TYPE Review
PUBLISHED 21 February 2024
DOI 10.3389/fbioe.2024.1359388

OPEN ACCESSEDITED BY

Hector Quemada,Retired, Kalamazoo, United States
REVIEWED BY

George Tzotzos,
Independent Researcher, Vienna, Austria
Naglaa A. Abdallah,
Cairo University, Egypt*CORRESPONDENCE

Shuichi Nakai,shuichi.nakai@bayer.com
RECEIVED 21 December 2023
ACCEPTED 22 January 2024
PUBLISHED 21 February 2024

Introduction and scientiﬁcjustiﬁcation of datatransportability for conﬁned ﬁeld
testing for the ERA of GM plants
Shuichi Nakai 1,2*, Andrew F. Roberts 3, Abigail R. Simmons 4,
Kazuyuki Hiratsuka 5, Douglas W. Miano 6 and Facundo Vesprini 7
1

Bayer CropScience K.K., Tokyo, Japan, 2International Life Science Institute Japan, Tokyo, Japan,
Agriculture & Food Systems Institute, Washington, DC, United States, 4CropLife International, Arlington,
VA, United States, 5Graduate School of Environment and Information Sciences, Yokohama National
University, Yokohama, Japan, 6Department of Plant Science and Crop Protection, University of Nairobi,
Nairobi, Kenya, 7Bayer CropScience, Buenos Aires, Argentina
3

CITATION

Nakai S, Roberts AF, Simmons AR, Hiratsuka K,
Miano DW and Vesprini F (2024), Introduction
and scientiﬁc justiﬁcation of datatransportability for conﬁned ﬁeld testing for the
ERA of GM plants.
Front. Bioeng. Biotechnol. 12:1359388.
doi: 10.3389/fbioe.2024.1359388
COPYRIGHT© 2024 Nakai, Roberts, Simmons, Hiratsuka,
Miano and Vesprini. This is an open-accessarticle distributed under the terms of theCreative Commons Attribution License (CC BY).
The use, distribution or reproduction in otherforums is permitted, provided the original
author(s) and the copyright owner(s) are
credited and that the original publication in thisjournal is cited, in accordance with accepted
academic practice. No use, distribution or
reproduction is permitted which does notcomply with these terms.

The concept of Data Transportability (DT) of Conﬁned Field Testing (CFT) to
support the Environmental Risk Assessment (ERA) of Genetically Modiﬁed (GM)plants was ﬁrst introduced in the literature by Garcia-Alonso et al., in 2014. Since
then, DT has been discussed in many countries and regions as a concept toprevent duplication of regulatory studies without compromising quality of the
ERA. However, despite its usefulness and scientiﬁc justiﬁcation, DT is not welladopted at this time and many regulatory agencies around the world require
additional in-country CFT be conducted before approving GM plants. Based on
the current circumstances, the authors organized a parallel session entitled“Introduction and Scientiﬁc Justiﬁcation of DT for CFT for the ERA of GM
plants” at 16th ISBR (the International Society for Biosafety Research). Thissession mainly consisted of the following three parts. The ﬁrst two speakers,
Andrew Roberts and Abigail Simmons provided an overview of DT and examples
of conditions for the transportability of ﬁeld data/conclusions advocated in thepeer-reviewed scientiﬁc journals. Next, the current status of DT adoption in somecountries/regions such as Japan and Africa, and a theoretical case study forArgentina were introduced by Kazuyuki Hiratsuka, Douglas Miano, and Facundo
Vesprini, respectively. Lastly, a risk hypothesis-based approach for DT which wasdeveloped in advance by the ﬁve speakers of this parallel session, was introduced.
During the discussion, there was a common understanding that transition to therisk hypothesis-based approach for DT was scientiﬁcally appropriate, considering
the accumulated evidences that several countries have conducted conﬁrmatory
local CFT for more than 20 years but they have not detected any differences
related to the ERA assessment endpoints in GM crops. The risk hypothesis-based
approach for DT introduced here is expected to play an important role indiscussions on the implementation of DT in various parts of the world in
the future.
KEYWORDS

data transportability, genetically modiﬁed plant, environmental risk assessment,
conﬁned ﬁeld testing, problem formulation

