From the Hill
Report calls genetically altered plants safe; White House to boost oversight
A National Research Council (NRC) report released on April 5 concludes that genetically engineered plants appear to be safe but that government oversight could be improved. Meanwhile, the Clinton administration, reacting to growing concerns about genetically modified organisms (GMOs), announced on May 3 a series of steps aimed at increasing regulatory oversight.
The NRC report, Genetically Modified Pest-Protected Plants: Science and Regulation, noted that members of a 12-person NRC study committee were not aware of any evidence suggesting that foods on the market today are unsafe to eat as a result of genetic modification. Perry Adkisson, the committee chair, said, however, that “public acceptance of these foods ultimately depends on the credibility of the testing and regulatory process, which must be as rigorous as possible and based on the soundest of science.”
The report points out that although conventional breeding techniques have been in practice for hundreds of years, genetically altered crops have been planted only since 1995. It emphasizes that no clear distinction could be found between the health and environmental risks of conventional plants and transgenic crops. “The breeding process is not the issue; it is the product that should be the focal point of regulation and public scrutiny,” the report said.
The committee urged that a high priority be placed on research to improve methods for identifying potential allergens in plants during the research stage. It also acknowledged the possibility that toxicity levels in transgenic plants could increase and pose a health concern, and thus recommended that the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) create a coordinated database that lists dietary and toxicological information that may indicate a potential risk.
On the topic of environmental risks, such as harm to beneficial insects, the report notes that “both conventionally bred and transgenic pest-protected crops could impact these so-called non-target species, [and that] the impact is likely to be smaller than that from chemical pesticides.” It recommended further research.
The report also addressed the possible creation of superweeds and superbugs from the transmittal of genetic traits via natural exposure. In order to better understand the relationship between transgenic crops and neighboring plants and targeted pests, the report said, further research is needed to assess the likelihood and the rate at which genes might spread, as well as techniques to decrease the probability of such changes.
Although the committee found that the regulatory system is working well, it identified some areas for improvement. The report recommends that EPA, FDA, and USDA improve exchanges of information on genetically modified pest-protected plants. More important, the report says that the scope of each agency’s oversight, as outlined in the 1986 Coordinated Framework for the Regulation of Biotechnology, should be clarified. The report also recommends that the agencies conduct research on the ecological effects of these plants on a long-term basis in order to predict adverse outcomes.
The NRC study focused strictly on plants that are altered genetically to be pest- and disease-resistant, and not for other purposes. And even though it did not address some of the more controversial issues involving GMOs, both proponents and opponents of genetically engineered plants had some criticisms.
Some industry and agriculture groups opposed the recommendation that EPA expand its regulation of transgenic crops to include plants altered with genes from a sexually compatible plant or with viral proteins. EPA currently grants categorical exemptions for these plants, but the study members concluded that these crops could raise potential human health and environmental safety concerns.
Environmental and consumer groups also criticized the report, saying that it was corrupted by conflicts of interest. The critics argued that some of the NRC committee members had received industry research grants and that such ties could cloud their objectivity. About two dozen people demonstrated outside of the National Academy of Sciences building before the report’s official release. Backed by Rep. Dennis Kucinich (D-Ohio), the protesters demanded that the NRC study be abandoned and a new one be conducted with a different panel of experts. The NRC responded that all potential conflicts of interest were examined and made public and that there is no reason to question the validity of the report.
The May 3 White House statement on GMOs asked the Council of Environmental Quality (CEQ) and the Office of Science and Technology Policy (OSTP) to conduct a six-month study to assess the interagency regulatory system that provides oversight of genetically modified agricultural products. In addition, the administration is requiring that appropriate agencies develop voluntary labeling guidelines, prepare reliable testing procedures, expand scientific research, and conduct risk assessments of agricultural biotechnology.
The 1986 Coordinated Framework for the Regulation of Biotechnology requires new biotechnology products to be regulated via existing federal statutes. Hence, three federal agencies are responsible for the regulation of plants and foods created through agricultural biotechnology: USDA, FDA, and EPA. Each agency acts independently and is responsible for a specific aspect of the process, although they must coordinate activities. The CEQ/OSTP study is aimed at providing an assessment of whether this existing regulatory framework is indeed providing the necessary oversight and at making recommendations to improve the system where appropriate.
