# Advisory Committee on Biotechnology & 21st Century Agriculture (AC21) Meeting: June 3-4, 2004

**Draft Meeting Summary**

**Fifth Plenary Meeting**

Wyndham Washington Hotel\
Washington, DC

On June 3-4, 2004, the United States Department of Agriculture (USDA)
convened the fifth plenary meeting of the Advisory Committee on
Biotechnology and 21st Century Agriculture (AC21). The meeting
objectives included:

-   Review a revised 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 and
    concerns, and a second on scenario development;

-   Provide workgroups guidance in adapting the draft documents they
    have developed into chapters of the committee report;

-   Consider presentations and discussions related to consumer opinion
    on biotechnology; 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, nongovernmental organizations, and academia. The following
AC21 members were in attendance: Dr. Patricia A. Layton, Dr. Daryl D.
Buss, Mr. Leon C. Corzine, Dr. Juan Enriquez-Cabot, Dr. Richard T.
Crowder, Dr. Michael D. Dykes, Ms. Carol Tucker Foreman, Mr. Duane
Grant, Dr. Randal W. Giroux, Dr. David A. Hoisington, Mr. Greg Jaffe,
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 the Department of State, 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. Michael Schechtman, the AC21's Executive Secretary
and Designated Federal Official (DFO), and Dr. Bernice Slutsky, Special
Assistant 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/wps/portal?navid=BIOTECH>.
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 9:00 a.m. by welcoming
all the members, ex officio representatives, and the public in
attendance to the fifth 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.

-   A compilation of the draft summaries of meetings held since the last
    plenary session by each of the three AC21 workgroups.

-   A timeline for the committee's work.

-   The draft meeting summary prepared from the fourth plenary meeting,
    held March 8-9, 2004.

-   The provisional agenda for the meeting.

-   The current draft version of the Issues and Concerns Chapter for the
    report on how biotechnology will change agriculture and USDA's role
    in the next five to ten years.

-   A draft version of two introductory chapters.

-   A draft chapter on Preparing for the Future.

-   An annotated outline for the report.

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

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

**II. Remarks from USDA Secretary Ann Veneman**\
Dr. Layton introduced the Secretary of Agriculture, the Honorable Ann
Veneman. Secretary Veneman thanked Committee members for their service.
She noted that Bernice Slutsky, the new Special Assistant for
Biotechnology, has replaced David Hegwood as her point person on
biotechnology issues.

Secretary Veneman remarked that biotechnology issues are the topic of
news headlines around the world. USDA seeks to improve understanding of
biotechnology issues to better define the appropriate role of government
regulation of the biotechnology system and maintain consumer confidence
in the food supply. The Department is taking the lead in an interagency
process to update regulatory systems that address the increasingly
diverse nature of biotechnology. Recent enhancements to federal
regulations and processes include: improving permit systems, increasing
inspections, training personnel, unifying compliance and enforcement
efforts within the Animal and Plant Health Inspection Service (APHIS),
and environmental and ecological analysis of regulations to identify
needed updates. APHIS is preparing an Environmental Impact Statement to
help consideration of possible revisions to its biotechnology
regulations to add additional safeguards and increase transparency of
the system, while protecting confidential business information.

Secretary Veneman also discussed USDA's biotechnology activities that
help feed hungry people, noting the USDA-hosted Ministerial Conference
on Science and Technology, which focused on the use of science and
technology to reduce the number of hungry people in the world. The
Secretary acknowledged that efforts to cut the number of hungry people
have not met previously set goals. Other regional conferences supported
by USDA provide forums for countries to discuss how to move technology
forward in cooperative ways and share expertise regarding regulatory
systems. USDA has also established a fellowship program in science and
technology to promote research and scientific exchange in this area and
is working to promote farmer-to-farmer dialogue. In closing, the
Secretary emphasized the importance of input from the Committee
supported by members' expertise.

In response to questions from Committee members, Secretary Veneman noted
that despite resistance to biotech products, such as by some individual
representatives of the Catholic Church, in some countries, there is
growing recognition that the technology can be wisely used for the
benefit of people. Secretary Veneman stated that it is important to
balance biotechnology and market access to countries in need: both
factors are important. Technical assistance for pest and disease
prevention and the creation of more regional trade would benefit these
countries.

