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OCA comments to FDA about proposal to allow irradiation of seeds for sprouting, without consumer labels

November 30, 2000

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

RE: Docket No. 99F-2673

To whom it may concern:

This is a second letter submitted for this docket on behalf of the Organic Consumers Association. OCA is a nonprofit, grassroots national organization that promotes food safety, organic farming and sustainable agricultural practices in the U.S. and internationally.

In our letter dated November 22, 2000, we objected to the FDA approval of ionizing radiation on seeds for sprouting, and asked that the FDA reevaluate its decision. The reasons given were: 1) the sprouts were likely to be nutritionally affected; 2) sprouts would contain radiolytic products similar to other plant foods; 3) the petitioner did not provide any justification for the 8 kGray level approved by the FDA.

In this letter, we submit several studies and abstracts with the goal of showing that sprouts grown from irradiated seeds are not substantially the same as sprouts grown from nonirradiated seeds. For this reason, irradiation should not be permitted on seeds for sprouting.

Attachment 1 (Sitton et al., Electron beam irradiation effects on wheat quality, seed vigor, and viability and pathogenicity of teliospores of Tilletia controversa and T. tritici, Plant Disease 1995; 79:586-589)
This study specifically addresses the issue at hand. The authors compared irradiated fungus spores and wheat at doses of 0.0, 1.2, 2.6, 4.6, 6.7 and 10.2 kGray for spore viability, wheat usability in baking, and germination. Germination was tested by storing the seeds on germination paper in the dark for 7 days at 20ºC, then planting them in soil in early spring. Table 3 ("germination test," the 'easiest' test) shows that no normal germination occurred at any irradiation dose. The percentage of seeds that did not germinate increased from 0.5% (control group) to 6.0% (10.2 kGray). The remaining seeds germinated abnormally. To reiterate, all the seeds that germinated from wheat irradiated at 1.2 kGray and above produced abnormal sprouts. (The lead author, in conversation November 29, 2000, said that he has unpublished data that confirms that the minimum irradiation dose studied (1.2 kGray) prevents normal germination of wheat seeds.)

The relevance for this docket is as follows: 1) The conditions under which the wheat was germinated (dark, temperature) were similar to those used by commercial sprouters. 2) Wheat has already been approved for irradiation, and there is very little literature on other seeds that are commonly sprouted which have not been approved. 3) Wheat and barley sprouts are sold by sprouting companies.

This study implies that sprouts grown from any irradiated seed at any dose will be morphologically abnormal due to genetic disruption, which will also affect enzyme activity (see attachment 3).

Attachment 2 (Choi and Hwang, Detection of hydrocarbons in irradiated and roasted sesame seeds, JAOCS 1997; 64:469-472)
One objective of this study was to determine if the presence of gamma-irradiation-created hydrocarbons could be used to determine if sesame seed had been irradiated. They irradiated unroasted sesame seeds at 0, .05, .1, .5, 1, 5 and 10 kGray and found that the radiolytic hydrocarbons 16:2, 16:3, 17:1, and 17:2 can be used as markers of irradiation at 0.5 kGray or higher. Table 1 shows this graphically, where the levels of radiolytic hydrocarbons in seeds irradiated at 1 kGray and above are approximately six to eight times higher, overall, than other hydrocarbons.

This study is relevant for the present docket, because oil-rich seeds like sunflower are often sprouted and sold commercially. Sesame seeds and sunflower seeds have are 48.6% and 47.3% fat by weight respectively.

This study shows that gamma irradiation creates radiolytic hydrocarbons in food oilseeds. Sprouts from irradiated sesame (or sunflower) seeds are substantially different from sprouts from nonirradiated seeds.

Attachment 3 (Patel et al, Behaviour of lipase activity of the gamma-irradiated groundnut during germination, Journal of the American Oil Chemists Society, 1965; 42:617-619)
This study investigated the effect of gamma irradiation on lipase activity of the groundnut (peanut) during germination. The dose levels were 10, 30, 50, 70, 90 and 120 Kiloroentgens, which convert to .1, .3, .5, .7, .9 and 1.2 kGrays. These doses range from one-eightieth to one-sixth the maximum dose requested in the subject docket. The suppression of lipase activity (Figure 1) is for almost all doses dose-dependent.

Figure 1 shows that a difference in the level and rate of lipase activity between control and irradiated seeds begins at day 6 and continues through the germination period. The authors state "irradiation of 50 kr [.5 kGray] and above induced damage to the active centers [of lipase production]." "In general the growth of irradiated seeds was poor (only epicotyls are developed) and seeds irradiated to higher dosage levels, i.e., 70 kr [.7 kGray] and above did not grow at all," although lipase increased without germination in these seeds. The authors attribute the abnormal timing of lipase production and failure to germinate to irradiation damage to the nucleus and mitochondria.

It is reasonable to conclude that sprouts grown from fat-rich seeds (peanuts have 40-50% fat, sunflower seeds have 47.3% fat) would be nutritionally affected by irradiation prior to germination, especially at FDA-approved doses six times the maximum dose in this study. This study suggests that sprouts from irradiated seeds may be different nutritionally from sprouts from nonirradiated seeds. Studies of the nutrition of irradiated food generally look only at vitamins, minerals, protein and macronutrients rather than enzymes, even though the presence of enzymes is the marker of raw food, and the human body needs these enzymes to thrive. The evidence of abnormal and impaired enzyme activity in this study suggests that further enzyme production during sprout growth may be impaired.

