Certification Training Pork Quality Assurance Plus® I PQA Plus® is composed of two main elements: ■ Food Safety ■Animal Well-being 2 Elements: 1. Certification for individuals 2. Site Status for sites(farms) 3. Third-party verification process 3 We Care: • Ethical Principles: – – – – – – 4 Produce safe food Protect and promote animal well-being Ensure practices to protect public health Safeguard natural resources Provide a work environment that is safe Contribute to a better quality of life in our communities Basis for the 10 GPP’s • Hazard Analysis and Critical Control Point principles (HACCP) • The Food and Drug Administration’s Compliance Policy Guide (CPG) 7125.37 – “Proper Drug Use and Residue Avoidance by Non-veterinarians.” • The Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 • Science-based animal care and well-being guidelines. 5 Good Production Practices (GPPs) I The PQA Plus program is built upon 10 Good Production Practices 6 GPP # 1 Establish and implement an efficient and effective herd health management plan. 7 Herd Health Management Plan Should include: ■ Regular herd evaluations by a veterinarian ■ Biosecurity ■ Rodent & pest control ■ Cleaning & disinfecting procedures 8 1 1 Regular veterinary health evaluations ■ Fulfill VCPR requirements (Veterinary/Client/Patient Relationship) ■ Help determine current herd health status ■ Provide “fresh set of eyes” ■ Provide opportunity to plan and strategize 9 1 Biosecurity Managing to prevent the transmission of diseases and disease agents ■External ■ Keeping disease out of the herd ■Internal ■ Preventing disease movement within the herd 10 Biosecurity Develop SOPs for biosecurity that may include: ■ Limiting visitors and other traffic ■ Isolating incoming animals ■ Using all-in, all-out flow ■ Using shower-in, shower-out ■ Keeping facility clean ■ Knowing your herd disease profile 11 1 Rodent and pest control 1 Rodents and other pests are biosecurity hazards ■ Pests also include: Birds, insects, cats & dogs ■ Prevent entry into facilities ■ Remove food sources ■ Remove living & hiding spaces ■ Bait & trap 12 1 Cleaning & disinfecting procedures ■ Remove organic matter ■ Manure, bedding, etc… ■ Thoroughly clean building and equipment ■ Disinfect ■ Allow to dry before repopulating 13 GPP #1 - Summary A herd health management plan should include these important components: ■ Regular herd evaluations by a veterinarian ■ Biosecurity ■ Rodent & pest control ■ Cleaning & disinfecting procedures GPP #2 Use an appropriate veterinarian/client/patient relationship (VCPR) as the basis for medication decision-making. 15 2 Veterinary/Client/Patient Relationship A VCPR as defined by the U.S. Code of Federal Regulations (21 CFR Part 530) includes: ■ ■ ■ A veterinarian assumes the role of making medical judgments for animals and owner/animal caretaker agrees to follow the veterinarian’s instructions The veterinarian has sufficient knowledge of the herd/animals The veterinarian is available for follow-up care Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animals by virtue of examination of the animals and/or by medically appropriate and timely visits to the premises where the animals are kept. 16 2 AMDUCA Federal Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 ■ ■ ■ ■ 17 Permits extra-label drug use by veterinarian with a VCPR Risks are increased, extended withdrawal times may be necessary Treatment records should be kept by the producer for 1 year after the animal is marketed Does not include medicated feeds, including VFD feeds Animal Drug Categories 2 ■ Over-the-Counter (OTC) ■ Prescription (Rx) ■ Veterinary Feed Directive (VFD) 18 Over-the-Counter (OTC) ■ Widely available ■Farm stores, mail-order, veterinary clinics ■ No purchase restrictions ■ Must be used according to label 19 2 Prescription (Rx) ■ Available only through veterinarians, pharmacists or distributors with a prescription on file ■ Requires veterinary order ■ Must be used according to label and/or any additional veterinarian’s directions 20 2 2 Veterinary Feed Directive (VFD) Drug ■ Antimicrobial used in or on feed ■ Use requires a VFD order issued within a VCPR ■ VFD allows producer to purchase medicated feed with a VFD drug ■ Records must be maintained for 2 years 21 Extra-label Drug Use 2 Examples of extra-label use include: ■ ■ ■ ■ ■ ■ Increasing the dosage Changing the frequency of administration Changing