Lawsuit: Dead rats, high arsenic levels found at Sunnyside juice plant
SUNNYSIDE, Wash. — The federal government is suing a former Sunnyside fruit processing company over claims it repeatedly violated food safety standards and sold juice products that were “unfit for human consumption.”
In the lawsuit against Valley Processing, inspectors from the Food and Drug Administration reported seeing dead rodents inside the facility, moldy fruit stored outside for months and juice products with high levels of toxins, including inorganic arsenic and patulin.
“Defendants have an extensive history of processing juice under grossly insanitary conditions,” the lawsuit said. “Although Defendants claimed to be interested in making necessary changes, compliance with the law has clearly not been a priority.”
The juice manufacturing plant sold their juice and juice concentrate products to companies nationwide, which, in turn, packaged and distributed the juice to consumers.
According to the lawsuit, apple juice originally processed at the Sunnyside facility eventually ended up in the hands of children across the country as part of a federal school lunch program — about three million servings every year.
“I am disappointed in the government’s decision to bring this action against the company,” owner Mary Ann Bliesner said in a statement to KAPP-KVEW. “I have always placed as my top priority the production of juice that is of the highest quality.”
In September, Bliesner shut down Valley Processing and sold the juice manufacturing plant to Milne Fruit Products, Inc.
“While it was a difficult decision to make, after decades of operating Valley Processing I made the decision to sell the company assets and leave the juice industry,” Bliesner said in her statement.
According to the Valley Processing website — which has since been taken down — their company was, “one of the largest, privately held, wholesale juice manufacturing plants in the nation.” It’s been in operation since 1980.
When asked for comment, FDA representatives told KAPP-KVEW “FDA does not comment on proposed or pending litigation. Please feel free to reach out once the case has been closed.”
Representatives from the U.S. Attorney’s Office — which filed the lawsuit Friday in the U.S. District Court for the Eastern District of Washington — did not respond to requests for comment.
FDA: Company failed to investigate high levels of arsenic in its fruit juice products
Prior to the closure, Valley Processing operated three manufacturing plants, an ambient — or “room temperature —warehouse, a cold room and three coolers at their main location at 108 Blaine Ave. in Sunnyside.
The company also had an outdoor, ambient storage facility at 130 U.S. Grape Rd. and a storage area in the maintenance building at 105 S. First St., the lawsuit said.
During annual inspections between 2016 and 2019, the FDA documented at least 14 violations of food safety standards at Valley Processing facilities.
“Defendants repeatedly promised, both orally and in numerous letters to FDA, to bring their facility into compliance with regulatory requirements,” the lawsuit said. “The most recent FDA inspection showed that Defendants kept none of these promises.”
Specifically, the lawsuit claims the company failed to comply with the Hazard Analysis and Critical Control Point regulations for juice — HACCP — and the Current Good Manufacturing Practice regulations for food, known as CGMP.
According to the lawsuit, FDA inspectors first detected high levels of arsenic in Valley Processing juice products during a routine, annual inspection in January 2016.
In one sample of ready-to-consume apple juice, inspectors found levels of inorganic arsenic at 88.1 parts per billion — nearly nine times the acceptable amount set by the FDA, which is 10 ppb.
Additionally, FDA records show that on Oct. 25, 2018, the company voluntarily recalled nearly 14,800 gallons of apple juice concentrate that had been distributed nationally and internationally after finding the juice contained high levels of inorganic arsenic.
Some arsenic naturally occurs in soil and is absorbed by nearby plants, but inorganic arsenic — which comes from pesticides and other manmade sources — can be toxic at high levels or with prolonged exposure.
“Inorganic arsenic is a toxic substance and prolonged exposure to high levels of inorganic arsenic is associated with cancer, skin lesions, developmental effects, cardiovascular disease, neurotoxicity, and diabetes in humans,” FDA inspectors told the company in a warning letter.
It’s unknown if any of the apple juice provided to schoolchildren contained high inorganic arsenic levels, but health officials note that arsenic is a greater concern for children, whose systems are not able to process harmful chemicals as well as adults.
Studies show exposure to arsenic, over time, can lead to children having a lower IQ, impaired brain development, growth problems, breathing problems, an unhealthy immune system and cancer as an adult.
Fruit containing higher levels of inorganic arsenic often comes from orchards that previously used lead-arsenate pesticides, which were frequently used in apple and pear orchards between 1905 and 1947, according to the Washington State Department of Ecology.
While they’re no longer in use, the pesticides left lasting arsenic and lead contamination in the surrounding soil throughout the state. The department estimates about 58,000 acres are potentially affected in Yakima County.
“You assert due to volcanic ash, inorganic arsenic is expected in fruit growing areas,” the FDA told the company in a warning letter. “However, this remains unclear on what, if any, controls have been implemented to prevent, eliminate or reduce the inorganic arsenic hazard.”
After being put on notice by the FDA, the company updated its food safety plan to include mandatory testing for total arsenic levels and a commitment to try to determine which orchard the high-arsenic fruit came from and take them off the supplier list.
If initial testing showed high total arsenic levels, Valley Processing was supposed to do another test to determine how much of the arsenic was of the more harmful, inorganic variety.
The lawsuit claims that while high total arsenic levels were noted on 17 lots of apple juice products produced between July 2018 and April 2019, none were retested to determine how much of it was inorganic and potentially harmful.
“[Valley Processing] only collected the total arsenic data but did not investigate, analyze, or trend the data to determine the cause of the high arsenic in the juice products,” the lawsuit said.
