**Advisory Committee on Biotechnology and 21^st^ Century Agriculture
(AC21)**

**Tenth Plenary Meeting**

# October 24-25, 2005

**Room 107A, USDA Jamie L. Whitten Building**

**Washington, D.C.**

# Meeting Summary

On October 24 - 25, 2005, the United States Department of Agriculture
(USDA) convened the tenth plenary meeting of the Advisory Committee on
Biotechnology and 21^st^ Century Agriculture (AC21). The meeting
objectives were:

-   To introduce a new Committee member, Russell Kremer

-   To continue on-going work towards completion of a paper examining
    the impacts of agricultural biotechnology on American agriculture
    and USDA over the next five-to-ten years, specifically to review and
    revise a new draft Chair's text.

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,
Mr. Leon Corzine, Dr. Carole Cramer, Dr. Michael Dykes, Ms. Carol Tucker
Foreman, Mr. Duane Grant, Mr. Robert Herdt, Dr. Josephine Hunt, Dr.
Gregory Jaffe, Mr. Russell Kremer, Dr. Margaret Mellon, Mr. Ronald
Olson, Dr. Bradley Shurdut, Mr. Jerome Slocum, Dr. Alison VanEenennaam,
and Ms. Lisa Zannoni. Dr. Patricia Layton chaired the meeting. Dr. James
Maryanski of the U.S. Food and Drug Administration and Dr. Elizabeth
Milewski from the U.S. Environmental Protection Agency attended as *ex
officio* members. Dr. Bernice Slutsky, Special Assistant to the
Secretary of Agriculture, and Dr. Michael Schechtman, the AC21 Executive
Secretary and Designated Federal Official (DFO), also participated in
the two-day session. Ms. Abby Dilley, Mr. Paul De Morgan, and Ms. Kathy
Grant 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.

I.  **Welcome and Opening Comments**

Dr. Michael Schechtman opened the proceedings at 8:30 a.m. by welcoming
all the members, including the one new member, *ex officio*
representatives, and the public in attendance, to the tenth meeting of
the AC21. He briefly introduced Dr. Patricia Layton, AC21 Chair, and
facilitators Ms. Abby Dilley, Mr. Paul De Morgan, Ms. Kathy Grant, and
Ms. Cynthia Sulton. He also introduced Dr. Bernice Slutsky, Special
Assistant to the Secretary for Biotechnology.

Dr. Schechtman explained that the Committee is currently working on
completing a paper that examines several aspects of the long-term
impacts of biotechnology on agriculture and the work of USDA. He noted
that background documents, previously distributed to AC21 members and
subject to discussion or reference during the course of the Committee's
deliberations, were available to the public:

-   The Official AC21 Charter

-   The AC21 Bylaws and Operating Procedures

-   A package of biographical sketches of all of the current AC21
    members, including new members

-   The draft meeting summary prepared from the ninth AC21 meeting, held
    on August 9 and 10 of this year.

# A package of meeting summaries from three open-ended work groups that met between the last plenary in August and this meeting. 

# A revised meeting summary from a meeting held with the four new members to acquaint them with the working of Federal advisory committees in general and this committee in particular. There had been a small but significant change requested last time and the revised document was put out for information of AC21 members.

All of the remaining documents were portions of draft Chair's text on
how biotechnology is likely to change agriculture and the work of USDA
over the next 5 to 10 years, along with compiled comments. They
included:

-   A compilation of the few very general comments received on texts;

-   A side-by-side rendition of text plus comments on two introductory
    pieces for that paper;

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-   Two side-by-side renditions for what the Committee is now calling
    "topics of discussion," one of topics that had been previously
    discussed by the Committee, and the other for the new "topics of
    discussion identified at the last plenary."

Dr. Schechtman informed the Committee of the October 13, 2005 Federal
Register Notice announcing an open nomination period for membership on
the AC21. The terms of approximately half of the members on the
Committee will end in February 2006. They, along with any other
candidates, can apply during the open nomination period.

