Are You Ready for an FDA Visit?

4/13/2013 7:00 AM
By Jessica Rose Spangler Reporter

LANCASTER, Pa. — Are you ready for the FDA to visit your farm?

Most farmers would probably say no to that question, let alone become excited or optimistic about such a prospect. In fact, the thought of the U.S. Food and Drug Administration paying a visit leaves a lot of farmers with a dreadful sensation in their gut.

Those feelings were part of the reasoning behind the Dairy Calf and Heifer Association devoting a general session at its annual conference to informing members about what FDA inspectors would be looking for should they have a milk or meat residue violation, and what steps they should be taking to avoid such a violation.

During the annual conference, held April 4-5 at the Lancaster County Convention Center, Gregory Edwards, veterinarian with Zoetis (formally Pfizer Animal Health), spoke about recent changes in antibiotic residue regulations surrounding milk and meat.

“My goal is to help you understand what you need to know,” Edwards said before diving into the rules and statistics. “You could be out of business if the FDA found you didn’t maintain records and finds residue. It could result in federal court.”

But “I don’t want to paint the FDA as the bad guy. They’re here for our safety,” he said.

Edwards started by defining which federal agencies are responsible for what.

“The FDA is the primary regulator and tester of the milk supply. In the case of meat, the Food Safety Inspection Service of USDA has responsibility for the inspection and testing of meat, poultry and eggs,” he said.

According to a 2008 FSIS residue study, dairy cows and young veal calves made up only 8 percent of total slaughtered animals but accounted for 90 percent of the residues.

Since 2008, this value has been trending down thanks to increased on-farm advice from vets encouraged by the FDA, Edwards said. This input should include a signed veterinary-client-patient relationship document.

“Further evaluation of the antibiotics resulting in residues indicated greater than 60 percent were from over-the-counter products not requiring a veterinary prescription,” he said. “In addition, on-farm FDA investigation revealed most of the residues were the result of extra-label drug use, and in many cases, without veterinarian input.”

Extra-label drug use is basically using a drug in any way that isn’t specified on the label, he explained. Such deviations include using a drug as intra-muscular instead of intravenous, giving a higher dose or using it for more days than the label allows.

Any and all deviations alter the withdrawal time stated on the label, thereby increasing the chance of having milk or meat residue, Edwards said.

The top five offenders, in order of occurrence, were penicillin, flunixin or Banamine, sulfadimethoxine, gentamicin, and ceftiofur.

In bob veal calves, those less than a month old, neomycin accounted for half of all residues, followed by gentamicin and flunixin.

The biggest problem with neomycin comes when it’s part of a medicated milk replacer, which still requires a withhold period, Edwards said.

Problems also arise when calves are sold for veal at auction when the farmer had no intent of that calf entering the food supply.

“All products are tested at the label instructions and known to be safe. A tolerance level’ is established for the maximum amount that may be present and safe for human consumption,” he said. “A label has dosage, administration and withhold instructions. If that’s followed, the animal byproduct is then safe for human consumption.”

A 2010 review of the FSIS residue program concluded that regulations were still not being met or enforced, resulting in more changes, including “Zero tolerance for residues of products in adult dairy cattle when the label reads not for use in female dairy cattle 20 months of age or older,’ ” Edwards said.

Additionally, “sampling sensitivity is now at parts per billion level for many compounds. How sensitive is that? One ppb is equivalent to 1 second in 31.7 years,” he said.

So what’s a farmer to do?

In Edwards’ conference hand-out, attendees were provided with the following list of seven suggestions that FDA inspectors would like farmers to do to avoid milk and meat violations:

Keep complete records, including animal ID, dates that all medications are administered, dosages and routes of administration, withhold dates, and who administered the drugs.

Follow the label.

When selling calves that have recently consumed colostrum or medicated feeds, have the buyer sign a dated document with all information.

When selling animals through an agent — sale barn, transfer site, jockey — record the back tag applied along with any other ID on the animal.

Vet involvement in product use.

Written protocols that are current and dated.

Use of the Milk and Dairy Beef Drug Residue Prevention Manual.

“Written records are fine,” Edwards said. “Computer records should be printed out at the end of the day and kept in a binder. All records should be signed by the drug administrator.”

“There’s talk of making all drugs prescription,” he said.


Has the Food and Drug Administration done enough to revise its produce safety rule?

  • Yes
  • No
  • Unsure

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