# Advisory Committee on Biotechnology & 21st Century Agriculture (AC21) Meeting: March 8-9, 2004

**Draft Meeting Summary**

**Fourth Plenary Meeting**

Oasis Room\
Sphinx Club\
1315 K Street, NW\
Washington, DC 20005

On March 8-9, 2004 the United States Department of Agriculture (USDA)
convened the third plenary meeting of the Advisory Committee on
Biotechnology and 21st Century Agriculture (AC21). The meeting
objectives included:

-   Review a draft Introduction to the report examining the impacts of
    agricultural biotechnology on American agriculture and USDA over the
    next five to ten years;

-   Review the progress of two workgroups, one on potential issues,
    concerns, and benefits and a second on scenario-setting;

-   Provide workgroups guidance in adapting the information they have
    developed into chapters of the Committee report;

-   Consider preliminary presentations and introductory discussions
    related to trends in public versus private biotechnology research
    and implications for public research; and

-   Discuss the progress of a work group drafting a separate report for
    the Committee's consideration on the issue of the proliferation of
    traceability and mandatory labeling regimes for
    biotechnology-derived products in other countries, the implications
    of those regimes, and what industry is doing to attempt to address
    those requirements for products shipped to those countries.

The AC21 includes representatives of industry, state and federal
government, non-governmental organizations, and academia. The following
AC21 members were in attendance: Dr. Patricia A. Layton, Dr. Daryl D.
Buss, Mr. Leon C. Corzine, Dr. Carole Cramer, Dr. Richard T. Crowder,
Dr. Michael D. Dykes, Mr. Duane Grant, Dr. David A. Hoisington, Mr.
Terry L. Medley, Dr. Margaret Mellon, Mr. Ronald D. Olson, Mr. Jerome B.
Slocum, and Dr. Lisa W. Zannoni. Dr. Patricia Layton chaired the
meeting. Dr. Peter Chase from Department of State, Dr. Elizabeth
Milewski from the U.S. Environmental Protection Agency, and Dr. Vincent
Vilker from National Institute of Standards and Technology (NIST)
attended as ex officio members. Dr. Michael Schechtman, the AC21's
Executive Secretary and Designated Federal Official (DFO), and Mr. David
Hegwood, Special Counsel to the Secretary of Agriculture, also
participated in the two-day session. Ms. Abby Dilley and Ms. Angela
Agosto of RESOLVE, and Ms. Cynthia Sulton of HW&W facilitated the
meeting.

A full transcript of the proceedings was prepared and will be available
on the USDA website <http://www.usda.gov/agencies/biotech/ac21.html>.
Presentations also will be available on this website. Below is a summary
of the proceedings, prepared by the facilitation team.

**I. Welcome and Opening Comments**

Dr. Michael Schechtman opened the proceedings at 9 a.m. by welcoming all
the members, ex officio representatives, and the public in attendance to
the fourth meeting of the AC21. He briefly introduced Dr. Patricia
Layton, AC21 Chair, and facilitators Ms. Abby Dilley, Ms. Angela Agosto,
and Ms. Cynthia Sulton.

Dr. Schechtman also referenced several documents, distributed to AC21
members, available to the public at the meeting, and subject to
discussion or reference during the course of the Committee's
deliberations, including:

-   The official AC21 Charter.

-   The AC21 Bylaws and Operating Procedures.

-   A package of biographical sketches of AC21 members.

-   The provisional agenda for the meeting.

-   A compilation of the draft summaries of two meetings each of the
    three AC21 workgroups.

-   The draft meeting summary prepared from the third plenary meeting,
    held December 4-5, 2003.

-   A draft outline of the Introduction to the report.

-   A draft Issues and Concerns document.

-   A one-page statement of the three scenarios agreed upon at the last
    plenary meeting.

-   A document from the Scenarios workgroup that outlines certainties
    and uncertainties.

-   A draft outline for the second report on Labeling and Traceability.

-   A timeline for the Committee's work, developed during the previous
    plenary session.

Dr. Schechtman provided updates on the AC21 membership. Per the
Committee's charter, half of the Committee memberships expired on
February 13, 2004. After soliciting nominations for the Committee,
Secretary Veneman reappointed eight members: Daryl Buss, Leon Corzine,
Carole Cramer, Michael Dykes, Randal Giroux, Margaret Mellon, Ron Olson,
and Jerome Slocum. The Secretary also appointed new member Carol Tucker
Foreman, from the Consumer Federation of America, to the Committee.

Dr. Schechtman also reported that Secretary Veneman announced on January
22 USDA's intention to update and strengthen its biotechnology
regulations for the importation, interstate movement and environmental
release of genetically engineered organisms. In the announcement, it was
indicated that USDA's Animal and Plant Health Inspection Service (APHIS)
would prepare an Environmental Impact Statement evaluating its
biotechnology regulations and several possible regulation changes. A
notice was published in the Federal Register soliciting public comment
until March 23. Dr. John Turner of APHIS was present in the audience to
answer any questions from Committee members.

As a conclusion to the opening remarks, Dr. Schechtman reviewed the
objectives of this fourth plenary meeting (listed above).

Dr. Layton welcomed members and the audience to the meeting.

**II. Review of December 4-5, 2003 Meeting Minutes and Outline Agenda**

Ms. Cindy Sulton briefly reviewed the highlights of the third AC21
meeting held on December 4-5, 2003 and asked for any additional comments
to the draft meeting summary. Given that there were no additional
comments, the meeting summary was finalized and will be posted on the
USDA AC21 website.

Ms. Abby Dilley then reviewed the meeting agenda in the context of the
objectives highlighted previously by Dr. Schechtman and noted the goals
for each segment of the agenda. Committee members finalized the agenda
and then proceeded with the deliberations of the fourth meeting. Ms.
Dilley noted that specific next steps for advancing the Committee's
work, including deciding what feedback was required from AC21 members
unable to attend this session, would be determined prior to the
conclusion of the two-day meeting in order for the work groups to move
forward with their respective charges.

