Deregulating GE papaya

October 31, 2008

Regulatory Analysis and Development
PPD, APHIS, Station 3A-0.38
4700 River Road, Unit 118
Riverdale, MD 20737-1238

Re: Docket No. APHIS-2008-0054 – Assessment for Determination of Nonregulated Status for Papaya Genetically Engineered for Resistance to the Papaya Ringspot Virus

On behalf of our 45,000 member/owner households, I’m writing to oppose the deregulation of genetically modified (GM) papaya trees on the U.S. mainland.

Our concerns are based on 1) the economic devastation caused by GM papaya in Hawaii and 2) the failure of U.S. regulatory agencies to address findings of potential allergenicity and other human safety hazards.

When GM papaya was introduced in Hawaii in 2001, proponents claimed it was a “solution” to the papaya ringspot virus problem. Instead it has been an environmental and economic disaster.
Hawaiian papaya farmers discovered that GM papaya is infected more easily by new plant fungi and diseases, such as “blackspot” fungus — a discovery that came five years after GM papaya was deregulated there. They now must spray toxic chemical fungicides on GM papaya plants every 10 days.

Canada has decided to accept GM papaya but most other export markets, especially the lucrative Japanese market, has not. The rejection of GM papaya by overseas markets has caused the selling price of GM papaya grown in Hawaii to plummet 30-40 percent below production costs. The price that farmers get for GM papaya is as much as six times lower than the price for organic papaya.

Regarding regulatory failures, the U.S. Environmental Protection Agency (EPA) should have examined whether eating the Papaya Ringspot Virus (PRSV) protein was safe or not. The EPA is required to play a part in regulating the GM Papaya (PRSV) plant, given that the viral seed coat protein (which makes the papaya immune to the ringspot virus) is a plant pesticide. But scientists report that the EPA did not require nor did it review any safety data.

For its part, the Food and Drug Administration (FDA) accepted voluntary assessments from the developer. However, scientists say that the sample sizes submitted for nutrient levels and toxicity were less than 15 papayas per study, rendering statistical accuracy virtually impossible. Given the developer acknowledges that eating unripe papaya may induce abortion in pregnant women (due to a plant compound known as BITC), experiments considering BITC in GM papaya should have been statistically sound but scientists say details from relevant experiments are lacking and the sample size again way too small to be reliable.

The FDA also has not addressed evidence that this GM papaya may cause life-threatening allergic reactions. A 2002 study by Dutch scientists (Kleter and Peijnenburg, BMC Structural Biology) found that that the PRSV seed coat protein contains a string of amino acids identical to a known allergen. Further testing for allergenicity must be required.

The FDA also has not addressed concerns that the GM PRSV papaya reportedly contains all or part of three genes encoding resistance to antibiotics used in human medicine — tetracycline, gentamycin and kanamycin.

As a retail grocer, we urge you to reject deregulation of the GM (PRSV) papaya on the mainland. A precautionary rejection, considering the gravity of the risks, is warranted in the interest of farmers livelihoods, the value and viability of our export balance sheet, the health of our customers, and in turn, the stability and health of our business.

Tracy Wolpert
Chief Executive Officer
PCC Natural Markets
Seattle, Wash.

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