WASHINGTON -- A U.S. Department of Agriculture advisorycommittee voted 11-2 on Wednesday to approve a finalversion of guidelines for researchers who conduct field studieswith genetically modified organisms (GMOs).
The guidelines of USDA's Agricultural Biotechnology ResearchAdvisory Committee (ABRAC) are patterned after NationalInstitutes of Health guidelines on recombinant research andapply to federally funded research.
They provide a road map for researchers to assess the level ofsafety for the parental organism, the genetic modification ofthe parental organism and the modified organism. Theguidelines also provide for confinement measures that wouldapply to organisms that may pose an unacceptable risk tohuman health or ecosystems that can be mitigated byconfinement.
The action leaves unresolved a decision about how and when toimplement the measure.
The final guidelines cover all GMOs, with some exceptions thatinclude traditionally bred plants and animals, and organismsthat are modified by introduction of non-coding, non-expressednucleotide sequences that cause no phenotypic or physiologicalchanges in the recipient organisms.
ABRAC also narrowed the definition of an exemption for"organisms" to "microorganisms" that result from deletions,rearrangements and amplifications within a single genome,including extra-chromosomal elements.
Not included in the exemptions are microorganisms modified toincrease virulence or toxin production, significant changes incompetitive ability or environmental requirements, orphenotypic properties that are harmful to humans or theenvironment.
ABRAC's final draft restores the term "genetically modifiedorganisms," which the White House Office of Management andBudget had replaced with the term "organisms withdeliberately modified hereditary traits." ABRAC also restoredsections on the scope and implementation of guidelines, whichhad been entirely removed by the OMB, said Dr. Alvin Young,ABRAC executive secretary.
The guidelines indicate that implementation will be handled byInstitutional Biosafety Committees (IBCs), which will helpresearchers apply the guidelines. However, the ultimatedecision about whether and how to implement rests with theassistant secretary of agriculture, Young said.
By making a final recommendation, "ABRAC is forcing the USDAto make a decision on implementation," Young said. A decisionwill be forthcoming in the next few months if President Bushand Secretary of Agriculture Edward Madigan either decide toappoint a new assistant secretary to fill the current vacancy orindicate that the acting assistant secretary, Dr. Harry Mussman,will not be replaced soon, Young predicted.
The implementation issue has not been resolved due to debatethat researchers will be required to adhere to unnecessaryadditional guidelines, Young said. He noted that environmentalgroups are pressing for mandatory implementation, and thatmany universities favor implementation as a "safety net" toavoid liability from adverse effects of experiments.
Because of concerns that further delays in government reviewof the guidelines will discourage academic field work, ABRACvoted to publish the recommendations, with an appendix ofassessments of specific organisms, in a supplement to theminutes of this week's meetings. They are to be published bythe USDA's Office of Agricultural Biotechnology sometimebefore ABRAC's next meeting on Feb. 19.
-- Kris Herbst BioWorld Washington Bureau
(c) 1997 American Health Consultants. All rights reserved.