# Advisory Committee on Biotechnology & 21st Century Agriculture (AC21) Meeting: December 9-10, 2004

Seventh Plenary Meeting\
December 9-10, 2004**\
**Waugh Auditorium\
USDA Economic Research Service

**Draft Meeting Summary**

On December 9-10, 2004, the United States Department of Agriculture
(USDA) convened the seventh plenary meeting of the Advisory Committee on
Biotechnology and 21st Century Agriculture (AC21). The meeting
objectives included:

-   To finalize, for submission by the Committee to the Secretary, the
    draft report on other countries' traceability and mandatory labeling
    regimes for biotechnology-derived products, the implications of
    those regimes, and how U.S. industry is addressing the requirements
    for products shipped to those countries;

-   To review and move towards finalizing the other draft report
    examining the impacts of agricultural biotechnology on American
    agriculture and USDA over the next five to ten years; and

-   To determine processes for finalizing the Committee reports.

The AC21 includes representatives of industry, state and federal
government, nongovernmental organizations, and academia. The following
AC21 members were in attendance: Dr. Patricia Layton, Dr. Daryl Buss,
Dr. Juan Enriquez-Cabot, Mr. Leon Corzine, Dr. Carole Cramer, Dr.
Michael Dykes, Ms. Carol Tucker Foreman, Mr. Duane Grant, Dr. Randal
Giroux, Mr. David Hoisington, Mr. Greg Jaffe, Mr. Terry Medley, Dr.
Margaret Mellon, Mr. Ronald Olson, Mr. Jerome Slocum, Mr. Keith
Triebwasser and Dr. Lisa Zannoni. Dr. Patricia Layton chaired the
meeting. Dr. James Maryanski of the U.S. Food and Drug Administration,
Dr. Elizabeth Milewski from the U.S. Environmental Protection Agency,
and Dr. Vincent Vilker from the National Institute of Standards and
Technology attended as ex officio members. Dr. Bernice Slutsky, Special
Assistant to the Secretary of Agriculture, and Dr. Michael Schechtman,
the AC21's Executive Secretary and Designated Federal Official (DFO)
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.
Below is a summary of the proceedings, prepared by the facilitation
team.

**I. Welcome and Opening Comments**

Dr. Michael Schechtman opened the proceedings at 9:00 a.m. by welcoming
all the members, ex officio representatives, and the public in
attendance to the seventh 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 listed as available to the public documents previously
distributed to AC21 members, and subject to discussion or reference
during the course of the Committee's deliberations:

-   Provisional agenda for the December 9-10, 2004 plenary meeting

-   AC21 Charter

-   AC21 Bylaws and Operating Procedures

-   Biographical sketches of AC21 members

-   Draft summary of the September 13 -14, 2004 AC21 plenary meeting.

-   Draft summaries of eight work group sessions convened in October and
    November

-   Current draft of the Issues to Consider chapter

-   Outline for the first introductory chapter

-   Revised text for the second introductory chapter

-   Draft of the chapter entitled, Preparing for the Future, consisting
    of an analysis of certainties and uncertainties perceived to be
    drivers for the future and three thought provocative scenarios.

-   Draft definitions.

-   Draft tentatively entitled, "Global Traceability and Labeling
    Requirements for Agricultural Biotechnology-Derived Products:
    Impacts and Implications for the United States."

Dr. Schechtman reviewed the objectives of this seventh plenary meeting
(listed above) the status of the AC21 rechartering process and
membership renominations. . He noted that the terms of half the
Committee members expire in February 2005. Dr. Schechtman advised that
while it was possible that the AC21 would not meet its initial goal of
getting two reports finished by the end of 2004, the work on the reports
for the Secretary would continue.

Dr. Layton welcomed members and the audience to the meeting and
expressed her pleasure with the progress on the AC21 reports to date,
but noted that much work remains.

