The FDA does not comment on ongoing investigations until they are complete, Megan Bensette, a spokesperson in the office of foods and veterinary medicine with the FDA, told FeedNavigator. Nor does it comment on whether or not there is the possibility of future legal action in a case.
Although there have been some questions over how information was made available to the public in the incident - which resulted in major losses for a group of family farms in Michigan - several related documents have now been posted on the FDA’s website.
Facts of the case
Shur-Green initially issued a voluntary product recall in October 2014 citing the deaths of turkeys in the previous August. The recall included all batches of soyoil containing Lascadoil sold on or before September 17. The item was intended for use as a non-food product because of the concentration of lasalocid sodium in the oil.
By that point, about 57,700 turkeys on Sietsema Farms had died and about 500 tons of feed mixed with the product were sent to the landfill. Additionally, about 35,900 head of pigs had to be kept from market for a 28-day waiting period after also ingesting feed laced with lasalocid as the product is not approved for use in pigs.
While that product is given to turkeys in small doses, the quantities reported to be found in the contaminated feed were at a far higher concentration.
Lascadoil is used in the biofuel industry and is a byproduct of the manufacture of the drug lasalocid. Lasalocid is used to prevent coccidiosis in poultry, and is approved for use in sheep and cattle as well. It is not approved for use in swine. The safe level for turkeys is 68-113 grams per ton.
However, a 483 form written in November 2014 and listing observations made by a representative of the FDA after a visit to the Shur-Green facility indicated that the company may have deliberately sold the tainted product. Comments on the form are considered notes and not the agency’s final determination.
The form records two observations:
- That the company ‘marketed, sold and shipped Lascadoil waste’ as an item that could be used in feed mixtures and told its broker on September 5 that Lascadoil was usable in feed.
- Additionally, Shur-Green had been told that animal feed had been contaminated by the Lascadoil it supplied yet the firm allegedly continued to provide it to feed manufacturers. The company was notified about an ongoing FDA investigation into tainted feed and told by its supplier to incinerate the Lascadoil, but a few days later reportedly sold Lascadoil to another firm making animal feed.
An additional warning letter was sent to the company in April alleging they had mislabeled the oil containing oleic acid, soy oil and lasalocid sodium as soyoil blend. It added that a response from Shur-Green to the November letter was lacking in details on how noted violations had been fixed and the steps taken to prevent similar instances from occurring.
The response from Shur-Green in June said that the company no longer supplied that product.
Legal action by Sietsema Farms
Sietsema Farms, the Michigan farming operations that initially reported turkey deaths from the tainted feed, is working with legal counsel regarding the possibility of pursuing charges against Shur-Green, said Rick Sietsema, company chief financial officer.
Turkey production has returned to normal now the tainted feed has been removed, he said. However, that sort of contamination is not covered by insurance.
He added that the farm has a copy of the information gathered by the state. However, he is still waiting to gain access to the information collected by the FDA.
“The state did its job, but it became a federal issue,” he said. “The state provided its information and report to us but it was fairly rudimentary – getting information from the federal level has been frustrating and it still isn’t available.”
Public disclosure
There have been questions about how much information has been readily available about the case.
The response from the Michigan Department of Agriculture and Rural Development (MDARD) is dictated by the type of event that takes place, said Jennifer Holton, director of communications for MDARD.
“If the product needed to be recalled, then communications would follow that process,” she said. “If the product was not recalled, but still of concern, communications would be similar – a possible press release, posting information on MDARD’s website, sharing the information with stakeholders to share with their members.”
In this case, information about the incident was shared both with counterpart agencies in neighboring states - Indiana, Ohio and Illinois - who also could have received the tainted product, and the FDA, she said. MDARD also contacted groups that were directly affected by the sale of the product like the Michigan Pork Producers and Michigan Turkey Producers to make sure they knew what had happened.
Because the contaminated grease had been shipped across state lines, the FDA was in charge of the investigation, and MDARD was not the lead group, said Holton. The state’s investigation has closed and information on their process and findings were reported to the state’s commission on agriculture in January.
“FDA posted Shur-Green Farms’ press release for the lascadoil recall to its website when it published it on October 23,” said Bensette. “The turkeys at Sietsema Farm Feeds that were exposed to feed contaminated with Lascadoil died before they made it to market, and exposed hogs were subjected to the recommended 28-day withdrawal period before going to slaughter.”
The 483 form listing observations made by a representative of the FDA when they visited the Shur-Green facility was also posted on the FDA’s website, she said.
Additionally, once the investigation is complete, information about the case may be obtained through use of a Freedom of Information Act request (FOIA), said Bensette. However, this does not include confidential commercial information or trade secrets gathered.
Such investigations, though, can take a while to complete because they may necessitate discussions with many of the groups involved including customers, retailers, sellers or the product’s manufacturer, she said. They also likely will include a review of the process that led to the contamination starting with the source of the ingredients through their distribution.
“Investigations gather preliminary findings to determine facts concerning a particular issue so the agency can make informed and sound decisions,” said Bensette. “FDA investigators are required not to release or divulge any information obtained during FDA investigative or inspectional operations, unless they are authorized to do so by law and the sharing (regardless of the manner) complies with FDA’s information disclosure laws and procedures.”
Preventing future contamination
Although Sietsema said he would gladly make any changes necessary to prevent a similar event from happening in the future, it would be an onerous task.
“What would I test for, or look for in every feed ingredient?” he said. “There are hundreds of thousands of contaminates so what would I look for?”
Additionally, it would take both time and space to have the ingredients tested and to store them while they are being evaluated, he said. He gave the example of buying gas at a gas station, consumers assume they are getting the type of gas they select at the pump and have little way of knowing if the gas is incorrectly labeled, nor do they have it tested every time they fill their car.
“I’ve got to rely on the vendors supplying the products to ensure they meet the specs,” he said.
The best practice recommended is to review product labels to ensure that ingredients are properly named, said Holton. Additionally, producers and distributers can review products and invoices to make sure feeds and feed ingredients are identified clearly and correctly.
No one at Shur-Green Farms has returned calls for comment.