Comments submitted by The Pew Charitable Trusts on behalf of 6,771 members of the public November 30, 2015 The Honorable Stephen Ostroff, M.D. Acting Commissioner U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 The Honorable Thomas Vilsack Secretary of Agriculture U.S. Department of Agriculture 1400 Independence Avenue, S.W. Washington, D.C. 20250 Director Tom Frieden, M.D. Centers for Disease Control and Prevention 1600 Clifton Rd Atlanta, GA 30333 Re: “Collecting On-Farm Antimicrobial Use and Resistance Data; Public Meeting; Request for Comments,” Docket No. FDA-2015-N-2768 Dear Commissioner Ostroff, Secretary Vilsack, and Director Frieden: FDA took a valuable step in May when it issued a proposed rule to collect species-specific antibiotic sales estimates. Thank you for collaborating with USDA and CDC to obtain public input on possible approaches for collecting additional on-farm antibiotic use and resistance data. To be most useful, on- farm use information should be quantitative and should shed light on why antibiotics are used in food animal production: for treating diseases or for preventing or controlling their spread. This information is essential to enhancing antibiotic stewardship, evaluating whether FDA policies and industry interventions are reducing unnecessary use, and illustrating trends in use and resistance. Your on-farm data collection plan should include the following elements: • Antibiotic class used and medical importance. • Dispensing status. • Purpose of antibiotic use. • Species and animal production class receiving the antibiotic. • Route of administration. Increasing on-farm sampling for antibiotic-resistant bacteria in live animals could help explain where and when antibiotic resistance emerges in the food animal production chain. Expanding National Animal Health Monitoring System surveys so that they are more frequent, include poultry production, and incorporate additional questions would provide a helpful snapshot of actual on-farm usage and resistance patterns. Finally, FDA should seriously consider options for developing a system to collect and analyze veterinary feed directive data. Complementing these data, FDA and USDA could work with large production companies to devise a mechanism to collect similar information on antibiotic use in water, voluntarily and confidentially. I hope that you develop a concrete plan with timelines for collecting on-farm antibiotic use and resistance data as swiftly as possible. Thank you for your attention to this very important public health issue and for considering my comment. Sincerely, First Name Last Name Address 1 City State Postal Code Personal Comment * The earth we abuse and the living things we kill will, in the end, take their revenge; for in exploiting their presence we are diminishing our future. - Lion Forest 391 29th Ave San Francisco CA 94121 Marya Mannes ...get rid of the antibiotics...gather and release the info.to the American people...!!! Unless, of course, stephen durbin 1251 rickover dr coupeville WA 98239 you have something to hide...????????? [We need to get a handle on the size, location and rationale behind antibiotic use in order to prevent Baird Swanson PO Box 981 Pine Island MN 55963 more resistant pathogens.] 80% of antibiotics used in this country are used on animals in CAFOs. This has created antibiotic resistant strains of many human diseases. Our entire antibiotic supply is at risk, and something must be done. The least we can do is start collecting data. We must address this situation or we are Cowan 4275 White Spruce looking at going back to the days before antibiotics Cathy Becker Lane Grove City OH 43123 existed. A concrete plan is needed RIGHT NOW for collecting on-farm data on antibiotic use and resistant Sandra Bader 7938 S. Alva Rd Harshaw WI 545299633 bacteria . A friend's life was under threat because initial IOSUPOVIC Imperial antibiotics did not work. I want this issue settled Miriam L I 1320 Seacoast Dr, S #L Beach CA 91932-3165 now. Lives are on the line. A healthy nation needs clean air, clean water and healthy food. Food with resistant bacteria is not Ke Chiang Hsieh 4443 E. Burns Tucson AZ 85711 healthy food. Virginia Rosenkranz 1211 SW 58th Avenue Portland OR 97221 a terrible practice for animals & humans! A young man I know, as a toddler, had to get an injection because he had a resistant bacterial infection. He was a toddler! And his parents, active and health conscious, certainly never overmedicated him. Please keep working to minimize antibiotic use Mary Johnson 25 Stewart Place Mount Kisco NY 10549 on farms. 