EBDCs: Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

In 1984, following settlement of a suit brought against EPA by the Natural Resources Defense Council, the agency agreed to issue data call-ins, requiring EBDC manufacturers to submit extensive product information for EPA to use in reassessing the risk of the chemicals. The manufacturers were directed to provide information relating to metabolism, skin absorption, ability to cause birth defects, residues and dietary exposure, ground water contamination, and long-term feeding and inhalation.

In 1987 EPA began a second special review, focusing on cancer risk from dietary exposure and risks of thyroid damage and birth defects for persons applying the pesticide.

In September 1989, the leading manufacturers of EBDCs Rohm and Haas Corporation, E.I. du Pont de Nemours & Company, BASF Corporation, and Pennwalt Corporation announced that they had asked EPA to amend the registrations for the chemicals to eliminate their use on all but 13 crops. Under the manufacturers proposal, the fungicides would still be sold for use on almonds, asparagus, bananas, corn, cranberries, figs, grapes, onions, peanuts, potatoes, sugar beets, tomatoes, and wheat.

Linda Fisher, EPA assistant administrator for the Office of Pesticides and Toxic Substances, was quoted in the Oct. 30 Food Chemical News as saying that EPA has enough concern about the dietary risks of the remaining EBDC uses to proceed with issuing a proposed regulatory action despite the cutback in these uses. Fisher said EPA is examining possible increased costs to farmers and consumers if EBDC fungicide registrations are cancelled, the availability of alternative pest control methods, and the possibility that the loss of the uses of EBDCs could result in incidents of human poisoning by produce infected with fungi. This would be in addition to evaluating the potential risk from eating treated foods or from handling or applying EBDC pesticides.

Pesticide Reduction Pledge

Four days after the EBDC manufacturers announcement, several consumer and environmental groups held a press conference in Washington, D.C., to promote a food retailer pesticide reduction pledge. At that conference, according to the Sept. 18 Food Chemical News, five small supermarket chains and one food distributor formally agreed with the Consumer Pesticide Project of the National Toxics Campaign Fund to reduce pesticide residues, including EBDCs, on produce sold in their stores. Their stated goal is to stop selling by Jan. 1, 1995 any fruits or vegetables treated with probable cancer-causing pesticides, as defined by EPA.

EPA's Fisher expressed concern about the environmental/consumer coalition's program. We are concerned that the coalition's campaign could cause confusion for consumers and unnecessary economic hardship for both consumers and American farmers, she said. Fisher noted that the present law requires EPA to balance the value to society with the risks that may be presented by pesticides, and that decisions must be based on top quality science.

In early November, United Press International reported that some of Florida's largest produce growers had stopped using EBDCs, fearing the kind of food safety scare that hit apple growers in February during the Alar controversy. The wire service reported growers' fears that vulnerable crops, such as lettuce, cucumbers and green peppers, would not survive Florida's warm, humid winter, adding that, according to the Florida Fruit and Vegetable Association, there is no alternative fungicide for some crops, such as lettuce.

Risk Assessment

Then, on Dec. 4, based on review of the data available to the agency, EPA decided that the current use of EBDCs presented an unreasonable cancer risk. The theoretical lifetime total dietary cancer risk from the EBDCs used on the 13 crops was calculated to be two cancer cases per 100,000 population. However, according to EPA, this risk estimate does not take into account the rapid degradation of EBDCs, but is based on residue data close to harvest and assumes the highest allowable application rates.

Because these 13 crops are not always treated with EBDCs, because the maximum applications are not always used, and because residues may dissipate significantly before the food reaches the consumer, the agency maintains that if grocery store exposure estimates were used, the risks for most crops would be significantly lower. Therefore, EPA has required manufacturers to conduct a grocery store level study and furnish results in September 1990.

In the meantime, EPA has proposed to cancel use of all EBDCs on 45 crops. These include the 42 crops that the manufacturers had requested be deleted from the registrations, as well as three others bananas, potatoes and tomatoes. The lifetime cancer risk of continuing use of the chemicals on the 10 remaining crops almonds, asparagus, cranberries, figs, grapes, onions, peanuts, sugar beets, sweet corn, and wheat is estimated at three in a million, and benefits from their use at $13 million to $26 million.

EPA maintains that EBDC residue levels on food are low and can be reduced further by washing and peeling fruits and vegetables. The chemicals remain on the surface of the produce; they don't penetrate. FDA also recommends peeling away outer leaves, skin or rinds and scrubbing certain vegetables such as potatoes and carrots.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.