HACCP FOR PROPER DRUG USE Proactive Approach to Drug Residue Prevention © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Wisconsin Veterinary Medical Association AMDUCA Taskforce AMDUCA: Animal Medicinal Drug Use Clarification Act Law regarding extra label drug use Best Practices Taskforce Addressed drug use on dairy Developed computer software Wisconsin topped the list for tissue residues Meat processors wanted more regulation Beef producers wanted to eliminate dairy meat harvest Milk processors were concerned with speed of commerce and expanded pharmaceutical testing of samples Dairy producers were angered by media attention, lack of current food safety credit © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

WVMA Residue Taskforce WVMA Taskforce created (2010) WVMA advocated for a non-regulatory approach (Each herd is unique) Education for all stakeholders Proposed Mindset Shift changes that needed to occur Identified and collected facts about residues Identified possible partners, supporters, spectators and detractors Professional Dairy Producers of Wisconsin (PDPW) WVMA and PDPW forms partnership (WHAT MATTERS: Safe Meat and Milk) Milk testing/FDA sampling Attention turned to milk FDA milk sampling © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Producing Two Safe Products © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Mindset Shifts for Dairy Industry BOTH meat and milk are food products and should be treated as such Assume all calves sent to market will be harvested and consumed Drug residue is a symptom, the disease is lack of DRUG VCPR Drug residues are a people problem, not a drug problem Drug VCPR includes usage oversight and treatment records Protocols: How you want treatment given in your name, in your absence Identify “problem cow”- (stop treating the incurable) Oversight involves both Rx and OTC drugs through treatment records © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

HACCP: Hazard Analysis & Critical Control Points Traditional HACCP Identify hazards Establish critical control points Monitors Breakpoints Action at breakpoint Mandatory records Verify the system © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA WVMA HACCP For Proper Drug Use

Meeting HACCP Requirements Identify Hazards VCPR and drug list Establish Critical Control Points VCPR responsibilities, protocols, SOPs Monitors Oversight Breakpoints Regulatory tolerances Non-regulatory appropriate drug use Action at breakpoint On-the-job training (teachable moment) Mandatory Records Drug list, protocols, prescriptions, cow side oversight Verification Milk processor oversight Veterinarian and producer oversight and records usage © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Three Areas of Focus 1. Food Safety Meat and milk residues 2. Appropriate Drug Use Label and Extra label drug use Accountability to treatability 3. Messaging Truth and half-truths © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Farm Veterinary/Client/Patient Relationship (VCPR) Slaughter Plant Truckers, Dealers & Markets FSIS Authority FDA Authority FDA Authority USDA Authority Dairy Beef Regulatory Authority System 90% of violations originate from dairy 70% cull cows 20% bob veal (few days old to 150 pounds)

Farm Veterinary/Client/Patient Relationship (VCPR) Slaughter Plant Truckers, Dealers & Markets FSIS Authority FDA Authority FDA Authority USDA Authority Dairy Beef Regulatory Authority System Sampling 1)Directed Random 2)Unscheduled Targeted Mastitis Metritis Pneumonia Injection lesions Surgeries And much more…

Farm Veterinary/Client/Patient Relationship (VCPR) Slaughter Plant Truckers, Dealers & Markets FSIS Authority FDA Authority FDA Authority USDA Authority Dairy Beef Regulatory Authority System © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA Cull Cows 1)Penicillin 2)Flunixin 3)Sulfas 4)Desfuroylceftiofur 5)Gentamicin Bob Veal 1)Neomycin 2)Sulfas 3)Gentamicin 4)Flunixin Top Tissue Violator Drugs Milk Residues Failed EU milk audit results in increased testing to maintain export market access January 2012 FDA blind sampling began Milk processors increase testing Processor Letter How will you ensure that “good milk” does not get dumped as a result of this additional testing? Answer: The only milk that we will reject under this program is milk that tests positive for the presence of drugs, using commercially accepted testing technology. The presence of any drug at any level in milk is considered adulterated under the FD&C and therefore prohibited. Our protocol for testing remains the same as it is today. We are simply expanding the universe of drugs for which we will test. As with current testing for Beta lactams, two additional tests will be run on any positive sample, thereby minimizing the risk of “good milk” being rejected due to a false positive test. Additionally, the cooperative that is responsible for the load will have the full opportunity to conduct follow-up testing on any milk that tests positive for the presence of drug residue.

