米国及び EU における動向について

米国
 NBT に関する USDA への相談一覧(平成 27 年 5 月 22 日現在)
 除草剤耐性セイヨウナタネの事例 バレイショのイントラジェネシスの事例

EU 欧州学術会議(EASAC)報告書要約
 欧州委員会(EC)に対する欧州植物学会(EPSO)の要望

 欧州委員会(EC)に対する環境保護NGO 団体の公開質問状

 Seeds of change (2015 Nature 520 131-132)

NBT に関する USDA への相談一覧(平成 27 年 5 月 22 日現在)
※赤字は前回の中間取りまとめ以降追記下内容を示す
１．ZFN によ

（１）質問者：ダウ・アグロサイエンス（2010 年 3 月）る変異導入技（２）内容：ZFN の DNA（宿主ゲノムには組み込まれない）を導入し部位特異的欠失を生じさせる術

場合、規制対象か否か。ただし、植物ペストに該当する配列は一切使われない。
（３）USDA の回答（2010 年 5 月 26 日）
植物ペストに該当しないので規制対象外 。
（４）USDA によるフォローアップ（2012 年 3 月 8 日）
ZFN により、宿主ゲノムに部位特異的塩基置換または遺伝子挿入を生じさせる場合は、ケー
スバイケースで検討。

２．メガヌク（１）質問者：セレクティス（の代理人）（2011 年 9 月 9 日）

レアーゼ（人（２）内容：メガヌクレアーゼそのもの、あるいはその mRNA、またはその DNA（宿主ゲノムには

工制限酵

素

の一種）による変異導入技術

組み込まれない）を導入し、①部位特異的欠失または②相同組換えにより部位特異的変異導入（鋳型 DNA を利用）を起こさせる場合、規制対象か否か。
（３）USDA の回答（2011 年 12 月 16 日）①

部位特異的欠失
材料が 植物ペスト由来でなければ、ほとんどの場合、規制対象外 。

②

相同組換えによる部位特異的変異導入（鋳型 DNA の活用）
植物ゲノムに多くの変化をもたらし得るのでケースバイケースで検討。

３．TALEN に（１）質問者：セレクティス（2013 年 7 月 29 日）

よる変異導入（２）内容：バレイショのプロトプラストに TALEN の DNA を含むプラスミドを導入し、部位特異技術

的欠失を生じさせた後、細胞分裂を経て得た植物体に対し、PCR により導入遺伝子が残存していないことを確認する場合、当該植物体は規制対象か否か。
（３）USDA の回答（2014 年 8 月 28 日）
導入遺伝子には、Xanthomonas 及びアグロバクテリウムなどの植物ペスト由来の配列が含まれているが、申請者は、適切な分子生物学的分析により、最終産物であるバレイショには導入遺伝子が含まれていないことを示しており、規制対象にはあたらない 。また、当該バレイショから
野生型バレイショへのジーンフローの可能性は極めて低いと考えられる。さらに、導入された変異が野生型のバレイショの適応度に影響を与えることはないだろう。
（１）質問者：セレクティス（2014 年 12 月 17 日）（２）内容：ダイズの子葉に TALEN をコードする遺伝子カセットを導入し、オレイン酸のリノール酸への生合成を触媒する FAD2-1A 及び FAD2-1B をコードする遺伝子に部位特異的欠失を生じさせた後、細胞分裂を経て得た植物体に対し、植物ペスト由来の導入遺伝子が残存していないことを確認する場合、当該植物体は規制対象か否か。
（３）USDA の回答（2015 年 5 月 5 日）
導入遺伝子には、Xanthomonas 及びアグロバクテリウムなどの植物ペスト由来の配列が含まれているが、最終産物であるダイズには導入した DNA が含まれておらず、植物ペストであるとは考えられない。そのため、本 FAD2KO ダイズは規制対象にはあたらない 。

４．シスジェ（１）質問者：ワーゲニンゲン大学（2012 年 2 月 23 日）

ネシス（２）内容：リンゴ由来の黒星病耐性遺伝子をアグロバクテリウム法によりリンゴに導入する場合、規制対象か否か。
（３）USDA の回答（2012 年 4 月 2 日）
当該手法により作出された黒星病耐性リンゴは、植物ペストであるアグロバクテリウムが使われているので、規制対象となるかもしれない。このような植物については、USDA はケースバイ
ケースで検討。

