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`JEFFREY B. CLARK
`Acting Assistant Attorney General
`Civil Division
`DANIEL J. FEITH
`Deputy Assistant Attorney General
`GUSTAV W. EYLER
`Director
`KENDRACK D. LEWIS
`Trial Attorney
`Consumer Protection Branch
`U.S. Department of Justice, Civil Division
`P.O. Box 386
`Washington, D.C. 20044
`Telephone: (202) 353-3881
`Fax: (202) 514-8742
`WILLIAM D. HYSLOP
`United States Attorney (EDWA)
`TIMOTHY M. DURKIN
`Civil Chief, Asst. U.S. Attorney
`Post Office Box 1494
`Spokane, WA 99210-1494
`Telephone: (509) 353-2767
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`Attorneys for Plaintiff
`
`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF WASHINGTON
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`
`
`UNITED STATES OF
`AMERICA,
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`Plaintiff,
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`v.
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`VALLEY PROCESSING, INC., a
`corporation, and MARY ANN BLIESNER,
`individually,
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`Defendants.
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`Case No. 1:20-cv-3191
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`COMPLAINT FOR PERMANENT
`INJUNCTION
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`Plaintiff United States of America, by and through its undersigned attorneys,
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.2 Page 2 of 20
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`respectfully represents as follows:
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`INTRODUCTION
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`1. The United States of America brings this action on behalf of the United States
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`Food and Drug Administration (“FDA”) pursuant to the Federal Food, Drug, and
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`Cosmetic Act (the “Act”), 21 U.S.C. § 332(a), to permanently enjoin and restrain Valley
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`Processing, Inc. (“Valley Processing”) and Mary Ann Bliesner (collectively,
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`“Defendants”), from introducing or delivering for introduction into interstate commerce,
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`or the causing thereof, food that is adulterated, in violation of 21 U.S.C. § 331(a), and
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`causing such food to become adulterated while it is held for sale after shipment of one or
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`more of its components in interstate commerce, in violation of 21 U.S.C. § 33l(k).
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`JURISDICTION AND VENUE
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`2. This Court has jurisdiction under 21 U.S.C. § 332(a) and 28 U.S.C. §§ 1331,
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`1337, and 1345, and personal jurisdiction over all parties.
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`3. Venue in this district is proper pursuant to 28 U.S.C. § 1391(b) and (c).
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`DEFENDANTS
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`4. Defendant Valley Processing is a Washington corporation previously
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`headquartered at 108 Blaine Ave., Sunnyside, Washington 98944. Valley Processing
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`manufactured single strength fruit juice and fruit juice concentrate, including bulk apple,
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`pear, and grape juice products distributed in pails, barrels, totes, and tanker trucks. The
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`company was incorporated on July 16, 1980, and had seventy-one (71) employees. The
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`company supplied apple juice through one customer to the United States Department of
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.3 Page 3 of 20
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`Agriculture (“USDA”) school lunch program, providing approximately 2,964,000 apple
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`juice servings to schoolchildren every year. The company’s facilities included three
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`manufacturing plants, an ambient warehouse (“Mojo Warehouse”), a cold room, and
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`three coolers, all located at the Blaine Avenue location. In addition to the Blaine Avenue
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`facilities, Defendants also stored product in an ambient storage facility, where product
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`was stored outside, located at 130 US Grape Road, Sunnyside, Washington 98944, and in
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`another storage room known as the Briner Cold Room, located in the maintenance
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`building at 105 South First Street, Sunnyside, Washington, 98944.
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`5. Defendant Mary Ann Bliesner is Valley Processing’s Owner, President,
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`Secretary, and Treasurer. At all times relevant to the allegations in this Complaint, Ms.
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`Bliesner was responsible for the day-to-day management of the company’s juice
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`production facility, including supervising and training employees. She was the most
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`responsible person at the company, overseeing operations, and had the authority to take
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`corrective actions, as well as the authority to hire and fire employees.
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` HEALTH RISKS ASSOCIATED WITH DEFENDANTS’ PRODUCTS
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`6. Defendants’ juice products have been found to contain inorganic arsenic and
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`patulin, both toxins which pose a health risk to consumers.
