inition in the draft of medically important antimicrobial drugs. An excerpt from the
“Questions and Answers on FDA’s Draft Guidance on the Judicious Use of Medically
Important Antimicrobial Drugs in Food-Producing Animals” clears up any misconceptions of FDA’s position on growth promotion:
“Is using medically important antimicrobial drugs to increase production in food-producing animals a judicious use?
No. FDA thinks that using medically important antimicrobial drugs to increase production
in food-producing animals is not a judicious use.”
It is therefore reasonable to infer that the FDA is looking to industry to rein in the
use of medically important antibiotics for growth promotion/feed efficiency purposes.
To evaluate antimicrobial resistance associated with antimicrobial drugs used in food-producing animals, FDA relies on the current approach outlined in the Guidance for
Industry (GFI) 152, “Evaluating the Safety of Antimicrobial New Animal Drugs with
Regard to Their Microbiological Effect on Bacteria of Human Health Concern.” GFI
152 recommends several measures to reduce the risk of antibiotic resistance.
Risk Analysis—Lack of Resources
Guidance 152 lays out a risk analysis methodology and the recommended process
for evaluating antimicrobial drugs for use in food animals as they have the potential to
cause antibiotic-resistant illnesses in humans. Considered in the risk-ranking schemes
are food consumption and food contamination data, as well as the duration of drug
use and its intended administration, be it on individual, select or entire flocks or herds
of animals. Out of scope of the guidance are the concerns over residues in food of ani-
6 Instead, it focuses on the potential that antimicrobials used in food ani-
mals contribute to the emergence of antibiotic strains of foodborne bacteria. “The
FDA believes that human exposure through the ingestion of antimicrobial-resistant
bacteria from animal-derived foods represents the most significant pathway for human
exposure to bacteria that have emerged
or been selected as a consequence of an-
timicrobial drug use in animals.”
A Timeline of Antibiotic Regulation
Researched & designed by Stanley E. Rutledge from
STOP based on information compiled by KAW.