５．イントラ（１）質問者：フロリダ大学（2012 年 2 月 8 日）

ジェネシス（２）内容：ブドウ由来のアントシアニン制御遺伝子と 2s アルブミンプロモーター及びターミネー
ターとの融合遺伝子をブドウにプロトプラスト注入法またはパーティクルガン法により導入する場合、規制対象か否か。
（３）USDA の回答（2012 年 4 月 2 日）
ブドウは植物ペストではなく、植物ペスト由来の材料も使われてないので規制対象外 。

６．プラムの（１）質問者：USDA・ARS ｱﾊﾟﾗﾁｱﾝ果樹研究所（2011 年 1 月 18 日）

世代促進育種（２）内容：プラムの世代促進育種を行うため、ポプラ由来の早期開花遺伝子を導入するが、最終的には、分離により導入遺伝子を含まない個体を選抜、PCR 等により導入遺伝子が残存していないことを確認する場合、最終産物は規制対象か否か。
（３）USDA の回答（2011 年 10 月 27 日）
従来育種により作出されるものと区別がつかず、導入遺伝子及び植物ペスト由来配列を含まないので規制対象外 。

７．タバコの（１）質問者：ﾉｰｽｷｬﾛﾗｲﾅ州立大学（2011 年 1 月 22 日）

世代促進育種（２）内容：有害性を減らしたタバコを早期に開発するため、シロイヌナズナ由来の早期開花遺伝子を導入するが、最終的には、分離により導入遺伝子を含まない個体を選抜、PCR により導入遺伝子が残存していないことを確認する場合、最終産物は規制対象か否か。
（３）USDA の回答（2011 年 10 月 27 日）
従来育種により作出されるものと区別がつかず、導入遺伝子及び植物ペスト由来配列を含まないので規制対象外 。

８．ソルガム（１）質問者：ネブラスカ大学（2011 年 12 月 20 日）における変異（２）内容：ソルガム内在性遺伝子 MSH1 (MutS HOMOLOG1; 植物特異的な核内遺伝子であり、ミト体の獲得

コンドリア及び色素体のゲノムの安定性に寄与するタンパク質をコードする。) の発現を RNAi 干渉により抑制するため、アグロバクテリウム法により該当遺伝子を導入後、遺伝的分離により導入遺伝子が残存していない個体を選抜した場合、その個体は規制対象か否か（RNAi 干渉により、矮性、開花時期の遅れ及び生育の遅れなどの形質変化が現れ、導入遺伝子が残存していない個体も同様の形質を示す。
）。
（３）USDA の回答（2012 年 6 月 6 日）
導入遺伝子を含まない最終産物は規制対象外。最終産物に導入遺伝子が残存していないことを分子生物学的分析により確認することを奨励する。しかし、植物ペスト由来の配列を含むベクターが使用されているため、組換え親系統は規制対象。

除草剤耐性セイヨウナタネの事例
1. 概要
本セイヨウナタネは、イミダゾリノン耐性及びスルフォニル尿素耐性のナタネである。
Cibus 社（米国）は、ODM（Oligo-directed Mutagenesis）を用いてセイヨウナタネに内在するアセト乳酸合成酵素遺伝子（BnAHAS1C、BnAHAS3A）に変異を誘発することにより、イミダゾリノン耐性及びスルフォニル尿素耐性のセイヨウナタネ（Canola
Cibus Event 5715）を開発した。
具体的には、アセト乳酸合成酵素遺伝子のアミノ酸配列の 574 位のトリプトファンをロイシンに置換した変異型アセト乳酸合成酵素を発現させることによって除草剤イミ
ダゾリノン及び除草剤スルフォニル尿素による阻害を受けない作物を作出した。
本セイヨウナタネは、米国では 2014 年から栽培されており、カナダにおいても 2017
年から栽培する見込み 1。
2. 規制当局の対応
１）米国
USDA、EPA 及び FDA のウェブサイトにおいて認可品種を調べたが、該当するものは見当たらず。
２）カナダ
カナダ食品検査庁 (CFIA)においては、環境リスクや飼料としての安全性に関する懸念はないと判断し、本セイヨウナタネを非遺伝子組換え生物とみなす旨の判断（2013年 12 月）2。
カナダ保健省（HC）においては、食品の安全に関する懸念はないと判断（2013 年
11 月）3。

