Mrs. Betsy Flores - Milk and Dairy Beef Residues: Incidence & Communications

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Milk and Dairy Beef Residues: Incidence & Communications - Mrs. Betsy Flores, Senior Director, Animal Health & Welfare, National Milk Producers Federation, from the 2013 NIAA Merging Values and …

Milk and Dairy Beef Residues: Incidence & Communications - Mrs. Betsy Flores, Senior Director, Animal Health & Welfare, National Milk Producers Federation, from the 2013 NIAA Merging Values and Technology conference, April 15-17, 2013, Louisville, KY, USA.

More presentations at http://www.trufflemedia.com/agmedia/conference/2013-niaa-merging-values-and-technology

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  • To understand the FDA regulations when it comes to antibiotics in milk it is important to understand the difference between a tolerance level and a safe level.A tolerance is established in the Code of Federal Regulations (21 CFR 556). The tolerance level is zero when no tolerance is specified. The tolerance is the legal level.A Safe Level is established by FDA-CFSAN Milk safety branch (MI-05-5) to avoid “constantly chasing zero” as testing became more sensitive. Not all drugs have safe levels.
  • The recently published National Milk Drug Residue Database Fiscal Year 2011 Annual Report demonstrates the dairy industry’s commitment to drug residue issues in milk. In 2011, 0.021% of all bulk milk pick-up tankers tested positive for a drug residue. This is a decline of nearly 70% in the last decade. There are 2012 numbers came out and there has been another drop in the bulk milk tanker testing.
  • In a culture where everyone is focused on antibiotics and this OIG report is another piece of the puzzle.
  • In the next two slides I will detail the residues which are most commonly found in dairy cull cows. This data was originally presented by FDA in a presentation in April 2012 in Albuquerque. Five drugs account for over 85% of all tissue residue violations observed in dairy cull cows: ceftiofur, flunixin, gentamicin, penicillin, and sulfdimethoxine. Nineteen other drugs account for the remaining 15% of violations.A number of the drugs which show up as tissue residues in dairy cull cows are prohibited from use in lactating cattle, such as sulfamethazine.Each year, nearly 3 million adult dairy cows are slaughtered for beef. Of that amount, a very small percentage actually test positive for a residue. Over the past few years, USDA has made several changes in its residue screening program including implementation of the KIST test which is more sensitive than earlier tests and increasing the number of tests conduct on dairy cull cows. In spite of these changes, the number of tissue residues in dairy cull cows have decreased by 25% since 2007 (20011 numbers are not yet available). Please note that the total number of dairy cull cows with tissue residue violations is lower than the overall tissue residue violations listed in these tables due to several factors including multiple tissues in the same animal found with a drug residue (such as kidney and liver in the same animal) or multiple drugs found in the same animal (such as flunixin and penicillin).
  • In the next two slides I will detail the residues which are most commonly found in dairy cull cows. This data was originally presented by FDA in a presentation in April 2012 in Albuquerque. Five drugs account for over 85% of all tissue residue violations observed in dairy cull cows: ceftiofur, flunixin, gentamicin, penicillin, and sulfdimethoxine. Nineteen other drugs account for the remaining 15% of violations.A number of the drugs which show up as tissue residues in dairy cull cows are prohibited from use in lactating cattle, such as sulfamethazine.Each year, nearly 3 million adult dairy cows are slaughtered for beef. Of that amount, a very small percentage actually test positive for a residue. Over the past few years, USDA has made several changes in its residue screening program including implementation of the KIST test which is more sensitive than earlier tests and increasing the number of tests conduct on dairy cull cows. In spite of these changes, the number of tissue residues in dairy cull cows have decreased by 25% since 2007 (20011 numbers are not yet available). Please note that the total number of dairy cull cows with tissue residue violations is lower than the overall tissue residue violations listed in these tables due to several factors including multiple tissues in the same animal found with a drug residue (such as kidney and liver in the same animal) or multiple drugs found in the same animal (such as flunixin and penicillin).
  • This slide shows the top ten drug violations in dairy cull cows.
  • The next two slides show the drugs that FDA is testing for during the survey.
  • This is the timeline since the FDA survey was first announced. The final report could be out in the next month or two.
