Questions surface on legality of Paylean

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SALEM, Ohio – Ohio Department of Agriculture officials continue to field phone calls from confused livestock exhibition sponsors after issuing a memo regarding the legality of Paylean, a feed supplement for hogs.

The memo, which proposes revisions to the state rule, reads, in part: “The Ohio Department of Agriculture is proposing revisions to rule 901-19-20 (E) of the Ohio Administrative Code to allow the use of ‘Paylean’ in show pigs in accordance with label directions approved by the United States Food and Drug Administration. Until any rule change is effective, the rule as provided is in applicable to prohibit the use of ‘Paylean’ in show pigs.”

The rule currently on the books states that “the exhibitor and the exhibition livestock will be disqualified from the exhibition at which the livestock tested positive for either a beta-agonist or an anabolic agent.”

Beta-agonist. Paylean is a trademark of Eli Lilly and Company’s Elanco Animal Health brand of ractopamine hydrochloride, a beta-agonist. The feed additive, available premixed in several show feeds or alone for use in on-farm feed mixing, claims to increase average daily gain, feed efficiency and lean yield percentage. It works by causing the hog’s metabolism to shift nutrients from fat to muscle growth.

Confusion. “The memo was poorly worded and was one great example of bureaucratic double-speak,” said Jan Solomon, Trumbull County fair board member and livestock club adviser.

“Is it applicable to prohibit feeding Paylean, is there a typo, or what exactly are they trying to say,” Solomon said.

“Yes, the drug is legal by FDA standards, but the Ohio rule clearly states that it’s not legal for use in food show animals,” she said. Technically, all exhibitors who fed the additive since its December 1999 approval have been breaking the state rule, she said.

Solomon said a boom in younger 4-H members taking a hog project for the first time in the county has left a lot of room for breeders to push their own agendas, many of which include feeding Paylean.

“The kids are being told there is nothing wrong with the product,” she said.

Up to interpretation. According to David Glauer, state veterinarian, “some people felt the rule precluded the use,” of Paylean, “but there is much room for interpretation” since the additive is federally approved.

Since the additive was approved by the FDA when licensed, its use is permissible if fed by label instructions, regardless of Ohio’s Livestock Reform Act, he said.

The proposed rule change is a move to rescind section 901-19-20, which is actually a duplicate of the disciplinary actions laid out in section 21, Glauer said.

The change doesn’t require legislative action, but is subject to review by the state Joint Committee on Agency Rule Review. A public hearing to gather producer and exhibitor insight is scheduled for April 23 at 9 a.m. at the Ohio Department of Agriculture headquarters in Reynoldsburg.

Glauer expects no difficulty in passing the revisions through the committee and intends to have the changes in effect prior to the 2002 show season.

Food safety. “If the director thinks that this particular additive affects food safety at any point, something will be done about it,” Glauer said, noting that there have been no indications of problems in pork as a result of Paylean’s use to date in the state.

However, there was scattered and “slight” confusion at hog shows across the state during the last show season as a result of the rule’s wording, he said.

“As we head into this show season, I see no reason for conflicts,” Glauer said.

By the label. Feeding Paylean is legal as long as label directions are followed accurately, Glauer said.

The label indicates it can be fed only from 150 pounds to 240 pounds live weight, and has no withdrawal time. Paylean is not for use in breeding animals and is not approved to be fed to any other species.

The additive should only be fed in rations with at least 16 percent crude protein, and dietary lysine concentrations and vitamin and mineral levels must also be increased. The label also indicates that ractopamine must be concentrated between 4.5 and 18 grams per ton.

The additive does not affect the meat quality factors of color, firmness and marbling in trials submitted to the FDA. Studies conducted by Elanco have indicated feeding Paylean does not cause an increase in the incidence of pale, soft and exudative or dark, firm and dry pork.

Research also shows an increase in loin eye area and a decrease in overall body fat when measured at the 10th rib. Meat from pigs fed Paylean does not need to be handled, prepared, or stored any differently than other pork.

Use caution. However, pigs fed a diet including the additive must be handled and transported more carefully.

The product label cautions that “pigs fed Paylean are at an increased risk for exhibiting the downer pig syndrome. Pig handling methods to reduce the incidence of downer pigs should be thoroughly evaluated prior to initiating use of Paylean.”

The additive produces a leaner, heavier muscled pig that is more susceptible to stresses associated with weather, transport, handling and show ring activities.

Since most project hogs are marketed at weights higher than 240 pounds, pulling them from a diet containing ractopamine puts the animal at risk of muscle atrophy, and animals begin to lose the benefits expressed by the use of the drug, research says.

“If this drug has the high possibility of creating all these problems, I don’t know why we’d let our kids feed it to their projects,” Solomon said.

“When packers keep getting hit in their pocketbooks, that’s going to kill the junior fair sale,” she said.

(You can contact Andrea Myers at 1-800-837-3419, ext. 22, or by e-mail at amyers@farmanddairy.com.)

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