Proposed criteria for identifying GE crop plants that pose a low or negligible risk to the environment under conditions of low-level presence in seed.
The low-level presence (LLP) of genetically engineered (GE) seeds that have been approved in the country of origin but not the country of import presents challenges for regulators in both seed importing and exporting countries, as well as for the international seed trade and the farmers who rely on it. In addition to legal, financial and regulatory challenges, such LLP situations in seed may also require an environmental risk assessment by the country of import. Such assessments have typically been informed by the national framework established to support decisions related to wide scale cultivation, and frequently do not take into account the low environmental exposure and prior regulatory history of the GE plant. In addition, such assessment processes may not be well suited to the decision-making timeframe that is necessary when dealing with an LLP situation in imported seed. In order to facilitate regulatory decision making, this paper proposes a set of scientific criteria for identifying GE crop plants that are expected to pose a low or negligible risk to the environment under LLP conditions in seed. Regulatory decision makers in some importing countries may decide to use these criteria to assist in risk analysis associated with LLP situations they are experiencing or could experience in the future, and might choose to proactively apply the criteria to identify existing GE plants with regulatory approvals in other countries that would be expected to pose low risk under conditions of LLP in seed.
Center for Environmental Risk Assessment, ILSI Research Foundation, Washington, DC, USA. aroberts@ilsi.org.
Andrew
A
Roberts
Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo, Brazil.
Flavio
F
Finardi-Filho
Biotechnology Regulatory Services, Animal and Plant Health Inspection Service, USDA, Washington, DC, USA.
Subray
S
Hegde
Asociación de Semilleros Argentinos, Buenos Aires, Argentina.
Juan
J
Kiekebusch
DuPont Pioneer, Johnston, IA, USA.
Gonzalo
G
Klimpel
Dow AgroSciences, Indianapolis, IN, USA.
Mark
M
Krieger
MAGyP, Buenos Aires, Argentina.|National University of Quilmes, Buenos Aires, Argentina.
Martin A
MA
Lema
Canadian Food Inspection Agency, Toronto, Canada.
Philip
P
Macdonald
Monsanto Co., St. Louis, MO, USA.
Claudia
C
Nari
Monsanto Co., St. Louis, MO, USA.|ILSI Argentina, Buenos Aires, Argentina.
Clara
C
Rubinstein
American Seed Trade Association, Alexandria, VA, USA.
Bernice
B
Slutsky
Center for Environmental Risk Assessment, ILSI Research Foundation, Washington, DC, USA.
Carmen
C
Vicien
D004782:Environmental Health; D030821:Plants, Genetically Modified; D018570:Risk Assessment; D012639:Seeds / Q000235:genetics*
ERA; Environmental risk assessment; Genetically engineered plants; LLP; Low level presence