  • One resource for dairy producers that is updated yearly is the Milk and Dairy Beef Residue Avoidance Manual. This is found online at www.nationaldairyfarm.com.
  • We will have tailored communication efforts to reach the following audiences:Producers – to put the results in context and use this as a “teachable moment” on residue avoidanceCo-ops and processors – to explain how the industry groups are liaising with the government and media on their behalf; and signal any changes that are potentially warranted by the resultsBovine veterinarians and greater veterinary community – to support their efforts to ramp up education with producers on residue avoidanceDairy producer trade orgs – to provide resources that have been developed by NMPF and the other national groups including talking points for media and producersHealth professional and marketing partners (ie Kroger, Dominos) – to provide science-based talking points and third-party information that health professionals and the supply chain can rely on to reassure consumersConsumers (via media and social media) – to provide reassurance that milk is just as safe as it’s always been
  • Let’s focus on consumers for the next few minutes.In order to hone our consumer messages, DMI conducted an in-depth exploration of the consumer mindset around dairy and antibiotics through both quantitative and qualitative research. I’d like to share our key insights. Checkoff funded the research.
  • On a day-to-day basis, the vast majority of the public doesn’t think about antibiotic residues in our milk supply. This shows data from our ongoing quantitative survey tool, the Issue Tracker, based on an introductory, open-ended question, “What comes to mind when you think about milk?” As you can see the most popular answer is a health deliverable, such as milk as a vehicle for calcium and vitamin D or “milk builds strong bones” or the value of milk in my kid’s diet as a nutrient source.Less than half of 1 percent of respondents mention antibiotics, and this is a representative sample of American adults.This is the underpinning for our communications approach. If we return to this level of awareness fairly quickly after FDA’s results come out, we’ll consider all the behind-the-scenes efforts a success.This is unaided survey and if aided by mentioning antibiotics they express conerns.
  • A quantitative, Internet-based survey can only get you so far. When it comes to testing messages to understand how best to communicate to the public about a complicated, technical topic, a much better methodology is the Focus Group.We conducted 9 focus groups in Dec. 2012 in three cities – Denver, Washington DC (Bethesda) and Chicago (Schaumburg). Our objectives were:Explore consumer familiarity with antibiotics in milk topicUnderstand reaction to current messaging Gauge reaction to alternate messaging developed to address potential outcomes of FDA workNot intended to be a representative sample of the US population.
  • Before we get into the findings, I’ll share with you the current set of industry messages that are used, on an if-asked basis, to explain how antibiotics are used on dairy farms and how residues are kept out of the milk supply.[PARAPHRASE MESSAGES ON SLIDE]
  • So, how did our messages resonate with consumers?Basically, consumers are a blank slate when it comes to this topic. They don’t know how, when, why or how often antibiotics are used on dairy farms. Those who expressed concern about “industrial farming” and such assumed that antibiotics were administered in the feed on a daily basis. So even for the cynical consumers, a simple explanation of the typical uses of antibiotics and the systems in place to prevent residues in the milk supply, per the PMO, was helpful.IF TIME ALLOWS: Specific points that were particularly well received were [ walk through each box]
  • For this project, we mocked up news articles that showed alarmist coverage of results the FDA deemed unacceptable, in order to get an understanding of how to communicate about a worst-case scenario to the public.Keep in mind, this was all FICTIONAL and we purposefully created a scenario that would be cause for concern. We don’t think this will be the case but want to prepare just in case. (worst case scenario)Not surprisingly, consumers had a strong, negative reaction. They looked to FDA and the industry for a serious and aggressive response including:Assurance that third party oversight will demand change and adherence to new protocolsImmediate consultation with experts – vets, public healthCommitment by dairy industry to do the right thingWebsite for further information (3rd party preferred)(Ask put out statements on social media, on websites)It was clear in watching the groups’ reactions that if they weren’t satisfied by the tone and extent of the steps that FDA and industry pledged to take, they would abandon cow’s milk for the time being, or at least switch to organic.
