GUIDE FOR

Product Launch OF

Biotechnology-Derived

Plant Products

Disclaimer

The Guide for Product Launch Stewardship of Biotechnology-Derived Plant Products (“Guide”) is

solely an educational tool and is guidance to assist users in developing and implementing their

own organization-specific process for launching plant biotechnology products.

The Guide is flexible and its application will differ according to the size, nature and complexity

of the organization and products involved. The guidance is representative and not

exhaustive. It is the responsibility of any user of this Guide to consider that user’s specific

circumstances (1) when developing a product launch stewardship process specific to

its organization, and (2) in meeting any applicable legal requirements.

This Guide is not, and should not be used as, a substitute for (1) a user’s own individual

understanding of its legal requirements, (2) consultation by a user with its legal counsel and

other advisors, or (3) direct contact with the appropriate regulatory agencies.

The Guide does not define or create legal rights or obligations, and Excellence Through

Stewardship (ETS) specifically disclaims any such rights or obligations. ETS and its members do

not make any warranties or representations, either express or implied, with respect to the

accuracy or completeness of the information contained in this Guide, or the sufficiency of the

general procedures and processes contained herein to eliminate risk inherent in the referenced

operations or processes; nor do they assume any liability of any kind whatsoever resulting from

the use of or reliance upon any information, procedures, conclusions, or opinions contained in

this Guide. ETS assumes no responsibility to update the Guide.

January 2009

Revised July 2010

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Contents

ETS Guide for

Product Launch Stewardship

Introduction …………………………………………………………………………………4 Product Launch Stewardship Policy …………………………………………..… 4 Product Launch Stewardship Activities …………………………………………5 Summary ………………………………………………………………………………..……8 Appendix A – BIO Food and Agriculture Section Policy on Product Launch Stewardship………………………………………………………….…….……9 Appendix B – CropLife International Product Launch Policy…….....17 Appendix C – Example of a Market and Trade Assessment………….20

INTRODUCTION

Organizations that develop and market biotechnology-derived plant products should consider policies for product launch stewardship as well as appropriate processes and plans that manage the commercialization activities. When carefully thought out, those steps will help an organization initiate actions that promote the responsible introduction of new products, minimize trade disruptions and facilitate the availability of crops and products with the appropriate function and composition for intended uses. The results of the planning will facilitate continued global adoption of plant biotechnology-derived products, and bring additional benefits and value to the marketplace. The Guide for Product Launch Stewardship provides guidance to an organization in its development and implementation of the policy and related activities recommended above for biotechnology-derived plant products, including commodity and specialty crops and, where applicable, consideration of their derivative products and by-products. For example, an organization may choose to implement product launch stewardship activities that are designed to direct biotechnology-derived plant products and crops either to or away from specific markets. Depending on the complexity of the organization, the product launch stewardship policy and related activities may be “stand-alone” elements or may be incorporated into the company’s broader product-stewardship program.

Product Launch Stewardship Policy An organization should develop a product launch stewardship policy that is suited to its business model, the nature of its products, and its product market(s). Such a policy will help guide the commercialization of biotechnology-derived products by directing, prior to product launch, due attention to regulatory approval requirements, market assessments, and other provisions. The Food and Agriculture Section of the Biotechnology Industry Organization (BIO) and CropLife International (CLI) have adopted product launch stewardship policies (see Appendices A and B). An organization may choose to use those policies and/or adopt similar policies as guidance in developing its own internal product launch policy. Whatever path is taken in the development of a product launch stewardship policy, it is important that representatives from the appropriate functions within the organization (e.g., stewardship, marketing, legal, licensing, production, regulatory, research, supply chain, and communications) be consulted. Essential internal communication and organization-wide understanding of the product launch stewardship policy can be achieved by periodic training of appropriate employees, postings on company websites, and e-mail communication with employees. Furthermore, an organization will benefit from communicating its product launch stewardship policy to external stakeholders.

