Certification Training

1. Certification Training

2. Pork Quality Assurance (PQA) Plus® • Implementing PQA Plus® will help a producer maintain or create: • A high quality pork product for the consumer from a food safety standpoint • A safe and productive environment for the swine, you and your employees • Increase profitability as an efficient and responsible producer

3. We Care: • Ethical Principles: • 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

4. 10 Good Production Practices (GPPs)

5. GPP # 1 Use an Appropriate Veterinary/Client/Patient Relationship (VCPR) as the Basis for Medication Decision Making

6. Objectives for GPP#1 • Describe how a veterinarian is vital to the medication decision-making process • Identify the three categories of approved drug distribution • Define extra-label drug use (ELDU) • Distinguish examples of legal and illegal ELDU • Define drug compounding and who can compound drugs • List examples of residue avoidance practices

7. Veterinarian/Client/Patient Relationship (VCPR) • The veterinarian: • Assumes the role of making medical judgments for animals and owner • Has sufficient access and knowledge of the herd/animals • Is responsible for providing continued care • The owner/client/caretaker: • Follows the veterinarian’s instructions • Provides access and documentation

8. Veterinarian/Client/Patient Relationship (VCPR) • Key veterinary activities for a VCPR: • Development of herd health plan to include appropriate vaccination and treatment recommendations • Direct use of pharmaceutical products • Extra-Label Drug Use • Appropriate vaccination use • Participate in record keeping • Provide information and support in the case of an adverse event • Be available to address herd health changes

9. Extra-label Drug Use - AMDUCA • Federal Animal Medicinal Drug Use Clarification Act (AMDUCA) of 1994 • 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 treated • Does not include medicated feeds, including VFD feeds

10. Extra-label Drug Use - Situations Examples of extra-label use include: • Increasing the dosage • Changing the frequency or 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

11. Extra-label Drug Use – Keys to Remember What is required of producers for extra-label use of medications? • An established VCPR for the herd must exist • Records showing the instructions from the veterinarian directing the extra-label drug use • Documentation in the treatment records showing the application of the veterinarian’s instructions

12. Distribution and Use of Approved Animal Drugs • Animal Drug Distribution Methods • Over-The-Counter (OTC) • Prescription (Rx) • Veterinary Feed Directive (VFD)

13. Issues with Compounding Drugs • Compounding is the mixing of two or more FDA-approved drugs • Withdrawal times are difficult to estimate • AMDUCA also allows a veterinarian with a VCPR to compound drugs for the client • Veterinarian assumes responsibility for safety, efficacy and withdrawal time of compounded drug • Producers and distributers of animal health product may NOT compound drugs

14. Residue Avoidance and Testing Residue Avoidance – follow all label instructions on withdrawal periods and dosage. If the residue status of an animal or group is in doubt, conduct a residue test. This may be due to: • ID tags or markings missing • Accidental animal access to medicated feed • Lost or damaged records Be prepared with a service provider’s information and emergency response plan

15. “Local News at 5” – Interview Activity Answer the questions: What is extra-label drug use? What is required for legal extra-label use? Why is the veterinarian vital in making extra-label use decisions?

16. Sample Test Items for GPP#1 • _____ medications can be purchased by anyone from places such as farm supply stores, animal health salespersons, catalogs and veterinary clinics. • A. Over-the-Counter • B. Prescription • C. Extra-label • D. Veterinary Feed Directive • Using a veterinarian as the basis for medication decision making is part of a(n) _______. • A. FIFRA • B. AMDUCA • C. VCPR • D. USCFR

17. GPP #2 Establish and Implement an Efficient and Effective Health Management Plan

18. Objectives for GPP#2 • Identify the four components of a health management plan • Identify the value of a VCPR • Summarize the purpose of a herd health plan • Define biosecurity • Using an example, examine both external and internal biosecurity measures • Recognize effective measures of rodent and pest control • Identify the plans that should be developed for foreign animal disease and agroterrorism awareness, reporting, and prevention

19. Health Management Plan • Four components of a health management plan • Development of and maintenance of a Vet-Client Patient Relationship (VCPR) • Development of an individualized herd health plan • Development of a herd-level biosecurity plan • Foreign animal disease and agro-terrorism prevention

20. 1. Development of and Maintenance of a Vet/Client/Patient Relationship (VCPR) • Benefits to the producer • Active involvement in herd health • Provide a professional outside view • Opportunity to plan and make informed management adjustments.