**III. Review of Draft Introduction to Report Examining the Impacts of
Agricultural Biotechnology on American Agriculture and USDA**

Dr. Schechtman opened the discussion of the draft report Introduction by
asking members whether the draft covers the right topics as well as
requesting suggestions for additional topics. The Committee expressed
general support for the direction and basic outline of the draft
Introduction. Members' suggestions for additional topics included more
discussion on the food and environmental issues outside the U.S.,
particularly China and Latin America, the role of developing countries,
and integrated management including alternative technologies. Others
suggested an additional historical perspective on the expansion of
biotechnology or genetic engineering. One member recommended that a map
indicating where the major grain crops are grown be included in the
document, because the application and adoption rates of genetically
engineered varieties and associated implications may vary by grain and
by location. Members also noted that the last portion of the
Introduction needs a conclusion and transitional language to the rest of
the report. One member cautioned against taking on too large a set of
issues and over-emphasizing biotechnology as the sole solution for cases
in which less resource- or technology-intensisve alternatives may work
as well.

Several members suggested the careful consideration of the terms used in
the report, encouraging the use of the term "genetically engineered"
rather than "genetically modified" or "GMO" in the document. Some
members noted that the report should include discussion of future
agricultural products beyond those that are genetically engineered.
However, by the end of the meeting, the Committee members concluded
that, while other technological applications may be very important for
future agricultural production, the report requested by the Secretary
should focus on genetically engineered agricultural products of the next
five-to-ten years.

With regard to the section of the Introduction related to "The
Promise..." one member emphasized the need for proper context setting
and a thorough discussion of the benefits of biotechnology, either in
this section or in the Issues and Concerns chapter. Another member
commented on the language referring to availability of new arable land,
suggesting that in Brazil and other countries outside the U.S., new
arable land is opening up every year. Other members questioned the
actual balance of arable to non-arable land worldwide, noting urban
encroachment and questioning whether all land cleared of forests is
necessarily arable or is sustainable as farmland.

Additional suggestions from Committee members included expanding
discussion on how application of biotechnology is improving continually
productivity in conditions of abiotic stress and drought, and how users
are becoming more effective at adopting and implementing the technology
generally.

Dr. Schechtman stated that as next steps on the Introduction, USDA would
compile comments and make the straightforward changes to the text. He
asked members to draft new text to reflect all of their suggested
substantive changes or additions and send the text to him.

**IV. Discussion of Progress of Work Group on Issues, Benefits, And
Concerns**

Ms. Dilley reviewed the activities of the Issues, Benefits and Concerns
Work Group since the December plenary meeting. Members of the work group
are Daryl Buss, Carole Cramer, Michael Dykes, Duane Grant, and Greg
Jaffe. The Work Group met twice via conference call to develop a revised
draft document. She noted that the current document has been reorganized
into three issue categories (regulatory, commercial, and consumer), with
subcategories under each. Ms. Dilley also noted that Work Group members
are drafting introductory text not yet included in the draft for each of
these sections. Following Dr. Buss' overview of the document, she
invited input from the Committee on the topics included or those that
need to be added to the document.

Dr. Buss provided an overview of the Consolidated Issues and Concerns
document. The Work Group agreed to change the working title from the
previous Issues, Benefits and Concerns, because the benefits discussion
would fit better in "The Promise..." section of the Introduction. He
noted that the document represents Work Group efforts to organize the
various issues generated during several previous plenary and multiple
work group discussions. Significant substantive work and editing of this
chapter is pending. He also explained that there is some overlap in the
discussion of issues among the three categories that the Work Group
developed. Also, the Work Group added brief introductory pieces to each
category.

*General Comments\
*Committee members offered a number of comments on discussing benefits
of the technology in both the Introduction to the report and within each
section of the Issues and Concerns document. Some members suggested
discussing benefits in both parts of the report. Several members thought
that each section of the Issues and Concerns chapter should be
introduced with a brief discussion of context, including what has been
achieved and demonstrated benefits, before listing issues and concerns.

Some members recommended that the Introduction contain the factual
information on the number and types of products approved, adoption
rates, etc., but avoid making judgments about the future. Other members
suggested that this context would be adequately provided in the overview
in the regulatory section. Members recommended reviewing the report for
redundancies on this topic and eliminating text in one of the report
sections.

*Regulatory Issues*\
A member suggested that the language regarding "robust risk analysis" be
clarified to show that the concern focuses on the greater risk of
becoming a plant pest. The member also recommended balancing and
potentially blending the paragraphs on cost and regulatory burden.

Regarding international regulatory issues, a member recommended adding
"bilateral negotiations" when "multilateral negotiations on
biotechnology issues" is mentioned and broadening the discussion to
include Brazil and Argentina. Other suggestions for the text on
regulatory harmonization include clarifying the use of terms
"harmonization" and "synchronization," particularly in discussing
approvals. Harmonization should focus on regulatory requirements that
deal with hazard identification and risk assessment rather than with
risk management or regulatory decision-making. One member suggested
noting the likelihood that more transgenic products will be developed in
other countries, and highlighting the issue of the ability of the U.S.
system to address products approved elsewhere. Another issue raised on
this topic was regulation and control of products as they move out of
use by the commercial sector and into the hands of resource poor
farmers.

A member noted that discussions of human health and safety need to start
with the recognition of allergenicity, toxicity and the presence of
anti-nutrients as the bases of human health and safety evaluations.
Members also commented that gene flow issues are important and merit an
expanded discussion. Dr. Schechtman responded that a new draft would
incorporate comments as best as possible, with the assistance of
commenters who suggested the need for particular more substantive
changes or additions.

*Commercial Issues*\
The Committee members suggested rewording or changing the tone of
several points in the section, including assumptions about transaction
costs, impacts of vertical integration, players' ability to negotiate,
and the inefficiency of the licensing system. Regarding liability
issues, a member urged that, in an international context, farmers'
capabilities, resources and vulnerabilities differ and should be
acknowledged. Other suggestions included expanding the discussion of
strict liability issues and adding validation and standardization in the
discussion of detection/testing methodologies. Other members suggested
that the complexity of licensing systems in a global context be added,
including impacts of increasing numbers of products and players in the
systems.

