk ranking project
  • Staged implementation strategy
• Next steps

Drivers for change

• Current product-based approach has not been effective in minimizing over/under medication and carryover
• Detection of residues of veterinary drugs in food has resulted in border closures
• Prevention or mitigation of anti-microbial resistant bacteria (super bugs)
• Other countries have or are moving forward to adopt progressive approaches

Guiding principles

• An outcome based approach to regulate the use of medications in feed
• Full, transparent consultation and engagement of stakeholders in development and application of regulatory framework
• Consideration of both regulatory and third party program delivery
• Application to all medicated feed manufacturers (commercial, on-farm)
• Consistent with international and domestic expert guidance
• Codex Code of Practice on Good Animal Feeding
• Feed Program Regulatory Reviews
• Health of Animals Act to provide regulatory framework
• Similar to manufacturing controls for "prohibited material" under the feed ban

Regulatory approach

Who and what regulated?

• Commercial and on-farm manufacturers of medicated feed

Proposed that facilities be regulated by:

• License to make or store medicated feed for sale
• Only licensed operators may manufacture or sell medicated feeds
• Only licensed operators may purchase medicated feeds requiring further mixing

Medicated Feed Regulations Consultative Stakeholder Process

• Consensus building with key stakeholders through face-to-face meetings and conference calls
• Develop "how to" guide – Manual of Procedures with assistance of technical experts
• Develop communication plan to engage broader base of affected stakeholders

Six Step Strategic Plan

1. Framing Basic Regulations
2. Risk Profiling Project
3. Implementation Strategy
4. Communication and Engagement Strategy
5. Linking Regulations with Sector Programs
6. Issue Resolution Forum

Step 1 - Framing Basic Regulations

3 Shared Outcomes

1. Medicated feeds contain the correct medication at the approved level
2. Feeds for food-producing animals do not contain drug residues that could have a negative impact on either animal or human health
3. Medicated feed manufacturers have a system to identify lots of feed that supports their rapid and complete withdrawal from the marketplace or production unit in the event that a system failure results in a human or animal health risk

Facility Licensing Requirements

• Manufacturing controls proposed to achieve the regulatory outcomes
  • Scale and Metering Device Performance Testing
  • Mixer Performance Testing
  • Managing Drug Carryover
  • Recall or Withdrawal Procedures

Scales and metering devices

Rationale for Regulatory Requirement

• Accurate measurement is critical to make medicated feeds of target potency
• Errors in measurement are impossible to correct elsewhere in the manufacturing process for that batch of feed
• Routine scale and metering device performance testing will help identify equipment maintenance issues that should be corrected to optimize animal performance

Proposed Regulatory Requirements

• Appropriate for the range of weights or volumes to be measure (capacity/graduation)
• Tested for accuracy after installation and annually thereafter
• If not functioning properly, necessary corrective measures taken

Compliance Costs - Industry Estimate

• Written procedures
  • $160 per facility
• Equipment testing
  • $100 per scale for contracting out

Mixing Equipment

Rationale for Regulatory Requirement

• Mixing equipment performance is critical to manufacturing consistent medicated feeds
• Testing or validating mixer performance helps determine whether mixing equipment is capable of producing feeds of uniform consistency
• Routine mixer performance testing will help identify equipment maintenance issues that negatively impact animal performance

Proposed Regulatory requirements

• Tested to ensure uniformity of mix for after installation and every 1-3 years thereafter depending on the risk profile of the facility
  • CV 5% for dilute drug premixes
  • CV 10% for micro or macro premixes and supplements
  • CV 15% for complete feeds and total mixed rations
• If not functioning properly, necessary corrective measure taken

Testing Mixing Equipment

Pilot Project Results (Pilot Phase)

Nutrient Tested (CV)	Mixer Type
	All Mixers (18)	Proportioner Mills (3)	Batch Mixers (Not TMR)(10)	TMR Mixers (5)
Sodium	16.20 (7.24-40.42)	16.92 (13.08-22.96)	16.64 (7.24-40.42)	14.9 (8.82-29.16)
Zinc	14.61	18.29	12.45	16.73
Manganese	15.14	20.19	13.13	15.32
Copper	28.71	27.12	29.36	28.49
# with CV15%	13/18 (72.2%)	2/3 (66.7%)	7/10 (70%)	4/5 (80%)
# with CV>15%	5/18 (27.8%)	1/3 (33.3%)	3/10 (30%)	1/5 (20%)