the route of administration Changing the duration of treatment Treating a disease or condition not on the label Changing species or life stage on the label Legal only if on the order of a licensed veterinarian. Extra-label use is NEVER legal for a VFD. 22 Compounding AMDUCA also allows a veterinarian with a VCPR to compound drugs for the client. ■ ■ 23 Combining two or more FDA-approved drugs Veterinarian assumes responsibility for safety and efficacy of compound 2 Residue Testing If the residue status of an animal or group is in doubt, conduct a residue test. This may be due to: ■ ■ ■ 24 ID tags or markings missing Accidental animal access to medicated feed Lost or damaged records 2 GPP #2 - Summary Veterinary/Client/Patient Relationship – – Veterinarian has assumed responsibility for making medical judgments – Owner or other caretaker agrees to follow the instructions of the veterinarian – VCPR only exists when a veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) Approved animal drug categories: – Over-the-Counter (OTC) – Prescription (Rx) – Veterinary Feed Directive (VFD) Only when a VCPR exists - FDA approved drugs can legally be used in food-producing animals in a way other than directed on the label – Extra label use is prohibited in medicated feeds According to FDA, VFD records must be kept for 2 years GPP # 3 Use antibiotics responsibly. 26 Use antibiotics responsibly 3 The basis for using antibiotics responsibly during pork production in order to protect public health involves: -Evaluating their use to protect animal health -Optimizing their effectiveness, and -Minimizing the risk of developing antibiotic resistance 27 Three Purposes of Antibiotics 3 Pork producers use antibiotics for three purposes ■ Treatment of illness ■ Prevention of disease ■ Improvement of nutritional efficiency 28 Take steps to decrease the need for antibiotics • Preventive strategies can help decrease the need for antibiotics – – – – – 29 Biosecurity programs Appropriate animal husbandry Hygiene Routine health monitoring Vaccination programs Assess the advantages/disadvantages A. Other management options should be considered B. Treat only as long as needed C. Review the need for continuing preventative antibiotic therapy D. Consider other impacts of using antibiotics 30 Use antibiotics only when they provide measurable benefits A. Assess the benefits of all uses B. Assessment should be based on scientific data 31 Responsible Use Guidelines 3 ■ Use veterinary input as the basis for all medication ■ ■ ■ ■ 32 decision-making Use antibiotics for treatment only when there is an appropriate clinical diagnosis Limit antibiotic treatment to ill or at-risk animals Antibiotics that are important in treating antibiotic resistant infections in human or veterinary medicine should be used in animals only after careful review and reasonable justification. Minimize environmental exposure GPP #3 - Summary Pork producers use antibiotics for three purposes: – Treatment – Prevention – Nutritional Efficiency • Principles and guidelines for responsible antibiotic use: – – – – – – – – Take appropriate steps to decrease need Assess the advantages and disadvantages of all uses Use only when they provide measurable benefits Use professional veterinary input Used for treatment only when there is an appropriate clinical diagnosis Treat the fewest animals indicated Use only after careful review and reasonable justification Minimize environmental exposure GPP # 4 Identify, track and maintain medication and treatment records for all treated animals. 34 4 Identification of Treated Animals Treated pigs, or groups of treated pigs, must be identifiable from the time of treatment until the withdrawal time has elapsed. 35 Individual Identification Individual animals may be identified with: ■ ID cards - Work best with adult animals housed singly ■ Paint marks - Short term, rub off easily ■ Tattoos - Permanent, harder to apply and read ■ Ear tags - Easy to see, cumbersome to apply, can be lost ■ Ear notches – Permanent, requires familiarization with site-specific system 36 4 Group Identification Treated animals housed in a group may be identified by: ■Pen or room number ■Group (building or site) Groups must remain intact until the withdrawal time has elapsed. Any animals removed must be identified individually. 