Responsible Use Biotech Tree Principles v.P.1.0.B

8/6/2019 Responsible Use Biotech Tree Principles v.P.1.0.B

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Responsible Use:Biotech Tree Principles

A publication by the Institute o Forest Biotechnology

140 Preston Executive Drive, Suite 100G | Cary, NC 27513 | USA

2011. The Institute of Forest Biotechnology. All Rights Reserved.


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People have always had, and will continue to have, an interdependence with orests. Given the reality o a growingworld population, more productive, healthy, and sustainably managed orests are needed. We rely on the servicesorests provide, like cleaning water and slowing climate change by absorbing atmospheric carbon. We need sustainably

managed trees to produce paper, packaging, homes, ood, and renewable energy. We need to keep our orests healthyand productive to ulll all these needs and to protect orested areas rom decline.

Tese Principles are crucial because biotechnology is increasingly being used on trees and in orests. Tese Principleswere developed in recognition that responsibly used orest biotechnology has the potential to benet society,economies, and the environment.

oday there are invasive threats damaging our orests. We ace a changing climate, deorestation, and illegal logging.Forest biotechnology can be a powerul tool against many o these threats. Scientists have already designed biotechtrees that are resistant to disease and changing climates, growth rates that produce more wood ber with ewerinputs on less land than conventional trees, and biometric tools to police illegally traded timber. oday there are overone million biotech poplar trees with the Bt gene that were established on commercial plantations in China in 2003.Genetic work on cacao trees is being explored to help the species that is susceptible to viruses in much o the world.Similarly, biotech papaya trees saved that industry in Hawaii rom being destroyed by the Ring Spot virus.

Hundreds o researchers and organizations around the world have helped to pioneer these technologies in a responsiblemanner. Forest biotechnology is also being practiced in new ways, in new places, and by new researchers. But not everynation has a robust regulatory system or opportunities or interested public stakeholders to engage in issues importantto them. We need the Responsible Use: Biotech ree Principles to help guide long-term stewardship o biotech treesregardless o where they are developed or used. We need these Principles to oster a higher standard in biotech treemanagement, biotech orest stewardship, and ethical behavior.

Trough an open dialogue that continues today, a broad spectrum o stakeholders, including university researchers,conservation and environmental groups, and industry leaders, created the Responsible Use: Biotech ree Principles thatare guided by these core belies:

Biotech trees should benet people, the environment, or both Risks and benets o biotech trees must be assessed ransparency is vital and stakeholders must be engaged Social equity and indigenous rights are important and must be respected Biotech tree use must ollow regulations in the country o their application

Tese Principles are unique because they are the rst, and only, guidelines that include the entire biotech tree liecyclerom conception to nal product. Te Institute o Forest Biotechnology will continue to manage this initiative in atransparent way. Please visit the website dedicated to strengthening these principles at www.responsibleuse.orgorcontact us directly with your ideas.

Tank you,

Adam Costanza - President Susan McCord - Executive Director

Thank you for your interest in the Responsible Use:

Biotech Tree Principles.
http://www.responsibleuse.org/http://www.responsibleuse.org/


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Our Purpose .............................................................................................................................................................................................. 1

Process ........................................................................................................................................................................................................ 1

Core Belies ................................................................................................................................................................................................ 1

5 ruths ....................................................................................................................................................................................................... 2

Use and Limitations o the Responsible Use: Biotech ree Principles ........................................................................................ 2

Components of the Responsible Use: Biotech Tree Principles ................................................................................................ 3

Value Chain, Sections, and Steps .......................................................................................................................................................... 3

Practices High Level ............................................................................................................................................................................. 3

Actions Low Level ................................................................................................................................................................................ 3

Recommendations and Discussion ...................................................................................................................................................... 3

ools ............................................................................................................................................................................................................ 3

In Accordance with Responsible Use: Biotech ree Principles ..................................................................................................... 4

User Reerence Sheet ............................................................................................................................................................................... 5

Responsible Use Practices, Actions, Recommendations, and Discussion .......................................................................... 6

Laws and Requirements Section ........................................................................................................................................................... 6

Laws and Requirements categorically include all Responsible Use: Biotech ree Principles ........................................... 6

Product Development Section .............................................................................................................................................................. 7

1. Product Conception ....................................................................................................................................................................... 7

2. Lab Research .................................................................................................................................................................................... 8

3. Field esting ...................................................................................................................................................................................... 8

4. Approval to Use ............................................................................................................................................................................... 9ree Growth Section .............................................................................................................................................................................10

5. Obtain ree .....................................................................................................................................................................................10

6. Growth and Stewardship ............................................................................................................................................................. 11

ree Products Section ........................................................................................................................................................................... 12

7. Product ranser ............................................................................................................................................................................12

Appendix .........................................................................................................................................................13

Biosaety Databases ................................................................................................................................................................................13

Industrial Biotech ree Products ........................................................................................................................................................ 13

Revisions ................................................................................................................................................................................................... 13

Risks and Benets ...................................................................................................................................................................................13

Sustainable Forestry ...............................................................................................................................................................................13

ools ..........................................................................................................................................................................................................14

General Documentation emplate ................................................................................................................................................15

In Accordance Declaration ...................................................................................................................................................................16

Denitions ................................................................................................................................................................................................ 16

Committees and Contributors ............................................................................................................................................................18

Contents


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RESPONSIBLE USE: BIOTECH TREE PRINCIPLES

Our PurposeTe Responsible Use: Biotech ree Principles (reerred to hereater as Principles) were developed to help protectorests wherever biotech trees1 are used. Tese Principles are the rst o their kind and were developed through atransparent, multi-stakeholder mechanism, to achieve the ollowing objectives:

Establish a high level o perormance or managing biotech trees that is recognized around the world. Create a simple and eective set o practices so users along the biotech tree value chain2 know how to use the

trees responsibly. Increase societal benets when biotech trees are used by promoting interaction and education between

oresters, biotechnologists, and other stakeholders.