-------------------------------------------------------------------------------------------------------------------1

www.cibus.com

3

www.hc-sc.gc.ca

2 www.inspection.gc.ca

バレイショのイントラジェネシスの事例
1. 概要
本バレイショは、熱調理時のアクリルアミドの生成の抑制や打撲による黒班化を防止することを目的として、米国のSimplot 社が開発。
本バレイショは、それら特性に関係する４つの遺伝子（下表）が逆位反復配列の形で導入されたイントラジェネシス。
当該２本鎖 RNA（dsRNA）を発現させ、dsRNA の働きによってそれぞれの内在性遺伝子の発現を抑制させることに 図. 皮をむいて３０分後の写真より、アクリルアミドの生成に関わるアスパラギンや還元 1. InnateTM バ レ イ シ ョ ( 手前), 従来品種（奥）糖等の産生を抑制。
それら４つの遺伝子はアグロバクテリウム法により導入されているが、ベクターの T-DNA ボーダー配列をバレイショが有する相同的な DNA
配列に改変。
表. 二本鎖 RNA の標的遺伝子 2)
遺伝子名
機能等
Ppo5
ポリフェノール酸化酵素遺伝子、黒斑の生成に関与する
AsnI
アスパラギン合成酵素遺伝子、アスパラギンの生成に関与する
pR1
ジキナーゼ遺伝子プロモーター、デンプンのリン酸化に関与する
pPhL
ホスホリラーゼ遺伝子プロモーター、デンプン分解に関与する
2. 規制当局の対応
USDA においては、４つの遺伝子がアグロバクテリウム法によって導入されているが、挿入ベクターの T-DNA ボーダー配列がバレイショ由来の相同的な DNA 配列に改変されていることから、USDA では植物ペストによるリスクが生じる可能性は低く、規制の対象外と判断（2014 年 11 月）3。
FDA の任意コンサルテーションでは、同種のバレイショと構成成分及び安全性において差異はないと判断（2015 年 3 月）。
今後、米国において商業生産が開始される見込み 4。

-------------------------------------------------------------------------------------------------------------------1 www.simplot.com

2 Patent No. US8,889,964 B1

3 www.aphis.usda.gov

4 www.fda.gov

Submissions on Bioengineered New Plant Varieties ... http://www.fda.gov/food/foodscienceresearch/biotec...

U.S. Food and Drug Administration
Protecting and Promoting Your Health

Biotechnology Consultation Agency Response Letter BNF
000141Return to inventory: Completed Consultations on Foods from Genetically Engineered Plant Varieties (http://www.fda.gov/bioconinventory)
See also Biotechnology: Genetically Engineered Plants for Food and Feed (http://www.fda.gov/geplantfoods) and about Submissions on Bioengineered New
Plant Varieties (/Food/FoodScienceResearch/Biotechnology/Submissions/default.htm)

See FDA's memo on BNF No. 000141 (/Food/FoodScienceResearch/Biotechnology/Submissions/ucm436173.htm) for further details

March 20, 2015
Tracy Rood
Senior Regulatory Manager
J.R. Simplot Company
5369 West Irving Street
Boise, ID 83706
Dear Ms. Rood:
This letter addresses J.R. Simplot Company’s (Simplot) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN)
and Center for Veterinary Medicine) on genetically engineered potatoes, events F10, E12, J3, J55, G11, and H50. According to information Simplot has provided, F10,
E12, J3, J55, G11, and H50 potatoes are genetically engineered to lower the levels of asparagine and reducing-sugars, thus lowering the potential for acrylamide
formation upon heating, and to lower the potential for black spot bruising, by lowering the levels of endogenous enzymes in the potato. All materials relevant to thisconsultation have been placed in a file designated BNF 000141. This file will be maintained in the Office of Food Additive Safety in CFSAN.

Submissions on Bioengineered New Plant Varieties ... http://www.fda.gov/food/foodscienceresearch/biotec...

As part of bringing this consultation to closure, Simplot submitted a summary of its safety and nutritional assessment of the genetically engineered potatoes on February
12, 2013. Simplot submitted additional information on September 30, 2013, August 25, 2014, and October 30, 2014. These communications informed FDA of the steps
taken by Simplot to ensure that food and feed from F10, E12, J3, J55, G11, and H50 potatoes comply with the legal and regulatory requirements that fall within FDA’s
jurisdiction. Based on the safety and nutritional assessment Simplot has conducted, it is our understanding that Simplot has concluded that food and feed derived from
F10, E12, J3, J55, G11, and H50 potatoes are not materially different in composition, safety, and other relevant parameters from potato-derived food and feed currently on
the market, and that genetically engineered F10, E12, J3, J55, G11, and H50 potatoes do not raise issues that would require premarket review or approval by FDA.
It is Simplot’s responsibility to obtain all appropriate clearances, including those from the Environmental Protection Agency and the United States Department ofAgriculture, before marketing food or feed derived from F10, E12, J3, J55, G11, and H50 potatoes.
Finally, as always, it is a producer’s or distributor’s responsibility to ensure that labeling of the foods it markets meet applicable legal requirements, including disclosure ofany material differences in the food. It is our understanding that F10, E12, J3, J55, G11, and H50 potatoes may be used in various food applications. Depending on theparticular food application, differences between the F10, E12, J3, J55, G11, and H50 potatoes and conventional potatoes may be considered material information requiring
disclosure under Sections 201(n) and 403(a)(1) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 321(n) and 343(a)(1)]. Companies marketing F10, E12, J3, J55,
G11, and H50 potatoes or products containing F10, E12, J3, J55, G11, and H50 potatoes are advised to consult with CFSAN’s Office of Nutrition, Labeling, and Dietary
Supplements, Food Labeling and Standards Staff, to discuss any required or voluntary labeling including statements relating to attributes of these potatoes and theirpotential for reduced acrylamide levels or reduced black spots or any other type of claim.
Based on the information Simplot has presented to FDA, we have no further questions concerning food and feed derived from F10, E12, J3, J55, G11, and H50 potatoes
at this time. However, as you are aware, it is Simplot’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with allapplicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000141, as well as a copy of the text of FDA’s memorandum summarizing
the information in BNF 000141, is available for public review and copying at http://www.fda.gov/bioconinventory.
Sincerely yours,
Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

