India okays Bt cotton
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582 NATURE BIOTECHNOLOGY VOL 18 JUNE 2000 http://biotech.nature.com IN BRIEF EU biosciences panel European Commissioner for Research Philippe Busquin has appointed 11 European scientists from different public research institutes to be part of the Biosciences High Level Group (BHLG), a new advisory body that will represent the EU bioscience research community in dialogs with the public. According to Axel Kahn, chair of BHLG and a senior scientist at the Cochin Molecular Genetics Institute (Paris), the group aims to involve the European Parliament and Council, consumers, nongovernmental organi- zations, industry, and the media in addressing controversies linked to advances in life sciences. Creation of BHLG is in line with Busquin’s proposal to create a unified European Research Policy across the EU that pays special attention to citizens’ expecta- tions and demands. The 1999 Eurobarometer opinion poll on public attitude to biotechnology revealed only 11% of respondents felt adequately informed about biotechnology. SL EU’s new orphan drug regulations On April 27, the European Commission implemented the first community-wide orphan drug regulations to encourage development of drugs for diseases affecting less than 5 out of every 10,000 of the EU population. Incentives include a 6- to 10-year period of market exclu- sivity and exemptions from market- approval fees, which can amount to more than £100,000 (US $150,000). A newly created independent Committee for Orphan Medicinal Products will assess a drug candidate’s eligibility for orphan status before submission to the European Medicines Evaluation Agency (EMEA), which regulates the approval of all drugs in the EU. The EMEA says that 31 companies have already expressed an interest in applying for the orphan status designation. Orphan drug regulation has been in effect in the US since 1983 and has been implemented subsequently in Japan, Australia, and Singapore. SL EPA rejects Greenpeace On April 20, the US Environmental Protection Agency (EPA; Washington, DC) rejected a petition filed by the environmental group Greenpeace in January calling for the revocation of current licenses for Bt transgenic crops. The day before EPA’s announcement, anticipating the rejection, Greenpeace released a report criticizing the research EPA subsequently cited in defending the licensing process, claiming that the agency “acknowl- edges that Bt crops could pose risks to monarch butterflies.” Although the EPA did refer to additional research done since the original licenses were granted, including a highly publicized laboratory study that sug- gested that pollen from Bt transgenic corn might be harmful to monarch butterfly larvae (Nat. Biotechnol. 17, 627, 1999), an EPA source familiar with the situation said that that study was cited only to explain voluntary measures implemented in 2000 to reduce but- terfly exposure to Bt crop pollen while field studies continue. Despite the apparent misin- terpretation, Ellen Kramer, an EPA spokesper- son, says the agency does not plan to engage in a public relations battle with Greenpeace. The petition was part of a lawsuit filed against EPA by Greenpeace in 1999. AD India okays Bt cotton For the first time, the Indian government’s Department of Biotechnology (DBT) has granted “biosafe- ty clearance” to a genetically modified crop. On April 3, the DBT strongly recommended that Monsanto’s Bt cotton, which has been engineered to contain a gene from Bacillus thuringiensis (Bt), should be introduced into the country in the interest of cotton farmers, who have been losing the battle against bollworm, a major pest of cotton. The decision was made after regulators were “fully convinced about its safety and potential economic benefits to farmers,” according to DBT adviser Prasantha Ghosh, who says it paves the way for large-scale cultivation and mar- keting of transgenic cotton in India, and opens the doors for the entry of other GM crops. Monsanto must now go through the formality of seeking permission from the Genetic Engineering Approval Committee for large-scale trials. KSJ Human fly bites rub Celera When news surfaced in April that the recently published genome sequence of the fly Drosophila melanogaster was contami- nated with human gene sequences, Celera (Rockville, MD), which produced the sequence, immediately removed the affect- ed portions of data from its web site and began correcting the errors. Biologists gen- erally agree that the scientific significance of the contamination in the initial sequence is trivial, but that did not stop researchers from the competing publicly financed Human Genome Project (HGP) from open- ly criticizing Celera for sloppiness. Celera spokesperson Heather Kowalski suggested that reporters at the Los Angeles Times, which broke the story to the general public, had “some kind of axe to grind with us, and [we] don’t believe that this was any kind of a story at all.” Kowalski adds that “it’s kind of hard for us to ponder. . . why people want to do us harm or say bad things about us.” The answer could lie in the ongoing acri- mony between the competing genome sequencing efforts: Earlier in April, Celera President Craig Venter told members of Congress that the HGP might be producing shoddy data in its effort to win the sequenc- ing race. AD Eco-terrorism penalties Legislation that would impose tough penal- ties on eco-terrorists guilty of destroying GM research crops was passed by a California committee in April. In the past year, antibiotech group Reclaim the Seeds has claimed responsibility for damage to crops and equipment owned by University of California, Pioneer Hi-Bred, and NK Seeds (Nat. Biotechnol. 17, 1053, 1999), but those responsible have not been caught. Under the new legislation, those actually caught dam- aging crops would be liable for twice the value of the crop, including the cost of related testing, research, and crop development—as determined by the court. No other state or country has passed anti-GM crop destruc- tion laws, according to the office of State Assemblywoman Helen Thomson (D- Davis), who introduced the legislation. The new law, which covers only university research and would impose the same penal- ties for destruction of livestock, awaits a vote by the entire legislature. EN © 2000 Nature America Inc. • http://biotech.nature.com © 2000 Nature America Inc. • http://biotech.nature.com
Transcript of India okays Bt cotton
582 NATURE BIOTECHNOLOGY VOL 18 JUNE 2000 http://biotech.nature.com
IN BRIEF
EU biosciences panelEuropean Commissioner for Research Philippe Busquin has appointed 11 Europeanscientists from different public research institutes to be part of the Biosciences HighLevel Group (BHLG), a new advisory body that will represent the EU bioscienceresearch community in dialogs with the public. According to Axel Kahn, chair of BHLGand a senior scientist at the Cochin Molecular Genetics Institute (Paris), the group aimsto involve the European Parliament and Council, consumers, nongovernmental organi-zations, industry, and the media in addressing controversies linked to advances in lifesciences. Creation of BHLG is in line with Busquin’s proposal to create a unifiedEuropean Research Policy across the EU that pays special attention to citizens’ expecta-tions and demands.
