31st Meeting of the OECD Working Group on the Harmonisation of
Regulatory Oversight in Biotechnology
OECD Headquarters, Paris, 27-29 March 2017
NOT FINAL
SUMMARIES OF DEVELOPMENTS RELATED TO BIOSAFETY ISSUES
SINCE THE 30TH MEETING OF THE WORKING GROUP
AUSTRALIA .................................................................................................................................................................. 1
AUSTRIA ...................................................................................................................................................................... 13
BELGIUM ..................................................................................................................................................................... 15
BRAZIL......................................................................................................................................................................... 16
CANADA ...................................................................................................................................................................... 20
CZECH REPUBLIC ...................................................................................................................................................... 24
DENMARK ................................................................................................................................................................... 25
FRANCE ....................................................................................................................................................................... 27
INDIA ............................................................................................................................................................................ 28
JAPAN........................................................................................................................................................................... 29
KENYA ......................................................................................................................................................................... 43
KOREA ......................................................................................................................................................................... 45
MEXICO ....................................................................................................................................................................... 47
THE NETHERLANDS ................................................................................................................................................. 51
PHILIPPINES................................................................................................................................................................ 54
SLOVAKIA................................................................................................................................................................... 55
SLOVENIA ................................................................................................................................................................... 57
SOUTH AFRICA .......................................................................................................................................................... 60
SPAIN ........................................................................................................................................................................... 72
SWITZERLAND ........................................................................................................................................................... 74
THE UNITED STATES ................................................................................................................................................ 76
BIAC ............................................................................................................................................................................. 83
NEPAD - ABNE............................................................................................................................................................ 84
AUSTRALIA
Part A – Tour de Table – Summary Overview
Part A provides a short summary of key issues. Further details are provided in Part B – General Issues and Part
C – New Plant Breeding Techniques.
REGULATORY REVIEW – a technical review of the Gene Technology Regulations 2001 is underway. The focus is on
clarification of regulatory status of new techniques. A Discussion Paper detailing options was released for public
consultation in October 2016. The paper and submissions are available on the OGTR website:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reviewregulations-1
A new Gene Technology Regulator, Dr Raj Bhula, commenced a five year term from July 2016.
Approvals since April 2016
Two (2) commercial GM cotton (Gossypium hirsutum) approvals:
 Insect Resistant, Herbicide Tolerant – Bollgard® 3 x XtendFlex® and
Herbicide Tolerant – XtendFlex® (December 2016)
 Insect Resistant, Herbicide Tolerant – GlyTol® x TwinLink Plus® and
Herbicide Tolerant – GlyTol® (December 2016)
Five (5) GM plant field trial approvals:
 GM potato (disease resistance)
 GM Brassica juncea (Indian mustard, altered oil content)
 GM cotton (insect resistant, herbicide tolerant)
 GM banana (disease resisance)
 GM wheat (nitrogen and water use efficiency)
One (1) vaccine clinical trial:
 Live attenuated GMO influenza vaccines
Applications under consideration
Commercial application
 live GMO vaccine against dengue (Therapeutic Goods Administration approval also required)
Field trials:
 GM wheat (disease resistance, drought tolerance, altered oil content, altered grain composition)
 GM wheat and GM barley (abiotic stress tolerance, yield improvement)
 GM sorghum (modified grain quality traits)
Details of all environmental release applications, assessments and approvals are available from the OGTR
website: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1
1
Guidance Documents & Forms
GM plants – new application form for commercial scale environmental releases, adopting the post-border weed
risk
assessment
approach,
and
including
a
set
of
example
answers
(July
2016)
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/apps-for-gmo
Revised biology documents –
 Banana (Musa L.) (October 2016)
 Canola - Brassica napus (canola / oil seed rape) and B. juncea (Indian mustard / juncea canola) (February
2017)
 Cotton – Gossypium hirsutum (upland cotton) and G. barbadense (pima cotton) (July 2016)
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/biology-documents-1
Gene Drives - Guidance to Institutional Biosafety Committees (IBCs) on contained work with GMOs containing
engineered gene drives (December 2016)
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ibc-1
New technologies - General guidance to regulated and other stakeholders on regulatory coverage new
technologies through current legislative definitions (October 2016)
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/newtechnologies-htm
Operational policy - variation of licences (May 2016)
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/policies-1
Other Issues
Biosecurity legislation
New Australian Biosecurity (quarantine, non-GM) legislation
http://www.agriculture.gov.au/biosecurity/legislation/new-biosecurity-legislation
commenced
in
July
2016
Updated import risk analysis guidelines have been issued by the Department of Agriculture & Water Resources
http://www.agriculture.gov.au/biosecurity/risk-analysis/guidelines
Synthetic biology and gene drives
There has been significant discussion in the Australia around synthetic biology and engineered gene drives.
In 2016, CSIRO launched a new research and development framework called the Future Science Platforms https://www.csiro.au/en/About/Future-Science-Platforms
One of these FSPs is Synthetic Biology – see https://research.csiro.au/synthetic-biology-fsp/ and https://www.csiro.au/en/Research/LWF/Areas/Synthetic-Biology
The Australian Academy of Science is also preparing a paper on gene drive research which is expected to be released
in April 2017.
OGTR has participated in a number of forums discussing gene drives and synthetic biology, providing
information on the current regulatory and risk assessment requirements.
Part B – Tour de Table – General Issues
Environmental Release of GMOs in Australia
All dealings involving the intentional release (DIR) of GMOs to the Australian environment require prior
assessment and authorisation by the Gene Technology Regulator under the Gene Technology Act 2000. The Office of
the Gene Technology Regulator (OGTR) prepares and undertakes public consultation on a Risk Assessment and Risk
2
Management Plan (RARMP) for each DIR licence application. Details of all licences issued, including the full
RARMPs,
are
available
from
the
GMO
Record
on
the
OGTR
website:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ir-1
General information on the regulation of GMOs in Australia is available on the OGTR website:
www.ogtr.gov.au An overview of other Australian legislation and agencies relevant to the regulation of
biotechnology is provided at Appendix 1.
Approvals issued by the Regulator
Australia’s Gene Technology Regulator has issued 129 licences for environmental release (as at 15 March 2017).
This includes:
20 licences for commercial scale release of GM plants, (GM cotton, canola, carnation, rose) and
5 licences for commercial scale release of human or veterinary therapeutics.
1 GMO Register entry - One GMO, blue carnations, has been determined to not require oversight by a licence and
was placed on the GMO Register in 2007.
New environmental release approvals (since April 2016)
Since the last WG meeting, the Regulator has issued seven licences for environmental release:
 2 commercial release
 5 limited and controlled releases (field trials)
Commercial releases since April 2016
Crop / therapeutic
GMO
Cotton
Bollgard®3 x XtendFlex®,
(Gossypium hirsutum)
XtendFlex®
Cotton
GlyTol®
(G. hirsutum)
GlyTol® x TwinLink Plus®
Trait & genes
Licence issued
Insect resistance (Cry1Ac, Cry2Ab and
Vip3A),
herbicide
tolerance
(glyphosate, glufosinate ammonium,
dicamba)
DIR 145
Herbicide tolerance (glyphosate or
glyphosate + glufosinate ammonium),
Insect Resistance (Cry1Ab, Cry2Ae,
Vip3A)
DIR 143
20 December 2016
8 December 2016
Limited & Controlled releases (field trials/clinical trials) since April 2016
Crop / therapeutic
Cotton
(Gossypium hirsutum)
Banana
(Musa spp.)
GMOs
Trait & genes
Conventional crosses of various
insect resistant and/or herbicide
tolerant GM cotton lines
insect
resistance
(mCry51Aa2,
Cry1Ac+Cry1Ab, VIP3Aa19)
GM banana lines
putative Fusarium-disease resistance,
stress tolerance genes from banana
Licence issued
DIR 147
23 January 2017
herbicide
tolerance
(glyphosate,
glufosinate ammonium, dicamba)
Anti-apoptosis gene from C. elegans
3
DIR 146
13
2016
December
Potato
GM potato lines
(Solanum tuberosum)
S.
tuberosum
genes
conferring
resistance to Potato virus X
DIR 150
20 February 2017
S. bulbocastanum genes conferring
resistance to Phytophthora infestans
Indian
mustard
(‘Juncea
canola’,
Brassica juncea)
GM B. juncea lines
Wheat
GM wheat lines, abiotic stress
tolerance
(Triticum aestivum)
Genes involved in biosynthesis of
omega-3 fatty acids
DIR 149
Genes involved in nitrogen and water
use efficiency
DIR 142
14 February 2017
19 April 2016
Applications being assessed
There are currently four applications for environmental release under consideration:
 1 commercial release
 3 field trials.
Commercial release applications
Crop / therapeutic
Dengue vaccine*
GMO
Dengvaxia
attenuated
Dengue virus vaccine
Trait & genes
Vaccine against
attenuation
dengue
Assessment stage
virus,
DIR 148
Public consultation on
risk assessment
*also requires registration as a human therapeutic by the TGA
Limited & Controlled release applications (field trials)
Crop / therapeutic
GMOs
Trait & genes
Assessment stage
Wheat
GM wheat lines
rust resistance;
DIR 151
(Triticum aestivum)
Disease resistance, water and
nitrogen use efficiency, oil
content
drought adaptation;
Public consultation on
risk assessment
altered starch metabolism;
increased oil content;
altered fibre content
Wheat
(Triticum aestivum)
GM wheat lines, GM barley
lines: abiotic stress tolerance;
yield improvement
frost tolerance;
DIR 152
yield enhancement
Risk assessment
preparation
GM sorghum lines: altered
grain quality – seed size, seed
number, protein content,
digestibility
modified
kafirin,
membrane protein genes
Barley
in
(Hordeum vulgare)
Sorghum
(Sorghum bicolor)
4
foldase,
DIR 153
Risk assessment
preparation
in
OECD BioTrack database
OGTR continued to provide entries of new commercial approvals to the OECD BioTrack database.
OGTR Biology documents
OGTR Biology documents provide information to support and inform risk assessment of GM plants and other
organisms. OGTR plant biology documents include a weed risk assessment of the parent species following
Australia’s National Post-Border Weed Risk Management Protocol (Standards Australia HB 294:2006, Keese et al
2013, FAO 2011). A list of all OGTR biology documents is provided in the table at Appendix 2. All documents are
available from the OGTR website http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/biology-documents-1
Biology documents revised since April 2016:



Banana (Musa L.) (October 2016, revised)
Canola – Brassica napus (canola / oil seed rape) and B. juncea (Indian mustard / juncea canola)
(February 2017, revised)
Cotton – Gossypium hirsutum (upland cotton) and G. barbadense (pima cotton) (July 2016,
revised)
The 2008 barley (Hordeum vulgare) document is currently being updated and preparation of a sorghum
(Sorghum bicolor) document is underway.
GM Plants – new commercial release application form
GM plants – new application form for commercial scale environmental releases, adopting the post-border weed
risk assessment approach, and a set of example answers (July 2016) The new documents are available from the
OGTR website: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/apps-for-gmo
The information and data requirements are focussed on the weed risk assessment process employed by OGTR,
based on HB 294:2006 National Post-Border Weed Risk Management Protocol (Standards Australia 2006) and also
adopted by the UN Food and Agriculture Organisation (FAO 2011). See also Keese et al (2013).
Guidelines reviews
The OGTR has an ongoing program to revise the Regulator’s Guidelines for Certification of Physical
Containment (PC) Facilities (the Certification Guidelines).
In February 2017, the OGTR commenced consultation on proposed revisions to Certification Guidelines for
PC2
Large
Scale
Facilities
(PC2
LS
Guidelines):
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/PC2LSrevisedguidelines-htm
The proposed revised PC2 LS Guidelines (version 3.1) have been changed in response to new information and
changes in industry practice.
In drafting the revised PC2 LS Guidelines (version 3.1), the OGTR has taken into account comments provided
by stakeholders, amendments to the Gene Technology Regulations 2001, OGTR inspections of certified PC2 facilities
in Australia, relevant national and international standards, analysis of comparable overseas guidelines, assessments of
the risks associated with the organisms likely to be contained in these facilities and the OGTR’s Guidelines for
Transport, Storage and Disposal of GMOs (2011).
The draft revised guidelines have been updated to ensure, as much as practicable, a consistent format with other
guidelines. This includes the separation of the guidelines into three parts: Part A: Requirements for Certification; Part
B: Conditions of Certification; and Part C: Work Practices.
5
Communications
A new membership of the Gene Technology Ethics & Community Consultative Committee (GTECCC)
commenced work in 2016. GTECCC met with a number of non-government organisations in November 2016 and a
communique
from
that
meeting
is
available
at:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/our-view
A new membership of the Gene Technology Technical Advisory Committee (GTTAC) began work in 2017.
Communiques from GTTAC and GTECCC meetings are available from the OGTR website:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/committees-index-1
Institutional Biosafety Committees (IBCs) play an important role in providing local oversight of GMO work in
Australia, particularly laboratory-based research. The OGTR will hold the 7th national IBC Forum in May 2017.
These forums provide an important opportunity for exchange of views with regulated stakeholders.
Regulatory Science Network
The Regulatory Science Network is a forum in which scientists from a number of Australian government
regulatory agencies (GMOs, food, biosecurity, industrial chemicals, pesticides and veterinary medicines, radiation
safety, human therapeutics, environmental chemical assessment) meet regularly to discuss issues and exchange
information. One focus of activity is on risk assessment in the regulatory context. OGTR has consulted within the
RSN on a draft Generic Risk Assessment Framework for Organisms (GRAFO). The GRAFO proposes a set of risk
factors which could be used to guide risk assessment of different types of organisms and in different contexts.
The RSN also hosts an annual scientific forum. In June 2016 the RSN collaborated with CSIRO to hold a
symposium on gene drive technology (see Tour de Table Part C).
International Activities
UN Convention on Biological Diversity (CBD) and Cartagena Protocol on Biosafety
Australia is a party to the CBD but not to the Cartagena Protocol.
Cartagena Protocol - Australia has maintained a keen interest in developments under the Protocol and has actively
participated in meetings as a non-Party, including the recent MOP7 meeting in Korea, and in other activities such as
the Ad Hoc Technical Experts Group on Risk Assessment and Risk Management (AHTEG-RARM) and submissions
on risk assessment guidance.
CBD – synthetic biology.
Synthetic biology was discussed at the 20th meeting of the Subsidiary Body on Scientific, Technical and
Technological Advice (SBSTTA 20) in April 2016 and the 13 th Conferences of the Parties (COP13) in December
2016. Australia participated in SBSTTA 20 and COP13, provided information in response to requests from the CBD
Secretariat, and continued to participate in the expert online forum.
Participation in other international symposia and fora
OGTR seeks to engage with international colleagues, particularly in relation to risk assessment of GMOs.
International collaboration and coordination activities undertaken by OGTR include:
-
Hosted a delegation from the Philippine Biosafety Committee of the Department of Science and
Technology, Canberra, May 2016
Presented on GMO risk analysis to Korean and Japanese officials at three workshops in Seoul and Jeonju,
South Korea; and Tokyo, Japan, May 2016
Hosted an Indian delegation of federal and state officials involved in gene technology regulation, February
2017
Hosting regulatory officials from Burkina Faso and Nigeria, April 2017
6
OGTR plans to participate in the 14th International Symposium on the Biosafety of GMOs (ISBGMO) in
Guadalajara, Mexico, in June 2016.
Further information
Further information about the activities of the Gene Technology Regulator is available from the OGTR website,
including annual reports: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reports-1 or on request from the
OGTR: [email protected]
References
Food & Agriculture Organisation of the United Nations (2011) Procedures for Post-border Weed Risk Management.
2nd
edition.
http://www.fao.org/fileadmin/templates/agphome/documents/Biodiversitypollination/Weeds/Docs/ProceduresPostBorderWeedRiskManagement.pdf
Keese, P.K., Robold, A.V., Myers, R.C., Weisman, S. and Smith, J. (2014) Applying a weed risk assessment
approach to GM crops. Transgenic Research 23: 957-969 http://link.springer.com/article/10.1007/s11248-013-9745-0
Standards Australia 2006. HB294:2006 National Post-Border Weed Risk
http://www.saiglobal.com/pdftemp/previews/osh/as/misc/handbook/hb294-2006.pdf
Management Protocol see
Part C – Tour de Table –
New Plant Breeding Techniques (NPBTs), and other New Technology Issues
Regulation of organisms as GMOs in Australia is determined by definitions of ‘gene technology’ and
‘genetically modified organism’ (GMO) in the Gene Technology Act 2000 (section 10) and exclusions in the Gene
Technology Regulations 2001 (‘techniques that are not gene technology’, Schedule 1A and ‘organisms that are not
GMOs’, Schedule 1). These definitions do not refer to NPBTs, intragenics, cisgenics or transgenics. The OGTR
continues to receive queries on the regulatory status of particular technologies. The OGTR cannot provide definitive
legal advice but responds to individual queries on a case by case basis.
Guidance on the current regulation of new technologies
In October 2016, the OGTR issued general guidance on the coverage of new technologies under current
Australian legislation, the Gene Technology Act 2000 (GT Act) and the Gene Technology Regulations 2001 (GT
Regulations). An excerpt from the guidance:
“… Section 10 of the Act contains a broad definition of ‘gene technology’ and thus also a broad definition of
‘genetically modified organism’ (GMO). The Gene Technology Regulations 2001 (the Regulations) provide
some exclusions to the definitions, some of which have not been changed since 2001. Although there are
challenges in applying the current definitions to some new technologies, the Regulator is obliged to perform
the functions required by the Act and apply the legislation as it stands today.
… When considering new technologies the Regulator must take a conservative approach, consistent with
promoting the object of the Act, and the broad scope of the definition of GMO contained in Section 10 of the
Act. …”
The
full
text
is
available
from
the
OGTR
website:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/newtechnologies-htm
Guidance on the engineered gene drives – containment requirements
In December 2016, the OGTR issued guidance to Institutional Biosafety Committees (IBCs) on the facility
physical containment (PC) and authorisation requirements for GMOs containing engineered gene drives:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/ibc-1
7
If gene technology is used to introduce or create a gene drive in an organism, the resulting organism will be a
GMO and subject to regulation under the Gene Technology Act 2000. The Gene Technology Regulations specify
GMOs classified as notifiable low risk dealings (NLRDs) and minimum PC requirements. IBCs undertake an
assessment of NLRD proposals, including consideration of appropriateness of PC facility type and level. If a GMO
contains a functional gene drive it would be considered to have a selective advantage as defined in the Regulations
and require at least PC2 containment. While many GMOs with engineered gene drives would be classified as NLRDs
some may require authorisation by a licence from the Regulator. OGTR has specific guidelines for PC2 and PC3
certification
of
animal,
aquatic
and
invertebrate
PC
facilities:
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/cert-pc2-1
and
http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/cert-pc3-1
Review of Gene Technology Regulations
The Gene Technology Regulator is undertaking a technical review of the Gene Technology Regulations 2001
(GT Regulations) – full details, including Discussion Paper and submissions received, are available on the OGTR
website: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/reviewregulations-1
The scope of the review is confined to the current policy settings (eg definitions in the GT Act). Changes to
policy settings would require changes to the GT Act. It is anticipated that a review of the Australian GMO regulatory
scheme and the GT Act may commence in 2017-18.
As noted above, the GT Regulations provide a number of exclusions from regulation. The review of the GT
Regulations will focus on new technologies, including clarification of exclusions, and examine:


cases where the capture or exclusion of these techniques is not clear, and whether those new
technologies should be regulated;
scientific evidence relating to risks posed as a result of using new technologies.
The review is particularly focussed on genome editing techniques, specifically oligo-directed mutagenesis and
site-directed nuclease (SDN) techniques. The review will also give some consideration to RNA interference, gene
drives, and to providing greater clarity on the current regulatory status of grafting, agro-infiltration and techniques
producing null segregants (including reverse breeding, particular proprietary seed production technology and
induction of early flowering).
In October 2016, a Discussion Paper outlining four options for the regulation of new technologies was released
for public consultation. Options focussed on oligo-directed mutagenesis and two SDN techniques:


SDN-1, involving the unguided repair of a targeted double-strand break (ie no template is used)
SDN-2, involving template-guided repair of a targeted double-strand break, using an
oligonucleotide to guide small sequence changes
A third SDN technique, SDN-3, was not considered as it is clearly within the scope of current regulation and
this status is not open to change through the review. SDN-3 involves template-guided repair of a targeted doublestrand break using a long template to insert new sequences.
The Discussion paper canvassed four options for the regulation of SDN-1, SDN-2 and oligo-directed
mutagenesis techniques:




Option 1: no amendment to the GT Regulations
Option 2: regulate all organisms developed with SDN techniques and oligo-directed mutagenesis
as GMOs
Option 3: process based - regulate as GMOs organisms developed with new techniques that use a
template to direct sequence changes
Option 4: product / outcome based – exclude organisms from regulation as GMOs if the genetic
changes introduced by new techniques are similar to or indistinguishable from conventional
breeding
8
The two figures below (excerpted from the Discussion Paper) give a pictorial representation of the current
regulatory situation and the three options, respectively.
Figure 1: Comparison of process and product features of some new technologies.
Site-directed nuclease (SDN) techniques and oligo-directed mutagenesis are represented according to their process and product
features, relative to unregulated techniques (natural mutations, chemical mutagenesis and radiation mutagenesis) and regulated
techniques (inserting transgenes). SDN-1 involves the un-guided repair of a targeted double-strand break, producing sequence
changes similar to natural mutations and mutagenesis. SDN-2 and SDN-3 involve template-guided repair of a targeted doublestrand break. SDN-2 and oligo-directed mutagenesis use an oligonucleotide to guide small sequence changes that may be identical
to the outcomes of SDN-1. SDN-3 uses a long template to insert new sequences, with similar outcomes to inserting transgenes by
other gene technology techniques.
9
Figure 2: Comparison of technologies that would be regulated under options 2, 3 and 4.
Site-directed nuclease (SDN) techniques and oligo-directed mutagenesis are represented according to their process and product
features, as in Figure 1. How organisms produced using these techniques would be regulated in accordance with options 2, 3 and 4
is indicated. Mutagenesis and transgenes, which are outside the scope of this review, are shown in pale colours for comparison
10
Gene Drives and Synthetic Biology
There has been significant interest in the potential application of engineered gene drives and synthetic biology in
Australia in the last year.
In 2016, CSIRO launched a new research and development framework called the Future Science Platforms https://www.csiro.au/en/About/Future-Science-Platforms
One of these FSPs is Synthetic Biology – see https://research.csiro.au/synthetic-biology-fsp/ and https://www.csiro.au/en/Research/LWF/Areas/Synthetic-Biology
The Australian Academy of Science is also preparing a paper on gene drive research which is expected to be released
in April 2017.
Many research activities currently being described as synthetic biology would equally be described as gene
technology or genetic engineering. The definitions of gene technology and GMO in the Australian GT Act do not
explicitly mention synthetic biology but are framed broadly, and for known applications, organisms derived through
synthetic biology would be regulated under the GT Act as GMOs.
OGTR has also participated in a number of forums regarding the potential applications of gene drives or
synthetic biology and provided information on the regulation and risk assessment requirements in Australia,
including:
 April 2016: CSIRO and Synthetic Biology Australasia: Synthetic Biology Cutting Edge Symposium
 June 2016: CSIRO–Regulatory Science Network symposium The Use of Gene Drive Technology in
Controlling Pests and Diseases
In October 2016 the OECD Co-operative Research Programme Workshop ‘Environmental Release of
Engineered Pests: Building an International Governance Framework’ was held in Raleigh, North Carolina, USA.
OGTR contributed to the paper Edward, O. and Thygesen, P. (2016) ‘The regulatory framework in Australia for gene
drive modified insect pests’. Abstracts and presentations are available at: https://research.ncsu.edu/ges/researchges/oecd-crp-meeting/
Appendix 1 - Regulation of Biotechnology in Australia
GMO regulation by the Gene Technology Regulator
In Australia, dealings with genetically modified organisms (GMOs) are regulated under the Gene Technology
Act 2000 (GT Act). The object of the Act ‘to protect the health and safety of people, and to protect the environment,
by identifying risk posed by or as a result of gene technology, and by managing those risks through regulating certain
dealings with GMOs’.
The GT Act establishes an independent decision maker, the Gene Technology Regulator (the Regulator), who
administers the legislation with the assistance of the staff of the Office of the Gene Technology Regulator (OGTR) –
see www.ogtr.gov.au.
Other regulations relevant to GMOs
The regulation of GMOs by OGTR is integrated with other product specific regulation. Depending on the end
use, GMOs may require assessment and approval by other regulators:




GM foods are assessed by Food Standards Australia New Zealand (FSANZ, www.foodstandards.gov.au.
Human therapeutics by the Therapeutic Goods Administration (TGA, www.tga.gov.au ).
Agricultural chemicals and veterinary medicines by the Australian Pesticides and Veterinary Medicines
Authority (APVMA, www.apvma.gov.au )
Pesticidal GMO crops (eg expressing Bt genes) also require registration by the APVMA, including insect
resistance management aspects. Herbicides for application to GM herbicide tolerant crops also require
registration by the APVMA, including herbicide resistance management requirements.
Import of live organisms and biological materials requires authorisation from Agriculture Biosecurity
http://www.agriculture.gov.au/import .
11
The Biosecurity Act 2015 (Biosecurity Act) and Biosecurity Regulation commenced on 16 June 2016 and
replaced the Quarantine Act 1908. see http://www.agriculture.gov.au/biosecurity/legislation/newbiosecurity-legislation/bio-legislation Updated Biosecurity Import Risk Analysis Guidelines were also
published
in
2016
to
match
the
new
legislative
requirements
http://www.agriculture.gov.au/biosecurity/risk-analysis/guidelines
Appendix 2: OGTR Biology Documents
All available from: http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/biology-documents-1
Plants
Common name
Scientific name
Current Version
Banana
Musa spp.
2016
Barley
Hordeum vulgare
2008
Canola and Indian Mustard
Brassica napus and Brassica juncea
2016
Carnation
Dianthus caryophyllus
2015
Cotton: upland and pima cotton
Gossypium hirsutum and G. barbadense
2016
Italian ryegrass, perennial ryegrass and Lolium multiflorum, L. perenne, L. arundinaceum
tall fescue
2008
Lupin or lupine
Lupinus L.
2013
Maize
Zea mays L spp. mays
2008
Papaya
Carica papaya
2008
Pineapple
Ananas comosus var. comosus
2008
Rice
Oryza sativa
2005
Rose
Rosa x hybrida
2009
Safflower
Carthamus tinctorius L
2015
Sugarcane
Saccharum spp.
2011
Torenia
Torenia x hybrida
2008
Wheat
Triticum aestivum
2016
White clover
Trifolium repens
2008
Other Organisms
12
Common name
Current Version
Bovine herpesvirus (BoHV-1)
2005
AUSTRIA
1. Legislation and Austrian Safeguard measures on GM crops:
In 2016 the Austrian Gene Technology Act was amended together with the law governing insurance contracts
which now prohibit the use of data from genetic analyses for certain purposes by employers and insurers. This also
includes the submission and acceptance of body substances for the purpose of conducting genetic analyses.
(German language only:
http://www.bmgf.gv.at/cms/home/attachments/7/8/8/CH1060/CMS1226929588865/ris.c.bgbl__i_nr__112_2016
.pdf).
So far Austria exempted its entire territory for cultivation of several GM maize events (MON810, 1507, 59122,
1507x59122, Bt11, GA21, MIR604 and Bt11xMIR604xGA21). With the exception of maize events
Bt11xMIR604xGA21 and MIR604 (applications withdrawn by applicants) the exemption proposals were accepted by
the respective applicants and will be implemented in EU-level decision documents. As the renewal of the
authorisation of cultivation of GM maize MON810 is currently ongoing, in the meantime the geographical scope of
the existing authorisation for cultivation was adjusted by Commission Implementing Decision (EU) 2016/321 of 3
March 2016.
An
overview
of
Austrian
legislation
on
GMOs
is
provided
at
http://bmg.gv.at/home/Schwerpunkte/Gentechnik/Fachinformation_Allgemeines/Description_of_Austrian_Regulatio
ns_on_Genetic_Engineering.
During the time of report (April 2016 – March 2017) no cultivation of GM crops as well as no deliberate release
of GMOs for field trials occurred in Austria.
The Committee on the coordination of national measures according to the national implementation of Directive
2015/412/EU (Beirat zur Koordinierung der Gentechnikvorsorge), which had been set up in 2015, had its first
constituent meeting in February 2016. The meeting approved the Rules of Procedure of the Committee and had a
brief discussion on issues concerning the justification of regional or national restrictions of the cultivation of GMOs
in accordance with Directive 2015/412/EU.
2. Publications and activities concerning the Risk Assessment of GMOs:
A number of respective studies have been conducted/published since April 2016:


Pascher K. (2016): Spread of volunteer and feral maize plants in Central Europe: recent data from Austria.
Environ Sci Eur (2016) 28:30, doi 10.1186/s12302-016-0098-1
Woegerbauer M., Stepanek W., Brueller W. (2016): GRACE: No place for doubts? An endorsement for
communicating uncertainty in scientific assessments. Archives of Toxicology 90(12), doi: 10.1007/s00204016-1841-5
13



Woegerbauer M., Stepanek W., Brueller W. 2016: GMTox16: Significance of in vivo feeding studies for the
toxicological risk assessment of genetically modified plants for food and feed use. Project GZ 70420/0011II/B/15/2016. Austrian Federal Ministry of Health. Summary Report p. 1 – 67.
Dolezel M., Miklau M., Heissenberger A., Reichenbecher W. (2017): Are Limits of Concern a useful
concept to improve the environmental risk assessment of GM plants? Environmental Sciences
Europe.Bridging Science and Regulation at the Regional and European Level 201729:7, doi:
10.1186/s12302-017-0104-2
Schütte G., Eckerstorfer M., Rastelli V., Reichenbecher W., Restrepo‑Vassalli S., Ruohonen‑Lehto M.,
Wuest Saucy A.-G. Mertens M (2017): Herbicide resistance and biodiversity: agronomic and environmental
aspects of genetically modified herbicide‑resistant plants. Environ Sci Eur (2017) 29:5, doi 10.1186/s12302016-0100-y
In addition the Environment Agency Austria supported the following activities:



The Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management established by
the Parties to the Cartagena Protocol on Biosafety was chaired by Austria and reported to the COP/MOP 8
meeting in Mexico, December 2016. The COP/MOP 8 took note of the results of the AHTEG and discussed
them at the meeting; the mandate for the AHTEG was not further extended.
Austria also chaired the Aarhus CBD Round table discussions (15.-17.11.2016)
Standards for the GMO-free production of soy in the Danube region were presented at a Conference held
25.4.2016 in Vienna.
At the conference the "Vienna Declaration for a common European Approach to GMO-free Labeling" was
adopted.
3. Information concerning state of affairs concerning application of New Techniques:
Concerning the legal status of New Breeding Techniques (NBTs) Austria is waiting for a interpretation of NBTs
by the European Commission and the Opinion of the Scientific Advice Mechanism which is expected to be disclosed
late March 2017. In addition the French administrative court addressed a request for a preliminary ruling to the
European Court of Justice, which will be answered before April 2018. According to the outcomes of the above
deliberations the discussion may be finally resolved whether the respective methods will be subject to the EU GMOregulations or not.
At the national level in Austria two discussion forums organized by the Austrian Agency for Health and Food
Safety were addressing different issues related to the use and regulation of NBTs.
These forums were held in the framework of a strategic process addressing the future of plant production initiated by
the Federal Ministry of Agriculture, Forestry, Environment and Water Management. A number of differnet events
were organised under the umbrella of the strategic process, meant to address different imminent issues and involving
all relevant stakeholder groups. Further information (in German language) on the process and the different events can
be found at: www.zukunft-pflanzenbau.at.


a Seed Production Summit was held on April 12th 2016 addressing three topics: new breeding objectives to
address future challenges, biopatents and crop variety protection regimes as regards the use of plant genetic
ressources and issues concerning the legal status of applications of NBTs as compared to GM crops.
a Round Table discussion on NBTs was held on February 27 th 2017. The event aimed to present the state of
the art as regards application of NBTs in plant breeding as well as the state of affairs of legal deliberation on
regulation of NBTs at the EU and national level.
Again all major stakeholders were participating in that discussion, including representatives of academia,
plant breeding institutions, farmers and organic-producers associations, civil society organisations and
federal as well as regional regulators.
In addition to participation to the national discussion Environment Agency Austria provided expert input at a
Workshop held at the German Federal Agency for Nature Conservation in Bonn on Sept. 19 th 2016, which was
addressing the question whether a process-based or a product-based approach to regulation may be considered more
adequate for organisms produced with NBTs from the point of view of environmental risk assessment and nature
protection.
14
BELGIUM
Notifications for commercialisation
Belgium is actively involved in the European Food Safety Authority (EFSA) consultation for placing on the
market of genetically modified organisms (GMOs). Input in the risk assessment is provided through the Biosafety
Advisory Council, which besides food and feed aspects also evaluates environmental impacts of GMOs. The
Biosafety and Biotechnology Unit (SBB) of the Scientific Institute of Public Health ensures the secretariat of the
Biosafety Advisory Council and provides permanent scientific support to its activities. Assessment reports and
relevant documents can be consulted on http://www.bio-council.be and http://www.biosafety.be. The OECD
consensus documents on the biology of plants are consulted during the evaluations.
Notifications for field trials in Belgium
General information about GM plants that have been approved in Belgium for deliberate release into the
environment is available at the Belgian Biosafety Server (http://www.biosafety.be/DTB). Currently, one field trial
with GM poplar (modified lignin content) and one field trial with GM maize (modified growth characteristics) are
still ongoing.
Opt-out Regulation and coexistence
Cultivation and coexistence are treated on a regional level in Belgium (Flanders, Wallonia and Brussels Capital
Region). Since 2014, cultivation of GM plants in open air has been forbidden in the Brussels Capital Region, a.o. due
to the high costs that would come with coexistence. Under the new Directive (EU) 2015/412, in force since the end of
April 2015, Wallonia has opted out of growing genetically modified crops on their territory. This all means that from
a legal point of view, currently only Flanders allows the cultivation of GMOs for commercial purposes.
The legal framework for coexistence (consisting of a decree on coexistence, which contains basic arrangements
on coexistence, liability and compensation schemes, and implementing measures, including rules for GM maize
cultivation) is completed in all regions. In Flanders, it includes crop-specific rules for maize, sugar beet and potato.
GMO detection in Belgium
Since June 2006 the 'National Reference Laboratory' for Genetically Modified Organisms (NRL-GMOs) is fully
operational and has been involved in all the enforcement actions implemented by the Belgian Federal Agency for the
Safety of the Food/Feed Chain and by the Federal Public Service Public Health, Food Chain Safety and Environment.
New Techniques
Belgium (represented by the SBB) has been actively involved in initiatives at EU level during the past years to
evaluate the technical, regulatory, safety and detection aspects associated with the use of new plant breeding
techniques. This included participation in:
 the New Techniques Working Group (NTWG) established by the European Commission to advise the Competent


Authorities on whether specific NPBTs would result in a GMO in the meaning of the EU legislation (that takes a
process-based approach;
the Task Force of the JRC (Joint Research Centre) of the European Commission to discuss challenges with
detection of products obtained by NPBTs (http://ftp.jrc.es/EURdoc/JRC63971.pdf);
the Working Group on Synthetic Biology, which issued three opinions providing an operational definition of
synthetic biology and addressing risk assessment methodology, knowledge gaps and research priorities (see
http://ec.europa.eu/health/scientific_committees/emerging/opinions/index_en.htm).
15
In 2016, the Flemish administration received a request from the public sector on the status (GMO or not) of
plants and animals obtained through the use of CRISPR/Cas technology. More specifically, the request was for the
use under containment of plants and animals modified by a purified CRISPR/Cas9 protein with or without the help of
a homologous repair DNA template. The Flemish government decided that plants and animals obtained through the
proposed type of CRISPR/Cas technology were not to be seen as GMOs under the Contained Use legislation as
(1) the modifications resulting from this type CRISPR/Cas are similar in type and extent to those that can be
obtained via natural or induced (using chemical or physical agents) mutagenesis; and
(2) this type of use of CRISPR/Cas9 system does not involve the use of recombinant nucleic acid molecules.
A similar question was raised to the Federal authorities for the use of plants, obtained through the use of the
transient presence of the CRISPR/Cas protein, in field trials. Based on the opinion of the SBB, the competent
authority concluded that, in this particular case, the developed plants, containing no traces of exogenous DNA, are
excluded from the scope of GMO legislation. The technique used has been considered as a form of mutagenesis.
Announcements
 Belgium organises the 8th MEACB (Meeting of the European Advisory Committees on Biosafety in the field of

contained use and deliberate release of GMOs), which will take place in Brussels the end of November 2017.
Belgium will host the 8th meeting of the IOBC-WPRS (International Organisation on Biological and Integrated
Control - West Palaearctic Regional Section). This meeting will take place in Gent on September 4-6, 2017 and
will cover “GMOs in Integrated Plant Production”.
BRAZIL
1. Regulatory Framework
There are some reviews in progress related with GMO Biosafety regulations by the National Biosafety
Technical Commission - CTNBio:


Normative Resolution No 2/2006: GMO risk classification and biosafety measures for contained activities
Normative Resolution No 5/2008: Annex for commercial approval of genetically modified microorganisms
2. Commercial Approvals
Since last Meeting the following genetically modified events were approved for commercial release in Brazil in
2016:







BAY98: immunostimulant DNA (Bayer S.A.);
MON-89Ø34-3 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 x DAS-40278-9: insect resistance and herbicide tolerant
maize (Dow AgroSciences Ltda.);
HIPRABOVIS IBR MARKER LIVE: recombinant vaccine for bovine herpes virus type 1 (Hipra Saúde
Animal Ltda);
OncoVEXGM-CSF for cancer immunotherapy (Laboratório Químico Farmacêutico Bérgamo);
MON-89Ø34-3 x MON-88Ø17 x DAS-Ø15Ø7-1 x DAS-59122-7: insect resistance and herbicide tolerant
maize (Dow AgroSciences Ltda.);
DAS-81419-2: insect resistance and herbicide tolerant soybean (Dow AgroSciences Ltda.);
SYN-IR1Ø2-7 x MON-15985-7 x MON-88913-8: insect resistance and herbicide tolerant cotton (Monsanto
do Brasil Ltda.);
16











OGM-Protease derivative (Du Pont do Brasil S.A);
MON-87411-9: insect resistance and herbicide tolerant maize (Monsanto do Brasil Ltda.);
Prototheca moriformis strain S8695 for oil production (Solazyme Brasil Óleos Renováveis e Bioprodutos
Ltda.).
MON-87427-7: herbicide tolerant maize (Monsanto do Brasil Ltda.);
SYN-E3272-5: heat resistant alpha-amylase maize (Syngenta do Brasil Ltda.)
*approved only for food and feed;
MON-87460-4: drought tolerance maize (Monsanto do Brasil Ltda.)
*approved only for food and feed;
Saccharomyces cerevisae strain M10682 for ethanol production (Lallemand Brasil Ltda.);
Prototheca moriformis strain S8885 and derivatives for oil production (Solazyme Brasil Óleos Renováveis e
Bioprodutos Ltda.).
MON-877Ø8-9: herbicide tolerant soybean (Monsanto do Brasil Ltda.);
Saccharomyces cerevisae strain S1260 for ethanol production (Novozymes Latin America Ltda.);
BIOTECH VAC SALMONELLA: recombinant vaccine against avian salmonellose (Vetanco do Brasil
Importação e Exportação Ltda);
The total number of commercial approvals of GMOs in Brazil are: 65 genetically modified plants (40 maize, 12
cotton, 11 soybeans, 1 eucalyptus and 1 common bean), 13 genetically modified microorganism, 1 genetically
modified mosquito and 27 recombinant vaccines and derivatives. Further information can be accessed in
http://ctnbio.mcti.gov.br/liberacao-comercial#/liberacaocomercial/ consultar-processo.
There are 19 events in
(http://ctnbio.mcti.gov.br/pautas):



















the
pipeline
in
the
CTNBio
agenda
for
commercial
approval
MON-877Ø8-9 x MON-89788-1: herbicide tolerant soybean (Monsanto do Brasil Ltda.);
MON-87751-7: insect resistance soybean (Monsanto do Brasil Ltda.);
DAS-444Ø6-6 x DAS-81419-2: insect resistance and herbicide tolerant maize (Dow AgroSciences Ltda.);
BCS-GHØØ2-5 x BCS-GHØØ4-7 x BCS-GHØØ5-8 x SYN-IR1Ø2-7: insect resistance and herbicide
tolerant cotton (Bayer S.A.);
MON-877Ø1-2: herbicide tolerant cotton (Monsanto do Brasil Ltda.);
PUREVAX RAIVA: recombinant vaccine for feline (Merial Saúde Animal Ltda);
SYN-BTØ11-1 x SYN-IR162-4 x MON-89Ø34-3 x MON-ØØØ21-9; SYN-BTØ11-1 x SYN-IR162-4 x
MON-89Ø34-3 and SYN-IR162-4 x MON-89Ø34-3: insect resistance and herbicide tolerant maize
(Syngenta Seeds Ltda);
Insect resistance sugarcane (Centro de Tecnologia Canavieira – CTC)
MON-87751-7 x MON-877Ø1-2 x MON-89788-1: insect resistance and herbicide tolerant soybean
(Monsanto do Brasil Ltda.);
MON-87751-7 x MON-877Ø8-9 x MON-877Ø1-2 x MON-89788-1: insect resistance and herbicide
tolerance soybean (Monsanto do Brasil Ltda.);
MON-89Ø34-3 x DAS-Ø15Ø7-1 x MON-ØØ6Ø3-6 x SYN-IR162-4: insect resistance and herbicide tolerant
maize (Dow AgroSciences)
GMO α-amylase derivative (Du Pont do Brasil S.A);
GMO hemicellulase derivative (Du Pont do Brasil S.A);
DAS-21023-5 x DAS-24236-5 x SYN-IR102-7: insect resistance and herbicide tolerant cotton Dow
AgroSciences Ltda.);
GMO α-glucosidase derivative (Du Pont do Brasil S.A);
DP-305423-1; DP-305423-1 x MON 04031-6: modified fatty acid profile and herbicide tolerant soybean (Du
Pont do Brasil S.A);
PROTEQFLU: recombinant vaccine for equine influenza (Merial Saúde Animal Ltda.);
GMO α-amylase derivative (Du Pont do Brasil S.A);
PUREVAX Recombinante FELV: recombinant vaccine for leuquemia virus (Merial Saúde Animal Ltda.).
17
3. GMO Research
In Brazil in 2016 there were 112 field trials approved, with different plant species, including maize, soybean,
cotton, sugarcane, eucalyptus, rice and citrus. The characteristics of the biotech crops included insect resistance,
herbicide tolerance, disease resistance, drought tolerance, increased yield, reduced lignin content, increased growth
and fiber quality. There are currently (February/2017) 55 field trials in the CTNBio agenda under analysis.
In 2016 there was a total number of 429 private and public institutions registered and approved by CTNBio to
conduct research with GMOs under containment, according to CTNBio website.
4. GM Crops production
According to the private sector estimative (Celeres Consulting, http://celeres.com.br) in 2016/17 the total area
will reach 49.1 million hectares cultivated with GM crops (soybean, maize and cotton) representing 93,4% of the area
cultivated with those species. The data are showing an area around 32.7 million hectares cultivated with GM soybean,
15.7 million hectares with GM maize and 0.72 million hectares cultivated with GM cotton. The staked events are
cultivated in 32 million hectares, representing 65,1% of the total. The stack soybean represents the highest rates of
adoption being cultivated in 20,2 million hectares in the 2016/17 season.
5. GMO Inspections
The Ministry of Agriculture, Livestock and Food Supply (MAPA) is one of the institutions responsible for
GMO inspections to check the compliance with biosafety normative requirements (Law 11.105/2005). The MAPA
carried out 650 inspections in field trials all over the country and 313 inspections in the commercial use of GMOs in
2016.
18
Total Number of Inspections in Each Brazil Region
350
311
300
274
237
250
200
150
100
69
72
North
Northeast
50
0
Midwest
Southeast
South
6. Participation in the Capacity-Building Activities, Meetings and Other Subjects:





















1st Seminar about SynBio for Decision Makers - IICA (Costa Rica, March/2016)
30th Meeting of the Working Group on Harmonization of Regulatory Oversight in Biotechnology / OECD
(Paris, April/2016)
23th Meeting of the Task Force for the Safety of Novel Foods and Feeds / OECD (Paris, April/2016)
International Seed Federation (ISF) Meeting: Plant Breeding Innovation – Towards Consistent Global
Policy (Paris, April/2016)
Third Meeting of China-Brasil Joint WG on Agriculture, Biotech and Biosafety (Brasília, May/2016)
Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA 20) (Montreal, May/2016)
8th Trondheim Conference on Biodiversity (Norway, June/2016)
SynBioBeta Conference (USA, October/2016)
USP Seminar – Biosafety Regulation in Brazil (São Paulo, March and October/2016)
ILSI Brazil Scientific Symposium: Application of the new techniques of gene editing (New Breeding
Techniques, NBTs) in the agriculture (São Paulo, September/2016)
Workshop about Plant Breeding Innovation – Seed Association of the America / SAA (Chile,
November/2016)
IICA Preparatory Meeting for COP-MOP8 (Costa Rica, November/2016)
Mission from Ukraine to check the GMO regulatory system (Brasília, November/2016)
COP13 – Convention of Biological Diversity; COP-MOP8 – Meeting of the Parties of Cartagena Protocol;
COP-MOP2 – Meeting of the Parties of Nagoya Protocol (Cancun, Dezember/2016)
US-Brazil High-Level Biotechnology Working Group (HLBWG)
Canada-Brazil Bilateral Meeting on Biotech
Brazil-Argentina Bilateral Dialogue on Biotech
CAS - Southern Agricultural Council (Conselho Agropecuário do Sul) (Costa Rica, November/2016)
GLI – Global Low Level Presence Initiative
Cartagena Protocol On line Forum: “Risk Assessment” and “Socio-Economic Considerations”
Convention on Biological Diversity On line Forum: “Synthetic Biology”
19
7. GM DATA BANK
Relevant information about GMOs approved in Brazil are being registered at the BCH, FAO GM FOODs
PLATFORM and BIO TRACK.
8. NEW BREEDING TECHNIQUES
There is a continuous work of the two working groups, one in the plant/environment subcomission and another
in the human/animal subcomission. Those WG were responsible for a scientific review of the genetic engineer
techniques and to analyze and define if the products of these techniques should or not be considered a GMO
according to the definitions in the Brazilian Biosafety Law N o 11.105/2005. The WG report was approved in the
CTNBio plenary in 2016. It was suggested by the WG the elaboration of a Normative Resolution with technical
requirements related with a previous consultation mechanism for the so-called “New Genetic Engineer Techniques”.
The proposed Resolution is still under discussion.
Regarding specifically the gene edition there were no requests for approval of organisms modified with these
techniques in 2016. The only requirement in place is a general consultation process under analysis at CTNBio asking
about the legal status of an organism modified with CRISPR/Cas9 technique, according to the Law 11.105/2005.
The other two questions about NBTs:
1)
What are the regulatory triggers (e.g. process and/or product) to initiate environmental risk/safety
assessment (ER/SA)?
The trigger of the Brazilian Biosafety Law is the process – the use of genetic engineer techniques - but the
risk assessment is done case by case according to the product. The National Biosafety Technical
Commission (CTNBio) has the attribution, by Law, to follow the advances and scientific development and
to elaborate technical rules. This attribution reflects the fact that the advances in the biotech field should
be followed by the necessity to update regulations reflecting an ERA proportionate to the risk presented.
For example for stack events there is already a simplified procedure. For gene editing and other techniques
considered NBT the risk assessment procedures are under discussion.
2)
What are the protection goals for environmental risk/safety assessment (ER/SA) in your country/region?
Under the “Brazilian Biosafety Law” (Law 11.105/2005) the protection goals are the human, animal and
plant health and the environment protection.
CANADA
Confined Field Trials
The Canadian Food Inspection Agency authorized 184 confined field trials for plants with novel traits in the
2016 growing season. We saw a continued high level of interest in wheat improvement, a growing number of
camelina field trials, and far fewer corn and soybean trials than have been performed in the past. Trials were
conducted at 62 locations across Canada.
20
Unconfined Environmental Release Authorizations
The Canadian Food Inspection Agency provides access to a database containing information on the status of
regulated novel plant products in Canada, including whether products have been authorized for unconfined
environmental release (e.g. cultivation), novel livestock feed use, novel food use, and variety registration. The
database listing includes and distinguishes between genetically-modified (GM) and non-GM plants with novel traits,
and is available at: http://active.inspection.gc.ca/eng/plaveg/bio/pntvcne.asp.
The Canadian Food Inspection Agency also prepares "decision documents" whenever regulatory decisions are
made about novel plant products, intended for unconfined environmental release and/or livestock feed use. They
explain what information was reviewed to make the decision, and why certain conclusions were reached. They
provide background information, describe the plant's novel traits, and discuss the results of the assessment and
evaluation of the potential environmental and livestock feed use impacts. Decision documents are available to the
public in hard copy and on the Canadian Food Inspection Agency’s web site at:
http://www.inspection.gc.ca/english/plaveg/bio/dde.shtml.
Health Canada publishes similar summaries for novel foods on their web site at: http://www.hc-sc.gc.ca/fnan/gmf-agm/appro/index-eng.php.
Although not a Party to the Cartagena Protocol on Biosafety, Canada is responsible for submitting summaries of
its decisions with respect to GM organisms to the Biosafety Clearing-House.
Since our last update in April 2016, Canada has authorized the following novel plant products for release into
the environment as well as use in livestock feed and food in Canada:


Insect resistant and herbicide tolerant maize MZHG0JG (SYN-ØØØJG-2) – Syngenta Canada
Inc.
Insect resistant maize MZIR098 (SYN-ØØØ98-3) – Syngenta Canada Inc.
As well, Canada authorized a herbicide tolerant rice (Provisia™ HPHI2) from BASF Canada Inc. for use in
livestock feed and food, which was modified through tissue culture mutagenesis and conventional breeding.
Applications for Unconfined Environmental Release Currently Under Review
The Canadian Food Inspection Agency, jointly with Health Canada, coordinates a voluntary “Notices of
Submission” process that describes the product and the types of data (e.g. description of the inserted genes,
agronomic data from field trials, etc.) they receive from product developers who have requested safety assessments of
novel plant products for unconfined environmental release and safety assessments of novel feeds and novel foods
derived
from
them.
The
list
of
notices
of
submission
is
available
at
http://inspection.gc.ca/english/plaveg/bio/subs/subliste.shtml.
Canada has received the following Notices of Submission:
 Male sterile and herbicide tolerant Brassica napus MS11 (BCS-BNØ12-7) – Bayer CropScience Inc.
Two additional products are currently under review, however the product developers opted not to subscribe to
the voluntary Notices of Submission process.
Risk Assessment of GM Atlantic salmon (AquAdvantageTM)
The Government of Canada completed its environmental and indirect human health risk assessment of the
AquAdvantageTM Salmon in 2013. In 2015, EcoJustice (an environmental legal organization), acting for the Ecology
Action Centre and Living Oceans Society (two environmental NGOs), requested and was granted a hearing in Federal
Court that challenged the assessment. The Federal Court heard the case in November 2015, and in December the
dismissed these challenges. In January 2016, the Parties appealed that decision. The Federal Court of Appeal heard
the case in October, 2016, and dismissed the challenges and indicated in its judgement that the dismissal of the
Judicial Review by the Federal Court was legally sound.
21
Regulatory Amendments
We continue to pursue regulatory amendments to our New Substances Notification Regulations -Organisms that
will exempt certain agricultural field trials from notification requirements. The amendment was published in Canada
Gazette, for 60-day comment period. Comments have been received and are being addressed, and the updated legal
text is being prepared for final publication and implementation.
In addition, we are continuing our efforts towards an additional amendment of our New Substances Notification
Regulations respecting higher organisms, specifically 1) ‘reporting’ of research and development and 2) new
notification groups (Schedules). A final stakeholder consultation took place on June 1 and 2, 2016. Final legal text is
being prepared.
Existing Microorganisms Assessment
The program of assessing ‘existing’ micro-organisms is coming to an end and should be completed in the next
year.
The list of micro-organisms that have completed risk assessments since our last report are:








Bacillus circulans ATCC 9500
Bacillus megaterium ATCC 14581
Chaetomium globosum ATCC 6205
Micrococcus luteus ATCC 4698
Saccharomyces cerevisiae F53
Trichoderma reesei ATCC 74252 (may be subject to a ‘significant new activity’ requirements)
Arthrobacter globiformis ATCC 8010
Cellulomonas biazotea ATCC 486
None of the above were found to be of concern with respect to adverse environmental or human health effects
for the uses that were assessed.
For the links to the full list of those draft Screening Assessment Reports:
http://www.chemicalsubstanceschimiques.gc.ca/fact-fait/glance-bref/index-eng.php#micro
For the links to the Canada Gazette notice:
http://www.chemicalsubstanceschimiques.gc.ca/micro/priorita-eng.php
New Substances Notifications
The New Substances program for organisms continues to be responsive to new advances in biotechnology
(including gene editing) because it focuses on the resulting organism and not on the technology used to create it. We
continue to receive new notifications for microorganisms regulated solely under CEPA, 1999. During the 2016-17
fiscal year, Environment and Climate Change Canada/Health Canada received 20 new notifications that have been
accepted and assessed. We have had one request so far for notification of a higher organism in 2017.
We are currently updating and rewriting (using ‘plain language’) our external guidance document to
stakeholders to help them better complete their notification package. A specific part of this guidance, on microbial
identification, has been prepared in the form of a Microbial Identification Framework for Risk Assessment. The
Framework was reviewed at an Expert Review meeting in 2016 and is currently undergoing final internal review. It
will be published in 2017 and may serve as a starting point for a future OECD project if there is sufficient interest.
We continue to publish summaries of some of our risk assessments; 3 additional summaries will be published on
our website in 2017.
The OECD consensus documents continue to be useful in facilitating our reviews and assessments of
microorganisms.
22
Whole Genome Sequencing
Between 2015 and 2017, the Canadian Food Inspection Agency and Health Canada collaborated to prepare for
the anticipated increased use of whole genome sequencing (WGS) by product developers to support the molecular
characterization component of submissions for the pre-market safety assessment of plants with novel traits, novel
livestock feeds, and novel foods. A series of steps was taken to build the knowledge base and capacity in this area.
In March 2015, the Canadian Food Inspection Agency hosted a symposium entitled “Applications of Next
Generation Sequencing and Bioinformatics for the Regulation of Novel Foods, Novel Feeds, and Plants with Novel
Traits”. There were approximately 50 attendees, with an additional 20 joining online via webinar, including product
developers, government regulators, and researchers from government and academia. Outcomes were summarized in a
final report. The symposium served as a first consultation with industry and subject matter experts in order to share
knowledge of the benefits and challenges surrounding the emerging applications of sequencing technology in a premarket regulatory context.
Following the symposium, Canadian regulators drafted an internal guidance document regarding WGS. This
guidance was intended for evaluators who have experience with the molecular characterization of novel products, but
potentially lack experience with WGS and bioinformatics. The guidance will enable evaluators to review WGS data
and determine if it adequately supports the product developers’ molecular characterization conclusions.
The internal guidance contains:








a background section presenting the general principles of WGS;
an overview of the experimental design considerations;
a discussion of data processing, bioinformatics tools, and analytical approaches relevant to
different aspects of the molecular characterization;
principles of data presentation;
an evaluators’ checklist for assessing the methodology and results of a WGS experiment;
references;
a glossary of terms;
and a series of appendices expanding on technical topics.
A list of WGS and bioinformatics experts in the Government of Canada is also provided. A workshop for
evaluators was held in the final drafting stages in which participants used the guidance to analyze case studies
constructed using simulated data. This event served as a capacity building experience, and was particularly useful in
demonstrating the strengths and limitations of using WGS for the molecular characterizations of novel products.
A second external guidance document was subsequently developed. This was intended as a tool to help product
developers design appropriate WGS studies, should they choose to use them, and understand how to structure their
regulatory submissions with a level of rigour that would clearly show the validity of the analysis. The document is
high-level and not prescriptive as to the specific platforms and analysis approaches that can be used. Canada plans to
post this draft guidance online in the near future in order to consult stakeholders for feedback.
Low Level Presence
Recognizing the importance of the issue of low-level presence (LLP), the Government of Canada, working in
collaboration with its international partners, has explored various approaches where LLP occurrences could be
managed to increase trade predictability and transparency. The findings have been summarized in a policy model
designed to stimulate international discussions on the development and use of trade-facilitative instruments to manage
LLP. Released in September 2016, the policy model includes the combination of: 1) proactive actions to mitigate the
potential risk posed by LLP and 2) a risk-based enforcement approach to provide enhanced transparency and
predictability on how LLP situations would be addressed.
23
Since the release, Canada has been discussing the policy model with the international community, including
during the 2016 Asia Pacific Economic Cooperation Food Security Week in Piura, Peru. It has also presented the
policy model during bilateral discussions with its trading partners and with GLI members.
In 2012, the Government of Canada initiated the Global Low LeveI Presence Initiative (GLI), a group of 15
countries1 committed to working collaboratively to develop international approaches that facilitate the management of
Low Level Presence (LLP). To date, the GLI has had 4 face-to-face meetings (Canada 2012, Argentina 2012, South
Africa 2013, and Rome 2016).
In addition to these efforts, the Government of Canada, in collaboration with the Government of Argentina,
hosted a workshop on the Codex Annex on LLP risk assessments on March 14-15, 2017, in Buenos Aires, Argentina.
This workshop was organized as a deliverable of the 2016 work plan of the GLI, and aimed to provide a platform for
GLI member countries and observers to discuss the use of the Codex Annex on LLP Risk Assessments which was
adopted by Codex Alimentarius in 2008. The workshop was attended by 12 GLI member countries, 3 observer
countries, as well as representatives from the FAO, the Inter-American Institute for Cooperation in Agriculture, and
industry.
Moving forward, discussions are currently underway with GLI members to develop an agenda for the next faceto-face meeting of the GLI, tentatively planned for mid-June 2017 in Rome, Italy.
New Plant Breeding Techniques
Canada welcomes the discussion on new plant breeding techniques (NPBTs) and the enhanced understanding of
the range of techniques that are currently considered under that broad term. Canada views these techniques as
additional tools for plant breeders that will join the current methods that range from conventional plant breeding
through to the application of modern biotechnology. In Canada, the approach to regulatory oversight has always been
based on the novelty of the product rather than the means of development. As a result, Canada’s regulatory
framework and its comparative, case-by-case safety assessment approach that concentrates on the crop, novel trait,
and receiving environment, will apply to novel plant products derived from NPBTs. Canada would welcome the
opportunity to share its experience with other countries interested in the risk/safety assessment of plants derived using
NPBTs.
CZECH REPUBLIC
Legislative framework
An amendment to the Czech Act on the Use of Genetically Modified Organisms has been in force since 1st
January 2017. It deals with
1) Simplification of the administration regarding contained use of GMOs,
2) Transposition of EU Directive 2015/412 providing the possibility to restrict or prohibit the cultivation of GMOs.
However, the Czech Republic has not imposed any ban on GM crop.
1
These countries are Australia, Argentina, Brazil, Canada, Colombia, Costa Rica, Indonesia, Mexico, Paraguay, Philippines, Russia,
South Africa, United States, Uruguay, and Vietnam.
24
Contained use
About 100 premises have been authorised for contained use of GMOs in the Czech Republic. These facilities are
classified as class 1 and/or class 2 contained use, with only one laboratory in class 3. The GMOs used are mostly
microorganisms and laboratory animals.
Field trials
In the growing season 2016, only few small field trials with GM plants for research purposes were conducted:
1.
2.
3.
Barley producing enzyme phytase and barley producing additional cytokinin dehydrogenase in roots, notified
by the Palacky University in Olomouc;
Flax with various modifications, notified by the Czech company Agritec;
Plum trees with a modification conferring virus-resistance (resistance to plum pox), notified by the Crop
Research Institute.
The total area of the field trials was less than 1 hectare. These trials will continue in 2017.
Commercial cultivation
The only GM crop authorised for commercial cultivation in the European Union is maize MON810. The area
sown with MON810 in the Czech Republic has gradually decreased since 2008. In 2016 it dropped to just 75 ha. The
Czech Republic has not banned cultivation of any GM crop. However, growers face increasing problems with placing
their products on the market, including meat and milk.
Information for the Public
The list of the authorised users, decisions, relevant legislation and other information are made available to the
public and updated on the website of the Ministry of the Environment, Czech Republic, at the addresses www.mzp.cz
in Czech and http://www.mzp.cz/biosafety in English.
New Plant Breeding Techniques / New Gene Techniques
No project aimed at a deliberate release of a product of new plant breeding techniques (NPBT) has been notified
in the Czech Republic so far. The harmonized EU regulatory framework applies to new gene techniques.
DENMARK
Changes in the organisation of GMO issues in Denmark
Following a merger in 2015 of the Ministry of Environment and the Ministry of Food, Agriculture and
Fisheries, the new Ministry of Environment and Food of Denmark is sole responsible for all GMO-regulation in
Denmark.
Tasks related to GMO are divided between three agencies. The DEPA (Danish Environment Protection Agency)
is the Competent Authority for regulations related to contained use of GMO’s. DVFA (Danish Veterinary and Food
25
Administration) is the Competent Authority for regulation (including marketing) of food and feed with GMO and
DAFA (Danish AgriFish Agency) is the Competent Authority for regulation concerning cultivation of GM crops and
GM field trials.
Legislative changes
Denmark implemented the EU directive 2015/412 (Barosso Directive) into Danish law in 2016.
Field trials with GMO’s
In Denmark, we are currently monitoring one GM field trial with spring barley. The approval for cultivation was
granted for growing seasons 2012 to 2016. Plants were only grown during the growing seasons of 2012 and 2013.
During an inspection in October 2016 (3 years after last cultivation of GM barley in the plot), DAFA found a number
of barley plants on the field plot. It was confirmed by DNA analysis, that some of the plants were GM. The agency
has demanded that the plot is steam treated to destroy any leftover kernels and the monitoring period has been
extended with four years, ending in 2020.
Unintended release into the environment of GMO’s
The agency current has two cases of unintended release of GMO’s in Denmark:
Oxy-235
In October 2015, the UK informed about the unintentional occurrence of a GM-oilseed rape (later typed as Oxy235) in a conventional batch of winter oilseed rape (HRC-918), which had been sown in a number of Member States,
including Denmark. GM-admixture was estimated at about 0.4%. Since oxy-235 is not authorized in the EU,
Member States are obliged to eliminate the release in their jurisdiction.
In Denmark, HRC-918 was sown late august 2015 on three small trial plots (a total of approximately 126 square
meters). The three plots were immediately treated with a herbicide (glyphosate) to destroy plants before flowering
and potential pollen spread. All trial plots were left uncultivated and no tilling was done. Plots were monitored during
the 2016 growing season and any germinating oilseed rape were registered and destroyed (no seedlings were
observed). In September 2016 plots were steam treated in order to destroy remaining seed in the topsoil. Inspections
two weeks after treatment showed that the steam treatment was not 100% effective as oilseed rape seedlings occurred
on one of the three plots.
DAFA has demanded that the plots are steam treated in 2017 to destroy any leftover seeds in the topsoil.
Genetically modified aquarium fish (GloFish®)
DAFA has in 2016 received two citizen inquiries regarding observations of genetically modified aquarium fish
(zebra fish, Danio rerio) in two different retail stores (private trade).
DAFA took sample fish from both stores and it was confirmed by DNA analysis that they were GM (confirmed
presence of red fluorescent protein and yellow fluorescent protein). DAFA demanded the remaining aquarium fish
destroyed.
Screening for unintended presence of GMO in non-GM seed batches
No GM varieties have been approved for cultivation in Denmark. The Danish GMO-control of seed and
propagating material has therefore focused on the unintentional presence of GMO’s in non-GM C1-certified seed.
Following the Oxy-235 incident in 2015, DAFA decided to initiate a GMO-screening of propagating material of
the crops oilseed rape and alfalfa in 2016. These crops were chosen because GM-varieties of both are commonly
grown worldwide but no GM varieties are authorized for cultivation in the EU. Oilseed rape, particularly winter
oilseed rape, is a commonly grown plant in Denmark, whereas alfalfa is more of a “niche-crop”.
26
Furthermore, for both species the occurrence of GM-material in the environment in Denmark would be rather
problematic. Both species are able to spread in the environment by seed and pollen. Seeds are potentially long lived
and wild relatives of both species occur in Denmark.
Both nationally produced and imported C1 certified seed batches were included in the screening. A total of 30
seed samples representing nearly 400 tonnes of sowing seed.
No GMOs were found.
New Breeding Techniques and new techniques.
(Agenda item 6a: Sharing information in the written “Tour de Table”)
Denmark is awaiting the EU Commission to publish their legal assessment of the New Plant Breeding
Techniques. The assessment should have been published in 2016 and the Danish government, private companies and
NGO’s are waiting for an EU position on the matter.
Denmark is following the French court case on new Plant Breeding Techniques that is currently in process.
FRANCE
1. GMOs
Cultivation
There are neither commercial GM crops nor GMO field trials in France.
Regulation
The French regulation on GMOs has not changed since the last meeting.
Evaluation
The High Council for Biotechnology (HCB), which is responsible for advising the government on all
biotechnological issues, was asked in October 2015 to work on the use of genetically modified mosquitos in the
context of the fight against populations of disease-carrying mosquitoes. HCB is studying the benefits and risks of the
use of these GM insects for France, including the oversea territories. The HCB opinion will be available by June
2017. http://www.hautconseildesbiotechnologies.fr/fr/actualite/moustiques-gm-strategies-lutte-anti-vectorielle
In October 2016, the HCB published a recommendation on the socio-economic and ethical analysis of the
cultivation of GMOs. http://www.hautconseildesbiotechnologies.fr/fr/avis/recommandation-cees-relative-a-directive2015412-a-lanalyse-socio-economique-ethique-mise
Research
A research project (GMO90 +) on toxicity studies, funded by the Ministry of the Environment, has been
completed. The project aimed to improve the predictability for toxicity studies by developing biomarkers. The results
publication is expected by the end of 2017. http://www.rechercheriskogm.fr/page/GMO90plus
2. New plant breeding techniques
The HCB is continuing its work on NBT. By a referral of 22 February 2016, the Government asked it to deepen
its analysis on various issues relating to NBT, such as traceability, coexistence, risks to health and the environment,
27
management measures for risk prevention, innovation capacity of economic actors, industrial property and regulatory
framework. The HCB is expected to deliver its opinion shortly.
Moreover, in the context of a case brought by several organizations to the Conseil d'Etat (the highest
administrative Court in France) on herbicide tolerant varieties derived from mutagenesis, the Conseil d'Etat asked
questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling. These questions relate in
particular to the inclusion or not of the organisms obtained by the new mutagenesis techniques within the scope of
Directive 2001/18/EC on GMOs and on the validity of this Directive in the light of the precautionary principle taking
into account the evolution of techniques. France has sent a contribution to the CJEU.
INDIA
The work in modern Biotechnology is governed under bio-safety rules and guidelines under Environment
(Protection) Act 1986 and Rules 1989 to protect environment and ensure safety of human and animal health. The
process involves a three tier mechanism as described below.
Tier-I: The Biotechnology activity will be recorded, recommend & for RCGM approval by Institutional Bio-safety
Committee (IBSC).The IBSC is registered with Review Committee on Genetic Manipulation (RCGM) in the
Department of Biotechnology (DBT), Ministry of Science & Technology, and Govt. of India. All the activities
related to Recombinants are restricted at the site (organisation/Industry).
Tier-II: RCGM take several policy decisions on bio safety aspects of agricultural/ bio-pharmaceuticals / industrial
products. The RCGM reviews the product profile and pre-clinical toxicity (safety) data of new drug(s) or similar
biologics for recommendations to Drug Controller (DCGI) for suitable clinical trials. Whereas GE crops will be
subjected for evaluation for safe agronomical viable transgenic at multi location field trial by Monitoring–cum–
Evaluation Committee (MEC) of State Agricultural University. The MEC analyses safety and recommend to Genetic
Engineering Approval Committee (GEAC) for large scale trials.
Tier- III: Genetic Engineering Approval Committee (GEAC) reviews the reports submitted and approves for large
scale use and for open release in to environment. The GEAC operates under the Ministry of Environment & Forests
(MoEF), GOI.
The following protocol is mandatory for bio-safety of all GMO’s as it is issued by Department of
Biotechnology (DBT), GOI and Indian Council of Medical Research (ICMR) of the Ministry of Health & Family
Welfare (MoH&Fw) GOI.
The Specific information of Genetically Engineered plants requires data on: i. Molecular characterization, ii.
Inheritance of introduced trait, iii. Stability of introduced trait, iv . Expression of introduced proteins, v.
Compositional analysis, vi. reproductive and survival biology, impact on non target organisms – tier I & tier II
testing vii. Food and Feed Safety assessment for both field and non field studies viii. Acute oral safety limit study
(with equivalent and pure protein), ix. Pepsin digestibility assay, x. Protein thermal stability, xi. Sub-chronic feeding
study (crop) in rodents, xii. Livestock feeding.
The Centre for Advanced Research for Preclinical Toxicology (PCT), that has been established at National
Institute of Nutrition, Hyderabad by Indian Council of Medical Research (ICMR) in 1999 to screen the Safety
(Preclinical regulatory toxicology) & Efficacy evaluation of Innovative Products such as Stem cells, DNA vaccine,
Recombinants, GM foods, Traditional preparations, Herbals, Bio-pharmaceuticals, Food or Food additives specially
where there are no defined guidelines. Currently the Centre is fully established with the necessary infrastructure for
evaluating and testing GMO’s for premarket regulatory approval in India. The safety assessment of following GM
crops have been undertaken at Centre from 2008 till date.
28
GM crops
S.No
Test details
GM Mustard
Bt.Brinjal
Bt.Cotton
Bt. Okra
Bt. Rice
1
Acute





2
Sub-Chronic




---
3
Bioinformatics
Analysis




---
4
Pepsin
Assay




---
5
Thermal Stability




---
6
Status
Awaiting for GEAC approval
Digestibility
Reports submitted to regulatory authorities
The above PCT Centre, in addition to safety testing undertakes Capacity building initiatives / programs through
Public Private Partnership programs facilitated by DBT, DBT-UDSC, DBT-BIPP, DST, ICMR, ICAR-NAIP,
NMITLI-CSIR, CCRAS, ICRISAT, Tea Board of India, MoH&FW, Govt. of India, CCRUM and private funding
agencies.
JAPAN
Update for the regulatory activities
In accordance with the Act on the Conservation and Sustainable Use of Biological Diversity through
Regulations on the Use of Living Modified Organisms (Cartagena Act), which was first enforced in 2004,
"Committee on Assessment of Adverse Effect on Biological Diversity" has been arranged by Ministry of Agriculture,
Forestry and Fisheries (MAFF) and Ministry of Environment (MoE). The Committee is composed of one Integrated
Committee and 5 Sub-Committees (Crops, Forest trees, Insects, Aquatic organisms and Microorganisms) with each
Committee consisting of several scientists and members with academic backgrounds.
Under the Cartagena Act, 168 GM events for commercialization in which cultivation, use as food or feed, and/or
processing (FFP) are allowed (5 alfalfas; 8 carnations; 15 oilseed rapes; 26 soybeans; 1 sugar beet; 77 corns; 1
papaya; 2 roses; and 33 cottons) are approved as of February 2017 with 14 events (6 soybeans; 6 corns; and 2 cottons)
newly approved since the last meeting in April 2016. The list of approved GMOs and some dossiers on risk/safety
assessment of the approved GMOs are available in the national Biosafety Clearing House
(http://www.bch.biodic.go.jp/english/ e_index.html).
Update the activities related New Plant Breeding Techniques (NPBTs)
There has been an increased interest in NPBT in Japan. In such a situation, positioning NPBT as one of the
important plant breeding techniques, Japanese government implements a national project and accumulates scientific
opinions, as well as it stimulates scientific outreach activities.
29
In March 2013, the progeny through a specific seed production technology (SPT) using DP-32138-1 was
decided not to be subject to Japan’s regulations for genetically modified organisms. However, any general decision
has not been made for dealing with products derived through NPBTs.
(1) Research and development related to New Plant Breeding Techniques (NPBTs)
In 2014, the Cabinet Office launched an innovation program, "Strategic Innovation Promotion Program" (SIP)
to strengthen industrial competitiveness based on Comprehensive Strategy of Science, Technology, and Innovation,
including the research and development on NPBTs.
Research and developments (R&D) related to NPBTs including following projects are strategically advanced
under the program.