21. 2. Development of an Individualized Herd Health Plan • Two major purposes • Address potential and current health challenges • Help prevent diseases from entering into your herd • Plans may: • Include periodic health checks • Be tailored for a herd and/or specific diseases of interest

22. 3. Development of a Herd-level Biosecurity Plan Biosecurity is a management measure used to prevent the transmission of diseases and disease agents on the farm. • External Biosecurity: keeping disease out of the herd • Internal Biosecurity: preventing disease movement within the herd • Rodent and Pest Control: preventing compromise of external and internal biosecurity measures

23. 4. Foreign Animal Disease (FAD) & Agro-terrorism Awareness, Reporting, and Prevention • FADs are a very serious concern for the entire industry and food supply • Contact your herd veterinarian if you have questions or concerns • Know and follow the plans your operation should have in place to prevent and report FADs

24. “Call and Answer” Review What are the 4 components of a health management plan? Why is a VCPR valuable? What is the difference between external and internal biosecurity? Give an example of each. What is FAD and why is it an important issue? What are the four elements of rodent and pest control? What is the benefit of a herd health plan?

25. Sample Test Items for GPP#2 • True or False? Through a VCPR, knowing the disease status of a herd can help your veterinarian create a specific health plan to help minimize the impact of a disease. • True • False • A herd health plan is designed to address potential and current health challenges and to help prevent _________ from entering into your herd. • A. low performers • B. flies • C. diseases • D. stress

26. GPP #3 Use Antibiotics Responsibly

27. Objectives of GPP#3 • Define the three purposes of antibiotic use in pork production. • Identify the five principles for responsible antibiotic use. • Recognize the components of each element.

28. Responsible Use of Antibiotics The basis for using antibiotics responsibly during pork production involves evaluating their use to protect animal health, optimize effectiveness and minimize the risk of developing antibiotic resistance, thereby protecting public health.

29. Antibiotic Purposes • Three antibiotic purposes: • Treatment of Illness • Control or Prevention of Disease • Improve Nutritional Efficiency

30. Principles for Antibiotic Use Take appropriate steps to decrease the need for the application of antibiotics. Principle I. Assess the advantages and disadvantages of all uses of antibiotics. Principle II. Use antibiotics only when they provide measurable benefits. Principle III. Fully implement the management practices described for responsible use of animal health products into daily operations. Principle IV. Have a working veterinarian/client/patient relationship and follow the responsible antibiotic use guidelines. Principle V.

31. Take appropriate steps to decrease the need for the application of antibiotics. Principle I. Principle 1 • Preventive strategies can help decrease the need for antibiotics • Biosecurity programs • Appropriate animal husbandry • Hygiene • Routine health monitoring • Vaccination programs

32. Assess the advantages and disadvantages of all uses of antibiotics. Principle II. Principle 2 • Other management options should be considered • Treat only as long as needed • Review the need for continuing preventative antibiotic therapy • Consider other impacts of using antibiotics

33. Use antibiotics only when they provide measurable benefits. Principle III. Principle 3 – • Assess measureable benefits of all uses of antibiotics • Assessing measureable benefits of use for nutritional efficiency should be based on scientific data

34. Fully implement the management practices described for responsible use of animal health products into daily operations. Principle IV. Principle IV - Compliance • Complete PQA Plus® and fully implement GPPs • Follow FDA Compliance Policy Guide 615.200 • Provides regulatory guidance for the development of cases resulting from the use of animal drugs contrary to label directions (“off label use") by non- veterinarians in food-producing animals • Also provides guidance on measures that can be taken by non-veterinarians to ensure proper drug use and avoid illegal residues

35. Have a working veterinarian/client/patient relationship and follow the responsible antibiotic use guidelines. Principle V. Principle V • Guideline A. Use professional veterinary input as the basis for all antibiotic decision-making. • Guideline B. Antibiotics should be used for treatment only when there is an appropriate clinical diagnosis. • Guideline C. Limit antibiotic treatment to ill or at-risk animals, treating the fewest animals indicated. • Guideline D. 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. • Guideline E. Mixing together injectable or water medications, including antibiotics, by producers is illegal. • Guideline F: Minimize environmental exposure through proper handling and disposal of all animal health products, including antibiotics.