Statement
European Plant Science Organisationwww.epsoweb.org

Crop Genetic Improvement Technologies
Brussels, 26.2.2015

Crop genetic improvement technologies for a sustainable and productive agriculture
addressing food and nutritional security, climate change and human health
EPSOs request to the European Commission
The European Plant Science Organisation welcomes the outcome of the majority opinion of
the Member States expert working group (the “New Techniques Working Group”) report (1)and asks the European Commission as a matter of urgency to provide a guideline documentthat follows these recommendations to provide legal certainty for science and industry
concerning the application and exploration of New Plant Breeding Techniques (NPBTs).
Since an increasingly number of new breeding techniques will be developed, a more detailed
and comprehensive discussion on a new approach for the regulation of new plants isrequired. This new approach might be based on the new characteristics of a product/trait andshould take the following into account:a. A clear and reliable definition, based on scientific evidence, of what constitutes a novel
plant trait, and thus needs to be assessed by an appropriate body (legal certainty);
b. The need to avoid overregulation whereby an unwarranted number of processes andproducts will have to undergo expensive and lengthy authorization procedures (disadvantage
for SMEs and scientists);c. The need to uncouple the question of environmental risk and safety assessment from thequestion of labeling (consumer acceptance).
Contribution of the EU agriculture sector
The EU agriculture sector makes a vital contribution to building the Knowledge-Based BioEconomy, to meeting the challenges of food security and safety, to mitigating the effects ofclimate change, to ensuring sustainable agriculture and to maintaining employment inEurope. The EU plant breeding sector is a strategic sector which has responded to several
major global challenges over the past 100 years. It has contributed, and continues tocontribute, to the creation of benefits for the EU economy and society as a whole: these
positive effects can only be achieved if plant breeders can deploy all appropriate tools which
include conventional breeding, genetic engineering, the New Plant Breeding Techniques andother emerging technologies. Additionally, the plant breeding sector should be supported bycontinuous funding opportunities for fundamental research as well as a clear, workablelegislative framework.
Crop genetic improvement technologies are progressing rapidly
Crossing of superior plants followed by selection of improved progeny has, for a long time,
been the basis for crop improvement. Such traditional breeding techniques have been
complemented since the last century by chemical or radiation mutagenesis, translocation
breeding and intergeneric crosses leading to a more sophisticated exploitation of natural
genetic variation by plant breeders. The emergence of genetic engineering in the 1980s
allowed the development of transgenic plants as an additional approach to complement plantbreeding techniques. These breeding techniques are complementary, not mutually exclusive
and are essential tools to meet the challenges of agriculture. From the beginning, thepotential risks of transgenic techniques were analysed and a complex GMO regulatory
system was put in place. Since then, the development of breeding techniques has continued
to progress rapidly resulting in even more sophisticated methods to create plants with newtraits. Collectively, these techniques are summarized as New Plant Breeding Techniques(NPBTs). Among them, site directed nucleases (SDN) and other genome editing andmodification techniques such as oligo-directed mutagenesis (ODM), allow the introduction ofsequence-specific changes in the plant genome. Thus precision-based mutation approaches
can now be used which, unlike chemical or radiation mutagenesis, do not create hundreds ofadditional mutations throughout a genome.
Current European legislation neither reflects the progress made in new crop genetic
improvement approaches nor the positive economic, social or environmental impactof the resulting biological outcomes
The current EU GMO-legislative framework is focused on the technique used to produce a
new plant, and not on the final trait/product. As some of the NPBTs require an intermediatetransgenesis step, the plants obtained by these techniques may be considered as GMOs.
This legislation is not reflecting the progress made in the development of new techniques. It
also does not reflect the evidence accumulated by thousands of GMO biosafety studies
clearly demonstrating that GM technology per se does not carry any greater risk of anegative impact on health and the environment than any other technology used in plant
breeding**. Therefore, it would be more evidence- and science-based to evaluate the crop
genetic improvement technologies including genetic engineering and the NPBTs and otherfuture ones according to the potential impact of the resulting end product/trait rather than thetechnique used. (2)The European Commission should create favourable regulatory conditions for theEuropean plant breeding sector
The European Commission’s delays in clarifying the legal status of the NPBTs weaken thecompetitiveness of the EU plant breeding sector. It is clear that for the plant breeding sector
and the farming community at large, the status quo on this dossier is not an option and would
have a significant negative impact on the current situation for EU farmers. EU farmers
already suffer unfair competition from primary producers in other regions of the world
regarding access to all appropriate tools including genetic engineering and NPBTs. It is
important that the European Commission creates favourable regulatory conditions for theEuropean plant breeding sector to maintain its position of worldwide leadership in the area of
research and innovation.
The European plant science community calls upon policy makers to implement ascience-based policy as a priority
The European plant science community is following the current debate on the legislativeclassification of NPBTs along the lines of European GMO legislation with great interest andconcern. We are concerned that more and more processes and products will have toundergo expensive and lengthy authorization procedures, even in cases where no foreign
DNA is contained in the resulting end product or where these products are completely
indistinguishable from traditionally bred crops. We support the conclusions of the New
Techniques Working Group (1) that the legal definition of a GMO does not apply to most of
the NPBTs and that these techniques either fall under the exemptions already established by
the legislation*** or should be exempted as they do not differ from plants obtained bytraditional breeding. We support the requests of the Plant ETP (3) based on the reports ofseveral scientific bodies that have assessed and evaluated NPBTs. The European plantscience community calls upon policy makers to implement a science-based policy as apriority. For a new start in Europe, the plant science community encourages the new
Commission President and his team of Commissioners and policy makers in the Member

