Docket Management
Docket: 98D-1146 - Eval. the Safety of Antimicrobial NADs Re. their Microbiological Effects on Bacteria of Human Health Concern
Comment Number: EC -13

Accepted - Volume 2

Comment Record
Commentor Dr. Eric Gonder Date/Time 2002-11-27 17:34:15
Organization Goldsboro Milling Company
Category Health Professional

Comments for FDA General
Questions
1. General Comments 106 Lancashire Dr. Goldsboro, NC 27534 (919) 778-3130 November 27, 2002 Dockets Management Branch (HFA 305), Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852. RE: Docket No. 98D-1146 “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The company for which I administer health services produces over 250 million pounds of turkey and over 250 million pounds of pork per year. Our laboratory oversees all diagnostic efforts in support of these animals and the breeding stock associated with them, and oversees and/or prescribes any indicated medications as appropriate. I have over 25 years experience in integrated veterinary health management, pharmaceutical and biological development and technical service, and have advanced degrees in both veterinary microbiology and pathology. I support the positions of the American Association of Avian Pathologists, the American Veterinary Medical Association, the National Turkey Federation, and the Animal Health Institute on this docket. These organizations represent the interests of everyone in production agriculture that I know. Perhaps more of us should write to you individually, but we generally assume that FDA understands what comments from these groups represent. The document itself has some flaws, which I will address later. However, I believe the basic premise that removal of antimicrobial drugs in food-producing animals would have a significant impact on human treatment failures due to food-borne pathogens from federally-inspected food to be a speculative assertion with unproven, controversial scientific underpinnings. The real question here is “How many human antibiotic-resistant infections of clinical significance have been acquired from federally inspected animal protein?” This argument has dragged on for over 30 years, and I have yet to see a single documented, published study by the Center for Disease Control designed to answer this question. If the hazard of humans acquiring antibiotic resistant infections from inspected food is large, where are the documented cases in the literature? Current federal press releases tend to run in the opposite direction - that federally inspected food has less food-borne pathogens in ready-to-cook product. CVM has not received adequate input from commodity groups and the veterinary profession, while receiving potentially misleading input from some elements of the public health establishment. In an October 4, 1994 letter to Dr. Stephen Sundlof, physician James M. Hughes, Assistant Surgeon General and Director, National Center for Infectious Diseases asserts “It is a common ‘therapeutic’ strategy to treat entire herds or flocks at the first sign of illness in one individual”. This statement, by a senior official of the Public Health Service and CDC, is completely, utterly incorrect. Unfortunately, it is not an isolated example. It was then paraphrased by Linda Bren in FDA Consumer, January/February 2001,and reprinted in FDA Veterinarian, January/February 2001, in the article “Antibiotic Resistance from Down on the Chicken Farm” http://www.fda.gov/cvm/index/fdavet/2001/Jan_Feb.PDF. It remains readily available in its uncorrected form on FDA/CVM’s web sites. My January 16, 2002 letter to Ms. Wanda Russ with the FDA Executive Secretariat (attached) remains unanswered. I hope that this does not represent active prejudice against the use of antibiotics in veterinary medicine by FDA, but FDA’s hesitance in resolving this festering situation leaves that impression. It tends to erode the credibility of the classification scheme in particular, which appears to have been developed by physicians for physicians, with little or no significant input from the veterinary or agricultural community Dialogue with the veterinary and agricultural communities may aid FDA in overcoming a major problem with the Guidance document, which is an extremely narrow definition of public health. The definition employed appears to define public health as the preservation of antibiotics exclusively for use in human health if there is any risk of resistance development or transfer between food and human species, at any cost. This interpretation is too narrow. Application of guidance criteria to currently approved drugs would result in their removal from the market due to financial considerations, if not direct regulatory action, and significantly interfere with development of new products. This will negatively impact mortality and feed conversion of animal agriculture. Anything that increases feed conversion has predictable effects on the environment - more feed is consumed for the same amount of meat, and more manure is produced for the same amount of meat. This is not a trivial concern. In our turkey operation alone, an increase in feed conversion from 2.45 to 2.50 would require an addition 12,500,000 pounds of feed a year, releasing an additional 437,500 pounds of nitrogen and 75,000 pounds of phosphorous into the environment with a 70 mile radius. Milling and delivering this feed would require 141,875 more kilowatt-hours of electricity and 6,000 more gallons of diesel fuel. A similar effect on all US animal agriculture would be very large. These environmental effects and the stress effects of decreased poultry welfare and decreased income on our growers and personnel should also be considered in the public health mission of CVM. An environmental impact statement should be prepared considering the public health effects of the environmental damage from decreased production efficiencies and increased food costs. There is a trade-off between the public health effects of antibiotic restrictions in food animals (which still can’t be reliably quantified, apparently) and the public health effects of increased food costs and increased amounts of nitrogen/phosphorous from animal facilities due to reduced production efficiencies that has not been addressed. It should be. While CVM is not legally concerned with animal welfare, I would make an appeal that it be given at least some consideration in these deliberations. My family has been in the turkey business since 1926 - I really like turkeys. It has been very satisfying to administer a fluoroquinolone to those few flocks with