Tissue Testing Consumer Reality Consumers do not want to hear you are within tolerance levels. They want to hear there are no residues in the products they buy. © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

13 Farm Veterinary/Client/Patient Relationship (VCPR) Slaughter Plant Truckers, Dealers & Markets FSIS Authority FDA Authority FDA Authority USDA Authority Dairy Beef Regulatory Authority System FDA Top 3 Reasons for Violations No Veterinary-Client-Patient-Relationship (VCPR) 1)No on-farm treatment records 2)Increased dosage without adjusting withdrawal times 3)No individual animal ID Cull Cows 1)Penicillin 2)Flunixin 3)Sulfas 4)Desfuroylceftiofur 5)Gentamicin Top Tissue Violator Drugs Bob Veal 1)Neomycin 2)Sulfas 3)Gentamicin 4)Flunixin ? Top Milk Violator Drugs Mastitis Metritis Pneumonia Common ELDU Conditions Solution Records + Oversight + VCPR © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

VCPR VETERINARIAN-CLIENT-PATIENT RELATIONSHIP © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

VCPR Regulatory accountability Take non-regulatory approach but accomplish intent of law within the diversity of individual dairies and people involved © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Statutory VCPR Veterinarians have a regulatory accountability Federal law State law WVMA HACCP For Proper Drug Use Non-Regulatory © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Non-regulatory team of people Patient - people working cow side Client - people representing management Veterinarians Attending, referral, consulting Who is responsible? What are their roles? Identify high risk people Roles and responsibilities © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA VCPR (Personalized)

Mindset Shift Focus attention on drug usage accountability and treated animal oversight © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

DRUG LIST © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Drug List Regulatory consideration is dealing with prescriptions All drugs (oral/injectable; prescription/over-the-counter) Identify Extra Label Drug Use (ELDU) Target high risk drugs © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

VCPR Accountability to the Drug List Work from list of ALL purchased drugs Prescription accountability for the drug on the list Extra Label Drug Use (ELDU) identification by protocol writer AMDUCA algorithm accountability Who secured withdrawal information for any Extra Label Drug Use? © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Drug Usage and Categories Approved use Over the Counter (OTC) Purchased without a Veterinary Prescription, use on label only (LDU) Prescription Purchase with prescription, use by label (LDU) Extra-label Drug Use (ELDU) OTC or Prescription Drugs not used in accordance to label directions No tolerance level for drug not approved for animal type Veal calves Not for animals>20 months of age Illegal use Prohibited drug list Approved drug list, but not for ELDU Leaving residue above tolerance Residue above sensitivity of test for drugs with no tolerance

High Risk Drugs – No Tolerance Level Label restrictions if used on veal calves Label restrictions if dairy is less than 20 months of age For example, but not limited to: Draxxin (Tulathomycin), Micotil (Tilmicosin), Tylan (Tylosin), Nuflor, Nuflor Gold, Resflor Gold (Florfenicol) Identifies risk and establishes critical control points © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Defining Extra Label Drug Use (ELDU) Giving an animal a drug (Over The Counter or prescription) in a manner different in any way from the manufacturer’s label When Over The Counter drugs are NOT used according to the manufacturer’s label directions they require a prescription A valid VCPR (Veterinarian-Client-Patient Relationship) Has requirements for use (records) AMDUCA: Animal Medicinal Drug Use Clarification Act of 1994 © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Illegal For Use Baytril Extra label use of florquinalones (Baytril) are expressly prohibited Sulfa Extra label use of sulfas are expressly prohibited There are a few ON LABEL uses of Sulfadimethoxine (Albon) in lactating cows (foot rot and pneumonia) Using any other sulfa is prohibited as well as using Albon for other conditions or giving oral solution IV Ceftiofur Limited extra label applications © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