Development and improvement of genome editing techniques
Identification of useful genetic resources
Developments of innovative agricultural and fishery products using NPBTs (ex. high-yielding rice and
tomatoes with functional nutrition)
Social science investigation for commercialization of NPBTs and accumulation of natural science
information on their potential risks
(2) Publication of the report by New Plant Breeding Technique Study Group
In October 2013, the New Plant Breeding Technique Study Group consisting of expert scientists was established
under the auspice of Agriculture, Forestry and Fisheries Research Council Secretariat.
In September 2015, the Study Group published a report “Towards the development and practical application of
crops using new plant breeding techniques (NPBTs) such as genome editing.”
The points to consider for promoting social understanding in the report are as follows:
i)
ii)
iii)
compliance with GM regulations
providing public with information and communication with it
promotion of international harmonization
Provisional translation (English) of the report is
http://www.affrc.maff.go.jp/docs/commitee/nbt/attach/pdf/top-2.pdf
available
from
the
following
URL;
(3) Information sharing and science outreach activities related to NPBTs
In the SIP and MAFF programs, Japanese government strategically promotes science outreach activities
regarding NPBTs. In the outreach activities, it is aimed to enable general public to compare the risks and benefits of
the products developed by NPBTs with concrete images of the benefits and review their value. It is also important for
researchers to get feedback including expectation, anxiety and concern from public through science communication
activities in the early stage of R&D.
According to the aim, in the SIP program, social research is conducted to improve ways of providing
information in order to generate public acceptance of NPBTs, and tools for communication in a comprehensive
manner are developed.
In addition, MAFF started a program in 2016 to promote science communication between scientists and general
public in order to foster public awareness and understanding of modern biotechnology including NPBTs and its
outcomes/benefit. In the program, MAFF dispatches scientists to scientific activities such as science experiment
classes for school children and science cafes for citizens, and it holds traveling exhibition of R&D outcomes at
museums.
MAFF also has study sessions on the social and economic impacts of NPBTs as well as the scientific evidence
with consumer organizations and/or media.
30
(4) The regulatory triggers to initiate environmental risk/safety assessment
In Japan, an environmental risk assessment is conducted before intentional use of a genetically modified
organism that meets the following definition;
Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use
of Living Modified Organisms (Act No. 97, 2003)
(Definitions)
Article 2
(2)
In this Act, “living modified organism” shall mean an organism that possesses nucleic acid, or a
replicated product thereof, obtained through use of the any of the following technologies:
(i) Those technologies, as stipulated in the ordinance of the competent ministries, for the processing of
nucleic acid extracellularly
(ii)
Those technologies, as stipulated in the ordinance of the competent ministries, for fusing of the cells
of organisms belonging to different taxonomical families.
Regulations related to the Enforcement of the Law concerning the Conservation and Sustainable Use
of Biological Diversity through Regulations on the Use of Living Modified Organisms (MOF, MEXT,
MHLW, MAFF, METI & MOE Ordinance No. 1, 2003)
Article 2 Technologies stipulated in the ordinance of the competent ministries under Article 2 paragraph 2
subparagraph 1 of the Act shall be the technology for processing nucleic acid extracellularly for the purpose of
introducing the nucleic acid into cells, viruses or viroids to transfer or replicate the nucleic acid, while excluding
those mentioned in the following:
(i) Technology for processing by using, as nucleic acid to be introduced into cells, only the nucleic acid
shown in the following:
A. The nucleic acid of living organism belonging to the same species as that of the living organism which
the cells originate from
B. The nucleic acid of living organism belonging to the species that exchanges nucleic acid with the species
of the living organism which the cells originate from in natural conditions
(ii)
Technology for processing by using, as nucleic acid to be introduced into viruses or viroids, only the
nucleic acid of viruses or viroids that exchanges nucleic acid with the viruses or viroids in natural conditions
(5) The protection goal for environmental risk/safety assessment in Japan
The protection goal for environmental risk/safety assessment is the conservation and the sustainable use of
biological diversity. In an environmental risk assessment, data submitted by an applicant is reviewed focused on the
possibility for transferred genes and altered organisms to diffuse and to negatively affect the population of wild lives
consequently.
31
32
33
34
35
36
37
38
39
40
41
42
KENYA
Background information about National Biosafety Authority (NBA)
Kenya is a signatory to the Cartagena Protocol on Biosafety having signed in the year 2000 followed by its
ratification in 2003. The Kenyan Cabinet approved the National Biotechnology Policy in 2006 which provided policy
direction for the development and safe applications of Biotechnology in the country. The policy proposed the
enactment of the relevant Biosafety laws and establishment of the National Biosafety Authority as a way of
domesticating the provisions of the Cartagena Protocol. In 2008, the Kenyan Parliament passed the Biosafety Bill. It
was subsequently enacted by the President in February 2009 to become what is referred as the Biosafety Act No. 2 of
2009.The overall mandate of NBA is to exercise general supervision and control over development, transfer, handling
and use of genetically modified organisms (GMOs) so as to ensure safety of human and animal health and provide
adequate protection of the environment. This includes all activities of GMO for food, feed, industrial, research or any
other use. To achieve this mandate, the Authority has developed the following biosafety regulations which are now
fully operational;
i.
ii.
iii.
iv.
The Biosafety (Contained use) Regulations, 2011 – The objective of these regulations is to guide
research on GMOs at laboratory, green houses and confined field trials.
The Biosafety (Environmental Release) Regulations, 2011 – The objective of these regulations is to
guide all activities of environmental or commercial release and placing on the market (sale) of GMOs
The Biosafety (Import, Export and Transit) Regulations, 2011 – The objective of these regulations is to
guide on the requirements for traders and any person who may be interested in importation, exportation or
trans-boundary movement of GMOs.
The Biosafety (Labelling) Regulations, 2012 – The objective of these regulations is to provide
information to consumers on the GM status of food/feed and to help traceability of the products when they
are in the market.
Status of GM approvals in Kenya
(A) Contained use/ Research
Kenya has considered and made determinations for a number of GMO applications. These are mainly
concentrated at research level as follows;
(i)
(ii)
Applications for contained use research (Laboratory, greenhouse and animal-based studies) experiments –
23 projects approved. Animal based projects are mainly proof of concept experiments for the
development of various vaccines.
Applications for Confined Field Trials (CFTs) – 14 projects approved, 13 of them are plant based and one
involves a GMO vaccine for animals (Cattle, sheep, goats and camels).
Some of the approved projects at Confined Field Trials (CFT) include;
Status of GMO Field Trials in Kenya
Crop/animal
Trait
Year(s) project
approved
Applicant
Status of project
Cotton
Insect resistance
2007
KALRO
CFT trials completed in 2010
Maize
Drought tolerance
2010
KALRO
CFT trials completed in 2014
Insect resistance
2012
KALRO
CFT trials completed in 2014
Stacked event of insect resistance 2015
KALRO
CFT, season 1 completed. 2nd season
43
and drought tolerance
Sorghum
starting in April 2017
Biofortified sorghum with enhanced 2011 (Phase I)
Vit A, Iron and Zinc
(ABS Project)
KALRO
2015 (Phase II)
First project (Phase I) conducted 6
CFT experiments and concluded in
2014.
Phase II: The project was re-approved
in 2015 with a different (improved)
event and season 1 testing already
completed.
Gypsophila
Flower colour modification (pink 2013
colouration)
KALRO
CFTs completed in 2015
Cassava
Bio-fortified cassava with enhanced 2011
Vit A
KALRO
CFT season 1 completed in 2012, no
further trials on-going
Virus resistance (Cassava Mosaic 2011
disease) – VIRCA Project
KALRO
CFT season 1 completed 2013,
further trials on-going
Virus resistance (cassava brown 2012(Phase I)
streak disease) – VIRCA Project
KALRO
First project (Phase I) conducted 2
CFT experiments and concluded in
2013.
2013 (Phase II)
Phase II: CFT, season 1 on-going
Virus resistance (African Cassava 2014
Mosaic Virus (ACMV) and
Cassava Brown Streak Virus
(CBSV) resistance
MMUST
CFT, season 1 complete
Sweet potato
Virus resistance
2014
KALRO
CFT, season 1 complete
Banana
Disease resistance
2016
KALRO
CFT, season 1 on-going
Cattle, sheep,
goats
and
camels
Rift
Valley
Development
ILRI
CFT season 1- mobilization stage
Fever
Vaccine 2016
no
NB: Research trials (contained use and CFTs) are conducted in research institutes eg (ILRI and KALRO) and
Universities (Kenyatta University and Masinde Muliro University).
(B) Imports and transit of GM Products (Milled/processed)
Kenya has considered and approved 15 consignments for imports and 13 consignments for transit of GM corn
and corn-soya blend in to Kenya and other neighbouring countries. The products were milled prior to importation and
were specifically for humanitarian relief supplies (not for placing on the market).
(C) Environmental release
NBA has so approved two applications for environmental release of GM crops. The Bt maize application (MON
810) was approved in January 2016 while the Bt cotton (MON 15985/BollGard II) application was approved in
September 2016. Both applications were given limited environmental release to allow testing under National
Performance Trials in several ecological zones in Kenya.
44
NBA is currently reviewing a third application for environmental release of Gypsophila cut flowers modified for
colour change.
Acronyms for Institutions
ILRI
KALRO
MMUST
:
:
:
International Livestock Research Institute
Kenya Agricultural and Livestock Research Organization
Masinde Muliro University of Science and Technology
KOREA
1. Regulatory Activities
In Korea, Living Modified Organisms (LMOs) are regulated under "Act on Trans-boundary Movement, etc. of
Living Modified Organisms." The objective of the Act is to aid the prevention of any adverse effects of LMOs on
public health and the conservation and sustainable use of biological diversity. The Act also ensures safety in the
development, production, import, export and distribution of LMOs. Depending on the use, assigned government
departments are in charge of the risk assessment and management of LMOs.
Since the last update in April 2016, the RDA and MFDS have approved 15 new LMOs for food, feed and
processing use, but none for environmental release or cultivation as follows:
a. RDA (142 events, up to date): soybean(24), Corn(72), cotton(28), canola(13), alfalfa(5)
b. MFDS (149 events, up to date): soybean(25), Corn(75), cotton(28), canola(14), alfalfa(2), sugar beet(1),
potato(4)
Further information is available at http://www.biosafety.or.kr
2. Biosafety Issues
a. Beefing up GMO Labeling
The Ministry of Food and Drug Safety (MFDS) announced its new rules on genetically modified organisms
(GMO) labeling on products, which took effect in February 2017. According to the new regulation, processed foods
containing genetically modified DNA or proteins should be labeled regardless of the amount the products consist. Up
to now, processed food makers had to label genetically modified agricultural products if they were among top five
ingredients. Based on the new regulation, it is mandatory to indicate in the label on all processed foods, the list of all
genetically modified agricultural products utilized regardless of usage.
However, processed foods such as cooking oil, soy sauce and syrup that passed through heat treatment,
fermentation, extraction, and filtration are exempted from the new regulation. Because the final products do not
contain genetically modified proteins or DNA after a high level of refinement and processing. Major processed foods
using genetically modified crops such as imported soybeans and corns are also exempted from labeling.
Consumers and NGOs criticized that the regulation does not satisfied the consumers’ demand to know not only
the information after processing but also the information about the crops that were used. On the other hand, the
Ministry of Food and Drug Safety countered that ‘when GMO labeling is mandatory for all processed foods, it will
cause price increase in the use of non-GM materials’.
45
b. Strengthening the ‘Special Committee on Bio’
The Special Committee on Bio was launched in March 2016. The committee is under the National Science and
Technology Council, consisted of officials and experts of government, industrial and academic sectors, which serves
as control tower of bio fields including R&D, industry development and regulatory improvement.
During the fourth-round meeting, a task force team was formed which aimed to improve bio regulations, nurture
bio industry and to continuously deregulate practical obstacles in bio industry development.
The Committee decided to change the current overlapping safety checks by different governmental departments
for LMO on related R&D and industrial facilities to conduct joint safety check system at a time. The Committee is
also discussing about deregulation on production of genetically modified intermediate materials under contained
facilities for cosmetics and feed.
While deregulation is being actively discussed, a genetically modified rice cell line for industrial production has
passed the assessment of human risk by the government, for the first time in Korea.
3. Regulatory Triggers
Environmental Risk Assessment (ERA) for Living Modified Organisms (LMOs) is ruled by the "Act on Transboundary Movement, etc. of Living Modified Organisms". In this Act, the term “living modified organism” means
any living organism that possesses a novel combination of genetic material obtained through the use of each of the
following modern biotechnology techniques: 1) insertion of artificially recombined genes or direct injection of
nucleic acids comprising a gene into cells or organelle; 2) the fusion of cells beyond the taxonomic family.
In Korea, there is no separate regulation on LMO using gene editing technology, hence the "Act on Transboundary Movement, etc. of Living Modified Organisms” is being applied.
Recently, government organizations including MFDS initiated a discussion on the necessity of separate
regulation on LMO using gene editing technology and its countermeasures.
4. NPBTs, CRISPR/Cpf1-mediated DNA-free plant genome editing
The Center for Genome Engineering of Institute for Basic Science (IBS), headed by Director KIM Jin-Soo has
achieved a string of successes in leveraging its research capabilities to enhance the accuracy of genome editors. In
2016, the technique was further refined. The research team was able to show the precision of CRISPRT Cpf1, a new
type of nuclease RNA-programmable nucleases.
Cpf1, a type V CRISPR effector, recognizes a thymidine-rich protospacer-adjacent motif and induces cohesive
double-stranded breaks at the target site guided by a single CRISPR RNA (crRNA). The research team showed that
Cpf1 can be used as a tool for DNA-free editing of plant genomes. They described the delivery of recombinant Cpf1
proteins with in vitro transcribed or chemically synthesized target-specific crRNAs into protoplasts isolated from
soybean and wild tobacco. Designed crRNAs are unique and do not have similar sequences (≤3 mismatches) in the
entire soybean reference genome. Targeted deep sequencing analyses showed that mutations are successfully induced
in FAD2 paralogues in soybean and AOC in wild tobacco. Unlike SpCas9, Cpf1 mainly induces various nucleotide
deletions at target sites. No significant mutations were detected at potential off-target sites in the soybean genome.
These results demonstrated that Cpf1–crRNA complex is an effective DNA-free genome-editing tool for plant
genome editing.
46
MEXICO
1. Regulatory framework and legal aspects.



Mexico regulates the use of GMO under the Law of Biosafety for Genetically Modified Organisms
(LBOGM), and applies its regulation by means of a coordinated Intersecretarial framework. During 2016, as
a result of the collaboration between the Secretary of Agriculture, Livestock, Rural Development, Fisheries
and Food (SAGARPA) and the Secretary of Environment and Natural Resources (SEMARNAT), one
Official National Standard has been developed. The Official National Standard PROY-NOM-000SAGARPA/SEMARNAT-2015 (Published on January 3rd, 2017 for its public consultation) establishes the
characteristics and requirements of the risk assessment studies that have to be presented when an
experimental release of a genetically modified organism to the environment is sought; the later, in terms of
the impacts that the GMO might have on the environmental and biological diversity, as well as animal
health, plant health and aquaculture.
A compendium of the national legislation called "National and International Legal Order on Biosafety of
Genetically Modified Organisms", CIBIOGEM (2015) was published (ISBN 978-607-8273-14-0) for its
wider distribution in 2016.
México, as an active Party of the Convention on Biological Diversity (1993), the Cartagena Protocol on
Biosafety (2003), the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress (2012), and
the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising
from their Utilization (2014), was selected to participate in the Pilot Project JBF2015-2016 BS-1 “Capacity
Building for promoting the integrated implementation of the Convention on Biological Diversity and its
Protocols at the National Level”. The goal of this project was to analyze how ten countries approached
biosafety mainstreaming into their national plans and strategies. The experiences on the implementation of
the national regulatory frameworks, made possible to identify the main challenges experienced and
recognize best practices. The Mexican diagnosis was integrated into the document "Analysis of the
integration of biosafety of Genetically Modified Organisms and the access to genetic resources into existing
national policy instruments, strategies and activities by the competent institutions". This is in the process of
being published.
Regarding legal aspects, the following subjects were outstanding in 2016:


Progress on the Indigenous People Consultation in attention to the resolution of the Supreme National Court
of Justice (SCJN) on the commercial release of genetically modified soy (MON-04032-6).
Three injunctions (amparo) trials related to the commercial release of the soy event MON-04032-6 were
revised and resolved by the Supreme Court of Justice (SCJN). The trials were promoted by honey producers
and civil associations of two states of the Yucatan peninsula (Campeche and Yucatán) claiming biosafety
and social issues. On November 2015, the Supreme Court of Justice did not express biosafety concerns,
however an obligation to consult the indigenous communities was deemed applicable by the Court at the
localities where the promoters of the trials live. In compliance with the mechanism for consultation to the
indigenous communities approved by CIBIOGEM in 2015, procedures are currently in place to fulfill the
mandate of the SCJN resolution and the recommendations received from the National Commission of
Human Rights in México (CNDH). The National Commission for the Development of Indigenous People
and CIBIOGEM are the organizations mandated to implement the consultation process. From January to
December 2016, 44 indigenous communities in Campeche have been reached, and the consultation process
is concluded in two of them. The consultation status for the rest of the communities (42) is at the stage of
prior agreement -a stage where the communities, by means of their legitimate representatives, adjust the
consultation working plan according to their uses and costumes. This step has been held five times
comprising several meetings between government officials and the representatives of the indigenous
communities.
47






Progress on the Indigenous People Consultation in attention to new application for environmental release of
GMOs
A total of five indigenous consultations have been implemented for indigenous communities in the north of
Mexico in relation to the environmental release of GM cotton. Two consultations correspond to communities
from the Cucapah ethnic group and three for the Tarahumaras. These consultations have reached the final
stage of the process.
Collaboration Agreement between CIBIOGEM and the National Commission of Human Rights in Mexico
(CNDH).
As mentioned, CIBIOGEM by means of its Executive Secretary has been working on the consultations to
indigenous communities in order to guarantee their participation according to national jurisdiction. The
objective of the consultative process is to determine in which level the collective rights of the indigenous
communities may be affected by the environmental release of GMOs in the territories where indigenous
people is established. This is to fulfill government obligations according to Convention ILO-169, article 108
of the Mexican Law of Biosafety, the recent legal resolutions of SCJN and CNDH recommendations in
protection of their rights. In order to promote the observance and respect of Human Rights, as well as for
facilitating the exchange of information among public servants on relevant topics such as biosafety,
biotechnology, and human rights, a collaboration agreement between the CNDH and CIBIOGEM, was
formalized on December 5th, 2016.
Resolution of a Civil Court on the Legal Action for GM maize.
In July 2013, a collectivity submitted a legal action for interests of diffuse rights against the environmental
release of GM maize crops to a civil court. By September 2013, the Judge in charge produced a cautionary
jurisprudence prohibiting the competent authorities from implementing any activity oriented to the emission
of permits for environmental release of GM maize (in any of the experimental, pilot or commercial scale).
The process continued and legal and technical opinions were revised. As a result, in March 2015, the Judge
resolved to deny the cautionary act. The eliciting party appealed this decision and requested further revision
of the case. Finally, in March 2016 the same Judge decided to lift the prohibition for experimental and pilot
release as long as the proper monitoring measures are observed and national competent authorities survey the
releases. Commercial release of GM maize is still suspended until further evidence is gathered.
2. Applications for food, feed, processing, and environmental release during 2016
A total of 40 new applications were received in 2016 and were submitted to the National Registry of GMOs,
classified as:
1) Authorizations of GMOs for food and feed use, and
2) Applications for environmental release of GMOs.
The information details can be reached at the CIBIOGEM webpage, following the link to the National Registry
of
GMOs
(http://www.conacyt.gob.mx/cibiogem/index.php/sistema-nacional-de-informacion/registro-nacionalbioseguridad-ogms),
and
The
Annual
Reports
on
the
status
of
biosafety
in
México
(http://www.conacyt.gob.mx/cibiogem/index.php/sistema-nacional-de-informacion/informes).
2.1 Applications regarding the authorization for the use of GMOs for food, feed and processing
In 2016, none authorization was issued by the Secretary of Health.
Source: (COFEPRIS, 2016) http://www.cofepris.gob.mx/AZ/Paginas/OGMS/Evaluacion-ogms.aspx
2.2 Applications for the environmental release of GMOs.
During 2016, the Secretary of Agriculture, Livestock, Rural Development, Fisheries and Food (SAGARPA)
received a total of 40 applications for environmental release of biotech crops. Table 1 shows the information related
to these applications:
48
Table 1. Applications for environmental release of GMOs in 2016
Crop
Alfalfa
Medicago sativa
Cotton
Phase of release
No. Applications
Total
Pilot Program
1
1
Experimental
7
Pilot Program
10
Commercial Program
4
Pilot Program
3
Experimental
8
Pilot Program
2
Experimental
3
3
Experimental
2
2
Gossypium hirsutum
Mexican Lemon
Citrus aurantifolia
Maize
Zea mays L.
Orange
Citrus × sinensis
Wheat
Triticum aestivum L.
21
3
10
Source: National Registry of GMOs: http://www.conacyt.gob.mx/cibiogem/index.php/sistema-nacional-deinformacion/registro-nacional-bioseguridad-ogms
3. Participation and organization of forums, workshops and symposia.
Several activities were developed in 2016, on one hand, for fulfilling the international commitment to host the
United Nations Conference on Biodiversity, and other national activities oriented to communication and
strengthening of national capacities. These activities aimed to reach different target publics including federal officers,
researchers, lawyers, general society, by using different means such as seminars, face to face meetings, and electronic
modalities.
3.1 Organization and development of the United Nations Conference on Biodiversity, Cancun, Mexico 2016.
The UN Biodiversity Conference took place in Cancun, Mexico, from December the 2nd to the 17th, 2016, and
was attended by over 6,000 participants including some 4,300 delegates from 170 countries and over 400
organizations. The Thirteenth meeting of the Conference of the Parties to the Convention on Biological Diversity
(COP 13), The Eighth meeting of the Conference of the Parties serving as the meeting of the Parties to the Cartagena
Protocol on Biosafety (COP-MOP 8), and The Second meeting of the Conference of the Parties serving as the
meeting of the Parties to the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of
Benefits Arising from their Utilization (COP-MOP 2), were held concurrently for the first time, according to COP
decision XII/34.
Preparatory activities along 2015 and 2016 allowed for a better integration and information exchange among
National Focal Points of the Convention and its Protocols, as well as with National Competent authorities and
government institutions in charge of biosafety and biodiversity issues.
49
The Conference resulted in significant commitments for action on biodiversity. A High level segment for
ministers of Environment, Agriculture, Forestry, Fisheries and Tourism was sustained before COP-13, COP-MOP/8
and COP-MOP/2 meetings; a large number of side-events and relevant summits took place over a period of two
weeks facilitating international networking and collaborations.
Agreements were reached on actions to integrate biodiversity in forestry, fisheries, agriculture, and tourism
sectors and to achieve the 2030 Agenda on Sustainable Development, as well as actions on specific themes including
protected areas, ecosystem restoration, marine biodiversity, biodiversity and health, synthetic biology, and traditional
knowledge, among others, and on strengthening capacity-development and the mobilization of financial resources.
The main outcomes of the Conference include:




The Cancun Declaration on mainstreaming the conservation and sustainable use of biodiversity for wellbeing.
Decisions of the 13th meeting of the Conference of the Parties to the Convention on Biological Diversity (37
in total)
Decisions of the 8th meeting of the Conference of the Parties serving as the meeting of the Parties to the
Cartagena Protocol on Biosafety (19 in total)
Decisions of the 2nd meeting of the Conference of the Parties serving as the meeting of the Parties to the
Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising
from their utilization (14 in total)
3.2 Communication and Public awareness in the National context.
The following activities were associated to biosafety communication, public awareness and education:





Seven Seminars on biotechnology and biosafety, with 82 participants on site and 116 via remote
connections: http://www.conacyt.gob.mx/cibiogem/index.php/seminarios-en-biotecnologia-y-bioseguridadde-ogms
Participation during the National Science Week, where 2445 persons were presented with information on
biosafety and the national regulatory framework:
http://www.conacyt.gob.mx/cibiogem/index.php/comunicacion/biotecnologia-y-bioseguridad-para-ninos/23sncyt
The Open House of the Executive Secretariat of the CIBIOGEM was organized on September 9th, 2016. This
activity is performed annually and it involves sharing information with the general public in a close and open
forum: http://www.conacyt.gob.mx/cibiogem/index.php/puertas-abiertas7
Presentations and activities on biosafety topics were displayed at the Science Museum of the National
Autonomous University of Mexico (UNIVERSUM) on April 14 th, 15th, 28th and 29th, where 400 people
attended.
4. Capacity Building and Regional Collaboration



The Workshop on Risk Assessment, theoretical practical training, was held on January 18 th to 20th, with the
participation
of
38
national
public
servers
and
2
colleagues
from
Peru:
http://conacyt.gob.mx/cibiogem/index.php/taller-evaluacion-riesgo-inicio
In order to continue with the development of the “Consensus document on the biology of Aedes aegypti” the
National Experts Group held one face to face meeting on February 16 th. The document was sent to the
international experts and will be reviewed at the present meeting of the Working Group.
The Third Edition of a Regional Training Course for Capacity Building on GMO Biosafety had place on
March 2016. This activity is dedicated to regulators, public servants and researchers from Latin America and
the Caribbean. On its third occasion 25 foreign participants from Argentina, Bolivia, Colombia, Cuba,
Ecuador, Guatemala, Honduras and Peru, as well as 18 national assistants participated in the event. Local
public servants from the institutions that integrate the Inter-secretarial Commission of Biosafety in Mexico
actively exchanged experiences and ideas, and all participants had the opportunity to visit the biosafety
facilities of the National Competent Authorities. For more information, please visit:
50
http://www.conacyt.gob.mx/cibiogem/index.php/curso-regional-tercero

In response to decision BS-VII/12, Mexico hosted one of the intersessional meetings of the Ad Hoc
Technical Expert Group (AHTEG) on Risk Assessment and Risk Management in July 2016, in preparation
to the COP-MOP.
The National Network of Laboratories for the Detection, Identification and Quantification of Genetically
Modified Organisms (RNLD-OGM) completed a ring trial in a collaborative study. The Network conveyed
at Mexico City for its 2016 Plenary Meeting on April 5 th, with the participation of 12 national laboratories in
order to sustain expert feedback and exchange of analytical information.
The First Regional Workshop GRULAC on Detection, Identification and Quantification of GMOs coorganized by CIBIOGEM and the Secretariat of the Convention on Biological Diversity was developed in
August 2016. It reached 20 officials from the Latin American and Caribbean region.