Embodied throughout is an understanding that biotech trees and their products should create sustainable benets.Benets may be derived rom the biotech tree, its products, or scientic insight gained through orest biotechnologyresearch. Te Practices give users tools to help them enhance the benets o orest biotechnology, mitigate risks andmaintain the integrity o a biotech trees history as it moves along the value chain.

ProcessTe Institute o Forest Biotechnology (IFB) developed these Principles rom a wide range o input rom internationalexperts in academia, environmental organizations, the orest products industry, and government agencies. Aglobal team o experts ormed the Implementation Committee that guided the development o the Principles whilenumerous stakeholders provided critical input throughout the process. In total there were ve large stakeholderorums, and dozens o discussions with Forest Biotechnology Partners and individualized meetings with environmentalorganizations to crat these Principles. Te goal to launch a set o stewardship Principles beore biotech trees werewidely available or use was a time-limiting actor. o best balance the immediate need or these Principles with theprocess o engaging a broad set o stakeholders, these Principles will be revised to ensure there is additional stakeholderinput and that the Principles keep pace with the science, dialogue, and stewardship o orest biotechnology. TesePrinciples will be reviewed every three years ater an initial review in 2012. Procedures or revisions are in the AppendixAdditional inormation about the process o developing these Principles is available at www.responsibleuse.org/process.

Inormation on the individuals and organizations that contributed to the development o these Principles is in theAppendix: Committees and Contributors.

Core BeliesTese Principles are in recognition that responsibly used biotech trees have the potential to benet society, economies,and the environment in ways that other trees cannot. Central to these Principles are core belies that:

Biotech trees should benet people, the environment, or both Risks and benets o biotech trees must be assessed ransparency is vital and stakeholders must be engaged

Social equity and indigenous rights are important and must be respected Biotech tree use must ollow regulations in the country o their application

1 Te Institute o Forest Biotechnology denes biotech trees as trees developed through genetic engineering or which contain discretelyengineered DNA, and their ospring. Tis denition is intentionally inclusive o both the process (developed through geneticengineering) and the resulting tree (containing engineered DNA). Additional detail on this denition is available in theAppendix: Denitions.

2 A value chain is a set o linked activities. It is so called because each activity creates additional value along the chain. In this instance itreers to the various research, commercial, and physiological aspects o biotech trees.

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5 TruthsAcademia, conservation groups, industry and all other stakeholders who developed these Principles agreed on vetruths, on which the Principles are based:

Forests are important to people and animals Biotechnology is a powerul tool Biotech trees provide the potential or unique and diverse applications Biotech trees raise personal, environmental, and cultural questions Biotech trees are being used around the world with dierent levels o oversight

Use and Limitations o the Responsible Use: Biotech Tree Principles Use o these Principles is strictly voluntary. Tese Principles are not a certication system. Tese Principles only apply to biotech trees that the Institute o Forest Biotechnology denes as trees that

are developed through genetic engineering or which contain discretely engineered DNA, and their ospring.Tereore, clonally propagated or traditionally bred trees that do not contain genetically modied genes are

not considered biotech trees by the IFB. Tis document is designed to stand alone or to be used as a complement to other programs or regulatory systems. Tese Principles do not take precedence over international, regional, local, or organizational regulations.

Tese Principles are additive to such systems and users should be aware that there will likely be areas ooverlap that are not explicitly detailed in this document.

I a user3 is already ullling the requirements o one o the Practices in this document through a dierentsystem, or when stricter regulatory requirements apply, then no additional eort is required other thandocumenting how the Practice is otherwise ullled.

It is not necessary to be a Forest Biotechnology Partner to be In Accordance with these Principles. Te Institute o Forest Biotechnology is not able to certiy or otherwise audit the ecacy o any person or

organization using these Principles. Responsible Use: Biotech ree Principles, Responsible Use, responsibleuse.org, Forest Biotechnology

Partnership, and IFB are trademarks o the Institute o Forest Biotechnology. Tis document and all materialat responsibleuse.org are copyright by the Institute o Forest Biotechnology. No part o these materials maybe reproduced without the written permission o the Institute o Forest Biotechnology.

Reer to www.responsibleuse.org or the most up-to-date version o these Principles and additionalsupporting material. Additions, corrections, case studies, and the Principle revision processes will beavailable at that website.

