Back in January 2011 President Obama signed into law the FDA Food Safety Modernization Act, or FSMA, which was heralded by the FDA as “the most sweeping reform of our food safety laws in more than 70 years…” aimed to “ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.”
One of the components of FSMA was to categorize dry bulb onions with leafy greens, subjecting onions and other vegetable crops that can be eaten raw to the same water quality standards as the greens.
Numerous studies have shown that although some consumers have become infected with E. coli or other water-borne pathogens from leafy greens and other eaten-raw vegetables, the same cannot be said for dry bulb onions from IEO’s Treasure Valley.
In Nov. 2013 Clint Shock from the Oregon State University Malheur Experiment Station, along with IEO growers and shippers, addressed the water quality regulations and the burden they place on storage onion growers – and they reiterated findings that dry onions had caused illness through pathogens.
The FDA standard for irrigation water was the same as for swimming pools and, those involved agreed, appropriate if irrigation water is directly applied to the part of the vegetable consumed. With dry bulb onions, any E. coli on the crop was gone after the onions were lifted. Practicing due diligence through the extension service, the industry is researching ways to reduce bacteria in the water.
On the FDA’s site, http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM429442.pdf, the proposed rule dated Jan. 9 states in part that the “ FDA has already acknowledged that the water quality standards require significant research and the FDA has observed that in many cases, a variance from the water quality standard is the only way many farms will be able to remain in production (for example, the dry onion growers in Oregon & the farmers using water from the Rio Grande for irrigation). The FDA has set an extraordinarily high bar to states seeking variances, one that the FDA has not complied with in setting the proposed water quality standards (the FDA relied on recreational water standards unverified by food safety protection). Under Subsection 112.173(c), the FDA requires a state seeking a variance to establish that the different procedure is ‘reasonably likely to ensure that the produce is not adulterated’ and will ‘provide the same level of public health protection’ as under this part.
“NASDA is concerned that the second standard, requiring the ‘same level of public health protection’ will require the use of risk modeling through the use of a yet undisclosed risk matrix. It is imperative that the FDA provide additional information as to the second standard and the risk indexes that will be applied to numeric standards and intervals proposed under this part (as to both the water quality standards and the biological soil amendment application intervals).”
The full draft EIS is viewable at the FDA site and can be downloaded.