At the same time, FDA said that it would require that it be informed at least 120 days before a company introduces a new biotechnology product, as opposed to the voluntarily consultation that takes place now. FDA also plans to develop guidelines that will allow companies to voluntarily label food that contains biotechnology ingredients. This voluntary standard is to ensure that labels are truthful, not misleading, and are easy to interpret by the average consumer.
Other administration initiatives include plans by USDA to work with farmers and industry to create testing procedures for distinguishing nontransgenic crops from genetically altered ones. Currently, USDA allows crops to be mixed together before and after harvesting. By establishing testing procedures, farmers will be able to separate their crops to improve marketability to countries that have been restricting the import of U.S. crops because of fears about GMOs. In addition, USDA will provide farmers with up-to-date information on market restrictions around the world so that they can determine whether they should continue to plant genetically altered seeds, whether to introduce new varieties, and where to market their crops.
The good news for the scientific research community is that USDA, in cooperation with FDA and EPA, plans to launch a program of competitive peer-reviewed awards to provide more information about public health and environmental safety issues involving GMOs. However, no actual dollar amounts were included in the administration’s initiative.
The administration has asked the State Department, along with USDA, FDA, and EPA, to develop a series of projects to educate the public, within the United States and abroad, on the existing mechanisms for regulating agricultural biotechnology crops and foods. This initiative will also focus on how existing U.S. regulations protect public health and the environment.
Congress is also weighing in on this controversial subject. Rep. Kucinich introduced two bills designed to improve consumer awareness of and ensure public safety from foods containing GMOs. The Genetically Engineered Food Right to Know Act (H.R. 3377) would require that all foods containing genetically altered materials bear labels. The bill states that consumers have a right to know whether the food they consume contains potential allergens or could compromise dietary restrictions. H.R. 3377 would impose civil penalties up to $100,000 for violating the labeling requirements. The second bill introduced by Kucinich, the Genetically Engineered Food Safety Act (H.R. 3883), would regulate GMOs as a food additive and require testing for allergenicity, toxicity, and other side effects. Sen. Barbara Boxer (D-Calif.) introduced a Senate version of H.R. 3377 (S. 2080) and Sen. Patrick Moynihan (D-N.Y.) introduced a companion of H.R. 3883 (S. 2315).
Also stepping into the fray is the Basic Research Subcommittee of the House Science Committee, which released a report in April 2000 that supports continued use of agricultural biotechnology. Seeds of Opportunity: An Assessment of the Benefits, Safety, and Oversight of Plant Genomics and Agricultural Biotechnology was prepared by subcommittee Chairman Nick Smith (R-Mich.) and is based on a series of hearings held on the subject. The report argues that there is no scientific justification for labeling food products that contain GMOs and that federal regulatory oversight should focus primarily on the characteristics of the plant rather than the method used to produce it. It notes that the risks associated with genetically altered plants, such as exposure to allergens, increasing toxicity levels, and the possible creation of superweeds, are the same for plants bred through traditional techniques.
Republican senators clash at hearing on stem cell research
At an April 26 hearing on the controversial issue of human embryonic stem cell research, two key Republican senators clashed openly, with Sen. Arlen Specter (R-Penn.) favoring federal funding of stem cell research that uses human embryos and Sen. Sam Brownback (R-Kan.) opposing such funding.
Research on stem cells derived from human embryos is a relatively new area of biomedical science that offers significant potential for curing disease. But obtaining stem cells requires destroying human embryos, raising serious ethical questions. The National Institutes of Health (NIH) has already proposed guidelines that would allow federal research funding. Specter’s proposed Stem Cell Research Act of 2000 (S. 2015) would explicitly allow NIH funding.
NIH scientists Allan M. Spiegel and Gerald D. Fischbach opened the hearing, held by the Senate Appropriations Committee’s Labor-Health and Human Services Subcommittee, with testimony on the science behind embryonic stem cell research. They said that the field has great potential for major breakthroughs in the treatment of many diseases, from juvenile diabetes to rheumatoid arthritis.
