The US Food and Drug Administration (FDA) published a warning letter last week to JBS USA about JBS Souderton, Inc – a company rendering facility in Pennsylvania – outlining concerns about some of the feed ingredients generated.
The warning followed a series of inspections done last year at the rendering plant, the agency said. The review was done in partnership with the Pennsylvania Department of Agriculture (PDA).
“Your rendering plant produces animal food ingredients distributed to animal food manufacturers,” Evelyn Bonnin, program division director for Human and Animal Food Division II East, said in the letter. “This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our inspection of your operation.”
The investigation noted that the company distributed adulterated products following a formal notification from a customer and after similar notification from the Pennsylvania Department of Agriculture that pentobarbital contamination had been found, the FDA said in the letter.
In an earlier response to the investigation, the company said it was cleaning its facilities and taking corrective actions, according to the FDA documentation. However, trace amounts of the contaminant were found in feed ingredients following the cleaning period, said the US regulator.
“FDA inquired whether you planned to recall, put a hold on distributing, or send notification to all customers regarding the animal food product contaminated with pentobarbital, regardless of the customer’s business,” Bonnin said. “You stated you did not plan to do so, but had made an offer to animal food producing customers that received animal food product to remove any product deemed positive for pentobarbital and to have their tank cleaned. For customers that accepted your offer, you stated that you removed the material(s) and cleaned their tank(s).”
It remains important to remove all the adulterated feed from the market, the FDA said. “It is your responsibility to recall or otherwise provide assurance that the product is not further distributed in the marketplace.”
The list of violations reported in the warning letter is not intended to include all the violations in the facility, the agency said. “As a producer of animal food products, you are responsible for ensuring that your firm complies all requirements of federal law and FDA regulations."
JBS has a 15-day period to provide a written response outlining the steps that have been taken to correct the issues mentioned, the agency said.
The company has nine beef plants that also include rendering facilities which generate tallow and meat and bone meal, according to company information. The company’s rendering facilities produce several products including feed ingredients, oleo chemicals, bio-diesel and pet food ingredients.
"MOPAC is committed to the safety of our products and regulatory compliance," the company told us regarding the warning letter. "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."
CGMP violation
The rending company was found to have violated the FDA’s current good manufacturing practice (CGMP) requirements related to animal feed in a manner that “causes your products to be adulterated,” the FDA said.
The animal fat feed ingredients generated also were considered to be adulterated because an amount of pentobarbital was found in them, which means they included “an unsafe new animal drug,” the agency said. “The drug is unsafe because it was not used in conformance with the drug approval, which does not have a tolerance established for the presence of pentobarbital in the edible tissues of animals.”
“Therefore, when used in food-producing animals, it can render the tissues of those animals adulterated,” the agency added.
Introducing or delivering animal food or feed that is adulterated or misbranded into interstate commerce also is prohibited, the FDA said.
The company failed to assess raw materials or ingredients used during manufacturing to make sure they were appropriate for use, the agency said.
“Specifically, our investigation found that you failed to identify and exclude raw materials and ingredients containing pentobarbital,” said Bonnin in the warning letter. “For example, your firm did not conduct testing on raw materials other than grease.”
During the investigation, JBS said several changes had been made to gather more information from ingredient supplies and improve the control on incoming ingredients, the FDA said.
“These actions included refusing to receive equine ingredients, having your suppliers complete a questionnaire about their food safety practices, having suppliers sign guarantees that they do not pick up euthanized animals, and excluding suppliers that could not meet these new requirements,” the agency said. “You stated you also performed a comprehensive cleaning of your equipment.”
The company also told the FDA that it had ceased providing tallow for use in animal feed unless the ingredient came from a clean tank and had been tested to confirm that the “initial material” was negative for pentobarbital. Other changes reported included that following the cleaning process tallow products would be randomly tested to make sure that the new protocols were working.
Samples of the feed ingredients gathered by the FDA following the cleaning period were found to have trace amounts of pentobarbital, said the FDA.
“This indicates that the changes you have made to your examination of raw materials and other ingredients from your suppliers may not be sufficient to prevent pentobarbital contaminated ingredients, such as those potentially sourced from euthanized animals, from entering your facility and contaminating your finished tallow product."
Trace levels of the drug indicate that the amount present was higher than 4.0ng/g – the limit for detection – but below the 10.0ng/g amount needed for quantification, the agency said. There is no tolerance set for pentobarbital residue in edible animal tissue.
“It should be noted that from February 23, 2018 to June 6, 2018, the PDA also collected and analyzed a variety of your animal food products at your facility and at your customers’ facilities,” Bonnin said in the letter. “Their analyses of these samples indicated levels of pentobarbital ranging up to 680 ppb (ng/g).”
“On November 26, 2018, you wrote to FDA, describing your withdrawals and attempted withdrawals of pentobarbital contaminated product from your customers,” she added. “We are unable to assess your corrective action because you have not implemented a voluntary recall or otherwise provided documentation demonstrating all contaminated products were removed from the marketplace.”