3 User reers to a person or entity applying these Principles.

2
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Value Chain, Sections, and StepsComponents o the Responsible Use: Biotech ree Principles are grouped in three ways. Te entire set o linkedactivities is the value chain. Tese components unction together to help users and stakeholders work within a holisticramework to use trees responsibly. Tere are our sections within the value chain denoted by colors along the top row

o the diagram below: Laws and Requirements, Product Development, ree Growth, ree Products. Steps are individualcomponents numbered 1 through 7. Steps are designed to be additive to those beore them. All steps ater the rst inthe value chain o biotech trees build upon inormation rom a previous step. For example, step 5, Obtaining a biotechtree, cannot be accomplished until a prior user has approval to use biotech trees, which is step 4.

Practices High LevelPractices describe what should be accomplished in broad terms. Tey are the perormance measures or achievingstewardship. Each step has at least one Practice while some have more. Practices can be achieved in various ways, suchas by ollowing specic Actions that are described below.

Actions Low LevelActions detail how users could implement the Practices in specic ways. Most o the Actions consist o documentingresults. Te level o documentation would likely be proportional to how unique the biotech tree is. In general, itis useul to provide more documentation when a biotech tree is the rst o its kind. In situations where detailedinormation is condential and has to be restricted rom outside parties, a secondary attestation by a party within theorganization, a responsible party, or a peer, can usually be made available without divulging proprietary inormation.Some Actions reerence alternative measures (designated as Alt in the margin) or widely recognized areas o overlapwith established systems. I you believe an overlap and alternative measure should be included that is currently not,please submit it or consideration at www.responsibleuse.org/participate.

Recommendations and DiscussionEach o the seven steps has Recommendations that users can ollow at their discretion. Users are encouraged to ollowas many o the Recommendations as easible. Each step also has a Discussion section that gives additional context and insight.

ToolsTe ools Appendix includes templates and worksheets to help biotech tree users complete Actions andRecommendations. Tese tools are intended to simpliy implementing these Principles while maintaining acomprehensive and veriable approach. Te tools are generic while biotech tree uses are oten unique, making itimportant to add inormation or modiy a template or worksheet to suit a specic situation.

Components of the Responsible Use: Biotech Tree Principles
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Additional tools, resources, and case studies will be developed over time at www.responsibleuse.org/resources . Te IFBencourages ongoing discussion rom users and sharing o best practices on the Responsible Use website. Please submityour comments at www.responsibleuse.org/participate.

In Accordance with Responsible Use: Biotech Tree PrinciplesUsers can selectively apply any part o these Principles to their use o biotech trees, but those interested in achievingmaximum eectiveness should complete each applicable Practice and associated Action. Once all Practices and Actionsare completed, the user can publicly attest to being In Accordance with the Responsible Use: Biotech ree Principles(reerred to as simply In Accordance throughout) or the respective value chain steps. Users should keep applicabledocumentation to veriy their assertion o being In Accordance. o promote condence in the thorough application othese Principles, the IFB encourages all users to be In Accordance, to ollow as many Recommendations as possible, andto make as much documentation relating to the application o these Principles readily available to stakeholders.

I users are members o the Forest Biotechnology Partnership4, the IFB will assist them in implementing the ResponsibleUse: Biotech ree Principles and publish any documentation they wish in support o an In Accordance assertion, andwill keep a list o all In Accordance assertions rom Forest Biotechnology Partners at www.responsibleuse.org/accordance

4 More inormation about the Forest Biotechnology Partnership and how to become a member is available at:www.orestbiotech.org/partners.html

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User Reerence SheetTis sheet is a quick overview o the Responsible Use: Biotech ree Principles starting with the Core Belies at the topo the page, moving down through steps to complete, and ending with the optional attestation o perormance at thebottom o the page.

Core Beliefs

Biotech trees should benet people, the environment, or both Risks and benets o biotech trees must be assessed ransparency is vital and stakeholders must be engaged Social equity and indigenous rights are important and must be respected Biotech tree use must ollow regulations in the country o their application

Value Chain

Te seven steps o biotechtree use all o which are

subject to applicable lawsand requirements

All Users are Encouraged toUsers that are In Accordance

with the Principles

Practices

What should beaccomplished or eachvalue chain step

Address all applicable Practices

ActionsHow the Practices can beaccomplished

Follow all Actions or applicable Practices

Recommendations

Optional steps users areencouraged to take

Follow as many Recommendations as easible Optional

ToolsWorksheets to help userscomplete Actions andRecommendations

Use and modiy worksheets as necessary

Attestation

Alert the IFB o being InAccordance with thesePrinciples

Publicly attest to completing all steps and beingIn Accordance

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Tere are seven steps in the biotech tree value chain. Each step is part o a section. Te Laws and Requirementssection is unique because it is overarching and inclusive o the entire value chain. Steps 1 through 4 are in the ProductDevelopment section, 5 and 6 are in the biotech ree Growth section, and 7 is the only step in the ree Products section.

Each step has at least one Practice, one Action, one Recommendation, and a Discussion. Practices describe what shouldbe accomplished and are the perormance measures or achieving stewardship in that step. Actions detail specic waysusers could implement the Practices. o be In Accordance with the Responsible Use: Biotech ree Principles, eachPractice and Action must be completed or a given step. Recommendations are optional activities that urther increasethe level o stewardship, and Discussions provides insight and background or each step.

Laws and Requirements Section

Laws and Requirements categorically include all Responsible Use: Biotech Tree Principles

Every step in the value chain must ollow all applicable laws and requirements rst and oremost.