One member commented that the lack of synchronization of the approval
process around world is a large barrier to progress in biotechnology.
Secretary Veneman emphasized that countries have many common interests
in research and promoting good regulatory policies on biotechnology and
should work together on these issues. Another member expressed that USDA
should take a more aggressive approach to promoting biotechnology around
the world to minimize the fear of the technology in some countries.
Secretary Veneman responded that the agency and the State Department are
making strides in changing opinions to address farmers' and
hunger-related issues. A member suggested that USDA expand its role in
documenting the risks of biotechnology through independent risk
assessment research and promotion of public good products. Secretary
Veneman noted that AHPIS is conducting an EIS process to examine risks.
She added that available public good research funds have declined, but
opportunities exist to leverage resources and establish partnerships
between government, universities, and the private sector to create more
products.

Dr. Layton also introduced Dr. Bernice Slutsky, Special Assistant for
Biotechnology. Dr. Slutsky has recently returned to USDA. She
complimented the Committee on the significant work and the broad range
of thinking and compromise shown in its documents.

**III. Review of March 8-9, 2004 Meeting Minutes and Outline Agenda**\
Ms. Cindy Sulton briefly reviewed the highlights of the fourth AC21
meeting held on March 8-9, 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. 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 fifth meeting. IV.
Discussion of Progress of Work Group on Labeling and Traceability

Dr. Schechtman introduced 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
by conference call since the previous plenary meeting. Dr. Schechtman
summarized the status and structure of the Labeling and Traceability
document. The document consists of a brief introduction, descriptions of
different approaches counties have adopted, descriptions of
international agreements that bear on the use of labeling and
traceability rules in trade, a section entitled "Commercial
impacts/realities", and a placeholder section for Policies and Issues
raised for the Secretary to consider.

*General Comments*\
Committee members offered a number of comments on the overall document.
One member suggested adding several topics to the document, including a
discussion of how government is responding to labeling and traceability
and a definition of "modern biotechnology." Other members recommended
the Committee discuss how to incorporate issues of coexistence. Another
member suggested that the Committee decide whether the document will
include grain and grain products as a case study for overall crops, or
whether broader terms should be used in the text.

*Introduction*\
A member suggested the document begin with a statement of the
Committee's philosophy regarding traceability and labeling. The
philosophy statement could include four goals: do not put excess costs
into system, do not use labeling as an artificial trade barrier, define
how labeling and traceability systems would address release pre- and
post-event, and discuss how niche markets would capture value. Dr.
Schechtman suggested that it might be useful for the Committee to come
to consensus on the goals/philosophy, but that if such a consensus were
reached, it might properly be elaborated in the later "Implications"
section of the report. A member noted that the section lacks focus and
does not link to specific labeling regimes. Some members recommended
that Committee consensus on key messages and conclusions to include in
the document be achieved possibly through further Work Group
deliberations. Dr. Slutsky added that the Secretary would benefit from
the Committee setting out issues and questions to consider, as agreed on
by the Committee.

*National and International Requirements*\
Members suggested that the Committee add a paragraph to provide context,
explain why national and international requirements affect labeling and
traceability regimes, and explain the purpose for the proliferation of
regulations and requirements. Members also discussed the categories of
regimes in the draft text. Some suggested that only two categories be
used, countries that do and countries that do not require mandatory
labeling. Other members commented that some countries have labeling
requirements that do not address biotechnology specifically. A member
added that the text should avoid discussing the merits of the different
systems, as that is not the role of the Committee.

In response to a member's recommendation that the document include a
list of countries in each category, members explained that the Work
Group had attempted to develop a list but decided against it because the
categories are not absolutely discrete. Some members noted that such a
listing is outside the charge of the Work Group. Members also suggested
that clarification was needed for several terms and definitions (e.g.,
more clearly indicating the scope of products covered in the report and
making the distinction between product labeling versus shipping
documentation).

*Exemptions*\
Members noted that the description of exemptions is not clear. The
section should distinguish between delineation of legal exemptions and
explanations of how they are implemented. Members suggested that this
section would also benefit from expanded discussion of the importance of
the exemption issue to provide context for food companies'
predisposition to avoid labeling on their food products. Other members
commented that the discussion of challenges associated with mandatory
labeling in the document, such as commingling and potential transfer of
liability, could be expanded.

A member recommended that the document discuss how labeling influences
consumer decisions to buy the products. Another member suggested that
the term "risk" be qualified in the document to distinguish between
health and safety risks.

Dr. Slutsky commented that this report is meant to be a brief synopsis
of the situation and identify commercial implications for U.S. policy.

