WASHINGTON -- Transgenic plant testing has become routine,and no unexpected mishaps have occurred. Now, the agencieswith jurisdiction over transgenic plants -- the FDA, theEnvironmental Protection Agency and the U.S. Department ofAgriculture -- are trying to streamline the regulatory process.

Streamlining and the role of each agency in approvingtransgenic plants was the subject of a session this week at the1993 Agricultural Biotechnology Conference, sponsored byCEEM, a Reston, Va., company that holds conferences dealingwith issues in the regulatory and environmental fields.

USDA regulates field testing, EPA regulates endogenous plantpesticides (whether they occur naturally or through geneticengineering), and FDA regulates food additives, including, bydefinition, proteins from inserted genes.

By the end of the 1993 fiscal year, 586 field tests of transgenicplants had taken place under the Animal and Plant HeathInspection Service (APHIS) of the USDA -- nearly half of themin 1993, said Sally Van Wert, senior biotechnologist at thepermit unit of the Biotechnology Biologics and EnvironmentalProtection division of APHIS.

Since the genetically modified plants invariably behaved liketheir unmodified brethren, the agency enacted a streamlinednotification alternative to the usual permitting process sixmonths ago. For eligible transgenic plants, field testing canproceed within 30 days.

Since the notification alternative went into effect, it has beenused for about 95 percent of all environmental releases.

Most field tests have involved major crops such as corn,tomato, potato, soybean, cotton and tobacco, said Van Wert. Themost common improvements to these plants were disease andpest resistance, herbicide tolerance, and altered processing ornutritional requirements.

EPA's contribution to streamlining has been a draft proposal toregulate pesticides in plants -- whether the pesticides occurnaturally or are added through genetic engineering -- ratherthan the plants themselves, said Bernice Slutsky of EPA's Officeof Pesticide Programs.

Plant pesticides would be exempt from regulation if they donot result in new exposures to a pesticide and do little harm tonon-target organisms.

Change is happening more slowly in regulation of microbialpesticides at the EPA.

To promote reduced-risk pesticides, including microbialpesticides, the agency has made them eligible for prioritytreatment, said William Scheneider, biotechnology coordinatorat the Office of Pesticide Programs (OPP).

To expedite the admittedly complex reviews for geneticallyengineered microbials, OPP has established a biotechnologywork group and a quality action team to monitor performanceof the biologicals program, said Schneider.

And according to Anthony Green, vice president of regulatoryaffairs and quality assurance for EcoScience Corp., the programneeds it. EcoScience, an emerging biotech company based inWorcester, Mass., waited almost a year to get an experimentaluse permit for a bioherbicidal fungus -- "much too long," Greencomplained. "Traditional taxonomy is not yet caught up withthe advances in genetic fingerprinting, leading to someconfusion," he added.

At FDA, oversight begins when a food product is sold, explainedEric Flamm of the office of policy at the office of thecommissioner of FDA.

Transgenic foods are subject to the same rules and regulationsthat govern "normal foods," said Flamm. Most substances nowintroduced into plant foods would be exempt from regulation.These "are proteins ... commonly found in food and at levelslow enough not to raise safety or nutritional concerns," and are"generally recognized as safe," said Flamm.

Regulated compounds include toxic proteins, such as lectins,proteins that can activate toxins, or those "that are not found infood and whose biological function is unknown or issignificantly different from that of other proteins found infood," said Flamm.

Proteins taken from foods that commonly cause allergies arepresumed to be allergens unless they are safe, said Flamm, andfoods with allergens must be labeled as such.

Flamm advised developers of biotechnology foods to consult"early and often with FDA to ensure that all regulatory issuesare resolved." FDA is considering a voluntary pre-marketnotification procedure, said Flamm.

-- David C. Holzman Washington Editor

(c) 1997 American Health Consultants. All rights reserved.