37 4 5 Medication and Treatment Records Records on treated animals should be maintained for these purposes: ■Food safety – Ensure that withdrawal time has elapsed ■Regulatory – Documentation of proper drug usage ■Management – Analyzing and planning production Treatment records should be kept for 12 months. 38 FDA Compliance Policy Guide 5 (CPG 7125.37) Minimum FDA required recordkeeping includes: Date 9-17-XX 39 Animal ID 145 Product name Penicillin Amount given 2cc Route IM Given by Withdrawal time Chuck 7 days GPP 4 Summary Records on treated animals should be maintained for these purposes: – Food safety – Regulatory – Management There are various tools and methods of identifying treated pigs and groups of pigs. The FDA has developed minimum requirements expected of producers while maintaining medication and treatment records. – Written record should be kept on file for one year after the hogs have been marketed. GPP # 5 Adhere to medication withdrawal times. 41 Withdrawal Times 5 Withdrawal time is the length of time it takes for a medication level in the body to fall below the safe level for humans (as established by the FDA). ■ Always read and understand the label, package insert, or feed tag 42 Maximum Residue Level (MRL) ■ Other countries may require withdrawal times for products different than the United States. ■ 43 For more information on export MRLs visit: http://www.pork.org 5 GPP #5 - Summary Withdrawal time - period required for the medication to be metabolized, broken-down, or excreted so that the level remaining in the body of the animal is below the level established as safe for humans Other countries may require withdrawal times different than the United States for some products GPP # 6 Properly store, label, and account for all drug products and medicated feeds. 45 Medication Storage 6 All medication should be treated as perishable ■ Temperature – Some require refrigeration, others fine at room temperature ■ Sunlight – Some require dark storage ■ Expiration – Check expiration date before using Always read and follow storage instructions on the label, tag, or insert. 46 Medication Storage 6 ■ Store injectables in clean, sealed containers ■ Use clean needle to withdraw medication ■ Feed pre-mixes should be stored in clean, dry pest-free areas ■ Dispose of unwanted medications properly 47 Medication Identity Preserve the identity of medications ■ Store medication in original container if possible ■ Do not store medication in a syringe 48 6 Medication Labels 6 Labels contain the following important information: ■Trade name ■Active ingredient ■Indications ■Dosage and directions for use ■Precautions ■Cautions ■Warnings – withdrawal times ■Manufacturer’s lot number ■Expiration date 49 Medication Inventory Drug inventory and usage records help to: ■ Monitor treatment trends ■ Reconcile treatment records with inventory ■ Prevent waste or theft 50 6 GPP #6 - Summary Drug labels contain the following information: – – – – – – – – – Trade name Active ingredient Indications Dosage and directions for use Precautions Cautions Warnings –withdrawal times Manufacturer’s lot number Expiration date – Always read and follow storage instructions on the label, tag, or insert. GPP # 7 Use proper administration techniques, needleuse procedures, observance of withdrawal times and methods to avoid marketing adulterated products for human food. 52 Administering Medications 7 Typical routes of medication delivery include: ■Oral ■Topical ■Injectable 53 Administering Medications 1. Oral ■Given through the mouth ■Good for large groups of animals ■ Water or feed delivery ■Reduced stress to animals receiving medication and caretakers giving it 54 7 Administering Medications 2. Topical ■ 55 Applied to the skin ■ Sprays ■ Dusts ■ Pour-ons ■ Dips 7 Administering Medications 3. Injectable ■ Useful when treating individual animals ■ Practical way of medicating pigs that are too sick to eat or drink and for some medications that are poorly absorbed from the gut 56 7 7 Administration of Injectable Drugs Five Methods of Giving Injectable Medications 57 ■ In the muscle (Intramuscular - IM) ■ Under the skin (Subcutaneous – SQ) ■ In the nasal passages (Intranasal – IN) ■ In the abdominal cavity (Intraperitoneal – IP) ■ In the vein (Intravenous – IV) 7 Administration of Injectable Drugs In the Muscle (Intramuscular - IM) ■ ■ ■ ■ 58 Use spot on neck behind and below ear Do not use a needle to inject in the ham or loin If using an alternative