Product Launch Stewardship Activities There are several activities that an organization should consider in honoring its commitment to product launch stewardship. Not all of the activities outlined below may be applicable or necessary for all organizations. Appropriate functions within an organization (e.g., stewardship, marketing, legal, licensing, production, regulatory, research, supply chain, and communications) should be consulted in the process of designing product launch stewardship activities to meet the specific needs of its products and markets. 1. Identify person(s) in the organization responsible for product launch stewardship. The individual(s) responsible for product launch stewardship should have sufficient knowledge and experience to coordinate effectively with various functions in the organization (e.g., stewardship, marketing, legal, licensing, production, regulatory, research, supply chain, and communications). Their primary role is to develop appropriate product launch stewardship activities and to be a point of contact for groups internal and external to the organization. 2. Identify whether product is for commodity use or special use. The intended use of a product or by-product, such as for commodity distribution or special uses, will help an organization assess its intended product launch stewardship activities. With the identification of the product’s intended use, the organization can determine the appropriate scope of the market and trade assessment. 3. Conduct a market and trade assessment to identify key markets and key import activities

prior to commercial launch of any new biotechnology-derived plant product (crop by event) in any country.

Prior to the commercial launch of a biotechnology-derived plant product, it is advisable to conduct a market and trade assessment of the product to assist in the development of regulatory, management and commercialization strategies. The assessment should map out the product’s—and any by-product’s—value chain1, stakeholders (e.g., grower groups, government regulators, trade associations), market segments, and trade (e.g., import vs. cultivation, plant part vs. processed fraction, by-products). In addition, for products with special uses, the assessment can be the basis to develop special approaches to the product launch. These special approaches can help anticipate, manage and mitigate potential significant or unintended processing, product functional or compositional negative effects that may be manifested in crop use or processing streams. The assessment guides the organization in determining appropriate product launch activities and how best to work with the value chain and other stakeholders to maximize the value of the product and avoid potential trade disruptions. Such a market and trade assessment will also help to identify alternative production methods and conditions that are conducive to maintaining product integrity. The assessment should be reviewed at key points during product development and commercialization planning.

The extent of the market and trade assessment will depend on the processing and use of the product and on the scope and complexity of the product’s value chain. For example, an evaluation may be quite brief if the product is not processed and the market is targeted and local. Or, it could be quite complex if the product is highly processed into multiple derived products and is globally traded. (See Appendix C for an example of a market and trade assessment for commodity soybean. While the example in Appendix C is for a food/feed crop, it should be understood that product launch stewardship practices are equally applicable to non-food/feed products e.g., plant-made pharmaceuticals, biofuels and like products).

In conducting the market and trade assessment, an organization should consult at an early stage with the value chain for the specific crop. There is an additional layer of complexity with exports of biotechnology-derived crops because some portions of the value chain may export goods to different countries and authorizations applied asynchronously across different countries for the same commercial product can lead to trade disruptions. In addition, for products with special uses, the products may need specific management plans depending on the results of the assessment. Consequently, coordination with the value chain downstream of the organization at an early stage is important. Remember that other trade groups may or may not implement differing stewardship activities.

Factors to consider in conducting a market and trade assessment include:

The countries importing the product(s);

The types of products (direct product, by-product, processed product) and approximate volume of export to these markets;

The regulatory system and how it functions in each country;

The status of regulatory approval in each country2;

Submissions to appropriate jurisdictions; and

Adherence to international standards, (e.g., the International Plant Protection Convention (IPPC3) and the Cartagena Protocol on Biosafety4).

For products with intended special uses, additional factors to consider in conducting a market and trade assessment may include:

The types and nature of the special use;

Whether the special use product has multiple uses and whether unique handling, distribution or other operational conditions exist;

Characterization of the product process or ingredient flows;

Whether significant, unintended processing, product functional or compositional negative effects are likely to be caused; and

Whether the product might be exported as grain, processed fractions or food/feed end products.

Global market and trade information on many crops can be obtained from government agencies (e.g., USDA ERS5 or FAS6) or from grower groups (e.g., the National Corn Growers Association7 or American Soybean Association8).

4. Develop regulatory and commercialization plans to meet applicable regulatory

requirements in key production and importing countries (as determined by the market and trade assessment) prior to commercialization of a new biotechnology-derived product.