36. “Antibiotics Scenarios” Review Review the scenario on each card and identify which principle best applies to the situation. As a group be ready to discuss your response.

37. Sample Test Items for GPP#3 • The basis for using antibiotics responsibly during pork production involves evaluating their use to protect animal health, optimize effectiveness, and: • A. Minimize the risk of developing antibiotic resistance • B. Elimination of all bacteria on the farm • C. Decrease the effectiveness of future antibiotic use • D. Improve meat color and firmness • True or False? The following is a principle for antibiotic use: Use antibiotics as often as possible to ensure maximum benefit. • A. True • B. False

38. GPP #4 Properly Store and Administer Animal Health Products

39. Objectives of GPP#4 • Identify the responsibilities of properly administering products • Determine the key components of drug labels and why this information is vital • Identify how to properly maintain drug inventory and usage records • Identify the three methods of administering medications • Distinguish between the five methods of injectable medication • Discuss the key elements for a needle standard operating procedure (SOP)

40. Responsibilities of Properly Administering Animal Health Products • Read, understand and follow label directions when giving any medication. • Devise a medication record and animal or group ID system that enables all caretakers to know the medication status of animals prepared for harvest. • Identify all treated animals. • Keep records for making judgments about marketing animals that have been treated. • Use medication records to determine that withdrawal times have been completed.

41. Parts of a Drug Label • Trade name • Active ingredient • Indications • Dosage and directions for use • Precautions • Warnings • Withdrawal times • Manufacturer’s lot number • Expiration date

42. Drug Inventory and Storage • Keep and maintain a drug inventory. • Follow drug storage instruction • Avoid the practice of withdrawing an injectable medication from the original glass vial and storing it in a syringe for later use

43. Administering Medication • Orally- Given through the mouth, and can be mixed with water and/or feed • Topically - Application to skin • Injection – Five possible options

44. Five Methods of Injectable Administration • In the muscle (intramuscular – IM) • Under the skin (subcutaneous – SQ) • In the abdominal cavity (intraperitoneal – IP) • In the vein (intravenous – IV) • In the nasal passages (intranasal – IN)

45. Standard Operating Procedure (SOP) for Needle Breakage • Needle breakage is an important issue for the industry. • You should have an SOP addressing this issue. • Considerations: • Broken needle prevention plan • Identification of animals that are at risk or carrying a broken needle • Communication with your packer • Disposal of sharps

46. “Be the Trainer” Exercise • Once assigned a group and SOP consideration, read the practices in the GPP handbook and be ready to share three key points and an example with the other groups. • Broken needle prevention plan • Identification of animals that are at risk or carrying a broken needle • Communications with your packer • Disposal of sharps

47. Sample Test Items for GPP#4 • Where can the producer readily locate precautions and warnings related to antibiotic withdrawal times? • A. Pork Safety Handbook • B. All of the responses are correct • C. The sow card • D. The product label • _____ medications are those that are given through the mouth. • A. Injectable • B. Topical • C. Oral • D. Prescription

48. GPP #5 Following Proper Feed Processing Protocols

49. Objectives of GPP#5 • Identify the goals of feed manufacturing • Differentiate between the cGMP guidelines for medicated and non-medicated feeds • Explain the special consideration regarding the feeding of ruminant-derived products • Using an example, explain the considerations when calculating the amount of medicated feed to add to the mixer

50. Goals of Feed Manufacturing • Meets specifications for nutritional composition • Meets the desired medication level, if appropriate • Is free of contaminants, or contaminants are below established tolerances or action levels