On Farm Testing? What is the role of on farm testing for residues? We cannot test our way out of proper drug use! © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

PROTOCOLS © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Protocols Treatments given in our name; in our absence Define condition, drug protocol, records, withdrawal times Identify label drug use opportunities first Plan food safety if ELDU is appropriate © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Protocols v. SOPs Protocol - What to do Defined condition (situation) Drug treatment - dose, route, duration Records to keep for verification of food safety and accountability for proper drug use Withdrawal for meat and milk SOP – How to do it Steps to a process and procedure People responsibilities © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Protocol Development Have sufficient knowledge about the farm’s clinical case definitions Perceived v. Actual First, identify and write protocols where on-label treatments will be effective Meat and milk withdrawals as labeled Challenge will be satisfying expectations of outcomes that satisfy VCPR team © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Protocol Development Second, identify where ELDU is needed If no treatment records, no ELDU Meat and milk withdrawals are calculated based on treatment duration, dose, route and frequency (Check with FARAD) Veterinarians have accountability to AMDUCA Algorithms Review and update annually, or as needed © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Justifying ELDU What evidence do we go through to justify ELDU? © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

True jeopardy… Having protocols and not following them © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA Worker consistency, compliance, and competency

SOPs © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

SOPs Consistency, compliance, competency Identifying people skills through the records Allows on-going, on-the-job training at oversight © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

SOPs Are the Steps of the Process Daily routines How we milk (pre-strip) Daily fresh cow exam (metritis) Daily cow observations (pneumonia) Health How does a mastitis case get processed? How does a metritis case get processed? Pneumonia case examination and treatment decision © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA SOP for withdrawal accountability after treatment

Mindset Shift Residues are not a drug problem. They are a people problem. © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

RECORDS © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Records Required records situations Three types of records on dairies Train record usage by VCPR team members Management usage (epidemiology, consistency, etc.) © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Records Statutory AMDUCA requirements for ELDU State law requirement (VE7) Wisconsin Examining Board © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Value = Records Usage by VCPR Team Patient – cow side personnel Client – management team Veterinarian – oversight © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Three Herd Categories No records herd or a management group Fundamental records (logs) Manage the case, food safety, Permanent level records (medical history) Manage case, food safety, herd epidemiology, oversight, outcomes © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

No Records, High Risk Label Drug Use Only Protocols for label usage and we best monitor compliance Note in veterinary records that we checked for records and repeatedly gave oral recommendations to follow label We have the right to refuse service (there is a process for this) If we are attending veterinarian do we have the right to refuse VCPR responsibilities? (Do we need to have assurance someone else holds VCPR if we attend this dairy?) Milk processors must oversee these dairies, we can’t verify drug use without records © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Fundamental Records Records that will manage food safety Daily drug treatment usage records Includes: Animal ID, condition, date treated, drug used, dosage, route, duration, meat and milk withdrawal Huge step up from no records, but can we verify a HACCP plan (proper drug use)? No. Fundamental Records ≠ WVMA HACCP © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Permanent Records The next level of record keeping is individual cow permanent records Permanent record information is collected from the cow side recording form Includes cow’s medical, fertility, production and other history The permanent record sets the stage for science-based appropriate drug usage with consideration of medical history Organizing individual permanent records is the basis for identifying epidemiology (disease patterns) and therefore prevention © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Permanent Records To meet WVMA HACCP For Proper Drug Use Permanent records must be kept Veterinarian oversight of those records is essential Allows us to identify opportunities to improve management Appropriate drug use Management of prevention Oversight of welfare Food safety Identify opportunities for increased profitability for dairies © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Value of Records Usage by VCPR Team Patient – (cow side personnel) Client - (management team) Veterinarian (oversight) © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Plan What to Record So You Can… Recognize SOP compliance and competency That was the reason for defining severity Recognize protocol drift Definitions match protocols Manage epidemiology By age, stage of lactation, severity, cause, history Ensure Food safety © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