technique, work with veterinarian or packer to determine acceptability Use proper needle gauge and length 7 Administration of Injectable Drugs Under the skin (Subcutaneously - SQ) ■ Inject only into clean, dry areas ■ Use the proper length needle ■ Insert at the proper angle ■ Slide the needle under the skin away from the site of skin puncture before depositing the product ■ ■ 59 Small pigs: use the loose flaps of skin in the flank or behind the elbow Larger pigs: inject in neck behind the ear 7 Administration of Injectable Drugs Other Injection Methods ■ In the nasal passages (Intranasal - IN) ■ In the abdominal cavity* (Intraperitoneal - IP) ■ In the vein* (Intravenous - IV) *Technique should only be used upon veterinary guidance as serious injury, including death of the pig, can occur. 60 Standard Operating Procedure for Needle Usage A Standard Operating Procedure (SOP) for needle usage should include: ■ Broken needle prevention ■ Animal identification ■ Packer notification procedures 61 7 SOP: Points to Consider 1. Evaluate the strength and detectability characteristics of the needles you are using 2. Provide needle-use guidelines to all animal caretakers NEVER straighten a bent needle! 62 7 SOP: Points to Consider Identification of hogs ■ Establish a plan for identifying hogs known or suspected of harboring a broken needle ■ Provide permanent ID ■ Record all pertinent information ■ Ensure employee training 63 7 SOP: Points to Consider Communications with your packer ■ Find out from your packer their policies for at-risk pigs 64 7 Disposal of Sharps ■ Needles, knife blades and syringes (sharps) must be disposed of properly according to your state or local regulations ■ Use rigid, puncture-resistant container ■ Container should be clearly labeled as a biohazard waste container ■ When full, the cap should be securely tightened and sealed 65 7 GPP #7 - Summary Medications are commonly administered to pigs in three ways: – Orally – Topically – Injectable There are five ways to give injectable medications to pigs: – – – – – In the muscle (Intramuscular - IM) Under the skin (Subcutaneous – SQ) In the nasal passages (Intranasal – IN) In the abdominal cavity (Intraperitoneal – IP) In the vein (Intravenous – IV) Never straighten a bent needle. GPP # 8 Follow appropriate on-farm feed and commercial feed processor procedures. 67 Feed Manufacturing Goals for manufacturing quality feed include: ■ Meets nutritional specifications ■ Meets desired medication level (if medicated) ■ Free of contaminants (or below tolerance levels) 68 8 Medicated Feed and cGMPs 8 Guidelines for processing medicated feed are known as current Good Manufacturing Practices (cGMPs) and set standards for: ■ Manufacturing facilities ■ Ingredients ■ Manufacturing processes ■ Monitoring ■ Labeling ■ Recordkeeping 69 cGMPs ■ Buildings and grounds – Clean, adequate space, pest controls in place ■ Equipment – Capable of task, in good repair, accurate meters and scales ■ Workspace and storage – Designed to prevent contamination, physically separated from other areas 70 8 cGMPs ■ Product Quality Assurance ■ Consider analyzing feeds periodically ■ Establish equipment cleanout procedures ■ Labeling ■ Receive, handle, and store medications and their labels in a way that prevents confusion ■ Recordkeeping ■ Written inspection and production records kept for 1 year, samples of feed and ingredients kept for 6 months 71 8 Mixing Medicated Feeds Proper drug concentrations are important to: ■ Achieve desired benefits of the drug ■ Prevent adverse health effects or violative residues 72 8 GPP #8 - Summary To prevent feed contamination current Good Manufacturing Practices (cGMPs) outline standards for: – – – – – – Manufacturing facilities Ingredients Manufacturing processes Monitoring Labeling Recordkeeping GPP # 9 Develop, implement and document an animal caretaker training program. 74 9 Caretaker and Employee Training All animal caretakers involved in the herd’s production must be trained and the training must be documented. 75 PTSDR Method of Training • Throughout a training program, a technique called the PTSDR method may be used to train others. 