FDA STATES BIOTECH TOMATO IS SAFE

JOANNA RAMEY

WASHINGTON (FNS) -- Calgene Fresh Inc.'s Flavr Savr tomato got a vote of confidence last week from the Food and Drug Administration, although the agency gave no indication when it will issue a final decision on whether the biotech tomato can be marketed.

News that FDA officials in charge of reviewing Calgene's application for marketing approval are looking favorably on the tomato came during a three-day conference on bioengineered vegetables and fruits earlier this month.

"The new product is as safe as other commonly consumed tomatoes," FDA said in a statement analyzing Calgene's data on the method it uses to genetically engineer the tomato. The Flavr Savr tomato is designed to stay firm after vine-ripening, enabling the shipment of mature tomatoes.

Calgene had anticipated FDA approval last fall following its submission for approval in July. In anticipation of approval, the Chicago-based company expanded distribution of its conventionally ripened tomatoes under the MacGregory label to more than 500 stores in the Midwest. Absent approval last fall, the company last month said it would furlough a "substantial" amount of its work force until the Flavr Savr is launched.

A spokesman for Calgene said company officials still feel certain of FDA approval, but are not forecasting an approval date.

"We do expect it this year, but we're not speculating when it will be," the spokesman said.

Calgene is also bullish on consumer acceptance of its Flavr Savr, shrugging off the chance that the tomato could receive widespread negative publicity like that received earlier this year for milk containing the newly approved synthetic BST hormone. Critics of the use of the milk-stimulating hormone question BST's safety, although FDA determined its use is unquestionably safe.

"Consumers aren't paying attention in the marketplace" to debate over the safety of new food technology and food, the spokesman said.

Criticism over the Calgene tomato already has started.

In testimony before FDA's Food Advisory Committee here April 6 to 8, which was meeting on biotechnology, Andrew Kimbrell, policy director of the Foundation on Economic Trends, questioned whether there's enough data to say bioengineered foods are safe. Kimbrell's group is allied with the Pure Food Campaign, a leading critic of BST.

"Such novel foods, under current FDA regulations, will not be required to be proven safe," Kimbrell testified. "Instead, foods containing genetically altered constituents will be treated just as their traditionally bred whole food counterparts are treated under the regulations.

"Foods such as the Calgene Flavr Savr tomato are on the verge of entering the consumer market. Given FDA's mandate to protect the health and safety of the American consumer, it is imperative that FDA undertake action to protect the public from the risks of food substances that have had no history of human consumption."