Pilot Project Results

Nutrient Tested (CV)	Mixer Type
	All Mixers (35)	Proportioner Mills (7)	Batch Mixers (Not TMR)(19)	TMR Mixers (9)
CV15%	27/35 (77.1%)	5/7 (71.4%)	14/19 (73.7%)	8/9 (88.9%)
CV>15%	8/35 (22.9%)	2/7 (28.6%)	5/19 (26.3%)	1/9 (11.1%)

Compliance costs - Industry Estimates

• Written procedures
  • $160 per facility
• Equipment testing
  • $185 per mixer for chemical testing (9 samples + shipping)

Managing Drug Carryover

Rationale for Regulatory Requirement

• Need to manage carryover of drugs in feeds so it does not negatively impact on animal or human health
• Thorough cleaning of equipment following every batch is impractical and unnecessary if appropriate precautions are taken
• Effective procedures to prevent the carryover of drugs that my negatively impact on animal or human health required for all cross-utilised equipment
• Need to manage use of flush materials.

Sequencing

• Manages but does not eliminate carryover and residues
• Sequencing is the preferred method of managing drug residues because it is the least disruptive to the manufacturing process and does not generate flush material
• An appropriately designed production sequence is an effective means of ensuring that the carryover of drugs between batches of feeds does not pose an animal or human health risk

Flushing

• Flushing is the act of passing an inert substance through equipment to "sweep-up" any left over material and eliminate carryover into the next batch
• There may be situations where equipment clean out procedures, other than production sequencing, may be required to ensure that feed does not contain unsafe drug residues
• Flush material can be added on top of previous batch or used in a feed intended to contain the same medication

Proposed Regulatory Requirements

• Feed manufacturers must develop and use appropriate production sequencing procedures and, when necessary, other equipment clean-out protocols
• Validate effectiveness of additional clean-out procedures
• Sequencing and other equipment clean-out procedures are clearly understood by all personnel responsible for feed production and scheduling
• When flush material is generated, it must be used as an ingredient in feeds intended to contain the same medication or disposed of in accordance with local environmental regulations

Compliance Costs - Industy Estimates

• Written procedures
  • $240 per facility
• Validation testing
  • $200 per test for drug testing + $60 to prepare and ship samples

Recall procedures

Rationale for Regulatory Requirement

• When a human or animal health risk is identified, need to remove affected feeds from the marketplace or discontinue access to food-producing animals as quickly as possible
• Records regarding the production, distribution and use of feeds or feed ingredients will facilitate prompt trace-back of feed to immediate previous source and trace-forward to next recipients.

Proposed Regulatory Requirements

• Feed manufacturers able to identify system failures that resulted in the manufacture of products on-site that pose a risk to animal or human health
• Written procedures for feed recall or withdrawal contain a step-by-step description of what to do when a feed must be removed the marketplace or access to food-producing animals is discontinued including when to notify authorities

Compliance Costs - Industry Estimates

• Written procedures
• $240 per facility*

* For species not covered by Feed Ban ONLY, e.g., farmed fish

Step 2 - Risk Profiling Project

Model Development
David Johnson, Senior Feed Toxicologist, CFIA
Aimé Kombé, HSD, VDD

Technical Guidance
Rajinder Sharma, Team Leader, HSD, VDD
Manisha Mehrotra, Team Leader, HSD, VDD
Javad Shabnam, Drug Evaluator, HSD, VDD
Bhim Batia, Drug Evaluator, HSD, VDD
Lateef Adewoye, Team Leader, HSD, VDD
Xianzhi Li, Evaluator, HSD, VDD
Catherine Italiano, Feed Toxicology Coordinator, CFIA

Project Objectives

• Risk ranking of feed-additive drugs for non-target species
  • Revise the CFIA drug sequencing guide to allow drug-species combinations identified as being low risk
• Identify where additional controls of the proposed Medicated Feeds Regulations including licensing are required

Project Scope

• Develop model to estimate animal and human exposure to drug residues from carryover using available data or conservative assumptions
• Develop "Carryover Risk Ranks" for each off label drug-animal combination using drug exposure estimates and acceptable daily intakes (ADIs)
• Generate "Approved Use Risk Ranks" for drugs in target species using same methodology