5. Biotech Product Database
The Mexican profile at the Biotrack Product Database is kept updated with 172 records from the country:
http://www2.oecd.org/biotech/byCountry.aspx
THE NETHERLANDS
Notifications for commercialisation
The Netherlands issued one permit for the importation of colour modified carnation line SHD-27531-4 under
directive 2001/18/EC. Furthermore the Netherlands also approved the renewal of the application for the importation
of colour modified carnation line FLO-40644-6 under directive 2001/18/EC.
The notification for the importation of colour modified carnation line FLO-40685-1 is still pending subject to
comitology procedure for approval. Earlier Netherlands has concluded the environmental risk assessment on this GM
carnation line.
The Netherlands continues to be actively involved in EFSA consultations for placing on the market of GM
crops.
Notifications for field trials and clinical trials in the Netherlands
The Dutch authorities received several new applications for deliberate release into the environment under
directive 2001/18/EC partB. General information about genetically modified organisms that have been approved in
the Netherlands for deliberate release into the environment is made available from the website of the Ministry for the
Environment / GMO Office (http://www.ggo-vergunningverlening.nl).
Over the last period Netherlands issued seven permits for (multicentre) clinical trials:
-
-
A multi-centre trial concerning safety and protective efficacy of genetically modified Plasmodium berghei
(Pb(PfCS@UIS4)) malaria parasites in healthy volunteers.
A multi-centre trial concerning a phase I dose escalation study evaluating the safety of ART-I02, a
recombinant adeno-associated virus (rAAV) serotype 2/5 gene transfer vector encoding human Interferon-β
(hIFN-β) under control of a nuclear factor-κB (NF-κB) responsive promoter, in patients with rheumatoid
arthritis.
Exposure of human volunteers to live genetically modified rodent Plasmodium berghei (Pb) parasites,
administered by mosquito bites.
51
-
-
A Phase I/II Open Label Clinical Trial Assessing Safety and Efficacy of Intravesical Instillation of the
Recombinant BCG VPM1002BC in Patients with Recurrent Non-Muscle Invasive Bladder Cancer after
Standard BCG Therapy.
The assessment of the safety and efficacy of CTLO19 (ex-vivo genetically
modified autologous T cells expressing a transmembrane chimeric anti-CD19 receptor) for the purpose of
developing a novel therapy against S ceil malignancies.
Gene therapy Clinical development program comprising of clinical trials using SAR422459, a nonreplicating, recombinant lentivirus vector derived from Equine Infectious Anemia Virus (EIAV) to express
ATP Binding Cassette A4 (ABCA4) transporter and correct its defective expression or function in
photoreceptors of patients with Stargardt macular degeneration and other ABCA4-associated retinopathies.
Furthermore over the same period the Netherlands issued one permit for a veterinary trial:
-
Vaccination of chickens with a herpesvirus of turkey vaccine with inserted the F-gene of Newcastle Disease
Virus and the VP2 gene of Infectious Bursal Disease Virus
Over the past 12 months no new notifications for field trials with GM plants were received.
Policy report on gene drives
Last year we already shared a policy report issued by the National Institute for Public Health and the
Environment (RIVM) on gene drives. The analysis indicated that current methods for assessing the risks to human
health and the environment are less suitable for the effects of gene drives. RIVM recommends that authorization
should be obligatory for applications in laboratories of organisms with a gene drive. Notification is insufficient.
In response to this policy report the Dutch government amended its rules on contained use of gmo’s to
accommodate applications for gmo’s with gene drives. This amendment of the Dutch GMO Ordinance came into
force on July 1, 2016. Until\l today, there have been no applications received by the authorities for activities with
gmo’s with a gene drive under contained use.
Furthermore, on January 25, 2017, The RIVM organized a small international expert meeting on contained use
activities with gene drive technologies. The aim of the meeting was to gain knowledge on gene drive technology with
respect to (future) scientific developments under contained use, in Europe; To share knowledge on possible gaps in
regulating procedures and the risk assessment methodology for contained use; To investigate the wish for future
collaboration on risk assessments for gene drive activities. A report of the meeting will be made available in the
future.
Research programme Biotechnology and safety
Biotechnology is a highly dynamic field of research, with new developments occurring at a rapid pace. New
DNA base pairs, interdisciplinary collaboration, and targeted changes to the genetic make-up of humans, animals and
plants are producing many opportunities for innovation. In this context, it is important that the safety of these future
uses and applications of biotechnology remain assured. The Dutch Ministry of Infrastructure and the Environment has
therefore commissioned the research programme ‘Towards Modernisation of Biotechnology and Safety’. The
programme will run until 2022 and has an allocated budget of 10 million Euro.
The main goal of the programme is to build scientific knowledge concerning the risks and uncertainties
associated with state-of-the art and future modern biotechnology developments and applications, as well as to gain
knowledge on ways to minimise and control those risks. As research on innovations does not automatically take into
account the risks associated with them, the aim of this Programme is to stimulate the integration of risk research into
current and future innovations in the field of modern biotechnology. The programme will generate knowledge that
can be used to further refine and develop the risk assessment and risk management system and consists of two calls
for proposals:
Call 1: Current Genetic Modification Techniques and Applications in relation to Safety;
Call 2: New and Future Modern Biotechnology Techniques and Applications in relation to Environmental Safety.
52
In preparation for the two calls one retrospective study was commissioned (for call 1) as well as three
exploratory studies (for call 2).
Title: Taking stock of the environmental risk assessment of genetically modified plants and gene therapy.
The report prepared by Perseus provides an overview of risk assessments over the last 25 years. In an
exploratory study on the environmental risk assessment (ERA) of plants and gene therapy is an update made to the
certainties and uncertainties of environmental risks. Over the years, a lot of knowledge and experience in the
assessment of genetically modified organisms on the risks to humans and the environment. The report examines the
assumptions are made in the ERA and that the data to test now available that.
The report is available at: http://www.stw.nl/sites/stw.nl/files/Biotechnology-and-Safety-Call-2_call-PerseusReport.pdf.
In biotechnology developments are advancing in a rapid pace. For example, variations of existing and new
biotechnological techniques have been developed that challenge the current definitions of genetic modification.
Another important development is synthetic biology, an emerging technology that builds on genetic modification.
This enables the aimed design and construction of (parts of) life forms. In three reports desk studies were conducted
in which the evolution and innovation of new biotechnological techniques are explored, as well as the way they are
applied in products. Given the diversity of developments and applications, we make this distinction between
developments in the industrial (white), agricultural (green) and medical (red) biotechnology. Currently the National
Institute for Public Health and the Environment is preparing a policy report that aims to assess the potential
consequences of these new biotechnology developments for human health and the environment, the legal framework
of the GMO legislation and the policy position.
Title: Analysis of new developments in white (industrial) biotechnology (Ameco).
The report is available at:http://www.stw.nl/sites/stw.nl/files/Biotechnology-and-Safety-Call-2_call-Analysis-ofnew-developments-in-white%20biotechnology_April%202016_RIVM_Ameco.pdf.
Title: New developments in green biotechnology – an inventory for RIVM (Wageningen University and Research –
Plant breeding).
The report is available at: http://www.stw.nl/sites/stw.nl/files/Biotechnology-and-Safety-Call-2_call-Newdevelopments-in-green-biotechnology_RIVM.pdf.
Title: Emerging gene expression and gene expression regulation technologies in medical biotechnology (Xendo).
The report is available at: http://www.stw.nl/sites/stw.nl/files/Biotechnology%20and%20Safety%20%20RIVM%20%20Emerging%20Gene%20expression%20and%20Gene%20expression%20regulation%20technolog
ies%20in%20medical%20biotechnology.pdf.
Further Publications
Besides the above mentioned reports other reports were published that we would like to share. We initiated
these studies in a need for background information for performing environmental risk assessments for informing
policy. These studies have been performed by several institutes under supervision of a steering committee consisting
of environmental risk assessors, policymakers of the ministry of environment, inspectorate, GM advisory commission
members and biosafety officers.
Title: Developments in novel medical products with modern biotechnology and specifically synthetic biology : A
quick scan.
Our scientific ability to understand, build and apply the programming language of life - the genetic code - is
increasing at a rapid pace. In modern biotechnology and including the emerging field of 'synthetic biology' several
scientific disciplines specifically aim to apply and make use of this genetic programming language in a way that is
beneficial for man and society. Synthetic biology has a broad range of possible fields of application, one of which is
medical products. Here we report on a quick scan to identify medical products which are currently being developed
53
using synthetic biology. Additionally, we identified the applicable regulatory frameworks. On the basis of our
investigation we identified three groups of medical products: biosensors, targeted drug delivery products and
engineered human cell products. The results confirm that the evolving field of synthetic biology indeed holds promise
with regard to medical applications. It will, however, probably take time before most of the products will actually
reach broad application in the clinic. Two types of regulatory frameworks are applicable: to cover the use of
genetically modified organisms and to regulate medical products. New medical products obtained using synthetic
biology might challenge the existing regulatory frameworks and this quick scan can serve as a basis to identify such
challenges in cooperation with key opinion leaders in the field.
The
report
is
available
at:
http://rivm.nl/Documenten_en_publicaties/Wetenschappelijk/Rapporten/2016/augustus/Developments_in_novel_med
ical_products_with_modern_biotechnology_and_specifically_synthetic_biology_A_quick_scan
Title: GM plants compared to the baseline; a whole genome sequencing approach.
The Netherlands Commission on Genetic Modification (COGEM) has commissioned a research project to
address the question what the value of NGS could be for the risk assessment of GM plants. The first main question
was whether genomic differences observed between a GM plant and its non-GM counterpart are due to the genetic
modification process, which does not only involve the insertion of foreign DNA but also specific culturing steps. The
second main question was how the spectrum of induced changes during the genetic modification process compares to
the natural baseline variation in the species. Finally, a third, more practical question was if NGS could replace the
elaborate screening of material for (multiple) inserts and their location by means of Southerns and PCR. The present
report addresses these questions in two ways. In the first section, the natural genomic variation of several plant
species is reviewed in a desk study. The second part employs an experimental approach, in which genetically
modified Arabidopsis thaliana and tomato were molecularly characterised by NGS, screening for new mutations
across the entire genome using bio-informatics tools.
The report is available at: http://www.cogem.net/index.cfm/nl/publicaties/publicatie/baseline-genoomvariatievan-planten?q=&category=onderzoeksrapporten&from=30-09-1998&to=08-02-2017&order=date_desc.
Tour-de-table on NPBT
As decided during the last WG meeting delegations will share information and experiences concerning NPBTs
if applicable. Overall the situation in the Netherlands has not changed a lot since the last WG meeting where
Netherlands presented the current state of play. Therefore, we refer to the report of the NPBT workshop for details.
The Netherlands is still awaiting clarity from the European Commission regarding the legal status of new plant
breeding techniques.
PHILIPPINES
The new regulations issued on 30 March 2016, DOST-DA-DENR-DOH-DILG Joint Department Circular No. 1
series of 2016, “Rules and Regulations for the Research and Development , Handling and Use, Release Into The
Environment, and Management of Genetically Modified Plant and Plant Products Derived From The Use of Modern
Biotechnology took effective 15 April 2016.
I. Approved Articles for Commercial Propagation
The Bureau of Plant Industry approved on 30 September 2016, the application for Corn MON
54
89034 x Corn NK603, a stacked product with insect resistance and herbicide tolerance traits.
The single traits MON corn 89034 and corn NK603 have existing biosafety permits and are listed I Annex G of
the JDC1s2016: List of Regulated articles with Valid Biosafety Permits until their expiry dates.
The stacked trait had been previously approved.
II. Application for Field Test
The Bureau of Plant Industry has received an application for “Field Test to Generate Data for Environmental
Biosafety Risk Assessment of Beta-carotene enriched “Golden Rice” Event GR2E last February 28, 2017. The
application is under processed.
For further details on the existing approval registries for release into the environment, please access
da.biotech.gov.ph.
Other Activities:
The Philippines participated in the 8th Meeting of the Parties to the Cartagena Protocol on Biosafety, in Cancun,
Mexico on December 2016.
SLOVAKIA
I. Legislative Framework
Without changes.
The legislative framework of Slovakia is harmonised with the law of the European Union.
The basic national legal instrument concerning use of GMOs is the Act No. 151/2002 on the use of genetic
technologies and genetically modified organisms, as amended, with an implementing Decree No. 399/2005. The Act
transposes Directives 2001/18/EC and 2009/41/EC, therefore it covers the contained use, deliberate release of GMOs
into the environment and placing on the market of GMOs as products or in products.
The Regulations (EC) 1829/2003 on genetically modified food and feed, Regulation 1830/2003 concerning
traceability and labelling of GMOs and Regulation 1946/2003 on transboundary movements of GMOs have been
directly applicable in Slovakia since its accession to the European Union on 1 May 2004.
General rules on the coexistence of genetically modified crops with conventional and organic farming are set by
the Act No. 184/2006.
The medicinal products containing a genetically modified organism are placed on the market under the
Regulation (EC) 726/2004.
On 29 April 2015, Slovakia ratified the Nagoya – Kuala Lumpur Supplementary Protocol on Liability
and Redress for damage resulting from transboundary movements of LMOs. The European Union approved the
Supplementary protocol by Council Decision 2013/86/EU and the provisions of this protocol are applied
by the Directive 2004/35/EC on environmental liability with regard to the prevention and remedying of
environmental damage. Slovakia implemented this directive by the Act No. 359/2007 on the prevention and
remedying of environmental damage, which became effective on 1 September 2007.
55
The Directive (EU) 2015/412 introduced the possibility, for a Member State, to demand that the geographical
scope of an authorisation for cultivation already granted be adjusted to the effect that all or part of the territory of that
Member State be excluded from cultivation. Such demands had to be presented from 2 April until 3 October 2015
to the European Commission. Slovakia did not apply for the exclusion.
II. State Administration
Without changes.
The Ministry of Environment is the National Focal Point for the Cartagena Protocol on Biosafety and the focal
point for the Regulation (EC) 1946/2003 as well. It deals with the contained use of GMOs under Directive
2009/41/EC and their deliberate release into the environment under Directive 2001/18/EC and performs evaluation
of environmental aspects of medicinal products containing a genetically modified organism within the meaning
of Directive 2001/18/EC.
The Competent Authority on state supervision of the use of GMOs is the Slovak Environmental Inspectorate.
It cooperates with other state supervision bodies in fulfilling this task.
The Ministry of Agriculture and Rural Development is the Competent Authority for genetically modified food
and feed.
Its control bodies are
- The Central Control and Testing Institute of Agriculture, Department of Molecular Biology is responsible for the
control of manipulation with the genetically modified seeds and for the control of commercial cultivation of GM
crops,
- The State Veterinary and Food Administration
executes the control of import, production, manipulation, handling and marketing of GM food and feed and also
the marketing of veterinary medicinal products produced from or by GMOs (through the State Control Institute for
Veterinary Biologicals and Medicines).
These two institutions serve as National Reference Laboratories for the Ministry of Agriculture and Rural
Development.
The Ministry of Health methodically manages its State Institute for Drug Control, which is the administration
body for human medicinal products produced from or by GMOs.
The Ministry of Education, Science, Research and Sport is an umbrella body for the promotion of education,
science and research, including the Slovak Academy of Sciences, which is the main research institution in the field of
biosafety.
III. Contained use activities
The Ministry of Environment received four notifications on new activities of low level risk (risk class 2) from
1st April 2016 till 31st December 2016.
The activities of moderate limited (risk class 3) or high level risk (risk class 4) were not notified.
The users of genetic technologies and genetically modified organisms and microorganisms that pose negligible
risk (risk class 1) are obligated to notify the data of the used genetic technologies once per 6 months for recording.
Detailed information about genetically modified organisms and microorganisms that were approved in Slovakia
for contained use is available on the website of the Ministry of Environment http://www.minzp.sk/ .
IV. Deliberate release into the environment (Field trials)
To date, we have not received any application for field trial since the last report in April 2016.
56
V. Commercial cultivation
In 2016, genetically modified maize MON810 was sown approximately at 111 hectares (with buffer strips of
conventional maize 46 hectares). The entire production will be used in the livestock production of the grower as
animal feed.
The information on growing area of the genetically modified maize MON810 is available at the website of the
Ministry of Agriculture and Rural Development of the Slovak Republic www.mpsr.sk (only in Slovak language).
Nineteen Member States of the European Union demanded the prohibition of the cultivation of MON 810 in all
or part of their territory according to the new Directive (EU) 2015/412. The territories where the cultivation of
genetically modified maize MON 810 shall be prohibited are listed in the Annex to the Commission Implementing
Decision (EU) 2016/321. The information set out in this decision shall be entered in the Community Register of
genetically modified food and feed.
VI. New Plant Breeding Techniques
Without changes.
There weren't any plants developed by the NPBT in Slovakia last year.
The European Commission is carrying out a legal analysis of a group of new plant breeding techniques, in order
to evaluate whether they lead to organisms falling under the scope of Directives 2001/18/EC on the deliberate release
into the environment of genetically modified organisms and 2009/41/EC on the contained use of genetically modified
micro-organisms. Until the status of the techniques is clarified, a protective approach is implemented in order to be
able to adapt to the requirement of EU legislation on GMOs should it be concluded that the organisms produced by
these techniques are subject to its rules.
SLOVENIA
CURRENT DEVELOPMENT IN SLOVENIA
Slovenia is an European Union member and shares the common European legislation. All preparations of legal
acts are taking place at the EU level, including policy decisions and approval procedures except for contained use of
GMOs. All acts concerning GMO's in food and feed are directly applicable in Slovenia.
Provisions of the EU legislation in the field of GMMs are transposed into Slovene Management of GMOs act
which also covers GM animals and GM plants in the contained use facilities. Currently there are 67 systems for
contained use of GMOs registered in Slovenia, 53 in biosafety level 1 and 14 in biosafety level 2. Most of them are
research facilities in institutes and Universities. Every year we observe more applications for an upgrade of contained
use facilities from biosafety level 1 to biosafety level 2, mainly due to use of viral vector expression systems.
Monitoring of GMOs in seed
In the framework to ensure safety in the use of products of modern biotechnology the Competent Authority for
contained use, deliberate release and placing GMOs on the market is in Slovenia Ministry of the Environment and
Spatial Planning. In that respect it is also responsible for monitoring of GMOs presence in seed which is taking place
in Slovenia for many years. In 2016, 22 samples of seeds of maize, rapeseed and soybean were analysed. Among
them, 15 samples of maize seed, 5 samples of rapeseed and 2 samples of soybean were tested for the presence of
57
GMOs. All samples were first, subject to screening analysis with the five-target method for the presence of genetic
elements: CaMV 35S promoter, NOS terminator, bar, pat and CTP2-CP4-EPSPS and determination of the reference
gene (presence of DNA or maize, rapeseed or soya). In case of soybean additionally MON 87701 (MON-877Ø1-2),
MON87769 (MON-87769-7), DP305423 (DP-3Ø5423-1), MON87708 (MON-877Ø8-9), CV127 (BPS-CV127-9),
were tested, because they are not covered by five-target method. All the samples tested were negative for the presence
of GM elements.
Traceability of GMO foods and feeds
The Competent Authority for GMO's in food and in feed is The Administration of the Republic of Slovenia for
Food Safety, Veterinary Sector and Plant Protection, which is the body within the Ministry of Agriculture, Forestry
and Food. Slovenia has no commercial cultivation of GMO's, neither field trial. On the basis of the annual monitoring
on GMO's in food and feed we are establishing that feed consisting of or containing GMO is often on the Slovenian
market, but we can rarely find the food consisting of or containing GMO's.
In 2016 we tested samples with the real-time PCR method pentaplex for the screening and with event specific
methods for the qualitative and quantitative detection. Our national laboratory National Institute of Biology has
validated and accredited method for the simultaneous determination of the presence of five target sequences
(screening elements). This method allows the simultaneous determination of the presence of DNA sequences of the
35S promotor, NOS terminator, bar gene, the pat gene and the construct CTP2-CP4-EPSPS, which are commonly
found in genetically modified organisms. In the year 2017, Slovenia is continuing with testing of the presence of
GMOs in food and feed.
Cultivation of GM plants
The Competent Authority for the cultivation on coexistence of GMO's is Ministry of Agriculture, Forestry and
Food. In 2016 the cultivation of GM plants in the Republic of Slovenia was not allowed in accordance with the
Directive (EU) 2015/412 of the European parliament and of the Council of 11 March 2015 amending Directive
2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically
modified organisms (GMOs) in their territory, where we used the first option and sent the request for the restriction of
the cultivation throughout Slovenian territory to the European Commission. The request was granted. In 2016 we also
carried out the monitoring in accordance with national legislation. Samples were taken prior the sowing and partly
from seed residues after the sowing.
Laboratory’s Capacity for GMOs detection
We have one accredited laboratory for detection of GMOs in plant materials in Slovenia. This is the laboratory
of Department of Plant Physiology and Biotechnology at the National Institute of Biology.
National Institute of Biology (NIB) is nominated as National Reference Laboratory for detection of genetically
modified organisms in food, feed and seed, development of methods and other tasks related to GM control by
Ministry of Agriculture, Forestry and Food and Ministry of the Environment and Spatial Planning. NIB is testing
samples of food, feed, plants and seeds for official control. NIB is a holder of the national measurement standard in
the category of amount of substances in food of plant origin. At the moment Department of Biotechnology and
Systems biology at National Institute of Biology has more than 70 accredited methods for qualitative and quantitative
testing of genetically modified organisms in foodstuffs and agricultural products of plant origin. NIB together with
Norwegian partners recently developed the multiplex digital PCR (dPCR) methods for detection of GMO soybean
and maize (DOBNIK, David, SPILSBERG, Bjørn, BOGOŽALEC KOŠIR, Alexandra, HOLST-JENSEN, Arne, ŽEL,
Jana). Multiplex quantification of 12 European Union authorized genetically modified maize lines with droplet digital
polymerase chain reaction (Analytical chemistry, 2015, vol. 87, iss. 16, str. 8218-8226, doi:
10.1021/acs.analchem.5b01208). The dPCR method for soybean was sent to publication and was accredited. Digital
PCR is the most recent approach in PCR that enables absolute quantification of nucleic acids. In 2016 two
international workshops on dPCR was organized at NIB. The EC Joint Research Centre, being the European Union
58
Reference Laboratory for Genetically Modified Organisms (GMOs) in Food and Feed (EURL GMFF) and the NIB
have organised and executed a “Training workshop on digital PCR and next generation sequencing for National
Reference Laboratories assigned under Regulation EC 882/2004” (http://www.nib.si/eng/index.php/novice/519training-workshop-on-digital-pcr-and-next-generation-sequencing). At the NIB dPCR Experience, a hands-on
workshop on dPCR on different dPCR platforms took place, where the team of NIB together with BioSistemika
shared their extensive knowledge on the technology with participants from Europe and USA
(https://biosistemika.com/wp-content/uploads/2016/10/NIB-dPCR-Workshop-2016-Programme.pdf).
Also
the
webinar on dPCR was prepared (https://www.youtube.com/watch?v=DBpxGOcLnF4&feature=youtu.be).
NIB cooperates intensively within European network of GMO laboratories (ENGL) and with Institute of
reference materials and methods (IRMM) and participates also in international research projects developing new
methods for GMO detection (e.g. Decathlon www.decathlon-project.eu). NIB also headed related research project
GMO Val - Validation of detection methods for GMOs which was successfully finalized (http://www.gmoval.com/).
At the national level, NIB cooperates in the project on risk assessment of organisms developed by so-called new
techniques, headed by Agricultural Institute of Slovenia. The Institute is also providing scientific and technical
support to authorities. NIB is also a member of the Network of Laboratories for the Detection and Identification of
GMOs operating under the Cartagena Protocol on Biosafety and plays an active role in preparing documents for the
network.
Another laboratory for GMOs in Slovenia is at the Agricultural Institute of Slovenia (KIS) which is a member of
European Network of GMO Laboratories (ENGL) and a member of the Network of Laboratories for the Detection
and Identification of GMOs operating under the Cartagena Protocol on Biosafety. In the field of coexistence KIS is
providing scientific and professional support to the Ministry of Agriculture, Forestry and Food. KIS is also
coordinating a project entitled 'Procedures for ensuring safety and social acceptability of new techniques and
applications of synthetic biology and modern biotechnology', financed by the Slovenian Research Agency and the
Ministry of the Environment and Spatial Planning. Project partners are National institute of Biology and University of
Ljubljana (Faculty of Chemistry and Chemical Technology and Biotechnical Faculty). Results of the project will be
crucial in deciding on the necessary adjustment and upgrading of existing biosafety system.
Nano
Slovenian innovation hub (SIS EGIZ, http://www.sis-egiz.eu/) is setting a national NanoTechnologicalPlatform in 2017 to discuss and share experience on nanomaterials and the use of nanotechnologies. The
nanotechnological companies, relevant ministries, governmental agencies and research institutes will be represented
in the network. The main purpose is to share experience and present coordinated opinions or viewpoints for the
government. In the future, also coordinated national legislative proposals are planned. This network will follow
research activities in Slovenia and abroad as well as administrative developments in EU and globally regarding
nanotechnologies. The main purposes of the NanoTechPlatform will be in the areas of:
1.
2.
3.
4.
safe production and handling of nanomaterials;
research, knowledge and technology transfer in the field of nanotechnologies;
communication of results;
support the companies in following existing legislation in the nanotech field.
We are aware that conducting verified qualitative and quantitative analyses of nanomaterials is a demanding
task. Therefore, the NanoTechnological-Platform will offer an InfoNano point for nanotechnology at national scale
and in the future at regional scale. All activities are and will be coordinated by SIS EGIZ. The activities related with
setting the platform were initiated by SIS EGIZ started in January 2017.
59
SOUTH AFRICA
1. GM crop production in South Africa
The South African regulatory framework requires a socio-economic assessment of a new GM crop line before it
will be considered and approved for commercial release. In these assessments, issues such as international trade,
sustainable livelihoods and possible social impacts are considered.
In the field of biotechnology, South Africa is the leader in Africa. No updated figures for 2016/2017 could be
found. Thus, it remains as reported in April 2016: South Africa grew 2.7 million hectares of maize, soya and cotton crops
in 2014 (Figure 1), a drop from 2.9 million hectares in 2013, mainly owing to the late onset of rain, lower commodity prices
and the adoption rate approaching saturation point. However, despite the drop, South Africa still ranks 9th in the adoption of
genetically modified organisms (GMOs) [August 2016, Department of Agriculture, Forestry and Fisheries (DAFF)
news No. 8].
60
Nearly 86% of maize produced in South Africa is GM, soybeans 92% and cotton 100% (2014). Maize is
estimated at 2.5 million ha in 2014 (2.73 million ha in 2013). Biotech maize comprised 2.14 million ha in 2014 (2.36
million in 2013). Soybean plantings in 2014 increased from 520 000 ha to 600 000 ha, with 92% biotech, with all 552
000 ha being herbicide-tolerant trait (92% and 478 000 ha in 2013). Total cotton area is estimated at 9 000 ha in 2014
(8 000 ha in 2013) [Status in Africa http://scenicsouth.co.za/biotech-gm-crops-can-make-a-major-contribution-tofeeding-a-global-population-of-9-billion-people-by-2050/].
The crops listed above are the only ones containing genetically modified genes that are allowed to be grown in
South Africa. There are no GM fruit or vegetables grown or on the market in South Africa.
2. GM maize in SA planted on nearly 20 million ha in 16 years
[August 2016, Department of Agriculture, Forestry and Fisheries (DAFF) news No. 8]
In 16 years, nearly 20 million accumulated hectares of GM maize were grown in South Africa, yielding well
over 50 million MT of grain. Farmers’ adoption of this new technology escalated at an unprecedented rate. This
makes biotechnology the fastest-growing crop technology in recent years. South Africa ranks 9 th as a global GM crop
producer.
In 2015, the worst drought in 35 years took its toll on biotech crops in South Africa. The biotech hectarage for
all GM crops decreased by 700 000 ha (25%) from the intended 3 million ha to 2.3 million ha. Economic gains for
South African farmers from biotech crops are now estimated at US$245 million per annum.
Dryland yields of maize before the advent of GM averaged 1.5t/ha. Today average yields are 5t/ha for GM
maize, an increase of 70%. GM maize under irrigation varies from 12t/ha to 20t/ha. It is interesting to note how much
more maize South Africa would have had to import were it not for the advent of the latest biotechnologies (GMOs)
and modern maize germplasms.
The 1991/92 season was the last drought South Africa experienced before the adoption of GM crops. In that
year the average maize yield was 0.85t/ha. The 2014/15 and 2015/16 seasons have both been drought years. With the
adoption of GM maize, the average yield is estimated at 3.72t/ha. If it were not for GM maize and the yield was still
0.85t/ha in South Africa, South Africa would have produced only 1.65 million tons of maize. To meet the local
requirements in South Africa, South Africa would have had to import 9.4 million tons instead of 3.8 million tons, at
an estimated additional cost of R33 billion.
3. The Department of Agriculture, Forestry and Fisheries (DAFF)
[http://www.daff.gov.za/]
Biosafety: Department of Agriculture Forestry and Fisheries (Genetic Resources)
[http://www.daff.gov.za/daffweb3/Branches/Agricultural-Production-Health-Food-Safety/Genetic-Resources]
Mission: To manage a bio-safety regulatory system focused on minimizing potential risks associated with
the impact of genetically modified organisms (GMOs) on the environment, human and animal health.
Functions