Dr. Schechtman then reviewed the meeting objectives (listed above) and
noted the Secretary's interest in receiving a completed report by the
end of the year. He acknowledged the challenge the Committee faces in
working past their differences to complete the paper on time. Dr.
Schechtman emphasized that a Federal advisory committee is most valuable
when, even in the presence of diverse views, it can present a picture of
where consensus exists.

Dr. Layton welcomed members of the Committee and expressed her desire to
complete most of the substantive work on the paper by the end of the
meeting. She reminded members that once the paper was finished, the
Committee could begin work on the new charges from the Secretary.

Dr, Layton then introduced the newest member of the Committee, Mr.
Russell Kremer, the owner of a small farm and first president of the
Missouri Farmers Union.

II. **Review of the August 9-10 meeting minutes and agenda outline**

Ms. Sulton referred the Committee to the draft meeting summary of the
ninth AC21 meeting held on August 9 -10, 2005. She asked that any
comments on the summary be provided within one week, so that the meeting
summary could be finalized and posted on the USDA AC21 website.

Ms. Dilley reviewed the meeting agenda and explained that the main
objective for the meeting was to make progress on the paper. She noted
that the discussions would focus first on the big picture approach to
each section of the paper and then on the actual text.

III. **Update on Committee work conducted since August meeting**

Dr. Schechtman summarized the Committee's work since the last meeting.
At that meeting, the Committee agreed that the Chair would develop a new
version of the previously developed "Topics of Discussion" in a
shortened format of 1-2 topic sentences, plus 3-4 sentences of
explanatory text. In preparation for the Chair's text, two "straw man"
text examples were sent to the Committee for comment. The Chair also
developed a shortened draft of the introductory section, which included
a piece on "Realizing the Promise."

Three open-ended work groups convened via telephone to prepare text for
the ten new "Topics for Discussion" identified at the August meeting and
to review the Chair's drafts of the Introduction and the previously
discussed "Topics of Discussion." The work group that reviewed the
Introduction developed an outline for a more abbreviated version of this
section, and a new Chair's text was developed based on those
discussions.

All the documents created by the work groups were circulated to the
Committee for comments. All the comments were collated and distributed
to the Committee in preparation for the October meeting.

Dr. Schechtman thanked those Committee members who sent in comments on
the drafts and reminded all Committee members that it will be imperative
that they all respond and promptly if the ambitious deadline for the
report, to be presented to the Secretary shortly after the January 5-6
meeting, is to be met.

##### Review outline for introductory sections 

Ms. Dilley summarized the results of the conference call with the work
group that reviewed the Introduction. The work group agreed that the
section should be streamlined, and that it should provide a more
integrated context for the "Topics of Discussion" section that will
follow. The work group also agreed that the Introduction should make
clear that, while the Committee has diverse views about where transgenic
products fit into the future of agricultural production, members share a
vision of a diverse marketplace that includes transgenic products along
with other products.

Ms. Dilley then reviewed the logical flow of the Introduction (see
attached Outline). The section will begin by setting the historical
context of agricultural transgenic products introduced in the first ten
years of their commercialization and currently in the marketplace. Then
the section will discuss briefly new agricultural transgenic products
that are technically feasible and have the potential for
commercialization in the next five to ten years. The introduction will
then discuss the evolving environment or world into which products will
be introduced. Finally, this portion of the paper will close with the
shared vision of the Committee about the diverse marketplace of
agricultural products, and a transition to the "Topics of Discussion"
section.

####### 

The Committee discussed the outline for the Introduction and agreed to
add language that states that, in addition to work on transgenic
products, advances in germplasm research and production also played a
role in increased agricultural productivity. The Committee also made
additions to the list of new products that are technically feasible in
the next 5-10 years. The Committee agreed to reference the fact that,
while work is being done on transgenic insects and cloned animals,
neither would be discussed in the paper.

##### Discussion of Introductory Text

(Note: The AC21 members discussed the Introduction during sessions on
the first day and second day of their deliberations. All of these
discussions are presented in this portion of the summary.)

The Committee reviewed ten of the thirteen paragraphs in the
Introduction and made several changes and additions to the text.