Compare Carryover Risk Ranks and Approved Use Risk Ranks

Definitions

Carryover Risk Rank

• The carryover risk rank considers potential unintended exposure of animals to residues of drugs in feeds resulting from carryover between batches

Approved Use Risk Rank

• The approved use risk rank considers exposure resulting from approved uses of drugs in feeds as defined by the Compendium of Medicating Ingredient Brochures (CMIB)

Information Sources

• Previous Health Canada health risk assessments
• International Sources
• Codex Alimentarius, EFSA, EMEA, USFDA
• Expert opinion
• Other relevant databases ( e.g., Toxnet, VIN)
• Drug companies
• gFARAD

Exposure estimates take into consideration:

• Drug Concentration in Feed
• Feed Carryover Factor in manufacturing equipment
• Feed Intake
• Pharmaco-/Toxico-Kinetics of the drug in the animal
• Withdrawal Time (if applicable)
• Carcass mass, daily milk volume, and egg mass
• Estimated human daily intake based on consumption of 0.5 kg of meat, 1.5 L of milk, and 10 eggs

Risk Rank Calculations and Comparison

• Calculate ratio of the Exposure Estimate and ADI for intended and unintended uses to establish risk rank
• Compare Carryover Risk Rank to highest calculated Approved Use Risk Rank
• When Carryover Risk Rank < Approved Use Risk Rank - unlikely to adversely affect human health
• When Carryover Risk Rank > Approved Use Risk Rank - may adversely affect human health

Risk Rank Comparison - Example

Monensin

Approved Use Risk Rank

• Dairy Cattle - 2.3
• Beef Cattle 1.9
• Broiler Chicken - 7.9

Carryover Risk Rank

• Swine - 3.2

Other Considerations

• Carryover residues which result from following a medicated premix or supplement with a complete feed would result in a higher risk rank
• Feed carryover factors may reduce the risk rank but need to be developed in a transparent fashion
• Data needs

Next Steps

• Work with industry stakeholders (CAHI, ANAC, gFARAD) to fill data gaps
• Pharmacokinetic data
• Feed Carryover Factor
• Use interim information to revise sequencing guide
• Continue compiling information on each drug
• Finalize Risk Ranking

Timelines and Milestones

Milestone	Completion Target Date
Information Gathering and Model Development	Ongoing
Incorporate interim results into Sequencing Guide	December 2007
Finalize Risk Ranking	March 2008

Step 3 - Implementation Strategy

Staged regulatory implementation – preferred option

1. Manufacturers who use at least one concentrated high risk drug
2. Manufacturers who use at least one dilute source of a high risk drug
3. Manufacturers who use concentrated drugs none of which are high risk
4. Manufacturers who use dilute sources of drugs none of which are high risk

Step 4 - Communication and Engagement Strategy

Four Phases

• Phase 1: Pre-Gazette 1 Discussions at Industry Meetings – Summer 2007
• Phase 2: Town Hall Meetings – Fall 2007
• Phase 3: Post Gazette 2 – Cross-country meetings for manufacturers using high risk drugs with specifics of "how to" comply with Regulations
• Phase 4: Post Gazette 2 – Manufacturers using only Low Risk Drugs – as above

Step 5 - Linking regulations with sector programs

• Approaches to align sector programs with the regulatory system to be discussed
• Considerations
  • Third-party inspection protocols and procedures
  • Liability
  • Cost
  • Notification

Step 6 - Issue resolution forum

• Ongoing issue resolution and process check
• Key Stakeholder Steering Committee serves as the focal point to resolve issues as they emerge

Regulatory Development Next Steps

• Conclude
  • Consultation and analyse input
  • Business Impact Study – Cost:Benefit
  • Regulatory Text Revisions
• Re-Publish regulatory proposal in Gazette I
  • Comment Period
• Publish final regulations in Gazette II

Integrated Regulatory Approach

Overview

• Current Regulatory Environment
  • Feeds Act and Regulations
  • August 1997 Mammalian to Ruminant Feeding Ban
  • July 2007 Feed Ban Enhancements
• Proposed Medicated Feed Regulations
• Current and Future Requirements
  • Written Procedures and Records

