2005N-0147 Sprout Safety Public Meeting
FDA Comment Number : EC2
Submitter : Mr. Robert Sanderson Date & Time: 07/15/2005 05:07:24
Organization : International Sprout Growers Association
Category : Food Association
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?
Seed sampling and testing, and spent irrigation water production testing, should be acknowledged as valid controls in a sprout production HACCP plan. Relative importance assigned to any critical control used in a sprout production HACCP plan should be based on demonstrated effectiveness in minimizing risk.
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?
Most outbreaks appear to be seed-related rather than facility- related.

There is a widespread agreement that seed for sprouting should be grown, processed, and handled using GAPs for food, but there is not a clear picture of how to implement this objective, since the use of GAPs in seed production would involve considerable expense. This expense would have to be ultimately justified at the consumer level.

The example of organic certification was offered as a model, not of adequate GAPs per se, but of a defined, monitored and enforced certification program, which is supported by consumer preference. However, in the absence of effective and very clearly defined GAPs, consistent oversight, and effective enforcement, a requirement for seed GAPs could easily become an invitation for unethical marketing practices.

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 use of GMPs in production is critical. HACCP as presently defined for sprouts mostly focuses on reducing seed-borne risk. Specific critical controls for minimizing risk which is introduced during sprout production have not gotten much attention- primarily because, beyond GMPs for food production, the need for specific production hazard controls has not been emphasized.
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.
It was widely felt that there should be more flexibility in allowed preventive controls. Some suggested interventions are mentioned at the end of this comment.
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?
In addition to the desired objective of requiring GAPs for the production of seed to be used for sprouting, specific GMPs, and also sampling and testing protocols need to be established for seed handling operations and suppliers. These procedures need to be regularly monitored, and effectively enforced.
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?
The regulatory mechanism may not be as important as the level of understanding and acceptance by the industry. Interventions must be demonstrated to work effectively for their intended purpose; they must be affordable, they must have consistent monitoring, and they need to have flexibility for review, evaluation, and inclusion of new methods.
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?
Presently it?s difficult or impossible to evaluate which interventions provide what degree of risk reduction.

Progress is in practice being measured by outbreaks or the lack thereof. It was suggested that, in the event of future outbreaks, a standardized data collection procedure be followed which would allow for a clearer analysis than what we now have of what works and what doesn?t.

Since it seems undesirable to have to wait for future outbreaks in order to learn how to better prevent them, if the standardized data collection procedure were developed and applied to reports of past outbreaks, this might provide some insight into the effectiveness of specific interventions, or lack thereof in the past, and therefore suggest where to put the primary effort toward improving existing interventions.
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
Since different types of sprouts are grown in different ways and appear to require different strategies for minimizing risk, there should be flexibility in designing effective interventions for different sprout products. Also for defining what is a sprout and what isn?t.
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?
No specific alternative systems or standards were mentioned.
GENERAL
GENERAL
This comment, pertaining to Docket # 2005N-0147, is being submitted on behalf of the International Sprout Growers Association by the ISGA Technical Review Board (TRB)

The comment addresses the 9 questions posted in the Federal Register notice of the CFSAN Public Meeting on Sprout safety which was held on May 17, 2005

Areas where research is needed:
1. Testing methods
a. PCR
b. Other rapid, accurate methods
c. Standardization of seed and production sampling protocols
d. Use of spent irrigation water concentration
(In an effective hold-and-release program for sprouts, time is a critical factor. Also, responsiveness of testing labs, and differences in costs, have a
major impact. Validation and allowance of testing methods which could shorten turn-around time would allow for more options for producers in selecting the best labs. Also, the concentration of spent irrigation water samples could allow for smaller samples to be sent more cheaply by overnight delivery, if this is necessary.)

2. Sanitizers
a. Tsunami
b. Germin-8-or
c. Chlorine dioxide
d. Other sanitizers which have shown good results
e. Benefits of agitation or sonication
f. Possible down-side of broad-spectrum seed treatments
i. Cross contamination
ii. growth of organisms not detected by testing step
3. Competitive Exclusion
4. Design of useful industry surveys; sharing of data
5. Review of data from past outbreaks to better understand what works and doesn?t work.
6. Research into how and where pathogens get on seed
7. Standardized procedures for evaluating treatment and testing effectiveness

In addition to these research areas, it would be helpful to the sprouting industry to have a clearer idea of how research results are evaluated, and how a rule or guidance can be updated to include useful innovations.

The ISGA TRB would like to thank FDA CFSAN for the opportunity to submit this comment. We look forward to working together to prioritize areas of research effort, and to cooperate to the greatest possible extent in the formulation of regulatory policy for the sprouting industry.

Yours truly,
Robert Sanderson,
President, International Sprout Growers Association.

Address for correspondence:
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