State Legislators Seek To Broaden Regulation Of Biotech Products

Scientists fear that a patchwork of local laws more stringent than federal restrictions may hamper research and industry As state legislatures throughout the United States take steps to intensify their participation in biotechnology regulation, some states are enacting restrictions on the use of biotechnological products. In some cases, these laws go beyond limits already put in place by the federal government. While legislators say they believe that such regulation protects their states' economic and public safety interests, some scientists say that more restrictive regulations may inhibit industrial and academic scientists from doing research in these states. "It becomes dismotivating and expensive for the business when there are too many differences across the states," says Jerry Barnett, director of government affairs for Monsanto Agricultural Co. in St. Louis. "It is not that we as an industry are opposing legislation at a state level, but we hope [the states] participate in what is a very comprehensive federal regulatory system." It was 1984 when the Environmental Protection Agency issued its first permit for a release of genetically engineered "ice-minus" bacteria, which lower the temperature at which strawberry plants freeze, into Monterey County, Calif. Since then, about 200 more field tests of genetically engineered organisms have occurred in the U.S. with permission from three main federal agencies--the Food and Drug Administration (FDA) for genetically engineered food and pharmaceuticals, the United States Department of Agriculture (USDA), also for food, and EPA for recombinant DNA pesticides. Agricultural scientist Peter Day knows that if he wants to plant his genetically engineered eggplant in southern New Jersey by 1992, cultivating relationships with local planning boards, homeowners associations, and farmers is as important as nurturing the seedlings in the greenhouse. So he and his Rutgers University team of scientists at the Ag/Biotech Center in New Brunswick, N.J., have put together a committee of representatives from these community groups. The scientists keep the committee informed of their progress as they move closer to a field test. "We know that we are going to be the first group, most likely, to do field tests in New Jersey so we couldn't just spring these plants on the community," says Laura Meagher, a consultant to the center. "Those companies and universities in other states that have had success in the past with field tests made the public comfortable with what they were doing first." While New Jersey isn't a major agricultural center in the United States, the eggplant it produces is still an important crop for the state and nation. New Jersey provides the country with half of its summer supply of eggplant. In 1986, the 900 acres of New Jersey farmland that were dedicated to the vegetable brought in $3.8 million of revenue. A major pest for this eggplant is the Colorado beetle. Farmers spend about $600 per acre annually on pesticides to kill the insect. Rutgers' genetically engineered eggplant contains a gene for a protein that is a toxic to the beetle. "Should these strains of eggplant be successful, farmers wouldn't have to use pesticides," says Meagher. Being the first group to plan a field test in a state like New Jersey, which is still working on its policy regarding release of genetically engineered organisms, doesn't intimidate the Rutgers group. "We figure we'll be the first to go through the hoops and help work out the system so others can follow," says Meagher. New Jersey regulators are in the process of reviewing the state's existing laws and regulations to see how they might relate to biotechnology products, says Roger Smith, a research scientist with the New Jersey Department of Environmental Protection. After this process is complete, they hope to coordinate the state laws with the federal ones and determine the roles the different state agencies will play in regulating biotechnology. Although no policy has yet been formalized, Smith predicts it will "probably complement, and not be more burdensome than, the federal requirements for release." --R.E. While relying on existing federal laws to regulate biotech, each agency is also in the process of writing or revising its regulations specifically for the technology, with EPA lagging behind with nothing yet on the record. Currently, all three agencies issue permits or product approvals for the use of biotechnology products after an application review process. Because of the lack of a strong, coordinated regulatory effort on the part of these agencies, Congress has stepped in. Last year, Rep. Robert Roe (D-N.J.) introduced a bill to create a uniform federal agency to handle genetically engineered organ- isms and their release into the environment (The Scientist, Nov. 12, 1990, page 1). The prospect of creating yet another regulatory body, as proposed in the House bill introduced by Roe to centralize the federal review process, is controversial. According to a 1991 survey by the market research and accounting firm Ernst & Young, the industry is split on the question of whether the government needs a national policy on biotechnology. In their replies, some companies expressed concern that more government involvement would mean more interference. But others suggested that a national policy would enable the U.S. to better compete with other countries, like Japan, that do have a national program. Meanwhile, given this lack of conformity at the federal level, some states, such as North Carolina, Minnesota, and Wisconsin, are moving forward to create their own regulations. Says biologist Scott Shore, an adviser to the North Carolina subcommittee that drafted its state biotechnology rules, "People thought when they wrote the legislation in our state that there were loopholes in the federal law." Adds Shore, who now reviews biotech product release permits for North Carolina, "We also wanted to let the citizens of North Carolina have a say in what was going on in their backyard and with our legislation they can." They also thought that state law would provide a framework under which industry could operate more efficiently. North Carolina granted three field test permits for release of genetically engineered organisms (GEOs) at the beginning of this year. North Carolina and Minnesota are currently the only two states in the country that require a state permit in addition to a federal one for the release of a genetically modified organism. And Wisconsin and Minnesota last year passed bills banning the use of recombinant bovine somatotropin (rBST)--a hormone given to cows to increase milk production--in their states. The FDA has approved its use in experimental trials and the sale of products derived from these tests. It has not approved general use of the hormone by farmers in the U.S. The use of rBST should resurface as an issue facing legislators in other states this year. In 1990, 10 states introduced bills that would have limited the use of rBST. More legislative activity is expected, at least in Wisconsin and Minnesota--which were successful in enacting these bans--following their expiration this year. "We will be introducing legislation about labeling of products derived from rBST-treated cows this session," says