The Committee discussed terminology to be used throughout the paper. The
Committee agreed that, while the definition of biotechnology is the
application of technology to living organisms, their paper would focus
primarily on organisms produced through genetic engineering and the
products that either are, or are derived from, those organisms. The
Committee further agreed that they would use the terms "derived through
modern biotechnology," "genetically engineered," and "transgenic"
interchangeably to refer to these organisms or their products. In the
paper, the Committee will reference that globally, other terms (such as
genetically modified organisms or GMOs and living modified organisms or
LMOs) are sometimes used.

The Committee made several changes to the paragraph that discusses the
shared vision of a diverse marketplace that embraces transgenic products
as well as the whole range of future agricultural products. During the
discussion, the Committee agreed to language indicating that achieving
their vision will require regulatory systems that engender public trust,
protect the environment, and ensure that the food and feed supply is
safe for humans and animals. They also agreed to have the Chair add
language in the opening vision sentence about preserving the safety of
food and add language later in the paragraph supporting international
trade.

The Committee will revisit and revise the third paragraph in the
Introduction when the remainder of the paper is completed to be sure it
still accurately summarizes the contents of the paper.

In its review of paragraph six of the Introduction, the Committee agreed
to note that, in spite of the rapid adoption by farmers of transgenic
varieties, there remains reluctance on the part of food processors and
retailers to introduce genetically engineered food products into the
marketplace in some instances. The Committee discussed how to articulate
the reasons for this reluctance.

In its review of paragraph six of the Introduction, the Committee also
discussed language regarding consumer and food processors and retailers
views toward genetically engineered foods and their introduction into
the marketplace. In the view of some members, consumer resistance stems
in part from a perception that genetically engineered foods offer them
no direct benefits. In the view of other members, consumers do receive a
benefit from some of these products, and it is unclear whether or not a
perception of no benefit is the cause of consumer resistance.

IV. **Discussion of format for "Topics of Discussion"**

Ms. Sulton reviewed the process for discussion of the "Topics of
Discussion." The Committee agreed that a work group should review all
the topics that mention the "Traceability and Labeling" (T&L) report,
previously submitted by the AC21 to USDA, to ensure consistency in
language. They also agreed that, at this point in the development of the
paper, they would not try to combine or divide the topics. The Committee
decided that any text that could be construed as a recommendation would
be highlighted for further review.

The Committee acknowledged that they might not reach consensus on the
language for all the topics. When consensus cannot be reached on a
topic, the Committee agreed that members who hold a particular point of
view would be responsible for writing the text that expresses their
view. The revised "Topics of Discussion" text, combining the differing
points of view, would then return to the Committee for further
discussion. It was stressed by USDA, however, that the Committee should
strive to minimize the number of issues on which this formulation is
required.

##### Discussion of "Topics of Discussion" 

The Committee reviewed and made changes and additions to twelve of the
twenty-eight "Topics for Discussion." Agreed upon text for each of the
twelve topics will be provided in the next iteration of the document.
For several of these "Topics," the Committee agreed on concepts that
should be captured in the text, and left it to the Chair to write the
actual language. The following is a list of the twelve topics discussed
at the meeting, including the original language of the topic sentence,
the new language for the topic sentence as agreed to at the meeting, a
summary of concepts for further elaboration in the topic description,
and outstanding issues for further discussion:

[Topic 1]{.underline}: (Old) As biotech products developed in other
countries are exported to the United States, it is important to have
adequate regulations and processes in place to address their safety and
to have a plan for communicating with the public about the products.

(New) *As transgenic organisms developed in other countries and products
made from them are imported into the United States, it is important to
have adequate regulatory systems in place to address their safety.*

In the descriptive paragraph for Topic 1, it was agreed that language be
added to address adventitious presence and the potential for
adventitious presence in grain products produced outside of the United
States.

Topic 3: (Old) Given the importance of trade to the U.S. economy,
continuing controversies, and the growing complexity of biotechnology,
it is important to anticipate the technical expertise and staffing
needs, both domestically and internationally, in order to respond to
information needs regarding modern biotechnology products.

