Livestock producers should expect new restrictions
By Jennifer Carrico
Many in the livestock industry wonder if the buzz about limiting antibiotic use in the United States is just hype or if it could actually happen.
Jim McKean, associate director of the Iowa Pork Industry Center, told attendees at the Iowa Pork Congress that the future of antimicrobials could include some limitations.
"We will have restrictions about how you use antibiotics over your lifetime in this industry. We will see limitations to labeled usages and prescription controls for over-the-counter products," he said.
McKean said the two legal uses of livestock medications are labeled use, where the producer follows label instructions, and extra-label use, where a veterinarian prescribes the medication along with specific instructions as to how to use the medicine and by setting a withdrawal time.
"Some medications have already have limited use in food animals. Some of these may be used under certain exceptions under labeled use," he said.
McKean said the exceptions are outlined as causing public health concerns, in which time the Food and Drug Administration would define recommendations for the specific use in food animal production.
Antibiotics can be used for treatment, control and prevention of animal diseases under the specific rules set.
Several guidances have been set to help with raising food producing animals. Principals sat using medically important drugs should be limited to uses necessary for assuring animal health and should include veterinary oversight.
Some terms McKean said are important to remember include medically important drugs, which are drugs that are important as therapeutics in humans. Judicious use is a medicine used for treatment, control and prevention of animal diseases under rules. Injudicious use is all other animal drug usages. Therapeutic drugs are used to treat specific disease. Subtherapeutic use of medication is when they are used a low levels for growth promotion and feed efficiency.
McKean said the draft guideline #213 is voluntary for the phase-in over the next three years. It will remove the over-the-counter status on water and feed antimicrobials. This will require companies to change labels on these medications. The new label must be directed at specific diseases and must be for short-term treatment only if it is a medically important drug.
"The bottom line is that the companies will make no new dosages or indications unless they have a very good reason to do so," he added. "Veterinary oversight will be required for the water or feed medicine uses."
If the Preservation of Antibiotics for Medical Treatment Act (HR 695) is passed, it would phase out the use of non-therapeutic use of medically important antibiotics in farm animals. This act is currently stalled, but will likely be introduced again. It would severely restrict non-therapeutic uses.
"Antibiotic resistance is the driving force behind all this activity worldwide," he said. "This is not a new problem. It has been around for a long time. The first mention of restriction of antibiotic use was in the United Kingdom in 1969."
The resistance issue has been talked about all around the world. In 2000, Denmark put in a voluntary growth promotants ban. The European Union put in a growth promotants ban in 2005. In 2010, Denmark put a ban on cephalosporin use on food animals.
"The Danes have driven the bus for others to follow for the ban. This may be easier said than done in the U.S.," McKean said. "While the Danes might not have growth promotants, they have seen a steady increase in prescribed antimicrobials. Their system also has a huge database to keep track of where the prescribed medicines are going and how they are being used."
The Danish system tracks medicine usage and regulates livestock producers to only use the amount of medicines needed as prescribed by the veterinarian.
Dutch producers and German producers have also started regulating drug usages in livestock.
In 2008 the Animal Drug User Fee Amendments required pharmacological companies in the U.S. to report their annual drug sales. There is currently no separation required by product type or species, but the FDA is looking for ways to improve the data to make it more meaningful to the industry.
"You should also know that FSIS (Food Safety and Inspection Service) has a new initiative for residue prevention across all species," he said. "This will increase testing across all species using multiple analyses on each sample. Multi-plex tests will be used to give multiple results and they will be using sophisticated analysis to look for 52-plus chemicals per sample.
"When this type of testing happens they are going to find things that we didn't realize (were) even there. There will be new lower detection limits, and the processor will be partly responsible as part of HACCP. Violations will be given to the FDA to use for farm inspections," he said.
He said they will be looking for a lot more residues and there will be a continual increase in violations unless producers quit using medicines that are not labeled for livestock use.
"As inspectors get more positive residue tests at the slaughter plants, they will likely continue to try to find where the violation is coming from," he said.
McKean warns of the residue violators alert list that FSIS has. He said no one wants to be on this list and definitely not on the repeat violators list.
"If we have increased violations in residues, we will likely have more FDA inspections. You don't want to have to experience this type of inspection because they have the right to examine your production practice since you are producing animals for food," he said.
McKean suggested having a plan in place in case an inspection is to happen. A senior member of the staff should handle the inspection and answer all questions. He said the rest of the staff should be aware that the inspection is happening and that they might be interviewed about what they do at the operation.
"Records should be in place, especially feed and medical records in order to show what is fed or what medicines are given, when, the route of administration, the person giving it and the withdrawal time," he said.
McKean stressed that the inspector has a public health mandate to find any problems and correct them. Remaining calm and professional will help make any inspection go more smoothly.
Jennifer Carrico can be reached by phone at 515-833-2120, or by email at email@example.com.