To synchronize launch efforts, regulatory timelines and assumptions should be communicated to the various organizational functions (e.g., stewardship, marketing, communications, licensing, production, and supply chain). There should be close communication between the research and commercial group(s) and the individual(s) who plan regulatory timelines. Contingency plans for product commercialization should be developed in case the regulatory approval process for a particular country takes longer than expected. An organization should consult with the value chain during the regulatory process. That source may be able to provide input in the early stages when the organization is still debating on the list of countries to which submissions might prove fruitful and in later stages when the product moves closer towards gaining approval(s). 5. For products with special use traits, develop management, mitigation and incident

response plans (as determined by the market and trade assessment) prior to commercialization of a new biotechnology-derived products.

Management plans, informed by the market and trade assessment for the special use trait and in dialogue with relevant stakeholders, would address significant and negative unintended processing, product functional or compositional effects, as appropriate to the likelihood or presence of the special use trait. The management plan, developed in dialogue with relevant, potentially affected stakeholders, could include identification and management of critical control points and plans to address potential escape or unintended presence of the trait. 6. Make a detection method available to stakeholders when and where appropriate. A detection method will enable stakeholders to verify the crop identity. Depending on the type of detection method to be developed, this process may begin before regulatory studies are initiated. An organization should consult with stakeholders to obtain their inputs on desired specifications for the detection method. 7. Communicate broadly and transparently with stakeholders and employees regarding

plans for company-specific product launch stewardship and their implementation. The development and implementation of a communication plan for product launch stewardship is recommended for guiding company personnel and informing stakeholders. Different

stakeholders (e.g., licensees, government regulators, grower associations, grain traders, and food and feed value chains) may need different types/levels of information at different stages. Communication to stakeholder groups often begins during the pre-commercial scale-up of the product and can continue throughout the marketing phase.

Summary The development of an organization-specific product launch stewardship policy and related activities should be tailored to the organization, the biotechnology-derived plant product involved, and the relevant product markets. The effort should include market and trade assessments, management plans, careful planning to meet appropriate regulatory timelines before product launch, and consistent communication with stakeholders and employees. 1. Value chain can be defined as “a string of companies or collaborating players who work together to satisfy market demands for specific products or services” http://www.valuechains.org/valuechain.html 2. A database of the commercial status of certain agricultural biotechnology products can be found at http://www. biotradestatus.com. The US database of completed regulatory agency reviews can be found at: http://usbiotechreg. nbii.gov/database_pub.asp. 3. https://www.ippc.int 4. http://www.cbd.int/biosafety/ 5. http://www.ers.usda.gov/Browse/TradeinternationalMarkets/ 6. http://www.fas.usda.gov/data.asp 7. http://www.ncga.com/ 8. http://www.soygrowers.com/

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APPENDIX A

BIO Food and Agriculture Section Policy on Product Launch Stewardship

Introduction

Through its advocacy efforts, BIO’s Food and Agriculture Section supports a regulatory

framework that facilitates and enables the development and commercialization of new

biotechnology-derived plant products1. Therefore, BIO’s Food and Agriculture Section is

committed to supporting appropriate regulatory and complementary stewardship efforts, in

coordination with the relevant stakeholders in the value chain, to advocate globally for

synchronous authorizations and elimination of non-science-based zero-tolerance regulatory

approaches and to facilitate the introduction of new biotechnology-derived plant products in

such a manner as to facilitate the flow of goods in commerce and minimize trade

disruptions.

New product introduction can effectively be achieved by a company, in part through its use

of trade and processing impact assessments (“Assessments”) prior to commercialization

that anticipate and consider the potential impacts within the value chain. The engagement

with various stakeholders in the value chain is important to the success of these

Assessments (e.g., identifying conditions related to handling, distributing, processing and

testing the products). Because of the differences in crops, products, product uses and

applications, each new biotechnology-derived plant product should undergo case-by-case

Assessments by the company introducing that product.

This policy, through its annexes2, sets forth general policy statements and recommended

processes for such Assessments as guidance for companies engaged in the launch of a new

biotechnology-derived plant product and as a basis for BIO’s Food and Agriculture Section’s

advocacy.

BIO’s Food and Agriculture Section believes that member companies should develop and

implement company product launch stewardship policies consistent with the general policy

statements and the guidance set forth in the annexes to this policy.