Practices

P0.1 Follow all applicable laws and requirements that apply to biotech tree use.

ActionsA0.1 Document the national, regional, and local laws as well as the institutional guidelines, and other mandatory

requirements that apply to these biotech trees. Document adherence to the laws and requirements that applyto these biotech trees. Have the document recognized and signed by a responsible party5.

Recommendations

R0.1 In countries where there are no laws, institutional guidelines, or other requirements that apply to biotechtrees, use the Responsible Use: Biotech ree Principles as a guide or stewardship o biotech trees whilesimultaneously working with organizations and agencies to implement stewardship measures or biotechtrees at a national or institutional level.

Discussion

Adhering to applicable laws and regulations is common to almost every stewardship program. While it may seemobvious that any person or organization involved in orest biotechnology would automatically ollow all applicable laws,it is useul to document what the laws are and how they are being ollowed. Tis step is especially useul or users incountries where there are no regulations governing biotech material. In such cases, documenting what steps were takenwith justication will build condence within the value chain that even in uncertain situations a thoughtul approachwas applied through these Principles.

5 A responsible party is someone who has both the technical skills to thoroughly understand what he or she is signing, and who has avested interest in assuring that the inormation is correct. For example, a responsible party could be a colleague in the same eld owork, or a supervisor in the organization, or a regulatory authority, among others.

Responsible Use Practices, Actions,

Recommendations, and Discussion


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Product Development Section

1. Product Conception

Te development o biotech trees to meet specic objectives.

Practices

P1.1 Develop biotech trees that benet society.P1.2 Evaluate the anticipated risks and benets o developing these biotech trees.

Actions

A1.1 Document anticipated benets rom these biotech trees. Te document should include the rationale ordeveloping these trees and explain how the benets are anticipated to outweigh the risks. Have the documentrecognized and signed by a responsible party.

A1.2 Document external, peer-reviewed inormation or regulatory inormation sources to estimate the risk andbenet o developing these biotech trees; a list o some resources is in Appendix: Risks and Benets. Have thedocument recognized and signed by a responsible party.

Recommendations

R1.1 Initiate consultations with stakeholders including biotech tree regulating authorities.R1.2 Broaden the intended benets o these biotech trees to include the widest range o people and places.R1.3 Review literature and databases that have inormation about the genes or gene constructs being considered

or these biotech trees; a partial list o resources is in Appendix: Biosaety.R1.4 Consider how these biotech trees might be monitored to help mitigate potential risks.

Discussion

Since responsibly used biotech trees are developed to meet a specic objective, this step ocuses on the intendedbenets. Benets may accrue through a variety o mechanisms including healthier orests, better orest products,enhanced carbon sequestration, and increased economic opportunities or landowners, among others. A thoughtulexplanation o the intended social, environmental, or economic benets will help create a clear product concept. Tereis tremendous value when research intent is aligned with social benets and communicated both inside and outside anorganization. Opportunities to engage broad groups o interested parties about the biotech trees are encouraged at this,

the earliest step o the biotech tree value chain. Tese interactions are ideal situations or all parties to gain insight intohow science could address specic social needs. Reviewing published inormation about the genes or constructs beingconsidered may generate opportunities to improve on the benets these trees may deliver. Such research could alsouncover known risks that have to be considered and mitigated.

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2. Lab Research

est biotech trees in contained indoor environments such as research laboratories and contained greenhouses.

Practices

P2.1 ake steps to prevent the release o living biotech trees and associated living material6.

Actions

A2.1 Document the steps taken to prevent the release o living biotech trees and associated living materialincluding pollen, seeds, and agrobacterium. Have the document recognized and signed by a responsible party.

Recommendations

R2.1 Begin consultations with stakeholders, including biotech tree regulating authorities, or continue discussionsalready established.

R2.2 Follow appropriate national or institutional biological containment guidelines as described in Appendix: Biosaety.R2.3 Evaluate whether data being sought can be obtained rom laboratory or greenhouse testing only.

Discussion

Users should establish a research environment that prevents the release o living biotech trees and their associatedliving material to the environment or other uncontrolled areas. Depending on the specic situation, it may bereasonable to expect that releasing these materials outside the laboratory will have negligible eect on the environment.However, to be In Accordance with this practice, take reasonable steps to prevent the release o these materials. It is alsoimportant to initiate stakeholder dialogues as early in the development o biotech trees as possible. Start or continuediscussions with interested parties including authorities that regulate biotech trees.

3. Field Testing

esting biotech trees outside o a contained indoor environment.

Practices

P3.1 Document the rationale or initiating eld testing.P3.2 Create a research plan or the eld test that includes an environmental assessment and mitigation plan.P3.3 Update the environmental assessment and mitigation plan or the duration o the eld test.P3.4 End the eld test so that these biotech trees or their environmental impacts do not persist.

Actions

A3.1 Evaluate the tradeos o eld testing these biotech trees versus continuing tests in a contained indoorenvironment. Document as many external, peer-reviewed sources o inormation as reasonably possible toestimate the risks and benets o perorming a eld test. Te document should include the rationale orperorming a eld test and explain how the benets are anticipated to outweigh the risks. Have the documentrecognized and signed by a responsible party.

