FDA Issues Warning Letter to Rendering Facility Regarding Tallow with Pentobarbital

The U.S.FDA issued a warning letter to JBS USA urging the company to take corrective actions at their Souderton PA rendering facility regarding the continued production and sale of beef tallow that may contain pentobarbital, a drug used for anesthetizing and euthanizing animals.  "FDA alleges that JBS Souderton, doing business as MOPAC, continued to sell adulterated products after receiving formal notification of pentobarbital contamination from a customer on Feb. 13, 2018, and after formal notification of positive pentobarbital samples from the Pennsylvania Department of Agriculture on or about April 5, 2018."

The Meatingplace article, also states "According to FDA, MOPAC said that as of May 2018 it had made several changes to try to correct the problems, everything from requiring suppliers to sign guarantees that they do not pick up euthanized animals to extensive tank cleaning to random testing of tallow. But the agency collected a sample on August 2018 from a tank that was positive with trace levels of pentobarbital, indicating the company’s efforts were not sufficient. Samples taken at customers’ facilities also indicated levels of pentobarbital, the agency noted

Meatingplace
http://www.meatingplace.com/Industry/News/Details/85383
FDA tells JBS to stop selling beef tallow contaminated with euthanasia drug 
By Tom Johnston on 5/3/2019



The U.S. Food and Drug Administration has issued a warning letter to JBS USA urging the company to take corrective actions at a Pennsylvania rendering facility to stop the continued production and sale of beef tallow that is contaminated with pentobarbital.

The late April letter comes after multiple FDA investigations at the JBS Souderton plant last year, finding that the facility’s operators failed to identify and exclude raw materials and ingredients containing pentobarbital.

Pentobarbital is a drug approved and commonly used for anesthetizing and euthanizing animals, but there is no established tolerance level for pentobarbital residues in animal tissues and thus FDA deems product contaminated with the barbiturate as adulterated.

FDA alleges that JBS Souderton, doing business as MOPAC, continued to sell adulterated products after receiving formal notification of pentobarbital contamination from a customer on Feb. 13, 2018, and after formal notification of positive pentobarbital samples from the Pennsylvania Department of Agriculture on or about April 5, 2018.

According to FDA, MOPAC said that as of May 2018 it had made several changes to try to correct the problems, everything from requiring suppliers to sign guarantees that they do not pick up euthanized animals to extensive tank cleaning to random testing of tallow. But the agency collected a sample on August 2018 from a tank that was positive with trace levels of pentobarbital, indicating the company’s efforts were not sufficient. Samples taken at customers’ facilities also indicated levels of pentobarbital, the agency noted.

Also in August 2018, FDA asked MOPAC if it planned to conduct a recall. The company, according to FDA, said it did not plan to do so, but rather offered customers to remove any product deemed pentobarbital-positive and to clean their tanks.

“We acknowledge this action, but it is important to remove all adulterated animal food from the marketplace regardless of the customer’s business because they may have used or distributed it for an animal food use,” FDA officials wrote in the letter.

In November, MOPAC described in a letter to FDA the company’s efforts to withdraw contaminated product from its customers. The agency said it was unable to assess that corrective action because the company has not provided documentation to that effect, and the company has not issued a recall.

FDA urged “prompt action” to correct the violations and implement procedures to prevent their recurrence, warning that the company’s failure to do so could result in seizure or injunction.

MOPAC was given 15 days from receipt of the April 23 letter to respond with a list of steps the company has taken to correct the issues.

The company said it is cooperating with FDA.

“MOPAC is committed to the safety of our products and regulatory compliance,” JBS spokesman Cameron Bruitt said in an emailed statement. “We are working with FDA on the issues raised in the letter and will review and enhance our procedures as necessary to ensure we continue to meet all quality and safety standards.”