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`7. Arsenic is an element that occurs in the environment from both natural and
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`manmade sources, including the erosion of arsenic-containing rocks, volcanic eruptions,
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`contamination from mining and smelting ores, and previous or current use of arsenic-
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`containing pesticides. Arsenic is found in both inorganic and organic forms, and
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.4 Page 4 of 20
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`inorganic arsenic is generally considered more toxic than organic arsenic. Exposure to
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`inorganic arsenic has been associated with cancer, skin lesions, cardiovascular disease,
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`neurotoxicity and diabetes in humans. Inorganic arsenic is a hazard that is reasonably
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`likely to occur in processing both apple and pear juice products. Thermal processing,
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`including pasteurization, does not destroy arsenic.
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`8. Patulin is a mycotoxin produced by certain species of molds that may grow on
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`a variety of foods, including apples and pears. High levels of patulin can be produced in
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`rotting or moldy apples or pears. Apples and pears that have been damaged, by falling off
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`the tree, by insects or birds, or by rough handling, are more susceptible to the growth of
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`patulin producing molds. Storage of apples under conditions that do not control mold
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`growth can also lead to high levels of patulin. If fallen fruit, moldy, rotten, bruised,
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`damaged, or improperly stored apples are used to make juice, high levels of patulin can
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`occur in the juice even if it is pasteurized. Thermal processing, including pasteurization,
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`does not destroy patulin.
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`9. Exposure to high levels of patulin over time may pose health hazards in
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`humans, including nausea, vomiting, and gastrointestinal disturbances. FDA has
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`established an action level of 50 parts per billion (“ppb”) in apple juice. Patulin can be
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`destroyed by fermentation, so it is not found in either alcoholic beverages or vinegars
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`produced from apple or pear juices.
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.5 Page 5 of 20
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`REGULATORY FRAMEWORK
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`10. Defendants’ juice products are food within the meaning of the Act, 21 U.S.C.
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`§321(1).
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`11. FDA’s food current good manufacturing practice (“CGMP”) regulations
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`establish basic practices that must be followed, and conditions that must be maintained,
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`by entities or individuals, like Defendants, who receive, prepare, process, pack, hold, or
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`distribute food. See 21 C.F.R. Part 117 subpart B. The purpose of CGMP is to ensure that
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`food is processed in a safe and sanitary manner.
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`12. Juice processors must monitor, with sufficient frequency, their sanitation
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`conditions and practices used during processing to ensure, at a minimum, that they
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`conform with CGMP regulations for manufacturing, packing, or holding human food,
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`see, e.g., 21 C.F.R. Part 117 subpart B. 21 C.F.R. § l 20.6(b). Violations of CGMP help to
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`determine whether the facilities, methods, practices, and controls used to process juices
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`are sanitary and safe. 21 C.F.R. § 120.5; see also 21 C.F.R. Part 117 subpart B.
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`13. Defendants are also subject to the juice Hazard Analysis and Critical Control
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`Point (“HACCP”) regulation, 21 C.F.R. Part 120, because they manufacture juice
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`products that are both sold as juice and that are “used as an ingredient in beverages,” see
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`21 C.F.R. § 120.1, and because Defendants’ manufacturing operations constitute
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`“processing,” as defined by 21 C.F.R. § 120.3(i)(l).
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`14. The juice HACCP regulation, 21 C.F.R. Part 120, creates a system to prevent
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`the occurrence of potential food hazards in juice. HACCP achieves this goal by requiring
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`juice processors to assess their processing operations (known as the hazard analysis),
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`identify points in the process at which various hazards may occur (known as critical
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`control points), and establish measures to control, prevent, or eliminate those hazards
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`(known as critical limits). See 21 C.F.R. §§ 120.7-120.13.