6 Tese materials are sometimes reerred to as Living Modied Organisms or LMOs. LMOs are simply any living organism thatpossesses a novel combination o genetic material obtained through the use o modern biotechnology. See denition in Appendix or amore detailed description and reerences.

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A3.2 Develop a research plan or the eld test that includes the processes and procedures or: transporting thesebiotech trees to and rom eld tests, monitoring the eld test, and the scientic tests to be perormed. Teplan should include strategies to contain gene fow based on the possibility o the genes establishing in theenvironment and the novelty o gene unction. A long-term land use plan or the eld test should also beincluded. Have the document recognized and signed by a responsible party.

A3.3 Evaluate monitoring data over the length o the eld test. Document inormation that changes the research

plan developed in Action 3.2 and any unanticipated changes on the site resulting rom the eld test.A3.4 I relevant laws and regulations allow eld tests to persist without devitalization, and allowing a eld test

to persist is in the research plan, document the ways in which the eld test poses no signicant risk tothe environment. Otherwise, devitalize the trees in the eld test by rendering them biologically inactive,ollowing appropriate national or institutional biological containment guidelines as described in Appendix:Biosaety. Monitor the test site to ensure complete devitalization based on the biotech trees physiology.

Recommendations


R3.2 Design the monitoring plan commensurate with the novelty o gene unction to veriy the level o gene

containment.R3.3 Assess the risks and benets o testing these biotech trees outside o a contained, indoor environment, and

proceed with eld testing only i the inormation required cannot be obtained in a laboratory or greenhouse.R3.4 Promote stakeholder involvement in the eld tests to engage and educate others in a real-world environment

on the benets and risks associated with these biotech trees.R3.5 Monitor the test site or a minimum o at least one year and possibly longer based on the biotech trees

physiology, to ensure complete devitalization.

Discussion

Tere are more than one hundred eld tests o biotech trees throughout the world, as eld testing is oten necessaryin the biotech tree value chain. Te reasons or perorming research outside o a laboratory or greenhouse depend onmany actors that the user should communicate to stakeholders whenever possible. In some instances, the purposeo the test may be to evaluate gene fow outside o the test area itsel, but in most cases the objective is to see how thebiotech trees will grow in a more natural environment. Te intended use o the results o these investigations shouldbe considered and documented whenever possible, because they will vary dramatically depending on whether thetest is or scientic investigation and academic use only, or i it will be used specically or biotech trees destined orcommercial use. Tese practices should ocus the researchers attention on the need to design tests that achieve theirintended purposes with respect to gene fow. Observing and documenting impacts on the site provides additionalinormation on the eect these biotech trees have on the environment over time.

4. Approval to Use

When biotech tree developers have obtained authority to use trees in an unconned environment.

Practices

P4.1 Enable a continuous chain o historic inormation about these biotech trees.P4.2 Inorm users about the biotech trees they are acquiring.

Actions

A4.1 Provide uture users o these biotech trees with relevant inormation rom application o the Responsible Use:Biotech ree Principles by consolidating non-proprietary documentation into a single package.

A4.2 Provide uture users o these biotech trees with a material prole o these biotech trees. Include inormation

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that typically accompanies trees when ownership is transerred. Include inormation that explains whatmakes these biotech trees materially dierent7 rom their non-biotech tree counterparts, and any uniqueinormation required to use these trees.

Recommendation

R4.1 Provide users with care and growing instructions, the intended use o these biotech trees, and any additionalinormation that will assist subsequent users in applying the Responsible Use: Biotech ree Principles.

Discussion

At this step the tree developer has received legal approval to sell or otherwise transer and use a biotech tree in anunconned environment. Following these Practices will help users o the biotech trees and their products knowwhat they are purchasing and will give them the tools to be good stewards o these trees and their products. ForestBiotechnology Partners that are In Accordance can direct users to www.responsibleuse.org/accordance , where thisinormation can be made available or them.

Tree Growth Section

5. Obtain Tree

ranserring living biotech trees to the next user.

PracticesP5.1 Ensure the biotech trees were legally produced and have proper documentation.

Actions

A5.1 Obtain rom the original producer, seller, or entity otherwise providing these biotech trees, verication thatthese trees have received approval rom the applicable regulatory authorities to be transerred. Obtain amaterial prole o these biotech trees that includes inormation on how to use them responsibly and explainswhat makes these biotech trees materially dierent rom their non-biotech tree counterparts.

A5.1-Alt Obtain biotech trees rom a producer In Accordance with the Responsible Use: Biotech ree Principles.

Recommendations


R5.2 Obtain biotech trees rom producers that are In Accordance with the Responsible Use: Biotech reePrinciples. A list o Forest Biotechnology Partners that are In Accordance is available at:www.responsibleuse.org/accordance .

R5.3 Tose obtaining biotech trees should be aware o the trees genetic modications, such as changed genesor constructs.

7 Materially dierent and materially changed are terms used in this document to describe biotech trees or their products that are dierentenough rom a non-biotech counterpart so that it warrants a distinction. Te level o what is warranted is not strictly dened, but itshould be based on stakeholder interactions and expert opinions.

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Discussion

Tis step gives those obtaining biotech trees inormation to make inormed decisions. It also provides a mechanism toensure that the trees were legally produced and carry proper use and care inormation with them. Obtaining biotechtrees rom an organization that is In Accordance can reduce the time, cost, and documentation requirements o thesetransactions.

