2005N-0147 Sprout Safety Public Meeting
FDA Comment Number : EC1
Submitter : Dr. Steven Boyd Date & Time: 07/15/2005 05:07:40
Organization : Hydros Inc.
Category : Device Industry
Issue Areas/Comments
1. What concepts or underlying principles should guide efforts to improve the safety of sprouts?
1. What concepts or underlying principles should guide efforts to improve the safety of sprouts?
simplicity, common sense and microbial biology
2. Which practices primarily contribute to the contamination with harmful pathogens of seeds used for sprouting?
2. Which practices primarily contribute to the contamination with harmful pathogens of seeds used for sprouting?
This is not well understood. But if seed sanitation is rigoruosly in place then this issue becomes less important
3. Which practices primarily contribute to the contamination with harmful pathogens of sprouts?
3. Which practices primarily contribute to the contamination with harmful pathogens of sprouts?
Lack of proper sanitation, cross contamination between lots. See below
7. There is broad variation within the seed and sprout industry, including variations in size of establishments, types of sees and sprouts produced, practices used in production
7. There is broad variation within the seed and sprout industry, including variations in size of establishments, types of sees and sprouts produced, practices used in production
See attached
8. Are there existing food safety
systems or standards (such as international standards) that FDA should consider as part of the agency's efforts to minimize foodborne illness associated with the consumption of sprouts?
8. Are there existing food safety systems or standards (such as international standards) that FDA should consider as part of the agency's efforts to minimize foodborne illness associated with the consumption of sprouts?
See attached
GENERAL
GENERAL
The Food and Drug Administration (FDA) is currently seeking advice for sanitation science related to foodborne illness associated with the consumption of sprouts. The plan since October 2004, is to produce "Produce Safety from Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption". Presently, sanitation efforts appear to be confusing if not stalemated due to the complexity of microbial growth, the variations in handling, seed source and sanitation procedures in practice today. With limited control over these variables it seems logical that a simple first sanitation step be employed to reduce the likelihood of microbial contamination in as early a process step as possible. To that end we and others have been examining sanitation procedures and reagents that might meet the following criteria:

Broad spectrum and significant microbial reductions
No sprout quality effects, minimal phytotoxicity
Simple to use
Safe for humans
Reasonable cost
Minimum environmental effects
Friendly to equipment
Enhanced likelihood of actual application

20,000 PPM Chlorine is currently suggested as a sanitizer of choice although most agree that it fails many of the above criteria and is thought to be marginally effective at best. In addition the use of such high levels put workers at significant risk if not properly trained and protected.

To date several studies have shown that chlorine dioxide and or chlorine dioxide in combination with other procedures holds the promise of meeting all of the above criteria. This is not to say all the work is complete or other reagents are not potentially as functional. We need to at least recognize that chlorine dioxide is approved in multiple regions of the developed world including the United States for a long list of consumables including water, foods, equipment sanitation etc.

Sprouts are unique and yet they do share qualities in common with many other food products. As a start, review what the FDA, USDA knows with the currently approved chlorine dioxide based products, include what are global neighbors in Canada, Japan and Europe are doing and solve this problem. This issue and similar problems such as global bio plant security all will require a similar integrated solution