Develop and implement policies and strategies to contribute to the safe use, handling and transfer of
genetically modified organisms.
Provide technical advice on matters relating to the application of genetically modified organisms in
South Africa, the region and the rest of Africa.
Facilitate a compliance system for assessing potential risks associated with the application of
genetically modified organisms.
Provide an administrative support system for the bodies established under the Genetically Modified
Organisms Act, 1997 (Act No. 15 of 1997) (GMO Act).
61
Role as the Competent National Authority: The Cartagena Protocol on Biosafety, which is an international
agreement that aims to ensure an adequate level of protection in the field of the safe transfer, handling and
use of living modified organisms (LMOs) resulting from modern biotechnology, was established under the
Convention of Biological Diversity. South Africa acceded to the Cartagena Protocol on Biosafety on August
14, 2003. In terms of the Protocol the Department of Agriculture Forestry and Fisheries (Directorate Genetic
Resources) is the recognized Competent National Authority for South Africa and is responsible for ensuring
that all provisions and obligations relating to the Protocol are met.
Note: No new general release additions since last meeting.
[http://www.daff.gov.za/doc/Events%20approved%20for%20General%20Release%20_GMO%20Act%2015,%20199
7.pdf]
OECD BioTrack Database: Dr D Oelofse has, with the assistance from DAFF, provided the OECD Secretariat with
all relevant information needed in order to enter all of the approved GMO events for general release in South Africa
into the OECD BioTrack database, dating back to 1997 [http://www2.oecd.org/biotech/default.aspx].
GMO ACTIVITIES APPROVED UNDER THE GENETICALLY MODIFIED ORGANISMS ACT, 1997
Type of approval: General release – conditional
Use of the event: Importation/exportation
Commercial planting
Food and/or feed
Event
Crop
Innovcax-ND
Vectormune
Ripens
HVT
NDT
&
MON87460
Trait
Company
Date approved
Vaccine
-
Intervet
21/10/2015
Vaccine
-
Ceva Animal Health
21/10/ 2015
Maize
Drought tolerant
Monsanto
12/06/2015
Antibiotic resistant
TC1507 X MON810 x NK603
Maize
Insect
resistance
Herbicide tolerant
Pioneer
18/11/2014
TC1507 X MON810
Maize
Insect
resistance
Herbicide tolerant
Pioneer
18/11/2014
TC1507
Maize
Insect resistance
Pioneer
27/07/2012
Syngenta SA
14/12/2010
Herbicide tolerant
BT11xGA21
Maize
Insect resistance
Herbicide tolerant
GA21
Maize
Herbicide tolerant
Syngenta SA
14/12/2010
MON89034xNK603
Maize
Insect resistance
Monsanto
14/12/2010
Herbicide tolerant
MON89034
Maize
Insect resistance
Monsanto
14/12/2010
Bollgard
IIxRR
flex
(MON15985x MON88913)
Cotton
Insect resistance
Monsanto
6/11/2007
MON88913 (RR flex )
Cotton
Herbicide tolerant
Monsanto
7/02/2007
MON810xNK603
Maize
Insect resistance
Monsanto
2/2/2007
Monsanto
21/10/2005
Herbicide tolerant
Herbicide tolerant
Bolgard RR
Cotton
Insect resistance
62
Herbicide tolerant
Bollgard II, line 15985
Cotton
Insect resistance
Monsanto
11/12/2003
Herbicide tolerant
Bt11
Maize
Insect resistance
Syngenta SA
26/92003
NK603
Maize
Herbicide tolerant
Monsanto
20/09/2002
GTS40-3-2
Soybean
Herbicide tolerant
Monsanto
1/08/2001
RR lines 1445 & 1698
Cotton
Herbicide tolerant
Monsanto
22/06/2000
Line 531 / Bollgard
Cotton
Insect resistance
Monsanto
20/08/1997
MON810 / Yieldgard
Maize
Insect resistance
Monsanto
20/08/1997
Note: New commodity clearance additions since last meeting in bold, black text.
[http://www.daff.gov.za/doc/Events%20approved%20for%20Commodity%20Clearance%20_GMO%20Act%2015,%
201997.pdf ]
OECD BioTrack Database: Dr D Oelofse has, with the assistance from DAFF, provided the OECD Secretariat
with all relevant information needed in order to enter all of the approved GMO events for commodity clearance in
South Africa into the OECD BioTrack database, dating back to 2001 [http://www2.oecd.org/biotech/default.aspx].
GMO ACTIVITIES APPROVED UNDER THE GENETICALLY MODIFIED ORGANISMS ACT, 1997
Type of approval: Commodity Clearance (Excludes events that have obtained general release clearance before
commodity clearance)
Use of the event: Importation for use as food or feed
Event
Crop
Trait
Company
Date approved
MON87708 x MON89788
Soybean
Herbicide tolerance
Monsanto
8/12/2016
FG72
Soybean
Herbicide tolerance
Bayer
8/12/2016
A5547-127
Soybean
Herbicide tolerance
Bayer
8/12/2016
Soybean
Herbicide tolerance
DowAgroSciences
8/12/2016
DAS-81419-2
Soybean
Insect resistance
DowAgroSciences
8/12/2016
3272 x BT11 x MIR604 x
GA21
Maize
Insect resistance
Syngenta SA
25/11/2016
TC1507 x MON810 x
MIR162
Maize
Du Pont Pioneer
25/11/2016
BT11 x TC1507 x GA21
Maize
Syngenta SA
25/11/2016
Monsanto
25/11/2016
Monsanto
25/11/2016
Monsanto
25/11/2016
DAS68416-4
MON89788-1
x
Herbicide tolerance
Insect resistance
Herbicide tolerance
Insect resistance
Herbicide tolerance
MON87427 x MON89034
x MIR162 x NK603
Maize
MON87427 x MON89034
x NK603
Maize
MON87427 x MON89034
x 1507 x MON88017 x
Maize
Insect resistance
Herbicide tolerance
Insect resistance
Herbicide tolerance
Insect resistance
63
59122
Herbicide tolerance
TC1507 x MON810 x
MIR162 x NK603
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
11/11/2016
TC1507
NK603
x
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
11/11/2016
TC1507 x MON810 x
MIR604 x NK603
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
11/11/2016
TC1507 x 59122
MON810 x NK603
x
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
11/11/2016
TC1507 X 59122 X
MON810 x MIR604 x
NK603
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
11/11/2016
DAS81910-7
Cotton
Herbicide tolerant
DowAgroSciences
11/11/2016
Cotton
Insect resistant
DowAgroSciences
11/11/2016
MON89034 x TC1507 x
MON88017
x
DAS591227 x DAS-40278-9
Maize
Insect
resistant
Herbicide tolerant
DowAgroSciences
11/11/2016
MON89034 x TC1507 x
NK603 x DAS-40278-9
Maize
Insect
resistant
Herbicide tolerant
DowAgroSciences
11/11/2016
3272 x BT11 x MIR604 x
TC1507 x 5307 x GA21
Maize
Insect
resistant
Herbicide tolerant
Syngenta SA
11/11/2016
DP4114
Maize
Insect
resistant
Herbicide tolerant
Du Pont Pioneer
1/06/2016
NK603 x T25
Maize
Herbicide tolerant
Monsanto
31/3/2016
MZHG0JG
Maize
Herbicide tolerant
Syngenta SA
31/3/2016
DP73496
Canola
Herbicide tolerance
Du Pont Pioneer
31/03/2016
MON87460 x MON89034
x NK603
Maize
Drought tolerant
Monsanto
21/10/2015
BT11 x MIR162
Maize
Insect
resistant
Herbicide tolerant
Syngenta SA
30/7/2015
MON87460 x MON89034
x MON88017
Maize
Abiotic resistant
Monsanto
15/07/2015
GA21 x T25
Maize
Herbicide tolerant
Syngenta SA
15/7/2015
SYHT0H2
Soybean
Herbicide tolerant
Syngenta SA
17/4/2014
BT11 x 59122 x MIR604 x
TC1507 x GA21
Maize
Insect
resistant
Herbicide tolerant
Syngenta SA
24 March 2014
BT11 x MIR604 x TC1507
x 5307 x GA21
Maize
Insect
resistant
Herbicide tolerant
Syngenta SA
BT11 x MIR162 x MIR604
x TC1507 x 5307 x GA21
Maize
Insect
resistant
Herbicide tolerant
Syngenta SA
24/3/2014
MIR162
Maize
Insect resistant
Syngenta SA
11/3/2014
x
MIR604
DAS-24236-5
21023-5
x
DAS-
Insect
resistant
Herbicide tolerant
Insect
resistant
Herbicide tolerant
64
24/3/2014
MON89034 x MON88017
Maize
Maize
resistant
tolerant
Insect
Herbicide
Monsanto
24/03/2014
MON87701 x MON89788
Soybean
Insect
resistant
Herbicide tolerant
Monsanto
5/12/2013
MON89788
Soybean
Herbicide tolerant
Monsanto
5/12/2013
DAS-44406-6
Soybean
Herbicide tolerant
Dow AgroSciences
12/05/2013
CV127
Soybean
Herbicide tolerant
BASF
9/07/2012
DAS-40278-9
Maize
Herbicide tolerant
Dow AgroSciences
19/06/2012
MON89034 x TC1507 x
NK603
Maize
Insect resistance
Dow AgroSciences & Monsanto
28/03/2012
MIR604
Maize
Insect resistance
Syngenta SA
26/9/2011
BT11 x GA21
Maize
Insect resistance
Syngenta SA
26/9/2011
Syngenta SA
26/9/2011
Herbicide tolerant
Herbicide tolerant
BT11 x MIR604
Maize
Insect resistance
Herbicide tolerant
MIR604 x GA21
Maize
Insect resistance
Syngenta SA
26/9/2011
Herbicide tolerant
BT11 x MIR604 x GA21
Maize
Insect resistance
Syngenta SA
26/9/2011
Syngenta SA
26/9/2011
Syngenta SA
26/9/2011
Syngenta SA
19/7/2011
Pioneer
26/09/2011
Herbicide tolerant
BT11 x MIR162 x MIR604
x GA21
Maize
BT11 x MIR162 x GA21
Maize
Insect resistance
Herbicide tolerant
Insect resistance
Herbicide tolerant
BT11 x MIR162 x TC1507
x GA21
Maize
TC1507 x NK603
Maize
Insect resistance
Herbicide tolerant
Insect resistance
Herbicide tolerant
59122
Maize
Insect resistance
Pioneer
26/09/2011
NK603 x 59122
Maize
Insect resistance
Pioneer
26/09/2011
Herbicide tolerant
356043
Soybean
Herbicide tolerant
Pioneer
26/09/2011
305423
Soybean
Higher oleic
content
Pioneer
26/09/2011
Pioneer
26/09/2011
DowAgroScience
26/9/2011
acid
Herbicide tolerant
305423 x 40-3-2
Soybean
Higher oleic
content
acid
Herbicide tolerant
TC1507 x 59122
Maize
Insect
resistant
65
Herbicide tolerant
TC1507 x 59122 x NK603
Maize
Insect resistant
DowAgroScience
26/9/2011
Herbicide tolerant
LLRice62
Rice
Herbicide tolerant
Bayer
26/9/2011
LLCotton25
Cotton
Herbicide tolerant
Bayer
26/9/2011
MON863
Maize
Insect resistant
Monsanto
26/9/2011
MON863 x MON810
Maize
Insect resistant
Monsanto
26/9/2011
MON863 x MON810 x
NK603
Maize
Insect resistant
Monsanto
26/9/2011
MON88017
Maize
Insect resistant
Monsanto
26/9/2011
MON88017 x MON810
Maize
Insect resistant
Monsanto
26/9/2011
MON89034 x TC1507 x
MON88017 x 59122
Maize
Insect resistant
DowAgroScience & Monsanto
26/9/2011
MON810 x NK603
Maize
Monsanto
1/04/2004
Monsanto
8/12/2003
Pioneer Hi-Bred
11/12/2002
Herbicide tolerant
Herbicide tolerant
Insect resistant
Herbicide tolerant
MON810 x GA21
Maize
Insect resistant
Herbicide tolerant
TC1507
Maize
Insect resistant
Herbicide tolerant
NK603
Maize
Herbicide tolerant
Monsanto
2/08/2002
GA21
Maize
Herbicide tolerant
Monsanto
18/10/2002
Bt11
Maize
Insect resistant
Syngenta
1/02/2002
T25
Maize
Herbicide tolerant
AgrEvo
25/09/2001
Bt176
Maize
Insect resistant
Syngenta SA
5/06/2001
Oilseed rape
Herbicide tolerant
AgrEvo
12/12/2001
Soybean
Herbicide tolerant
AgrEvo
12/12/2001
Topas
19/2,
Ms1Rf2,
Ms1Rf1,
Ms8Rf3
A2704-12
4. Regulatory triggers (e.g. process and/or product) to initiate environmental risk/safety assessment (ER/SA) in
South Africa
Department of Environmental Affairs (DEA) [https://www.environment.gov.za/content/home]
Mandate and core business: The DEA is mandated to give effect to the right of citizens to an environment that is
not harmful to their health or wellbeing, and to have the environment protected for the benefit of present and
future generations. To this end, the department provides leadership in environmental management, conservation
and protection towards sustainability for the benefit of South Africans and the global community.
The National Environmental Management Act (NEMA) provides for the cooperative environmental governance,
by establishing principles for decision making on matters affecting the environment prohibition, restriction and
control activities, which are likely to have a detrimental effect on the environment. Section 24 (5) of NEMA, lays
66
down minimum requirements to be satisfied in an environmental impact assessment (EIA). The release of GMOs into
the environment is a listed activity in terms of the EIA regulations.
Environmental Risk Assessment Framework for Genetically Modified Organisms: A Guidance Document
[https://www.environment.gov.za/legislation/actsregulations]
The presence of a transgene in an organism, regardless of the method used to introduce it, will trigger the
requirement for an ERA to be conducted before authorisation may be granted by the Department of
Environmental Affairs and Tourism (DEAT) to release it into the environment. This therefore means that
organisms that have stacked traits resulting from either intentional intra specific or inter specific crosses
between GMOs already authorised for commercial release will still require comprehensive risk assessments.
Comparative compositional analysis: Compositional analysis should be carried out alongside appropriate
controls grown in the same location and the experiments designed to yield meaningful data. Where the
substantial equivalence of parental lines containing genetically modified events has been fully tested in
replicated field trials over at least two seasons, one year’s field trialling of events combined by crossing is
acceptable where geographical localities are representative of the climatic conditions to which such crops
will be exposed. Based on the outcomes of this assessment, additional follow-up analysis of compositional
characteristics over further growing seasons may be required if unexpected differences occur beyond the
range of natural variation. On a case-by-case basis, this may trigger further assessment. In terms of the
nutrients, anti-nutrients and natural toxins, these need to be analysed following the OECD published
consensus documents on the key components that should be considered in the comparative assessment of the
new crop varieties of particular species. Measurement of these components can be regarded as the minimum
requirement for genetically modified events combined by crossing.
Criteria that may be used to trigger an environmental impact assessment of a GMO: An EIA may be evoked
by the Minister of DEAT in consultation with scientific experts if it is deemed that one of the following
criteria is applicable:











GM in question will result in changes in conventional use, eg, pharmaceuticals in plants, biofuel
production.
GM will result in substantial changes in current agricultural practices and pest (medical, veterinary,
agricultural) management practices, eg, expansion into new agricultural areas.
GMOs where there is prior evidence of changes in the agro-ecosystem dynamics that may lead to
substantial changes in current agricultural practice, such as evidence of secondary pest emergence
or evidence of resistance development.
Potential negative impact on threatened or protected organisms listed in terms of the National
Environmental Management: Biodiversity Act (NEMBA).
Release of indigenous GM organisms.
GMOs with cultural geopolitical significance, or potentially negative socio-economic impact.
GMOs that have wild indigenous relatives.
GMOs that have non-indigenous weedy relatives.
GMOs that have the potential to become invasive.
Release of modified microorganisms that are expected to have a significant negative effect on the
environment.
The scope of the application entails any environmental release of GMOs to be used for bioterrorism.
5. The protection goals for environmental risk/safety assessment (ER/SA) in South Africa
Department of Environmental Affairs (DEA) [https://www.environment.gov.za/content/home]
Protection goals relating to GMOs are listed in various legislation in South Africa, i.e. NEMA 107 of 1998,
Chapter 1, Section 4; NEMBA 10 of 2004, Chapter 5, Section 78; and the GMO Act. The GMO Act’s objective
states “… providing for adequate level of protection during all activities involving GMOs that may have adverse
67
impact on the conservation and sustainable use of biological diversity, human and animal health on the other
hand NEMBA provides for the management and protection of the country’s biodiversity, protection of species
and ecosystem in need of protection……”.
Environmental Risk Assessment Framework for Genetically Modified Organisms: A Guidance Document
[https://www.environment.gov.za/legislation/actsregulations]
Objectives of environmental impact assessment: The objectives environmental impact assessment is to
precisely evaluate the effects imposed by GMOs and their products on environmental quality and ecosystem
evolution when undertaking research, commercialisation, and application of and releasing of GMOs and GM
products to agricultural ecosystem, grasslands, forestry, water environment and other natural elements.
Based on these assessments, effective measures will be taken to prevent or minimise adverse effects. Below
are detailed requirements for environmental impact assessment as stipulated by NEMA:






Identifying impacts of GMOs and their products on the environment; defining level and frequency
of such impacts.
Evaluating mode of impact.
Analysing environmental elements and identifying them for evaluation and protection objectives.
Description of environmental impact assessment results according to studies and analyses.
Comparing and analysing socio-economic and environmental benefits of various protection
measures.
Proposing impact prevention or mitigation measures.
6. Products from new plant breeding techniques (NPBTs) and NFFS assessments
[Please note that I am not the authorised focal point to speak on the matter, but that this is my understanding of
the local situation based on the responses received from the role players in South Africa]
South Africa has shown interest in the regulatory implications of NPBTs, and are in the first stages of starting a
process of regulatory and scientific review. The GMO Act has been drafted in a way that enables the Executive
Council (EC) to implement a case-by-case risk assessment approach for new technologies. Regarding NPBTs, the EC
is expected to deal with this on a case-by-case basis as they are empowered to so by law. The current environmental
risk assessment process being followed in the country will be able to cover NPBTs.
Regulatory implications of new genetic engineering technologies workshop
The Academy of Science of South Africa (ASSAF) has a strong focus on issues of national importance and
currently is conducting a consensus study, commissioned by the Department of Science and Technology (DST),
titled ‘Regulatory implications of new genetic engineering technologies’.
A number of new genetic technologies have been developed since the implementation of the biosafety
regulations for South Africa in 1997 (GMO Act, 1997). The reflection on the regulatory controls for new
technologies is thus a necessary and ongoing process and this is for two main reasons: to ensure South African
policy appropriately and adequately addresses biosafety requirements to ensure safe and sustainable products;
and, secondly, to ensure the regulatory requirements are appropriate to the technologies or products.
Dr D Oelofse, ARC, was invited to and participated in the consultative workshop involving key stakeholders
that was held on 11 October 2016. The workshop discussions included the current global approaches to the
regulation of these new technologies. Thus, Dr Oelofse informed the participants on the OECD initiatives
regarding environmental risk assessments of products derived from novel plant breeding techniques. Following
requests from the participants, Dr Oelofse provided all participants with the report of the OECD workshop on
environmental risk assessment (ERA) of products derived from novel plant breeding techniques (NPBT), held
on 10 February 2014, which was highly appreciated by all.
The workshop discussions were based on the objectives of the study (as listed below), which will take into
68
consideration the existing regulations for Biosafety (GMO Act 1997, with modifications):
1. Evaluate the risk/benefit implications and ethics of all relevant new technologies (generally, but also with
specific reference to their ability to sustain the diversity of agricultural crops, their ability to improve the
agronomy, production and/or value of the crops).
2. Determine, with justification, which new technologies should fall under the GMO Act and which should
not.
3. from (2) above, outline a framework, which can be used to assess the applicability of future technologies to
the existing GMO Act and regulations.
4. Assess the appropriateness of South African biosafety regulatory framework for biosafety risk evaluation
and management of all relevant new technologies.
The purpose of the study is to interrogate the biosafety implications of new genetic engineering technologies,
their fit with the existing GMO Act (1997), and the robustness of the current biosafety regulations to
accommodate/cater for the new technologies. This should result in recommendations on:
1. How to assess new and future technologies on their applicability to the existing GMO Act.
2. How current biosafety policy and regulations may need to be amended to accommodate the varying
biosafety implications (of those technologies, which are considered to fall under the GMO Act).
3. Where appropriate, recommend modifications/revisions and/or additions to the existing regulations,
individually or collectively, for the new technologies.
The workshop proceedings and other related communication/engagements on this study will be assessed for
incorporation into the overall final consensus study report.
7. Survey of products developed by the OECD Task Force for the Safety of Novel Foods and Feeds
[As from 1 January 2017 this group will be called the Working Group on the Safety of Novel Foods and Feeds]
[Please note that I am not the authorised focal point to speak on the matter, but that this is my understanding
of the local situation based on the responses received from the role players in South Africa that completed
the OECD questionnaire]
South Africa has benefitted from the availability of consensus documents. The documents are very useful for
commodity clearance for food, feed and processing, as well as cultivation applications to the authorities.
The development of the consensus documents on compositional analysis and the biology documents are very
useful reference documents for applicants and other members of the regulatory system in South Africa. Documents
that focus on crops and traits that are important for developing countries, in particular African countries, where such
consensus documents do not exist, are particularly useful.
Those food/feed components identified for the crops for which the OECD Task Force for the Safety of Novel
Foods and Feeds have developed consensus documents for have become standard requirements for compositional
comparative assessments.
In training regulatory authorities in Africa and elsewhere, the status of these documents is important. The
message that we convey to regulatory authorities in SADC and other African regions is that at OECD level,
consensus is reached by experts from a number of countries on which components of crops can be described as
characteristic of that crop.
The topics that have been considered have been carefully deliberated and this is reflected in the choice of topics
that are highly relevant. The consideration of abiotic traits such as drought tolerance may also be considered. We also
support continued work on topics that are particularly relevant to African countries, for example, work that has
already been done on sorghum.
“History of safe use” is a possible subject that the OECD can further discuss as there is no consensus on this
concept. There seems to be different views on what it really means and what the criteria are.
69
It is requested that the OECD continues with information dissemination and worldwide sharing, especially
information on the latest technologies being developed that could assist in the safety assessment and regulation of
novel foods and feeds, including:


The use of high-throughput DNA sequencing in the safety assessment of genetically engineered plants.
New plant breeding techniques: This is currently a ‘hot’ topic in South Africa. A workshop on the regulatory
implications of new genetic engineering technologies was held in Pretoria, South Africa in October 2016.
South Africa has shown interest in the regulatory implications of NBTs, and are in the first stages of starting
a process of regulatory and scientific review.
8. LLP update
[Please note that I am not the authorised focal point to speak on the matter, but that this is my understanding of
the local situation based on the responses received from the role players in South Africa]
South Africa continues to participate in ongoing discussions regarding LLP mindful that we are both importers
and, albeit, to a lesser extent, exporters of GMOs. We remain convinced that all risk assessments and management
should be based on relevant science, and that no arbitrary distinction should be made between food and feed. South
Africa currently applies a zero tolerance in this regard.
9. Usefulness of the OECD Consensus documents
Biosafety South Africa [www.biosafety.org.za]
Biosafety South Africa is a platform within the national Technology Innovation Agency, which is an initiative
of the national Department of Science and Technology. BSA is an independent national authority and service
provider for all regulatory and biosafety issues related to biotechnological products.
Biosafety South Africa states that a biology document is intended to:




provide background information on the biology of a particular plant species,
its centres of origin,
its related species,
the potential for gene introgression from the plant into relatives, as well as details on the life forms with
which it interacts.
The conclusions drawn in a biology document only relate to knowledge and experience of plants with no novel
traits of the species concerned. Information on the untransformed species assist in defining the baseline and scope
(comparator against which transformed organisms will be compared). Although the document is not an environmental
risk/safety assessment of the species, information in a biology document is used to specifically address the
environmental risk/safety of genetically modified or engineered i.e. GM/ GE (transformed) plants. Species-specific
information will be used to determine whether there are significantly different/altered interactions with other life
forms resulting from presence of GM plants.
The information described in biology documents are in a format readily accessible to regulators. Biology
documents are categorised into several sections ranging from species specific information to information on the
potential effects of the crop species on human health and biosafety. The information in the biology document is
essentially an assessment of the information applicable to the environmental risk/safety assessment from collective
peer reviewed sources. In addition, a complete list of references and appendices are included at the end of the
document.
Below is a comprehensive list of published biology consensus documents on commercially released GM crops,
as well as those GM crops with potential for commercialisation in South Africa.
Cassava
 http://biovisioneastafrica.com/publications/Cassava%20biology%20document.pdf
Cotton
70

http://www.olis.oecd.org/olis/2008doc.nsf/LinkTo/NT0000794A/$FILE/JT03257
Maize/ Corn
 http://www.inspection.gc.ca/english/plaveg/bio/dir/dir9411e.pdf
 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/650f3eec0dfb990fca25692100069854/330c90ca0496618
fa2574d0001d4dd6/$FILE/biologymaize08.pdf
 http://www.olis.oecd.org/olis/2003doc.nsf/LinkTo/NT0000426E/$FILE/JT00147699.PDF
Potato
 http://www.oecd.org/dataoecd/25/62/27854542.pdf
Soybean
 http://www.inspection.gc.ca/english/plaveg/bio/dir/t11096e.pdf
 http://www.olis.oecd.org/olis/2000doc.nsf/LinkTo/NT00002C3A/$FILE/00085953.PDF
Sugar Beet
 http://www.olis.oecd.org/olis/2001doc.nsf/LinkTo/NT0000096E/$FILE/JT00118011.PDF
Sugar Cane
 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/sugarcane-3/$FILE/biologysugarcane.pdf
Sunflower
 http://www.olis.oecd.org/olis/2004doc.nsf/LinkTo/NT000092F2/$FILE/JT00177388.PDF
Wheat
 http://www.ogtr.gov.au/internet/ogtr/publishing.nsf/Content/wheat-3/$FILE/biologywheat08.pdf
 http://www.olis.oecd.org/olis/1999doc.nsf/LinkTo/NT00002B2A/$FILE/04E94444.PDF
Department of Environmental Affairs (DEA) [https://www.environment.gov.za/legislation/actsregulations]
Comparative compositional analysis: In terms of the nutrients, anti-nutrients and natural toxins, these need to be
analysed following the OECD published consensus documents on the key components that should be considered in
the comparative assessment of the new crop varieties of particular species. Measurement of these components can be
regarded as the minimum requirement for genetically modified events combined by crossing.
10. Labelling of foods with any GM content
[Fact Sheet: GMOs in South Africa, Biowatch South Africa, May 2016]
To ensure our right to choice and to know what we are eating, food producers must label their GM products. The
Consumer Protection Act requires the labelling of foods with any GM content.
The following labels are mandatory in South Africa when foods contain GMOs:
 “Contains GMOs” if there is 5% or more GM content.
 “Produced using genetic modification” when the food comes directly from a GM source, for example maize
meal.
 “May contain GMOs” when the manufacturer can show that it is impractical to test for GM, but suspects that
it is.
Food producers can also use the following voluntary labels:
 “Does not contain GM content” if there is less than 0.9% GM content.
 “GM content is less than 5%”
11. Water Efficient Maize for Africa (WEMA) project
[August 2016, Department of Agriculture, Forestry and Fisheries (DAFF) news No. 8]
The DroughtTEGOTM hybrid was developed by the Agricultural Research Council (ARC) under the WEMA
project. The GM technologies will be deployed to smallholder farmers royalty free. The farmers are likely to double
71
their farm gate income this year. The implications on food security are numerous. The technology guarantees output
in difficult production seasons. The expectation is that more smallholder farmers will be enticed back into agriculture.
The yields we are seeing today show us what can be achieved if we work together to put smallholder farmers on the
road to becoming commercial farmers.
The project is expected to deliver its first biotech stacked drought tolerant maize with insect control (Bt) for
commercialisation in South Africa as early as 2017, subject to regulatory approval. Africa grows 90% of its maize
under rain-fed conditions and up to 25% of the area suffers from frequent droughts. Monsanto donated the biotech
drought tolerant (DT) maize technology (MON 87460), DroughtGard™ (Cold shock protein gene (CspB)
from Bacillus subtilis) to the public sector agriculture R&D institutions in five countries in Sub-Saharan Africa
(South Africa, Kenya, Uganda, Mozambique and Tanzania). WEMA is coordinated by the African Agricultural
Technology Foundation (AATF) based in Nairobi, in collaboration with Monsanto and CIMMYT for further
technology development. The project is funded jointly by the Gates Foundation, the Howard G. Buffett Foundation
and USAID. The first stacked biotech insect resistant/drought tolerant (Bt/DT) maize hybrids are expected to be
available to farmers (subject to regulatory approval) as early as 2017. South Africa is expected to be the first country
to deploy the technology in 2017. South Africa has conducted controlled field trials with the DT maize for 7 seasons
already. It is projected that the WEMA stacked DT/Bt maize hybrids may yield up to 20 to 35% more than other
commercial hybrids under moderate drought, resulting in an additional 2 to 5 million metric tons of maize to feed
about 14 to 21 million people in Africa.
SPAIN
1) Regulatory framework
The Spanish Ministry of Agriculture and Fisheries, Food and Environment (MAPAMA) is finalising the
transposition of EU Directive 2015/412, of 11 March 2015, amending Directive 2001/18/EC as regards the possibility
for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in all or part of
their territory. In this regard, Spain will continue to grow MON 810 maize in any part of its territory.
In addition, the MAPAMA is still working on the possibility to establish coexistence measures that have to be
implemented according with the mentioned EU Directive for the MON810 maize cultivation regarding the border
neighbours, especially with regard to France which has banned the cultivation of this Bt maize.
2) Activities with GMOs
General information about all these activities with GMOs which have been approved in Spain as contained use
or deliberate release into the environment is available from the Ministry of Agriculture and Fisheries, Food and
Environment
(MAPAMA)
Web
Page:
http://www.mapama.gob.es/es/calidad-y-evaluacionambiental/temas/biotecnologia/organismos-modificados-geneticamente-omg-/
a) Contained use activities
Since the last meeting in April 2016, 41 new facilities for different contained use activities have been notified
and assessed by the Spanish Commission on Biosafety (19 BSL1; 18 BSL2 and 4 BSL3).110 different activities have
been notified to be carried out in these facilities (most of them are classified as BSL2 (60) and 29 activities of BSL3).
The main genetically modified organisms used are bacteria (E. coli, Mycoplasma pneumoniae, Staphyloccocus
aureus, Brucellas, Pseudomonas putida, Bordetella bronchiseptica, Salmonella, Enterococcus faecalis, etc.), yeasts
(Pichia pastoris, S. cerevisiae), viruses (Zika virus), viral vectors (adenovirus, lentivirus, retrovirus, parapoxvirus,
72
vaccinia), and several cell lines (human and murine lines). There are genetically modified animals (lab mice and rats,
rabbits, Drosophila, pigs and zebrafish) and GM plants (Solanum tuberosum, Arabidopsis thaliana y Nicotiana spp),
which are being used under contained conditions.
For detailed information:
http://www.mapama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificadosgeneticamente-omg-/notificaciones-y-autorizaciones/uso_confinado.aspx
b) Experimental deliberate release into the environment
From April 2016, twelve applications for deliberate release trials have been evaluated: 3 are trials on genetically
modified plants (maize, oilseed rape and wheat) and 9 are clinical trials in humans with viruses or genetically
modified cells for the treatment of different diseases. A combination vaccine against infectious of fowlpox (FP),
laryngotracheitis (ILT) and avian encephalomyelitis (AE) diseases in chickens has been also presented
and assessed.
Trend towards the reduction of field trials with genetically modified plants and increase of the activities of
contained use for the purposes of biomedical research and clinical trials of gene therapy are maintained.
For detailed information:
http://www.mapama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificadosgeneticamente-omg-/notificaciones-y-autorizaciones/liberac_voluntaria.aspx
c) Placing on the market
In 2016, the growing surface of Bt maize (MON10) in Spain was around 130.000 ha. The monitoring plan for
the commercial cultivation of this Bt maize continues ongoing and for the time being, no insect resistant populations
have been detected after 18 year of growth in the main maize cropping area in Spain.
In June last year, the EC proposed for revising three pending draft Decisions of genetically modified maize
Applications for the cultivation in the EU (authorisation of 1507 maize, for Bt11 maize and the the renewal of
MON810 maize). Spain has been actively involved in the discussions with the Commission for including new
requirements in the Post-market Environmental Monitoring (PMEM) Plans for these three Bt maize.
For detailed information:
−
−
http://www.mapama.gob.es/es/calidad-y-evaluacion-ambiental/temas/biotecnologia/organismos-modificadosgeneticamente-omg-/notificaciones-y-autorizaciones/Cultivo.aspx
http://www.mapama.gob.es/es/estadistica/temas/estadisticas-agrarias/agricultura/esyrce/
New Breeding techniques (NPBTs)
There weren't any plants developed by the NPBT in Spain last year. Our country, as the other Member States, is
still waiting for a legal interpretation from the European Commission (EC) to provide helpful elements of
interpretation to decide whether organisms produced by new plant breeding techniques fall under the GMO.
On the other hand, the EC commissioned to the Scientific Advice Mechanism (SAM) to prepare an explanatory
note, in scientific terms, about new techniques used in animal and plant breeding as compared to current breeding
techniques. This should also provide an outlook on further technological developments in this area. As far as we
know, the discussions with EC services have not yet led to the production of a scoping paper which is expected to be
ready for the end of March 2017.
Meanwhile The Spanish Commission on Biosafety continues assessing each technique, or a specific application
using one of these techniques and its final product under a ‘case by case’ approach.
73
SWITZERLAND
1. Biotechnology activity in CH:
 Biotechnology activities in contained use: the level of biotechnology activities in contained use is high but
stable. To be noticed; there are above 3000 activities, some activities using new breeding technologies such as
Crispr-Cas.
 Approval or ongoing trials of Gene therapies: human melanoma (Herpes) and Human liver cancer treatment
 GMO cultivation: Since 2005 a moratorium excludes GMO cultivation for agricultural purposes. The parliament
recently refuses a coexistence regulation and accepted the prolongation of the moratorium until 2021.
 Food and Feed: no new authorization delivered since 2015. Currently there are 5 authorizations for food and feed
products (soya Mon 40-3-2 / Mays Bt 176 (SYN)/ Mas Bt11 (SYN)/ Mays Mon 810/ Mays DAS 1507 (pioneer).
But on the facts there is no import of these authorized goods.
 Field releases: The installation of a “protected site”, financed by public funding, permits the safe realization of
experimental releases.
Four field releases are ongoing:
 one with wheat with improved mildew resistance 1
 one with wheat with increased yield potential 2
 one with apple tree with improved fire blight resistance3
 one with cisgenic potatoes with improved resistance to late blight 4
At the time being, the trials did not raise much reaction within the public.
According to Swiss regulation given or ongoing risk assessment documents, field trials authorizations and reports
are
publicly
available;
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/infospecialists/experimental-releases/experimental-releases-of-genetically-modified-organisms--gmos-.html
 The federal office for the environment published a report on the state of biosafety in Switzerland, which concludes
that the level of biosafety is good in Switzerland, due to the enforcement by the government (federal and local)
and due to the awareness of the partners,
https://www.bafu.admin.ch/bafu/fr/home/themes/biotechnologie/publications-etudes/publications/biotechnologiesuisse-risques-innovation.html
2. Regulatory activities
 Coexistence regime: As required by the federal Council and Parliament, a draft of a Coexistence Regime had
been elaborated. On the beginning of March 2017, the Swiss Parliament refused the options for coexistence and
postponed the actual moratorium on the use GMO into the agriculture until 2021. As a consequence, the
coexistence legal frame for the post moratorium is suspended until further discussions 5.
1
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/experimental-releases/experimental-releases-of-geneticallymodified-organisms--gmos-/b-ch-13-01--b13001---application-to-release-genetically-modified0.html
2
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/experimental-releases/experimental-releases-of-geneticallymodified-organisms--gmos-/b-ch-16-01--b16001---application-to-release-genetically-modified.html
3
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/experimental-releases/experimental-releases-of-geneticallymodified-organisms--gmos-/b-ch-15-01--b15001---application-to-release-a-genetically-modifi.html
4
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/experimental-releases/experimental-releases-of-geneticallymodified-organisms--gmos-/b-ch-13-01--b13001---application-to-release-genetically-modified0.html
5
Swiss info : http://www.swissinfo.ch/fre/g%C3%A9nie-g%C3%A9n%C3%A9tique_zones-avec-ogm-%C3%A9cart%C3%A9es-et-moratoireprolong%C3%A9/42998842
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Proposals
for
a
Coexistence
Regime
(only
in
german
http://www.bafu.admin.ch/biotechnologie/04490/12683/index.html?lang=de&msg-id=60062
french
and
italian):
 Nagoya Protocol: Switzerland ratified the Nagoya Protocol regulating the access and benefit sharing, resulting
of the utilization of genetic resources and is implementing the national regulation since 2016.
Nagoya
Ordinance:
https://www.bafu.admin.ch/bafu/en/home/topics/biotechnology/info-specialists/nagoyaprotocol.html
3. GMO monitoring:
For the fifth year, the presence of unauthorized GMO plants in the environment was monitored. After two years
of presence of GMO rape populations along railways, number of locations first decreases and are stable yet.
Considering the fact that Oilseed Rape Monsanto GT73 had been identified in imported wheat from Canada, the
hypotheses that the GMO plants come from domestic transport of imported food and feed is confirmed (adventitious
presence threshold). As theses GMO plants are not authorized in the environment, the regional authorities are in
charge of the elimination.
https://www.bafu.admin.ch/bafu/de/home/themen/biotechnologie/fachinformationen/monitoringgentechnisch-veraenderter-organismen.html
Monitoring:
4. NPBT:
At the moment there is no demand for authorization of NPBT products. But there is an increase use of Crispr
Cas in contained use.
Nevertheless, Switzerland is debating the biosafety issues related to new plant breeding techniques in the
context of the relevance and applicability of the existing national GMO legal framework.
CH is looking into the possible need for adequate adjustment of the existing legal framework, with regard to
bio-safety, potential adverse effects on biological diversity, food security, human health and consumer choice. But
high relevance is given to the process used for a given product and the environmental risk analyze.
As Switzerland hasn’t got a definitive position on the status of every NPBT (GMO or non- GMO), the actual
practice of the competent authorities is to enforce the Gene Technology Act per default (federal Act on non-Human
gene technology or GTA). It is a process- and product-triggered regulation, based on a case by case approach. Other
than Environmental risk assessment obligation, the Gene Technology Act (GTA) gives provisions such as consumer’s
freedom of choice (Protection of GMO free production), product fraud, public information, taking due care and
liability guarantee. These issues are very relevant in the NPBT debate too.
(Currently, the competent authority gives case by case decision, and only on the basis of a formal request,
deposited by an applicant.)
CH published some interesting documents (the links will be available in our revised tour de table)
Technical report on NPBT:
https://www.bafu.admin.ch/dam/bafu/en/dokumente/biotechnologie/externe-studienberichte/grundlagen_der_rechtlichenregulierungneuerpflanzenzuchtverfahren.pdf.download.pdf/grundlagen_der_r
echtlichenregulierungneuerpflanzenzuchtverfahren.pdf
Report on intellectual property and NPBT:
http://www.ekah.admin.ch/fileadmin/ekahdateien/dokumentation/gutachten/Neue_Pflanzenzuchtverfahren_und_geistige_Eigentumsrechte_E.Gelinsky_aktu
alisiert_November_2013.pdf
Ethical considerations ECNH on NPBT:
https://www.news.admin.ch/message/index.html?lang=de&msg-id=60946
http://www.ekah.admin.ch/fileadmin/ekahdateien/dokumentation/publikationen/EKAH_New_Plant_Breeding_Techniques_2016.pdf
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Report on a public discussion organized by FOEN and FOAG and the Swiss Academy of Science:
http://www.naturwissenschaften.ch/uuid/db223854-0011-5649-aadc548db33ddff8?r=20161005181841_1475028790_6d7a963b-646a-5941-b2c3-0c0a0da45d24
5. Activity within European Protection Agencies EPA:
Switzerland is leading a technical working group dealing with environmental issues related to GMO within the
network of the directors of European Protection Agencies EPA and Conservation Agencies ENCA.
Members of the group recently published position paper on GMO monitoring and environmental effects of
genetically modified herbicide resistant plants (GMO HR plants).
Position paper on environmental effects of HR plants: http://www.bafu.admin.ch/biotechnologie/01786/13519/index.html?lang=en
6. International Activities under Convention on biological biodiversity CBD
Switzerland is a Partie of the CBD, the Cartagena Protocol and the Nagoya protocol. CH is actively enforcing
these instruments. Topics such as synthetic biology, gene drive processes and digital sequences are very relevant
issues for Switzerland.
7. Emerging Issues:


Synthetic Biology: The provisions of the national GMO legal framework cover the organisms and many
products resulting from synthetic biology techniques. Switzerland doesn’t see any urge to develop an
international regulatory framework, before good scientific knowledge regarding the techniques, the potential
adverse effects on biological diversity, food security and human health is available.
Ethical considerations on synthetic biology; http://www.ekah.admin.ch/en/topics/synthetic-biology/
Dual use: CH is examining the relevance of regulating gain of function research with regard to biosecurity
issues
Other references and links:
Protected site: http://www.agroscope.admin.ch/biosicherheit/06948/index.html?lang=en
THE UNITED STATES
Modernizing the Regulatory System for Biotechnology Products:
Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology
In 2015, the Administration initiated an effort to modernize the regulatory system for biotechnology products
by asking the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the United
States Department of Agriculture (USDA) to accomplish three tasks:



clarify the current roles and responsibilities of the EPA, FDA, and USDA in the regulatory process;
develop a long-term strategy to ensure that the Federal regulatory system is equipped to efficiently assess the
risks, if any, of the future products of biotechnology; and
commission an expert analysis of the future landscape of biotechnology products.
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Clarifying current roles and responsibilities
The January 4, 2017 release of the 2017 Update to the Coordinated Framework for the Regulation of
Biotechnology represents the first time in 30 years that the Federal government has produced a comprehensive
summary of the roles and responsibilities of the three principal regulatory agencies with respect to regulating
biotechnology products. This update and the accompanying National Strategy for Modernizing the Regulatory
System for Biotechnology Products (Strategy) offer the public a complete picture of a robust and flexible
regulatory structure that provides appropriate oversight for all products of modern biotechnology. Within that
regulatory structure the Federal agencies maintain high standards that, based on the best available science, protect
health and the environment, while also establishing transparent, coordinated, predictable and efficient regulatory
practices. This update was completed after reviewing the public comments submitted in response to the proposed
Update to the Coordinated Framework that was released on September 22, 2016. A brief summary of those
comments, along with additional information that addresses the comments that asked for clarification o n current
regulation of biotechnology products, is included in the final version. Information on this effort can be found at
the following website:
https://obamawhitehouse.archives.gov/blog/2017/01/04/increasing-transparency-coordination-and-predictabilitybiotechnology-regulatory
The long-term strategy
The Strategy, which was released in September 2016, sets forth a vision for ensuring that the Federal
regulatory system is equipped to assess efficiently the risks, if any, associated with future products of
biotechnology while supporting innovation, protecting health and the environment, maintaining public confidence
in the regulatory process, increasing transparency and predictability, and reducing unnecessary costs and burdens.
In the Strategy, the Federal agencies demonstrate their sustained commitment to ensure the safety of future
products of biotechnology, increase public confidence in the regulatory system, and prevent un necessary barriers
to future innovation and competitiveness.
The future landscape of biotechnology products
Early in 2016, EPA, FDA, and USDA commissioned an independent study by the National Academy of
Sciences, Engineering, and Medicine (NAS) on future biotechnology products. The study was to identify (1) major
advances and potential new types of biotechnology products over the next five to ten years, (2) potential future
products that might pose a different type of risk relative to existing products and organisms, (3) areas in which the
risks or lack of risk relating to biotechnology are well understood, and (4) the scientific capabilities, tools, and
expertise that may be useful to the regulatory agencies as they oversee potential future products of biotechnology.
The study Preparing for Future Products of Biotechnology was released on March 9, 2017 and can be accessed at
http://nas-sites.org/biotech/ The report describes the new types of biotechnology products likely to emerge over the
next 5-10 years and assesses whether future products could pose different types of risks relative to existing products.
It also identifies the scientific capabilities, tools, and expertise needed to support the oversight of these products by
the U.S. regulatory system.
National Academy of Science, Engineering, and Medicine
In May 2016, the National Academy of Science, Engineering, and Medicine (NASEM) NASEM released a
report entitled, “Genetically Engineered Crops: Experience and Prospects”. The report and additional information on
the NASEM study are available at https://nas-sites.org/ge-crops/.
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Regulatory Update for the United States Department of Agriculture
 Petitions for nonregulated status. Since April 15, 2016, USDA’s Animal and Plant Health Inspection Service
(APHIS) has granted three petitions for nonregulated status. These included one extension for browning resistant
apple, one for glyphosate resistant creeping bentgrass, and one extension for two potato varieties with late blight
resistance, low acrylamide potential, lowered reducing sugars, and reduced black spot.
Determination of Nonregulated status April 2016-March 2017
Date:
 Okanagan Specialty Fruits Enzymatic Browning Resistance/NF872 Apple
 J.R. Simplot Late Blight Resistance, Low Acrylamide Potential, Lowered
Reducing Sugars, and Reduced Black Spot/X17 and Y9 Potatoes
 Scotts/Monsanto Glyphosate-Resistant/ASR368 Creeping Bentgrass
09/23/16
10/28/16
01/17/17
Currently there are two pending petitions: 1) ArborGen freeze tolerant eucalyptus, and 2) Bayer CropScience
extension for male sterile and glufosinate-ammonium resistant canola. APHIS is currently developing an
Environmental Impact Statement (EIS) for the freeze-tolerant eucalyptus petition. APHIS is currently developing
a Plant Pest Risk Similarity Assessment (PPRSA) and a draft Environmental Assessment (EA) for the male
sterile and glufosinate-ammonium resistant canola petition.
 Applications for import, interstate movement, and environmental release. In Fiscal Year (FY) 2016, APHIS
received 1,290 applications for import, interstate movement, and environmental release. Of those, APHIS issued
338 permits and acknowledged 784 notifications. In addition, 17 applications are pending, 103 were withdrawn,
and 48 were denied for reasons unrelated to risk (e.g., applicant needed to apply for a permit instead of a
notification or the application was not deemed complete prior to the regulatory deadline). During FY 2017
(10/1/2016 through 03/05/2017), APHIS has received 487 applications. Of those, APHIS has issued 103 permits
and acknowledged 217 notifications. In addition, 116 are pending, 36 were withdrawn, and 15 were denied for
reasons unrelated to risk.
 Compliance and oversight. In FY 2016, the USDA-APHIS and its state partners conducted 797 inspections to
meet BRS compliance and oversight goals for the regulation of GE field trials. During FY 2017 (10/01/16
through 03/01/2017), APHIS and its state partners have completed ~150 inspections.
Proposed Revision of Regulation 7CFR part 340
The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is
proposing to revise our regulations at 7 CFR part 340 regarding the importation, interstate movement, and
environmental release of certain genetically engineered organisms in order to update the regulations in response to
advances in genetic engineering and our accumulated experience in implementing the current regulations, as well as
reduce the burden on regulated entities. This is the first comprehensive revision of the regulations since they were
established in 1987. The proposed rule is open for a 150-day comment period from January 19, 2017 until June 19,
2017 on Regulations.gov. The information available at Regulations.gov includes the primary document: Proposed
Rule (open for comment). It also includes supporting documents: 1) Draft Programmatic Environmental Impact
Statement; 2) Regulatory Impact Analysis & Initial Regulatory Flexibility Analysis; and 3) the Information Collection
Package.
The proposed rule and additional information accompanying the proposed rule may be found at
www.aphis.usda.gov/biotechnology/2016-340-proposed-rule
This site includes the following:



Overview of the proposed rule
Draft Weed Risk Assessment Work Instructions
Example Weed Risk Assessments
78




