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AHI Statement: Antibiotic usage on the farm is heavily scrutinized

A recent New York Times article called into question the government oversight of antibiotics used to keep food animals healthy.  Antibiotic usage on the farm is heavily scrutinized.  A rigorous FDA review process is backed up by USDA testing for residues and FDA management over the monitoring of resistant pathogens in meat, animals and humans.  Several published risk assessments1,2,3,4 have all come to the conclusion that using antibiotics in animals results in an extremely low risk to humans while helping keep animals healthy.

The NY Times article raises three important issues regarding antibiotic usage in food animals.   Public policy that is effective must be based on information that is accurate.

1.        What volume of antibiotics is used in animal agriculture and what is the public health significance?

The NY Times article repeats the misinformation that “80 percent of antibiotics used in the United States are used in food animals.  This so-called “fact” is based on erroneous data wrapped in assumptions and topped with bias.

  • Thirty-five percent of the antibiotics used in animals are not used in humans – so they cannot contribute to the burden of antibiotic resistance in humans.
  • Human sales data and the animal sales data are not comparable – they were not collected in the same way and don’t measure the same compounds.  It is this reason we continue to note “you can’t compare apples and oranges.”
  • Even the Food and Drug Administration, in two separate documents,5,6 has listed five reasons why the human and animal data are not comparable.

There is animal antibiotic data available.  Each year, companies that manufacture antibiotics are required to submit two different reports to FDA on the sales of antibiotic products.   One submission is part of an annual report companies must make on each and every FDA-approved product they sell, and that report must contain the number of units of each product distributed during the preceding year.  This is confidential business information not made public by FDA and is used to evaluate the significance of any reported adverse reactions.  Each company also submits a second report by March 31 of each year as required by law and requires the reporting of the volumes of active ingredient by antibiotic class sold in the previous year.  FDA summarizes that information in a way to protect confidential business information and makes the summary public.

The real question is this:  What is the public health impact of the use of antibiotics in food animals?  The simple answer is that the small risk of antibiotic resistant bacteria transferring from animals to humans is more than offset by the important benefit of keeping animals healthy as the starting point for a safe food supply.

2.       What is the level of robustness in the surveillance data available?

Surveillance data is different from sales or use data.  FDA runs a surveillance program known as the National Antimicrobial Resistance Monitoring System (NARMS). NARMS that has three key components:

  • The Food and Drug Administration (FDA) coordinates the program and monitors for resistant bacteria in retail meats  (http://www.fda.gov/cvm/narms_pg.html)
  • The Centers for Disease Control and Prevention (CDC) collects isolates, or samples, from public health laboratories to monitor for the emergence of antibiotic resistant food-borne pathogens in humans. (www.cdc.gov/narms)
  • The USDA Agricultural Research Service (ARS) collects samples from slaughter and processing facilities to monitor for antibiotic resistance trends in animal carcasses. (www.ars.usda.gov/main/site_main.htm?modecode=66120508)

 

The NY Times article states this program “contains such small samples that most scientists say they are reluctant to rely on it.”

We agree that the NARMS retail meat program is not robust and is not nationally representative, and we have recommended improvements that should be made.  Yet it is exactly this data that is the basis of the lead paragraph in the NY Times story.  In paragraph one, the “numbers released quietly by the federal government this year were alarming.”  Later in the story, “most scientists say they are reluctant to rely on it.”

NARMS is an important program that should be improved and made more robust.

3.       Is there sufficient regulatory oversight?

The NY Times states that regulatory responsibility is fractured and quotes Dr. Glenn Morris as saying “There’s nobody in charge.”

Dr. Morris, a former USDA official, should know this is not true.  The FDA’s Center for Veterinary Medicine is clearly in charge of regulating the use of antibiotics in animals and as previously discussed gets help from USDA and CDC in monitoring for residues and resistant bacteria.   The FDA review and approval process is stringent – antibiotics used in food animals require more data packages to be submitted to FDA than do antibiotics for use in humans.  In the past decade CVM has implemented a progressive series of steps circumscribing the use of antibiotics in food animals:

  • 2003:  FDA/CVM issued Guidance #152, describing new risk management guidelines companies need to follow in the review of antibiotics.  These requirements are aimed at measuring and reducing the risk of an antibiotic used in food animals.
  • 2010:  Issued Guidance #209, explaining new FDA policy to phase out production uses of antibiotics in food animals and phase-in veterinary oversight of all medically important antibiotics used in animal feed.
  • 2012: Further tightened the restrictions on extra-label use of cephalosporins.  Note this compound is used only by injection.  There are no feed uses of cephalosporins, and any extra label use of antibiotics use in feed is strictly prohibited.
  • 2012:  Finalized Guidance #209 and issued further instructions, including a timeline, for the removal of all growth promotion, or production, uses of medically important antibiotics.  The agency also initiated rulemaking to make changes to the Veterinary Feed Directive that will be used to achieve veterinary oversight of all medically important antibiotics.

 

1Public Health Consequences of Macrolide Use in Food Animals: A Deterministic Risk Assessment.  Hurd, et. al., Journal of Food Protection, vol. 67, No. 5, pgs. 980-992.

2Assessing Potential Human Health Hazards and Benefits from Subtherapeutic Antibiotics in the United States: Tetracyclines as a Case Study.  Cox and Popken, Risk Analysis, 2010.

3Human Health Risk Assessment of Penicillin/Aminopenicillin Resistance in Enterococci Due to Penicillin Use in Food Animals.  Cox, et.al., Risk Analysis, Vol. 29, No. 6, 2009.

4 Risk Assessment of Streptogramin Resistance in Enterococcus faecium Attributable to the Use of Streptogramins in Animals (PDF).

5http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm261160.htm

6Letter from Karen Meister, Food and Drug Administration, to Congresswoman Louise Slaughter, April 19, 2011.

 

Media Contact:

Ron Phillips   (202) 637-2440

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