  • Switching gears a bit, we all know consumers are skeptical of anything industry groups or for-profit companies say, regardless of our intent to do the right thing. So we need to rely on third parties to carry the water for us. We gauged consumer reaction to different potential spokespeople and groups. Of course doctors and public health professionals are the most trusted in terms of reassuring people the milk is safe for their families. Veterinarians, individual dairy farmers and FDA are also credible in this regard. (NOTE: Data on this slide is from quantitative research, but was corroborated during the focus groups)As part of our communication plan, we have prepped a variety of spokespeople and experts to be on-call for media inquiries:NMPF – industry voiceAVMA, AABP and their member veterinarians – veterinary medicine and animal health perspectiveDairy Farmer Spokesperson Network (DFSN) – producer commitment to milk safety & qualityDairy Research Center food safety experts – PMO regs and QA practices that ensure residues are kept out of the food chain (university - more product focused)Health & Wellness Professionals – public health risk is remote. NOTE: Nat’l Dairy Council has ongoing relationships and initial commitment from spokespeople representing these orgs to support milk:American Academy of Pediatrics (AAP)Academy of Nutrition & Dietetics (AND, formerly American Dietetic Association)School Nutrition Assoc (SNA)International Food Information Council (IFIC)
  • For informational purposes, I’m going to share the DRAFT messaging we have penciled in to address the results. Since we don’t know the results, these by their very nature lack specifics and need to be considered preliminary.[PARAPHRASE MESSAGES ON SLIDE, emphasize that we’re not putting words in FDA mouth]This set of messages assumes FDA found no significant difference between the tissue violator group and control group. If the incidence rate is higher among the residue violators , we’re actually in a stronger position from a consumer communications standpoint because it’s more of a “bad actor” scenario – we can readily show that the issue is contained to a subset of a small, previously identified group of producers.In this scenario, our messaging will say that the results indicate a very small segment of dairy farms are operating in a way that fails to meet the high standards consumers have come to expect from the dairy industry. And in this scenario – our next steps are much more clear and we’ll be able to put a stake in the ground right away with a pledge to redouble education and outreach efforts with this group.
  • The communications group has drafted a set of materials that will be finalized and shared with stakeholders just as soon as we have the opportunity to review and assess the FDA report. We will initially be in reactive communications mode, but we will change that posture quickly based on our monitoring of the media/social media environment.If you’d like to make sure you receive the materials, let me know.In the meantime, I wanted to highlight a few existing resources that are available to you to assist with any inquiries/conversations you have the opportunity to engage in between now and then.
  • Dairy Farming Today.org provides a broad picture of dairy farming for the consumer audience. In the video featured here, PA vet Dr. Bridget Griffin, DVM / Lancaster Veterinary Associates / Lancaster, PA gives an overview of a typical herd health program and how antibiotics fit into it.
  • National Dairy Council.org focuses on nutrition and health information, but I wanted to call out one piece that is relevant to the topic at hand. The Dairy Council Digest on food safety is basically a Cliff’s Notes of the PMO and Grade A programs, so it’s useful if you need to provide information to a more technical/sophisticated individual.
  • DairyGood.org is the hub of the dairy industry’s Consumer Confidence efforts. It brings-to-life how producers and the rest of the dairy supply chain work together to provide healthy products, protect the environment and make positive contributions to local communities. In this blog post here, Illinois dairy farmer Linnea Kooistra talks about her dedication to the comfort and health of the cows and her commitment to the responseible use of antibiotics.

