Milk and Dairy Beef Residues: Incidence & Communications Dairy Response Planning Betsy Flores, Nat l Milk Producers Federation April 16, 2013
What We ll Cover Antibiotics and milk production FDA drug residue sampling program Communications goals and plan Consumer research viewpoint Messaging
Drug Residues in Milk and Cull Dairy Cows
Milk Residue Regulatory Levels Tolerance established in the Code of Federal Regulations (21 CFR 556) Zero when no tolerance is specified Safe Level established by FDA- CFSAN Milk safety branch (MI-05-5)
Milk Drug Residue Screening Industry shall screen all bulk milk pickup tankers, regardless of final use, for Beta lactam drug residues FDA Commissioner can require additional screening if a potential problem exists Grade A Pasteurized Milk Ordinance 2011 Revision
Other Drug Residue Screening PMO related Example: on-farm bulk tank testing when a producer is concerned about a drug residue Contractual Example: random sulfa-drug testing recently required by a major fluid processor Export Certification Example: tetracycline testing for exports to Russia
Percent of Bulk Milk Tankers Positive for Antibiotic Residues Data from National Milk Drug Residue Data Base
Drug Residues in Cull Cows
USDA OIG Residue Report Finding 2: FSIS Needs to Strengthen Oversight of the National Residue Program, Especially at Plants Slaughtering Dairy Cows and Bob Veal Source: USDA OIG Audit Report 24601-08-KC
Reasons for Tissue Residues Top causes identified in FDA investigations: Poor identification of cattle Treatment not recorded as a written record Not following the manufacturer or veterinarian prescribed label directions for the appropriate withdrawal period Not following veterinarian s recommendation when using any drug FDA Investigation Question: Did the producer have a Valid Veterinary Client Patient Relationship? Yes 30% No 70%
DRUG 2007 2008 2009 2010 2011 Total Percent Penicillin 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%
DRUG 2007 2008 2009 2010 2011 Total Percent Tylosin 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.
TISSUE RESIDUES in Dairy Cull Cows (FDA Data, 2005-2011) 55%
FDA CVM Drug Residue Survey
FDA CVM Drug Residue Survey Hypothesis: The same practices associated with tissue residues in culled dairy cattle may also result in drug residues in milk. Through voluntary cooperation of the dairy industry FDA collected 900 samples from dairy farms with a cull dairy cow tissue residue violation in the past 3-4 years 900 samples from other dairy farms
FDA Residue Survey Veterinary Drug Tolerance or Safe Level (PPB) Notes Penicillin G 5 34.5% Tissue Violations Flunixin 2 22.9% Tissue Violations Sulfadimethoxine 10 14.7% Tissue Violations Cephaparin 20 7.6% Tissue Violations Gentamicin 30 6.5% Tissue Violations Sulfamethazine 10 3.5% Tissue Violations Prohibited Extra Label Use Oxytetracycline 300 2.3% Tissue Violations Neomycin 150 2.3% Tissue Violations Tilmicosin NA 2.2% Tissue Violations Limit of Test Detection Ampicillin 10 1.4% Tissue Violations
FDA Residue Survey Veterinary Drug Tolerance or Safe Level (PPB) Notes Chloramphenicol NA Prohibited Use Limit of Test Detection Sulfachloropyridazine 10 Prohibited Extra Label Use Sulfadiazine 10 Prohibited Extra Label Use Sulfamerazine 10 Prohibited Extra Label Use Sulfaquinoxaline 10 Prohibited Extra Label Use Sulfathiazole 10 Prohibited Extra Label Use Bacitracin 500 Chlortetracycline 300 Tetracycline 300 Cipro-/Enro-Floxacin NA Limit of Test Detection
FDA Residue Survey Veterinary Drug Tolerance or Safe Level (PPB) Cloxacillin 10 Notes Doxycycline NA Limit of Test Detection Erythromycin 50 Florfenicol NA Limit of Test Detection Sarafloxacin NA Limit of Test Detection Thiabendazole 50 Tripelennamine 20 Tulathromycin NA Limit of Test Detection Tylosin 50 Virginiamycin NA Limit of Test Detection
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
Likely FDA CVM Survey Outcomes Hypothesis: The same practices associated with tissue residues in culled dairy cattle may also result in drug residues in milk. Residues found, no difference between groups Higher residues found for farms with a previous tissue residue violation in the past 3-4 years
Producer Resources
Industry Outreach and Education 2013 Milk and Dairy Beef Residue Avoidance Manual
Consumer Communication Plan
Communication Goal Maintain consumer confidence in milk safety and quality
Issues Management Approach RELEASE DAY: Response-mode communication only Position industry as cooperative with regulators and committed to continuous improvement Reinforce milk safety and quality LONGER TERM: Align industry around action steps that drive continuous improvement
Stakeholders Producers Co-ops and processors Bovine veterinarians and greater veterinary community Dairy producer trade orgs Health professional and marketing partners Consumers (via media and social media)
Consumer Confidence Special Report: Antibiotics and Milk Production Consumer Research Funded by the National Dairy Checkoff