The Committee also discussed the Work Group's suggested elimination of
the adventitious presence issue. Some members proposed that the topic be
discussed in its own section, also noting that this issue is a growing
problem faced by USDA. Others offered that the text could fit better in
other parts of the report and that different aspects of adventitious
presence are relevant to regulatory and commercial issues.

The issue of segmentation of farmers, although identified as important,
was suggested to fit better in the Introduction rather than in the
contracting discussion. A member stated that the poultry industry system
could serve as a model for contracting, segmentation, and liability
issues.

*Consumer Issues*\
The Committee members offered several comments on reorganizing and
changing the tone of section C, "Public Awareness, Education, and
Consumer Choice." Members suggested that the section should highlight
more specific issues and that the definition of "consumer" should be
clarified. Regarding public awareness issues, a member noted that not
all parties in the food chain support the promotion of biotechnology
products and requested that the statement be reworded. Another member
suggested that the section be more balanced to focus on issues of
consumer choice and the government's role in providing balanced
information rather than a goal of public acceptance. Members suggested
revising the language and organization to allow for inclusion of more
information and emphasizing USDA's roles in consumer information and
protection and safety.

One member disagreed with the statement in the text that the
contribution of biotechnology to reducing food costs in unclear, stating
productivity changes in biotechnology corn as an example of positive
change in reducing food costs.

Other members suggested making distinctions between the issues of
domestic and international public awareness, consumer choice, and
consumer attitudes. Members noted the need to raise understanding of
basic information on agriculture, both in the U.S and in other
countries. Some members suggested that education regarding agricultural
biotechnology should be targeted to key groups.

Members also discussed the significance of consumers' associating
recognized food brands with safety. Key issues include consumers'
attitudes toward technology adoption, the importance of brand, and the
influence of trust in the company and government food agencies on
consumer acceptance. In addition, it was suggested that a lack of
adequate regulatory regimes for transgenic animals and associated food
safety concerns could negatively impact consumer confidence in products
of agricultural biotechnology.

Ms. Dilley summarized the main messages and recommendations from the
Committee for the Issues and Concerns document, including the following:

-   Clear context setting for each major section is needed.

-   The Consumer Issues section needs to be reworked.

-   In each subcategory, the issues need to be clearly articulated and
    key issues prioritized in detail.

-   Authors should not worry about redundancy now; the document will be
    edited later.

-   A placeholder is needed for ethical and religious issues, which the
    Committee has not yet discussed.

**V. Discussion of Work Group Progress on Scenarios Development**

(Note: The AC21 members discussed scenarios development during two
sessions on the first day of their deliberations, as well as returned to
the topic briefly on the second day. All of these discussions are
presented in this portion of the summary.)

Dr. David Hoisington, a member of the Scenarios Work Group, provided an
overview of the Work Group activities and accomplishments. The
participants of the Work Group include Mardi Mellon, Terry Medley, Jerry
Slocum, Juan Enriquez-Cabot, Keith Triebwasser, and Dr. Hoisington. The
Work Group held two conference calls to define in more detail the three
scenarios identified by the full Committee during the December plenary
meeting. The Work Group prepared a list of certainties and uncertainties
regarding factors influencing the future, as well as further developed
the scenarios briefly described during the December Committee meeting.

Dr. Hoisington reminded the Committee that the scenarios provide
contrasting views of alternative futures to help the Committee in its
discussions and in drafting its report. The Work Group defined
"scenarios development" as telling stories created around a cluster of
factors that may impact the development of agriculture biotechnology in
order to understand how events can change perceptions of the future.

Mr. Medley described the three scenarios drafted by the Work Group:

1.  "Biotechnology Bust" -- in ten years, technology does not deliver
    beyond the first wave of products, alternatives are used in
    agriculture, and supermarkets are not purchasing products;

2.  "Cornucopia" -- in ten years, there is commercialization in
    abundance and research has delivered beyond expectations;

3.  "Continental Islands" -- in ten years, variable biotechnology
    adoption rate is locally driven by national and local politics and
    international tensions exist.

The Work Group also examined the driving forces that could influence the
development of one of the scenarios. The Work Group divided the driving
forces into certainties and uncertainties, with subcategories of
demographic, technical, environment, and social.

Ms. Dilley emphasized that the purpose of scenario development is not to
create consensus pictures of the future. Dr. Schechtman added that USDA
could benefit from scenarios through the identification of "signposts"
that help the agency recognize trends. The scenario text has not yet
been distributed to members, but will be revised based on Committee
comments. Dr. Schechtman also urged members not to try to assign
probabilities to the scenarios, but to assess whether the concepts are
internally consistent.

*Scenarios*\
In reaction to the brief descriptions of the three scenarios, some
members expressed the view that Scenario 1 is highly unlikely because
significant products are already making an impact in agriculture and
that it is not likely that the adoption of products will decrease from
current rates. Some members added that with liberalization of
agricultural trade, more countries would use biotechnology to manage
import and export markets. Other members offered that Scenario 1
describes a future where there is a lack of delivery of a second wave of
products because of controversy around acceptance and, while not likely,
is a possibility. Some Committee members noted a possibility exists that
events could cause rollback of even current uses of biotechnology.
Members suggested that the language be clarified to focus on the second
wave of technology and to focus on the safety issue. In addition,
"Biotechnology Bust," if this term is used, should be further defined
and clarified with regard to new products and existing products.

A member suggested that Scenario 3, the Continental Islands or variable
adoption scenario could encompass the use of alternatives to ease food
and agricultural production challenges, including through the use of
other technologies. Another member thought this aspect would fit more
appropriately in the Biotechnology Bust scenario within the controversy
surrounding the use of genetic engineering.

Regarding Scenario 3, one member noted that variable adoption does not
have to be tension driven, but rather can reflect different approaches
to addressing needs. Other members noted that Scenario 3 includes the
use of other technology to achieve goals and that a gap between
information on genes and the development of real applications could
continue to exist in the next ten years.

*Certainties and Uncertainties*\
The committee discussed the list developed by the Work Group and
provided as a meeting document. Additional drivers suggested by
Committee members for the list included: (Note: For some driving forces,
the Committee discussed whether the issue was a certainty or
uncertainty. The suggestions by members are noted after each driver
below)

-   Developments within biotechnology itself.