States to work towards balanced support for all crop genetic improvement technologies thatallow the plant science sector to address the Grand Challenges facing our planet.
** to avoid misinterpretation: this does not imply that conventional breeding should be restricted bysimilar regulations*** techniques that are not considered to result in genetic modification (Annex I, Part B of Directive
2009/41/EC and Annex IA Part 2 of Directive 2001/18/EC) or yield organisms that are excluded fromthe Directive (Annex II Part A of Directive 2009/41/EC and Annex IB of Directive 2001/18/EC)
Contacts
Joachim Schiemann
Julius Kühn-Institut, DE
T: +49-3946 47503
joachim.schiemann@jki.bund.deJonathan JonesThe Sainsbury Laboratory, UK
T: +44-1603450420
jonathan.jones@tsl.ac.uk

Karin Metzlaff
EPSO, BET +32-2213-6260
epso@epsomail.org

Useful links(1) New Techniques Working Group (2012) Final Report of the European Commission(2) EASAC Report “Planting the Future”(3) Plants for the Future ETP: Statement on New Breeding Technologies, September 2012
EPSO Working Group on Agricultural Technologies: www.epsoweb.org/agricultural-technologies-wogr
Statements drafted by this group and approved by the EPSO representatives are for instance:
 EPSO statement on Crop Genetic Improvement Technologies, 26.2.2015
 EPSO statement on Plant Breeders’ rights and patent rights, 26.2.2015
 EPSO statement on GMO cultivation – national opt-out, 26.2.2015
EPSO Science Based Policy, 1.9.2013
EPSO member institutes and universities: www.epsoweb.org/membership/members
EPSO representatives: www.epsoweb.org/membership/representatives
About EPSO
EPSO, the European Plant Science Organisation, is an independent academic organisation that
represents more than 220 leading research institutes and universities from 28 European countries,
Australia, Japan and New Zealand. EPSO’s mission is to improve the impact and visibility of plantscience in Europe.
www.epsoweb.org

27 January 2015
Mr Vytenis Andriukaitis
Commissioner for Health & Food Safety
European Commission
Rue de la Loi / Wetstraat 200
1049 Brussels