Frank E. Young, a former Food and Drug Administration commissioner, advocated restricting research to adult stem cells, which can be obtained without destroying an embryo. Brownback and Mary Jane Owen, executive director of the National Catholic Office for Persons with Disabilities, backed Young’s views.
However, according to written testimony submitted by Spiegel and Fischbach, adult cells are not as promising as embryonic cells. “[Embryonic] and adult stem cells are not qualitatively alike,” they wrote. “[Embryonic] stem cells have truly amazing abilities to self-renew and to form many different cell types, even complex tissues, but in contrast the full potential of adult stem cells is uncertain, and, in fact, there is evidence to suggest they may be more limited.” Outlawing research on embryonic cells, Spiegel said, “would be tying one hand behind our back.”
Specter emphasized that scientists have proposed using excess embryos that are routinely destroyed by fertility clinics. His bill would allow only these embryos to be used and only if the parents who produced the embryos give their consent.
But Specter’s argument did not sway his critics. Owen, who is blind and confined to a wheelchair, described the current pursuit of medical treatments as “frenzied.” She said, “I am deeply opposed to any gain in my sight, mobility, or even my hearing if it was purchased at the cost of a single human life.” In response, Sen. Tom Harkin (D-Iowa) argued that an embryo is no larger than a pencil dot and is not a sentient being.
In the hearing’s most dramatic exchange, Brownback compared embryonic stem cell research to Nazi experiments on concentration camp prisoners during World War II. “You are taking live human embryos in this case, and stem cells [will be extracted] from them. You had the Nazis in World War II saying, ‘Now these people are going to be killed. Why don’t we experiment on them and find out what happens? They’re going to die anyway.'”
“They were living people,” Specter interjected.
“These are living embryos,” Brownback replied.
Though the debate had similarities to the abortion debate, the two issues are not entirely parallel. Sen. Harry Reid (D-Nev.), who describes himself as pro-life, strongly supports embryonic stem cell research, saying we should go “no holds barred.” And Specter argued that unlike a fetus, a discarded embryo such as one that could be donated for research is not “on its way to life.”
S. 2015 would also prohibit the sale of such embryos for profit. This is analogous to a ban on the for-profit sale of fetal tissue used in federally funded research. Specter and his supporters contend that profiteering from the sale of human embryos would be less likely to occur in private-sector research if the federal government enters the field. If federal funding is approved, they argue, the resulting NIH guidelines would be followed voluntarily by many private organizations.
Also testifying at the hearing were actor Christopher Reeve, who was paralyzed in a horse-riding accident, and Jennifer Estess, an actress who suffers from Lou Gehrig’s disease. Both hailed embryonic stem cell research and the potential it shows for treatment of their diseases. “Is it more ethical for a woman to donate unused embryos that will never become human beings,” Reeve asked, “or to let them be tossed away as so much garbage when they could help save thousands of lives?”
Although Senate Majority Leader Trent Lott (R-Miss.) has pledged to allow a vote on Specter’s bill during the current session, he and several key senators signed a letter to NIH opposing this research and will likely work to defeat the bill.
NASA reexamines faster, better, cheaper strategy
After years of streamlining and downsizing as part of its “faster, better, cheaper” management strategy, the National Aeronautics and Space Administration (NASA) has declared that its cuts have gone too far. Two reports examining NASA’s Mars program have blamed the 1999 failures of the Mars Climate Orbiter and the Mars Polar Lander on management problems and a lack of funding that are byproducts of the faster, better, cheaper philosophy. Consequently, NASA said that it has cancelled a new Mars lander scheduled for 2001 but will go forward with plans for a new orbiter.
An April 2000 report by the Mars Program Independent Assessment Team headed by Thomas Young, a retired Lockheed Martin executive, examined all of the Mars missions undertaken since the advent of faster, better, cheaper. It identified a probable cause of the lander’s failure and made recommendations for the program’s future. Although “faster, better, cheaper, properly applied, is an effective concept,” the report found, misunderstandings of the philosophy resulted in “significant flaws” in the program. The report emphasized the need for sound project management and adequate financial margins in deep space missions.