*International Requirements*\
Committee members' suggestions on the section on International
Requirements included: clarify the specific type of labeling discussed
(consumer labeling for food products or shipping documentation), shorten
the section, focus its scope, and add a reference to the liability
issues associated with labeling requirements (to be discussed in more
detail in the Committee's other report). Several members agreed that
labeling of seeds should not be addressed in this report. The
possibility that traceability requirements might be expanded to cover
all products within the European Union was also mentioned as an issue.

*Commercial Impact and Realities*\
Members commented on the need to specify whether the term "risk" refers
to health or commercial issues in this section as well. A member
suggested by written comment that the Work Group expand the discussion
of contracting and liability to explain the context and provide
examples. The member also noted that control and reference standards
could also be discussed within testing-associated risks. A member
questioned whether there exists evidence to support market segmentation
as stated in the report. Members also suggested using more accurate
terms such as "allowed" or "met requirements" rather the word
"approved."

**V. Discussion of Progress of Work Group on Issues And Concerns**\
(Note: AC21 members' discussions of issues and concerns during a session
on the first day of their deliberations and on the second day are
presented in this portion of the summary.)

Dr. Schechtman opened the discussion of the Committee's first report,
beginning with the Issues and Concerns chapter. He noted that the
chapter is not yet close to its final form and requires additional text
and editing. He highlighted the major differences in organization and
text from the previous draft of the chapter. He asked Committee members
to think about a change in the chapter title to "Issues to Consider."

*General Comments*\
Some members suggested that the specific issues in the chapter be
clarified and that the chapter be reorganized by products, product
traits, and associated concerns, rather than by regulatory, commercial,
and consumer categories to minimize overlap and redundancy. Some members
expressed the view that the chapter should not speculate about specific
future products and concerns because of insufficient information on
future products at this time. Other suggestions include shortening the
chapter, selecting four to five prioritized issues to discuss, and
clarifying whether issues apply to food, feed, or both.

Members then decided to brainstorm product categories expected to be in
the market in five to ten years in order to better identify what is
known about current and future technology. The suggestions included:

-   Herbicide tolerance

-   Insect resistance

-   Virus tolerance

-   Combination/stacked trait products

-   Compositional changes (nutritional enhancements)

-   Plant made pharmaceutical (non-food or feed)

-   Plant made industrial (non-food or feed)

-   Animals engineered as pharmaceutical production facilities

-   Stress tolerance

-   Disease resistance

-   Transgenic animals that will be eaten

-   Transgenic animals bred for medical purposes (xenotransplantations)

-   Transgenic cattle resistant to BSE for pharmaceutical purposes

-   Transgenic animals (non-food)

Members discussed and agreed on several major categories for the
products, distinguishing non-food uses and uses specifically for
industrial or pharmaceutical purposes. The categories are:

-   Agronomic traits

-   Stacked traits

-   Compositional traits

    -   Food

    -   Non-food/feed

-   PMP

-   PMIP

-   Animals

    -   Food

    -   Non-food (including novelty products)

**ISSUES**\
(Note: As the Committee continued discussions on the various draft
sections of this chapter, members suggested specific issues to highlight
in the text, either from the existing draft or new issues. The list of
issues is included as Attachment 1 to this meeting summary.)

*Regulatory Issues*\
Members emphasized the need to ensure that the tone of the section
focuses on enhancing the regulatory system and recommended changing
phrases such as "is inadequate" or "adequacy." Another member suggested
that when possible changes to FDA's regulatory framework or procedures
are discussed, clarity and accuracy will be very important, and it would
be helpful to indicate whether the changes discussed fall within
existing FDA authorities.

Members discussed whether mechanisms exist to deal with deliberate
misuse of biotechnology. Some members commented that enhanced compliance
efforts and the Homeland Security Coordinator involved in developing
USDA's plans are there to address this issue. Some members noted that
any military uses of biotechnology, while important, are out of the
scope of this Committee.

*Commercial Issues*\
Among the general themes emerging from members' discussion of key
commercial issues were: recognition of intellectual property, testing
and detection, identity preservation, transparency of the regulatory
system, international acceptance, availability of liability insurance,
tolerances, and licensing.

*Consumer Issues*\
The Committee discussed a list of consumer issues to be considered for
inclusion in the report, emphasizing that there are different types of
consumers (e.g., retailers, processors, producers, and end users).
Members suggested that the report should consider these different types
of consumers and be explicit, if possible, about which group of consumer
is being discussed whenever the term "consumers" is used.