Dr. Bernice Slutsky also offered opening remarks in which she emphasized
the value to USDA of the issues the Committee is addressing in its two
reports. She explained that biotechnology is of interest to virtually
every agency in USDA. Further, she suggested that there would be new
areas of work for the Committee and opportunities for greater
interaction between the Committee and USDA's senior staff and policy
level groups.

**II. Remarks by Dale Moore**

Mr. Dale Moore, Chief of Staff to the Secretary of Agriculture, reported
that he and the Secretary are updated regularly on biotech issues and on
the activities of the Committee. He noted that Secretary Veneman is
extremely interested in and appreciative of the Committee's work on the
two reports. They are on the cutting edge and will serve as the
foundation for ongoing work for Secretary-Designate Johanns. On behalf
of Secretary Veneman, he thanked the Committee for their hard work.

In response to members' questions, Mr. Moore noted that an interest in
examining the existing biotech framework does exist at USDA. While
reform is not just around the corner, the Department is looking into
revising the framework with a balanced, cooperative approach.

**III. Review of the September 13-14, 2004 Meeting Minutes and Agenda
Outline**

Ms. Sulton briefly reviewed the highlights of the sixth AC21 meeting
held on September 13-14, 2004, and asked for any additional comments on
the draft meeting summary. Given that members offered no additional
comments, the meeting summary was finalized and will be posted on the
USDA AC21 website.

Ms. Dilley then reviewed the meeting agenda, but noted that the timing
would be flexible to allow the Committee to focus on finishing the
"Traceability and Labeling" report.

**IV. Discussion of Progress of Work Group on Traceability and Labeling
and the Draft Report**

(Note: The AC21 members discussed and developed the "Traceability and
Labeling" report, as well as determined further plans for its
finalization, during sessions on the first day and second day of their
deliberations. All of these discussions are presented in this portion of
the summary.)

Dr. Schechtman introduced the work of the Traceability and Labeling Work
Group and summarized the status and structure of the document that the
Work Group drafted for the full Committee's consideration. Ms. Sulton
suggested that the discussion of the report begin with reactions to the
documents as whole, then focus on the implications section before
reviewing each section.

*General Comments on Report*

A member expressed reservations about sending only the "Traceability and
Labeling" report to the Secretary in view of the importance of the other
report on long-term issues. The member commented that the "Traceability
and Labeling" report is written from industry's point of view, addresses
an important but narrow set of issues and, therefore, should not be a
separate and independent document. She suggested that to prevent
misinterpretation, the Executive Summary clearly state that the
"Traceability and Labeling" report is the first of two reports that are
both part of the AC21's charge and that the other document will be
completed and sent to the Secretary within a specified timeframe.

Another member commented that the report is written from the perspective
of U.S. as an exporter in the grain market, but also should recognize
that, in the future, the U.S. could become an importer of biotech
agricultural products. Others disputed the advisability of addressing
importing in this report. In discussing which crops should be covered in
this report, members also considered whether to include minor crops and
agreed that, while minor crops were not discussed specifically, the
issues identified were relevant for major and minor crops for grain and
grain products. Another member suggested that the report clearly
distinguish between issue statements and recommendations.

A member suggested that the report include a few paragraphs under a
distinct heading acknowledging that the impact of countries'
differential traceability and labeling requirements on consumers. The
member noted that consumers in some countries have access to information
on genetically modified ingredients and GM-free products that is
generally not available in the U.S. and studies have found that
consumers want this information. Others commented that the supply chain
serves the consumer and that the cost of traceability and labeling could
be higher than some think. Others noted places in the report where
consumer issues such as "right to know" are already mentioned. After
discussion, the Committee agreed that during meeting breaks a small
group of members should draft a section on the impacts on consumers of
various labeling regimes.

Some members disagreed with the use of terms "transgenic free" or
"GM-free" in the report because it is not commercially feasible to
achieve levels of zero genetically engineered ingredients. In addition,
different tolerances among countries affect the interpretation of the
meaning of the term "free." Another questioned whether the report was
too "European Union-centric."