The 1999 Eurobarometer opinion poll on public attitude to biotechnology revealed only11% of respondents felt adequately informed about biotechnology. SL
EU’s new orphan drugregulations
On April 27, the European Commissionimplemented the first community-wideorphan drug regulations to encouragedevelopment of drugs for diseasesaffecting less than 5 out of every 10,000of the EU population. Incentives includea 6- to 10-year period of market exclu-sivity and exemptions from market-approval fees, which can amount tomore than £100,000 (US $150,000). Anewly created independent Committeefor Orphan Medicinal Products willassess a drug candidate’s eligibility fororphan status before submission to theEuropean Medicines Evaluation Agency(EMEA), which regulates the approvalof all drugs in the EU. The EMEA saysthat 31 companies have alreadyexpressed an interest in applying for theorphan status designation.
Orphan drug regulation has been ineffect in the US since 1983 and has beenimplemented subsequently in Japan,Australia, and Singapore. SL
EPA rejects Greenpeace
On April 20, the US EnvironmentalProtection Agency (EPA; Washington, DC)rejected a petition filed by the environmentalgroup Greenpeace in January calling for therevocation of current licenses for Bt transgeniccrops. The day before EPA’s announcement,anticipating the rejection, Greenpeacereleased a report criticizing the research EPAsubsequently cited in defending the licensingprocess, claiming that the agency “acknowl-edges that Bt crops could pose risks tomonarch butterflies.” Although the EPA didrefer to additional research done since theoriginal licenses were granted, including ahighly publicized laboratory study that sug-gested that pollen from Bt transgenic cornmight be harmful to monarch butterfly larvae
(Nat. Biotechnol. 17, 627, 1999), an EPAsource familiar with the situation said thatthat study was cited only to explain voluntarymeasures implemented in 2000 to reduce but-terfly exposure to Bt crop pollen while fieldstudies continue. Despite the apparent misin-terpretation, Ellen Kramer, an EPA spokesper-son, says the agency does not plan to engage ina public relations battle with Greenpeace.
The petition was part of a lawsuit filedagainst EPA by Greenpeace in 1999. AD
India okays Bt cotton
For the firsttime, the Indiang o v e r n m e n t ’sDepartment ofBiotechnology(DBT) hasgranted “biosafe-ty clearance” toa geneticallymodified crop.On April 3, theDBT stronglyrecommendedthat Monsanto’s
Bt cotton, which has been engineered tocontain a gene from Bacillus thuringiensis(Bt), should be introduced into the countryin the interest of cotton farmers, who havebeen losing the battle against bollworm, amajor pest of cotton. The decision wasmade after regulators were “fully convincedabout its safety and potential economicbenefits to farmers,” according to DBTadviser Prasantha Ghosh, who says it pavesthe way for large-scale cultivation and mar-keting of transgenic cotton in India, andopens the doors for the entry of other GMcrops. Monsanto must now go through theformality of seeking permission from theGenetic Engineering Approval Committeefor large-scale trials. KSJ
Human fly bites rub Celera
When news surfaced in April that therecently published genome sequence of thefly Drosophila melanogaster was contami-nated with human gene sequences, Celera(Rockville, MD), which produced thesequence, immediately removed the affect-ed portions of data from its web site andbegan correcting the errors. Biologists gen-erally agree that the scientific significanceof the contamination in the initial sequenceis trivial, but that did not stop researchersfrom the competing publicly financedHuman Genome Project (HGP) from open-ly criticizing Celera for sloppiness. Celeraspokesperson Heather Kowalski suggestedthat reporters at the Los Angeles Times,which broke the story to the general public,had “some kind of axe to grind with us, and[we] don’t believe that this was any kind ofa story at all.” Kowalski adds that “it’s kindof hard for us to ponder. . . why people wantto do us harm or say bad things about us.”The answer could lie in the ongoing acri-mony between the competing genomesequencing efforts: Earlier in April, CeleraPresident Craig Venter told members ofCongress that the HGP might be producingshoddy data in its effort to win the sequenc-ing race. AD
Eco-terrorism penalties
Legislation that would impose tough penal-ties on eco-terrorists guilty of destroying GMresearch crops was passed by a Californiacommittee in April. In the past year,antibiotech group Reclaim the Seeds hasclaimed responsibility for damage to cropsand equipment owned by University ofCalifornia, Pioneer Hi-Bred, and NK Seeds(Nat. Biotechnol. 17, 1053, 1999), but thoseresponsible have not been caught. Under thenew legislation, those actually caught dam-aging crops would be liable for twice thevalue of the crop, including the cost of relatedtesting, research, and crop development—asdetermined by the court. No other state orcountry has passed anti-GM crop destruc-tion laws, according to the office of StateAssemblywoman Helen Thomson (D-Davis), who introduced the legislation. Thenew law, which covers only universityresearch and would impose the same penal-ties for destruction of livestock, awaits a voteby the entire legislature. EN
© 2000 Nature America Inc. • http://biotech.nature.com©
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