Data requirements for permit applications, regulatory status inquiries
List of evaluated GE organisms and their proposed regulatory status
Questions and Answers about the proposed rule
Stakeholder announcement
New Biotechnology Quality Management Support Program Program Available
On January 18, 2017, the USDA-APHIS Biotechnology Regulatory Services (BRS) announced the availability
of a new voluntary Biotechnology Quality Management Support Program (BQMS). This new program is more
flexible, more customizable, and less costly than the Biotechnology Quality Management System Program it replaces.
It is designed to help organizations of any size (universities, small businesses, and large companies) develop sound
quality management practices to enhance their ability to comply with regulations governing genetically engineered
organisms found at 7 CFR part 340.
Organizations participating in the new BQMS program now have access to web-based tools and resources. It is
a modular system where users can easily choose the modules they need to meet their own unique compliance
assistance needs. All of the tools are available online for easy access by all, no matter how big or small their
organization. BQMS users continue to have the option upon request to receive one-on-one tailored assistance from
BRS staff, as in the past.
More information can be found at the revised BQMS Webpage
(https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/bqms/bqms_new)
Detection of GE Wheat Volunteer Plants in Washington State
After a thorough examination regarding the genetically engineered (GE) wheat detection in Washington State,
USDA-APHIS announced December 1, 2016 that it had closed its fact finding. The Agency found no evidence of GE
wheat in commerce.
On July 29, 2016, USDA confirmed the discovery by a farmer of GE wheat plants growing in an unplanted
agricultural field in Washington State. After thoroughly examining the farmer’s property, APHIS detected a total of
22 wheat plants that were volunteering in an unplanted field. The GE wheat in question is resistant to the herbicide
glyphosate, commonly referred to as Roundup®.
Working with the farmer, APHIS took measures to ensure that no GE wheat moved into commerce. Although
the volunteers were not in a planted field, out of an abundance of caution, APHIS tested the farmer’s full wheat
harvest for the presence of any GE wheat material. All samples were found to be negative for any GE wheat material.
The GE wheat was developed by the Monsanto Company and is referred to as MON 71700, containing the CP4EPSPS protein. The U.S. Food and Drug Administration (FDA) previously evaluated crops containing the CP4EPSPS protein for safety through its voluntary biotechnology consultation process. Due to the small number of
affected plants, and based on the available information about MON 71700 and CP4-EPSPS, FDA concluded it is
unlikely that the wheat would present any safety concerns if present in the food supply as a result of this incident.
There are no GE wheat varieties for sale or in commercial production in the United States at this time, as APHIS
has not deregulated any GE wheat varieties.
Regulatory Update for the United States Environmental Protection Agency
Office of Pesticide Programs, Biopesticides and Pollution Prevention Division (OPP/BPPD)

Update of the Coordinated Framework for Regulation of Biotechnology (January 4, 2017)
o https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/modernizing-regulatorysystem-biotechnology-products
 Corn rootworm insect-resistance management (IRM) framework – finalized and implemented in 2016
o https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/framework-delay-cornrootworm-resistance
79
 BPPD held a public workshop presenting data to support the registration of plant-incorporated protectants
(PIPs) – materials are available on the web
o https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/plant-incorporated-protectantsdata-symposium
 Registrations and Experimental Use Permits for Plant Incorporated Protectants in 2016
 MON 87411 (DvSnf7) breeding registrations approved (March 2017)
o FIFRA Scientific Advisory Panel (SAP) held in September 2016, report issued December 2016
o https://www.epa.gov/sites/production/files/201612/documents/rnai_sap_sept_2016_final_minutes.pdf
o Commercial registrations pending
 VNT1 in potato (late blight) – commercial registrations approved (January 2017)
o https://www.regulations.gov/docket?D=EPA-HQ-OPP-2016-0036
 MON 88702 (mCry51Aa2) in cotton (lygus bug control) – EUP issued (January 2017)
 Spinach defensin (SoD2, SoD7, SoD8) in citrus – CTV viral vector (citrus greening disease) – EUP
issued (August 2016)
 X17-2 Papaya (papaya ringspot virus) – commercial registration approved (January 2016)
Regulatory Update for the United States Food and Drug Administration
In addition to participation in the effort to modernize the regulatory system for products of biotechnology, FDA
released specific documents for public comment, including:

On January 19, 2017, FDA released draft revised Guidance for Industry (GFI) #187, “Regulation of Intentionally
Altered Genomic DNA in Animals,” and requested public comment regarding the regulation of animals with
intentionally altered genomic DNA, including animals produced through the use of genome editing technologies
or genetic engineering. The draft guidance is available at
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UC
M113903.pdf. Electronic comments can be submitted through April 19, 2017 at http://www.regulations.gov,
Docket No. FDA-2008-D-0394.

On January 19, 2017, FDA issued draft Guidance for Industry #236, “Regulation of Mosquito-Related Products.”
The document, developed in coordination with EPA, describes FDA’s understanding that mosquito-related
products intended to function as pesticides by preventing, destroying, repelling, or mitigating mosquitoes for
population control purposes are not “drugs” under the FD&C Act, and, when the guidance is finalized, will be
regulated by EPA under FIFRA. Under the draft guidance, FDA would continue to have jurisdiction over
mosquito-related products that meet the FD&C Act drug definition, such as those intended to prevent, treat, or
cure a disease. The comment period ended on February 21, 2017. The document can be accessed at:
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UC
M533600.pdf.
New Plant Breeding Techniques
New Plant Breeding Techniques: USDA-APHIS
To date, the phrase “new plant breeding techniques” is not one employed by USDA-APHIS or within the
regulatory framework within the United States. In general, the current view of the US regulatory approach regarding
NPBT is as part of a continuum of tools available for use in plant breeding. Regardless of the techniques used, if the
modified plant meets USDA-APHIS’ definition of a regulated article, then it is regulated by USDA-APHIS. USDAAPHIS regulations under the Plant Protection Act (2001) apply “only (to) genetically engineered organisms or
products for which there is a reason to believe are plant pests, and not to…an organism or product merely because of
the process by which it was introduced (7 CFR part 340).” As a result, plants have been regulated with, for example,
insertions produced by site directed nucleases (e.g., zinc fingers) and plants that might be characterized as cisgenic
have been tested in regulated confined field trials of genetically engineered (GE) plants.
80
USDA-APHIS has had practical experience fielding questions from developers regarding the regulatory status
of new plants and plant products, including those developed with a variety of techniques. USDA-APHIS launched an
“Am I Regulated” (AIR) process in 2011. This can be accessed via a webpage that instructs developers how to
submit an AIR inquiry for confirmation as to whether (or not) a described product is a regulated article under its
regulations (7 CFR part 340). A total of 33 inquiry and response sets have been posted to the website
https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/am-i-regulated
The primary analysis conducted through the AIR process is to determine whether or not the organism described
in the AIR inquiry is a regulated article under 7 CFR part 340. The organisms in question range from clearly
regulated (e.g. GE plants with DNA inserted by the plant pest Agrobacterium tumefaciens) to clearly not regulated
(e.g. non‐modified progeny of GE plants, i.e. true null segregants). Inquiries about some products have presented
challenges. Specifically, one of the commonly used gene‐editing techniques, TALENs, is constructed with plant pest
DNA. USDA-APHIS has responded to four inquiries regarding organisms with gene knockouts induced by TALENs;
in each case, the final product in question was determined not to be a regulated article because it contained no
inserted DNA (i.e. any inserted DNA in parental lines had been segregated out during the breeding process).
USDA-APHIS has also regulated a number of plants in field trials that were developed using site directed
nucleases (i.e. TALENS, CRISPRs, and ZnFinger nucleases) that were inserted using Agrobacterium. In addition,
cisgenic potatoes were deregulated in 2014.
A formal environmental risk assessment is done only once the plant is determined to be regulated and was to be,
for example, field tested or is going through the process of “deregulation”. Therefore, while some modified plants
developed using NPBT may be determined to be regulated by USDA-APHIS based upon meeting the criteria for
regulatory jurisdiction, the specific technique that was used to develop the modified -plant is not considered an a
priori risk factor when performing the risk assessments.
USDA-APHIS response to request for additional information:
1.
What are the regulatory triggers (e.g. process and/or product) to initiate environmental risk/safety
assessment (ER/SA)?
The Plant Protection Act (PPA) authorizes the Animal and Plant Health Inspection Service (APHIS) to protect
plant health in the United States. Under that authority, APHIS currently regulates certain genetically engineered
organisms (GE) that may present a plant health risk. Biotechnology Regulatory Services provides the regulatory
oversight of certain GE organisms to protect plant health, by regulating the introduction—meaning the importation,
interstate movement, and environmental release—of those GE organisms that may pose a pest risk to plants under the
regulations at 7 CFR part 340. The definition of a regulated article is found at 7 CFR § 340.1:
Regulated article. Any organism which has been altered or produced through genetic engineering, if the donor
organism, recipient organism, or vector or vector agent belongs to any genera or taxa designated in §340.2 and
meets the definition of plant pest, or is an unclassified organism and/or an organism whose classification is
unknown, or any product which contains such an organism, or any other organism or product altered or
produced through genetic engineering which the Administrator, determines is a plant pest or has reason to
believe is a plant pest. Excluded are recipient microorganisms which are not plant pests and which have resulted
from the addition of genetic material from a donor organism where the material is well characterized and
contains only non-coding regulatory regions.
2.
What are the protection goals for environmental risk/safety assessment (ER/SA) in your country/region?
Table 1 of the 2017 Update to the Coordinated Framework indicates the following protection goal for the Plant
Protection Act: “Protect agricultural plants 6 and agriculturally important natural resources 7 from damage8 caused by
organisms that pose plant pest or noxious weed risks.”
6
“Agricultural plants” are plants that have a function in agriculture, including crops, trees, pasture, and others.
81
New Plant Breeding Techniques: EPA-Office of Pesticide Programs
 EPA is part of the US Coordinated Framework for Regulation of Biotechnology. If a biotechnology product,
such as a plant-incorporated protectant (PIP), produces a pesticidal trait, it is regulated by EPA. Unless
specifically exempt from the regulatory statutes, all PIPs that are sold or distributed are regulated by EPA and
must be registered, and if used for food or feed, a tolerance exemption for the pesticidal substance must be
obtained or a tolerance established. The regulatory trigger focuses on the pesticidal substance no matter how that
substance is made. Thus, whether a PIP has been developed using NPBTs or any other technique has no bearing
on its regulated status per se.
 In general, the current view of the US regulatory approach regarding NPBTs or other techniques is that these
techniques are part of a continuum of tools available for use in plant breeding. The continuum is dynamic and
rapidly expanding. This continuum includes not only existing techniques but will likely include other yet-to-be
developed techniques. And, it is expected that many of these individual techniques will be used in combination to
achieve a desired breeding outcome.
 EPA continually scans the product-development horizon to identify new types of products, including those
developed using newer techniques such as NPBTs, in order to ensure that its regulatory oversight continues to
appropriately address both current and newly-developed biotechnology products.
EPA response to request for additional information:
1.
What are the regulatory triggers (e.g. process and/or product) to initiate environmental risk/safety
assessment (ER/SA)?
With regard to the regulatory trigger, under EPA’s pesticide authorities, the focus is on the product and the
intention to use the product for a pesticidal purpose. For example, a plant-incorporated protectant or PIP is defined in
part as “a pesticidal substance that is intended to be produced and used in a living plant, or in the produce thereof, and
the genetic material necessary for the production of such a pesticidal substance.” In another example, the trigger is the
intention to use a microorganism for a pesticidal purpose. A microorganism can be naturally occurring or genetically
engineered but will still be subject to Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) if the intent is to
use it for a pesticidal purpose.
2. What are the protection goals for environmental risk/safety assessment (ER/SA) in your country/region
Table 1 of the 2017 Update to the Coordinated Framework indicates the following protection goal for Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA):
“Prevent and eliminate unreasonable adverse effects on the environment
·
For environmental and occupational risks, this involves comparing economic, social and environmental risks
to human health and the environment and benefits associated with the pesticide use
·
For dietary or residential human health effects, the sole standard is the safety of all the combined exposures
to the pesticide and related compounds.”
“Agriculturally important natural resources” are natural resources that have some function in or provide services to agriculture,
e.g., grazing land, flowing streams that provide water for agriculture, pollinators.
8 “Damage” is biological, chemical, or physical damage, not damage due to market impacts, including those due to the presence of
GE material (Damage is defined thus for the purposes of this document and the proposed revision of 7 C.F.R Part 340).
7
82
BIAC
Celebrating 20 Years of Plant Biotechnology
In 1996, farmers began growing the first commercially approved biotech crops. Since then, more than 18 million
farmers in 28 countries around the world have adopted the technology – faster than any other advance in the history
of agriculture. From increasing the productivity of their crops to enjoying improved livelihoods with their families to
preserving the earth’s finite natural resources, farmers have cited many reasons why they choose to plant biotech
seeds year after year. In 2016, CropLife International and the global biotech industry held more than 20 Table for
Twenty dinners in 16 countries, bringing together approximately 500 influential voices throughout agriculture,
government, academia, and industry to celebrate 20 years of biotechnology. At these dinner dialogues, attendees
heard from a number of stakeholders on the opportunities that may be in store for farmers and consumers with the
technology, as well as discussed the challenges and barriers to innovation. Videos and photos from CropLife
International and its global network’s Table for Twenty events are available at www.TableForTwenty.org.
Plant Science Industry Supports Outcome of Convention on Biological Diversity and Cartagena Biosafety
Protocol Discussions
Led by CropLife International, the Global Industry Coalition (GIC) joined the 170 countries that are Party to the
Cartagena Protocol on Biosafety (BSP) at the United Nations' Convention on Biological Diversity (UN CBD)
meetings held in Mexico last month, adding the plant science industry's voice to key discussions on regulations
addressing trade of living modified organisms (LMOs). With over 40 people representing 15 countries, the GIC
contributed to negotiations on a number of key Articles within the BSP, including those relating to environmental risk
assessment, unintentional transboundary movements of LMOs, and the role of socio-economic considerations in
decision-making. Progress made during those negotiations help ensure that the transboundary movement of LMOs
continues to protect biological diversity, while maintaining uninterrupted international trade and ensuring farmers
have access to sustainable agricultural innovations.
Apart from the negotiations, CropLife International hosted three side events, including one on synthetic biology
(read more below); one on the past 20 years of plant biotechnology; and one, co-organized by AgroBio Mexico, on
preserving centers of origin and centers of diversity while still ensuring food security in Mexico. CropLife
International and members of the GIC and plant biotech industry will continue to participate in the intersessional
meetings scheduled by the Parties prior to their ninth meeting in Egypt in 2018.
In addition, CropLife International members also attended a side event organized by the OECD on Thursday
Dec. 8th titled “OECD and Risk-Safety Assessment in Modern Biotechnology’ which highlighted the main
opportunities, challenges and lessons learned on mainstreaming biodiversity and development. The side event drew
on on preliminary messages from an on-going OECD project that examines mainstreaming efforts in a range of
countries, at national and sectoral levels (including agriculture, forestry and fisheries), insights from development cooperation, as well as possible approaches to monitor and evaluate mainstreaming. Speakers from national
governments will share experiences and insights on the key opportunities and challenges to mainstreaming
biodiversity (e.g. EU, Mexico, Viet Nam, Ethiopia and others)
New Resource Focuses on Criteria for Regulatory Systems to Evaluate Biotech Products
The CropLife International Plant Biotech Regulatory Committee recently finalized a document that defines the
performance criteria that can be applied to government regulatory systems overseeing the approval of biotech crops,
focusing on the regulation of food, animal feed and processing. In the spirit of dialogue with regulatory bodies and
seeking continuous improvements for the benefit of all stakeholders, CropLife International offers these criteria to
evaluate the performance of regulatory systems worldwide and highlight opportunities where regulatory bodies can
better meet the needs of agricultural stakeholders, while still ensuring that they are able to conduct comprehensive
safety assessments. The CropLife International global network will use this resource in their discussions with the
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governments and regulatory agencies in their various countries and regions to address specific issues, such as how to
leverage evaluations across countries with similar approaches to risk assessment and what to do when there are
asynchronous approvals as a result of the varying length of time for risk assessments in the regulatory systems. For
more information, see the link below for the full document: http://croplife.org/wp-content/uploads/2017/01/CLIPerformance-Criteria-for-GMO-Regulatory-Systems-FINAL.pdf
Plant Biotechnology Industry Engaging on New Technologies
The plant biotechnology industry is increasing its regulatory and educational outreach efforts on new
technologies, such as RNA-based products, precision breeding techniques (also known as New Plant Breeding
Techniques), and synthetic biology.
CropLife International and its global network is collaborating with the International Seed Federation and its
global network to address regulatory questions related to plant breeding innovations, including New Plant Breeding
Techniques. Continued innovation in plant breeding is necessary in order to provide farmers and consumers with
maintained and increased crop productivity, nutritious food choices, and sustainable agricultural practices. The joint
efforts will help address and answer technical questions that policymakers may have as products move towards
commercialization.
Although agricultural products developed with synthetic biology are still far from the marketplace, international
policymakers are beginning to discuss the potential role this technology can have on food security. Synthetic biology
was considered as part of the discussions at the 13 th Conference of the Parties (COP-13) to the Convention on
Biological Diversity this December in Cancun Mexico this last December, and CLI with its global partners
participated and successfully ran a side events that was well attended by parties and other participants. Prior to the
COP 13 meeting, the plant science industry provided background information, infographics, and positions on
Synthetic biology to the appropriate technical work groups.
New Materials
CropLife International published its annual product pipeline documents that lists member products in their
development phases. The product pipeline resources can be found online at http://croplife.org/wpcontent/uploads/2016/09/CropLifePlantBiotechPipeline2016_LoRes1.pdf.
NEPAD - ABNE
http://www.nepadbiosafety.net/
The African Biosafety Network of Expertise (ABNE) of the NEPAD Planning and Coordinating Agency
(NPCA) continues to assist African Union member states build their biosafety regulatory systems. Areas of
intervention include education and training on various aspects of biosafety, technical assistance and regulatory study
tours.
In 2016 NEPAD - ABNE reorganized its work plans to achieve the following three main objectives:
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Assist five countries - Ghana, Kenya, Uganda, Malawi, and Nigeria - to approve commercial release of GM
crops of their priority interest. Cameroon was recently added to the list.
Assist five countries - Mozambique, Swaziland, Ethiopia, Tanzania and Zambia - to approve and conduct
confined field trials (CFTs) or multi-locational trials (MLTs) of GM crops of their priority interest
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
Continue to support countries - Burkina Faso and Sudan- that have already commercialized GM crops in
order to avoid backtracking; and also provide a minimal support to a number of emerging countries including
Togo, Senegal, Namibia, Mali and Côte d’Ivoire.
In addition, ABNE has started joining the global community on initial consultations on emerging technologies
including gene drives applications and their regulatory requirements.
Updates of ABNE interventions have been compiled into a publication titled “ABNE in Africa: Towards
building functional biosafety systems in Africa” that is yearly reviewed. The report is available for free download
from the ABNE website www.nepad-abne.net.; the link for direct download is http://nepad-abne.net/wpcontent/uploads/2016/01/ABNE-in-Africa-2016.pdf
Country updates
Significant progresses achieved in 2016 include: (i) 3 countries, namely Nigeria, Kenya and Malawi approved
commercial release of GM cotton or maize, and (ii) 4 countries, namely Ethiopia, Swaziland, Mozambique and
Tanzania approved and planted their first CFTs or multi-location trials of GM crops
Kenya - Bt cotton and Bt maize applications from Monsanto and AATF were approved for environmental release.
The GM varieties will be subjected to national performance trials, as per the requirement for variety registration for
commercial cultivation in the country. The Kenya National Biosafety Authority (KNBA) and the National
Environmental Management Authority (NEMA) are both responsible for the regulatory functions covering
environmental release of GM crops.
Malawi - Bt cotton application from Monsanto was approved for environmental release. Large scale on-farm testing
for variety registration is envisaged with ultimate goal of commercialization. Malawi has also started confined field
trials of GM banana for bunchy top virus disease resistance.
Nigeria - Bt cotton application from Monsanto was approved for commercial release while Bt maize from the same
company was approved for confined field trials.
Cameroon - Currently conducting multi-locational trials of a staked herbicide and insect resistant cotton from
Bayer Crop Science, after completion of several years of confined field trials. Commercial release is expected
next year
Ethiopia - Bt cotton application was approved for multi-location trials in 2016. The trials were planted at seven
locations in the major cotton growing agro-ecologies of the country. First year data have been gathered and the
country is fast-tracking with commercial cultivation envisaged in 2018. A limited commercial release may even
happen in 2017.
Mozambique – Water Efficient Maize for Africa (WEMA) from AATF was approved for CFT and was planted.
Tanzania - WEMA Maize application approved for CFTs, after the Government amended the biosafety regulation in
2015 to remove the restrictive provisions, and after the National Biosafety Committee (NBC) was inaugurated in
2016. The CFT was planted.
Zambia - The National Biosafety Authority (NBA) continues the review of the Biosafety Act of 2007 to address
stakeholders’ demand for a more workable law. The NBA indicated needs for biosafety communication capacity
strengthening to enable the Authority effectively engage in public awareness creation, education and consultations
Burkina Faso – Has suspended in 2016 the cultivation of Bt cotton, but has approved in the same year the contained
use of GM mosquitoes. Disputes with Monsanto were recently settled. Negotiations could start between various
partners for a probable reintroduction of GM cotton in the near future. Field trials of Bt cowpea are going on.
Sudan - Approved commercial release of the first Bt cotton variety in 2012. This contributed to salvage the
collapsing cotton sector by easing pest challenges and increasing the competitiveness of the cotton crop. The country
has diversified its Bt cotton technology portfolio by approving commercial cultivation of hybrid Bt cotton from JK
Seeds of India in 2016. Despite this success, there is a growing challenge of misinformation of the public on the
technology. ABNE will focus its interventions on assisting the county on biosafety communication and awareness
creation.
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Togo - The revised biosafety bill is still pending for adoption by the National Assembly. The process has been
too slow for various reasons including a misinterpretation of the challenge facing the neighboring country
Burkina Faso with Bt cotton.
Côte d’Ivoire - The Government ratified the Cartagena Protocol on Biosafety in 2015 and immediately enacted
a biosafety law in 2016. ABNE will assist to develop implementing regulations
Mali – Is involved in the GM mosquito project together with Burkina Faso and Uganda. The National Biosafety
Committee has received an application for contained studies. A successful handling of such an application on
transgenic mosquitoes may also pave the way for agricultural biotechnology.
Regional Regulations Harmonization and Networking
The Economic Community of West African States (ECOWAS) harmonized biosafety framework - The
West Africa regional economic bodies namely the West Africa Economic and Monetary Union (WAEMU), the
Economic Community of West Africa States (ECOWAS) and the Permanent Interstates Committee for Drought
Control in the Sahel (Le Comité Permanent Inter-Etats de Lutte contre la Sécheresse dans le Sahel (CILSS) have
been working together since 2007 to develop a regional harmonized biosafety framework. The draft is now ready
and awaiting for adoption. Implementing regulations are currently being developed. ABNE will seek
collaboration and partnership to provide the necessary support to complete the process.
The Common Market for Eastern and Southern Africa (COMESA) Biotechnology and Biosafety Program
– Since the adoption of the COMESA biotechnology and biosafety program in 2014, NEPAD-ABNE has been
working closely with COMESA to enhance regulatory capacity in various countries in the region. In 2016 joint
and cost sharing regulatory trainings organized by ABNE and COMESA benefited Kenya, Swaziland, Ethiopia
and Sudan.
Association of National Biosafety Agencies in Africa (ANBAA) – Was established under NEPAD – ABNE as
a regional network of Government biosafety regulatory agencies whose aim is to collaborate, share and enhance
safe, and responsible work on biotechnology in Africa.
Technical and Legal Support Networks
African Biosafety Lawyers Network – Was established in 2013 to facilitate interaction and information sharing
amongst peers and facilitate easy access to legal counsel by African countries where necessary. Specialized
trainings have been conducted since 2013. In 2016, two trainings – one in Addis Ababa, Ethiopia and the other in
Ouagadougou, Burkina Faso were conducted.
Food safety resource network for Africa – Was launched in 2016 to serve as a resource pool for biosafety
competent authorities for building capacity for food safety assessment and for conducting joint review of food
safety dataset.
Environmental Biosafety Network for Africa (EBNA) – Was launched in 2016 as a specialized network to
harness and strengthen the capacity of African environmental biosafety experts; empower African National
Biosafety Agencies (NBAs) to make sound decisions on biosafety; and inform African environmental biosafety
policy formulation and implementation.
Three other networks including the Socio-Economic Resource Network, the Communication Resource
Network and the Network of GMO detection laboratories are expected to be launched in 2017.
Collaboration on global issues and challenges – Cartagena Protocol parties’ meetings
In 2016, in response to the African delegates’ request for a more coordinated and effective participation in the
meetings of Parties to the Cartagena Protocol on Biosafety, NEPAD-ABNE worked closely with the Human
Resources, Science and Technology Department (HRST) of the African Union Commission to provide the necessary
guidance and support for the MOP 8 held in Cancun. Preparatory meetings were organised in Accra and Addis-Abba.
ABNE also provided secretariat services to the delegates during the meeting.
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Emerging Technologies
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NEPAD-Agency strives to implement the January 2016 resolutions and decisions of the African Union (AU)
Heads of State and Government who agreed to developing and applying existing and emerging technologies
to realize the AU Agenda 2063.
A landmark decision was made in December 2016 to establish the High Level African Panel on Emerging
Technologies (APET) with which NEPAD-Agency and the African Union Commission will closely work
together to assist Member states and RECs assess the safety and regulatory requirements for harnessing
benefits of emerging technologies.
NEPAD-ABNE has been partnering with various institutions including the Regional Economic Communities
(RECs) in Africa, and the US based Danforth Plant Center and the Foundation of the National Institutes of Health to
develop regulatory capacity for novel vector control approaches including the use of gene drive mechanism on
populations of the Anopheles gambiae mosquito species. A first workshop on gene drive was organized in October
2016 in Accra, Ghana, for participants from the Economic Community of West Africa States. The second meeting of
the sort is scheduled in 2017 for the Eastern and Southern Africa region.
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