Jim McKean
Jim McKean

While Congress presently has bigger fish to fry, you can bet that antibiotic use in animals still is on the minds of some legislators, and the pork industry will continue to see challenges regarding antibiotics in the future.

Jim McKean, swineExtension veterinarian at Iowa State University, told producers that over their lifetime, they would likely see limitations on labeled usages, prescription control for over-the-counter (OTC) products, constriction of extra-label use (direct and indirect), more specific residue detection and subsequent action to violators.

Animal drug classifications

“There are two legal uses of drugs in the United States,” points out McKean.“There is labeled use (with NADA limitations) and there is extra-label use, which is under veterinary script. In other words, the veterinarian must be involved in the operation and the producer must accept what the veterinarian tells him to do. All other use of antibiotics is illegal – think about that and factor in its implications.”

McKean explains Guidance 209, which is now official,outlines FDA public health concerns, summarizes key scientific reports and outlines recommendations for “judicious” use in food-producing animals. “Its recommendations are not legally binding,” he says.“It is a discussion document but it does indicate future actions, and the recommendations refer specifically to food-producing animals.”

Producers should remember the term “medically important drugs,” which are drugs traditionally used as therapeutics in humans. According to McKean, Guidance 209 states medically important drugs should be limited to uses necessary for assuring animal health and should be used with veterinary oversight.

Guidelines for the approved use of these products include:

  • Evidence of the drug’s effectiveness
  • Consistency with accepted veterinary practices
  • The drug’s use is linked to specific etiologic agent
  • Its use is appropriately targeted
  • There are no reasonable alternatives (i.e. other approved products)

Draft Guideline 213 has a voluntary phase-in over three years, which is to remove these medically important drugs from OTC use. Water-soluble medications will need a veterinary script for use and feed-based antibiotics will need a veterinary feed directive. Products will have new label indications/claims and will be directed for use to control a specific disease.

“The bottom line is that there will not likely be new dosages or indications – it gives a little wiggle room but not a great deal,” explains McKean.

Supplemental activities by the government include Guidance 152, which is a risk-based approval testing process for NADA. It primarily applies to food-animals and makes the use of medically important antibiotics difficult other than when they are targeted to small groups or individual treatment.

There is also the Preservation of Antibiotics for Medical Treatment Act. This is Louise Slaughter’s bill HR 695. “I see no reason why she won’t try to push this through again,” says McKean. “It involves the phase-out of non-therapeutic use of medically important antibiotics in farm animals. It is currently stalled, but it could come back and become bi-partisan. This includes control and prevention in addition to sub-therapeutic.That’s the environment we have in the United States right now.”

The USDA Food Safety and Inspection Service (FSIS) has an initiative for residue prevention that will increase testing across all species, explains McKean. Multiple analyses on each sample using sophisticated equipment are replacing older technologies.

“For years, there was one test on each sample,” says McKean. “Now, there are test protocols that evaluate 52-plus compounds in a single sample. We’re going to find things we didn’t even know were there. In addition, there are lower detection limits.”

Processors are responsible for meeting standards as part of Hazard Analysis Critical Control Points (HACCP). If there are enough positive tests, it may become a hazard, and violations will be given to FDA for farm inspections.

“If the packer has more violations, the inspector at that location can request more samples,” notes McKean.“If they suspect an individual farm is more likely to submit suspect animals, they can request more samples from that farm. I will promise you that as inspectors get more samples, they’ll do selective sampling to find more positives.

Pre-Plan for an Investigation

Even though you have no reason to believe your herd will be investigated, put a plan in place.  You and your staff will be better prepared in the event your herd does undergo a site inspection. In fact, you may want to consider a “mock” investigation, just to make sure you are following proper procedures on your farm.

“Investigators have the right to examine production practices,” says McKean, “and it will probably be one of the longest days you’ve ever spent in your life.”

While the option exists for the government to perform random inspections, these are unlikely with budget constraints as they are. Ifan inspector comes to your farm, it will be because he or she believes there is just cause.

What the inspector will do
During producer investigations, McKean says inspectorsmay:

  • Examine all drugs on the premises (injectable and water medications as well as medicated feed premixes and complete feeds)
  • Examine where you store drugs (adequacy of storage and inventory – labels and products)
  •  Ask you who has access (who is responsible, who maintains the records, etc.)
  • Interview your employees to
    •  Find out about training and employees’ understanding of the training
    • Evaluate their proficiency
    • Review your medication records
      • Adequacy of records and information captured
      • System for captured after-treatments
      • Adherence to withdrawal time requirements
      • Evaluate records for animals in interstate commerce

They will also want to see your medication records:

  • Animals treated
  • Dates of administration
  • Drug administered
  • Route of administration
  • Amount administered
  • Person who administered the product
  • Product withdrawal period

See the Pork Quality Assurance Plus program for more information regarding the kind of information you should record and monitor.

What you should do
“You will need time, patience and social skills,” says McKean. In addition, you need to be well prepared. Here are some valuable steps McKean recommends you follow:

  • If you aren’t going to manage the investigation yourself, designate a senior member of your management team
  • Alert your staff of steps to take when the inspector arrives
  • “Learn your rights in the state;” contact your state pork producer association
  • Keep your records in order
  • Ask why he or she is there so you can narrow the scope of the inspection
  • Make sure you can show records that review pertinent information
  • Prepare for a facility tour during the inspection
  • Prepare for the inspector to interview your staff

“They’ll want to ‘follow the trail,’ if there is one,” points out McKean, “and they can make your life a living hell if they detect even a whiff of hiding or deception.”

 You may feel you’re being scrutinized as the inspection takes place, and therefore prone to defending yourself. By remaining calm, professional and forthcoming with specific information, you can help avoid an uncomfortable situation and therefore, you’ll be more likely to achieve a favorable outcome.

If the Inspector Comes to Your Farm

If your herd is going to be inspected, there are certain things you can do to make the process go as smoothly as possible, says McKean. He suggests you use these strategies:

  • Be courteous, collected and professional – not defensive
  • Be sincere and respectful of the inspector’s time
  • Be truthful but answer succinctly – answer only the questions asked – there’s no need to offer additional information or explanations
  • If unclear about a question, ask for clarity
  • During the site visit, be aware of areas of interest to the inspector and plan accordingly
  • Remember the inspector has a public health mandate; he or she will be looking for evasion or wrongdoing, or anything that might present a public health risk. The inspector’s job is to protect the public; respect that duty.
  • Allow copies to be made of original documents; make duplicates of any samples taken by the inspector
  • Maintain a record of all materials taken
  • If offered, read the inspector’s report/notes – if there are questions, attempt to clarify in written form, not verbally. Don’t sign the report unless you are in full agreement, because your signature indicates that the facts as they are presented are acceptable. Now is the time to clarify!