(New) *As new transgenic organisms are developed in the United States
and enter the marketplace, other countries have questions about how
those organisms are regulated in the United States and about their
safety. To answer these questions, it would be useful for staff at
embassies to be better educated about the U.S. regulatory system and the
products that have gone through the system.*

In describing Topic 3, it was agreed that language would be added to
frame the need in the context of modern biotechnology's continuing place
in the vanguard of agriculture in the United States. The new description
should also emphasize the role that the staff referenced in Topic 3 play
as primary conduits of information.

Topic 4: (Old) The lack of capacity of the poorest developing countries
to address scientific, intellectual property, regulatory and
international negotiation requirements related to biotechnology will
have an impact on the growth of U.S. food and agricultural exports in
the future.

(New**)** *The least developed countries lack capacity to address
scientific and regulatory issues related to modern biotechnology.*

In rewriting the text for the descriptive paragraph on Topic 4, the
Committee asked for language that makes it clear that: 1) the least
developed countries may be exporters as well as importers and 2) they
are developing safety and regulatory systems and, therefore, need
assistance in order to make informed decisions about policy options. The
text will also note the important role businesses and non-governmental
agencies can play in capacity building efforts.

Topic 5: (Old) The adoption of agricultural biotechnology domestically
and globally has had, and may increasingly have, important impacts on
crop production patterns. The extent and degree of adoption of
biotechnology in certain crops/plant species will impact producers and
U.S. agricultural production patterns.

(New) *The adoption of transgenic crops domestically and globally has
had, and may increasingly have, important impacts on crop production
patterns. The extent and degree of adoption of transgenics in certain
crops/plant species will impact producers and U.S. agricultural
production patterns.*

Topic 6: (Old) Funding for agricultural biotechnology research has a
direct impact on agricultural policy, and which biotechnology-derived
crops get commercialized impacts where scientists gravitate.

(New) *The private sector provides most of the funding for research and
development of new genetically engineered crops, and this funding is
largely directed toward major crops, not minor crops. Without
appropriately supported public research those minor crops will suffer
further competitive disadvantage.*

Members of the Committee requested descriptive text for Topic 6 to
include language about the need for public funding for a broad set of
applications, not just for the development of new crop varieties.

Topic 7: (Old) One of the keys to the future of biotechnology is
effective and objective documentation of the impacts of agricultural
biotechnology products, including on soil loss, pesticide use, and other
environmental impacts.

(New) *Effectively and objectively documenting the use and researching
the impacts of the use of transgenic organisms is key to the future of
modern biotechnology.*

Members asked that the text discussing Topic 7 include examples of
economic, environmental, and social impacts, and incorporate the
following language: "It is essential that there be adequate resources to
collect, analyze, and disseminate information regarding impacts of
agricultural biotechnology. USDA has a unique role in providing
definitive information to the public in a fair, unbiased,
understandable, and factual way, and in encouraging peer-reviewed
analyses of that information."

Topic 8: (Old) Government policy on alternative energy sources and the
need for energy will drive changes in agricultural production.

(New) *Energy demands and government policies have increased the use of
crop-based fuels; genetically engineered crops may be developed to
provide alternative sources of energy.*

Topic 9: (Old) It is important to anticipate the impacts of a new
generation of technologies, such as RNAi gene silencing technology, that
will be available in the next ten years, on agriculture, on regulatory
policy needs and on testing.

(New) *It is important to anticipate how a new generation of
biotechnologies that may not be transgenic, such as RNAi gene silencing
technology, will be addressed by the regulatory system.*

Members suggested that the paragraph discussing Topic 9 should include
language about the market environment for these technologies.

Topic 11: (Old) Managing the coexistence of different agricultural
products and production methods intended to meet different market
specifications has become more complex with the emergence of
biotechnology-derived crops.

(New) *Managing the coexistence of different agricultural products and
production methods intended to meet different market specifications has
become more complex with the emergence of genetically engineered crops.*

Topic 14: (Old) The regulatory system for plant-derived products not
intended for food or feed use must ensure appropriate containment,
address all relevant safety considerations, and ensure the integrity of
the food/feed system, but some are not satisfied that the current
approach adequately meets these requirements and will prevent unintended
contamination in the system.

