Letter to Dr Henney of the FDA
Letter to Dr. Henney of the FDA urging that swift action be taken to protect the effectiveness of antibiotics by limiting their subtherapeutic use in agriculture.
CSPI Report 5/28/98
Send a letter to the FDA
March 9, 1999
Jane Henney, M.D.
Dear Dr. Henney:
In 1977, the Food and Drug Administration (FDA) initiated proceedings to ban the subtherapeutic
uses of penicillin and tetracyclines in animal feed. Unfortunately, that important work was never
completed. Since 1977, new research further demonstrates that adding antibiotics to livestock feed
contributes to the growing problem of antibiotic resistance among foodborne and other pathogens.
Those resistant bacteria can be transferred to humans via contaminated food products or through
direct or indirect contact with animals.
While both agricultural and medical uses of antibiotics contribute to antibiotic resistance,
subtherapeutic use in animals is an important contributor to the problem.(1)
I. The FDA should ban subtherapeutic uses of antibiotics in livestock of those antibiotics that
may be used in (or that are related to those used in) human medicine.
The ban should include subtherapeutic uses of penicillin, tetracyclines, erythromycin, lincomycin,
tylosin, virginiamycin, and other antibiotics used in human medicine or related to those used in
human medicine for growth promotion and disease prevention. Subtherapeutic use of those
antibiotics in agriculture may jeopardize their effectiveness in treating human or animal diseases.
Banning subtherapeutic agricultural antibiotic uses can lead to a decrease in antibiotic resistance
among foodborne pathogens. For example, in Sweden, where glycopeptides have not been used as
growth promoters since the early 1980s, and were formally banned in 1986, vancomycin-resistant
enterococci are not found in isolates from pigs.(2) In contrast, in the Netherlands, where glycopeptides
only recently were banned, 39 percent of enterococci isolated from swine are vancomycin resistant.
II. The subtherapeutic use of antibiotics in livestock jeopardizes new human-use antibiotics
and jeopardizes human health.
A class of antibiotics called streptogramins is one of the last weapons against deadly antibiotic-resistant bloodstream infections caused by antibiotic-resistant enterococci. Although it has not yet
been approved for use in humans, the potential value of one streptogramin -- Synercid -- already has
been compromised because of subtherapeutic use of another antibiotic in the same class. That is
because resistance to one antibiotic can cause resistance to the entire family of antibiotics. Turkeys
that had been fed subtherapeutically another streptogramin, virginiamycin, harbor enterococci
bacteria that also are resistant to Synercid.(3) If people handle or consume turkey that is contaminated
with those streptogramin-resistant enterococci and become ill, Synercid, if and when it is approved
for human use, would be ineffective against that illness. In the U.S., Synercid-resistant bacteria have
not yet been found in humans. However, in Germany, a country in which Synercid is not yet used in
humans but in which virginiamycin is used subtherapeutically in livestock, Synercid-resistant
enterococci have been detected in humans.(4)
III. Leading health authorities around the world have called for banning subtherapeutic uses
of certain antibiotics in agriculture.
A number of authoritative organizations recognize that subtherapeutic antibiotic use in livestock
contributes to the development of antibiotic resistance and may pose a risk to human health.
The World Health Organization (WHO) recommends that the use of any antimicrobial for
growth promotion in animals should be banned if it is (1) used in human therapeutics or (2)
known to select for cross-resistance to antimicrobials used in human medicine.(5)
The U.S. Centers for Disease Control and Prevention (CDC) has advised that the U.S.
adopt the WHO position.(6)
The National Academy of Sciences recently concluded that agricultural uses of antibiotics
pose a risk to the public health.(7)
In addition, most developed nations, with the notable exception of the United States and Canada,
have banned the subtherapeutic use of penicillin and tetracycline. Sweden has banned the use of any
antibiotic. Denmark and Finland have banned several antibiotics for growth promotion. In
December 1998, the European Union banned the use of four antibiotics used in animal feed because
of concerns that those uses will undermine the effectiveness of antibiotics in human medicine (earlier
it had banned other antibiotics).
We urge you to take swift action to protect the effectiveness of antibiotics by limiting their
subtherapeutic use in agriculture. Without such action, we jeopardize one of the great advancements
in human and veterinary medicine.
David Acheson, M.D.
Assist. Prof. of Medicine
Department of Infectious Diseases
New England Medical Center
Alan G. Atherly, Ph.D.
Robert Baltimore, M.D.
Martin J. Blaser, M.D.
Malcolm J. Casadaban, Ph.D.
Don B. Clewell, Ph.D.
Larry Culpepper, M.D., M.P.H.
Jacob W. E. Dijkstra, M.D.