*Next Steps*\
The Committee agreed that the Issues and Concerns Work Group would
elaborate on the set of thirty-nine issues identified by the Committee.
The Work Group should follow a common format explaining each issue by
addressing four questions:

-   What is the issue?

-   Why it is important for USDA to consider?

-   What is the current state of activity on the issue (if any)?

-   Additional comments.

**VI. Discussion of Work Group Progress on Scenarios Development**\
Dr. Schechtman provided an overview of the Scenarios Work Group
activities and accomplishments. The Work Group met three times prior to
the plenary session and has prepared for Committee consideration a new
draft chapter entitled, "Preparing for the Future." The draft identifies
key driving forces that might change the future of biotechnology and
three alternative futures. These scenarios are meant to be instructive
tools for USDA to consider the range of possibilities, not to be
predictions of the future. The three scenarios, as currently titled,
are: "Cornucopia," in which biotechnology really delivers; "Continental
Islands", in which the differential adoption of biotechnology in
different parts of the world persists; and "Biotech Goes Niche" in which
biotechnology is moving out of food commodities and into more strictly
niche applications.

*Drivers: What We Know (Or Think We Know) and What is Much Less
Certain*\
Members commented that Committee agreement on the certainties and
uncertainties is crucial, because they form the foundation for the
scenarios. Members also noted that the drivers should be linked to the
scenarios, making sure that they are contained in at least one scenario
and the drivers in the scenarios are discussed in this section. A member
suggested that the report should emphasize the tie between the scenarios
and the issues and concerns in the introduction. Another general comment
suggested that some drivers are U.S.-based and some are more
globally-based.

The Committee discussed the list of drivers by first identifying those
items with which at least one member had a comment or disagreement, and
then discussed them in greater detail. A summary of the discussion
follows. (In the chart below, only the bolded sentence from each
paragraph in the draft is provided for reference.)

  ----------------------------------- -----------------------------------
  **Driver**                          **Comments/Action**

  *What We Know (Or Think We Know)*    

  Increasing public concern with      • Clarify and soften the
  health and nutrition, and           description of the evolution of
  increasing scrutiny by consumers,   traceability
  especially in developed nations,    
  will drive change in the food       
  system                              

  Consumers will be increasingly      • Specify that awareness exists,
  aware and finicky about the         especially in developed nations\
  products they buy                   • Delete last sentence on
                                      traceability

  Consumers will be increasingly      • Clarify that this is a broad
  interested in methods of food       global trend.\
  production.                         • Delete last sentence on the
                                      market for certain products.

  The food marketplace will continue  • Change "whip-lashed" to "be
  to be whip-lashed by trends based   influenced by" or similar term.\
  on consumer perceptions of health.  • Replace "trends" with "changes."\
                                      • Change last phrase to read "will
                                      continue to experience rapid
                                      changes in consumer demand."

  The trends toward urbanization and  • Specify whether the trend is in
  agricultural mechanization will     the U.S. or global.\
  continue.                           • Rewrite to clarify that fewer
                                      people are involved in food
                                      production agriculture and that
                                      these people tend to not have a
                                      strong political voice around the
                                      world.\
                                      • Move the influence of rural
                                      voters to section on uncertainties.

  Life sciences research will         • Specify the types of products
  continue to mushroom on both the    referred to (transgenic or other
  basic and applied fronts.           new applications?)\
                                      • Move last sentence to section on
                                      uncertainties or re-word.\
                                      • Re-word driver.

  The United States will remain a     • Not clear how this is relevant to
  dominant global power.              scenarios.\
                                      • Elaborate that the U.S is the
                                      main source of research and drives
                                      the life science revolution
                                      globally.

  The expanded European Union will    • Reverse sentence order to make
  remain a huge market for global     the second sentence the new
  agriculture, especially for         heading.\
  processed products.                 • Delete "processed products."\
                                      • Add an uncertainty about the
                                      impact of new Eastern European
                                      countries on production within the
                                      EU.

  There will be decreasing            • Replace the word "set-aside" with
  availability of arable land...      the phrase "conservation program or
                                      needs."\
                                      • Add soil degradation.\
                                      • Qualify that the driver is not
                                      limited to South America, but
                                      rather refers to globally available
                                      land.

  Consumer opinion about transgenic   • Move to section on uncertainties.
  products will become more settled.  