Transcript

  • 1. Milk and Dairy Beef Residues:Incidence & CommunicationsDairy Response PlanningBetsy Flores, Nat’l Milk Producers FederationApril 16, 2013
  • 2. What We’ll Cover• Antibiotics and milk production• FDA drug residue sampling program• Communications goals and plan• Consumer research viewpoint• Messaging
  • 3. Drug Residues in Milkand Cull Dairy Cows
  • 4. Milk Residue Regulatory Levels• Tolerance – established in the Code ofFederal Regulations (21 CFR 556)– Zero when no tolerance is specified• Safe Level – established by FDA-CFSAN Milk safety branch (MI-05-5)
  • 5. Milk Drug Residue Screening“Industry shall screen all bulk milkpickup tankers, regardless of finaluse, for Beta lactam drug residues”• FDA Commissioner can require additionalscreening if a potential problem existsGrade “A” Pasteurized Milk Ordinance 2011 Revision
  • 6. Other Drug Residue Screening• PMO related– Example: on-farm bulk tank testing when aproducer is concerned about a drug residue• Contractual– Example: random sulfa-drug testingrecently required by a major fluid processor• Export Certification– Example: tetracycline testing for exports toRussia
  • 7. Percent of Bulk Milk Tankers Positive forAntibiotic ResiduesData from National Milk Drug Residue Data Base
  • 8. Drug Residues inCull Cows
  • 9. USDA OIG Residue Report• “Finding 2: FSIS Needs toStrengthen Oversight of theNational Residue Program,Especially at PlantsSlaughtering Dairy Cowsand Bob Veal”Source: USDA OIG Audit Report 24601-08-KC
  • 10. Reasons for Tissue ResiduesTop causes identified in FDAinvestigations:– Poor identification of cattle– Treatment not recorded as awritten record– Not following the manufactureror veterinarian prescribedlabel directions for theappropriate withdrawal period– Not following veterinarian’srecommendation when usingany drugFDA Investigation Question:“Did the producer have aValid Veterinary Client PatientRelationship?”Yes30%No70%
  • 11. DRUG 2007 2008 2009 2010 2011 Total PercentPenicillin 413 304 267 210 180 1374 34.48%Flunixin 262 233 182 167 69 913 22.91%Sulfadimethoxine 159 135 114 124 54 586 14.71%Ceftiofur * 71 116 70 44 301 7.55%Gentamicin 58 50 66 55 28 257 6.45%Sulfamethazine 33 22 37 28 18 138 3.46%Oxytetracycline 21 32 9 21 9 92 2.31%Neomycin 23 21 15 19 13 91 2.28%Tilmicosin 14 4 22 33 14 87 2.18%Ampicillin 13 8 14 10 9 54 1.36%Tetracycline 7 15 6 15 4 47 1.18%Dihydrostreptomycin 8 3 1 1 6 19 0.48%Phenylbutazone 4 3 2 0 0 9 0.23%
  • 12. DRUG 2007 2008 2009 2010 2011 Total PercentTylosin 1 1 0 1 1 4 0.10%Sulfadoxene 0 0 0 0 3 3 0.08%Tulathromycin 0 0 2 0 0 2 0.05%Amikacin 0 1 0 0 0 1 0.03%Fenbendazole 0 0 1 0 0 1 0.03%Florfenicol 0 0 0 1 0 1 0.03%Furazolidone 0 0 1 0 0 1 0.03%Lincomycin 1 0 0 0 0 1 0.03%Paromomycin 0 0 0 0 1 1 0.03%Sulfadiazine 0 0 0 1 0 1 0.03%Sulfathiazole 0 0 0 1 0 1 0.03%Total 1017 903 855 757 453 3985 100.00%* Prior to July 28, 2008, USDA could not quantify Ceftiofur.
  • 13. TISSUE RESIDUES in Dairy Cull Cows(FDA Data, 2005-2011)55%
  • 14. FDA CVM DrugResidue Survey
  • 15. FDA CVM Drug Residue Survey• Hypothesis: The same practices associated withtissue residues in culled dairy cattle may alsoresult in drug residues in milk.• Through voluntary cooperation of the dairyindustry FDA collected– 900 samples from dairy farms with a cull dairy cow tissueresidue violation in the past 3-4 years– 900 samples from other dairy farms
  • 16. FDA Residue SurveyVeterinary Drug Tolerance orSafe Level (PPB)NotesPenicillin G 5 34.5% Tissue ViolationsFlunixin 2 22.9% Tissue ViolationsSulfadimethoxine 10 14.7% Tissue ViolationsCephaparin 20 7.6% Tissue ViolationsGentamicin 30 6.5% Tissue ViolationsSulfamethazine 10 3.5% Tissue ViolationsProhibited Extra Label UseOxytetracycline 300 2.3% Tissue ViolationsNeomycin 150 2.3% Tissue ViolationsTilmicosin NA 2.2% Tissue ViolationsLimit of Test DetectionAmpicillin 10 1.4% Tissue Violations
  • 17. FDA Residue SurveyVeterinary Drug Tolerance orSafe Level (PPB)NotesChloramphenicol NA Prohibited UseLimit of Test DetectionSulfachloropyridazine 10 Prohibited Extra Label UseSulfadiazine 10 Prohibited Extra Label UseSulfamerazine 10 Prohibited Extra Label UseSulfaquinoxaline 10 Prohibited Extra Label UseSulfathiazole 10 Prohibited Extra Label UseBacitracin 500Chlortetracycline 300Tetracycline 300Cipro-/Enro-Floxacin NA Limit of Test Detection
