Written Testimony - Perishable Pundit

Maccabee Seed Company PO Box 401 Davis, California 95616 (530) 756-2508
with HUS are named after him. About thirty years ago the genes associated with shiga toxin laterally
transferred to E. coli strains. Unlike dysentery, coliform bacteria were generally perceived
as indicator species for fecal contamination and as early warning signals for far more serious
diseases.
With hindsight, the appearance of shiga toxin E. coli should have been treated from the beginning
as a new disease entity; and as a model case for appearance of a toxin-associated, highly
pathogenic disease, with many of the same characteristics public health officials would have to
deal with in an intentional contamination.
In my view, the FDA should lead an interagency working group covering all aspects of contamination
and outbreaks including therapeutics. This should include special funding and research on
HUS therapies.
[The only therapeutic I know of entering phase II clinical trials is a (monoclonal antibody) mAb
combination antitoxin; research originally done at the Uniformed Services University, sublicensed
and now controlled by a biotech company in Canada; it has Orphan Drug status in the
US and EU.]
For the leafy green and salad industries, better therapeutics for HUS would mean that growers,
handlers and consumers would be exposed to the risk of a greatly reduced harm.
The FDA-led working group should also conduct a complete review of off-site health dangers
posed by practices in the production of meat and milk in the
cattle and dairy industries. Cattle and dairy have been repeatedly identified as the principal reservoir
of O157 and other shiga toxin E. coli strains of concern. They have also been reported to
be important origins and reservoirs of multiple antibiotic resistances of concern to human health.
Both reservoirs should be identified and reduced.
For the leafy green and salad industries, a reduction in the sources and reservoirs of contamination
would mean a much smaller risk of causing a harm. They would have a safer environment in
which to operate. An environment, for example, with uncontaminated irrigation water.
Better therapeutics for HUS combined with reduction in the reservoirs and sources of contamination
would result in a reduced risk of a greatly reduced harm. I think improvements in growing
and handling practices will be more effective in a lower risk environment.
Thank you for hearing my testimony.
[Both of these risk reductions are scale neutral; they would benefit farm operations of all sizes
from Hmong farmers with under 10 acres, to organic farmers with 2-300 acres, to the very large
operations with tens of thousands of acres and multiple locations.
Some proposed changes in food safety regulation are not scale neutral, and may adversely affect
smaller farmers far more significantly.
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