The orbiter, which was designed to settle into orbit around Mars and provide climate data, was lost in September 1999 when it went hurtling into the planet’s atmosphere. The cause was identified shortly thereafter as an embarrassing failure to convert operating data from English to metric units. The Young report determined that oversight and testing that could have revealed potential flaws were “deficient.”
The lander, which was designed to examine the planet’s surface, was lost in December 1999. The report said that the most probable cause of failure was premature shutdown of the landing engines, causing the lander to crash into Mars at roughly 50 mph rather than the planned landing speed of 5 mph. Because the craft was not equipped to maintain radio contact throughout its descent, there was no way to determine how close it came to the surface before something went wrong and therefore no way of verifying the cause of the failure. The decision to forego capability for radio contact was a gamble that saved money but sacrificed NASA’s ability to learn from its errors. The Young report called the decision “a major mistake.”
As with the orbiter, testing of the lander was incomplete. Trouble with the landing system was obscured in initial tests by a wiring flaw. After this flaw was fixed, the tests were not repeated. If they had been, the fatal problem would probably have been detected and could have been fixed by a simple change in the system’s computer code, the report said.
Although the Young report criticizes NASA’s management failures, it recommends that the Mars program continue to operate under the principle of faster, better, cheaper. It suggests that the program be given greater funding, that training and mentoring programs be set up for staff, and that management principles be augmented with clear definitions, policies, and procedures to guide a project’s implementation.
The second report, which was produced by a panel chaired by John Casani of the Jet Propulsion Laboratory (JPL), focused only on the Mars lander failure. It criticized the project’s funding, management, and staffing levels. The cost of the lander, which was much lower than earlier planetary missions, was about 30 percent too low, the reports found. The lander was kept on a very tight schedule to accommodate a narrow launch window, exacerbating the funding problems. Since the onset of faster, better, cheaper, JPL has been working on three times as many projects simultaneously as it used to, and the lab’s experienced project managers have been stretched to the limit. As a result, the lander and orbiter projects used inexperienced managers. The lack of funding led to staffing shortages, the Casani report found, rendering the workforce insufficient for “the levels of checks and balances normally found in JPL projects.”
In response to these reports, the Senate Commerce Committee’s Subcommittee on Science, Technology, and Space announced that it would step up oversight of NASA. The subcommittee has obtained NASA documents on the testing of the lander, which it has shared with the House Science Committee. An independent review of these documents is planned. “A thorough review is not just in order, but is imperative,” said Senate Commerce Committee chairman John McCain (R-Ariz.). Subcommittee chairman Bill Frist (R-Tenn.) echoed this concern. “It may be time to amend NASA’s mantra of faster, better, cheaper to include back to the basics,” he said.
At a March 22 subcommittee hearing, NASA Administrator Dan Goldin vigorously defended faster, better, cheaper. Of 146 missions carried out under this principle, Goldin testified, 136 have been successful. He vowed that NASA would not abandon its risk-taking philosophy and compared the agency’s current strategy to the more conservative one that preceded it. “I have absolutely no regrets, no concerns, no apologies,” he said. “When you’re afraid, you set mediocre goals, everyone’s happy, and budgets go up.”
Goldin did make clear, however, that he is addressing the agency’s recent problems. “NASA is deliberately encouraging a culture change in which any person can speak up,” he said. The agency will put a halt to its cost-cutting measures, institute new training and mentoring programs, and form better oversight and review procedures. Accordingly, NASA has requested its first budget increase in seven years and plans to hire 2,000 new employees. “We wanted to see where the boundaries [of faster, better, cheaper] were,” Goldin said. “We have now hit the limit.”
House Science Committee chairman F. James Sensenbrenner, Jr. (R-Wisc.), who has often been at odds with Goldin, held a hearing addressing the Mars failures that featured testimony from Young and Casani. Sensenbrenner opened the April 12 hearing by stating his belief that effective management is NASA’s biggest challenge. “Our role is not to try to micromanage each mission, project, or program,” he said. “But after reading these reports, I am left to wonder: Who was managing them?’
