FDA Issues Warning Letter to Michigan Juice Operation for Juice HACCP Violations

FDA issued a Warning Letter to a Michigan juice processor who did not have a HACCP plan in place.  It seems the operation was trying to skate between the Juice HACCP regulation and the Preventive Controls regulation.  The issue was that the company used a central kitchen to produce juice for sale at that central operation but also sell it form smaller juice operations under the control of the company.

"A “retail establishment” is defined by the juice HACCP regulation as “an operation that provides juice directly to the consumers and does not include an establishment that sells or distributes juice to other business entities as well as directly to consumers” (21 CFR 120.3(l)). In short, a retail establishment (1) provides juice directly to consumers and (2) does not sell juice to other business entities. Your Berkley facility sells juice to other business entities. Therefore, it is not considered a retail establishment, and the juice HACCP regulation applies to all of the juice produced at that location. Also, note that as reflected in the guidance you reference in your May 19, 2020 response (i.e., Answer 19 of Guidance for Industry: Questions and Answers on juice HACCP Regulation), juice is only considered to be provided directly to consumers if it is provided to consumers at the same location where it is produced. Accordingly, if you no longer provide juice to consumers at your Berkley facility, then it is not considered a retail establishment for this additional reason."


FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/panther-james-llc-610082-03052021
Panther James LLC
MARCS-CMS 610082 — MARCH 05, 2021
Product:  Food & Beverages

Investigation Continues into Chemical Contamination in Juice that Injured Two Children

In a very bizarre case, two children ingested a toxic chemical while at a restaurant.   According to the report, a 10 year old boy threw up blood and his half sister, aged 4, vomited after drinking apple juice out of foam cups at a Lancaster eating establishment.  

So far, methanol was one of the identified chemicals.  So this is not your typical food operation cleaning chemical.  Also, since only two children at the same table became ill, the contamination event occurred from point of dispensing to point of consumption.  So thus the criminal investigation.

Lancaster online
http://lancasteronline.com/news/local/east-lampeter-police-investigate-if-incident-of-children-drinking-caustic/article_cc170c5e-02a3-11e7-b682-8bd62449c9a2.html
East Lampeter police investigate if incident of children drinking caustic substance at restaurant was criminal or accidental

Unpasteurized Apple Juice Leads to Two Outbreaks

Fresh apple cider in autumn...nothing better.

But unfortunately, contamination on apples can make its way into the cider unless preventive controls are taken.  So far this season, there have been two examples of contamination in fresh cider.

A small California farm stand, High Hill Ranch, was linked to seven cases of E. coli illness among  residents who consumed the unpasteurized apple juice from High Hill Ranch in mid-October.
In an statement issued by the owners of the farm, it appears that they are missing the point (below).
E. coli is more likely to be picked up from ground apples (wind fallen apples, drops, or whatever you want to call them).

A second case in Illinois may be a case of cryptosporidium, a parasite often originating from a contaminated water source, such as contaminated wash water or irrigation water.  Again, apples off the ground can be an issue.

Many folks like to have that fresh juice, however having it processed can eliminate any potential risk.  This is the reason the Juice HACCP regulation of 2001 was implemented.  There are other means of having it process that do not impact the flavor as much as heat pasteurization.  One is UV treatment and the other is high pressure processing.  These two methods impact flavor less but can help retain that fresh

County of El Dorado
https://www.edcgov.us/pressreleasedetail.aspx?id=30064771392
High Hill Ranch Issues Voluntary Recall of Unpasteurized Apple Juice

Department: Public Health Contact: Creighton Avila  Phone#: (530) 621-5153
Date: October 23, 2015

High Hill Ranch, located in the community of Camino in El Dorado County, has initiated a voluntary recall of its unpasteurized apple juice following notification from local health officials of suspected contamination with bacteria, likely Escherichia coli (E. coli.). El Dorado County health officials are warning consumers to not drink and dispose of any unpasteurized apple juice purchased from High Hill Ranch on or after October 6, 2015.

Juice Processor Ordered to Cease Operations for Lack of Compliance

An Idaho juice processor was ordered to cease production after not complying  with FDA regulations.  The juice processor was not heat pasteurizing, and according to juice regulations, there must be validated reduction steps in place.  Normally, juice processors use heat pasteurization to accomplish this.  It is unclear what, if anything, this processor was doing.

