From an emailed press release, not online yet. Looks like they are releasing three long-delayed documents at once: Guidance 209 (growth promoters/feed efficiency), Guidance 213 (labeling) and their Veterinary Feed Directive (veterinarian involvement). Voluntary controls, not mandatory.
“Today, the FDA is issuing three documents that will help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems. Under this new voluntary initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.
“It is critical that we take action to protect public health,” said FDA Commissioner Margaret A. Hamburg, M.D. “The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”
The FDA is publishing three documents today in the Federal Register.
—A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
—A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
—A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.
“USDA worked with the FDA to ensure that the voices of livestock producers across the country were taken into account,” said Dr. John Clifford, USDA Chief Veterinary Medical Officer, “and we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”
On the surface, the expansion of HACCP Plans to include [pathogenic E. coli other than O157, also known as “pSTECs”] should be easily accomplished. On closer evaluation, however, there are so many missing pieces, that I for one am finding it difficult to generate reasonable and scientifically based HACCP plans for pSTECs.
One problem is that more research is needed to scientifically validate the numerous beef slaughter interventions for control of pSTECs. The limited studies that have been conducted to date support the concept that intervention for E. coli O157:H7 are also effective for pSTECs http://www.amif.org/research/10-113/ However, specific validation studies are needed to document the reductions for the six regulated pSTECs associated with all slaughter interventions.
Another problem is that it’s much more difficult to design effective testing programs for pSTECs (a group of organisms) than it is for E. coli O157:H7 (a single organism).” —
Testing meat for the “other E. coli’s” (the six Shiga toxin-producing strains, other than O157:H7, that meat processors must now consider “adulterants” in the legal sense) is going to be more difficult than it looks. A column at Meatingplace.com (free subscription) explains some of the nitty-gritty.
On Jan. 4, the Food and Drug Administration proposed banning some extra-label uses of cephalosporins, a category of antibiotics used in farming that are also critical drugs in human medicine.
The 60-day public comment period closes March 6 - that’s today.
Here’s where to comment.
Here’s my original blog post explaining why this ban is so unusual for the FDA, and why it’s a first step in addressing uncontrolled agricultural antibiotic use.
Blaming “Writer’s Block” is wonderful. It removes any responsibility from the person with the “block”. It gives you something to blame, and it sounds fancy.
But it’s probably more honest to think of it as a combination of laziness, perfectionism and Getting Stuck.” —
(go read the whole entry, it’s worth it.)
Old-media nepotism: Getting your kid a publishing contract.
New-media nepotism: Getting your grand-grandmother one?