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GRAPHICAL ABSTRACT

1 Introduction

part of the ERA to determine whether cultivation or incidental
release of the GM crops could cause environmental harm.
Sometimes, even in the absence of country-speciﬁc risk
hypotheses, regulatory agencies require local laboratory and/or
CFT in a country intending to cultivate GM crops. Someagencies also require local agronomic studies when the GM plant
products (e.g., grain) is intended only for import, not for cultivation.
For example, regulatory agencies in Japan (Ministry of Agriculture,
Forestry and Fisheries, MAFF and Ministry of the Environment,MOE) have required local ﬁeld studies for import approvals forsome GM events, depending on the crop (s) and trait (s). The
regulatory agency in China (Ministry of Agriculture and Rural
Affairs, MARA) accepts global data as part of the import permit
application, but local ﬁeld studies as well as other laboratory-based
studies are then commissioned by MARA to be conducted by a local
institution in China. The requirements to repeat studies in different
countries without identiﬁed risk hypotheses leads to duplication ofdata and add time and complexity to the regulatory process of GM
plant without improving the ERA.
DT has been discussed in many countries and regions as a way toprevent the unwarranted duplication of regulatory studies withoutcompromising the quality of the ERA. However, despite its
usefulness and scientiﬁc justiﬁcation, DT is not yet fully adopted,
as many regulatory agencies around the world require additional incountry CFT be conducted before approving GM plants. There are
primarily two factors why DT is not fully adopted. Firstly, in contrast
to controlled environment like laboratories or greenhouses, where
testing conditions can be consistently regulated, the growth of GM
crops in ﬁeld, like all crops in the ﬁeld, may exhibit phenotypicvariation in different environment, such as different soil types andweather conditions. Consequently, some regulatory authorities
advocate the necessity of conducting CFT speciﬁc to thereceiving environment. Secondly, there is difﬁculty of amending
the guidelines that regulate GM crops once they have been
established. The process of amending guidelines typically entails
a complex procedure, which includes a public comment period.
Consequently, even in the presence of accumulated scientiﬁc

The cultivation area of GM crops worldwide increased from
1.7 million hectares to over 202.2 million hectares from 1996 to
2021, and the number of cultivation countries also increased from
6 to 27 countries (AgbioInvestor, 2023). The majority of GM crops
currently grown commercially are soybean, corn, cotton and canola,
but other GM crops such as alfalfa, sugar beet, brinjal, rice, sugar
cane, wheat, potato, and tomato have also been commercialized(AgbioInvestor, 2023). Since the beginning of commercial
cultivation in 1996, GM crops have been rapidly accepted by
farmers around the world, mainly due to improved farmer
incomes resulting from increased yield and cost reductions, aswell as reduced pesticide usage (Brookes, 2022).
Although GM crops are expected to beneﬁt farmers around theworld, there are various barriers to adoption. According to a2022 study from Agbio Investor, which surveyed four leading
biotech crop developers (BASF, Bayer, Corteva, and Syngenta),
the average time it takes for a new GM crop to becommercialized has increased by about 26% from 13.1 years for acrop launched 2008–2012 to 16.5 years for a crop launched2017–2022. Additionally, it was revealed that the regulatory
phase accounts for 37.6% of the total cost and takes up 51.1% of
the nonconsecutive time (AgbioInvestor, 2022). The extra time
taken in the regulatory process delays the access of farmers andconsumers to innovations in both cultivation and import countries.
Another consequence of this situation is that developers in small
companies, startups or from the public sector are discouraged frompursuing interesting projects involving GM crops, limiting
innovations to large multinational companies and majorcommodity crops (Lewi and Vicién, 2020).
Global regulatory data requirements that are ﬁt for purpose andhypothesis-driven, based on the application of adequate problem
formulation process, would help overcome these barriers and allow
valuable innovations to contribute to food security and reduce
environmental impact without compromising biosafety.
Laboratory and/or ﬁeld studies on GM crops are conducted as