6. Growth and Stewardship

Planting, growing, and using biotech trees in the open environment.

Practices

P6.1 Use orest resources sustainably.P6.2 Keep records o where these biotech trees are planted.P6.3 Enable a continuous chain o inormation about these biotech trees and the land on which they are planted.P6.4 I products8 rom these biotech trees are harvested and used, then ollow the Principles in step 7.

ActionsA6.1 Follow applicable sustainable orest management practices. Document the management practices ollowed

and the associated results. Have the document recognized and signed by a responsible party.A6.1-Alt Obtain certication rom an internationally recognized sustainable orest management system or the orest

resources being used; examples o some are listed in Appendix: Sustainable Forestry.A6.2 Develop and implement an oversight plan or these biotech trees at a spatial level appropriate to the area

where they are planted. Include the spatial extent o these biotech trees, and inventorying techniques andrequency. Have the document recognized and signed by a responsible party.

A6.3 Provide documentation to new or contract landowners that includes the material rom Practices 6.1 and 6.2and inormation on what additional Responsible Use: Biotech ree Principles were previously ollowed.

A6.4 Attest that products are not being harvested and used at this stage. I biotech tree products are beingharvested or used then complete the Practices in step 7.

Recommendations


R6.2 Follow an internationally recognized sustainable orest management standard; examples o some are listed inAppendix: Sustainable Forestry.

R6.3 Maintain as much oversight and inormation about these biotech trees as is easible, such as stand location,planting dates, monitoring data, long-term oversight plans, and original supplier.

R6.4 Consider gathering additional inormation, or collaborating with other researchers to better understand theenvironmental eects o biotech trees. Examples o desirable types o inormation are available atwww.responsibleuse.org/resources.

R6.5 Inorm local tree arms and other landowners about these biotech trees.

Discussion

During this step biotech trees will have an impact on the environment; this is also true or non-biotech trees. Te objective isto make sure the current user o the biotech trees has the tools necessary to make a positive impact by ollowing established

sustainable orest management practices. While some sustainable orest management systems explicitly disallow the use obiotech trees or certifcation, their guidelines on how to grow healthy trees and how to be good orest stewards can still beapplied. Maintaining oversight is useul when transerring trees or land to uture users who want to know their history.

8 Biotech tree products are anything that is collected or harvested rom a biotech tree, or the tree itsel. See Appendix or examples.

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Tree Products Section

7. Product Transfer

ranserring non-living biotech tree products.

Practices

P7.1 Users currently in possession o the biotech tree products should inorm those acquiring the products aboutany material dierences rom similar, non-biotech tree products, and any additional product inormation theydeem necessary.

P7.2 Users acquiring the biotech tree products should make themselves aware o any material dierences rom

similar, non-biotech tree products.

Actions

A7.1 Document material dierences o the biotech tree products rom similar, non-biotech tree products. Provideadditional use inormation i necessary. Have the document recognized and signed by a responsible party.

A7.2 Obtain documentation rom the user in possession o the biotech tree products that details any materialdierences rom similar, non-biotech tree products.

A7.2-Alt Purchase rom a biotech tree user In Accordance with the Responsible Use: Biotech ree Principles.

Recommendations

R7.1 Begin stakeholder consultations or continue discussions already established.R7.2 Obtain biotech tree products rom users In Accordance with the Responsible Use: Biotech ree Principles. Alist o Forest Biotechnology Partners that are In Accordance is available at: www.responsibleuse.org/accordance.

R7.3 Tose involved in the transer o biotech tree products should be aware o what makes the trees unique, suchas changed genes or constructs.

Discussion

Tis step provides users acquiring biotech tree products with inormation to make inormed decisions. In someinstances, the product may be no dierent rom those made rom non-biotech trees. In other cases, the productmay have unique aspects because its source was a biotech tree, in which case the customer should know what thosecharacteristics are and how to properly use the product. However, only biotech tree products that are materially

changed rom their non-biotech tree counterparts require attention. Another option is to acquire the product roma biotech tree user In Accordance with the Responsible Use: Biotech ree Principles to reduce the time, cost, anddocumentation requirements o such transactions. A list o Forest Biotechnology Partners that are In Accordance isavailable at: www.responsibleuse.org/accordance .

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BiosaetyWidely recognized biosaety guidelines that are applicable to biotech trees include, but are not limited to, the ollowing:

U.S. National Institute o Health Appendix P online at:http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_P.htm

UN Living Modied Organisms Article 6 ransit and Contained Use; Article 18 Handling, ransport,Packaging and Identication online at: http://bch.cbd.int/protocol/text/

Virginia echs Practical Guide to Containment, Greenhouse Research with ransgenic Plants and Microbes online at: http://www.isb.vt.edu/Containment-guide.aspx

Industrial Biotech Tree ProductsTe Responsible Use: Biotech ree Principles can be used as a starting point or biotech trees that produce industrialproducts or accumulate toxic materials. However, the scope o these principles does not ully cover the specialstewardship requirements o these categories o biotech trees. Please reer to: www.responsibleuse.org/resourcesor thelatest guidance available regarding these types o biotech trees.

RevisionsReer to www.responsibleuse.org/processor additional inormation about the revision process or the Responsible Use:Biotech ree Principles.

iming: Tese Principles are dynamic and will be revised on a regular basis.