General Policy Statement

To encourage the continued adoption of agricultural biotechnology globally and to continue

to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food

and Agriculture Section supports actions that facilitate the flow of goods in commerce,

minimize trade disruptions, and facilitate the availability of crops and products with the

appropriate function and composition for intended uses. BIO’s Food and Agriculture Section

believes that henceforth and pursuant to the specific policy statements set forth in the

1 Biotechnology-derived plant products means those derived by the application of 1) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles or 2) fusion cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection. This definition of modern biotechnology has been adopted by the Cartagena Biosafety Protocol under the Convention on Biological Diversity and by the Codex Alimentarius Commission. 2 Under BIO’s bylaws and applicable antitrust law, individual member companies are not bound by this Association policy or its annexes.

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annexes to this policy, individual companies should determine whether biotechnology-

derived plant products, which a company intends to commercialize, are intended for

commodity use or special use, and then conduct Assessments appropriate to the

biotechnology-derived plant product, develop management plans appropriate to the product

and the Assessments, and undertake early, regular and mutual consultations with relevant

stakeholders during the assessment and management plan development process.

Companies should communicate promptly, broadly and in a transparent manner with

stakeholders regarding company-specific product launch stewardship policies and their

implementation.

In light of the constantly changing regulatory and trade environment, the Food and

Agriculture Section Governing Board will undertake regular reviews of this policy and its

annexes and adopt additional annexes, as appropriate.

Policy Approved: May 21, 2007

Updated: Dec. 10, 2009

Updated: June 18, 2012

Updated: November 27, 2012

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Annex 1: Commodity Crops3 (and Their By-Products) Intended for Food and Feed

Introduction

Since the commercial introduction of biotechnology-derived plant products in 1996, an

increasing number of biotechnology-derived plant products intended for food or feed use are

authorized for commercial production in many countries throughout the world; however,

authorizations in importing countries vary depending on the timing of submissions for

import authorization as well as the duration of the authorization process in each country.

As a consequence of these asynchronous authorizations, low levels of recombinant-DNA

plant materials that have completed full safety assessments in accordance with national and

international standards in one or more countries may, on occasion, be present in food or

feed in countries in which the authorization process of the relevant recombinant-DNA plant

material has not been completed.

Asynchronous authorizations combined with importing countries maintaining “zero

tolerance” for recombinant-DNA products not yet authorized results in the potential for

major trade disruptions. The potential occurrences of trade disruptions will only increase

given the substantial amount of research that will bring many new products and

combinations of products to market. The problem could be further compounded as

countries that currently have no regulatory authorization systems for biotechnology-derived

plant products establish them in the future. The potential for trade disruption could be

significantly reduced if all countries provided authorizations simultaneously or if there was

international governmental consensus to eliminate zero tolerance policies.

BIO’s Food and Agriculture Section is committed and seeks the commitment of the value

chain to continue to actively engage in ongoing concerted efforts to harmonize science-

based agricultural biotechnology regulatory approaches to achieve synchronous

authorizations and to eliminate zero tolerance policies. As a beginning, the Codex

Alimentarius Commission has developed an international food safety standard for the low

level presence of recombinant-DNA plant material in food. With national adoption, this

international standard will help address the problem, but it is not a substitute for full safety

authorizations. In the interim, one pragmatic approach is to minimize the number of

asynchronous authorizations in countries of production and import. This can be achieved by

companies commercializing their new biotechnology-derived plant products after meeting

applicable regulatory requirements from identified countries most likely to produce or

import the seed or products derived from in those new biotechnology-derived plant

products.

3 A “Commodity Crop” is a crop which in the ordinary course is grown using common agricultural practices and is commingled and not segregated for special handling or use when it enters the chain of commerce. For purposes of this policy, Commodity Crops are generally grain and oilseed crops traded on commodity exchanges.

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BIO’s Food and Agriculture Section establishes the following policy statement to address

these matters.

Specific Policy Statement

To encourage the continued adoption of agricultural biotechnology globally and to continue

to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food

and Agriculture Section believes that individual companies, prior to commercialization4 of a

new biotechnology-derived plant product in a Commodity Crop intended for food and feed,

should meet applicable regulatory requirements in key countries identified in the trade

assessment that have functioning regulatory systems5 and are likely to import commodities

including the new biotechnology-derived plant products.