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evidence, the immediate amendment of these guidelines is generally
challenging.
As it was revealed that the regulatory phase accounts for 37.6%of the total cost and takes up 51.1% of the nonconsecutive time
(AgbioInvestor, 2022), the extra time taken in the regulatory processincluding this additional in-country CFT delays the access offarmers to this innovation which could improve farmer incomes
resulting from increased yield and cost reductions, as well as reduce
pesticide usage. Based on the current circumstance, the authorsorganized a parallel session entitled “Introduction and Scientiﬁc
Justiﬁcation of DT for CFT for the ERA of GM plants” at 16th ISBR.
In this paper, the authors will introduce the results of this parallelsession divided into three items: 1. Overview of DT and examples ofconditions for the transportability of ﬁeld data/conclusion, 2. Current
status of DT adoption in some countries/regions such as Japan, Africa
and Argentina and, 3. A risk hypothesis-based approach for DT.

formulation refers to the process of developing a testable
hypothesis of how a GM plant could affect deﬁned protection
goals/values. When an ERA is conducted using problem
formulation, a set of data such as the nature of intended traits,
the receiving environment and the biology of the unmodiﬁed crops
is considered ﬁrst. Additional data should only be requested, if there
is a plausible testable hypothesis of a pathway to harm from the GM
plant (Anderson et al., 2021). CFT is typically conducted in the
country where the GM plant is developed, and speciﬁc locations are
selected to be representative of the agricultural environments wherethese crops are grown. The data from these well-designed
comparative assessments should be transportable even in theabsence of agroclimatic similarity. It was argued that additionaldata, including local CFT should only be requested when a plausible
pathway to harm of a protection goal has been identiﬁed as the resultof conducting problem formulation.

2 Overview of DT and examples ofconditions for the transportability ofﬁeld data/conclusion

3 Current status of DT adoption in somecountries/regions such as Japan, Africa
and Argentina

Andrew Roberts, CEO of Agriculture & Food Systems Institute(AFSI) and a member of organizing committee of 16th ISBR, gave
the ﬁrst presentation entitled “Introduction of Key Concepts for
Data Transportability.” Dr. Roberts explained DT as the ability touse data collected in one geographic region or legal jurisdiction to
inform a risk assessment in another region or jurisdiction. He also
cited the avoidance of duplication of regulatory efforts as a key
beneﬁt of adopting DT. AFSI began studying the conditions for DT
in 2011 and published a conceptual framework paper in 2014
(Garcia-Alonso et al., 2014). This paper provides guiding
principles for the practical adoption of DT stating that theenvironmental and agronomic conditions under which the CFT
was conducted in the remote country (ies) must be relevant to theconditions in the local country where the GM plant is intended to be
cultivated. One way to demonstrate the relevance of environmental
conditions is through the use of agroclimate, an aggregate measureof characteristics of the physical environment over time (Melnick
et al., 2023). As a tool to visualize similar agroclimate zone, heintroduced “Global Environmental Zones Explorer (GEnZ
Explorer) (AFSI, 2023). The GEnZ Explorer can provide scientiﬁcjustiﬁcation for planning and location of ﬁeld testing, as well as
demonstrating the relevance of previous trials for consideration inanother jurisdiction conducting a risk assessment. Dr. Roberts
stressed that having a similar agroclimate is one way todemonstrate that an environment has relevance, but it is not arequirement for DT. Rather GEnZ Explorer is intended to provide
simple visual information to support scientiﬁc justiﬁcation by risk
assessors who need to present a case to decision makers or
skeptical public.
Abigail Simmons, Regulatory Manager of CropLife
International, gave a second presentation entitled “DataTransportability for Studies Performed to Support an
Environmental Risk Assessment for GM crops.” Her presentation
was made on the basis of the paper written by Bachman et al. (2021).
Dr. Simmons explained the rationale for DT using an ERA
framework that relies on problem formulation. Problem

