Laura Alvey, spokesman for the FDA's headquarters, declined to elaborate.
But in an Aug. 14 "warning letter," the FDA's Joann M. Givens said Vreba-Hoff's livestock facility on Dillon Highway in rural Lenawee County is "so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply."
"You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues," Ms. Givens, director of the FDA's district office in Detroit, wrote.
The letter was sent to Steven Vander Hoff, part-owner of that dairy and another one Vreba-Hoff operates three miles to the west off U.S. 127 in Hillsdale County. The two facilities, with 6,000 cows between them, are defined by Michigan as concentrated animal feeding operations, or CAFOs. Vreba-Hoff's development company, across the state line in Fulton County's nearby Wauseon, has been helping emigrees from the Netherlands establish their own dairy CAFOs in the Michigan-Ohio-Indiana region.
The FDA gave Vreba-Hoff until Aug. 29 to respond. The company was told that regulatory action could include "seizure and/or [court] injunction," according to the Aug. 14 letter.
Ms. Givens declined to be interviewed. So did Ms. Alvey, except to confirm Tuesday that its case against Vreba-Hoff remains open, and the company met its deadline for responding.
The Lenawee County site was inspected by the FDA April 24-26, the letter said.
Vreba-Hoff on Tuesday released a statement about the probe through Edward Howard & Co., a public relations firm in Cleveland. The firm quoted Vreba-Hoff spokesman Cecilia Conway as saying the company strives to comply with all state and federal regulations.
Vreba-Hoff cows sold to undisclosed recipients on Dec. 14, 2005, and June 17, 2005, had excessive penicillin and oxytetracycline, respectively, when "slaughtered for human food use," according to the FDA's Aug. 14 letter.
Ms. Conway, through the Cleveland public relations firm, said the cow with penicillin received a "dry cow" treatment to prevent infection and to "increase the quality of milk production when a cow begins giving milk again after giving birth to a calf."
Vreba-Hoff waited 71 days before releasing that animal for slaughter, 11 more than the required 60-day period, the statement said.
The June, 2005, incident "apparently resulted from a regrettable human error regarding proper dosage of an antibiotic [oxytetracycline] being used in one cow and the correct recording of that treatment," according to the statement attributed to Ms. Conway.
It also said procedures to administer antibiotics and record data have been improved "to avoid future errors."
The FDA refused to release the company's response.
But Vreba-Hoff provided a copy of it to The Blade Tuesday night. Dated Aug. 21 and signed by Jeff Poland, herd manager for Vreba-Hoff's facility on Dillon Highway, the letter stated that the cow with penicillin was the only one treated with that drug.
Mr. Poland also stated in that document that the cow with oxytetracycline originated from Vreba-Hoff's facility in Hillsdale County. He said the FDA should recognize the two facilities as separate operations.
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