The order covers Finger Lakes Farmstead Cheese Company, Trumansburg, and its co-owner Nancy Taber Richards.
Richards told FoodQualityNews.com that the rules have changed and time is needed to catch up with the extra requirements under the Food Safety Modernization Act (FSMA).
“I make raw milk cheese, and age it on wooden shelving, and it is hard for me not to feel targeted as I know the FDA is extremely uncomfortable with both those things, although I am in compliance with all regulations as far as I know, and am intent on producing an excellent product,” she said.
“My complaint would only be that I was not clear on what the FDA needed me to do to be in compliance, especially given my business size and gross annual income.
“The FDA has been given extra time to implement FSMA but they come to a business like mine and expect it all done already.
“I don't have firm numbers, but I have probably lost almost a year's income over this action and personally feel that it would have been much more effective for the FDA to help me understand what they needed, it would have saved both of us a lot of legal fees and wasted time.”
Consent decree order
Finger Lakes, the manufacturer and distributor of raw cow’s milk cheese, cannot receive, prepare, process, pack, hold or distribute food until it demonstrates a control program to eliminate Listeria monocytogenes from its production facility and products.
The company must retain an independent sanitation expert; develop a control program for Listeria in the facility, train employees on sanitary food handling; and destroy all food currently in the plant.
It has been in business since 2006 making aged raw milk Gouda-style cheese from the milk of the family's dairy and has a 2200 sq. ft. plant, about 600 sq. ft. production and 900 sq. ft. aging, which was built in 2004.
Richards said she was raised on a dairy farm and started the business with an experienced Dutch cheesemaker who was there until 2006, adding that artisan producers can be viewed as less sophisticated than larger plants when the real issue is fewer financial and manpower resources.
It makes about 12,000lbs of cheese a year with four months of cheesemaking but has ambitions to produce up to 60,000lbs. She has had employees in the past but is currently operating alone.
FDA laboratory testing in 2012 and 2013 found Listeria monocytogenes in Finger Lakes’ finished cheese products and in its facility but no illnesses have been reported.
On the same side
Richards said that while she may not agree with all of the process both parties are on the same side – in that they don’t want anyone to get sick.
“In 2012, we dropped everything and did a solid week of extra cleaning prior to restarting production. We did the same in 2013," she said.
“Where I think I went 'wrong' was that I failed to do my own subsequent environmental swabbing to assure that the extra cleaning was effective.
“I want to say that even though I may not agree with some of the process, I respect the FDA's position and am not averse to being monitored.
“I am absolutely in concord with not wanting anyone to get sick from my product, and wanting to maintain the plant in top notch professional condition, albeit on a small artisan scale.”
Warning letter and inspection
FDA inspections since 2012 have documented deficiencies in the company’s processing facility and issued a warning letter in October 2012.
The agency inspected the facility from June 5 - 21, 2012, and from July 9 - 12, 2012.
FDA said in June 2012 it collected a sample of Bianco Brie-style Cheese found to be contaminated with Listeria monocytogenes, however it was not distributed and was destroyed.
Five environmental swabs collected on June 5, 2012 tested positive for the pathogen.
The swabs were from inside of a brine tank (right side); cheese rack in the aging cooler; cheese board in the aging cooler; outside of a brine tank (left side); and a processing room floor drain.
Analysis using Pulsed Field Gel Electrophoresis (PFGE) showed that the isolates from the environmental samples were indistinguishable by a primary and secondary enzyme, indicating that the pathogen may have been transported throughout the facility and established in niche areas.
Richards said that while the 2012 and 2013 sampling showed the presence of Listeria, the FDA views it as an ongoing problem while it is ‘reasonable to conclude’ that it was a potential recontamination.
Cleaning procedures are in place and the suppliers of the chemicals they use help set up the best way to use them, she added.
After being informed of the results the firm stopped production to clean and sanitize the facility.
During the July 2012 inspection the FDA said an investigator found food contact and non- food contact surfaces were not cleaned as necessary to protect against contamination.
“You failed to clean and sanitize all of the wooden boards used to hold your Gouda-style cheese in the large aging cave even after FDA informed you of positive L. monocytogenes results found on one of these boards,” said the agency in the warning letter.
If the company is permitted to resume operations, the FDA may require it to recall products or cease production if future violations occur.