From Japan, Kazuyuki Hiratsuka, Yokohama National
University and a Committee member of the ERA under theJapanese Ministry of Agriculture, Forestry and Fishers(MAFF), and Ministry of the Environment (MOE) made apresentation entitled “Data Transportability of GM corn andcotton for familiar traits in Japan” to introduce the current status
of ERA and DT in Japan. In introducing the ERA process inJapan, Dr. Hiratsuka emphasized that the committee members
who carry out the ERA are made up of experts from various ﬁelds
with comprehensive expertise. This allows the ERA of GM crops
to be conducted from multiple perspectives. Regarding theexamples to adopt DT in Japan, Dr. Hiratsuka explained thatJapan adopted DT of GM corn and cotton with familiar traits in2014 and 2019, respectively. He also introduced that 7 GM corn
events have already been accepted for DT until today. As the
future prospect, Dr. Hiratsuka mentioned the possibility to
expand the scope for accepting DT beyond GM corn and GM
cotton with familiar traits with scientiﬁc rationale andaccumulated evidence.
From Africa, Douglas Miano, University of Nairobi, made apresentation entitled “Evolving dialogue and policy considerations
on biosafety data transportability for advancing agricultural
biotechnology in Africa.” In Africa, the number of countries withfunctional Biosafety frameworks increased from 6 to 11 between
2011 and 2022. However, even though there are unpublished reportsof the use of DT in some African countries like Ghana and Nigeria,
widespread use of DT has not been adopted yet, and currently CFT isrequired for each country planning to cultivate GM crops. In otherregions, CFT is usually conducted for 1 year, but in Africa eachcountry requires an average of about 3 years of CFT. Even thoughuseful CFT data has already been available in some other countries,
it is not possible to transport that data, resulting in additional timerequired for obtaining approval of commercialization of GM crops,
making it difﬁcult for African farmers to access this innovation. In
the presentation, Dr. Miano referenced the African Union
Development Agency-NEPAD (AUDA-NEPAD) which has a

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ﬂagship biosafety program that was established to support Africa
Union (AU) member states on matters of biosafety regulation and to
facilitate technical cooperation among them. In recent times,
AUDA-NEPAD, Michigan State University (MSU) and Bayer
Crop Science established a Science Fellowship Program to design
and implement research on existing and potential barriers to thetransportability of biotech efﬁcacy data towards timely and costeffective decision making in Africa. This ongoing research (Mianoet al., 2023) explores pragmatic, science-based and ﬁt-for-purpose
solutions to help overcome these barriers. By adopting DT, thisgroup is aiming to eliminate redundancies in local (efﬁcacy) testing
requirements by leveraging existing data.
From Argentina, Facundo Vesprini, Bayer CropScience,
Argentina, made a presentation entitled “Transportability ofconclusions from Conﬁned Field Trials.” He presented atheoretical experience exploring the transportability of conclusionof the ERA from Brazil to Argentina, applied to a GM bean which
was developed by Brazilian Agricultural Research Enterprise(EMBRAPA), that confers resistance to the Golden Mosaic Virus.
This exercise has already been published in 2019 and tests thetransportability of conclusions from EMPRAPA 5.1 ﬁeld trials tobean growing regions in Argentina (Vesprini et al., 2020). To assess
the transportability of conclusions of agro-phenotypic (for ERA)
and compositional studies (for food and feed safety assessment)
carried out in Brazil, three main criteria were established:“appropriate experimental design and methodologies,” “relevanceand consistency of measured endpoints across studies” and“diversity of environmental conditions selected for the CFT
within the crop production zones.” It is worth noting thatsimilarity of agroclimatic conditions is not included in thecriteria. However, it was mentioned that if plausible risk
hypotheses were to be identiﬁed in a particular environment,
local CFT in Argentina may be required, or similarity of climaticconditions become relevant to address the concerns at the particularenvironment with the available studies. Given the criteria on DT
described above, the conclusions of the agro-phenotypic andcompositional studies conducted in Brazil were consideredtransportable to Argentina.