76 PTSDR Method of Training Step 1: Prepare Stage – Focus on objectives and outcomes to achieve within the training – Determine the time constraints needed for an employee to obtain a desired skill – Identify any activities that should be implemented – Gather the materials needed to carry out activities and the entire training program 77 PTSDR Method of Training Step 2: Tell Stage – Address the key points needed to obtain knowledge and skills Focus on objectives and outcomes identified in the Step 1 Step 3: Show Stage – Demonstrate how to complete the specific task 78 PTSDR Method of Training Step 4: Do Stage – Learner practices what they have seen and heard in Steps 2 and 3 Step 5: Review Stage – Individual is evaluated on his or her performance – After evaluation, the individual is given feedback and recommendations for improvement 79 Document Training ▲Individual Development Plan ▲Group Training Record ◄Individual Training Record 80 GPP #9 - Summary All animal caretakers must be properly trained The PTSDR method may be used to train others and consists of five steps: 1) Prepare, 2) Tell, 3) Show, 4) Do and 5) Review. Training must be documented GPP # 10 Provide proper swine care to improve swine well-being. 82 Care and Well-being Principles Proper swine care and well-being requires commitment on the caretaker’s part. 83 10 10 Recordkeeping ■ Veterinary/Client/Patient Relationship (VCPR) ■ Medication and treatment records ■ Caretaker training program including: ■Euthanasia ■Animal handling ■Husbandry 84 Emergency Backup Support ■Written action plan ■ Covers various emergencies – fire, weather, ■ power outage, etc... Telephone numbers for owner, veterinarian, fire and police ■Emergency detection system ■ Alarms for power failure, drastic temperature ■ changes Facility location may allow for visual detection ■Emergency backup system ■ Automated intervention in the event of a ■ 85 mechanical ventilation failure Test backup system regularly 10 PQA Plus® Site Assessment 10 ■ Provides a tool to benchmark and track the operation ■ Allows for a “fresh set of eyes” to view the operation ■ Sites should be assessed at least once every 3 years 86 Daily Observation ■ Routine observation 10 ■ Helps ensure prompt reaction to any needs ■ Keep records of observations ■ Seriously ill, non-ambulatory, or dead animals ■ Should not go undetected ■ Treatment pen 87 Animal Evaluation ■ Production Performance ■ Average Daily Gain ■ Farrowing Rate ■ Mortality ■ Physical Evaluation ■ Lameness ■ Skin lesions (abscesses, wounds) ■ Rectal prolapses ■ Swine Behavior ■ Indicator of care and suitability of facilities 88 10 Body Condition Score (BCS) 10 ■ Indicator of management and animal well-being 1 2 3 5 Score Condition Detection of ribs, backbone, “H” bones, and pin bones 1 Emaciated Obvious 2 Thin Easily detected with pressure 3 Ideal Barely felt with firm pressure 4 Fat None 5 Overly fat None Taken from “Assessing Sow Body Condition” by R. D. Coffey, G. R. Parker, and K. M. Laurent (ASC-158; 1999). 89 4 Body Space ■ For pig space to be considered adequate the pig must be able to: ■ Easily lie down fully on its side (full lateral recumbency) without having to lie on another pig and easily stand back up ■ Lie down without the head having to rest on a raised feeder ■ Additionally, a pig housed in a stall must be able to lie down fully on its side (full lateral recumbency) without the head having to rest on a raised feeder and the rear quarters coming in contact with the back of the stall at the same time. 90 10 Euthanasia 10 ■ Written euthanasia plan which considers: ■ Human safety ■ Pig well-being ■ Practicality and technical skills ■ Caretaker compliance ■ Aesthetics ■ Limitations ■ Timely euthanasia ■ Minimizes animal pain or distress ■ No improvement or prospect for improvement after 2 days ■ Functional equipment available 91 10 Facilities ■ Pen maintenance ■ Pens and flooring in good repair, and appropriate for the phase of production, so as not to cause injury. ■ Feeders and waterers in good state of repair to allow for unobstructed feed and water delivery ■ Feeder space ■ Ample space for daily ration consumption and prevention of unnecessary fighting and competition ■ Water availability ■ Sufficient flow rate 92 Proper Handling When pigs are improperly handled: – Sows do not produce to peak levels – Incidence of “non-ambulatory pigs" may increase – Loading and unloading pigs may take longer and be more stressful – Market pigs may lose weight – Carcass shrink and/or trim loss may increase – Meat quality will be affected Proper swine handling will: – – – – 93 Reduce stress Increase meat quality