Scope: All aspects o the Responsible Use: Biotech ree Principles are eligible to be revised, including the revisionprocess itsel.

ransparency: Te IFB will announce when public comment periods are open and the overall progress o a revisiononline at www.responsibleuse.org/process. All material or public comment will be available online.

Risks and BeneftsGuidance on the risks and benets o biotech trees is an ongoing eort or the Institute o Forest Biotechnology. Pleasereer to http://www.responsibleuse.org/resources or the latest guidance available regarding these types o biotech trees.

Sustainable ForestryTere are a number o sustainable orestry management systems that provide basic levels o assurance that sustainablecriteria are being met. A list o internationally recognizable systems is available rom Metaore:www.metaore.org/index.php?p=Introduction_to_Certication_Programs&s=167 .

As noted at the link above, there are a number o systems designed to help manage orests sustainably, including but notlimited to:

Te American ree Farm System (AFS) is a program or small, private, non-industrial landowners (amilyorest landowners). AFS certies contiguous parcels rom 10 - 20,000 acres and was endorsed by PEFC inAugust o 2008. Online at: www.treearmsystem.org .

Te Canadian Standards Association is a national standard or sustainable orest management and trackingand labeling certied material. It covers operations in Canada. Online at:www.csa-international.org/product_areas/orest_products_marking/program_documents.

Te Forest Stewardship Council is an international system covering orest management practices and thetracking and labeling o certifed products and paper products with recycled content. Online at: www.scus.org

Appendix
http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_P.htmhttp://bch.cbd.int/protocol/text/http://www.isb.vt.edu/Containment-guide.aspxhttp://www.responsibleuse.org/resourceshttp://www.responsibleuse.org/processhttp://www.responsibleuse.org/processhttp://www.responsibleuse.org/resourceshttp://www.metafore.org/index.php?p=Introduction_to_Certification_Programs&s=167http://www.treefarmsystem.org/http://www.csa-international.org/product_areas/forest_products_marking/program_documentshttp://www.fscus.org/http://www.fscus.org/http://www.csa-international.org/product_areas/forest_products_marking/program_documentshttp://www.treefarmsystem.org/http://www.metafore.org/index.php?p=Introduction_to_Certification_Programs&s=167http://www.responsibleuse.org/resourceshttp://www.responsibleuse.org/processhttp://www.responsibleuse.org/processhttp://www.responsibleuse.org/resourceshttp://www.isb.vt.edu/Containment-guide.aspxhttp://bch.cbd.int/protocol/text/http://oba.od.nih.gov/oba/rac/guidelines_02/APPENDIX_P.htm


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Te Programme or the Endorsement o Forest Certication Schemes is a mutual recognition ramework ornational orest certication standards. Online at: www.pec.org.

Te Sustainable Forestry Initiative Program is a sustainable orest management standard targeting largeindustrial operations in Canada and the United States. Online at: www.sprogram.org .

Each system is dierent, with inherent strengths and weaknesses. Note that no particular sustainable orestry

management system is endorsed by the Responsible Use: Biotech ree Principles.

Toolsemplates and worksheets are provided here to help biotech tree users successully complete actions eciently andin a robust manner that is capable o being veried i desired. Te templates and worksheets that ollow are genericand should be accompanied by details specic to the biotech tree use situation. Additional tools are available online at:www.responsibleuse.org/resources .

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Example Documentation emplate

Tis assertion document reers to this Practice:

Actions asserted to in this document:

Recommendations asserted to in this document:

1. Document inormationResponsible Use Principles version: Date:

2. Primary Responsible PartyName:Organization:Email address: Phone #:

3. Secondary Responsible Party (required to be In Accordance)Name:Organization:Email address: Phone #:

4. Relevance to SectionsPractice:Action:Recommendation:

5. Proo o Perormance

How perormance was achieved (attach additional sheets i necessary):

6. Additional inormation to ulll the goal o the practice/s (attach additional sheets i necessary):

Signature o primary responsible party: ____________________________

Signature o secondary responsible party (optional): ____________________________

Optional public attestation to be In Accordance with the Responsible Use: Biotech ree Principles:Te undersigned is responsible or the air presentation o the inormation contained in this document, and or mak-ing this inormation easily accessible to the public. Statements refect the undersigneds best judgment and are basedon the completeness and accuracy o inormation available and analyzed at the time o completion.

Signature o Responsible Party: ____________________________

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In Accordance DeclarationAn individual or organization wishing to assert that their use o these Principles constitutes being In Accordance withthem can use the ollowing language in communications to stakeholders.

Tis report has been prepared In Accordance with the Responsible Use: Biotech ree Principles. It represents abalanced and reasonable assertion that all applicable practices have been completed according to their actions based on

the completeness and accuracy o inormation available and analyzed on or beore (date o completion here).

DefnitionsTe denitions printed here are current as o this documents printing date. Updated denitions are available online at:www.responsibleuse.org/resources .