This risk hypothesis-based approach for DT introduced during
discussion of this parallel session is not entirely new but wasdeveloped by integrating the DT criteria and conditions alreadyproposed by several authors during the session. Speciﬁcally, thisapproach is structured around a concept of the ERA based on
problem formulation as proposed by Anderson et al, (2021), DT ofthe data collected in well-designed CFT that test a clear risk
hypothesis proposed by Bachman et al. (Bachman et al., 2021)
and with transportability of conclusions from conﬁned ﬁeld trials
proposed by Vesprini et al. (2020). These ﬁrst two papers played acentral role in structuring Dr. Simmons’s session and are also part ofa “Special Issues on Genetically Modiﬁed Organisms” (Molins,2021). This special issue contains seven reports developed by
CropLife International (CLI) to contribute to the development ofa scientiﬁc and internationally harmonized regulatory system basedon 25 years of experience since the start of commercial GM crop
cultivation. Two of the seven reports summarize recommendations
regarding the ERA. Anderson et al. (2021) explains that the ERA
should be based on problem formulation and only require relevant
data. Bachman et al. (2021) describes the conditions for DT within
the framework of problem formulation. These papers conclude that
if no biologically relevant differences between a GM plant and its
conventional counterparts are observed in one country or region,
data from well-designed studies can be transportable for ERA toanother country regardless of agroclimate zone.
The paper (Vesprini et al., 2020) introduced by Eng. Vesprini also
recommends local CFT, only if there is a risk hypothesis identiﬁed for
the GM crops in a particular environment, and pointed out that“appropriate experimental design and methodologies,” “relevanceand consistency of measured endpoints across studies” and“diversity of environmental conditions in CFT locations within thecrop production zones” are the three key criteria proposed fortransportability of conclusion which are basically the same idea as
the risk hypothesis-based approach for DT.
Dr. Roberts introduced a paper written by Garcia-Alonso et al.
(2014) which propose four conditions for practical DT. One of thesecriteria is that evaluators must have scientiﬁc justiﬁcation for the useof CFT data from other places, and one way provide this justiﬁcation
is to demonstrate similarity in agroclimate (Melnick et al., 2023). As
previously mentioned, he emphasized that the concept of similarityof agroclimatic zone may be helpful for rational selection of CFT
sites, but it is only one way to demonstrate that the environment
where data was collected is relevant for consideration during risk
assessment, not a requirement for DT.
As introduced by Dr. Hiratsuka, Dr. Miano and Eng. Vesprini inthis session, there are different degree of adoption of DT, dependingon factors like the experience with ERA process for GM crops, public
acceptance of GM crops in each country and region, and others.
Even in countries that have accumulated experience with the ERA of
GM crops, one of the reasons for low adoption of DT is the idea that
GM crops will grow differently in different growing environments.
In such case, it is important to recognize the purpose of CFT for the
ERA, that is, not to characterize GM crops in as much detail as
possible in each of different environmental conditions. Rather, thepurpose of CFT for GM crops is to identify whether any unintended
and adverse changes occurred related to the ERA assessment
endpoints by comparing the GM crop to the conventional cropunder highly controlled testing conditions (Anderson et al., 2021).

4 A risk hypothesis-based approachfor DT
To conclude the session, a risk hypothesis-based approach for
DT developed in advance by the authors, was introduced (Graphic
abstract). For this approach, it is recommended to conduct an ERA
with existing information related to the receiving environment, theintroduced trait and the biology of host crop, in addition to existing
CFT data, when available, before asking for local CFT in othercountries by default. In this case, existing CFT data should meet thefollowing two conditions: a) testing should be well-designed
comparative study; b) testing should be of an adequate scale, andmultiple sites under diverse environmental conditions should beselected. If the previously collected CFT data meets these conditions,
regulatory authorities should consider requesting local speciﬁc CFT
only when a plausible risk hypothesis speciﬁc to the receiving
environment (such as biological factors, climatic conditions orothers) is identiﬁed.