Policy Guidance

In implementing this policy statement, BIO’s Food and Agriculture Section encourages the

following process for assessing and launching Commodity Crop products to guide a company

in its development and commercialization of these products globally. This guidance does

not limit the implementation of additional measures designed to facilitate adoption and use

of those products and to prevent disruption of the production and use of or the trading of

the commodity.

1. Conduct a trade assessment to identify key countries of production and import

(herein referred to as “key countries”), prior to the commercialization of any new

biotechnology product (crop by event) in any country of commercial launch. In preparing

the trade assessment, consult at an early stage with the value chain for the specific crop.

Manage the product’s introductions so that choice of production methods and purpose or

use (e.g., specialty, identity preservation, and global) for that crop are available and

preserved.

2. Meet applicable regulatory requirements in key countries for imports for each

country of production prior to commercialization of a new biotechnology product in

commodity corn, soybeans, and canola, unless determined otherwise in consultation with

the value chain for the crop.

3. Circumstances within the value chain can change, e.g. countries may become key

importing markets or develop functioning regulatory systems. Therefore, the determination

of which regulatory systems are functioning, as well as the Assessments, need to be

regularly re-evaluated by a company in consultation with the value chain as circumstances

change. If there is a significant change in circumstances, the company should re-evaluate

its stewardship of a planned (where U.S. cultivation is approved and seed production or

4 Commercialization for purposes of this annex is defined as the transfer of title and control of seed to the purchaser for the planting and production of a crop or crop product that will be placed into general commerce. 5 A “functioning” regulatory system is science-based, with clearly defined timelines and processes for regulatory review and decision-making, and for appropriate protection for proprietary information and data. In a “functioning” regulatory system, the regulatory and decision-making processes must be predictable and not subject to undue political influence. The term “predictable” includes, without limiting the definition, that the regulatory system accepts submissions in the ordinary course without preconditions related to the regulatory status in other countries, and the regulatory process for import authorization is completed routinely within 30 months or less. Since regulatory systems continue to evolve and change globally, countries’ systems may become functional or dysfunctional. Over time, a country should develop a track record of systematic authorizations with consistent and predictable timelines and processes.

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significant commercial development activities are underway) or ongoing product launch, or

where a product has already been launched, taking into account the changed

circumstances, and should adjust its stewardship plans, as appropriate, to minimize the

potential for trade disruption where already launched or if continuing the launch. Given

production country approval, meaning that there are no environmental, health or safety

concerns associated with the product, the company should consider, and the value chain

support, a full complement of regulatory alternatives (e.g. low level presence thresholds,

waivers, changes in or acceleration of the authorization process) in importing countries

which become key countries.

4. Follow generally accepted best seed quality practices designed to prevent low level

presence of unauthorized products and minimize unintended incidental presence of products

authorized in the country of production pending full implementation of the company’s

program under Excellence Through Stewardship®.

5. Make available prior to commercialization a reliable detection method or test for use

by growers, processors and buyers that enables crop identity verification for intended use.

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Annex 2: Special Use Traits6 in Commodity Crops

Introduction

This policy statement addresses the unique and evolving area of food and feed Commodity

Crops with one or more special use biotechnology-derived traits and provides guidance for

companies in the development and commercialization7 of these special use traits.

Specific Policy Statement

To encourage the continued adoption of agricultural biotechnology globally and to continue

to have products of agricultural biotechnology bring value to the marketplace, BIO’s Food

and Agriculture Section encourages individual companies to conduct processing

assessments for special use traits in Commodity Crops prior to their commercialization to

anticipate, consider, and develop approaches to help manage and mitigate any potential

significant, unintended processing, product functional or compositional negative effects in

crop use or processing streams.

Policy Guidance

In implementing this policy statement, BIO’s Food and Agriculture Section encourages the

following process for assessing and managing special use traits to guide a company in its

development and commercialization of these products globally. This guidance does not limit

the implementation of additional or alternative measures designed to facilitate adoption and

use of those products and to prevent disruption of the production and use of or the trading

of the commodity.

