“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,” the warning said. A written response from the company on Feb. 16 indicated that the product contaminated with inorganic arsenic was on hold at the facility and would be voluntarily disposed, according to FDA. Additional problems pointed out in the warning letter concerned the food hazard of patulin, a mycotoxin found on rotten, moldy and damaged apples. “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,” the warning letter said. “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.” While the agency acknowledged that Valley Processing does not physically sort every apple, it stated that the firm’s current operational procedure is not adequate to control for patulin. “Your response states you purchase cull apples, which may contain decay, worm holes and internal breakdown, and states cull apples are acceptable to process. Any apples which are rotten, moldy, bruised or damaged should be trimmed or culled from production,” FDA stated in the warning letter. The company identified metal debris as a food hazard, but it was not identified in its revised HACCP plan nor are critical control points listed to control metal, the agency added. While company plans were to install and calibrate metal detectors at each packaging location, FDA found that response inadequate. “A food hazard that is reasonably likely to occur is one for which a prudent processor would establish controls because there is a reasonable possibility that, in the absence of those controls, the food hazard will occur. Your response does not identify what, if any, control measures are currently in place, absent a functioning metal detector, to prevent, eliminate or reduce the metal hazard,” the warning letter stated. Finally, FDA noted that Valley Processing holds apples outside prior to processing, without atmospheric or temperature controls, in open wooden bins for two months or longer before processing. “Your written response indicates that it is an acceptable industry practice to store apples intended for juice processing in the outside environment. We do not agree with your assessment and find your written response inadequate. Storage in this condition will increase the probability of patulin production as well as the level of patulin in the finished product,” the warning letter stated. Adriatic Seafood Inc. On June 16, FDA sent a warning letter to Adriatic Seafood Inc. of Staten Island, NY, stating the company’s seafood importing facility had been inspected from April 22 through May 12, 2016. That inspection revealed “serious violations” of the seafood HACCP regulations, according to the letter, specifically that the company did not implement an affirmative step for its fresh anchovies and fresh sardines as required by federal regulations. If these problems are not promptly corrected, FDA noted, the agency can refuse entry to the U.S. for these imported fish or fishery products, including placing them on “detention without physical examination” status and seize the products and/or otherwise stop the firm from further violation of the law. Suisan Co. Ltd. Seafood HACCP issues were also identified after FDA inspected the seafood processing facility of Suisan Co. Ltd. in Hilo, HI, on March 22 and 24. According to a June 14, 2016, warning letter, the company’s revised HACCP plan for its tuna intended for raw consumption was inadequate to control for “the significant hazards of histamine formation and pathogens.”