Feeds Act and Regulations

Objectives

• Regulate manufacture, import and sale of feed
• Safe, effective and labelled to avoid fraud
• End product controls - not designed to control how feeds are manufactured

On Farm and Feed Mill Inspections

Confirm that:

feeds contain only approved ingredients
feeds contain only approved medications at the correct levels and for the intended purpose
feeds do not contain harmful levels of biological or chemical contaminants, including drug residues
controls are in place to meet the regulatory outcomes related to product uniformity and chemical composition
required records are being maintained

Mammalian to Ruminant Feeding Ban (August 1997)

• Regulations promulgated under the Health of Animals Act prohibit the feeding of prohibited material to ruminants
• Labelling, record keeping and following written procedures to prevent cross contamination are regulatory focus

Strenthening the Feed Ban

• First native case of BSE in North America was found in May 2003
• Canada has taken steps to strengthen BSE safeguards
  • removal of SRM from human food
  • enhancing animal ID
  • increasing BSE surveillance
• Removal of SRM from animal feed was a key recommendation of international team of animal health experts
• They also stressed the importance of preventing opportunities for cross-contamination

Enhanced Feed Ban (July 12, 2007)

• SRM removed from "prohibited material"
• Modified the BSE warning statement for feed labels
  • now also required on labels for rabbits, mink, fox, and fish
• Records providing evidence that cleanout procedures were followed between feeds containing "prohibited material" and ruminants feeds must be retained for 10 years
• Recall procedures required

Proposed Medicated Feed Regulations

• Proposed regulations establish minimum feed manufacturing standards to better protect animal health and food safety
• Will apply to all manufacturers of medicated feed for food-producing animals

Written Procedures and Records

Records and/or Procedures Required	Feeds Regulations	Health of Animals Regulations (August 1997)	Health of Animals Regulations Enhanced Feed Ban (July 12, 2007)	Medicated Feed Regulations
Animals Covered by Regulations	Horses, cattle, sheep, goats, swine, foxes, fish, mink, rabbits and poultry	Ruminants, equine, porcines, chickens, turkeys, ducks, geese, ratites or game birds	Ruminants, equine, porcines, chickens, turkeys, ducks, geese, ratites or game birds	Animals that are used for food for humans or that produce food for humans
Mixing Formula (Theoretical Composition)	Yes - retention periods from 6-12 months after the last batch of feed made with the formula depending on the type of feed	Yes - two year record retention	Yes - ten year record retention	Yes - three year retention period Impact primarily on food-producing animals not covered by the Health of Animals Regulations
Mixing Sheet	No	Yes - two year record retention	Yes - ten year record retention	Yes - three year record retention period Impact primarily on food-producing animals not covered by the Health of animals Regulations
Vet Prescriptions	Yes	No	No	No
Invoice	No	Yes - farms that have ruminants and receive "prohibited material". Retain for two years.	Yes - farms that have ruminants and receive "prohibited material". Retain for two years.	No
File on Manufacturing Errors and Corrective Actions	No	No	No	Yes
Flush Use Records	Yes - "medications" as part of the Mixing Formula requirement	Yes - "prohibited material" as part of the Mixing Formula and Mixing Sheet requirement	Yes - "prohibited material" - ten year retention period	Yes - three year retention period Impact primarily on food-producing animals not covered by the Health of Animals Regulations
Equipment Cleanout Procedures and Records	Zero-tolerance for residues Enforce feed compositional standards for "high risk" situations	Required for facilities using "prohibited material" and making ruminant feeds. Records to be retained for two years.	Required for facilities using "prohibited material" and making ruminant feeds. Records to be retained for ten years.	Yes - Specific requirement for written procedures that manage the risk. Records to be retained for three years
Equipment Cleanout Procedures and Records	Zero-tolerance for residues Enforce feed compositional standards for "high risk" situations e.g., withdrawal medications in finisher feeds and susceptible species	No	No	Yes - Requirement for validation of cleanout procedures other than sequencing if used. Records retained for three years
Mixer Performance Testing Records and Procedures	Not specifically required though need to have a uniform product to meet regulatory intent	No	No	Yes - Requirement for written procedures to test performance of mixers used to make medicated feeds. Records to be retained for three years
Scale and Metering Device Performance Testing Records and Procedures	Not specifically required though need to have a product of the intended chemical composition (including medication level) to meet regulatory intent	No	No	Yes - Requirement for written procedures to assess appropriateness and test performance of scales and metering devices used to make medicated feeds. Records retained for three years
Recall Records and Procedures	No	No	Yes - Records to be retained for 10 years	Yes - three year retention period Impact primarily on food-producing animals not covered by the Health of Animals Regulations