1. Identify relevant stakeholders for the trait and crop, and:

a. Communicate with those stakeholders and other relevant stakeholders identified to

the company on the function of the trait, and the benefits, properties, uses and the

company’s understanding of the potential for significant unintended processing,

product functional or compositional negative effects of the plant product on other

processes or products; and,

b. While protecting the confidential business information and intellectual property of all

participants, engage relevant stakeholders in early, regular and mutual dialogue

during the development of the processing assessments and of any product

management plans prior to the issuance of a proposed regulatory authorization of

the plant product.

2. In the development of plans for product commercialization, conduct processing

assessments of the trait and of the crop. The Assessments may include:

6 A special use trait is a value-added, quality or other specialty biotechnology-derived trait resulting in functional or compositional change that may have significant, unintended processing or product functional or compositional effects in crops, crop uses and/or processing streams. Plant-made pharmaceuticals are outside the scope of this policy and are separately addressed by BIO’s Containment Analysis and Critical Control Point Plan. 7 “Commercialization” for the purposes of this annex is defined as: 1) the transfer of title and control of seed to the purchaser for the planting and production of a crop which will be placed into commerce to be processed into a crop product with or utilizing a special use trait; or, 2) the first production of a crop product with a special use trait that will be sold into general commerce.

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a. The types and nature of the special use trait use(s);

b. Whether the plant product or byproduct with the special use trait has multiple uses,

including commodity uses and what types of downstream products or processes will

likely be negatively affected;

c. Whether these alternate uses require unique handling, distribution or other

operational conditions;

d. To the extent possible, based on publicly available information, information provided

to the company, and company-developed information, map or otherwise characterize

those product process/ingredient flows (to include by-product streams) that would

likely be significantly and negatively affected;

e. To the extent possible, based on publicly available information, information provided

to the company and company-developed information, assess whether special use

trait presence is likely to cause significant, unintended processing, product functional

or compositional negative effects, the types of downstream products that are likely

to be so affected, and what levels of trait presence, if any, would cause those

significant, unintended processing, product functional or compositional negative

effects;

f. Whether the special use trait in a Commodity Crop will be exported as grain,

processed fractions or food/feed end products; and

g. As relevant, assess whether the value chains in countries of import have similar or

different uses for the plant products or byproducts.

3. On a case-by-case basis and as relevant, develop management, mitigation and incident

response plans appropriate to the significant, unintended processing, product functional

or compositional negative effects, if any, of the special use trait in a Commodity Crop or

crop product processing stream, and appropriate to the likelihood of presence of the

special use trait, including:

a. The identification and management of critical control points.

b. The development of plans to address potential escape or unintended presence of the

trait such as:

Meet applicable regulatory requirements in key countries of production and

import with functioning regulatory systems;

Develop production, handling and use systems designed to control, contain or

manage the intended use of the trait; and

Develop plans and tools (e.g., reliable detection methods or tests) to enable

the technology provider and stakeholders to manage, mitigate or abate any

significant, unintended processing, product functional or compositional

negative effects of the presence of the special use trait in crop use and

processing streams.

4. Undertake appropriate outreach, communications and education necessary to effectively

implement the management, mitigation and incident response plans, including

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identifying the risks and providing the information necessary to implement the

management plans.

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APPENDIX B

CropLife International Product Launch Stewardship Guidance The CropLife International Product Launch Guidance provides guidelines for the introduction of new biotechnology-derived plant products that will facilitate the flow of goods in commerce and minimize trade disruptions. The guidance encourages individual member companies to, prior to commercialization, meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems, and are likely to import the new biotechnology-derived plant products. The CropLife International Product Launch Stewardship Guidance is international in nature. Introduction An increasing number of biotechnology-derived plant products1 intended for food or feed use are authorized for commercial production in many countries throughout the world; however, authorizations in importing countries vary depending on the timing of submissions for import authorization as well as the duration of the authorization process in each country. As a consequence of these asynchronous authorizations, low levels of recombinant-DNA plant materials that have completed full safety assessments, in accordance with national and international standards, in one or more countries may, on occasion, be present in food or feed in countries in which the authorization process of the relevant recombinant-DNA plant material has not been completed. Asynchronous authorizations combined with importing countries maintaining “zero tolerance” for recombinant-DNA products not yet authorized results in the potential for major trade disruptions. The potential occurrences of trade disruptions will only increase given the substantial amount of research that will bring many new products and combinations of products to market. The problem could be further compounded as countries that currently have no regulatory authorization systems for biotechnology-derived plant products establish them in the future. The potential for trade disruption could be significantly reduced if all countries provided authorizations simultaneously or if there were international governmental consensus eliminating zero tolerance policies. CropLife International is committed and seeks the commitment of the value chain to continue to actively engage in ongoing concerted efforts to harmonize science-based agricultural biotechnology regulatory approaches to achieve synchronous authorizations and to eliminate