-   Changes in water quality and quantity and potential biotechnology
    impacts on these factors (some aspects certainties, others probably
    uncertain).

-   Human health (HIV/AIDS, obesity/western lifestyle, increasing
    research on prevention of chronic disease, life sciences research,
    impact of tobacco related disease in developing world); possible
    addition of a new section on these issues.

-   Increasing use of synthetic fertilizers and impact on the amount of
    available arable land, especially in Brazil (certainty).

-   Genome information expansion.

-   Newly discovered diseases of plants and animals seen with human
    encroachment in new lands.

-   Vulnerability of food and agriculture systems due to movement and
    spread of diseases.

-   Energy needs and bio-based energy production (certainty).

-   Infrastructure needs in the U.S. (e.g., waterways, transportation,
    storage, highways).

-   Increasing number of sanitary and phytosanitary issues (certainty).

-   State of education of public on biotechnology (uncertainty).

-   Negative biotechnology event of some sort (certainty).

-   Food is treated differently in national policies than all other
    goods traded globally, based on national self-interest and sanitary
    issues (certainty).

-   Liberalization of agricultural trade (certainty).

-   Biotechnology development may "leapfrog" in China and India and may
    bring with it associated trade issues (uncertainty).

-   Increasing dialogue and exchange among developing countries
    (certainty).

-   Increasing importance of biotechnology in other countries and
    product approvals in those countries that might impact the U.S.
    (uncertainty).

-   Technology adoption by countries with more resources (certainty.)

Some members commented that the EU would continue to be a large market
and an importer with a strong international voice, while others believed
that the EU's influence in driving global agricultural policy could
decrease, with the region remaining a major purchaser with influence on
the global economy.

In response to a member's request to elaborate on the connection between
biotechnology and water shortages, members explained that in
demonstration plots simulating dry conditions, biotechnology crops have
worked well with no-till approaches with dry crops allowing crops to be
grown with less water.

A member recommended that inconsistencies between certainties and
uncertainties be edited out in the final report.

*General Comments*\
The Committee discussed the scope of and basic definitions used in the
scenarios and overall report, such as "genetically engineered" products,
noting that the less precise term "genetically modified organisms
(GMO's)" should be avoided. A member suggested that scenarios should
encompass broader technology than transgenics and should go beyond
existing crops and include those anticipated in the next ten years.
However, other members explained that the draft language of the report
indicates a focus on transgenics and that broadening the scope could
result in too many variables to include in the scenarios, as well as
make the report scope unmanageably expansive. Members commented that
focusing on genetically engineered products throughout the report and in
discussions is important, recognizing that the use of information from
genomics in enhanced traditional breeding also merits discussion.
Members also emphasized that the scenarios should be built around the
scope of agricultural biotechnology products discussed in the early
chapters of the report and be consistent in all three scenarios.

It was suggested that when drafting the text, the Work Group use less
emotional language and less extreme situations, although many members
recognized the value in emphasizing differences among the scenarios.
Others commented that the scenarios need to be different enough to see
the effect of different drivers and impacts.

Members also suggested that the cost of not adopting or the cost of not
moving forward with research be factored into the scenario analysis.

Regarding the use of scenarios, members asked whether the scenarios
would be used as a lens through which to view the identified issues and
concerns or existing USDA policies. Some suggested that the scenarios
include a list of the drivers that influence the increased or decreased
use of technology and that the scenarios could help shape research and
USDA priorities. Members noted the different purposes of scenario
building. One purpose is to determine what future is likely or preferred
and then to develop strategies to achieve the preferred future. An
alternative approach is using scenarios to prepare for any of several
possible futures. Scenarios can be used to examine the drivers'
influence on technology development and highlight those that USDA could
influence. Some members emphasized that scenario development conducted
by this Committee should describe potential futures and help USDA
prepare for the potential of multiple scenarios. USDA should review and
interpret the information contained in the report on scenarios as a tool
to make appropriate decisions on policy and resources in preparing for
varying futures. The report should not determine which future is
preferable and then suggest how USDA can set policy to shape that
preferred future. One member recommended using key uncertainties to base
the different scenarios and to keep the scenarios within the realm of
possibility.

Members also discussed the organization of the report, specifically the
order of the Issues and Concerns chapter and the Scenarios chapter. Some
Committee members recommended that the Scenarios chapter be discussed
before the Issues and Concerns chapter to provide a lens for examining
the issues. Others supported the reverse order, with the Issues and
Concerns chapter first, and then the Scenario chapter.

Mr. Hegwood commented that the Committee generally is moving in the
right direction and encouraged the Committee to go beyond where the
technology is currently going to help USDA examine issues, drivers and
the changes on potential futures. For example, he noted, the report
could address the extent to which changes in agriculture, the way
animals are produced, and the nature of their interactions with humans,
affect, or are affected by, global pandemics.

*Scenario Work Group Charge and Next Steps*\
Dr. Schechtman noted that USDA is seeking agreement from the Committee
on the direction of the scenarios. Ms. Dilley listed key next steps,
including defining a charge to the Work Group to be reviewed by the
Committee, clarifying the terminology used in the report, and
determining how the list of certainties and uncertainties will be used,
depending on the defined goal of scenario development. She also noted
that the discussions of why different scenarios would unfold are just
beginning and would be a next step of the Work Group.

Members reviewed a draft Work Group charge distributed at the meeting.
Although, in general, the Committee agreed with the draft charge,
wording changes were recommended, discussed, and adopted, resulting in a
slightly modified draft charge.

Members returned to a discussion concerning the purpose of scenario
building. Various Committee members offered the following potential
purposes: to write a story of a future new reality; to look at different
impacts on agriculture; to be able, by assuming that a scenario has
actually occurred based on identified driving forces, to examine what
policies have evolved from that, or to contemplate possible futures and
think about how to prepare for any or all of the scenarios. Members
offered differing viewpoints on whether an analysis of the implications
of the scenario is included as part of the scenario or conducted after
the scenario in reflecting back on the issues and concerns. Members also
discussed whether probabilities should be assigned to the scenarios. It
was suggested that this probably would not be useful or appropriate.