The principle of faster, better, cheaper was first incorporated into the Mars program in 1996, when NASA launched two tremendously successful missions: the Mars Global Surveyor, which is still orbiting the red planet and sending back valuable scientific data, and the Pathfinder mission, which featured a small rover and performed important scientific tests while returning dramatic photographs.
Ehlers introduces three bills aimed at bolstering science education
Rep. Vernon J. Ehlers (R-Mich.), vice chairman of the House Science Committee, has introduced a trio of bills aimed at bolstering science education. The bills would establish several new programs designed to improve science, math, engineering, and technology education in grades K-12; place a renewed emphasis on teacher mentoring and professional development; and create a tax credit for science teachers.
The proposals came just as debate was beginning to escalate on increasing the number of immigration visas granted to foreign high-tech workers. The high-tech industry has argued that an increase is necessary to overcome a severe shortage of U.S. workers. Ehlers argues that although a short-term increase in foreign workers may be necessary, the best long-term solution is to improve education in the sciences, thus better preparing students for careers in technical fields. Ehlers believes that in 15 years “it will be impossible to get meaningful employment” without some understanding of science and technology. Already, he says, industry spends more money retraining high school graduates than the federal government spends on education.
The centerpiece of the three bills is the National Science Education Act (H.R. 4271), which would establish several National Science Foundation (NSF) programs. The most important would be a “master teacher” program that would give grants to elementary and middle schools to hire educators who would have the specific responsibility of mentoring young teachers and providing laboratory support. The program’s goals are to help schools retain young teachers and encourage better use of hands-on educational materials. H.R. 4271 would also set up programs to train teachers in the use of technology in the classroom, award scholarships to teachers who pursue scientific research, establish a National Academy of Sciences study on the use of technology in the classroom, and create a working group to identify and publicize strong curricula nationwide.
The second bill (H.R. 4272) addresses programs in the Department of Education. It would amend the Elementary and Secondary Education Act to place new emphasis on mentoring of young teachers, authorize peer-reviewed professional development institutes, and establish after-school science programs.
The third bill (H.R. 4273) would create a 10-year, $1,000-a-year tax credit for teachers who attend rigorous, content-based preparation programs, as well as several tax incentives to encourage partnerships between schools and industry.
Although Ehlers hopes to move H.R.4271 quickly through the Science Committee, the other two bills face hurdles in other House committees. A tight legislative calendar, meanwhile, presents a challenge for all three bills. Despite these obstacles, Ehlers is optimistic and has won support from several key House members in both parties. Sen. Pat Roberts (R-Kan.) has introduced companion bills in the Senate. Also expressing support for the package is a broad array of organizations representing scientists, educators, and industry.
At a May 17 Science Committee hearing, two educators and an industry representative expressed strong support for H.R. 4271 and described an urgent need to attract more students into science and engineering as well as more scientists and engineers into teaching. John Boidock, vice president of government relations at Texas Instruments, said that a severe shortage of electrical engineers was hampering his company, adding that the number of students entering electrical engineering is declining. He testified that many students do not appreciate the relevance of technical fields in their everyday lives. Jeffrey I. Leaf, a high school technology instructor representing the American Society of Mechanical Engineers, echoed this concern. It is “exciting to do science but not necessarily to have it taught to you,” he explained in support of the bill’s efforts to aid teachers and encourage development of good curricula. He also expressed concern about the misconception that only straight-A students in science and math can be successful engineers.
NSF, meanwhile, has been noncommittal about the bill so far. According to a statement prepared for the hearing but not delivered, Judith S. Sunley, NSF’s interim assistant director of Education and Human Resources, strongly praised the goals of the bill but said that “both the spirit underlying the bill and the types of actions suggested are implemented in extant NSF activities.”
“From the Hill” is prepared by the Center for Science, Technology, and Congress at the American Association for the Advancement of Science (www.aaas.org/spp) in Washington, D.C., and is based on articles from the center’s bulletin Science & Technology in Congress.