a legislative aide to Wisconsin state Sen. Russ Feingold. Biotech industry watchers predict, however, that most state legislatures will continue to rely on existing state and federal laws to deal with biotechnology. Last month, for example, representatives of the West Virginia department of agriculture announced they would introduce legislation that expands on extant statutes for state biotechnology policy. To date, nine states have specific legislation that deals with the release of GEOs (see table). In 1983, California became the first state to develop a policy for dealing with the release of GEOs designed for agriculture. Today about 30 percent of the states are in various stages of developing their own GEO release and product policy (see accompanying story). When California formulated its policy on GEOs, it relied on existing laws on plant pests and agriculture without enacting specific legislation just for biotechnology. Other states followed California's example. "We reviewed our laws and wrote into them legislative language that would give the various state agencies statutory authority to work with the feds on GEOs," says Connie Riherd, assistant director of the Florida Department of Agriculture and Consumer Services. Some states, however, passed more restrictive laws. In 1989 the North Carolina legislature mandated a state permitting process for field tests. The law became effective Jan. 1, 1991. The biotechnology industry criticized the state for its action, fearing that the law would create costly delays in doing field tests. "They just went too far," says David Glass, a Boston-based biotechnology industry consultant. North Carolina regulator Shore disagrees. "All they have to do is submit an exact copy of what they send to the federal agency to us," says Shore. "We initiate a review and make sure there's nothing that troubles us. Four scientific teams are going through the process now. Even though our critics said that permitting would delay the field tests, we have been able to make our decision 45 days before the USDA." Hawaii did not go as far as North Carolina, but in 1988 the legislature there demanded that the state Department of Health, as well as the applicable agriculture or environmental agencies, be notified of a field test of a GEO. And Hawaii's policy may become even more restrictive. Last year a bill was introduced in Hawaii that would require a state environmental assessment of GEOs in addition to the federal one. "It is a particularly contentious issue, although last year's bill was killed," says Val Giddings, a senior staff geneticist at the USDA who reviews federal permits. "The particular field test before the state [regulators] was for an herbicide-resistant cotton. State regulatory agents were concerned that the cotton may cross-pollinate and threaten the endemic species of cotton." "Hawaiians resent mainlanders coming in to do science in their backyard," consultant Glass explains. "Industry is upset because Hawaii serves as a winter nursery for some companies." Any additional regulatory requirement, he says, is considered a burden by industry and a poor precedent as other states watch as they write their own policy. "Of course regulation is good for business for regulatory consultants," quips Glass. For the past three years, regulators from different states have been holding annual national meetings to learn from each other's experience. At the conference held last July in Sacramento, Calif., a seven-member committee issued a document called "Guidance for State Governments on Oversight of Biotechnology" to help states in the process of defining their policy. The committee also culled biotechnology product case histories from all states and drafted a report. Copies of both documents eventually will be available through the Statewide Biotechnology Research and Education Program at the University of California, Los Angeles. The group's next meeting is planned for July in St. Louis. "Although the guidelines are general, they provide a good jumping board for state regulatory officials to develop a realistic policy," says Roger Smith of the New Jersey Department of Environmental Protection, who is cochairman of the committee. The document suggests that states should examine existing oversight structures and consider whether biotechnology's commercial products and research activities are covered under them. It also encourages state agencies to develop cooperative agreements with the federal agencies and make use of the resources they offer. In addition, the guidelines recommend that states develop mechanisms for broad participation in the regulatory process, to include local government and public outreach. "Essentially, we say that the process should complement, and not duplicate, the federal process," says Smith. Such proactive behavior can avert the political problems that arise from biotech regulation. The controversy about rBST in Wisconsin, for example, prevented all research on that hormone in the state. The ban and the subsequent moratorium on research resulted from farmers' fears about the economic consequences of the use of the hormone. "rBST is expensive to use," says a spokesman for Wisconsin's Sen. Feingold. "We are concerned about the smaller farmers not being able to compete with the larger ones that would more easily absorb the initial costs." Proponents of the hormone's use argued that farmers would be paid for the extra milk their cows produced before they would have to pay for the rBST. Some farmers were also concerned that the safety of the hormone wasn't adequately addressed by the feds and feared the public would see this product as unnatural and not buy it. The other side responded by saying that the marketplace should decide and argued that the public can be educated. "After all, the public is willing to use medical biotechnology products," says Laura Meagher, consultant to the Ag/Biotech Center of Rutgers University in New Brunswick, N. J. After the heated and widely publicized controversy, Wisconsin banned the use of the hormone in the state until July 1, 1991. But part of the legislation that the governor signed had a provision giving $230,000 a year to the University of Wisconsin, Madison, to do research on rBST-treated commercial cattle. University scientists were to investigate the efficacy of the hormone and monitor the health of the treated cattle. "But we can't do it," says Leonard Maurer, associate dean at Wisconsin's School of Agriculture in Madison. "We couldn't sell the milk from the treated cattle to producers in the state. They wouldn't want to buy either rBST milk or control milk. To do the research required by the legislative intent, we would have had to pay commercial farmers providing us with their herds more money for the milk coming from the trials than we had available [from the state]." Maurer adds: "What we have said from the beginning is that we as a college should have the right to do research that answers questions about this technology...and that doesn't make us advocates for it. Should this technology become available, it is better for us in the state to have done the research--to have determined its advantages and problems in order to eventually help our farmers."

State Legislators Seek To Broaden Regulation Of Biotech Products

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