Open letter to the Commission on new genetic engineering methods
Dear Commissioner Andriukaitis,
In the interest of protecting the environment and public health, genetically modified crops are
subject to risk assessment, an authorisation process and labelling rules under EU law. All nontraditional breeding processes that change the structure of DNA using genetic engineering
technologies or interfere with gene regulation fall within the scope of these GM regulations. Someare now calling on the European Commission to exempt new genetic engineering techniques fromGM rules. The undersigned groups argue that such an exception could threaten the environment andour health, and would violate EU law.
Any attempt to engineer genomes by invasive methods can cause unexpected and unpredictableeffects. For example, “cisgenesis” - a genetic engineering technique that uses genes from the same
species - is still genetic engineering and is therefore subject to unexpected and unpredictable effects
caused by the genetic engineering process itself, and not by the trait or sequence inserted. New
techniques to genetically engineer plants and animals, such as so-called DNA scissors (nucleases)
and interventions in gene regulation, raise additional concerns.
Most of these techniques are so new that there is not sufficient information to properly assess therisks. Some also allow more radical changes to plant genomes than genetic engineering methods
currently used in commercialised products.
We call on the Commission to reject any attempt to exclude these new techniques from EU
regulation.
EU laws on genetic engineering should continue to be based on the precautionary principle,
transparency and traceability. These same principles must apply to all new genetic engineering
techniques and applications.

In particular, we urge the Commission to ensure that:o Organisms produced by these new techniques will be regulated as genetically modified
organisms under existing EU regulations (Directive 2001/18). This means that they will require afull risk assessment before any approval or authorisation is given.
o Any food, feed and seeds as well as other breeding material produced using such new techniques
will be labelled and fully traceable throughout the food and feed supply chain.
o Nothing in the TTIP and CETA negotiations will limit Europe’s sovereignty and ability toregulate new genetic engineering methods and products as GMOs.
o Current GM health and environmental safety testing requirements are strengthened in light of theenhanced ability of these new techniques - individually or in combination - to alter the genetic
code of plants, animals and other organisms.
We would be very happy to elaborate on our concerns in a face-to face meeting and await yourresponse.
Yours sincerely,
Francesco Panella, President, Bee-life European Beekeeping Coordination
Nina Holland, Researcher, Corporate Europe Observatory
Dr. Ricarda Steinbrecher, Co-Director, Econexus, UK
Andrea Ferrante, Coordinating Committee, European Coordination Via Campesina
Mute Schimpf, Food Campaigner, Friends of the Earth Europe
Dr Helen Wallace, Director, GeneWatch, UK,
Saskia Richartz, Acting Director, Greenpeace European Unit
Christoph Then, Executive Director, Testbiotech, Germany

THIS WEEKEDITORIALS

MOON SHOT Fresh estimates
support cosmic-collision
origin p.132

WORLD VIEW Test aircraft
engines to benefit fromvolcano science p.133

APRON STRINGS Hundredmillion-year-old insect
mothered young p.134

All that glitters

A review of the United Kingdom’s progress towards ‘gold’ open-access research is
instructive — for funders, publishers and scientists both at home and abroad.

In 2012, the United Kingdom took a bold leap on open-accesspublishing, announcing that all research articles produced by its
publicly funded scientists should be made free to read. A finepledge, but three years on, it has experienced some practical difficulties. It is instructive to examine them.
To quote the mantra of Research Councils UK (RCUK), the umbrella
body for the seven national funding agencies that is overseeing the
publishing conversion: “open access is a journey, not an event.” Continuing that metaphor, it seems that the United Kingdom has been sentout as an advance party on this journey. Its scientists and publishers
are scouting through thickets of confusion on their way to bringing
about ‘gold’ open access. This is the system in which a published article
is immediately made freely available, with maximum opportunity toreuse it for applications such as text-mining and translation.
Many nations have not set open-access policies. Others, including
the United States, are loitering with little intent, and mandating only
delayed access to an author’s version of a peer-reviewed manuscript —a ‘green’ form of open access that ultimately benefits science less (seeNature 494, 401; 2013). RCUK favours a mixed model, but one that
gradually migrates towards gold. A review of its progress, publishedin March, serves as a useful guide and should be examined by funders,publishers and institutions (see go.nature.com/tz2orl).
One problem is that it is hard to track progress, good or bad. RCUKand many British institutions cannot systematically count RCUKfunded papers, let alone those published as open access. As a result,
RCUK, although strongly confident, cannot be entirely sure whetherthe £17-million (US$25-million) open-access fund it gave to universities in 2013–14 has produced the desired result of at least 45% of its
funded papers being either green or gold open access.
This underlines the need for researchers to use the ORCID system, asingle digital identifier for individuals that links their published papers
and grant applications. Use of FundRef, a service from non-profit publisher alliance CrossRef for reporting funding sources, is also essential.
Open-access licences are another major source of confusion. The
London-based biomedical charity the Wellcome Trust, which has long
mandated gold open access and provides the funds to cover it, reported
last month that it now sees 87% compliance with its policy — but that
only 66% of papers are accompanied by a liberal publishing licencethat allows extensive reuse of text. Licence information, it says, is often
ambiguous or contradictory, and records for open-access payments
can be lost between authors and publishers.
RCUK says that the licence problem is compounded by researchers not understanding which licence they need to use to comply withthe open-access policy, and by publishers offering a range of ‘open’
licences. (Since January, all 18 open-access journals owned by Nature
Publishing Group have switched to using the fully liberal CC-BY 4.0
licence as a default, and to charging a flat fee.)
And then there are costs. All experiments should be encouraged in