OVERSIGHT © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – The “Key” to Making it All Work! What is Oversight? The regular, timely review of the dairy producers’ medical records Monitor treatment, outcome and compliance No Records = No Oversight © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Is the “Key” Because… It validates VCPR (“sufficient knowledge”) It allows you to monitor, validate, refine protocols and SOP’s Are people doing what we agreed? (drift) Are patients responding? (effectiveness) Did the pattern change? (epidemiology shift) It allows you to watch the drug list Where did that Miraclemycin come from? It reinforces the value of keeping records to the producer It reinforces the value of veterinary involvement in treatment decisions and drug use to the producer It allows identifying “teachable moments” © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Target Herd Needs Identify drug usage hazards and resolve them with a control plan Improve welfare by finding opportunities to treat cows in need Improve appropriate drug use by finding cows that don’t need to be treated Find opportunities to improve profitability within treatment plan Teachable moment is when the treatment decision is fresh © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Which Records Need to be Reviewed? Permanent & Fundamental Records Different clients will have varying records, competencies and needs Remember why we’re here today: To stop residue violations in dairy beef and milk products Proper drug use © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Moving to the Next Level The Permanent Record - Bringing Information to Management Measure outcomes of protocols and SOPs Becoming sub clinical status after treatment Measuring relapses, reoccurrences, retention in the herd, etc. Noting changes in productive potential post treatment Begin to understand disease processes occurring on the farm (epidemiology) Define incidence, prevalence, management groups Look for patterns across parity, days fresh, seasons Severity, pathogens, treatment Do records suggest an intervention, or management decision © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Moving to the Next Level The Permanent Record - Bringing Information to Management Determine quantity of drugs being used - reconciliation Per cow, per case, per condition, per management group Cowside by totaling cc’s, pills, bottles from “daily treatments records” In the office by reviewing drug purchases (BPW) (starting inventory + purchases-ending inventory=drug use) Is there any glaring over usage? Under usage? Use records to characterize the economic impact of disease on the farm Quantify drug costs per case, per cow, per condition, per management group Days out of tank (DOOT) - value of discarded milk Costs due to death and premature culling © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Oversight – Where Do I Start? First Things First - Stop Drug Residues in Milk and Dairy Beef Review fundamental records Answers who, what, when, how, and why drugs are being used Validate that meat and milk withdrawal times are correctly established and observed Review animals that were sold or died Validate that meat withdrawal times are correctly established and observed Doing sold/dead cows can suggest a need to refine any protocols/SOPs Don’t forget about bull calves – free of residues? © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

Mindset Shift Identification of “problem cow”- Stop treating the incurable © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA

59 Conclusion Clarify Extra Label Drug Use Veterinarians Producers © 2012 Wisconsin Veterinary Medical Association, Inc. Reproduction prohibited without license from WVMA FDA Top 3 Reasons for Violations No Veterinary-Client-Patient-Relationship (VCPR) 1)No on-farm treatment records 2)Increased dosage without adjusting withdrawal times 3)No individual animal ID Cull Cows 1)Penicillin 2)Flunixin 3)Sulfas 4)Desfuroylceftiofur 5)Gentamicin Top Tissue Violator Drugs Bob Veal 1)Neomycin 2)Sulfas 3)Gentamicin 4)Flunixin ? Top Milk Violator Drugs Mastitis Metritis Pneumonia Common ELDU Conditions Solution Records + Oversight + VCPR