Lee L. Schulz Dept. of Economics, Iowa State University

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CHALLENGES TO CHANGING ANTIBIOTICS USE IN FOOD ANIMAL PRODUCTION: ECONOMICS, DATA, AND POLICY National Press Club, Washington, D.C. September 6-7, 2018 Impacts of 2017 FDA Antibiotic Use Policies on Producers VFD Implementation Impacted Pig Farmers, Their Veterinarians, and Feed Providers: Perspectives and Lessons Learned Lee L. Schulz Dept. of Economics, Iowa State University This material is based upon research that is supported in part by the Economic Research Service through USDA/ERS Cooperative Agreement # 58-6000-6-0064, entitled Economic Effects of Changing Antibiotic Use Preferences in US Livestock Production.

https://www.card.iastate.edu/ag_policy_review/article/?a=72 No anticipated difficulties establishing and maintaining a VCPR. Complying with the VFD requirements will be moderately burdensome. Independent producers, compared to contract producers, will incur more added costs due to the VFD requirements. (KSU MAB Thesis in progress) Economic Implications of the Veterinary Feed Directive Final Rule on the Swine Industry Brittni Lamoreux Ted Schroeder, Dustin Pendell, Joleen Hadrich, Lee Schulz (Committee)

The revised Veterinary Feed Directive (VFD) final rule went into affect on October 1, 2015, and label changes requested in GFIs 209, 213 took affect on January 1, 2017 ISU swine extension specialists conducted interviews: Independents Contract growers Integrators Veterinarians Nutritionists Fall 2016 (Pre) Preparation Anticipated and experienced changes in business operations Expected and incurred economic impacts Fall 2017 (Post) Actual impacts and adjustments made to comply Impacts on production decisions and management Assess how well the interviews support or refute possible implications of the new antibiotic use guidelines Pre- and post-interviews and existing literature help to develop hypothesized causal relationships, or propositions

Published research data clearly show that the use of antibiotics during all phases of growth benefits the rate and efficiency of body weight gain, reduces mortality and morbidity, reduces subclinical disease, and improves health in pigs. The economic benefits are several-fold greater than the cost of the antibiotic when a cost-effective antibiotic is used for this purpose. Cromwell, G.L. 2002. Why and How Antibiotics are Used in Swine Production. Animal Biotechnology 13(1):7-27 it may be possible for producers to somewhat offset productivity impacts by using improved management techniques Miller, G.Y., X. Liu, P.E. McNamara, and E.J. Bush. 2005. Farm-Level Impacts of Banning Growth-Promoting Antibiotic Use in U.S. Pig Grower/Finisher Operations. Journal of Agribusiness 23(2):147-162. McBride, W.D., N. Key, K.H. Mathews. 2008. Subtherapeutic Antibiotics and Productivity in U.S. Hog Production. Review of Agricultural Economics 30(2):270-288.

More on economic benefits Risk is reduced and profits are increased from use of AGP. Combined impacts of increased average daily gain and decreased variability in live weight increase producer profits by $2.99 per pig marketed. Liu, X. G.Y. Miller, and P.E. McNamara. 2005. Do Antibiotics Reduce Production Risk for U.S. Pork Producers. Journal of Agricultural and Applied Economics 37(3):565-575. Pig productivity improves with use of AGP. Relative to current use, a complete ban would decrease producer profits by $1,400 per 1,020-head barn, and profits increase $1,992 per barn when fed AGP for 61 to 90 days. Miller, G.Y., X. Liu, P.E. McNamara, and E.J. Bush. 2005. Farm-Level Impacts of Banning Growth-Promoting Antibiotic Use in U.S. Pig Grower/Finisher Operations. Journal of Agribusiness 23(2):147-162. Productivity was significantly improved when STA were fed to nursery pigs. Restrictions on feeding STA during the nursery phase would likely impose significant economic costs on U.S. hog producers. McBride, W.D., N. Key, K.H. Mathews. 2008. Subtherapeutic Antibiotics and Productivity in U.S. Hog Production. Review of Agricultural Economics 30(2):270-288.

Hog Operation Business Arrangements in Iowa, 2012 Census of Agriculture and Interviews 2012 Census of Ag No. of Interview Participants Type Operations Sales, % of % of w/ Sales head Operations Sales Pre Post Independent producer 3,550 21,626,145 53.7% 47.0% 26 15 Contract grower (contractee) 3,012 26,236,425 45.5% 46.1% 16 7 Contractor or integrator 54 1,493,278 0.8% 7.0% 3 1 Nutritionist 8 7 Veterinarian 8 6

Anticipated and reported cost impacts of VFD on independent producers Increase costs? If yes, how much? 100% 90% 80% time (labor) record-keeping veterinary visits disease management Pre Post 100% 90% 80% Pre Post 70% 70% 60% 60% 50% 50% 40% 40% 30% 30% 20% 20% 10% 0% 19 9 6 6 1 0 Yes No Unsure 10% 0% 12 8 4 0 3 1 Minimally Significantly Unsure

