"Dehn’s Pumpkins offers a Halloween attraction that is open to the public every year. In 2013, children were allowed to pet and feed cows that are raised on the property. Testimony at trial proved that on the day the child visited the facility, manure, contaminated bedding, and hay were in the enclosure where the cows were kept. Manure was also on the cows’ hides and hooves, and on the gate that separated the children from the animals."While this is awful for the child, you have to think every a farm operation that has a petting area for farm animals is reading this and asking themselves if it is worth the risk. At a minimum, it is important to have handwashing signage and an areas to wash hands.
"There were no handwashing stations, warning signs, or any other measures to prevent transmission of disease at the facility. The business owners claimed they had no idea that children could get sick by touching animals. They did not take preventive measures because they didn’t think the setting was a risk to children."
"The 10 year old girl went to the farm with her parents on the weekend of October 12 – 13, 2013 and got sick a few days later. At least seven people were sickened in that particular E. coli O157:H7 outbreak. The Minnesota Department of Health linked the illnesses to cows that were in the animal attraction at the farm. At least three of the case patients had bacterial isolates with the same DNA fingerprint."
"We asked representatives from industry associations and other organizations we interviewed about their experiences submitting questions to the TAN. These representatives generally told us that wait times for answers from the TAN can be long, and some had not yet received answers to their questions. For example, representatives from one industry association told us it took 4 months to get an answer through the TAN."While FDA is working on reducing the response times, there are questions that are not as easy to answer. In some cases, the rule is still under development or the questions are more complex.
".....according to FDA officials, response times to TAN questions may be longer in some cases because agency guidance on the produce rule and other FSMA rules is still under development, and the agency does not want to provide information through the TAN that might conflict with the subsequent guidance. In addition, officials said that while simpler questions can often be addressed immediately by FDA staff that monitor the TAN, about 95 percent of the questions are more complex. These questions are forwarded to subject matter experts within the agency and, consequently, require more time for a response. According to FDA, median response time for questions forwarded to subject matter experts is 22 business days. FDA officials told us that if a question is still unaddressed after 30 days, FDA will send an automated message saying the agency is working on a response; a second automated message is sent after 60 days if the question is still unresolved."These rules are new for many including the FDA, and many components of the rule have not yet been worked out for every permutation So while delays in response times are completely understandable, I think that FDA officials and their surrogates need to acknowledge this when suggesting people go to the TAN for answers. And considering that FDA technical support staff have a hard time answering these questions, this needs to be taken into account when inspectors are doing facility inspections.