FDA News Release
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm470328.htm
FDA orders juice manufacturer to cease operations
For Immediate Release
October 30, 2015
Release

Bottles of Sparkling Beverage Recalled Due to Potential for Glass Fragments

Martinelli, a California bottler of sparkling fruit juice is recalling certain lots of Martinelli’s 8.4 oz. mini glass bottles of cider and sparkling grape juice due to the possibility of small glass chips at the top of the bottles occurring when opening the bottle, which could possibly enter the beverage and cut or injure the consumer.
The company discovered the issue through their own internal testing.

 FDA Notice - Recall: Firm Press Release
http://www.fda.gov/Safety/Recalls/ucm467264.htm
Notice of Voluntary Recall of Certain Martinelli's 8.4 oz. Sparkling Beverages Due to Potential for Glass Fragments

For Immediate Release
October 15, 2015

Contact Consumers  S. Martinelli & Company   1-800-662-1868

S. Martinelli & Company of Watsonville, California, today announced a voluntary nationwide recall of certain lots of Martinelli’s 8.4 oz. mini glass bottles of Gold Medal Sparkling Cider, Sparkling Cider Northwest Blend, Sparkling White Grape, and Sparkling Red Grape, due to the possibility of small glass chips at the top of the bottles occurring when opening the bottle, which could possibly enter the beverage. Consumers could potentially be cut or injured if a chip occurs.

Fruit and Vegetable Juice Blends - Reviewing the Risks and Their Control

Juice blends, the mixing of juice from different fruits and vegetables, are growing in demand. But some processors may not realize there can be a risk of foodborne pathogens if that juice operation does not handle and process the fruits and vegetables properly. This goes for both when serving juice fresh without any processing treatment, or fresh juice receiving a processing treatment that serves to reduce/eliminate pathogenic microorganisms (a 5 log reduction). According to the Food Code, if a processor does not use a microbial reduction process, that product must be labeled as such. (Consumers should know the difference between these two, because the non treated juice does have a higher risk for foodborne illness, especially when that juice is low acid, and/or stored for any time rather than consumed immediately).

Low acid / high pH juices are the result of using a high proportion of low acid produce such vegetables, including spinach or kale, in the blend These low acid juices, as compared to the higher acid juices, are a bigger concern in that they better able to support the growth of pathogenic bacteria if present (as compared to more acidic juices like apple juice.) When these low acid receive a processing treatment, such as those processed by ultraviolet light (UV) or by high pressure processing, Clostridium botulinum is a risk.

What are the concerns related to juice:

Inventure is Recalling Frozen Vegetables and Juice Blends Due to Potential for Listeria Contamination

Inventure's Georgia facility is recalling fresh frozen vegetables and  smoothie kits after the company discovered Listeria in that Georgia processing facility.  There have been no reported illnesses to date.

While Listeria in smoothies can be a risk, specifically since the product is considered ready-to-eat.  The vegetables on the other hand, do have cooking instructions.  However, there is a risk if the consumer undercooks the product or if they use it in the preparation of vegetable juice blends.

The other interesting point is that this action is being taken for positive environmental sample, not a product sample testing positive.  There is no indication as to the location in the environment of the positive sample or whether product was actually tested.  Since two product lines were recalled, either these lines shared the same pieces of equipment, or there were more than one positive samples.

FDA Warning Letter Issued to Vegetable Juice Processor

In a recent post, the risks associated with fresh vegetable smoothies was discussed.  But there are also issues when the juice is processed, such as with high pressure processing (HPP).   In an FDA warning letter released this week, FDA sent a letter to a juice processor on processed vegetable smoothies that points out the risk associated with that type of product.

In this warning letter, a company was sited for not addressing the risk associated with the product.
 

"we note that your 100% juice blends, made from purees of kale, celery, spinach, cucumber, parsley, chard, etc., are all low acid juices, and the pertinent microorganism for these juices is Clostridium botulinum (C. botulinum). HPP is not effective to control C. botulinum spores in low acid juices (i.e. pH above 4.6) and therefore, controls for C. botulinum in these low acid juice ingredients used in any juice blend or beverage is pH. We acknowledge that your firm appears to monitor pH of your juice products as a final quality specification; however, your use of low acid juice ingredients that are susceptible to the growth of C. botulinum and toxin formation unless pH is controlled necessitates a critical control point for pH."

So basically, using vegetable blends will make low acid juice (a pH above 4.6).  The juice is processed using high pressure processing, but this process is not adequate to destroy the spores, and so this product can be a Clostridium botlulinum risk if pH is not controlled through sufficiently lowering pH.



FDA Warning Letters - 2015
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm440587.htm