Attachment 4 (Andrianarison et al, Alterations in polyunsaturated fatty acid composition of Voandzeia subterranea seeds upon gamma irradiation, J Agric Food Chem 1992; 40:1663-1665)
The authors studied the effect of irradiation for disinfestation of a tropical legume, the bambara groundnut, on fatty acids. They irradiated green seeds, flour and lipid extract at 0, 2, 4, 6, 8 and 10 kGray. They found that ionizing irradiation induces peroxidation of fatty acids. Table II shows that, compared to the control group, polyunsaturated fatty acids in green seeds decreased by 15% at 4 kGray, 30% at 6kGray, and 52% at 8 kGray.

At the end of their Discussion, they say "The high concentration of hydroperoxy fatty acids in the diet may cause several abnormalities in the human body. In addition, linolenic acid, one of the unsaturated essential fatty acids, was reduced upon ionizing radiation treatment of V. subterranea, suggesting that the quality of seeds is rendered poorer upon ionizing radiation."

We recognize that seeds for sprouting do not constitute an important source of fatty acids in the American diet. However, this study shows that the chemical composition of the seeds are seriously altered by irradiation.

This study is relevant to the docket because alfalfa and clover are legumes, and their seeds may affected in a similar fashion, perhaps proportionately to the amount of fat present in the seed.

Conclusions

Irradiation of seeds impairs the nutritional quality of the sprout
Wheat sprouts grown from seeds irradiated at 1.2 kGray and above are always visibly abnormal. This study was done because China's 'no tolerance' policy for wheat fungus made this an urgent and fundable study. Alfalfa seeds or clover seeds (the reason the FDA is considering irradiation of seeds for sprouting), which do not otherwise produce crops for human consumption and studies of irradiation of these seeds have no commercial benefit. Therefore, we have to look at studies of irradiation of other seeds.

In the docket, the FDA bases its approval of seed irradiation solely on the assumption that radiolysis products in the sprout will not be significant. The wheat study shows that disruption of cell division has occurred. The groundnut study shows that the rate of enzyme activity has been altered and the amount of enzyme activity suppressed, correlating to increasing doses of radiation. It is reasonable to assume that enzyme activity in the sprout is also affected. The food is substantially different, as in the well-known equation of irradiated food to cooked food.

Sprouts from irradiated seeds are nutritionally different from sprouts of nonirradiated seeds, and the consumer should be informed
· Wheat sprouts grown from seeds irradiated at 1.2 kGray and above are always visibly abnormal, and probably have irradiation-induced enzyme damage.
· Irradiated oilseeds like sunflower have detectable and proportionately increased levels of radiolytic hydrocarbons.
· Legume sprouts from irradiated seeds will show enzyme abnormalities, when they germinate at all.
· The fatty acids of legumes are impaired, causing growth abnormalities in the sprouts.

Seeds that are sprouted for food are eaten along with the sprout, therefore the sprouts should be labeled
The sprouts of sunflower seeds, lentils, chickpeas, mung beans and other large seeds are not detached from the seed when eaten; the seed is visibly part of the sprout. The sprouts of small seeds like alfalfa, clover and fenugreek 'use up' the seed (the seed coat remains behind). In both cases-large and small (used up) seed-all the nutrition of the seed is ultimately transferred to the consumer. We direct you to expert opinion from the sprout industry for confirmation. To distinguish between seed and sprout, and claim that "the irradiated article is not what is generally eaten" (Docket, section III.B) is disingenuous.

Irradiation of seeds for sprouting is not necessary
The FDA's own document "Guidance for industry: Reducing Microbial Food Safety Hazards for sprouted seeds (October 27, 1999)" states that microbial testing for pathogens "can be done with irrigation water as early as 48 hours into what is generally a 3 to 10 day growing period."

Request
The petition and the FDA's ruling is very broad, covering "seeds" in general, even though the public health concerns have centered on only two types of seeds, alfalfa and clover. The ruling perforce includes a variety of seeds for which there is no public health justification for irradiation, lacking any significant history of causing foodborne illness.

We would like to point out that there will be no tracking or monitoring of the use of irradiated seeds. Despite labeling requirements, these seeds could conceivably be planted, or sold to farmers or gardeners here or overseas, thus degrading the food supply. They could also be sold to consumers for home sprouting, without labels. Oilseeds could be used for oil.

We ask that the FDA reverse its present stance and disallow this petition. However, if it chooses to accept the petition despite the public interest, the FDA should use its discretionary power to acknowledge that the irradiated seeds of sprouts are an integral part of the food product sold to the consumer, and that therefore sprouts from irradiated seeds must be labeled like other whole fruits and vegetables.

Sincerely,


Organic Consumers Association

Attachments
Attachment 1 (Sitton et al., Electron beam irradiation effects on wheat quality, seed vigor, and viability and pathogenicity of teliospores of Tilletia controversa and T. tritici, Plant Disease 1995; 79:586-589)

Attachment 2 (Choi and Hwang, Detection of hydrocarbons in irradiated and roasted sesame seeds, JAOCS 1997; 64:469-472)

Attachment 3 (Patel et al, Behaviour of lipase activity of the gamma-irradiated groundnut during germination, Journal of the American Oil Chemists Society, 1965; 42:617-619)

Attachment 4 (Andrianarison et al, Alterations in polyunsaturated fatty acid composition of Voandzeia subterranea seeds upon gamma irradiation, J Agric Food Chem 1992; 40:1663-1665)