colibacillosis resistant to other antibiotics and watch the mortality drop from 40-50 per day to 4-5 per day, and the flock improve in appearance. I’ve never got used to watching my patients sicken and die of histomoniasis after all treatments were removed from the market some years ago. I’m certainly wouldn’t enjoy watching animals under my care sicken and die because pharmaceuticals such as penicillin must be reserved for use in humans, no matter how poorly quantified the human benefits/costs from such reservation. The guidance document thereby contains no controls to prevent the “easiest path” scenario from occurring - restriction of all antibiotics to use in humans. The classification system is a good example - - antibiotics that have been in use in human and veterinary medicine for over 40 years – penicillin and streptomycin – are in the highest possible category. Surely a rational system would recognize that any significant resistance effects for the antique agents should have appeared long since. Requiring additional work on these drugs presents two problems: Surely in 40 years, documented risks from food-borne infections should have manifested themselves. Requiring additional studies in food animals of these drugs seems foolish. Both are old drugs with small margins - manufacturers would probably elect to not market them rather than face increased regulatory costs to prove that a problem does not exist. It is frequently difficult and expensive to prove a negative The guidance document contains no clear provisions for revision of classification based on food processing techniques or results. Should a turkey company electing to irradiate or cook all its product be faced with the same lack of choice of therapeutic alternatives as one selling fresh ready-to-cook product that hasn’t been terminally pasteurized prior to shipment? This issue is central to the public health aspects of this document, and should be clearly elucidated. Otherwise, it would appear that this effort ignores the overall federal food safety effort from the farm to the table. The document should be structured so that a drug would not be forced off the market for speculative reasons, only to have withdrawal result in clostridial or gram-negative overgrowth in the target species’ gut resulting in carcass contamination, possibly with irradiation resistant spores. It is not clear to me from the guidance document how such a decision tree would be averted. Sincerely, Eric Gonder, DVM, MS, PhD, PAS, ACPV 106 Lancashire Dr. Goldsboro, NC 27534 January 16, 2002 Wanda Russ, Policy Analyst Executive Secretariat Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 Re: Your November 8, 2001 letter Dear Ms. Russ: Regretfully, I cannot concur that this matter is closed. I have observed the correction you mentioned in the November-December 2001 FDA Consumer on the web-site at http://www.fda.gov/fdac/departs/2001/601_upd.htm#corrections – it takes 4 clicks from the FDA home page and one must know exactly where to look since “Corrections” is under “Updates”, and there is no mention of the context of the correction in any of the preceding links. Additionally, in the January-February 2002 FDA Consumer, in the “fda.gov” section, under the subtopic “Resisting Antibiotic Resistance” the offending article is referenced yet again in its uncorrected form at http://www.fda.gov/oc/opacom/hottopics/anti_resist.html. Was this deliberate? The original, uncorrected article remains at both http://www.fda.gov/oc/opacom/hottopics/anti_resist.html and http://www.fda.gov/fdac/features/2001/101_chic.html and is available only 2 clicks from the FDA home page and is clearly labeled by title “Antibiotic Resistance from Down on the Chicken Farm” at the first link for “Antibiotic Resistance”. It apparently is being repetitively referenced in FDA Consumer – the correction is not. I was unable to locate Dr. Sundlof’s exchange of letters with the American Association of Avian Pathologists in the November-December 2001 FDA Consumer as you had mentioned in your November 8, 2001 letter. It also wasn’t in the January-February 2002 edition. Forgive me, but I am quite vexed that after submitting several docket comments correcting the erroneous comment that “so when a veterinarian diagnoses an infected bird, the farmers treat the whole flock….”, some 4 letters, 3 e-mails, the involvement of a professional association, and an admission by CVM that “no significant factual basis exists for the incorrect portrayal of the proper approach veterinarians use to diagnose poultry flocks before treatment with an antimicrobial”, the uncorrected story by Linda Bren is still readily available on the FDA web-page, and the most recent FDA Consumer. It continues to confuse and misinform the public. The offending quote has been paraphrased in recent stories in both the New York Times and the Campaign to End Antibiotic Overuse. The original story with the incorrect material remains more readily available than the correct information – this just doesn’t seem right. I don’t see what public health purpose is served by the continued availability of the uncorrected article, especially in readily available electronic form, nor why FDA continues to reference it without correction. It certainly does not reassure poultry clinicians that FDA desires to work with them, or vigorously inform the public of the conditions under which fluoroquinolone (or other) antibiotics are used in poultry – indeed, it does just the opposite. I cannot believe it is FDA’s willful intention to continue to malign poultry practitioners, but the attempts to date to correct the extraordinarily prejudicial statement in Ms. Bren’s article and the damage caused by it seem quite ineffective. I am not an expert in these matters, but I certainly expect that a more comprehensive effort could be made. Please don’t hesitate to contact me if FDA has made further efforts in this area and I have missed them. Otherwise, I look forward to your further response, or production of data supporting Ms. Bren’s assertion. Sincerely, Eric Gonder, DVM, MS, PhD, PAS, ACPV Cc Hon. Tommy G. Thompson Secretary, Dept. of Health & Human Services 200 Independence Avenue SW Washington, DC 20201 Dr. Bernard Schwetz Acting Principal Deputy Commissioner, FDA 5600 Fishers Lane Rockville, MD 20857-0001 Dr. Niall Finnegan AVMA Governmental Relations Office 1101 Vermont Ave., NW, Suite 710 Washington, DC 20005-3521 Dr. Robert J. Eckroade American Association of Avian Pathologists University of Pennsylvania New Bolton Center 382 West Street Road Kennett Square, PA 19348




EC -13