the evolving gold open-access market, but academics should knowthat fees for papers published in fully open-access journals are lower
than those of ‘hybrid’ subscription journals that allow an open-access
option. The Wellcome Trust says that the average fee levied by hybrid
journals is 64% higher than that charged by fully open-access titles.
British funders are now pondering steering the market by dissuading researchers from publishing in hybrid journals, as other countries
have done.
“Britain looks
The RCUK review did not have the remit
to question whether RCUK should continue
increasingly
to hand out money for gold open-access pubisolated in its
lishing. But with a new UK government in the
gold-leaning
offing and the country looking increasingly
stance.”isolated in its gold-leaning stance, there must
be a concern that the agency might end up scrapping its gold preference.
Last year, four influential UK university-funding bodies announced
a green open-access policy that will further steer academics towards
delayed public archiving of manuscripts.
In conclusion: the road to gold open access will be bumpy and hardto navigate. But what is encouraging is that these issues are being aired,with publishers, funders and researchers talking to each other about
the costs and challenges. The take-home message from the RCUK
review is the need to keep discussing difficulties publicly — for only
then can other nations learn from the United Kingdom’s experience. ■Seeds of change

The European Union faces a fresh battle overnext-generation plant-breeding techniques.

T

he US plant-breeding company Cibus is proudly rolling out
its first crop created with an innovative precision gene-editing
technology: herbicide-tolerant oilseed rape.
The crop will be planted in the United States this spring and thefirm already has authorization to cultivate it in Canada. The technology switches just a few nucleotides in a plant’s DNA; the company’s
webpage points out that because it works without integrating foreign
genetic material, the resulting plants cannot be stigmatized as transgenic. They will, it optimistically declares, “be globally acceptable”.
Cibus, based in San Diego, California, hopes that plants imbued inthis way with traits that improve their robustness or nutritional value
will also find favour in the European Union (EU), where many countries vehemently oppose genetically modified (GM) crops created bytransfer of specific foreign genes.
9 A P R I L 2 0 1 5 | VO L 5 2 0 | NAT U R E | 1 3 1© 2015 Macmillan Publishers Limited. All rights reserved

THIS WEEK EDITORIALS
That hope has logic on its side, and it is not misplaced. In February, authorities in GM-hostile Germany told Cibus that they would notconsider products created by gene editing as GM, but as products of conventional plant breeding. However, with new battle lines already being
drawn, broader approval and acceptance are unlikely to be so simple.
The first battle for GM crops in Europe is currently drawing to an
unsatisfactory close. EU legislation from 2001 dictates that the European Food Safety Authority (EFSA) must carry out a scientific risk
assessment of any GM strain submitted for authorization. Member
states must then vote on whether to pass it, obliging all of them topermit the crop’s cultivation if it is approved.
But these votes have almost never yielded the required majority foror against any strain given the EFSA green light. And the European
Commission has never dared to exercise its right to enforce a positive
decision in cases of impasse. Instead, it has proposed new rules, whichcame into force last week, allowing EU member states to opt out of arequirement to allow cultivation on non-scientific grounds.
Although it is smart politics, the rule will not be enough to breakthrough the authorization impasse, because all nations must still vote,and a qualified majority must be reached. So, in the next few weeks,
the commission will propose further legislation that is likely to allow
member states to opt out of the authorization process too. This could
finally get the system going again, and give GM-friendly countries
such as Spain a wider range of GM crops to choose from.
Meanwhile, science has moved on. Plants without foreign genes
can now be created with a variety of methods and technologies thatprecisely tweak or change the regulation of a native gene. Such plants
should reassure anti-GM lobbies that criticize the moral right ofscientists to ‘play God’, and the alleged instability of foreign genes. But
environmental groups such as Greenpeace seem far from convinced.
In January, several groups wrote an open letter to the commission
insisting that new methods that change DNA structure or interferewith gene regulation in any way should also be subject to the EU’s tight