Other suggestions included adding a series of key questions to be
reflected upon under different scenarios in order to highlight
particular considerations and writing the scenarios with the certainties
and uncertainties in mind. Another member offered the thought that,
based on other scenario development efforts, the length of each scenario
should be approximately 5-6 pages long.

Mr. Hegwood reminded the Committee that the scenarios should address the
issues within the USDA's authority and mandate, such as issues
associated with assisting farmers, transportation, energy, research,
animal and plant health and safety, food safety, changes in rural
communities, and changes in economic developments.

Dr. Schechtman noted that, due to time constraints, the Committee has
begun developing scenarios before basic principles have been
established. Some members expressed that the process being followed is
nonetheless similar to those seen in business environments. Dr.
Schechtman also noted that Juan Enriquez-Cabot, a Committee member who
was a key proponent of scenario development, will be mostly unavailable
to the Committee in the next few months, but he will look to other
resources to contribute to the effort. He also asked the Committee to
send additional written comments on the scenarios to him.

**VI. Public Comment**

The public comment period was scheduled from 3:30 to 5:00 pm on the
first day of the AC21 meeting. No individuals requested public comment
at that time.

**VII. Introduction and Presentations on Trends in Public versus Private
Biotechnology Research**

Dr. Schechtman introduced the four presentations on the topic of trends
in public versus private biotechnology research. He noted that support
for agricultural research is an essential component of USDA's mission,
carried out through its research agencies. Examples of trends include a
move towards smaller acreage crops in the public sector and the
increasing investment of the private sector in transgenic plant
research. Public sector applied biotechnology research, especially USDA
funded research, is largely targeted towards developing varieties that
are not expected to create sufficient financial returns to attract major
commercial funding.

USDA-APHIS has to date completed regulatory review and deregulated
transgenic varieties of 14 crop species. Dr. Schechtman added that,
although 70 public institutions are participating in field trials of
transgenic plants, only two biotechnology varieties, virus-resistant
squash and papaya, have been approved or are being planted in the United
States. This highlights an overall trend of public sector research
products not making it into the end stages of the regulatory process. He
then posed a number of questions to the Committee on cost, regulatory
burden, consumer confidence, partnerships, institutions developing
countries, and other issues to think about during the presentations.

Dr. Schechtman also noted that other entities are exploring this topic.
the Cooperative State Research, Education and Extension Service
(CSREES), the Agricultural Research Service (ARS), the National Center
for Food and Agricultural Policy (NCFAP), State agricultural experiment
stations, small business, and the three regulatory agencies (USDA-APHIS,
EPA, and FDA) are planning a national expert workshop to study the
question, \"What can USDA research agencies do to facilitate the
regulatory consideration of small-market biotechnology crops resulting
from their research programs and from the research of their partners?\"

*Commercializing USDA Innovations via Public-Private Partnerships*\
The first speaker, Ms. June Blalock, Coordinator, Technology Licensing
Program, USDA Agricultural Research Service (ARS), presented
"Commercializing USDA Innovations via Public-Private Partnerships." She
began with a review of federal technology transfer legislation,
including five Acts instituted between 1980 and 2000. Ms. Blalock noted
that Congress continues to view public-private partnerships as an
important route for accomplishing technology transfer.

Ms. Blalock outlined several USDA goals for facilitating and supporting
technology transfer and USDA technology transfer policies related to
patent and licensing decisions. The roles for private sector partners in
transferring public sector innovations include investing in the
development and marketing of licensed products and services, making
licensed products and services widely available, and providing the
complementary assets required for commercialization. She highlighted a
new Congressionally granted tool that allows for the protection of
federally-owned inventions while offering private partners some scope of
exclusivity to protect the capital investments required to commercialize
inventions.

Ms. Blalock presented selected data on USDA technology transfer for
fiscal year 2003 including information on Cooperative Research and
Development Agreements (CRADA), patents, licenses, income and revenues,
as well as specific examples of licensed USDA technologies.

She also listed several factors affecting the "partnership value" of
agricultural biotechnology innovations including consumer acceptance,
industry consolidation, biosafety regulations and liabilities,
international trade agreements and enforcements, IPR availability,
enforcement and freedom to operate, and advances in tools and
technology. Ms. Blalock concluded by discussing the complementary
assets, such as facilities, access, expertise and investment capital
needed from partners for agricultural biotechnology innovations. She
also noted that partners are critical for turning research results into
marketable products.

In response to Committee members' questions, Ms. Blalock described two
(non biotech-related) licenses that went off patent: a technology for
vaccinating chickens in ovo and a nutritional supplement for chromium.

Regarding research in industrial applications, she noted that most of
the research focuses on production issues, based on Congressional
funding. One member inquired about the amount of effort and resources
devoted to supporting organic agriculture compared to transgenic
agriculture. Ms. Blalock answered that both types of research comprise a
small amount of the USDA's research budget and much of the overall
research is applicable to organic farmers. In response to questions
about how revenue from patents is used, she explained that Congress
directs how the money is allocated. The first \$2000 plus 15% goes to
the inventor and the rest of the revenue is reinvested in technology
transfer, patent costs, and salaries in the Office of Technology
Transfer.

*Publicly Funded Agricultural Biotechnology Research*\
Dr. Randy Woodson, Associate Dean and Director of Agricultural Research
Programs at Purdue University, presented "Publicly Funded Agricultural
Biotechnology Research." He opened by describing several challenges to
bringing agricultural biotechnology products to market. The challenges
include cost of regulatory approval, market valuation, public funding of
agricultural research, access to IP, sharing of information, and the
changing research university agenda. The millions of dollars required to
bring a product to market limits the type of products that are developed
and limits commercialization to the private sector. He suggested
approaches to address the cost issues, such as university --industry
partnerships, public funding of agriculture biotechnology research, and
an IR-4-like organization to develop data for biotechnology applications
in the public good.

Dr. Woodson also further described the challenges of minor crops,
fragmentation of IP ownership, and limited support that influence market
value and market choices for agricultural biotechnology products. Other
areas, such as low value crops, low value traits, developing country
agriculture and breeding partnerships between the public and private
sector are missed opportunities in the agriculture biotechnology field.
Dr. Woodson also stated that an integrated technology platform is
required for research.