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`15. Under the juice HACCP regulation, every juice processor must develop, or
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`have developed for it, a written hazard analysis to determine whether there are food
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`hazards that are reasonably likely to occur during processing for each type of juice
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`produced and to identify control measures that the processor can apply to control those
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`hazards. 21 C.F.R. § 120.7(a). Whenever a hazard analysis identifies one or more food
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`hazards that are reasonably likely to occur during processing, the processor must have
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`and implement a written HACCP plan to control the identified food hazards. 21 C.F.R. §
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`120.8.
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`16. Additionally, a juice processor’s HACCP plan must identify “critical control
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`points” (“CCPs”) in the juice manufacturing process at which a control measure can be
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`applied that “is essential to reduce an identified food hazard to an acceptable limit.” 21
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`C.F.R. §§ 120.3(d), 120.7(a)(5).
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`17. For each CCP, the HACCP plan must establish a “critical limit,” i.e., the
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`“maximum or minimum value to which a physical, biological, or chemical parameter
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`must be controlled ... to prevent, eliminate, or reduce to an acceptable level, the
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`occurrence of the identified food hazard.” 21 C.F.R. §§ 120.3(e), 120.8(b)(3).
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`18. The juice HACCP regulation further requires that juice processors have and
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`implement a sanitation standard operating procedure that addresses sanitation conditions
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`and practices before, during, and after processing. 21 C.F.R. § 120.6.
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`19. Under the Act, 21 U.S.C. § 342(a)(4), food is adulterated if it has been
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`“prepared, packed or held under insanitary conditions whereby it may have become
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`contaminated with filth, or whereby it may have been rendered injurious to health.”
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`20. Under the Act, 21 U.S.C. § 342(a)(3), food is adulterated if “it consists in
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`whole or in part of any filthy, putrid, decomposed substance, or if it is otherwise unfit for
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`food.”
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`21. Juice products that are processed without adhering to the CGMP requirements
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`or the juice HACCP regulation are adulterated within the meaning of 21 U.S.C. §
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`342(a)(4).
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`22. In addition, juice products are adulterated under 21 U.S.C. § 342(a)(4) when a
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`manufacturer’s quality control operations do not ensure food is suitable for human
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`consumption. See 21 C.F.R. § 117.1(a)(1)(ii); 21 C.F.R. § 117.80(a)(2).
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`DEFENDANTS’ VIOLATIONS
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`23. Defendants violated 21 U.S.C. § 331(a) by introducing or delivering for
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`introduction into interstate commerce, or the causing thereof, food that is adulterated
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`within the meaning of 21 U.S.C. § 342(a)(4) and 21 U.S.C. § 342(a)(3).
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`24. Defendants violated 21 U.S.C. § 331(k) because they cause food held for sale
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`after shipment of one or more components in interstate commerce to become adulterated
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`within the meaning of 21 U.S.C. § 342(a)(4) and 21 U.S.C. § 342(a)(3).
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`25. Defendants distributed their juice products in interstate commerce to
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`customers located in California.
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`26. Defendants received tartaric acid, a preservative used in their juice products,
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`from a supplier in Spain.
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`27. Defendants’ juice products are adulterated within the meaning of 21 U.S.C. §
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`342(a)(4), in that they have been prepared, packed, or held under insanitary conditions
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`whereby they may have been contaminated with filth, or whereby they may have been
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`rendered injurious to health. In addition, because Defendants’ juice products are
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`processed without adhering to the requirements of 21 C.F.R. Part 120, they are
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`adulterated within the meaning of 21 U.S.C. § 342(a)(4). See 21 C.F.R. § 120.9.
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`Defendants’ failure to have and implement an adequate HACCP plan created insanitary
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`conditions that may render their juice injurious to health. See 21 C.F.R. § 120.9.
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`28. In addition, Defendants’ juice products “consist[] in whole or in part of any
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`filthy, putrid, or decomposed substance” or are “otherwise unfit for food,” and thus are
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`adulterated under 21 US.C. § 342(a)(3).
