2005N-0147 Sprout Safety Public Meeting
FDA Comment Number : EC4
Submitter : Mr. Ken Kimes Date & Time: 07/18/2005 04:07:17
Organization : Greensward / New Natives
Category : Food 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?
1) Seed and seed producers need to be brought into the equation. It is our understanding that seed is the major contributor to food safety problems in sprouts. There may be jurisdictional problems for the agency in pursuing this component on to the farm. In such a case we would recommend adoption of the excellent protocols developed by Mr. Bob Rust and others to ensure that this basic ingredient is safe before it enters the sprouting process.
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?
2) It is our belief that raw animal manure disposal, either as a waste or fertilizer, onto the seed crops themselves, and the grazing of animals in such fields, is the major vehicle of transmission of harmful pathogens to the sprouting seed. Surprisingly, to our knowledge, there is no restriction on the use of raw manure in such crops in the US or elsewhere in the world. The one exception would be certified organic acreage. Organic practices in the US require composting of manure before use in the field. We note this as an exception only, not to imply less risk. Further research would be required to establish that composted manure is less a problem than raw in this regard. Note: One small county in CA has to dispose of 30 million pounds of dairy manure yearly
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?
3) Continuing on a theme, introduction of contaminated seed we believe is the primary vehicle of sprout contamination. Our thought experiment goes as follows; Alfalfa and clover are primary, high protein forage and feed crops for dairy and meat production. Their cultivation and harvest is therefore closely associated with those aspects of agriculture. In California these crops are routinely fertilized with slurry from the waste pits of the associated dairy. This slurry is easily applied as a liquid straight from the pit through large rainbird type sprinklers. It follows that since ninety percent or greater of the outbreaks attributed to sprouts have occurred in alfalfa and clover sprouts that these cultivation practices might be responsible. This obviously poses a dilemma for the agency in terms of jurisdiction if the agency was determined to regulate these practices. It wouldn't happen, the disposal of manure is too big an issue for the dairy and livestock industry. The sprout industry then must employ
intervention type of testing as noted above or required GAPs of farmers that would grow our seed.
4. Although FDA's current recommendations address practices by all parties, efforts to promote adoption of effective preventive controls have focused largely on sprouting facilities.
4. Although FDA's current recommendations address practices by all parties, efforts to promote adoption of effective preventive controls have focused largely on sprouting facilities.
4) We would recommend that the guidance be revised to eliminate or greatly reduce the concentration of chlorine in the seed soak. The 20k PPM is such a liability to the industry in terms of worker health, and environmental concerns that it alone could permanently stain sprout growing as a dangerous and unhealthful industry. Interventions as above could accomplish so much more by greatly reducing the contamination of the incoming seed.
4. Do the preventive controls recommended in FDA's sprout guidances need to be explained?
4. Do the preventive controls recommended in FDA's sprout guidances need to be explained?
The sprout seed industry, growers and sellers, should formulate a set of GAPs to help contain or eliminate the contamination of sprouting seed.
5. Is a regulation likely to be an effective means of achieving the goal of minimizing foodborne illness associated with the consumption of sprouts?
5. Is a regulation likely to be an effective means of achieving the goal of minimizing foodborne illness associated with the consumption of sprouts?
We believe that the agency efforts thus far have accomplished a great deal. We would like to propose what to us seems a sensible approach. The agency should concentrate any further levels of guidance and intervention on alfalfa, clover, and possibly mung sprouts specifically. Because of the prevalence of these particular sprouts in associated outbreaks, we believe the most "bang for the buck" could be gained in a sharp focus rather than broad initiatives at this time. Lessons learned from a focused initiative could then be transferred as appropriate to other sprouted products. Given the wide variety of "sprouts " and associated growing techniques a broad brush approach is bound to dilute efforts to safer sprouts as all of those exceptions are noted and then shoehorned into an overly broad effort. Solve the problems of alfalfa and clover sprouts and the industry doesn't look so bad.
6. How can progress toward the overarching goal (to minimize foodborne illness associated with sprout consumption) be effectively measured?
6. How can progress toward the overarching goal (to minimize foodborne illness associated with sprout consumption) be effectively measured?
No comment.
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
Please see above. Once again we believe a sharply focused approach would give the industry the biggest gain in safety at this juncture. We should be clear that we are not advocating for the producers of those sprouts not currently associated with outbreaks to be not held to standards of cleanliness or not regularly inspected. Regular inspections and third party food safety audits have been a tremendous asset to our company.
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?
We are unable to comment on this question at this time. But would seem to make sense to look at the regulation in other countries and try to assess the effectiveness of such regulation.