  • 18. FDA Residue SurveyVeterinary Drug Tolerance orSafe Level (PPB)NotesCloxacillin 10Doxycycline NA Limit of Test DetectionErythromycin 50Florfenicol NA Limit of Test DetectionSarafloxacin NA Limit of Test DetectionThiabendazole 50Tripelennamine 20Tulathromycin NA Limit of Test DetectionTylosin 50Virginiamycin NA Limit of Test Detection
  • 19. FDA CVM Survey Timeline• Dec 2010 – Announcement of survey• Winter-Spring 2011 – FDA Stakeholder meetings• Summer-Fall 2011 – FDA refines survey protocol• Dec 2011 – FDA finalizes survey protocol• Jan 2012 – Milk collection begins• Feb 2012 – Lab analysis begins• Nov 2012 – Milk collection ends• Dec 2012 – Lab analysis ends• Q1 2013 – FDA drafting final report
  • 20. Likely FDA CVM Survey OutcomesHypothesis: The same practices associatedwith tissue residues in culled dairy cattle mayalso result in drug residues in milk.• Residues found, no difference between groups• Higher residues found for farms with a previoustissue residue violation in the past 3-4 years
  • 21. Producer Resources
  • 22. Industry Outreach and Education2013 Milk andDairy Beef ResidueAvoidance Manual
  • 23. ConsumerCommunicationPlan
  • 24. Communication GoalMaintain consumerconfidence in milksafety and quality
  • 25. Issues Management ApproachRELEASE DAY: Response-modecommunication only– Position industry as cooperative with regulatorsand committed to continuous improvement– Reinforce milk safety and qualityLONGER TERM: Align industry around actionsteps that drive continuous improvement
  • 26. Stakeholders• Producers• Co-ops and processors• Bovine veterinarians and greater veterinarycommunity• Dairy producer trade orgs• Health professional and marketing partners• Consumers (via media and social media)
  • 27. Consumer ConfidenceSpecial Report: Antibiotics and Milk ProductionConsumer Research Funded by the National Dairy Checkoff
  • 28. Top-of-Mind Mentions of Antibiotics are TinyNegatives related to dairyissues – animalcare, environment, school…are less top-of-mind24%14%6% 6% 6%4% 3% 2% 2%0.1% 0.1% 0.04%Health Deliverable Ads Non-Dairy AlternativesPricing Enjoyment Safety Health UncertaintiesIndustry Environment Animal Care School Related AntibioticsWhat isTop-of-Mind RecallRelated to Milk?Source: Dairy Tracker Q3 201228
  • 29. Message Testing: Focus Groups29SituationMilk currently tested forfour to six commonantibioticsFDA survey under way totest for additionalantibiotic residues todetermine if there is anissue in milk supplyObjectiveExplore consumerfamiliarity with antibioticsin milk topicUnderstand reaction tocurrent messaging on topicGauge reaction to alternatemessaging developed toaddress potentialoutcomes of FDA workMethodQualitative researchNine focus groups (66 adultconsumers)- regular milk buyers- organic buyers- consumers strugglingfinancially- consumers who self-define as influencers inhealth & wellnessThree cities:Chicago, Bethesda, Denver
  • 30. Evergreen Messages• Strict FDA and state regulations govern the use of all FDA-approvedmedications used to treat dairy cows on the farm and require dairy foodcompanies to test milk for commonly-used antibiotics. This oversight isdesigned to protect public health and ensure consumers are getting safeand wholesome dairy products.• On the farm, dairy farmers work with veterinarians to keep their cowshealthy. Sometimes a cow needs antibiotics when she is ill, just as peopleoften do.• The FDA requires that all milk – organic and regular – be tested forcommonly-used antibiotics when it arrives at the dairy plant. Every singlebatch (truckload) is tested. Any milk that tests positive is rejected by theplant.• Dairy farmers have strong incentives to keep their milk free of antibiotics.In the rare instance of a positive test at the plant, the milk is rejected andthe farmer is financially liable for the entire batch. After more than oneviolation, state regulators apply additional penalties, such as a fine and/orrevoking the farmer’s license to sell milk.