GM regulations. They argue that the precautionary principle should
continue to apply — and that because of the enhanced abilities of thetechnologies, the safety bar should in fact be raised.
The commission is again playing for time. In 2007, it appointed anexpert panel to advise it on the ever-expanding plant-breeding toolbox.
The panel’s report was submitted in 2012 but never published. The commission now says that it has set in motion a “thorough legal analysis”
of the definition of ‘GM organisms’ in its own“The European
legislation, and of the criteria for excluding
certain technologies. The conclusions of theCommission isagain playing for analysis, it warns, “cannot be anticipated”.
Most plant scientists consider the new tools
time.”
to be helpful extensions to normal plantbreeding practice. In many cases, they say, the plant products are indistinguishable from the original plants and are intrinsically even safer thanGM plants. Two years ago, the European Academies Science Advisory
Council, an umbrella group for national academies in Europe, argued
that the time had come for regulators to abandon their fixation on planttechnologies and instead carry out risk assessments on the individual
plant products. In February, the European Plant Science Organisation,
an independent body representing more than 220 research institutes anduniversities from 28 European countries, as well as Australia, Japan and
New Zealand, reiterated the message.
Late last month, the Leopoldina, Germany’s national academy ofsciences, published a similar position paper in the hope of influencing
its government, as the country deliberates anew the legal environmentof its GM regulations. Both Germany and the commission are watching and waiting. In their letter to Cibus, the German authorities notedthat their statement of readiness to consider products of gene editing
as non-GM would be invalidated if the European Commission were
finally to decide otherwise.
As Europe’s first battle on GM staggers to an uneasy truce, a second— and perhaps more important one — is approaching. ■Lunar affairs

raised in a similar neighbourhood. A chance meeting set the two on
a collision course. The meeting is violent, and — here it helps if you
imagine the most gravelly cinematic voice-over you can manage — life
for both will never be the same again.
Theia becomes a giant cloud of dust infused with bits spewed fromthe injured proto-Earth, which quickly comes together to form theMoon. Earth gains a dependant.
The script might sound familiar; the plot more of a remake than of
anything original. But here is the difference. Previously, many planetary scientists considered that it was too much of a stretch to saythat young Theia and Earth were so closely related. It is much moreplausible, given the chaos of the time, to present Theia as a random
stranger. But that creates a continuity error: the mineral compositionof rocks retrieved from the Moon is eerily similar to those of Earth.
Either Theia and Earth are related, or our best models of how theMoon formed are wrong. But if they are related, then why is it that theother bodies in the Solar System that we have studied seem to be sodifferent from each other? What are the chances, given the numberof objects out there at the time, that proto-Earth would be hit by anear clone?
The latest study runs computer simulations of those early days, toinvestigate the possible backstories of the major characters, including
how and where they formed and their probable orbits. (A note to film
directors: this bit is probably best presented as a montage.) The number crunching offers a realistic script: there is a one-in-five chance that
proto-Earth and Theia could have formed at about the same distancefrom the Sun, so from the same stuff, and then
NATURE.COM
run into each other to make the Moon. True, it
To comment online,
is not a cut-and-dried ending that ties up all the
click on Editorials at: loose ends before the credits roll. But all the best
go.nature.com/xhunqv stories leave room for a sequel. ■A study in Nature adds a dramatic twist to thebackstory of a neighbour we thought we knew.

In the stories of many human cultures, the Solar System issomething of a family affair. The Norse people and the Incas ofSouth America believed that the Sun and the Moon were brotherand sister. A Native American myth has them as husband and wife
(although the husband wants to eat his children, the stars). The Moon
as a mother is a common theme.
Now scientists have suggested a rival celestial tale with a twist that ismore common to terrestrial television dramas: the sudden appearanceof a long-lost sibling. The early Earth had a near-identical geologicaltwin, they say. The two young planets, of course, had a falling out
and the twin vanished. But before it did so, it saddled Earth with anorbiting Moon-child.
The the origin of the Moon is a classic story that has been told manytimes. The latest version — written in a research paper on page 212 —still has some plot holes. But it is a cracking tale.
The time: some 4.5 billion years ago, in the earliest days of the Solar
System. The place: hostile. A long time ago, if you like, in a galaxy notvery far away. Thousands of adolescent protoplanets whizz aroundthe Sun, bashing into each other, some breaking into smaller pieces
and forming others as they soak up the freed materials. One of these
protoplanets, lying not too far from the Sun and not too close, is what
we now call Earth.
Enter, stage left, protoplanet Theia. Smaller than proto-Earth, it was
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