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`FDA INSPECTIONS
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`29. Defendants have an extensive history of processing juice under grossly
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`insanitary conditions and with an inadequate HACCP plan that has not been properly or
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`fully implemented. This pattern of continuing violative conduct has been documented by
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`FDA investigators during inspections on May 6 to June 20, 2019 (the “June 2019
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`inspection”); April 30 to July 31, 2018 (the “July 2018 inspection”); March 28 to April
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.9 Page 9 of 20
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`26, 2017 (the “April 2017 inspection”); and December 7, 2015, to January 29, 2016 (the
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`“January 2016 inspection”).
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`30. Although FDA found violations of CGMP and HACCP during all inspections,
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`as discussed further below, during the July 2018 inspection, FDA investigators learned
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`that Defendants were storing grape juice concentrate outside in covered barrels at
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`ambient temperatures at a previously undisclosed facility on US Grape Road. Many of
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`these barrels contained grape juice concentrate that was several years old, with some lot
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`codes dating back to 2008. As confirmed by FDA sampling, the grape juice concentrate
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`in these barrels was contaminated by filth and mold, and thus not suitable for human
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`consumption.
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`31. FDA investigators also discovered that Defendants processed the “bottoms”
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`of stored grape juice concentrate. The “bottom” of juice concentrate is the leftover sludge
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`that accumulates at the bottom of the barrel, after Defendants open a barrel to pull
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`product off the top, exposing all of the product in the barrel to possible contamination.
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`Defendants diluted the “bottoms,” likely to contain contaminants, to be blended with
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`newer juice. Defendants mixed the juice concentrate from the both the ambient barrels
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`and the “bottoms” with newer lots to hide the contamination. Defendants promised to
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`stop both of these practices, described in paragraphs 30 and 31, but as detailed below,
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`FDA investigators confirmed during the June 2019 inspection that Defendants continued
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`both of them.
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.10 Page 10 of 20
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`Most Recent Inspection
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`32. During the June 2019 inspection, FDA investigators observed multiple
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`violations of the CGMP requirements, as the Defendants continued their grossly
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`insanitary manufacturing and storage practices for their juice products, and recurring
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`HACCP violations.
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`CGMP Violations
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`33. Defendants failed to comply with 21 C.F.R. § 120.6(b), which requires them
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`to monitor sanitation conditions and practices with sufficient frequency during juice
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`processing to ensure conformance with CGMP, as set forth in 21 C.F.R. Part 110 and 21
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`C.F.R. Part 117, subpart B. FDA investigators observed numerous deviations from
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`CGMP including, but not limited to, the following:
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`a. Defendants did not have appropriate quality control operations to ensure
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`that food is fit for human consumption, as required by 21 C.F.R. § 117.80(a)(2). During
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`the June 2019 inspection, FDA investigators observed that, despite Defendants’ promises
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`to stop the practice both during and following the July 2018 inspection, Defendants
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`continued to blend grape juice concentrate with lot numbers dating back to 2011, and
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`stored outside at ambient temperatures, with newer product. FDA investigators also
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`observed that quality processes that Defendants developed and implemented to ensure
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`that all blended products were fit for human consumption were inadequate as written and
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`were often not followed;
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` b. Defendants did not conduct their operations under conditions and controls
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.11 Page 11 of 20
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`necessary to minimize the potential for contamination of food, as required by 21 C.F.R. §
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`117.80(c). Specifically, during the 2019 inspection, FDA investigators observed
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`Defendants continuing to blend “bottoms,” likely to contain contaminants, with newer
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`juice. Defendants still used this process despite being told at the July 2018 inspection by
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`FDA that this process could make the blended juice unfit for human consumption and
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`promising to FDA investigators that they would discontinue this practice;
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`c. Defendants did not maintain their facility in a clean and sanitary condition
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`or keep the facility in good repair, as required by 21 C.F.R. § 117.35(a). For example,
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`FDA investigators observed gaps in the walls of the Briner Cold Room and the Mojo
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`Warehouse leading directly outside and liquid leaking from a hole in the roof at the Mojo
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`Warehouse onto cleaning materials;
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` d. Defendants failed to exclude pests from their facility to protect against
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`contamination of food, as required by 21 C.F.R. § 117.35(c). For example, FDA
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`investigators observed a dead squirrel on the floor of, and live birds flying in, the Mojo
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`Warehouse, and bird feathers, bird excreta, and insect fragments on barrels holding juice
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`concentrate in the Briner Cold Room; and
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`e. Defendants failed to develop any sanitation standard operating procedures
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`(“SSOPs”), or monitor sanitation with sufficient frequency, in several locations at their
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`facility, as required by 21 C.F.R. § 120.6(b). Specifically, FDA investigators observed
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`that Defendants did not have any SSOPs or sanitation monitoring records for the Briner
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`Cold Room or US Grape Road. Defendants had a sanitation monitoring record for the
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.12 Page 12 of 20
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`Mojo Warehouse that recorded conditions on a weekly basis, but the record from five
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`days before the inspection showed no insanitary conditions, while FDA investigators
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`observed egregious insanitary conditions, including a dead squirrel, live birds, bird and
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`mouse excreta at that location. Defendants did not have an SSOP for the Mojo
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`Warehouse.
