- Valley Processing, Inc.
- Issuing Office:
- Seattle District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Seattle District |
22215 26th Avenue SE, Suite 210
Bothell, WA 98021
June 2, 2016
In reply refer to Warning Letter SEA 16-12
Mary Ann Bliesner, President
Valley Processing, Inc.
108 East Blaine Avenue
Sunnyside, Washington 98944
Dear Ms. Bliesner:
The United States Food and Drug Administration (FDA) inspected your food processing facility, located at 108 East Blaine Avenue, Sunnyside, Washington, from December 7, 2015, through January 29, 2016. The inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation (Title 21, Code of Federal Regulations (CFR), Part 120) and the Current Good Manufacturing Practice (CGMP) regulations for foods (21 CFR Part 110). In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP plan that complies with the requirements of Part 120, renders the juice products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your apple and pear juice, concentrate and essence products, are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s homepage at www.fda.gov.
During the inspection, FDA collected samples of apple juice concentrate, including sample 936998. Analysis revealed inorganic arsenic levels at 88.1 nanograms per gram (ng/g) or parts per billion (ppb) in single strength or ready-to-be consumed apple juice when utilizing the minimum Brix level listed in 21 CFR 101.30(h)(1) to calculate the percentage of juice from concentrate for a single strength juice. As evidenced by this sample result, your apple juice concentrate, represented by sample 936998, is adulterated within the meaning of Section 402(a)(1) of the Act, 21 U.S.C. § 342(a)(1).
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. Based on the Agency’s July 2013 quantitative risk assessment, FDA established an action level for inorganic arsenic in single-strength apple juice of 10 ppb. Sample 936998 contained levels of inorganic arsenic above 10 ppb. Based on the level of arsenic in this sample, and other data and information on the adverse health effects of arsenic at such levels, apple juice concentrate represented by this sample is adulterated within the meaning of Section 402(a)(1) of the Act, because it bears or contains an added poisonous or deleterious substance which may render the food injurious to health.
We received your written response on February 16, 2016, concerning the observations noted on the Form FDA 483, Inspectional Observations, which was issued to your firm. According to your response, the product contaminated with inorganic arsenic is on hold at your facility and will be voluntarily disposed. We further address your response to the significant violations below.
The significant violations were as follows:
1. Your HACCP plan must, at a minimum, list the critical limits that must be met at each critical control point, to comply with 21 CFR 120.8(b)(3). A critical limit is defined in 21 CFR 120.3(e) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food hazard.” However, your revised HACCP plan for apple juice, concentrate and essence products, provided with your written response, lists a critical limit of “[m]ust run less than (b)(4)% apples or pears containing decay and breakdown by volume per lot” at the Fruit Sorting critical control point (CCP) that is not adequate to control the food hazard of patulin. 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. 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.
Your response acknowledges that you do not physically sort every apple and do not have (b)(4) in place. 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. Additional information regarding the chemical hazard of patulin and possible control measures to be incorporated into your juice HACCP plan(s) can be found at www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm072557.htm.
2. Your HACCP plan must, at a minimum, list all food hazards that are reasonably likely to occur, to comply with 21 CFR 120.8(b)(1). A food hazard is defined in 21 CFR 120.3(g) as “any biological, chemical, or physical agent that is reasonably likely to cause illness or injury in the absence of its control.” However, your revised HACCP plan for apple juice, concentrate and essence products, provided with your written response, does not list the food hazards of inorganic arsenic and metals. Specifically,
a. Your firm has found instances where inorganic arsenic exceeded 10 ppb, such as two batches of unfiltered single strength apple juice which you tested after distribution and found values of (b)(4) ppb, (b)(4) ppb and (b)(4) ppb inorganic arsenic.
Your written response is inadequate. We acknowledge that you added heavy metals, specifically, inorganic arsenic, to your hazard analysis; however, you did not identify inorganic arsenic as a food hazard in your revised HACCP plan provided with your written response and did not include any critical control point. Your justification in your hazard analysis for determining that inorganic arsenic was not significant states “FDA regulated” and “Letter of guarantee.” This is not adequate justification. We acknowledge your response during the inspection that you assert due to volcanic ash, inorganic arsenic is expected in fruit growing areas; however, this remains unclear on what, if any, controls have been implemented to prevent, eliminate or reduce the inorganic arsenic hazard.
b. Your hazard analysis for apple and pear juice, concentrate and essence products identifies metal debris as a food hazard at the metal detection step; however, this hazard is not identified in your revised HACCP plan and no critical control points are listed to control metal.
Your written response is inadequate. Your response states that you are currently installing and calibrating metal detectors at each packaging location. We note that you revised your hazard analysis to state “pending” at the metal detection step, and continue to identify metal debris as a significant hazard. 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.
3. Your firm failed to hold raw materials in a manner to prevent the food from becoming adulterated within the meaning of the Act, as required by 21 CFR 110.80(a)(5). Specifically,
a. Apples are stored outside, without atmospheric and temperature controls, in open, wooden bins for two months or longer, as evidenced by one lot of Granny Smith apples received April 9, 2014, and processed June 12, 2014; and one lot of Granny Smith apples received September 28, 2015, and processed December 7, 2015. 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.
b. The in-line hopper in which apples are dumped for processing is located outside, uncovered and exposed to environmental conditions, like rain as our investigators observed on December 7, 2015. Your written response is inadequate, which states that it is acceptable industry standard practice for apples to be dumped into a hopper that is open to the environment.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product and/or enjoin your firm from operating.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
In addition, we have the following comments:
- During our inspection, we noted your practice of addressing hazardous levels of patulin in specific lots of your apple juice products by blending those lots with higher levels of patulin with additional juice with an unknown level of patulin and creating a new lot from the blended product. This is not an acceptable means of addressing the hazard of patulin and may result in the adulteration of the blended product, per FDA’s Compliance Policy Guide, Section 555.200. In your response, you indicate that you only blend product with high levels of patulin after the adulterated batch has been treated with (b)(4). However, in the absence of a study supporting the adequacy of your reconditioning procedure, a prudent processor should test the batches to ensure neither batch is adulterated with high levels of patulin prior to blending.
- We note your firm does not routinely test finished product for patulin; however, you provide Certificates of Analysis which state “<50 ppb”="" patulin="" for="" juice="" intended="" for="" non-alcoholic="" and="" alcoholic="" beverage="" manufacturers="" when="" no="" patulin="" testing="" has="" been="" performed. our="" investigators="" documented="" at="" least="" one="" instance="" where="" you="" provided="" a="" certificate="" of="" analysis="" to="" your="" customer="" indicating="" the="" apple="" juice="" concentrate="" contained="" less="" than="" 50="" ppb="" of="" patulin;="" however,="" test="" results="" for="" the="" lot="" indicated="" the="" juice="" contained="" patulin="" above="" 50="" ppb. we="" request="" that="" your="" response="" explain="" how="" you="" intend="" to="" address="" this="">50>
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Katherine L. Arnold, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Arnold at 425-302-0437.
Miriam R. Burbach
Washington State Department of Agriculture
Food Safety Program
P.O. Box 42560
Olympia, Washington 98504-2560