- Harmless Harvest Thailand
- Issuing Office:
- Center for Food Safety and Applied Nutrition
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||College Park, MD 20740 |
NOV 13, 2015
VIA EXPRESS DELIVERY
Mr. Guy Gavelle
Harmless Harvest Thailand
7 Moo 5
Kamphaeng-Saen, Nakhon Pathom
Reference No.: 460982
Dear Mr. Gavelle:
The U.S. Food and Drug Administration (FDA) is issuing your firm this letter to advise you of serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) Systems regulation, Title 21, Code of Federal Regulations, Part 120 (21 CFR Part 120) identified during our assessment of the documentation that your firm provided to support the admissibility, in response to several notices of detention, of your 100% Raw Coconut Water products packaged in 8 oz. and 16 oz. retail packages offered for import. Coconut water products are considered juice and are subject to the juice HACCP regulation, 21 CFR Part 120.
The information and documentation received by the Agency included:
- A validation study of the microfiltration process your firm applies to your coconut juice products at your facility along with the risk assessment for this process that was received by the Agency on June 9, 2015.
- A HACCP plan, a HACCP manual that includes your process flow diagram and a description of your processing operations for your coconut juice products, and copies of several general studies and abstracts related to the use of microfiltration processing for juice that were received by the Agency on November 4, November 18, and December 23, 2014.
- Information and documentation related to the High Pressure Processing (HPP) that is applied to the retail packs, by a U.S. processor, after receipt of the coconut juice products here in the United States. This information included a study conducted by the University of Guelph related to HPP.
Our review of the information and documentation provided by your firm reveals that the coconut juice products manufactured by your firm and offered for entry into the United States are processed in a manner that does not comply with the juice HACCP regulation, 21 CFR Part 120.
In accordance with 21 CFR 120.9, failure of a processor to have and implement a HACCP system that complies with 21 CFR 120.6, 120.7, and 120.8, or otherwise to operate in accordance 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 coconut juice products, which are subject to the requirements of 21 CFR Part 120, 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, the Juice HACCP Hazards and Controls Guidance, and the Refrigerated Carrot Juice and other Refrigerated Low-Acid Juices Guidance through links in FDA's home page at www.fda.gov
Your significant violations are as follows:
1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism to comply with 21 CFR 120.24(a). Additionally, you must validate that your HACCP plan is adequate to control food hazards that are reasonably likely to occur to comply with 21 CFR 120.11(b). However, your HACCP plan for your coconut juice products lists a critical limit at critical control point 3, a filter, of (b)(4). You have not adequately validated that this critical limit will effectively control the pertinent microorganism for your product. Specifically, the validation needs to ensure that the critical limit (b)(4) adequately achieves a 5-log reduction of the pertinent microorganism, namely Clostridium botulinum, for your coconut juice products. Our Agency review of the validation study you submitted revealed that (b)(4) the initial amount of Clostridium botulinum after inoculation, and (b)(4) demonstrate a 5-log reduction of Clostridium botulinum at the conclusion of the filtration process.
Additionally, your validation study revealed that (b)(4). Spores of Clostridium botulinum have demonstrated the ability to germinate and grow in low acid juices (such as coconut juice), producing toxin. Since Clostridium botulinum toxin can cause serious illness, including death, in humans, FDA requires that this hazard be controlled in your juice products.
2. Your firm must have and implement a sanitation standard operating procedure (SSOP) that addresses sanitation conditions and practices before, during, and after processing, to comply with 21 CFR 120.6. Specifically, your SSOP is required to address the safety of water that comes into contact with food or food contact surfaces and address the protection of food and food packaging material from biological contaminants. 21 CFR 120.6(a)(1) and (a)(5). Contaminants in the bottles and caps may serve as a source of biological contamination of the product. The Agency also is concerned with the safety of water that comes into contact with your packaging and that may potentially re-contaminate your product at the filling step. Your firm is relying on a (b)(4) of the containers to control contamination after the filtration processing step. Contaminants from the (b)(4) may serve as an additional source of contamination of the product. A disinfecting control step for your bottles and caps prior to filling, using a sanitizer rather (b)(4), or using a sanitizer after the (b)(4), to adequately ensure control of post-process contamination of your finished juice products is an example of a procedure that would likely meet the requirements of 21 CFR 120.6.
In addition to the violations discussed above, we have the following comments:
Your firm has advised the Agency that your coconut juice products are intended to be further processed in the United States via HPP. Your firm included with your HACCP manual for your microfiltration process a HACCP plan for the HPP intended to be applied by a U.S. processor. However, the HACCP plan for the HPP processor does not identify the reasonably likely food hazard of toxin produced by Clostridium botulinum, to comply with 21 CFR 120.8(b)(1). Furthermore, the HACCP plan does not include control measures to produce a 5-log reduction in Clostridium botulinum, as required by 21 CFR 120.24, or the validation of the HACCP plan required by 21 CFR 120.8(b)(6). The study you submitted conducted by the University of Guelph entitled “High Hydrostatic Pressure Inactivation of Model Pathogens and Spoilage Microbes Introduced into Coconut Water” did not take into consideration the pertinent microorganism, Clostridium botulinum.
As a result of several instances of botulism poisoning from refrigerated carrot juice (a low acid juice), the Agency recommends that a process be applied to low-acid juices that will ensure that Clostridium botulinum growth and toxin production will not occur should the juice, as offered for sale by the processor, be kept unrefrigerated in distribution or by the consumer. This guidance can be found at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Juice/ucm072481.htm.
You should respond in writing within 15 working days from your receipt of this letter. Your response should include documentation reflecting the changes you made, such as a copy of your revised juice HACCP plan for coconut juice, the validation study for your (b)(4) filtration system, five (5) consecutive days of completed monitoring records (i.e., records for the production of 5 production date codes of the product) to demonstrate implementation of the plan, and any additional information that you wish to supply that provides assurance of your intent to fully comply now and in the future with the Act and its implementing regulations. Submission of the information in English will assist in our review. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take action to detain without physical examination under Section 801(a) of the Act (21 U.S.C. § 381(a)) your 100% Raw Coconut Water products. FDA’s detention without physical examination is an administrative procedure whereby products offered for import into the United States may be detained without physical examination. Such products ultimately may be refused admission. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the juice HACCP regulation is Import Alert #20-07 “Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation.” You may view this alert at: http://www.accessdata.fda.gov/cms_ia/importalert_761.html
This letter may not list all the violations at your facility. You are responsible for ensuring that you firm operates in compliance with the Act, the juice HACCP regulation (21 CFR Part 120), the cGMP regulation (21 CFR Part 110), and other applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.
Please send your reply to the U.S. Food and Drug Administration, Attention: Asha Dwarka, Compliance Officer, Food Adulteration Assessment Branch (HFS-607), Division of Enforcement, Office of Compliance, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding any issue in this letter, you may contact Ms. Dwarka at (240) 402-5164 or via email at Asha.Dwarka@fda.hhs.gov
William A. Correll, Jr.
Office of Compliance
Center for Food Safety
and Applied Nutrition
Doug Riboud, Co-Founder, Harmless Harvest, Inc.
714 Sansome Street, San Francisco, CA 94111
Justin Guilbert Co-Founder, Harmless Harvest, Inc.
714 Sansome Street, San Francisco, CA 94111
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