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`HACCP Violations
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`34. During the June 2019 inspection, FDA investigators observed that
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`Defendants had not adequately corrected the HACCP violations that FDA previously
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`noted related to the control of inorganic arsenic in apple and pear juice products, and
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`patulin in apple and pear juice products. These HACCP violations were the same or
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`similar to previous inspections, including, but not limited to:
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`a. Defendants failed to adequately implement the monitoring procedures at
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`critical control points that they identified in their HACCP plans, in violation of 21 C.F.R.
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`§ 120.8. For example:
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`(i) Defendants’ HACCP plan to control inorganic arsenic required
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`Defendants to sample apple juice products for total arsenic levels, and to perform
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`additional testing to determine inorganic arsenic levels if total arsenic levels are above 10
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`ppb and less than 12 ppb. FDA investigators observed that one lot of apple juice
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`contained 28 ppb total arsenic, but Defendants did not test the inorganic arsenic levels or
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`divert the lot from distribution;
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`(ii) Defendants also failed to monitor the critical limits for patulin in
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.13 Page 13 of 20
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`their apple and pear juice products. Defendants’ HACCP plan included the critical limit
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`to control patulin: “No visible rotten, moldy or deteriorating apples or pears.” But during
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`a ten-minute period at the June 2019 inspection, FDA investigators observed
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`approximately 46 apples that were visibly deteriorated with mold and rot pass through the
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`sorting/culling critical control point;
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`b. Defendants failed to adequately implement corrective actions identified
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`in their HACCP plans, in violation of 21 C.F.R. § 120.l0(a). For example:
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`(i) Defendants’ HACCP plans to control inorganic arsenic for both
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`apple and pear juice products included the following corrective actions for the detection
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`of high levels of inorganic arsenic: “high levels will be investigated, analyzed, and
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`trended to ascertain potential origin of high arsenic” and “supplier may be removed from
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`supplier list if found to be source of contamination.” During the June 2019 inspection,
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`FDA investigators found that 17 lots of apple juice products produced between July 31,
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`2018, the date of the close of the previous FDA inspection, and April 10, 2019, had total
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`arsenic levels that exceeded 12 ppb, and 2 lots of pear juice products produced between
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`the same dates had total arsenic levels that exceeded 23 ppb. Defendants only collected
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`the total arsenic data but did not investigate, analyze, or trend the data to determine the
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`cause of the high arsenic in the juice products;
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`(ii) Defendants’ HACCP plan to control patulin also required that they
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`investigate, track, or trend any patulin levels above the critical limit of 50 ppb to
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`determine the cause. FDA investigators found no evidence that Defendants investigated,
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.14 Page 14 of 20
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`tracked, or trended any patulin levels above the critical limit of 50 ppb; and
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`c. Defendants failed to identify an appropriate critical limit for controlling
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`a known hazard, as required by 21 C.F.R. § 120.8(a)(3). For example, FDA investigators
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`found that in October 2018, Defendants changed their HACCP plan for control of patulin,
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`raising the critical limit for core rot at the sort/cull critical control point from less than 1%
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`to less than 10%, meaning that whereas they had previously accepted for processing any
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`apple consisting of 1% or less of core rot they now process any apple consisting of 10%
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`or less of core rot. Defendants made this change in their written HACCP plan despite a
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`history of high patulin levels and after being advised by FDA that apples with a small
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`percentage of rot can produce juice with high levels of patulin. When questioned by FDA
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`investigators about the change, Defendant Mary Ann Bliesner was unaware of the
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`change, despite signing the revised HACCP plan, and could not provide any scientific
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`justification or support for the change.