Biotech ree

Te Institute o Forest Biotechnology (IFB) denes a biotech tree as a tree developed through genetic engineering orwhich contains discretely engineered DNA. Tis denition is intentionally inclusive o both the process (developedthrough genetic engineering) and the resulting tree (containing engineered DNA). Te IFB considers biotech treeospring to also be biotech trees unless it can be rigorously proven that such ospring does not contain geneticallyengineered DNA. I a biotech tree is crossbred with a non-biotech tree then the resulting ospring may or may notcontain the engineered genes present in the biotech tree parent, and thereore it is unknown i the resulting treecontains engineered DNA, in which case the IFB would consider this ospring a biotech tree.

Biotech ree Products

Anything that is collected or harvested rom a biotech tree, or the tree itsel. Some examples include, but are notlimited to, the ollowing products, i they originate rom a biotech tree: seeds, ruit, pine needles, leaves, sap or syrup,tree branches and stems.

Contained / ContainmentA set o controls including the sae methods, equipment, and acilities needed to reduce the potential o uncontrolledinteractions o people and the environment with biotech tree materials.

Devitalize

Rendering biologically inactive. Cease lie processes. Complete cell death. Unable to propagate and grow.

Peer Review

Te process o subjecting work, research, or ideas to the scrutiny o others who are experts in the same eld.

Gene Flow

Te transer o genes rom one population to another. In the context o this initiative it reers to genes rom a biotechtree being transerred to non-biotech trees.

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Gene Function

How a gene and the proteins it encodes behave in the intact organism. In the context o this initiative it reers togenetic changes in biotech trees as compared to non-biotech trees and the resulting dierence in the tree itsel romthat genetic change. Tis concept is important in understanding the dierence between novel gene unction andamiliar gene unction:

Novel gene unction has more risk associated with it because the change in the biotech tree is not completelyknown at the outset.

Familiar gene unction has less risk associated with it because the change in the biotech tree is somewhatknown at the outset.

Tere is a spectrum o amiliarity o gene unction that ranges rom completely novel, which would be absolutelyunknown, to completely amiliar, which would be well known.

Greenhouse

A structure in which temperature and humidity can be controlled or the cultivation or protection o plants. In thecontext o this initiative it reers to areas where trees can grow in an enclosed space without concern that they could

establish or transer genetic material to the outside environment.

Lab or Laboratory

A room or building equipped or scientic experimentation or research. In the context o this initiative it reers to anindoor, highly enclosed space where research is accomplished and where genetic material cannot transer to the outsideenvironment.

Living and Modied Organisms

Any living organism that possesses a novel combination o genetic material obtained through the use o modernbiotechnology is a term created and dened by the United Nations Cartagena Protocol on Biosaety to the Conventionon Biological Diversity. Montreal, 2000. Available online at: http://www.biodiv.org/doc/legal/cartagena-protocol-en.pd

Industrial Biotech ree Products

A biotech tree that either produces material or industrial applications or accumulates toxic material. In the contexto this initiative industrial biotech tree products are novel trees with specic industrial uses. Te resulting biotech treeis usually a vector to produce material or industrial applications or to accumulate toxic material. Applications couldinclude environmental remediation o soil contaminated with hazardous waste, and production o pharmaceuticals,unique biouels, or chemical eedstock intermediaries. Tis technology is on the very cutting edge o orestbiotechnology today. Please reer to www.responsibleuse.org/resourcesor the latest guidance available regarding thesetypes o biotech trees.

Materially Dierent or Materially ChangedReadily distinguishable as signicantly dierent. In the context o this initiative it reers to a biotech tree or itsproducts being changed enough rom its non-biotech tree product counterpart so that it warrants a distinction bythe user. Te level o what is warranted cannot be strictly dened at this point, but it should be based on stakeholderinteractions and expert opinions.

Risk

Te probability that an action or event will have an adverse or benecial eect. In the context o this initiative itmeans there is a potential or a negative result, but both the result and the degree to which it occurs is unknown.

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Spatial

Occurring, relating to, or requiring space to exist. In the context o this initiative it simply means the extent, or area, oa population o trees.

Stakeholders

A person or group that has an interest in something. In the context o this initiative, it is anyone who wants to make apositive contribution to the ongoing improvement o the Responsible Use: Biotech ree Principles. Tereore, you canbe a stakeholder. I you would like to benecially participate, please contact us at www.responsibleuse.org.

raceability

Reers to the completeness o the inormation about every step in the biotech tree value chain. It is the ability to veriythe history, location, or application o a biotech tree item through documentation in a way that is veriable.

Committees and ContributorsTe Responsible Use: Biotech ree Principles have been made possible thanks to a number o people and organizationalsupport. Te list o individuals that made this work possible is available online at www.responsibleuse.org/process.

IFBs Board o Directors

Te Institute o Forest Biotechnologys Board o Directors enthusiastically supported the development o thesePrinciples. Both past and current Board members have played an active role in the Responsible Use Initiative.

Implementation Committee

Includes experts who contributed an extensive amount o time to develop the Practices, Actions, and Recommendationsthat make up the unctional part o these Principles.

Initiative Sponsors

Sponsors have contributed the unding necessary or the Institute o Forest Biotechnology to manage the developmento these Principles through its Responsible Use Initiative.

Biouels Center o North Carolina MWV North Carolina Biotechnology Center Weyerhaeuser Foundation

Stakeholders

Numerous stakeholders have reviewed various versions o these Principles during their development.

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Documents

Responsible Use Biotech Tree Principles v.P.1.0.B