28 Top-of-Mind Mentions of Antibiotics are Tiny 24% 14% What is Top-of-Mind Recall Related to Milk? 6% 6% 6% 4% 3% 2% 2% 0.1% 0.1% 0.04% Health Deliverable Ads Non-Dairy Alternatives Pricing Enjoyment Safety Health Uncertainties Industry Environment Animal Care School Related Antibiotics Negatives related to dairy issues animal care, environment, school are less top-of-mind Source: Dairy Tracker Q3 2012
Situation Objective Method Message Testing: Focus Groups Milk currently tested for four to six common antibiotics FDA survey under way to test for additional antibiotic residues to determine if there is an issue in milk supply Explore consumer familiarity with antibiotics in milk topic Understand reaction to current messaging on topic Gauge reaction to alternate messaging developed to address potential outcomes of FDA work Qualitative research Nine focus groups (66 adult consumers) - regular milk buyers - organic buyers - consumers struggling financially - consumers who selfdefine as influencers in health & wellness Three cities: Chicago, Bethesda, Denver 29
Evergreen Messages Strict FDA and state regulations govern the use of all FDA-approved medications used to treat dairy cows on the farm and require dairy food companies to test milk for commonly-used antibiotics. This oversight is designed to protect public health and ensure consumers are getting safe and wholesome dairy products. On the farm, dairy farmers work with veterinarians to keep their cows healthy. Sometimes a cow needs antibiotics when she is ill, just as people often do. The FDA requires that all milk organic and regular be tested for commonly-used antibiotics when it arrives at the dairy plant. Every single batch (truckload) is tested. Any milk that tests positive is rejected by the plant. 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 and the farmer is financially liable for the entire batch. After more than one violation, state regulators apply additional penalties, such as a fine and/or revoking the farmer s license to sell milk.
Current Antibiotics Evergreen Messaging Positive Messaging Elements Dairy Farmers are Accountable Strong incentives to keep milk free of antibiotics Farmer is financially liable Fines and revoking farmer license Farmer penalty after more than one violation Third Party Oversight Comprehensive process in place to ensure safety State regulators/inspections of farms Strict quality control procedures FDA regulations FDA approved medicines Consumers Prefer No Antibiotics but Most Will Accept Low Incidence Example: 5 parts per billion Mention of decline in number of positive tests over time wellreceived Procedures Treat sick animals Milk from cows treated with antibiotics is separated Would like assurance that milk is destroyed, not used elsewhere 31 Source: T. Gacek Qualitative Research Dec 2012
Messengers Who Can Be Effective Spokespeople on Antibiotic Topic Dairy Farmer Near universal agreement among adults that dairy farmers produce a safe product Veterinarians, Public Health Experts 70% of adults trust the Am Veterinary Med Assoc on animal care matters* FDA 79% of adults trust FDA in matters of food safety Honest Trustworthy Hard-working Doing what s right Qualified, respected outsiders to serve as consultant Most view as powerful and respected government office that has public s interest in mind * (17% not familiar) Source: T. Gacek Qualitative Research Dec 2012, DMI Dairy Monitor 2010 32
Messaging
Response Messages: Residues found, no difference between tissue violator group and control group [ACKNOWLEDGE SPECIFIC FINDINGS.] The U.S. dairy industry is committed to maintaining the highest safety and quality standards. To that end, we are immediately consulting with regulators as well as veterinary and public health experts to determine how best to address FDA s findings. Dairy farmers, veterinarians and dairy food companies all have a stake in protecting the integrity of the milk supply and we will 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 of antibiotics: FDA has stated that while the results indicate some farms are out of compliance with existing regulations, the antibiotic levels are much too low to pose a health risk. You can continue to drink milk with confidence.
3 Communication Materials Message track/q&a Fact Sheet on antibiotics and milk production Fact Sheet on FDA Sampling Program Industry response statement Dairygood.org blog post Third party expert commentary
Dairy Farming Today www.dairyfarmingtoday.org/dairy- Interactive/Videos/Pages/LOTFAntibiotics.aspx
National Dairy Council www.nationaldairycouncil.org/sitecollectiondocuments/r esearch/dairy_council_digests/2011/dcd11-1w.pdf
3 DairyGood.org Dairy Farmers Committed to Producing Safe, Wholesome Milk http://dairygood.org/dairy-farmers-committed-toproducing-safe-wholesome-milk/
Conclusion Bridge to protocols already in place to protect milk safety Producer audience => education on residue avoidance Consumer audience => education on modern dairy farming practices