494 SW Hollyhock Abuse and overuse of antibiotics has created major Kay Novak Circle Corvallis OR 97333-1773 health problems in animals and humans. Action needs to be taken NOW. Not after long delays Charlotte Pisoni 930 Peace Haven Drive St. Louis MO 63125 while you contemplate how to get this done. cheryl ERB 1068 Park Ave NE Salem OR 973012547 Actual data on drug-use would be valuable. ce After your failure to act re: Genetic engineering, this is what I've come to expect. Do your job for we the Charles Dineen 80490 28th St. Lawton MI 49065-9644 people,not Monsanto and Big Pharma. colin Kay 7637 161st Pl Tinley Park IL 60477 Again, we should know. Agricultural use of antibiotics and resultant resistance in humans is a huge and pressing public health problem. A large body of accurate data needs Susan Blain 156 Vernon Street Gardner MA 1440 to be collected quickly and effectively. Al these antibiotics are leading to drug resistant William Schultz 339 w 4th whitefish MT 59937 super bugs All human diseases and most ecosystem destruction is caused by producing living beings to die as your poison food. JUST WAKE UP, THAT'S ALL. WAKE Hal Anthony 3995 Russell Road Grants Pass OR 97526 UP!!!!!!!! All policy decisions should be made based on the best available science. So, I urge the U.S. government to collect as much data as possible on 26301 Wyldewood all issues, but especially this one, to better protect Jon Olson Drive Webster MN 55088 human and animal life. All the meat I buy says it contains no antibiotics, but 500 Mendon Rd. Unit I don't believe them. Thomasin Kellermann 111 Cumberland RI 2864 Let science settle this once and for all. Alexa Venturini P.O.Box 98 Cornwall CT 6753 Already accomplished in California! Also collect data from the antibiotic sales stores and Duane Benton 1706 Briery Rd Farmville VA 23901 cross check with farmers data. Although I am a vegetarian, I care deeply about the health and treatment of all God's creatures. Please don't resort to mega doses of antibiotics to increase your output of meat for profit. These animals need proper ventilation, wholesome food, clean water, proper exercise and not know fear as a way of life, (as it causes the hormone cortisol to flood their systems and thus be ingested by consumers) . These factory farms are filthy, the animals brutally mistreated, over medicated to quell any disease and downer animals quickly scooped up and blended into the feed lots of their fellow farm mates. Do you really think this is how farming should be done? Would you feed these diseased and dying animals to YOUR families? Would you let your children go on a field trip to a slaughter house to see where and how their food is produced? Would you take that trip? I think not. Shame on all of us for allowing this to happen to such docile, sentient beings for our own profit and consumption. We need to work smarter, from our hearts and souls for our bodies well being, not greedier from our ego to fill our pockets. Stop allowing Dow, Monsanto and all the pharmaceutical companies to influence and write their own laws and meal tickets to regulate the farming/agricultural industry. I hope there are some of you still out there that truly care about what you do and who you are working for. I want to believe you have our health and well-being as your first priority. I would think that includes treating our food sources with dignity, kindness and allowing them to thrive for the short time they have here on earth. To quote Gandhi:The greatness of a nation & its moral progress can Barbara Jones 691 Everdell Ave West Islip NY 11795 be judged by the way its animals are treated. Namaste'! Americans need to know what is in their food, how it impacts animals in which chemicals/substances are being consumed, how food is produced and processed, and what is being done to protect their janine scoville 2926 curving oaks way orlando FL 32820 health at all times. TRANSPARENCY is essential And please don't use antibiotic mfr funding for the Judith Passmore 2 Court St Middletown CT 6457 data collection! Animals deserve better. FDA - get your act Joyce Filauri 1507 Staunton Drive Coraopolis PA 15108 together!!! Animals need space to live and grow. Factory farms are not natural or safe for the animals. Recommendations to help prevent the need for antibiotics are important to solve this antibiotic Sissy Aron 10 Brookview Lane New Milford CT 67762532 crisis. Animals should be given antibiotics so that the Bernadett animals do not get diseases which could be passed e Belcastro 68 Crocus Ave. Floral Park NY 11001 on to humans. 19700 Cantwell Ranch Animals that are humanely raised do not need Karin Rada Rd. Lower Lake CA 95457 antibiotics! Antibiotic abuse on farms need to come to an end. A Charles Brumleve 2416 Wilmar Drive Manhattan KS 66502 plan should be completed to deal with this. Susan Hanger 20940 Waveview Topanga CA 90290 Antibiotic excess really needs to be stopped.