                                       

  *What is Much Less Certain*          

  New Issue: Global hunger and        • Add as an uncertainty whether
  malnutrition will continue to be a  USDA will meet Millennium hunger
  global issue.                       goals in the next ten years.
  ----------------------------------- -----------------------------------

*Scenarios*\
In reaction to the descriptions of the three scenarios, members agreed
that overall, as the Work Group had discussed, each of the scenarios
should be revised to be more parallel in format and in questions
addressed. Another member suggested adding more geographic context to
the scenarios.

For the Cornucopia scenario, members suggested: including the idea of
the increased availability of foods more tailored to individual health
needs; removing the reference in the last paragraph referring to
increasing problems of intellectual property conflict; and changing
"set-aside" to conservation land. Members also noted that the corn
prices given as examples are not realistic, suggesting adding at least
\$1 to corn prices as well as adding context for the price to illustrate
the point that new crop opportunities would be less dependent on
subsidies and farm policy. Other recommended additions to this scenario
included: a discussion of international regulatory harmonization and
consideration of impacts on family farms with greater vertical
integration, as well as consumer impacts.

Member comments on the Continental Islands scenario included: adding
Japan to the list of countries in the second paragraph, reworking the
regulatory paragraph to add discussion of the status under the scenario
of regulatory harmonization and reduction of trade barriers, indicating
whether transgenic animals are on the market, and clarifying the
distinction between food and feed. In addition, food company use of
transgenics exclusively for export belongs in the "Biotech Goes Niche"
scenario. The E.U. countries' role as importers of food and commodities,
while other countries export, biotech products also needs to be
clarified. In response to some members who expressed disagreement with a
statement implying food aid would be linked to biotechnology resources,
the Committee decided to eliminate that language and add a general
statement about the tradeoffs of costs associated with compliance and
implementation of the system.

In discussing the general concept of the scenario "Biotech Goes Niche,"
some members expressed concern about the negative tone of the text.
Other members emphasized that this scenario represents the contracting
of biotechnology and is a necessary part of the scenarios development
process. Other members recommended that the definition of "niche" be
expanded to clarify whether the term refers to niche products or
application in geographic niches. Members also suggested adding an
explanation of how niche markets developed and why.\
Specific suggestions included rewording the second paragraph to clarify
that it refers to resistance to the herbicide and addressing the
difference between food and feed as part of the commodity system. A
member suggested that price implications for consumers could be
addressed. Other members noted that the cost of raw materials is only a
small part of consumers' food bill.

Overall, members supported the general concepts of the three scenarios
to be revised the by Work Group, but some suggested that the titles
should be revised.

**VII. 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.

**VIII. Presentations on Consumer Opinions on Biotechnology**\
Dr. Schechtman introduced two presentations on public reactions to new
biotechnology. He emphasized the importance of the Committee and USDA
awareness of trends and information. The Committee will address consumer
views in the Issues to Consider chapter section on consumer issues.

*Food Biotechnology: Understanding the Consumer for Effective
Communication*\
Ms. Cheryl Toner, Director, Health Communications, International Food
Information Council (IFIC) and Foundation, presented, "Food
Biotechnology: Understanding the Consumer for Effective Communication."
She began with a description of IFIC's mission, which is to communicate
science-based information of food safety and nutrition issues to health
professionals, journalists, educators and government officials. She
outlined additional background on IFIC partners and publications and
described the general guidelines for the communications process.

Ms. Toner then reviewed IFIC's food biotechnology consumer research
principles and process. The research, conducted through telephone
surveys with open-ended questions, began in 1997 and continued through
January 2004. She presented the findings of key survey questions over
five different time periods, emphasizing relevant biotechnology-related
responses. In response to questions about food safety concerns, Ms.
Toner advised that no respondents reported eating less of or avoiding
biotech products or ingredients. Small percentages of respondents
indicated a desire for more information on genetically engineered
ingredients on food labels or expressed food safety concerns with
engineered food.

The survey found a high level of basic awareness about biotechnology,
but few respondents had heard or read a lot on the subject. Answers
regarding which biotech foods are currently in the supermarket indicated
some occasional accurate perceptions regarding biotech vegetables, and
inaccurate perceptions that biotech meats are available.

Respondents indicated that reduced pesticide use is most likely to
influence their purchase of biotechnology-derived food. Ms. Toner noted
that, as shown through attitude changes among different time periods,
increased media coverage of issues tends to increase negative attitudes.
Consumer expectations of capturing such benefits from biotechnology as
improved quality, taste, and nutrition in the next five years is
decreasing. The survey also found some support for the FDA labeling
policy, but findings indicated that this support decreased with rising
concern about mad cow disease and negative media coverage on
biotechnology.

