This letter was initially issued to state agricultural directors, state feed control officials, and food, feed, and grain trade organizations in 1993, and FDA is now placing it on our guidance page website for ease of accessibility.

Guidance for Industry and FDA

Letter to State Agricultural Directors, State Feed Control Officials, and Food, Feed, and Grain Trade Organizations

Final Guidance

For questions regarding this guidance, please contact Rhoma Johnson at (301) 436-2066.

Additional copies are available from:
Office of Plant and Dairy Foods
Division of Plant Product Safety, HFS-305
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

http://www.cfsan.fda.gov/guidance.html

U.S. Department of Health and Human Services
Food and Drug Administration
September 16, 1993

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Guidance for Industry and FDA⁽¹⁾

Letter to State Agricultural Directors, State Feed Control Officials, and Food, Feed, and Grain Trade Organizations

This guidance document represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You may use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, please contact the Office of Plant and Dairy Foods, Division of Plant Product Safety at 301-436-2066.

State Agricultural Directors
State Feed Control Officials
Food, Feed, and Grain Trade Organizations

Gentlemen:

In recent weeks FDA has received numerous reports indicating that a significant portion of the 1993 hard red spring wheat crop from the upper midwest states may contain high levels of a mold-produced toxin, deoxynivalenol (DON), commonly called vomitoxin. DON is produced by several molds of the genus Fusarium, especially F. graminearum, which causes pink scab disease in wheat. It is not possible to completely avoid the presence of DON in wheat. DON is sometimes found in wheat grown under normal weather conditions, however, the fungus thrives in the cool, wet conditions that occurred in the midwest in the spring and summer of 1993. When DON occurs in wheat, the levels are reduced by the processing of wheat into wheat products like flour, but processing does not totally eliminate DON.

The matter of DON in wheat was the subject of an FDA advisory issued in 1982. At that time the agency noted the levels of DON in wheat and wheat products that it believed would not present a public health hazard. However, because only limited toxicological data on DON were available at that time, FDA stated that it was difficult to estimate the potential public health hazard posed by DON.

The agency has reviewed additional data on DON that have become available since 1982. These data include reports of outbreaks of DON-associated acute gastrointestinal illness in humans in China in 1984/85 and in India in 1987. Although uncertainties exist concerning the precise role played by DON in these outbreaks, the data provide a clearer picture of the factors associated with human exposure to DON contaminated wheat.

Based upon the available data and information, FDA can now state with more confidence, the levels of DON in wheat and wheat derived products that would not appear to present a public health hazard. Thus, FDA is updating its advisory levels for DON in wheat and wheat derived products and is also addressing other grains used as animal feed. This advisory is responsive to circumstances resulting from the abnormally wet conditions experienced in the midwest earlier this year.

The advisory levels for DON are as follows:

1. 1 ppm DON on finished wheat products, e.g. flour, bran, and germ, that may potentially be consumed by humans. FDA is not stating an advisory level for wheat intended for milling because normal manufacturing practices and additional technology available to millers can substantially reduce DON levels in the finished wheat product from those found in the original raw wheat. Because there is significant variability in manufacturing processes, an advisory level for raw wheat is not practical.
2. 10 ppm DON on grains and grain by-products destined for ruminating beef and feedlot cattle older than 4 months and for chickens with the added recommendation that these ingredients not exceed 50% of the diet of cattle or chickens.
3. 5 ppm DON on grains and grain by-products destined for swine with the added recommendation that these ingredients not exceed 20% of their diet.
4. 5 ppm DON on grains and grain by-products destined for all other animals with the added recommendation that these ingredients not exceed 40% of their diet.

Any questions concerning specific occurrences of DON should be directed to the appropriate FDA district office. Questions concerning agency policy on DON should be directed to Dr. Terry C. Troxell at the Center for Food Safety and Applied Nutrition (202-205-5321) or to Dr. George Graber at the Center for Veterinary Medicine (301-594-1724).

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{¹⁾ This guidance has been prepared by Office of Plant and Dairy Foods, Center for Food Safety and Applied Nutrition, at the Food and Drug Administration (FDA).