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FDA approves final rendering regulation

By TIM THORNBERRY
Kentucky Correspondent

FRANKFORT, Ky. — An enhanced animal feed ban, that many in the agriculture community had hoped to avoid, has been implemented by the Food and Drug Administration (FDA) contrary to many complaints.

The ruling went into effect on April 27 and will in essence change rendering procedures by mandating the removal of “specific risk materials,” notably the brain and spinal cord, from cattle 30 months and older.

Agriculture officials from Kentucky and other states including Agriculture Commissioner Richie Farmer pled their case to the FDA during a meeting of the National Association of State Departments of Agriculture last February in Washington, where they met with congressional leaders and officials in the Obama administration to seek a delay in implementation of the rule.

The FDA did propose a 60-day delay in the April 9 Federal Register and provided a seven-day comment period in which over 400 were received.

According to a statement by the agency, “Many of the comments indicated that certain entities were not adequately prepared to comply with the final rule and that adequate alternative carcass disposal methods had not been developed. However, a significant number of comments received opposed delaying the effective date of the final rule due to public and animal health concerns.”
The statement went on to say, “In consideration of all comments received, FDA believes the most appropriate action is to confirm the April 27, 2009, effective date, and establish a
compliance date of October 26, 2009, for those who need additional time to address compliance and implementation concerns.”

The action prompted harsh criticism by Farmer who said the “Washington bureaucrats” were out-of-touch.

“I am disappointed that the FDA and out-of-touch Washington bureaucrats have made the decision to become enemies of animal agriculture,” Farmer said.

“The new rule will put many small family farmers, renderers, haulers and associated businesses out of business. I understand that we need to minimize the risk of Mad Cow disease in the United States. But the risk is already extremely low, the controls that are already in place work very well, and there are better ways to achieve what the FDA wants to do. They simply chose not to listen.”

The agency contends the regulation change is an effort to strengthen the 1997 Ruminant to Ruminant Feed Ban which prohibits the feeding of any mammalian/ruminant derived protein (meat & bone meal) to cattle and other ruminants.

The rule was introduced to lower the BSE (Mad Cow disease) risk by requiring rendering facilities to remove those “at risk” materials.
The regulation will also bring the U.S. up to World Animal Health Organization recommendations. The ban is expected to increase producer cost by millions of dollars annually to meet compliance as well as present disposal problems that those in the cattle industry said could create environmental hazards.

“This decision is extremely disappointing,” says Dr. Elizabeth Parker, chief veterinarian for the National Cattlemen’s Beef Association (NCBA).

“By going ahead with implementation of this unnecessary ban, the FDA is ignoring the substantial costs and environmental burdens it imposes on America’s cattle producers.”

Parker added that the ruling amounts to an unfunded mandate.
“FDA has acknowledged that this rule creates tremendous disposal issues for producers, yet they have not identified any viable solutions to that problem. Moving forward with implementation without addressing these concerns is irresponsible.”

Farmer went on to say that, “The FDA’s own announcement said some of the comments they received talked about a heightened risk of Mad Cow disease from imports of live cattle from Canada. Doesn’t it make more sense to restrict imports from countries with a higher risk of Mad Cow disease than to destroy American animal agriculture?”

He added that the FDA doesn’t have the resources to efficiently or effectively enforce this rule.

“They can’t keep up with the responsibilities they already have,” said Farmer. “Producers can’t afford the additional costs the final rule will impose on them. The state doesn’t have the resources to dispose of tens of millions of pounds of animal carcasses.
The FDA simply did not give enough consideration to the unintended consequences of the new rule.

Washington succeeded in killing the tobacco quota program, and now they’re going after animal agriculture.

The FDA threw out sound science and common sense when it made this rule. This isn’t over.”

Kentucky Department of Agriculture Spokesman Bill Clary said the next step would be through legislative action.

“The next step for us is to continue talks with our congressional delegation to make sure the legislative branch, which has the final authority in all these matters understands the position of animal agriculture in Kentucky and they understand how important animal agriculture is to the state,” he said.

Clary added that Congress can override anything that an administrative agency does which may be the only way the ban can be reversed.

“We’re cautiously optimistic but it’s not going to be easy.
On the other hand, we have uncovered enough support in the Senate that at least we should be able to get another hearing,” he said.

The FDA will now conduct outreach to help those affected comply with the rule. The agency will also hold a 50-state call to discuss the disposal issues in various states or regions and plans on finalizing the Small Entities Compliance Guide #195 for Renderers to provide additional information specific to the concerns of the rendering industry.

4/30/2009