2005N-0147 Sprout Safety Public Meeting
FDA Comment Number : EC3
Submitter : Mr. Katsuyoshi Enomoto Date & Time: 07/18/2005 04:07:48
Organization : DAISEY MACHINERY CO., LTD.
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?
We must primarily regard sprouts eaten raw as fresh foods like cut fresh salads. They need high-grade hygiene care through the production 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?
GAP for the production of seeds are needed. The seeds used for sprout production must be cultivated separately with other products. This area should be fenced in (like farm) not to permit the entrance of any wild or domestic animals.
Seed test methods should be guided or regulated and should be done by distributors.

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?
Disinfection of seeds is prime step. 20,000ppm of Calcium hypochlorite treatment is not enough to disinfect seeds effectively. Other effective and safety methods for the sprouts and for staffs should both be developed. We have investigated these areas and developed a hot treatment system of seeds for the production of sprouts. (T. Suzuki and T. Takizawa, Sprouted vegetable seeds sterilizing method, and sprouted vegetables cultivating method. US patent 5,615,518. Apr. 1 1997. Enomoto K. et al. Hot-water treatments for disinfecting alfalfa seeds inoculated with Escherichia coli ATCC 25922. Food Sci. Technol. Res. 8(3), 247-251, 2002.) In Japan, hot water treatment of seeds is a very popular way to disinfect and is used for mung bean, black matpe seeds and soybeans. For these seeds, hot water treatment is the most suitable way for their disinfection. Because bean sprouts are cultivated more in Japan than USA, FDA should consider Japan?fs strategies as well.
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.
Guidance for industry: Microbial testing of spent irrigation water during sprout production should be restricted to spouts eaten raw.
I think the amount of sample is too huge, especially for the salmonella test. It brings too much amount of culture medium for the enrichment cultivation. As reported by Jaquette et al. (Jaquette C.B. et al. Efficacy of Chlorine and Heat Treatment in Killing Salmonella stanley Inoculated onto Alfalfa Seeds and Growth and Survival of the Pathogen during Sprouting and Storage. Applied and Environmental Microbiology. 62(6), 2212-2215, 1996.), a population of Salmonella stanley is regarded to increase to 106 CFU/g during a 30-h sprouting stage. I think smaller amount of sample is enough for the spent irrigation test.

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?
As mentioned in Q2, seed test by seed distributor should be presented on the guide.
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?
Spent irrigation water test is very expensive and they tend to put too heavy a burden on sprouting facilities. A regulation will not be effective. A kind of subsidy for the tests should be considered.
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?
Regular sample tests of final products at retail stores by the government should be considered and the percentage of contaminated products by human pathogenic bacteria should be investigated.
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
Guidance should be written for each variety of sprouts. But some types of seeds may have similar guidance with others.
In addition, sprouts ready to cook (eaten after cook) and sprouts ready to eat (eaten raw) should be distinguished through indication, by putting labels on the final products. There will be two types of market products for each kind of product. For sprouts eaten cooked, spent irrigation water testing is not necessary.

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?
Guidelines for the Hygienic Manufacture, Distribution and Retail Sale of Sprouted Seeds with Particular Reference to Mung Beans (1989 U.K.).
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