2005N-0147 Sprout Safety Public Meeting
FDA Comment Number : EC6
Submitter : Dr. Douglas Archer Date & Time: 07/20/2005 04:07:51
Organization : University of Florida
Category : Academia
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?
The main concept should be the validity of the epidemiology that is driving this effort. Although the word "suggest" is frequently used by CDC in presenting the epidemiology, firm conclusions appear to come from those suggestions, such as the fact that the FDA guidances may not be working. There are indications that some state epidemiology studies have lacked sufficient rigor, and thus, recall actions based on epidemiology alone may have been premature. There is a need for increased openness and sharing of epidemiological data.

The other underlying principle is that a thorough risk-benefit analysis needs to be done. Sprouts, especially certain types of sprouts, some never implicated in causing ilness, are valuable sources of unique phytochemicals. Is restricting the availability of sprouts by over-regulation the best public health decision to make?
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?
The testimony at the public meeting strongly suggests that there are a substantial number of sprouters that are not following FDA guidance, and indeed, are operating in less than sanitary facilities. Before new regulations are contemplated, the guidance should be followed up by GMP inspections and appropriate corrective actions.
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?
I disagree with the statement that sprouting facilities bear the burden of controls. It appears that seed distributors have been targeted because of the prevailing belief that all problems with sprouts originate with seed, a supposition not based on sound science.
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?
I believe that FDA has all authorities necessary without new regulation. I fear that at this time, a new regulation is premature because the science does not support defining certain interventions, such as the appropriate level of chlorine for soaking seeds. Likewise, although some work has been done to address the issue of compositing spent water for testing, the issue is apparently unresolved.
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?
The sprout industry has demonstrated the desire to achieve the overarching goal of reducing illness associated with sprout consumption to the lowest level possible. The level of illness can be measured within available monitoring systems, but care should be taken to extrapolate the known illnesses to inflated numbers of illnesses through the "disease pyramid." Perhaps 20 years ago there was gross under-reporting, but in this 24- hour-a-day news environment, with public awareness of food safety issues, and the litigious nature of society, the pyramid may have a very narrow base.
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
The interventions that may be proposed as part of a new regulation should be targeted to those types of sprout operations that have been demonstrated to have caused illness. There are types of sprouts that may have properties that make contamination very unlikely. The science should be reviewed, and the needs determined before a new regulation blankets all sprout operations.
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?
It was suggested at the public meeting that there is a system for monitoring the international trade of seed. It is currently used to monitor for plant
pests and diseases, but the lessons learned from that activity about sampling and testing may be very useful to the human pathogen problem.
GENERAL
GENERAL
I do not support the writing of a new regulation at this time. My observations on the public meeting is that the science is not there to support definitive interventions. I also observed that overstatement of epidemiological data has led to the "theory" that FDA guidance has not been effective. I do not agree with that theory based on what I consider over-extrapolation of the epidemiology.