(New) *The regulatory system for genetically engineered organisms that
produce a non-food product must ensure appropriate containment, address
safety considerations, and ensure the integrity of the food/feed system.
Some stakeholders are not satisfied that the current approach adequately
meets these requirements and \[prevents (acceptable zero)\] unintended
contamination in the system.*

After the discussion of Topic 14, several outstanding issues remained:

-   Some Committee members suggested that the phrase "will prevent
    unintended contamination in the system" be deleted from the topic
    sentence. Their expressed view is that the earlier phrase "ensure
    appropriate containment" covers the issue of contamination and that
    the meaning of the word "prevent" is unclear. Another member
    supported including the phrase, because of his view that there is a
    difference between the phrases "appropriate containment" and
    "prevent contamination."

-   Some members wanted the words "integrity of the food/feed system" in
    the topic sentence to be changed to "integrity of the food supply,"
    because of their view that consumers concern about food safety gets
    lost if the broader language is used. Other members preferred not to
    separate issues about the integrity of the feed and food systems,
    because the regulatory system does not distinguish between the two
    and, in their view, both are of equal importance.

-   As regards the text discussing Topic 14, some members suggested
    including specific examples of consumer concerns about food safety,
    for example, a concern about pharmaceuticals in their food. Other
    members wanted to be careful not to imply that the existence of
    transgenic products in food creates a safety risk. Two members
    agreed to try to write language that addressed both these issues and
    send it to the Chair.

Topic 15: (Old) New and novel agricultural biotechnology products,
whether produced in the U.S. or imported, will challenge the abilities
of the U.S. regulatory system to deliver careful, efficient, and
coordinated evaluations of them.

(New) *Unique transgenic organisms and products derived from them may
challenge the abilities of the U.S. regulatory system to deliver
scientifically sound and efficient evaluations.*

Members asked that the descriptive text for Topic 15 include examples,
such as GloFish, of the novel products that could challenge the
regulatory system. Two outstanding issues remain for Topic 15:

-   One member asserted the right to reserve judgment about whether the
    issue addressed by Topic 15 should be raised as a topic or as part
    of the conclusion to the paper.

-   Another member suggested adding language clarifying the boundary
    between "substantially equivalent" and "substantially different"
    agricultural biotechnology products alluded to by "new and novel" in
    the topic sentence. He agreed to provide language on that point to
    the Chair.

Topic 16: (Old) Transparency in the regulatory system is important for
enabling stakeholders and the consuming public, in the U.S. and
elsewhere, to have confidence in the safety of genetically engineered
agricultural products.

(New) *Transparency in the regulatory system is important for
stakeholders and the consuming public, in the U.S. and around the world,
to have confidence in the safety of genetically engineered organisms.*

It was agreed that language be added to the description of Topic 16 to
indicate that transparency facilitates public awareness of the existence
of regulatory systems and how they work.

One member pointed out that there were several inaccuracies in the
sentences discussing Topic 16, adding that none of the examples used
were critical of USDA's lack of disclosure. He agreed to send suggested
revisions to the Chair.

Topics 2, 10, 12, 13, and 17 -28 were not discussed at the meeting,
topics 2, 10, 12, 13, 24 and 25 because they were considered to have
been covered at least partially in the T&L report and were hence
"parked," and the remainder because there was not enough time.

##### Public Comment

###### 

No members of the public offered comment at the meeting.

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

In order to meet the goal of completing the paper by January 2006, the
AC21 discussed and agreed to the following next steps to prepare drafts
of each section of the paper:

### Scheduling

Dates will be set for conference calls to conduct work group discussions
before the January meeting. During the first week of November, an
Introduction Work Group conference call will be scheduled to discuss the
paragraphs of the Introduction not discussed at this week's plenary
session (paragraphs 10, 11, and 13 prior to 11/04). As indicated at the
plenary, this discussion may require a second conference call.