FDA: High levels of the mycotoxin patulin exacerbated by unsanitary conditions
According to the lawsuit, FDA inspectors repeatedly found high levels of patulin at the plant, a mycotoxin produced by certain species of molds that grow on apples, pears and other foods.
“Exposure to high levels of patulin over time may pose health hazards in humans, including nausea, vomiting, and gastrointestinal disturbances,” the lawsuit said.
On June 28, 2019, the company voluntarily recalled 11,500 gallons of apple juice that had patulin at a level greater than 50 ppb, which is the FDA’s limit.
Recall records show the apple juice had been distributed to California juice manufacturer Ludford’s Inc, which sells Cal-Maid brand juice.
In the lawsuit, FDA officials said the company’s unsanitary practice of storing fruit outside, with no atmospheric or temperature controls in uncovered wooden bins for months at a time contributed to their high patulin levels.
“Your written response indicates that it is an acceptable industry practice to store apples intended for juice processing in the outside environment,” FDA officials said in a warning letter to the company. “We do not agree with your assessment and find your written response inadequate.”
Additionally, company officials reportedly told the FDA they purchase “cull apples,” which are apples that growers determine aren’t good enough to sell at a grocery store; they can be blemished, incorrectly sized, misshapen or otherwise undesirable.
“Even a small percentage of rotten, moldy, and damaged apples may contain high enough levels of patulin to result in the finished product exceeding FDA’s 50 ppb action level,” FDA officials said in a warning letter to the company.
In the letter, FDA officials said the sorting process is especially important when dealing with cull apples because they “may contain decay, worm holes and internal breakdown.”
“We are particularly concerned given that your firm only monitors the top visible layer of incoming apple bins, which is not an adequate sorting method,” FDA officials told the company in a warning letter.
The lawsuit claims that, similar to when the alleged arsenic level violations were reported, Valley Processing promised to test and further investigate high patulin levels, but failed to do so.
“FDA investigators found no evidence that Defendants investigated,” the lawsuit said.
At one visit to Valley Processing, inspectors saw about 46 apples that made it past the sorting line in a 10-minute period, despite being visibly deteriorated with mold and rot, the lawsuit said.
Instead of working harder to limit the amount of moldy fruit they use, the lawsuit claims Valley Processing lowered its quality control standards to allow greater levels of rot in their apples.
In October 2018, around the same time of the patulin-level-based apple juice recall, the company increased the amount of core rot an apple can have, from less than 1% to less than 10%, according to the lawsuit.
“When questioned by FDA investigators about the change, Defendant Mary Ann Bliesner was unaware of the change, despite signing the revised HACCP plan, and could not provide any scientific justification or support for the change,” the lawsuit said.
FDA: Company mixed ‘leftover sludge’ and expired juice concentrate with new product to hide contamination
During an inspection in July 2018, FDA investigators reportedly learned the company was storing grape juice concentrate outside in covered barrels at ambient temperatures at a previously undisclosed facility.
“Many of these barrels contained grape juice concentrate that was several years old, with some lot codes dating back to 2008,” the lawsuit said. “As confirmed by FDA sampling, the grape juice concentrate in these barrels was contaminated by filth and mold, and thus not suitable for human consumption.”
The company reportedly took the expired grape juice concentrate and mixed it with the “bottoms” of the barrels, described in the lawsuit as “leftover sludge” likely to contain contaminants.
“Defendants mixed the juice concentrate from both the ambient barrels and the “bottoms” with newer lots to hide the contamination,” the lawsuit said.
The company reportedly used the same “unacceptable” process to cover up hazardous patulin levels in apple juice, blending high-patulin products with fresh juice to dilute the levels.
“Defendants promised to stop both of these practices,” the lawsuit said. “But … FDA investigators confirmed during the June 2019 inspection that Defendants continued both of them.”
FDA: Unsanitary practices rendered juice products “unfit for human consumption”
The lawsuit claims that in addition to filth, contamination and mold, FDA inspectors found certain areas of the facility in disrepair, with gaps in storage room walls leading directly outside and liquid leaking from a hole in the roof of a warehouse onto cleaning materials.
According to the lawsuit, Valley Processing had no standard operating procedures for sanitation and did not frequently monitor or keep accurate records of sanitation conditions in their facilities.
FDA inspectors observed “egregious” unsanitary conditions, including animal droppings, bird feathers and insect fragments on top of barrels holding juice concentrate, the lawsuit said.
While inspecting conditions at one of the warehouses, investigators reportedly found a dead squirrel on the floor and live birds flying around inside.
“During the 2018, 2017, and 2016 inspections, FDA investigators observed numerous live and dead animals, including mice, rats, squirrels, and birds, throughout various buildings used for both storage and manufacturing,” the lawsuit said.
Lawsuit: Company should not operate again, must pay back FDA investigation costs
The lawsuit asks for a permanent injunction preventing Valley Processing from reopening, ordering any leftover juice products to be destroyed and requiring the company to pay back the costs of the FDA investigation.
Rather than going to trial, attorneys representing the federal government proposed a consent decree, which allows parties to resolve a dispute in a civil case without the defendants admitting liability.
Under the consent decree, Bliesner could not reopen the company without going through a rigorous FDA process. Her full statement to KAPP-KVEW read:
“I am disappointed in the government’s decision to bring this action against the company. I have always placed as my top priority the production of juice that is of the highest quality. I recognize the government identified numerous areas in which the company could have done a better job of complying with regulatory requirements. While it was a difficult decision to make, after decades of operating Valley Processing I made the decision to sell the company assets and leave the juice industry. I intend to fully comply with the terms of the consent decree.”