A member of the Work Group responded to questions about the report's not
addressing food additives, food colorings, enzymes, etc. by explaining
that the Work Group had discussed the topic and advocates limiting the
discussion to fee, grain and grain products. However, he noted that this
limitation could be specifically stated up front in the introduction.

After discussion of optional report titles, the Committee decided to
retain the present title for now.

Other key changes to the overall report identified by AC21 members
included:

-   The meaning of the term "risk" as regards health, safety,
    environment or commerce needs to be clarified in a new definitions
    section and the term used consistently throughout the report.

-   The term "grain and grain products" needs to be used consistently in
    the report, rather than the term "food and feed," and it needs to be
    noted that the implications of traceability and labeling for
    non-commodity or specialty plant-based food products are likely to
    be similar to those for commodity crops.

-   The introduction to the report needs to be revised to include
    descriptions of the scope of the report, the process for developing
    it, and key definitions used.

Toward the end of the first day of the plenary session, new texts
drafted by small work groups for the following subsections of the
introduction: Process, Scope, and Definitions. Time did not allow for
the full AC21 to discuss these new texts.

*Section III: Policies/Issues Raised*

The Committee provided comments on this section of the draft. It was
noted that this section should be called "Policy Concerns/Issues
Raised." During the discussion, members agreed to make minor revisions
on three of the issues, to combine some issues, and to delete the texts
of three issues because they were redundant or outside the primary scope
of the report. A number of the remaining issues were assigned to small
groups of members to revise during later breakout group sessions. There
was insufficient time, however, for the AC21 to consider these new texts
during the plenary. A question remained about whether one particular
issue in the text under review, relating to the role of international
organizations, should remain in the text. Because the originator of that
item was not in attendance, the status of that issue remained unclear.
Also, a new issue was added regarding labeling requirements and public
attitudes.

*Sections I and II: National and International Requirements with Respect
to Traceability and Labeling and Commercial Impacts/Realities*

The Committee then discussed the sections of the document on "National
and International Requirements with Respect to Traceability and Labeling
and Commercial Impacts/Realities." Members offered specific editorial
and language changes to clarify points and achieve the appropriate tone
in the document. The agreed upon changes will be incorporated into a
revised document. One point that remained unresolved was how precisely
to characterize the factors that influence the tolerance levels
countries may set for adventitious presence. The Executive Secretary and
facilitators offered to provide some options on how this might be
presented.

*Small Group Sessions*

During the afternoon of the first day of the meeting, the plenary format
was suspended to enable members to meet in small groups to draft text or
revise text on several areas of the report. Members drafted text for the
several revised policies/issues raised, portions of a revised
introduction to the report, and text for a new section on consumer
impacts. As indicated above, there was insufficient time during the
meeting for the full committee to consider all of these new sections.
The new texts are to be specifically noted as being open for comment in
a revised draft that will go out to AC21 members for their review.

*New Consumer Impacts Section*

In response to the Committee's earlier discussion on consumers, a new
section, one of those prepared by a small group of members for committee
consideration, was new draft text, in the Commercial Impacts/Realities
Section, on consumer impacts Opportunity was made for the full committee
to consider this section during the plenary. In reaction to the new
section, members made suggestions including removing any value judgments
and reducing redundancy with other parts of the report. Members also
suggested language revisions and reordering/combining points to improve
the clarity and flow of the section. The Committee agreed to add this
section to the report, although it was not clear whether a final
designation of its placement within the report had been made.

The Committee also discussed adding a new issue in Section III of the
report addressing the concept that the continuing debate over different
retail labeling requirements affects U.S. public attitudes towards
biotechnology. Because not all members agreed with this concept, no text
was added.

**V. Discussion of Progress of Work Group on Issues to be Considered**

With relatively little time remaining in the session, Ms. Dilley
switched discussions to the other AC21 report and began discussions on
the "Issues to be Considered" chapter. She introduced the three issues
on which the Issues Work Group has focused: adventitious presence,
asynchronous approval, and coexistence. The Committee was asked to
provide general opinions on the Work Group's overall approach to this
portion of the report.