Reduce weight loss Reduce non-ambulatory pigs Flight Zone Imaginary circle around an animal Entering a pig’s flight zone causes the pig to move away Size varies from pig to pig Work from edge of flight zone Point of Balance Located at animal’s shoulder Handler approaches from rear = Animal moves forward Handler approaches from front = Animal moves backward Blind Spot Pigs’ – Eyes are on sides of head – Approximately 310° field of vision – Will not move solely due to visual cue if handler approaches directly from rear blind spot Following/Herding Pigs like to – Stay in visual/physical contact – Follow each other An advantage when moving pigs – Up or down ramp/chute – Through hallway/alleyway – Into or out of a pen or room People/Pig Interactions Pigs may not understand a handler’s intentions Pigs experiencing positive interactions are typically – Less fearful of handlers – Easier to handle Walk pens daily Proper Handling Handlers should – – – – Act calmly Avoid sudden movement, loud noises, other distractions Move pigs at their normal walking pace Avoid aggressive handling Aggressive handling includes – – – – – – Overuse, or improper use, of electric prods Loud noises and yelling Moving pigs too fast Moving too many pigs per group Overcrowding pigs in chutes, ramps and alleyways Rough physical contact Willful acts of abuse are unacceptable Pig Types and Sizes Breeding Stock Piglets Nursery and Finisher Pigs Breeding Stock Large, powerful pigs – Sows, gilts, boars – Use appropriate handling tools, not handler’s body Can be unpredictable, aggressive – Example: Boars may use tusks as a form of defense – Example: Sows protecting a litter being processed Utilize known pig behavior – Example: Leave front door of stall open when loading from rear Piglets May be safety challenge – Sharp teeth – Active (squirm, wiggle) Pick up piglets – Under rib cage – By a rear leg above the hock Nursery and Finisher Pigs Work in handler pairs Use appropriate handling tools, not handler’s body Group Sizes Balance safety and efficiency Handler should always be able to control the lead pig Pig type/size Suggested group size Weaned piglets 20 Nursery pigs 10 Finished/Market pigs 3-5 Sows/Gilts 1-51 Boars 1-51 1Depending upon temperament and safety conditions, may require moving individually. Non-ambulatory pigs Are unable to walk because they are: – Ill, – Injured, or – Fatigued. Should be: –Given medical treatment, – Allowed to rest, or – Humanely euthanized. The position of the National Pork Board is that any pig that is unable to walk or that is ill and will not recover should be humanely euthanized on the farm and not transported to market channel. 105 Tools and Equipment Tools can be used as a/an – – – – Physical barrier – Sort board Visual barrier - Matador’s cape Auditory stimulus – Rattle/Shaker paddle Visual stimulus – Nylon flag Tools and Equipment Electric prods are stressful to pigs – Avoid or minimize use – Never prod sensitive areas Eyes Nose Anus Testicles Etc. – Evaluate handling procedures and facilities if prod use is regular – Should not be the primary handling tool 10 Ventilation ■ Temperature ■ Pig behavior is a good indicator of thermal comfort ■ Heating/cooling provisions should be in place ■ Air Quality ■ Ammonia (NH3) < 25 ppm 108 Willful Acts of Abuse ■ Abuse and neglect are unacceptable ■ Defined as acts outside of normally accepted production practices that intentionally cause pain and suffering including, but not limited to: ■ Applying prods to sensitive areas like: eyes, ears, nose, rectum ■ Malicious hitting/beating ■ Purposeful failure to provide food, water or any minimal care ■ Be familiar with local or state laws that address animal cruelty 109 10 GPP #10 - Summary Recordkeeping includes keeping records of a VeterinarianClient-Patient Relationship (VCPR), medication and treatment of animals, and of a caretaker training program It is also very important to have: – – – – – – – – – A written emergency action plan and an emergency backup system Daily observation of animals and facilities Appropriate animal evaluation Evaluation of body condition scores (BCS) Adequate pig space A written plan for euthanasia, and euthanasia performed in a timely manner Proper facility maintenance and management Correct use of animal handling tools and handling practices Adequate ventilation • Willful acts of neglect or abuse are unacceptable Thank you!