  • 31. Current Antibiotics “Evergreen” MessagingPositive Messaging Elements31Dairy Farmers are Accountable• Strong incentives to keep milk freeof antibiotics• Farmer is financially liable• Fines and revoking farmer license• Farmer penalty after more than oneviolationConsumers Prefer “No Antibiotics” butMost Will Accept Low Incidence• Example: 5 parts per billion• Mention of “decline” in number ofpositive tests over time well-receivedThird Party Oversight• Comprehensive process in place toensure safety• State regulators/inspections offarms• Strict quality control procedures• FDA regulations• FDA approved medicinesProcedures• Treat sick animals• Milk from cows treated withantibiotics is separated• Would like assurance that milk isdestroyed, not used elsewhereSource: T. Gacek Qualitative Research Dec 2012
  • 32. More serious, fearful consumer reaction•Viewed as a breach of trust•Warning/danger sign•Consumers say they would rethink their milk useConsumers expect a serious and aggressiveindustry response•Assurance that third party oversight will demand changeand adherence to new protocols•Immediate consulting with experts – vets, public health•Commitment by dairy industry to do the right thing•Website for further information (3rd party preferred)32Fictitious Scenario: FDA Finds UnacceptableLevels of Antibiotic Residue in MilkSource: T. Gacek Qualitative Research Dec 2012
  • 33. Messengers Who Can Be EffectiveSpokespeople on Antibiotic Topic33Dairy FarmerNear universalagreement amongadults that dairyfarmers produce a safeproductHonestTrustworthyHard-workingDoing what’s rightVeterinarians,Public HealthExperts70% of adults trust theAm Veterinary MedAssoc on animal carematters*Qualified, respectedoutsiders to serve asconsultantFDA79% of adults trust FDAin matters of foodsafetyMost view as powerfuland respectedgovernment office thathas public’s interest inmind* (17% not familiar)Source: T. Gacek Qualitative Research Dec 2012, DMI Dairy Monitor 2010
  • 34. Messaging
  • 35. Response Messages:Residues found, no difference between tissue violatorgroup and control group• [ACKNOWLEDGE SPECIFIC FINDINGS.] The U.S. dairyindustry is committed to maintaining the highest safety andquality standards. To that end, we are immediately consultingwith regulators as well as veterinary and public health expertsto determine how best to address FDA’s findings.• Dairy farmers, veterinarians and dairy food companies all havea stake in protecting the integrity of the milk supply and wewill work together to implement the recommended next steps.Sign up for updates at www.nationaldairyfarm.com.• If pressed about milk safety in light of trace amounts ofantibiotics: FDA has stated that while the results indicatesome farms are out of compliance with existing regulations, theantibiotic levels are much too low to pose a health risk. Youcan continue to drink milk with confidence.
  • 36. Communication Materials• Message track/Q&A• Fact Sheet on antibiotics and milkproduction• Fact Sheet on FDA Sampling Program• Industry response statement• Dairygood.org blog post• Third party expert commentary3
  • 37. Dairy Farming Todaywww.dairyfarmingtoday.org/Dairy-Interactive/Videos/Pages/LOTFAntibiotics.aspx
  • 38. National Dairy Councilwww.nationaldairycouncil.org/SiteCollectionDocuments/research/dairy_council_digests/2011/DCD11-1w.pdf
  • 39. DairyGood.org3http://dairygood.org/dairy-farmers-committed-to-producing-safe-wholesome-milk/“Dairy Farmers Committed toProducing Safe, Wholesome Milk”
  • 40. Conclusion• Bridge to protocolsalready in place toprotect milk safety• Producer audience =>education on residueavoidance• Consumer audience=> education onmodern dairy farmingpractices