GMO import bans would be both unnecessarily costly and pointlessDownload
The Green G-Nome’s guide to GM crops and policies in the EUDownload
Europe’s specialty foods like hams and cheeses are exported into other parts of the world. But few of us are aware that the EU is also the world’s biggest importer of agri-food products. Our livestock farmers are particularly dependent on imported feeds, and especially on imported protein sources.
Almost all soya is provided by South and North American countries, where GM technology adoption is over 90%. In total, the EU imports approximately 35 million tonnes (MT) per year or over 60 kg of soya bean products per citizen (including crushed soya meal). Soya beans primarily feed our cows, pigs and chickens, helping EU livestock farms prosper which drives EU exports, jobs and growth.
This paper details the weight of evidence (WOE) and stepwise approaches used to assess the food and feed safety of newly expressed proteins (NEPs) in genetically modified (GM) plants, based on previously reported principles. The WOE approach is critical, as in a vast majority of cases no single assay or biochemical characteristic can identify a protein as a hazard. A stepwise approach is recommended to evaluate the safety of NEPs taking the totality of information into account. Potential triggers for the need for supplementary toxicology studies are discussed, and an alternative in vitro method for the acute toxicology study is proposed.
Jason Ropera, Elizabeth A. Lipscombb,∗, Jay S. Petrickc,∗, Rakesh Ranjanb,∗, Alaina Sauve-Ciencewickid,∗, Laurie Goodwine,∗∗
aCorteva Agriscience TM, Johnston, IA
bBASF Corporation, Research Triangle Park, NC cBayer, Crop Science Division, Chesterfield, MO dSyngenta, Crop Protection, LLC., Research Triangle Park, NC eCropLife International, Washington, DC
Additional safety assessment of a stacked trait product produced by conventional breeding should not be required unless there is a plausible and testable hypothesis for interaction of the traits. However, the different approaches employed for the regulation of stacked trait products between countries results in asynchronous approvals, increasing the potential for trade flow disruptions, and adds to the regulatory burden for product developers.
Laurie Goodwina,∗, Penny Hunstb, Luis Burzioc, Laura Rowed, Stephanie Moneye, Suma Chakravarthya,∗∗
aCropLife International, Washington, DC
bBASF Corporation, Research Triangle Park, NC cBayer U.S. – CropScience, Chesterfield, MO dCorteva Agriscience TM, Johnston, IA
eSyngenta, Crop Protection, LLC., Research Triangle Park, NC
A set of core studies including molecular characterization, expression and characterization of the newly expressed proteins (or other expression product), and safety assessment of the introduced protein, are appropriate to characterize the product and assess safety. Using data from core studies and employing a “problem formulation” approach, the need for supplementary hypothesis-driven or case-by-case studies can be determined. Employing this approach for the evaluation of GM plants will remove regulatory data requirements that do not provide value to the safety assessment, and provide a consistent framework for global regulation.
Stephen Watersa, Adela Ramosb, Angela Hendrickson Cullerc, Penny Hunstd, Lawrence Zephe, Rachel Gaste, Debbie Mahadeoc, Jordan Sottosantod, Scott Hubere, Guomin Shanb, Suma Chakravarthyf,∗, Laurie Goodwinf,∗∗
aWaters International Consulting, Bousval, Belgium bCorteva Agriscience TM, Johnston, IA
cBayer, Crop Science Division, Chesterfield, MO dBASF Corporation, Research Triangle Park, NC eSyngenta, Crop Protection, LLC., Research Triangle Park, NC fCropLife International, Washington, DC
Risk assessment of genetically modified (GM) crops includes an evaluation of hazard and exposure to newly expressed crop constituents, exempli- fied herein by newly expressed proteins (NEPs). Guidance directing dietary exposure assessments (DEAs) is limited and/or globally inconsistent. Best practices for conducting DEAs are presented and include a preliminary problem formulation step to determine if a formal DEA is necessary to support the risk assessment. If a formal DEA is deemed necessary, the type of exposure (acute or chronic) and the availability of food con- sumption data relevant to the targeted population should be identified.
Carey A. Mathesiusa, Alaina Sauve-Ciencewickib,∗, Jennifer Andersona, Cheryl Clevelandc, Carrie Flemingd, Gregory E. Frierdiche, Laurie Goodwinf, Mark Grunenwaldg, Frank Laporteh, Elizabeth A. Lipscombc, Regina Oberdoerferi, Jay S. Petricke, Patricia A. Baumanb
aCorteva AgriscienceTM, Johnston, IA 50131, USA
bSyngenta, Crop Protection, LLC, Research Triangle Park, NC 27709, USA cBASF Plant Science L.P., 26 Davis Drive, Research Triangle Park, NC 27709, USA dCorteva AgriscienceTM, Indianapolis, IN 46268, USA
eBayer, Crop Science Division, Chesterfield, MO, 63017, USA
fCropLife International, Washington, DC, USA
gSyngenta Crop Protection LLC, Greensboro, NC 27419, USA
hBayer, Crop Science Division, Lyon, France 69009
iBASF Agricultural Solutions GmbH, 67063 Ludwigshafen, Germany