1 Biotechnology-derived plant products or plant products derived from modern biotechnology means the application of 1) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles or 2) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection. This definition of modern biotechnology has been adopted by the Cartagena Biosafety Protocol under the Convention on Biological Diversity and the Codex Alimentarius Commission.

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zero tolerance policies. As a beginning, work in Codex is underway to develop an international food safety standard for the low level presence of recombinant-DNA plant material in food. Such an international standard will help address the problem when completed, but it is not a substitute for full safety authorizations. In the interim, one pragmatic approach is to minimize the number of asynchronous authorizations in key markets. This can be achieved by CropLife International member companies commercializing their new biotechnology-derived plant products after meeting applicable regulatory requirements from the key countries most likely to produce or import the seed or products derived from those new biotechnology-derived plant products.

CropLife International establishes the following guideline to address these matters. General Guideline CropLife International believes in access to the shared benefits of crop biotechnology. To help ensure the continued adoption of agricultural biotechnology globally and to continue to have products of agricultural biotechnology bring value to the marketplace, CropLife International supports actions that facilitate the flow of goods in commerce and minimize trade disruptions. CropLife International believes that henceforth individual member companies should, prior to commercialization2, meet applicable regulatory requirements in key countries identified in a market and trade assessment that have functioning regulatory systems3 and are likely to import the new biotechnology-derived plant products.

Specific Guideline Objectives Consistent with this general guideline, CropLife International believes that henceforth individual member companies commercializing biotechnology-derived plant products should, and encourages them to: 1. Conduct a market and trade assessment to identify key import markets, including those with functioning regulatory systems, prior to the commercialization of any new biotechnology product (crop by event) in any country of commercial launch. In that market and trade assessment, consult at an early stage with the value chain for the specific crop. Manage the product’s introductions so that choice of production methods (i.e., facilitate coexistence) and markets (e.g., specialty, identity preservation, and global) for that crop are available and preserved.

2 Commercialization for this document is defined as the first planting of seed sold into commerce for the production of a crop 3 A “functioning” regulatory system is science-based, with clearly defined timelines and processes for regulatory review and decision-making, and appropriate protection for proprietary information and data. The regulatory and decision-making processes must be predictable, completed in a timely manner, and not subject to undue political influence.

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2. Meet applicable regulatory requirements in key markets prior to commercialization of a new biotechnology product intended for international commodity trade unless determined otherwise in the consultation with the value chain for the crop. 3. Follow generally accepted best seed quality practices designed to prevent adventitious presence of unauthorized products and minimize unintended incidental presence of products authorized in the country of production. 4. Make available prior to commercialization a reliable detection method or test for use by growers, processors and buyers that enables crop identity verification for intended use. 5. Promptly communicate broadly and in a transparent manner with stakeholders as to its company-specific product launch stewardship policies and their implementation. In light of the constantly changing regulatory and trade environment, CropLife International will keep this guideline current. Approved May 2008, Plant Biotechnology Strategy Council (PBSC). Updated July 2008.

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End User / Consumer

Technology Provider

Seed Company

Seed Dealer

Grower Elevator ProcessorDistributor/

Retailer

Value Chain

APPENDIX C EXAMPLE OF A MARKET AND TRADE ASSESSMENT: COMMODITY SOYBEAN Following is a sample market and trade assessment for commodity soybean. This example is intended as guidance and is representative only. Individual organizations are encouraged to develop their own market and trade assessment approach that will be best suited to their business model, the specific nature of their product, and their product market. While the market and trade assessment example discussed here involves a food/feed crop, it should be understood that product launch stewardship practices are applicable to food/feed and non-food/feed (e.g., plant-made pharmaceuticals, biofuels) products alike. The value chain for commodity soybean intended for food/feed use can be illustrated as below:

To expand, a typical value chain could consist of the following elements:

1) A technology provider discovers and develops the trait in soybeans, and licenses that trait to a seed company or produces and markets the seed.