90% 80% 70% 60% Use of antibiotics to prevent disease as reported by independent producers Pre Post Prevention or treatment? 50% 40% 30% 20% 10% 0% 20 6 6 9 15 9 11 6 11 9 15 6 Yes No Yes No Yes No In-feed In-Water Injectable

100% 90% 80% 70% 60% Use of antibiotics to prevent disease as reported by contract growers Pre Post 50% 40% 30% 20% 10% 0% 16 4 0 3 14 5 2 2 None interviewed reported using injectable antibiotics for prevention purposes; used only in treatment Yes No Yes No Yes No In-feed In-Water Injectable

A couple sentiments we heard: I am concerned with the time needed to complete/file (even electronic) the paper work... it takes time away from working with pigs and people in the barns... that is where I earn my keep for my clients. -- swine veterinarian The new regulations are helping me develop a closer relationship with clients, they are calling me in sooner when problems arise because they now need me to get the antibiotics they need. It is helping solve disease issues earlier and more effectively. -- swine veterinarian I have more communication with company veterinarians and feed mills as a result of changes in requirements. -- swine nutritionist

Implications Practitioners can use this information to perform a benchmark assessment of their individual preparedness and anticipated impacts. Preliminary evidence suggests the industry will go beyond simply complying with the federal guidance for judicious use of antibiotics by collectively implementing more completely and stringently suggested herd-health and production plans. https://www.aasv.org/shap/issues/v25n5/v25n5p247.html (SUBMITTED) Swine veterinary assessment of the impact of new FDA regulations on antibiotic use: A post-enactment survey of swine practitioners Christopher J. Rademacher, Christopher C. Pudenz, and Lee L. Schulz,

How many visits in year do you think is required for a swine producer and veterinarian to have a VCPR? In order to fulfil the VCPR requirement for a producer how many sites do you visit? 60% 50% Pre Post 70% 60% Pre Post 40% 50% 40% 30% 30% 20% 20% 10% 10% 0% 1 2 3 4 5 6 or more I don't know 0% 1 2 or more (but not all) All

What are you charging to write VFDs and prescriptions for new and existing clients? Provision of VFDs 12.5% 87.5% Per VFD for existing clients $27.46 $23.75 Per VFD for new clients Per prescription for existing clients Per prescription for new clients $30.38 $24.19 $19.33 $19.33 Pre Post Provision of Prescriptions 43.2% 56.8% $0 $10 $20 $30 $40 $50 Separate Line Item Fee Part of a Consultation/Service Fee

90% 80% 70% 60% 50% How do you plan to provide VFDs to producers? Pre Post The FDA will require that a record of every VFD be kept for a period of 2 years. How do you plan to meet the additional record keeping requirement? Used a third party service (e.g., GVL), 61.9% No changes, 9.5% Used existing staff, 26.2% Hired new staff, 2.4% 40% 30% Have you used a pre-made VFD form or created your own? 20% 10% 0% Whatever the producer prefers Whatever the feed supplier prefers Third party electronic service (e.g., GVL) Fax E-mail Hard copies Other Used electronic VFD service (e.g., GVL), 75.6% Created VFD form for your clinic, 15.6% Used VFD provided by a drug sponsor, 8.9% Percents may reflect multiple answers

40% 30% 20% What is the average number of head you write a VFD for? Avg = 5,916 Med = 2,600 SD = 9,070 At what level of production do you most often write a VFD for? Group or lot, 21.4% System, 7.1% Site, 28.6% Flow, 42.9% 10% 0% Less than 1,200 1,200-2,399 2,400-4,999 5,000-9,999 10,000-19,999 20,000 or more Number if head

By how much has the VFD affected your business cost? Per year for writing and delivering VFDs Mean (Std. Dev.) Pre Post 8,757 4,051 (12,439) (3,446) Per year for maintaining records for VFDs 2,283 (2,830) 3,561 (7,663) Per year for educating clients and others on the VFD requirements Per year to train staff on VFD requirements Pre Post 4,717 (7,828) 1,840 (2,223) 1,171 (1,673) 787 (826) Per year for other 6,333 (7,522) 11,800 (11,597) $0 $2,500 $5,000 $7,500 $10,000 $12,500 $15,000 $17,500 $20,000 $22,500 $25,000

How much of a burden do you envision (pre) / think (post) complying with the VFD requirements (will have) has had? 70% No burden A little burden A moderate amount of burden Very burdensome 60% 50% 40% 30% 20% 10% 0% Pre Post Pre Post Pre Post Pre Post Veterinarians Feed Suppliers Producers Consulting Nutritionists

100% 90% What have you done to prepare (pre) / educate (post) yourself and staff on VFD requirements? Pre Post 100% 90% What have you done to prepare (pre) / educate (post) swine clients on VFD requriements? Pre Post 80% 80% 70% 70% 60% 60% 50% 40% 30% 20% 10% 0% I have not done any education Attended meetings (including webinars) to learn more about the VFD Read literature on the VFD Create an information bulletin on the VFD to distribute to staff 50% 40% 30% 20% 10% 0% I have not done any education Sponsored inclinic meetings (including webinars) to present information and discuss requirements Met in-person with clients to discuss requirements Sent a notice of requirements to clients in a regular newsletter Created an information bulletin to distribute to clients Percents may reflect multiple answers