While responses to questions regarding animal biotechnology indicate
some consumer awareness of the topic, only a small percentage of people
have substantial knowledge. Impressions are that the extent of use of
biotechnology in animal production is actually pretty low. Respondents
indicated mixed reactions regarding why animal biotechnology should be
used. Among the areas of biotechnology, genomics showed the most
favorable reaction and cloning the least favorable. More than half of
the respondents said they would be likely to purchase food from cloned
animals if FDA issued a safety determination, a finding that shows a
large impact of FDA assurance of safety on consumer attitudes.

Ms. Toner explained that the factors affecting consumer attitudes toward
food biotechnology are awareness, information sources, education, trust,
perceptions of safety, and terminology. In 2004, consumers surveyed
indicated a high overall awareness that biotechnology is not a food
safety concern, continuing overall support for the FDA labeling policy,
expectations for benefits from biotechnology, but unclear attitudes
toward animal biotechnology. Key principles for communicating with
consumers include placing biotechnology in context, explaining the goals
and benefits, giving an accurate view of safety, speaking in familiar
terms, and telling stories about real foods, products and applications.
Ms. Toner concluded that the weight of evidence indicates support for
biotechnology.

*Societal Perspectives on Agricultural Biotechnology*\
Dr. Thomas Hoban, Professor of Sociology and Food Science, North
Carolina State University, presented "Societal Perspectives on
Agricultural Biotechnology." After noting that he served on the previous
USDA Committee on biotechnology, Dr. Hoban listed several emerging
social issues impacting USDA from consumer views to industry activities
and a WTO case. He showed graphics of trends in U.S. consumers'
awareness of biotechnology from 1992 through early 2004 and explained
how many consumers know that biotechnology products are in supermarkets,
which was 36% in early 2004. He noted data show that most U.S. consumers
do not realize they already are eating genetically engineered foods.

Dr. Hoban next discussed data indicating that U.S. acceptance of
biotechnology, especially for animals, has dropped. He added that
American support for agricultural biotechnology is still higher than in
most of Europe. He stated data also show that most consumers have
serious concerns about meat and milk from cloned or transgenic animals,
because of people's concerns about animal pain and suffering and the
trend toward vegetarianism.

According to studies, U.S. consumers have heard the most about cloning
and hormones related to biotechnology. A large percentage of respondents
expressed the belief that cloning humans and animals is morally wrong.
Along with data on consumer's impressions of three different forms of
animal biotechnology, Dr. Hoban presented definitions of the three
forms: genomics, genetic engineering, and cloning.

Dr. Hoban stated that half of consumer respondents said they would be
unlikely to buy animal-derived food products enhanced through genetic
engineering even if FDA determined that the products were safe. He added
that U.S. consumers' belief that animal biotechnology is morally wrong
is the strongest explanatory factor for these views. More consumers find
nutrition-related applications in plants acceptable than find
applications involving animals or human genes.\
Regarding policies and regulations, Dr. Hoban showed that American
consumers express concerns over biotech risks, particularly of serious
accidents, and that they have doubts about the motives and management of
the creation of genetically engineered foods. Most Americans agree with
more FDA regulation of genetically engineered food, such as submission
of safety data for FDA review. He added that data indicate public
support for FDA's labeling policy has fallen in recent years.

Dr. Hoban then discussed several implications from the findings
presented. A key implication is that animal biotechnology is leading to
significant consumer concerns. Lack of regulations, ethical issues,
small size of companies, and lack of communication contribute to these
concerns. He also stated that USDA must respect the needs and concerns
of the food value chain, from processing, retail and service sectors.
Dr. Hoban provided suggestions for how to prevent future rejection of
biotechnology, focusing on concerns related to consumers, research and
development, the food industry, regulatory programs, and farmer
compliance. He concluded with a number of points for reflection,
emphasizing the role of emotions and perception in food attitudes and
stressed the need for more research and consultations for new products.

*Questions and Discussion*\
Ms. Toner and Dr. Hoban then responded to questions and comments from
the Committee. They clarified that similar studies on attitudes toward
organic foods showed general awareness is high and consumers have
generally positive impressions. Regarding the term cloning, they
acknowledged that consumers are less aware of the widespread use of
cloned plants.

A member inquired why consumer acceptance continues to decline even
after years of education about the benefits. Ms. Toner noted that the
high media coverage of potential negative risks and mixed messages to
consumers contribute to the decline. There was discussion, without
consensus, on whether press coverage of issues surrounding biotechnology
tends to be positive or negative.