Other conference calls will be scheduled to discuss each of the
following: (1) the five "parked" topics (i.e., those discussed in the
"T&L" report), (2) topics discussed during this week's plenary session,
and (3) topics not discussed in the plenary sessions. The discussion of
the third item may require two conference calls.

### Report Development

Members will submit further editing suggestions to the Chair, who will
rewrite the entire paper by November 4th and share the revised paper
with the group.

Subsequent to the workgroup conference calls, the Chair will complete
another rewrite of the paper by December 7th, and will disseminate to
the group both a clean version and a table version.

Members are strongly encouraged to meet the deadline for submission of
their comments on the draft out of respect for each other's need to
review all comments in advance of the meeting. Upon receipt of the
comments to the December 7^th^ draft, the chair and staff will complete
a Final Draft, with 'side by side' comments, by December 16 so that
members can review it prior to the holidays in anticipation of
discussions at the January 5-6, 2006 meeting.

*Future Schedule and Meeting Dates*

The next AC21 meeting will be held on January 5-6, 2006. The meeting
will begin at 8:00 a.m. each day and end at 6:00 p.m. on Thursday.

##### Summary 

Dr. Layton thanked Committee members for their work during the meeting
and for the extensive work that will take place before the next meeting.
She adjourned the meeting at 4:00 p.m.

> **Attachment 1**
>
> **USDA AC21**
>
> **Outline for Introductory Sections of the Emerging Committee Report**

1)  Historical Context of Current Agricultural Biotechnology Products

    a.  Agricultural biotechnology products have been in commerce for
        the last decade.

    b.  These products have emphasized enhanced production.

    c.  Many people see benefits to these products and they have been
        rapidly adopted by growers.

    d.  These products have not entered the marketplace without
        controversy, some domestically but especially globally

    e.  The marketplace has responded to the diverse needs and interests
        regarding transgenic and non-transgenic agricultural
        biotechnology products.

2)  Future (5-10 years) Agricultural Biotechnology Products (*Note*:
    Participants proposed not adding to this section discussions of
    potential benefits or risks in order to eliminate conjecture)

    a.  A broad variety of future agricultural biotechnology products
        are anticipated in the next five to ten years, including the
        following product categories:

        i.  Nutritionally enhanced

            1.  Soybeans with omega 3 fatty acids

            2.  High oleic corn

        ii. Drought resistant

        iii. Improved animal feeds

             1.  Better nutrient density

             2.  Enhanced nutrient utilization (phytate pig)

        iv. Pharmaceutical crops

            1.  Monoclonal antibodies

            2.  Vaccines

        v.  Transgenic animals

            1.  Fish

            2.  Spider silk mild goats

        vi. Industrial crops

            1.  Biofuels

            2.  Enzymes

        vii. Pest resistant

        viii. Extension of shelf life

    b.  New products are entering into a new environment -- Topics
        Discussed

        i.  Regulatory

        ii. Consumers role has increased

        iii. Players in the full food production chain more involved

        iv. Global trade

    c.  Governing future agricultural biotechnology products in order to
        provide these products a fair and equitable chance in the
        marketplace.

3)  Vision

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a.  Committee members may have different visions of how central to
    American agriculture biotechnology will be in the future but all
    members envision agricultural biotechnology products as important
    and part of a diverse marketplace. Suggested Alternative language:

    i.  "AC21 members share a vision of a diversified agricultural
        marketplace, sensitive to and able to meet the needs and
        preferences of customers and consumers in the United States and
        the world for transgenic-derived and non-transgenic-derived
        products, supported by a strong regulatory system that ensures
        safety and by evolving and strengthening regulatory mechanisms
        in other countries. All recognize, however, that achieving this
        goal will not be easy."

    ii. "AC21 members share the hope that the potential for transgenic
        derived products will be achieved and provide new products that
        are safe and acceptable to consumers, processors and farmers. In
        the United States, consumer acceptance will depend on whether
        the new products offer direct and substantial benefits and
        whether consumers are confident that the regulatory system
        assures the products are safe."

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4)  Relevance to USDA (*Note*: transition paragraph to discuss the
    relevance to USDA of the next section, Topics Discussed)