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Author contributions

Many papers comparing the results of CFT conducted indifferent countries and regions have been published andconﬁrmed that no unintended or adverse changes occurred
related to the ERA assessment endpoints in GM crops which do
not have unique risk hypothesis in the receiving environment.
Clawson et al. (2019) shared the results of agronomic
characterization of GM corns performed in ﬁve regions(Argentina, Brazil, Mexico, Pakistan, and the United States) from2004 to 2014. It was demonstrated that risk assessment outcomesfrom agronomic characterization of the 3 GM corn events (MON89034, NK603, and MON 89034 × NK603) were consistent acrossmultiple global regions. Additionally, Nakai et al. (2015) comparedselected plant characteristics data which related to weedinesspotential from the CFT performed in Japan and multi-locationsin the US for already approved 3 GM corn events (LY038, MON
89034, and MON 87460), expressing diverse traits such as
nutritional improvement, lepidopteran insect-protection anddrought tolerance, respectively. The study showed the differences
related to weediness potentials that were not detected in the US CFT
were similarly not detected in the Japan CFT for all of the 3 GM corn
events. Finally, Matsushita et al. (2020) compared agronomic datafrom the CFT performed in Japan and multi-locations in the US for
already approved 11 GM soybean events and demonstrated thesimilarity of results obtained in Japan and the US.
As described above, existing conditions for DT that have alreadybeen advocated to date have fallen into three categories. The ﬁrst is
Agroclimate similarity-based approach, as introduced by Dr. Robert.
The second is Familiarity-based approach, as introduced by Dr.
Hiratsuka from Japan and the third is Risk hypothesis-based
approach, as introduced by Dr. Simmons and Eng. Vesprini.
While each condition maintains scientiﬁc validity, a great deal ofscientiﬁc knowledge has accumulated over more than 20 years,
including the result of CFT conducted in various countries andregions subsequent to some of conditions of DT were proposed. In
this context, the authors, who had previously advocated different DT
conditions, convened for this DT parallel session. After considering
the latest scientiﬁc insights, they collectively endorsed the Risk
hypothesis-based approach as one of the most scientiﬁcally valid
DT conditions currently available.
Based on the accumulated evidence, the discussion of thisparallel session was concluded with an agreement that the
proposed risk hypothesis-based approach for DT is scientiﬁcallyreasonable. The authors believe that the results of local conﬁrmatory
CFT, accumulated over the past 20 years and the science-based
criteria established for transportability, will contribute thediscussions in countries and regions contemplating the adoptionof DT in the future, even for GM crops with new traits.

SN: Writing–original draft, Writing–review and editing. AR:
Writing–review and editing. AS: Writing–review and editing. KH:
Writing–review and editing. DM: Writing–review and editing. FV:
Writing–review and editing.

Funding
The author(s) declare ﬁnancial support was received for the
research, authorship, and/or publication of this article. Author AR’swork on data transportability was supported by grants from the
USDA Foreign Agricultural Service, and his participation in the
ISBR Symposium was supported by a grant from CropLife
international. Author KH's participation in the ISBR Symposium
was supported by ILSI Japan. ILSI is a non-proﬁt network ofscientiﬁc, tripartite institutions that advocate for the use ofscience for the improvement of human health and wellbeing andsafeguard the environment. Author DM’s participation in the ISBR
Symposium was supported by Michigan State University.

Acknowledgments
The authors acknowledge the support of Shinobu Sato, Yukihiko
Toquenaga, Junichi Tanaka, Mai Tsuda, and Kei Takamoto todevelop the risk hypothesis-based approach for DT.

Conﬂict of interest
Author SN was employed by Bayer CropScience K.K. Author AS
was employed by CropLife International. Author FV was employedby Bayer CropScience.
The funder had the following role in the article, Bayer
CropScience supported the open access publication of this work.

Publisher’s noteAll claims expressed in this article are solely those of the authorsand do not necessarily represent those of their afﬁliatedorganizations, or those of the publisher, the editors and thereviewers. Any product that may be evaluated in this article, or
claim that may be made by its manufacturer, is not guaranteed or
endorsed by the publisher.

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