In response to a question about the usefulness of "risk and safety"
explanations in consumer acceptance, the presenters noted that the moral
and ethical concerns need to be addressed and a "risk communication
model" adopted.

One member took issue with a comment made by Dr. Hoban which suggested
that in a particular instance meat from transgenic pigs entered the U.S.
food supply, suggesting that in fact the animals were "no-takes," i.e.,
animals used in transgenic research that had not taken up the transgenic
DNA and were not, in fact, transgenic. There was additional discussion
about existing policies relating to the appropriateness of no-take
research animals to be offered for slaughter for food.

Regarding whether consumer actions reflect the findings on consumer
opinions, Dr. Hoban noted that products with non-GMO labeling are likely
selling well, but little information exists on the impact of other
labeling regimes.

In response to a question about gender and race differences in
attitudes, the presenters noted that males are generally more accepting
of biotechnology than women, but researchers did not find significant
differences among races.

IX\. Discussion of Revised Draft Introduction to Report\
The Committee did not hold a substantive discussion of the draft
Introduction to the report during meeting. Members expressed differing
opinions on whether it would be better to draft the introduction before
or after the Committee completed other sections of the report. Because
of time constraints, the Committee agreed to set aside detailed
discussion of this section of the report (Chapters I and II) until the
September meeting. Some members expressed the view that the new
"benefits" section in the Chapter II draft needed to be shortened and
that some of the materials cited there would prove to be problematical.
This view was not shared by all members. The Committee agreed that no
further work would be conducted on the chapters until the substantive
discussions take place.

**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 two reports.

Some members requested clarification of the objectives of the report to
inform the work plan of the Committee. Dr. Schechtman referred members
to the current draft Introduction of the report, which states, "The
intent of this report is to help USDA understand the kinds of products
that may be coming, the sorts of issues that may be raised by them,
including those that may be raised through the success of new products
and new technologies, and help the Department plan for a range of
possible futures. The report, where appropriate, highlights issues and
choices that may confront USDA as the technology and its uses evolve.
Where specific recommendations are made by the AC21, they are
highlighted in the text." Several members commented that while the text
is not necessarily in the format of objectives, they concur with the
general concept of what the report should cover.

Dr. Schechtman also clarified that the report is intended to address the
status of current products to some extent, but focus primarily on future
products. On the topic of Committee recommendations, Dr. Slutsky noted
that the Committee may choose a different description of the format for
advice to the Department if that helps work move forward.

Next Steps for *Issues to Consider*

-   The Issues Work Group will elaborate on the set of issues identified
    by the Committee. For each issue, the Work Group will address four
    questions:

    -   What is the issue?

    -   Why it is important for USDA to consider?

    -   What is the current state of activity on the issue (if any)?

    -   Additional comments.

-   Additional members may be asked to participate in the drafting and
    further development of Chapter III. Michael Schechtman will divide
    up the identified issues and distribute them to drafters very soon
    in order that new material in that format can be discussed at the
    next conference call.

-   For other portions of the chapter, Michael Schechtman will prepare a
    new draft incorporating the most straightforward suggestions made
    during the plenary meeting. This will include the pending section on
    public research being prepared by Mardi Mellon and Duane Grant.

-   The Issues Work Group may re-word and combine issues to clarify and
    eliminate redundancies and overlaps, and may, if there is time,
    consider prioritization of issues.

-   After discussions via conference calls, the Issues Work Group will
    present the expanded descriptions of issues to the full Committee
    for discussion and prioritization of issues.

-   The Issues Work Group will also begin drafting the Implications
    section of Chapter III prior to the next plenary session, with input
    from the Committee.

Next Steps for *Preparing for the Future*

-   Michael Schechtman will prepare a new draft of the section on "What
    We Know/What is Less Certain" by incorporating the most
    straightforward suggestions made during the meeting. The Scenarios
    Work Group will review the revised draft.

-   The Scenarios Work Group will continue to develop the three
    scenarios. The Work Group will develop a common format for the
    scenarios to address a set of questions on the impact.

-   The Scenarios Work Group will draft the Implications section to
    highlight what is important for USDA to take away from the scenarios
    exercise.

Next Steps for the *Labeling and Traceability report*

-   Michael Schechtman will prepare a new draft of the Labeling and
    Traceability report incorporating the suggestions made during the
    meeting.

-   The Labeling and Traceability Work Group will draft the text of the
    Implications section prior to the September meeting.