Michael Edmond, M.D., M.P.H.
Richard T. Ellison III, M.D.
Stanley Falkow, Ph.D.
Leo Galland, M.D.
Marie J. George, M.D.
Kim Gerstadt, M.D.
Donald Goldmann, M.D.
Linda R. Gooding, Ph.D.
Michael Green, M.D.
David P. Greenberg, M.D.
Thomas C. Greenough, M.D.
Howard Hada, Ph.D.
Garret M. Ihler, Ph.D.
Michael D. Iseman, M.D.
Henry D. Isenberg, Ph.D.
Joseph John, Jr., M.D.
Howard Kator, Ph.D.
Ann Marie Kimball, M.D., M.P.H.
Calvin Kunin, M.D.
Kwan Kew Lai, M.D.|
Assoc. Prof. of Medicine and Infectious Diseases
University of Massachusetts Medical Center
Joyce C. Lashof, M.D.
Joshua Lederberg, Ph.D.
Jay M. Lieberman, M.D.
S. Michael Marcy, M.D.
Sheldon Margen, M.D.
Robert C. Moellering, Jr., M.D.
J. Glenn Morris, M.D., M.P.H.
Barbara E. Murray, M.D.
Eugene W. Nester, Ph.D.
Richard P. Novick, M.D.
Jack L. Paradise, M.D.
Abigail Salyers, Ph.D.
W. Michael Scheld, M.D.
Kultar Shergill, M.D.
Richard P. Silver, Ph.D.
P. Fred Sparling, M.D.
Hannis (Hank) Stoddard, Jr., D.V.M., D.T.V.M.
Guenther Stotzky, Ph.D.
Anne O. Summers, Ph.D.
Donald J. Tipper, Ph.D.
Anne K. Vidaver, Ph.D.
Ellen Wald, M.D.
Richard Wenzel, M.D., M.Sc.
Alan T. Wortman, Ph.D.
Marcus Zervos, M.D.
American Medical Women's Association
American Public Health Association
Animal Welfare Institute
Association of Public Health Laboratories
Association of State and Territorial Health Officials
Bertie Citizens Action Coalition, Inc.
Bison Land Resource Center
Boston Women's Health Book Collective
Center for Science in the Public Interest
Community Association for Restoration of the Environment
Consumer Federation of America
Environmental Defense Fund
Food Animal Concerns Trust
Friends of the Earth
Global Resource Action Center for the Environment
Henry A. Wallace Institute for Alternative Agriculture
Humane Farming Association
Humane Society of the U.S.
Illinois Stewardship Alliance
Illinois Sustainable Agriculture Society
Institute for Agriculture and Trade Policy
Juniata River Community & Farm Alliance, Inc.
Land Stewardship Project
Michael Fields Agricultural Institute
Minnesota Food Association
Mothers and Others for a Livable Planet
National Catholic Rural Life Conference
National Consumers League
National Women's Health Network
Natural Resources Defense Council
New Pear Farm Land Trust
Northern Plains Sustainable Agriculture Society
Ohio Family Farm Coalition
Oklahoma Department of Environmental Quality
Pennsylvania Environmental Network
People's Medical Society
Potomac Headwaters Resource Alliance
Public Citizen's Health Research Group
Sierra Student Coalition - University of Arkansas
Society for Animal Protective Legislation
Union of Concerned Scientists
Water Keeper Alliance
2. van den Bogaard, A., London, N., Driessen, C, Stobbering, E. The effect of growth promoters on the resistance in faecal indicator bacteria of pigs. Abstract from 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, American Society for Microbiology, September 24-27, 1998, San Diego, CA.
3. Thal, L.A., Welton, L.A., Perri, M.B. Donabedian, S, McMahon, J., Chow, J.W., Zervos, M.J. Antimicrobial resistance in enterococci isolated from turkeys fed virginiamycin. Antimicrobial Agents and Chemotherapy 1998; 42: 705-708.
4. Witte, W. Medical consequences of antibiotic use in agriculture. Science 1998; 279: 996-997.
5. World Health Organization. The Medical Impact of the Use of Antimicrobials in Food Animals: Report of a WHO Meeting, Berlin, Germany; October 13-17, 1997.
6. Angulo, F.J., Centers for Disease Control and Prevention. Remarks at Emerging Antimicrobial Resistance in Foodborne Enteric Pathogens meeting, Athens, GA; September 1, 1998.
7. National Research Council and Institute of Medicine. The Use of Drugs in Food Animals: Benefits and Risks. Washington, DC: National Academy Press; 1998.
Copyright © 1998, 1999, 2000, 2001 by the Center for Science in the Public Interest. References available by request.