Policy and public health basis
- The Departments find that chloramphenicol has proven value as an antibiotic for life threatening infections in humans.
- The Departments also find that chloramphenicol used by mixing with feed for food raised animals creates a clear public health danger.
- The Departments determine that high levels of chloramphenicol residues can occur in meat, milk, and eggs.
- The Departments act to prevent human exposure and associated public health risks, including aplastic anemia and increased chloramphenicol resistance in human pathogens.
Joint findings supporting the ban
- The Subcommittee on Veterinary Drugs of the National Drug Committee recommends prohibiting chloramphenicol in food producing animals due to residue dangers.
- A task force created by the Department of Agriculture concurs with the same prohibition recommendation.
- The Departments recognize chloramphenicol’s human usefulness when used discriminately through physicians’ prescription after a sound diagnosis.
- The Departments find that, in food animals, chloramphenicol residues build up in animal tissues and are then ingested by humans through consumption.
- The Departments state that human tolerance for residues cannot be established because effects may or may not be dose- or duration-related, and no acceptable residue level has been recommended due to uncertainty of safety for sensitive individuals.
Coverage: who and what is covered
- Chloramphenicol is banned from use in all food producing animals, including aquaculture.
- The ban applies regardless of the route of administration.
- The prohibition covers the use of chloramphenicol for purposes of food producing animal treatment.
Absolute substantive prohibitions
- Chloramphenicol is banned from use in all food producing animals, including aquaculture, regardless of route of administration.
Registration and future applications
- The registration of chloramphenicol products for use in food-producing animals is withdrawn.
- Future applications for similar registration for use in food-producing animals are disapproved.
Implementation and public education duty
- Concerned personnel are instructed to implement the ban.
- Concerned personnel are instructed to educate the public on the reasons for the ban.
Competent authorities and responsibility
- The ban is ordered by the Secretaries of Agriculture and Health, jointly and severally.
- The Department of Health role is supported by its veterinary drug expert subcommittee recommendation.
- The Department of Agriculture role is supported by its task force concurrence and by agricultural enforcement through concerned personnel.