The FDA announced Thursday that it was denying a request for a hearing on the ban and that it was moving forward with its decision to debar the Quebec-based feed and feed additive company. The ban took effect on March 1 and a notice was published in the Federal Register.
“The Food and Drug Administration (FDA) is denying a request for a hearing submitted by Meunerie Sawyerville, Inc. and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Meunerie Sawyerville for 5 years from importing articles of food or offering such articles for import into the United States,” the agency said. “FDA bases this order on a finding that Meunerie Sawyerville was convicted of felony offenses for conduct relating to the importation of food into the United States.”
The FDA informed the company in July of 2017 that the agency was considering halting the company’s ability to import products to the US and that it could request a hearing on the matter. However, when that request was denied, the import ban took effect.
The feed company did not respond to requests for comment ahead of publication.
In 2015, Meunerie Sawyerville pleaded guilty to two felony counts related to the exporting of cattle feed into the US and the use of fake documents, according to information from the US Attorney's Office for the District of Vermont.
At that time, the company was sentenced to one year of probation and two fines for the felony convection totaling $80,000, according to the US Attorney’s Office.
The company was charged with making a false statement to officials with Customs and Border Protection and of sending to market cattle feed with overly high levels of the drug monensin, said the FDA. The monensin levels in the feed were higher than packaging indicated and above the level allowed by the FDA.
When the feed tested high for the drug at the border, the company was told to store the feed pending additional testing, according to information from the US Attorney’s Office. However, the company delivered the cattle feed, without informing the producer, and generated a second shipment of similar cattle feed with the apparent plan of using fake documents to cross the border and then deliver the second shipment for the required testing.
In July, Yves Bolduc, company president was informed that the FDA was planning on issuing a five-year ban on the company’s ability to import feed or food into the US stemming from the two felony counts. The company was offered a chance to request a hearing on the matter.
The FDA has the ability to debar a person from importing feed, or offering it for import, into the US if a person has been convicted of a felony related to importing feed, the agency said. The action is considered “timely” because it is taking place less than five years after the conviction.
“In this case Meunerie Sawyerville, Inc.’s felony convictions were related to the importation of cattle feed medicated with the drug monensin at a concentration above that allowed by FDA and above the amount indicated on the feed label,” the agency said. “As such, FDA finds that the felony convictions were for conduct relating to the importation into the United States of an article of food, in this case a medicated cattle feed.”
The 5-year period of debarment was considered, in part, because the company’s management was involved in the incident. Other elements reviewed included the lack of steps taken to mitigate the effect of the violation on the public and the nature of the offenses, although the lack of previous criminal convictions was considered a favorable factor.
“FDA concludes that the facts supporting the unfavorable factors outweigh those supporting the favorable factors, and therefore warrant the imposition of a five-year period of debarment,” it said.
The hearing was offered if Meunerie Sawyerville had specific information relating to the case, said the FDA. Allegations or denials were not sufficient to support a hearing.
The company’s request for a hearing was denied on the grounds that it had not provided the necessary information, the agency said. The company did not dispute the seriousness of the offenses, the involvement of management or that it is subject to debarment under regulation.
Meunerie Sawyerville argued that it has taken steps to prevent the contamination of animal feed with monensin in the future by ceasing to use monensin, and that its voluntary actions to mitigate the problem should not be considered unfavorable, the agency reported. The company also argued that being debarred would hurt the business.
However, a review found that the same management remains in place, that the company has not done enough to address the causes that led to the offences or to provide assurances they will not happen again and that it did not do enough to actually mitigate the situation, said the FDA. Additionally, issues raised about the potential for damage to the company were not a relevant reason for a hearing.