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
An investigation of the potential aller- genicity of newly expressed proteins in genetically modified (GM) crops comprises part of the assessment of GM crop safety. However, allergenicity is not completely predictable from a definitive assay result or set of protein characteristics, and scientific opinions regarding the data that should be used to assess allergenicity are continuously evolving.
The goals of this paper are to: 1) define the process for identifying potential pathways to harm based on robust problem formulation; 2) provide an overview of data that inform the science-based ERA for cultivation approval; 3) provide examples of data that are routinely or occasionally required but do not inform the ERA; and 4) make recommendations for harmonization of global ERA data requirements. Refinement and harmonization of data requirements across global regulatory authorities will add transparency and predictability to the ERA of GM crops globally, while ensuring that each country’s protection goals are respected.
Jennifer Andersona,∗, Pamela Bachmanb, Andrea Burnsc, Suma Chakravarthyd,∗∗, Laurie Goodwind, Laura Privallee, Shuang Songc, Nicholas Storera
aCorteva Agriscience TM, Johnston, IA
bBayer, Crop Science Division, Chesterfield, MO cSyngenta, Crop Protection, LLC., Research Triangle Park, NC dCropLife International, Washington, DC
eBASF Corporation, Research Triangle Park, NC
Genetically modified (GM) plants used for food and feed have an established history of safe use over more than 25 years of their commercialization. Developers and regulatory authorities have accumulated extensive experience in evaluating their safety over time. The studies required for the safety assessment of GM plants used for food and feed should now be re-defined to leverage this experience and increased scientific knowledge. This paper, a companion paper for Waters et al. also published in this issue, presents a systematic approach for the safety assessment of newly expressed proteins (NEPs) in GM plants by evaluating the two components of risk: hazard and exposure.
Phil Brunea,∗, Suma Chakravarthyb,1,∗, Gerson Grasera,∗, Carey A. Mathesiusc,∗, Scott McClaina,2,∗, Jay S. Petrickd,∗, Alaina Sauve-Ciencewickia,∗, Barry Schaferc,∗, Andre Silvanovichd,∗, Kent Brinkc,∗∗, Kristina Burgina,∗∗, Dean Busheyd,∗∗, Matthew L. Cheevere,∗∗, Thomas Edringtond,∗∗, Huihua Fue,∗∗, Veerle Habexf,∗∗, Rod Hermanc,∗∗, Emir Islamovice,∗∗, Elizabeth A. Lipscombe,∗∗, Shawn Motykae,∗∗, Laura Privallee,∗∗, Rakesh Ranjane,∗∗, Jason Roperc,∗∗, Ping Songc,∗∗, Gregory Tiltond,∗∗, John Zhangc,∗∗, Stephen Watersg, Adela Ramosc, Angela Hendrickson Cullerd, Penny Hunste, Rachel Gasta, Debbie Mahadeod, Laurie Goodwinb,3
aSyngenta, Crop Protection, LLC., Research Triangle Park, NC bCropLife International, Washington, DC
cCorteva Agriscience TM, Johnston, IA
dBayer, Crop Science Division, Chesterfield, MO eBASF Corporation, Research Triangle Park, NC fBASF BBCC, Innovation Center Gent, Belgium gWaters International Consulting, Belgium
Based on experience and scientific advancements over the past two decades, a revised approach for the assessment of the allergenic potential of newly expressed proteins (NEPs) in genetically modified (GM) plants is warranted.
Scott McClaina,∗, Rod A. Hermanb,∗∗, Emir Islamovicc,∗∗, Rakesh Ranjanc,∗∗, Andre Silvanovichd,∗∗, Ping Songb,∗∗, Laurie Goodwine,1
aSyngenta, Crop Protection, LLC., Research Triangle Park, NC bCorteva Agriscience TM, Johnston, IA
cBASF Corporation, Research Triangle Park, NC dBayer, Crop Science Division, Chesterfield, MO eCropLife International, Washington, DC
Deloitte prepared a high level overview of the latest CAP proposal for CropLife EuropeDownload
CropLife Europe- DAPT position on the applicability of the EFSA guidance on dermal absorption in the context of the draft Brazilian regulation and guidance on Exposure assessment of operators, workers, residents and bystanders for the risk assessment to pesticides