Summary

• Written procedures and records are already required on farm and in commercial feed mills
• CFIA wants to enhance controls over feed manufacturing
• Government shares responsibility for food safety with industry stakeholders
• HACCP-based programs are a great base to complement Regulations

Providing Input to the Regulatory Process

Overview

• Other regulatory initiatives
  • Table 4
  • Toxic substances regulations
• Providing comment

Table 4 Overview

• Table 4 was first developed and included in Schedule I of the Feeds Regulations in 1983 with updates in 1990 and 1993
• Table 4 provides ranges of nutrient guarantees for complete feeds (minimums and maximums) for the various species and classes of livestock
• Table 4 ranges represent levels of common mineral and vitamins (generally considered essential) needed to support maintenance, growth and production and include a margin of safety for livestock, humans and the environment
• These nutrient ranges are used to used to determine whether feeds are exempt from registration though they are still subject to the Regulations
• Of primary interest to commercial feed manufacturers; Table 4 provides flexibility to change nutrient guarantees to suit individual needs without a requirement for registration For livestock producers, this ensures timely availability of feeds that provide adequate and safe nutrition

Table 4 updates - Why?

• Current nutrient ranges are dated and based upon the nutrient levels in common use over a decade ago
• There have been advances and changes in animal nutrition and production practises
• The Animal Nutrition Association of Canada (ANAC) formally requested amendment of specific values in Table 4; both parties subsequently agreed that a comprehensive review for the major food producing species: beef, dairy, chickens, turkeys and swine was required

Table 4 updates - The Review

• CFIAcontracted nutrition experts for each species to provide advice
• Nutritionists were asked to recommend changes based on scientific literature and standard feeding practices
• Lower limits are intended to reflect minimum nutrient requirements in a production setting
• Upper limits are intended to reflect a maximum nutrient requirements not maximum tolerable concentrations

Table 4 - Updates

• CFIA is updating Table 4 for chickens, turkeys, swine and dairy and beef cattle
• This requires following the regulatory amendment process, i.e., publication in Canada Gazette Parts I and II
• Prior to publication in Gazette I, the CFIA is consulting with stakeholders and has posted the proposed amendments to Table 4 on the internet to solicit input

Table 4 Updates - Next Steps

• Formal written comments on the proposed modifications were submitted to Ray Perron before December 31, 2007
• More information is available on our site: Consultations on Proposed Policy Changesweb site.
• Comments will be reviewed and shared with stakeholders
• The revised Table 4 will then proceed to the regulatory amendment process

Toxic Substances Regulations

Background

• A regulatory amendment is being proposed to better the control of chemical contaminants in the food chain
• The Health of Animals Act was rewritten in 1990 to include provisions for controlling toxic substances, along with reportable diseases
• To date this has never been established as no substance was named.
• New regulations will provide a list of toxic substances in the Health of Animals Regulations

Toxic Substances

• Toxic substances include contaminants of concern that may be commonly found in an agricultural setting:
  • veterinary drugs
  • pesticides
  • environmental contaminants
    • Dioxins
    • PCBs
    • Heavy Metals

Anticipated impact of regulatory amendments

• Strengthens CFIA's oversight of the food continuum
• Better protects animal health
• Strengthens public health
• Enhances marketability of Canadian products abroad
• Complements on-farm food safety programs already underway
• Serves as an educational tool for industry and farmers on toxins

Toxic Substances - Next Steps

• Completing consultations with stakeholders
• Submit regulatory amendments for publication in Canada Gazette, Part I (planned for winter 2008)
  • Final publication in Canada Gazette, Part II (anticipated later in 2008)
• For more information: contact Catherine Italiano

Providing Input

• For Gazette I publications, follow instructions in the Gazette and provide written comments to contact person identified
• For consultations on proposed policy changes (and pre-Gazette I).