Dr. Woodson posed the question of whether public research organizations
can take an approach similar to the private sector in IP management
strategies. Public Resource Intellectual Property for Agriculture
(PIPRA), a new organization, is a collective of 27 public research
universities that have agreed to share information and educate the
research community on availability of public sector agricultural
biotechnology, as well as to encourage access to IP for developing
countries. He showed data on the growth in agricultural biotechnology
patents and the concentration of ownership of agriculture biotechnology
patents, which are largely held by the private sector, although
universities hold a moderate portion of the patents. As an example, Dr.
Woodson showed a comparison of public and private intellectual property
holdings related to environmental stress resistance, an area in which
the public contribution is significant.

Dr. Woodson continued with a description of the characteristics of
public sector agriculture biotechnology IP, including a broad variety of
technologies that are highly scattered across technology systems and
across institutions. He summarized the state of public funding for
agricultural research as down overall except for support for genomics
and risk assessment. He stated the need for a publicly funded system for
generating regulatory data. He also described the increasing control
over exchange of information and material and the challenges of access
to IP and technology for academic scientists.

Dr. Woodson concluded by presenting a model showing the historic
transition of the public research universities from having exclusively
academic and educational goals to acquiring economic development
functions that require public sector partners to move discoveries and
contribute to commercialization of new products.

Following the presentation, a member expressed support for a IR-4-type
biotechnology entity and asked how such a biotechnology IR-4 would be
funded and structured. Dr. Woodson responded that budget requirements
are difficult to estimate, but a publicly funded program to acquire
necessary data on product safety and utility would be useful for the
regulatory framework. Another member asked for clarification on USDA
funding for agricultural biotechnology over time. Dr. Woodson answered
that the funding has been flat in current dollars since 1980 and
comprises only 3% of USDA's research budget. He added that dollars from
one program, the Initiative for Future Food and Agricultural Systems
(IFAFS), a one-time program, have had significant impact on minor crops.
A member asked what the impact on minor crop agriculture research would
be if regulatory approval requirements for minor crops were expanded to
include crop improvements through mutagenesis. Dr. Woodson responded
that this technique is used in minor crop breeding and thus such an
expansion could have a significant impact.

A member asked what mechanisms could be used to identify the scattered
research on non-major crops in developing countries. Dr. Woodson
explained that the USDA Current Research Information System (CRIS)
database provides access to all publicly funded agricultural research
and a US Agency for International Development (USAID) database contains
information on research focused on developing countries.\
In response to a question regarding the success of non-exclusive
licensing arrangements with the private sector, Dr. Woodson stated that
licenses are used in a way to get the product to market and to the most
consumers quickly, often through non-exclusive arrangements.

A member commented that the list of public universities patents holding
in the presented did not contain products with direct consumer benefit
and recommended that more of these products should be identified. Dr.
Woodson responded that other ongoing research that is not connected with
stress resistance includes some patents that do offer consumer benefits.
He added that agriculture schools are now beginning to turn more
attention to markets and the research needed to support it. Another
member added that public agricultural research deserves more attention,
not just from the producer community, but also from the public at large
and warned of dangers of the current system of limited monopolies that
allow people to restrict access to data. Large transaction costs, which
do not function effectively for new agricultural areas, are expended in
the patent system. The member suggested rethinking IP to encourage
innovations and noted that consumer demand for some biotechnology
products is low while existing technology is sufficient for some
products.

*University-Industry Relationships in Agricultural Biotechnology:\
Filling the Information Gaps*\
Dr. David Ervin, of Portland State University, presented
"University-Industry Relationships in Agricultural Biotechnology:
Filling the Information Gaps." With USDA funding, a team of
universities, foundations, and non-profit organization is undertaking a
project to assess research, licensing and other university-industry
relationships (UIRs) in agriculture biotechnology. The project includes
several objectives for developing an information base on UIRs, building
and testing models of factors affecting agricultural biotechnology UIRs,
analyzing the extent to which UIRS foster public goods and policy
options, and fostering dialogue. He also reviewed forces shaping UIRs
and university research and developing funding trends since 1960.

Dr. Ervin outlined four major activities of the project, including an
expert workshop, case studies, a national survey of bioscientists, and
educational outreach. The purpose of the expert workshop, held in 2002,
was to identify knowledge gaps in an effort to collect baseline
information on agricultural biotechnology UIRs and factors affecting
scientists' research agendas, such as tenure, industry funding, and the
presence of an Office of Technology Transfer. The workshop also examined
issues around scientists' research and intellectual property and
technology transfer issues.

Case studies are ongoing at seven universities and collaborating firms.
Some of the preliminary findings Dr. Ervin discussed were that
university administrators believe that researchers are driven more by
scientific interest than potential commercial uses and that they have
favorable opinions of UIRs. While a minority of administrators is
concerned about the potential negative impact on public science, the
general positive view of UIRs could help promote more market-oriented
research.

The project also includes a web-based national survey of 1,400
bioscientists working on agricultural biotechnology. Scientists from
land grant, public non-land grant, and private universities are included
in the survey, which has achieved a high response rate. Key preliminary
findings presented reveal that the Federal government is providing a
large proportion of funding in this area, while about 22% is coming from
private firms. Funding from firms is a small percentage of these
researchers' funding portfolios, according to the survey.

Dr. Ervin concluded with several key research questions on how industry
support is related to scientists and their research agendas, as well as
how scientists' views of university roles affect their research field or
topic.

In response to questions following the presentation, Dr. Ervin clarified
that he hoped to gain from the analysis of the scientists' survey and
case studies insight regarding the presence of a public-oriented mission
in public universities' approach to research. He noted apparent
differences in culture among research universities, and even among the
land grant universities. He said that he hoped to gain insight into the
researchers' views on the roles of the university in public research

Dr. Ervin also explained that the bioscientists who were sent the survey
were selected by prescreening them through a random selection of ten
each of the three types of universities. The survey team then contacted
the relevant department chairs at these universities to obtain further
information on bioscientists working in the biotechnology field.