2) A seed company may develop a trait and then produces and markets the seed. 3) The seed dealer sells and then distributes the seed to growers. 4) The grower plants the seed, and harvests the soybean grain. 5) The grain is transported to an elevator for grading, drying and storage. 6) It is then sold to a processor, which may convert it into products such as soybean oil,

soybean meal, soy protein, and others. 7) It may then go to other companies for further processing, or as ingredients for other

products. 8) The finished product is shipped to a distributor/wholesaler, which sells it to a grocery

store. 9) Finally, the consumer purchases the end product.

In preparing a market and trade assessment, stakeholders should be identified and stakeholder consultation plans put in place for each identified stakeholder. Stakeholders include those directly involved in the value chain (e.g., growers, grain traders, processors, distributors, etc.). These groups often have trade organizations to represent their industry, and consultation with these organizations can be very valuable during the planning of a product launch. (In the case of soybeans examples include The American Soybean Association, National Grain and Feed Association, Grocery Manufacturers’ Association, North American Export Grain Association and

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others). Other stakeholder groups to consider include regulators (domestic and international) and for some products, academics should be involved.

A complete market and trade assessment also considers the need for alternative production methods and conditions to maintain product integrity. The launch of a soybean product intended for the commodity market generally will not need to consider alternative production methods or conditions for product integrity. Where needed, “Identity Preservation” (IP) methods and conditions are well established for soybean, as there are a number of IP high-value soybean traits currently on the market (e.g., clear hilum, high protein, etc.). Trade and market information on commodity soybean is available from the American Soybean Association; the data is available at Soy Stats1. An example of Soy Stats data showing US soybean and soy product exports, and the 10 largest export countries for these products is given below.

Top Ten U.S. Export Customers $ Million 2007 Source: Department of Commerce Calendar Year

1 http://www.soystats.com/

U.S. Soybean & Soy Products Exports 2007

Source: USDA Calendar Year

Value in (1,000) Dollars

Soybeans 10,004,300

Soybean Meal 2,149,633

Soybean Oil 761,926

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Soybean Exports

China+Hong Kong $4,119

Mexico $1,170

Japan $1,096

European Union-27 $1,022

Taiwan $714

Indonesia $401

Egypt $166

Korea $158

Turkey $126

Thailand $123

All Others $909

Total $10,004

Soybean Meal Exports

Mexico $439

Canada $352

Philippines $190

Japan $125

Dominican Republic $122

Colombia $77

Guatemala $72

Taiwan $68

Cuba $53

Saudi Arabia $50

All Others $602

Total $2,150

Soybean Oil Exports

China+Hong Kong $160

Mexico $136

Canada $66

Algeria $58

Morocco $51

Korea $46

Venezuela $33

Guatemala $23

Cuba $20

Japan $16

All Others $153

Total $762

Several of the export countries listed above have established biotechnology regulatory frameworks. Other countries are in various phases of developing their regulatory framework for biotechnology-derived crops. Thus, an organization planning the commercialization of a biotechnology-derived commodity soybean for food and feed uses may expect to conduct market and trade assessments, develop commercialization plans, and submit dossiers for import, food and feed use (grain, meal or oil) in all those countries with a functioning regulatory system. In this example regulatory submissions for a biotechnology-derived soybean product would begin with cultivation approval in the United States. Although the United States does not export soybean grain to Canada, soybean meal and oil are major exports to Canada. Thus, regulatory submissions to Canada would be expected. Some countries (e.g., Japan) will also require an additional cultivation approval, even though cultivation is not planned in the country. The biotechnology-derived soybean product may also be commercialized with contemporary cultivation submissions in other countries, such as Argentina and Brazil. In that case, a market assessment, regulatory plan and commercialization plan matrix would be developed taking into account each country of cultivation and each of those countries’ key export markets. This example is based on a regulatory submission beginning with cultivation in the United States. Depending on the countries involved, there may be other commercialization and launch plans and approvals required.