What % have your swine producers reduced the use of antibiotics in feed as a result of the VFD? How has the VFD changed the use of antimicrobials in water and injectable in U.S. swine production? 25% 80% 70% Water Injectable 20% 60% 15% 50% 40% 10% 30% 5% 20% 10% 0% 0% 1% to 10% 11% to 20% 21% to 30% 31% to 40% 41% to 50% 51% to 60% 61% to 70% 71% to 80% 81% to 90% 91% to 100% 0% Increased Decreased Not changed I do not know

100% 90% 80% 70% 60% 50% 40% 30% 20% 10% How do you plan to advise your clients (pre) / which changes have your producers made (post) in response to the new antibiotic-use guidelines? Pre Post 0% Modified biosecurity Increased vaccinations Increased non-antibiotic feed additives Modified nutrition Modified housing Modified animal purchase strategies Modified population density Other Percents may reflect multiple answers

What percentage of your producers have made the following changes to growth promotion use? Antibiotics that are already VFD or Rx based: avilamycin, florfenicol, tilmicosin; or Rx - Tylosin. 59% 17% 24% Antibiotics that are not medically important: Ionophores (monensin, lasalocid, narasin (Skycis,etc. ) Bacitracin (BMD, bacitracin zinc) Bambermycins (Flavomycin) Carbadox (Mecadox) Tiamulin (Denagard) Eliminated some uses of antibiotics for growth promotion Moved to non-medically important growth promotants Eliminated all uses of antibiotics for growth promotion Antibiotics that now require a VFD: Chlortetracycline (CTC) CTC + Tiamulin (CTC + Denagard) lincomycin (Lincomix) Oxytetracycline (OTC) OTC + neomycin (neo-terramycin) tylosin (tylan) virginiamycin (stafac) Other drugs (that are not antibiotics), including: Anthelmentics: Coumaphos, Fenbendazole, Ivermectin Beta agonists: Ractopamine, Zilpaterol Coccidiostats: Clopidol, Decoquinate, Diclazuril

%, Significant ADG response Evaluation of AGP alternative trials on growth performance (ADG) responses 100 90 80 70 60 50 40 30 20 10 0 2.2 2.2 0.0 0.0 2.7 1.1 1.0 0.6 39 1.5 58 11 14 0.0 87 4.9 81 34 1.5 65 22 25 2.4 1.1 9 16.7 73 72 73 Be very wary of antibiotic alternatives without rigorous scientific testing 43 0.6 56 11.1 44 11.1 33 1.4 29 3.4 66 (0) (-) (+) nr Schweer, W.P., J.F. Patience, K. Schartz, D. Linhares, C. Rademacher, H.K. Allen, C.L. Loving, A. Ramirez, and N.K. Gabler. A Review of and Evaluation of Antibiotiv Alternatives in the Literature. J. Anim. Sci Vol. 95, Suppl. 2/J. Dairy Sci. Vol. 100, Suppl. 1

In your opinion, has the VFD, improved, harmed, or not changed overall animal health in U.S. swine? Not changed, 56% Harmed, 17% Improved, 22% I do not know, 5%

VFD in Beef Cattle Sector Ted Schroeder Kansas State University Objectives Determine VFD Effects on producers (cow-calf, stockers, feedlots) Determine how beef cattle consulting veterinarians adjust business practices and client relations to address VFD requirements Procedure Interviewed 15 producers (cow-calf, stockers, feedlots): Pre-VFD: July 2016 (in-person NCBA summer meetings) Post-VFD: August 2017 (telephone follow-up same group) Surveyed consulting beef veterinarians (138 responses to listserv survey) September 2016

Findings Beef Cattle Producer Interviews Producers across all sectors not concerned about VFD either pre- or post-enactment were uncertain about costs in prebut said they were minimal in post & required a little time to set up, but easy to keep current once set up All had veterinary client relationships in place Noted post they had to make sure they had prescriptions in place but that it simply required being more organized None found managing VFD prescriptions or documentation requirements of significant cost

Findings Beef Cattle Producer Interviews Common producer sentiment we heard: The ultimate goal here is to make our U.S. beef the safest it can be for our consumers. If this program has helped in this area, it is a win-win for everyone. -Texas cow-calf producer

Findings Beef Cattle Consulting Veterinarian Survey https://www.beefcattleinstitute.org/beef-consulting-veterinarian-feed-directive-preparedness-survey/

Findings Beef Cattle Consulting Veterinarian Survey

Further Research o Changes in farm financial records and key performance indicators is another possible way to examine impact of new antibiotic-use guidelines. o Are antibiotic free premiums driven more by demand or supply? Has this changed post VFD enactment?