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Kimberly Egan

FDA Compliance

Save Us from Sprouts and Cilantro

FDA’s ‘Proposed Rule for Produce’ tidies up the dirty task of growing things

Published: Monday, January 28, 2013 - 12:44


On Jan. 4, 2013, the Food and Drug Administration (FDA) took the first step in its history to regulate produce farmers. The agency issued a 547-page proposed rule that spends a lot of time reducing everything humanity has learned about plants since agriculture emerged in the Fertile Crescent 10,000 years ago into U.S. governmental jargon.

It is interesting reading if you like that sort of thing. There is an entire section devoted to the hazards of sprouts and another to the taxonomic and agricultural definition of mushrooms. FDA takes no position on glass or metal fragments in soil, but the “hazards unique to cilantro” warrant mention. We are introduced to an excellent new phrase: “pre-consumer vegetative waste.”

There are some stupid new acronyms, like RAC (raw agricultural commodity) and some blindingly obvious regulatory findings, such as: “The statutes we describe above, and previous interpretations of the concepts of RACs and processed food as set forth in the 1998 Joint EPA/FDA Policy Interpretation and the Antimicrobial Guidance, lead FDA to tentatively conclude that the basic purpose of farms is to produce RACs and that RACs are the essential products of farms.” (Translation: Farms grow produce and produce is what farms grow.)

There are also a lot of exemptions, such as food grown for your own use and food that is not normally consumed raw. This means that FDA’s first-ever effort to regulate farmers does not apply to asparagus, corn, eggplants, figs, lentils, peanuts, or potatoes, among many others. Figs? Why not figs? Fresh black mission figs on a cracker with brie are yum....

To spare you the agony of reading the whole thing, I have boiled the 547-page proposal down to a few key points. If you are a farmer:
• Wash your hands.
• Clean your equipment.
• Send sick employees home (this means for infectious diseases as well as suppurating wounds).
• Change your clothes if you just spent a bunch of time shoveling manure.
• Don’t put portable toilets smack in the middle of your irrigation source.
• Don’t dump raw sewage on your fields.
• Don’t let dead wildlife decompose in your fields.
• Don’t harvest rotten apples.
• Don’t bother with Purell; it doesn’t work on actual clods of dirt or manure.

Were I Queen, I would add:
• Wash your produce before you eat it.
• Know where your produce comes from, and don’t eat it if it came from a sewer or a nuclear power plant.
• Follow the “Diplomats’ Rule” they use when traveling, i.e.,:
—Things with rinds or husks (e.g., oranges, nuts) are usually safe
—Things filled with water (lettuce, tomatoes, and cucumbers) less so
—Eventually you will acclimate
—Alcohol cures all

But this is, in fact, a serious topic, and I think the Food Safety Modernization Act misses the point. FDA really can’t do this by itself, and the produce farmer is not the problem. If we want to improve the safety of our food supply, we need to:
• Figure out a way to keep pharmaceuticals out of the water supply. If they aren’t in the water supply to begin with, they won’t end up in our lettuce and cucumbers.
• Figure out a way to reduce our over-reliance on antibiotics. We would be less susceptible to food-borne illnesses in the first place if we didn’t routinely carpet bomb the flora in our bodies that keep us healthy.
• Figure out a way to prevent surface water runoff. I propose building codes that require green roofs for all new commercial structures over a certain size, and that require green verges on all new roads.
• Apply existing tort law to food producers who negligently or intentionally put a dangerous food product (raw or otherwise) into interstate commerce. For biotech crops and hybrid seeds, this could include design defect and manufacturing defect claims, which can carry substantial financial penalties.
• Take serious steps to increase agricultural biodiversity, which would include ending or seriously reducing subsidies for corn, wheat, and sugar, and encouraging effective crop rotation.
• Solve the problem of migrant farm labor. We depend on undocumented workers to harvest our crops because it turns out that picking tomatoes is not really “unskilled labor,” as the recent example in Alabama shows.

In the meantime, let’s keep things in perspective. A little dirt never hurt anyone.


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About The Author

Kimberly Egan’s picture

Kimberly Egan

Kimberly Egan is a litigation and regulatory lawyer with a background in pharmaceutical and medical device litigation and advice, Consumer Product Safety Commission work, food safety counseling and litigation, and commercial and mass tort litigation. Her food work has included risk-management planning and strategic assessments related to obesity claims, litigation analyses in connection with an acquisition of a company manufacturing dietary supplements, advice on FDA’s food additive and food contact regulations, advice on FDA’s Generally Regarded as Safe (GRAS) regulations, and general advice on food safety issues, product recalls, and supply-chain rationalization. She is a regular contributor to the AssurX blog.