One member asked if the survey would measure the proportion of
outcome-based research. Dr. Ervin responded that the survey would rank
typical discoveries, from basic to applied, in order to provide a sense
of the distribution of types of research. In response to further
questions on relationships, he replied that the team is trying to build
and test some models about why agricultural bioscientists interact with
industry, what are the motivations, what kinds of impacts they derive
from those interactions, what sort of support they get, and what the
impacts are on their research portfolios. A member commented that
administrator attitudes could affect the relationships and direction of
research significantly.

*Challenges in Bringing Public Sector Biotechnology Products to
Developing Country Farmers*\
Dr. Anatole Krattiger, of Cornell University and bioDevelopments, gave a
talk on "Challenges in Bringing Public Sector Biotechnology Products to
Developing Country Farmers."

Dr. Krattiger began with an overview of features of technology transfer
to developing countries, noting that the issue is complex and involves
different drivers, motivations, and perceptions among interested
parties. He provided two examples of biotechnology in Bt cotton in South
Africa and China.

Addressing perceptions about technology transfer, Dr. Krattiger stated
that, in his view, intellectual property (IP) is not a significant
obstacle to technology transfer except in the absence of IP rights and
enforcement. IP considerations affect the assembly of technology rather
than its transfer and, in his view, trade secrets are more important
than IP. Public-private partnerships and collaboration can address
challenges in this area. He noted other differences between features of
assembly and technology transfer, emphasizing that technology transfer
is best served by critical mass, general applicability, and shared or
complementary market interests. Overall, reallocating resources to the
South and promoting stewardship downstream are important.

Dr. Krattiger listed several factors that drive technology adoption,
including demand, market structure, and divisibility of technology
(i.e., who benefits.)

On the topic of university biotechnology transfer activities, Dr.
Krattinger presented the five forms of transfer as turn-key investments,
mergers and acquisitions, strategic alliances, licenses, and capacity
building. Examples of these initiatives are research in areas such as
golden rice and genomics and fellowships and internships for students.
Dr. Krattiger displayed a graphic representation of the international
agricultural research and development system which identified the points
of transfer and noted that few universities have direct links to
developing countries. He listed several service initiatives that involve
collaboration, partnerships, and in-country initiatives as well as model
funding schemes.

Dr. Krattiger listed private sector constraints, biotechnology
capabilities, the product development process, and public sector
effectiveness as key challenges for bringing public sector biotechnology
products to developing country farmers. He added that transfer is driven
by factors such as stewardship, regulations, pricing, market access, and
funding.

Dr. Krattiger also briefly discussed the biosafety process, the need for
sound biotechnology policy, and the benefits of agricultural
biotechnology for the national economies of certain countries. In
conclusion, Dr. Krattiger emphasized the benefits of products such as
golden rice and the associated GDP increases in developing countries.

Following the presentation, a member asked whether the fact that patents
on some early biotechnology applications that will soon expire will
affect transfer issues. Dr. Krattiger responded that it would make only
a small difference because most patents are not issued in the developing
world. He added that contacts and transfer agreements are particularly
important.

Another member asked for clarification on the benefits to small farmers
in developing countries. Dr. Krattiger answered that in some countries,
the market for technology commercialization is uneven; black markets
have developed in some counties without licenses. Regarding a question
about difficulties in technology transfers to Uruguay, he commented that
reluctance in the new area of feed crops and concerns about public
perception and liability issues, were the issues in that instance.

In response to a question about potential solutions to trade issues, Dr.
Krattiger suggested that service organizations could be set up to assist
with regulatory aspects, regulatory standards could be eased to
facilitate technology deployment, or licenses could be offered only for
crops not being traded internationally.

A member discussed the current situation in the Philippines, and noted
that early on, even though a biosafety structure had been put in place,
initial technology transfers were not successful. Dr. Krattiger agreed
that, although the Philippines was the first developing country to
create a biosafety law, there had not been one single field trial for a
number of years because of a lack of political will. He added that
biotechnology policy decisions should be made on scientific evidence and
risk assessment.\
Another member noted that several developing countries have been
successful in public sector application of technology in specialty
crops. Dr. Krattiger responded that some have used public/private
entities and the situation will change as significant investments are
made and proper testing is conducted to get the crops to market. A
member inquired about when these countries will produce products for
export to the U.S. Dr. Krattiger replied that the current driver is
national consumption and he would not expect exports in the next
five-ten years, except in manufactured products. He added that entering
the U.S. market would be fairly easy, given predictable, science-based
regulations and less expensive requirements than some countries.

Dr. Schechtman wrapped up the series of presentations by reminding the
Committee to think about a process to reflect on the issues raised
during the session in the Committee's report.

**VIII. Discussion of Progress of Work Group on Other Countries'
Traceability and Labeling Regimes for Biotechnology-Derived Products**

Ms. Sulton introduced the discussion of the work of the Labeling and
Traceability Work Group. Leon Corzine, Richard Crowder, Randy Giroux,
Ron Olson, Lisa Zannoni, and Greg Jaffe participate in the Work Group,
which met twice via conference call.

Mr. Olson summarized the process and results of the Work Group's
efforts. The charge to the Work Group was to develop an outline for a
report assessing traceability and labeling requirements and commercial
implications for U.S. origin products. Mr. Olson then reviewed the draft
outline of the traceability and labeling report. The three major
sections of the outline are 1) scope of requirements, 2) commercial
impacts/realities, including a discussion of compliance and several
other issues, and 3) key policy issues. The group has addressed and
developed background papers on several topics within the first two
sections, but has not yet addressed policy issues. He discussed tracing
and labeling requirements and commercial implications for U. S. origin
products in view of global legal and commercial requirements and
international agreements. He then reviewed the draft outline of the
report that was distributed to the Committee, highlighting the Work
Group's discussion of compliance categories for the various countries,
adventitious presence, the scope and range of traceability systems with
primary focus on grains and ingredients, the interplay between testing
and tracing, liability or risk transfer, contracting, market
segmentation, and value sharing.