Dr. Layton noted that for the next plenary session, the Committee will
have work products a week and a half prior to the meeting as well as
directed questions on each chapter for discussion.

*Meeting Dates*\
The specific dates for the September plenary meeting will be determined
soon, pending securing the meeting venue.

**XI. Summary of Fifth Plenary Session**\
Dr. Layton thanked Committee members for their hard work over the
two-day meeting, and adjourned the meeting at 4:00 p.m.

**ATTACHMENT 1: Issues to Consider**

Regulatory Issues

1.  The FDA voluntary pre-market notification regulatory system for
    plants.\
    a. Transparency\
    b. Confidence in adequacy for safety

2.  Clear pathway to commercialization for transgenic animals.

3.  Regulatory structure for plant-made pharmaceuticals (PMPs) and
    plant-made industrial products (PMIPs) in food crops (including
    containment issues).

4.  Regulatory system that can cover transgenic animals not used for
    food (specialty products).

5.  Lack of international consensus or harmonization on key standards
    and/or standardization of key requirements (e.g., adventitious
    presence).

6.  Federal pre-emption for purposes of domestic synchronization.

7.  Cost of regulatory compliance (particularly affecting minor crops).

8.  Applicability of current US standards for imported products.

9.  Continuous tension between process-based versus product-based
    regulatory philosophy.

10. Regulatory system establishing containment measures and procedures.

11. Adequacy of capacity building for establishing functional regulatory
    systems in other countries.

12. Regulatory system and process capable of rapid response to
    unforeseen products and events.

13. Increasing importance of co-existence between organic and
    genetically engineered products.

14. Confusion about impacts of the organic rule on transgenic products.

Commercial Issues

1.  Intellectual property

    a.  International recognition of intellectual property

    b.  Transaction costs

    c.  Market segmentation

    d.  Land grant universities' role associated with intellectual
        property

        i.  Role in creating public IP ownership

        ii. Role in technology transfer

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1.  Inability to capture value without adequate marketing freedom.

2.  The concept of biotech testing and the ability to detect.\
    a. Cost\
    b. Speed\
    c. Standards\
    d. Accuracy

3.  What is adequate or required for a certified IP system?

4.  Decisions by other countries to adopt systems under which market
    acceptance plays a deciding factor in regulatory approvals.

5.  Transparency of regulatory system to buyers from other countries.

6.  Availability of liability insurance along the food/feed chain.

7.  Need for the end seller to have a more definable position vis-à-vis
    any claim of harm arising out of presence of the biotech food
    material in a product.

8.  Inability of merchandizing system to respond to market demands for
    traceability.

9.  Confusion regarding organic rule and transgenic products.

10. Establishment of "acceptable zero" for adventitious presence.

11. Numerical tolerances in other countries being driven by
    technological capabilities.

12. Role of humanitarian use licenses in technology transfer to
    developing countries.

Consumer Issues

Notes: Discussion needs to address the different "consumers" (retailers,
processors, producers, individuals) and it should be explicit in
references as to which consumers are being discussed.

Also, in contrast with the lists from the other sections, it is not
clear that each of these (as originally written at the meeting or as
very slightly edited here) actually reflects an upcoming "issue", as
opposed to information to which the Committee may wish to alert the
Secretary's office. A number of these may need more work on improving
the issue statement. Also, #6 specifically was reworded for clarity, but
please check to be sure if the original intent was properly captured.

1.  Need for increased transparency on the part of multiple parties in
    the whole process of product research, development, regulation, and
    commercialization

2.  Significance of consumer decision making as driven by emotional and
    ethical considerations.

3.  Distinction between education and risk communication as tools for
    public involvement.

4.  Public participation and inclusiveness.

5.  Need for trust in an impartial regulatory system.

6.  How is consumer confidence influenced? Are regulatory systems
    amenable to consumer assurance?

7.  Broad future impacts of animal biotechnology.\
    a. Is the regulatory system inadequate for transgenic animals and
    will this impact confidence in the system for plant products?

8.  Impact of other global events on perceptions regarding
    biotechnology.

9.  Impact of retailers and their decisions with regard to
    biotechnology.

10. Are there differences between what people say (polls) and what they
    do (purchasing patterns)?

11. Factors affecting the individual purchasing decisions of shoppers.\
    a. Price\
    b. Taste\
    c. Convenience\
    d. Safety\
    e. Ethics\
    f. Concerns about globalization and concentration\
    g. Others

12. Value of marketing and the need for both sides of the equation
    (demand/pull and supply/push).