One member inquired about the status of the issue of proliferation of
stacked events, including definitions, compliance and enforcement. Other
members noted that this is different from asynchronous approval. The
Committee agreed that this issue needs further development and a
decision on where it fits within the report.

It was noted that the Work Group is also working to frame an issue
around consumer acceptance.

In general, the Committee supported the structure of this section: a
"neutral" issue statement and a collective articulation of the issue.
The Work Group will continue to develop the three issues, as well as
issues previously identified by the Committee and Work Group members.

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

Ms. Agosto summarized the current structure of the "Preparing for the
Future" chapter, focusing on the approach to the Implications section.
This approach currently consists of five framing implications questions
to be answered for each scenario:

1.  What is the economic impact of the scenario?

    -   Competitive drivers

    -   Economic growth

    -   Trade development/exports

    -   Farmer income

    -   Other

2.  What is the impact of the scenario on the natural environment?

3.  What are the implications of the scenario for USDA?

    -   Resources

    -   Regulatory structure

    -   Trade and promotion

    -   Impacts on other government agency resources that could affect
        USDA

    -   Research agenda

4.  What are the implications of the scenario for public acceptance?

5.  What are the implications of the scenario for addressing food
    sufficiency and security?

In response to members' questions, Work Group members clarified that
these questions all apply to the implications for USDA. Members also
commented that the terms "food sufficiency" and "food security" could be
defined in more detail, for example, whether this includes human health
and nutrition issues. Another member recommended that because of the
wide range of possible implications in each scenario, the Work Group
should consider prioritizing the implications for the different
scenarios when discussed in the report. The Committee briefly discussed
the general approach to Implications and raised no objections to
proceeding with drafting the Implications section of the chapter as
outlined. Dr. Slutsky raised the question of whether examining all the
proposed implications for the scenarios would prove to be an
unmanageable undertaking, in view of time constraints. The Committee
decided to keep its current approach, but would remain mindful of this
limitation.

**VII. Public Comment**

No members of the public offered comment at the meeting.

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

*Future AC21 Meetings*

A number of members expressed a strong desire that maximum effort be
focused on completing the "Traceability and Labeling" report prior to
February 13, 2005, the expiration date for both the current AC21 Charter
and the terms of membership for half the present Committee members.
Accordingly, it was agreed that the AC21 would meet prior to that date
for a plenary session in January or early February 2005. If needed,
based on the level of members' comments, a conference call would be
scheduled before the plenary meeting. Based on this accelerated plenary
timetable, no additional Work Group meetings will be scheduled prior to
the next plenary.

*Next Steps for the Traceability and Labeling Report*

Michael Schechtman will revise the "Traceability and Labeling" report
based on all of the comments provided at this meeting, and will
circulate it to the AC21 for review. Members will be asked to review the
new draft prior to the next plenary meeting, focusing on sections of old
or new text that were not discussed during this plenary. Strictly
editorial comments would also be welcomed. Based on additional comments
received, the report will be revised and prepared for final review
during the next plenary meeting.

*Next Steps for Chapters I &II: Introduction*

At the next plenary meeting, the Committee will review and discuss the
outline for Chapter 1 and the revised text of Chapter 2.

*Next Steps for Issues to Consider*

At the next plenary meeting, the Committee will discuss the three issue
statements and associated text drafted to date.

*Next Steps for Preparing for the Future*

The Scenarios Work Group will continue reviewing the three draft
scenarios and completing drafts of implications for all three scenarios.

*Final Reports*

When the reports are finalized by the Committee, the AC21 Chair will
submit them to the Secretary and they will be posted on the AC21
website. A small representative group of AC21 members may meet with the
Secretary to formally present the reports.

**IX. Summary of Seventh Plenary Session**

Dr. Layton thanked Committee members for their work during the meeting.
She adjourned the meeting at 3:30 p.m.