Dr. Zannoni provided insight on the commercial issues at the
international level by relating her experience at the recent meeting
first Meeting of the Parties to the Biosafety Protocol in Kuala Lumpur,
Malaysia. About 70 countries are Parties. Only Parties to the Protocol
are allowed to participate in decisions, but others observed and offered
comments. Dr. Zannoni explained that the treaty covers only actions
outside country borders. Domestic laws and regulations take precedence
once a product is inside country borders. Several working groups met
during the meeting, was and those groups were open for comments from
countries who have not signed on to the Protocol on topics such as
documentation and terminology. Documentation discussions relating to
commodities for food, feed, or processing included a possible
requirement for a unique code or verification number such as has been
developed by the OECD, a"may contain LMOs (living modified organisms)"
or other information requirements. Major exporting countries raised
concerns about the practicalities of implementing the requirements while
maintaining effective trade.

Committee members commented on the challenges of documentation,
including the sheer volume of codes and numbers of farmers and others
involved throughout the supply chain. At the farm level, technology such
as global positioning systems (GPS) and other systems are being
evaluated with regard to cost and value in a limited market. Other
members added that USDA should take a proactive role in development of
detection methodology at the international level. It was noted that
stacked traits present another challenge in international trade, as they
are not approved in some countries and there is not a good test for
evaluation.

**IX. Guidance to Work Group on How on Adapt the Information Developed
on Traceability and Labeling into a Report**

The Committee members then offered specific comments on the topics
highlighted in the outline. On the topic of adventitious presence, some
members requested further clarification on why four different types of
adventitious presence are addressed. Members noted the need for a
working definition of adventitious presence in the report. Elements that
should be addressed in the definition include unintended presence and
negligence. Another member added the need to examine the issue of
thresholds for adventitious presence and legal liability. Mr. Olson
noted that other entities within USDA are working on these issues and
will not be addressed in detail in this report. After discussion,
members agreed that the Traceability and Labeling Work Group would draft
a definition of adventitious presence and send it to all Committee
members for comment and incorporation into each part of the report.

Some members also recommended keeping a placeholder for a discussion of
seed supply issues.

A Committee member emphasized the importance of identity preservation
systems for the traceability discussion. Another member countered that
little resources exist in the system to pay for an extremely
sophisticated tracing system and the focus should be on segregation
rather than identity preservation. The system needs to be economically
viable and to accommodate bulk grain movement, which is a large
challenge for identity preservation. Another member noted that the U.S.
might be required to follow some types of requirements for the country
of destination as a party to the International Plant Protection
Convention.

In response to questions about labeling issues, Mr. Olson clarified that
the group has not focused on the interplay between labeling and tracing
as yet.

At the conclusion of the comments, Ms. Sulton stated that the goal of
the group is to have a draft of the traceability and labeling report to
Committee members by the June plenary meeting. Dr. Schechtman confirmed
support by Committee members for the general direction of the report and
the development of a document with the suggested modifications.

**X. Discussion of Work Plan and Next Steps**

Ms. Dilley and Dr. Schechtman reviewed the next steps identified by the
Committee for work on the report:

-   Revise the report Introduction.

-   Review and revise the Issues and Concerns document.

    -   Members are encouraged to submit comments in writing.

    -   Members may be asked to write paragraphs for specific sections
        of the report.

    -   USDA and the meeting facilitators will incorporate the comments
        and submit the documents back to the Committee.

-   Create plans for Work Groups proceeding with their charges and
    developing chapters of the final report from the draft working
    documents.

-   Discuss further how benefits will be organized in the report,
    whether in introductory sections or in the issues and concerns
    chapter.

-   Revise and distribute the report outline.

-   Meet with new Committee member Carol Tucker Foreman (USDA).

-   Prepare a next steps memo outlining action items and assignments
    (RESOLVE and USDA)

The Committee offered additional suggestions for the organization of the
report, including shortening the Introduction and adding a section on
status of the technology. The Committee considered placing the
discussion of benefits/promise in the Introduction, Issues and Concerns,
or a separate section of the report on the status of the technology. One
member thought that the "Perils of Forecasting" section should not be
included in the Introduction. Another member also encouraged the
Committee not to let the structure of the report drive its substance. It
was decided that there would be two introductory chapters, one outlining
the purpose and contents of the report and the second discussing current
benefits and promise of the technology, plus providing the snapshot of
what types of products would be most likely to be commercialized over
the next 5 to 10 years. A description of "the perils of forecasting"
would be included as part of the introduction to the scenarios chapter.

Ms. Dilley asked Committee members for their recommendations for
addressing research questions identified by the Committee. She suggested
such options as addressing research issues in another report or adding
them to the Issues and Concerns discussion of the current report. A
member suggested that the impact of regulations on publicly funded
research and enhancements of minor crops and a lack of increase in
funding should be addressed, possibly in the regulatory issues section.
Several members supported including a brief discussion of research as
context in the Issues and Concerns section or in the Introduction.
Research issues proposed for inclusion were minor crop issues, publicly
funded research, and infrastructure development. A more comprehensive
discussion and possible report on this topic was proposed to be taken up
subsequent to the completion of the two reports currently under
development by the Committee. Ms. Dilley asked for volunteers to develop
a short piece on these issues to be added to the current report, most
likely in the Issues and Concerns chapter. Duane Grant and Mardi Mellon
volunteered to take the lead on this effort. In addition, the Scenarios
Development Work Group was encouraged to include some element of this
issue in developing the different scenarios.

Dr. Schechtman recommended that Committee members interested in scenario
building refer to the book The Art of the Long View by Peter Schwartz
for information on the process.

*Meeting Dates*\
The Committee confirmed dates for the next plenary session of June 3rd
and 4th. The facilitator will check with the Committee members not
present to ensure no major conflicts exist. Committee members requested
that the meeting on the 4th, because it is a Friday, begin at 8:00 a.m.
and conclude by 4:00 p.m., allowing adequate time to return home that
evening. Committee members also asked that future dates not overlap with
other USDA advisory Committees. RESOLVE will send out a scheduling
request to set dates for plenary meetings in September and December,
2004.

**XI. Summary of Fourth Plenary Session**

Dr. Layton closed the meeting with a review of the many topics covered
and commended members for their comments and ideas. She thanked
Committee members for their hard work preparing documents for the
meeting. She added that much work is before the Committee prior to the
June meeting in developing report chapters. The meeting was adjourned at
4:15 p.m.