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`Previous Inspections
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`35. FDA investigators observed significant ongoing violations of the Act, the
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`CGMP requirements, and the juice HACCP regulations during its July 2018, April 2017,
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`and January 2016 inspections, and issued Lists of Inspectional Observations (“Forms
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`FDA-483”) at the conclusion of each inspection. The Forms FDA-483 included
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`observations of the same type of deficiencies observed at the June 2019 inspection.
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.15 Page 15 of 20
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`Previous CGMP Violations
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`36. At all three previous inspections, FDA investigators observed that
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`Defendants failed to comply with 21 C.F.R. § 120.6(b) that required them to monitor
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`sanitation conditions and practices with sufficient frequency during juice processing to
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`ensure conformance with CGMP, as set forth in 21 C.F.R. Part 110 and 21 C.F.R. Part
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`117, subpart B. FDA investigators observed numerous deviations from CGMP including,
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`but not limited to, the following:
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`a. Defendants did not have appropriate quality control operations to ensure
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`that food is fit for human consumption, as required by 21 C.F.R. § 117.80(a)(2). For
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`example, during the 2018 inspection, FDA investigators discovered Defendants were
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`storing years old grape juice concentrate outside in covered barrels at ambient
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`temperatures. The grape juice concentrate in these barrels was contaminated by filth and
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`mold, and thus not suitable for human consumption. Defendants mixed the juice
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`concentrate from these barrels with newer lots to hide the contamination;
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`b. Defendants did not conduct their operations under conditions and
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`controls necessary to minimize the potential for contamination of food, as required by 21
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`C.F.R. § 117.80(c). FDA investigators also discovered in 2018 that Defendants process
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`the “bottoms” of stored grape juice concentrate. The “bottom” of juice concentrate is the
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`leftover sludge that accumulates at the bottom of the barrel, after Defendants open a
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`barrel to pull product off the top, exposing all of the product in the barrel to possible
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`contamination. Defendants dilute the “bottoms,” likely to contain contaminants, to be
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.16 Page 16 of 20
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`blended with newer juice;
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`c. Defendants failed to exclude pests from their facility to protect against
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`contamination of food, as required by 21 C.F.R. § 117.35(c). During the 2018, 2017, and
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`2016 inspections, FDA investigators observed numerous live and dead animals, including
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`mice, rats, squirrels, and birds, throughout various buildings used for both storage and
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`manufacturing. In several instances, FDA investigators also observed rodent excreta on
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`top of the barrels used to store juice products; and
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`d. Defendants failed to monitor sanitation conditions and practices with
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`sufficient frequency during juice processing to ensure conformance with CGMP, as
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`required by 21 C.F.R. § l 20.6(b). For example, during the 2018 inspection, FDA
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`investigators found that Defendants’ sanitation records did not reflect any of the
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`insanitary conditions that FDA investigators observed, and Defendants’ sanitation
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`program excluded the US Grape Road location and the Mojo Warehouse.
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`Previous HACCP Violations
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`37. During all three previous inspections, FDA investigators observed recurring
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`significant HACCP violations related to the control of inorganic arsenic in apple and pear
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`juice products and patulin in apple and pear juice products. These HACCP violations
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`included, but were not limited to:
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`a. Defendants failed to adequately implement the monitoring procedures at
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`CCPs that they had identified in their HACCP plans, in violation of 21 C.F.R. § 120.8.
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`Specifically, at all three previous inspections, Defendants failed to adequately monitor
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`Complaint for Permanent Injunction
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`Case 1:20-cv-03191-SAB ECF No. 1 filed 11/06/20 PageID.17 Page 17 of 20
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