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

**Seventeenth Plenary Meeting**

**Washington, D.C.**

**Draft Meeting Summary**

On November 28-29, 2007, the United States Department of Agriculture
(USDA) convened the seventeenth plenary meeting of the Advisory
Committee on Biotechnology and 21^st^ Century Agriculture (AC21). The
meeting objectives were:

-   To complete all substantive work on a paper addressing the question,
    "What issues should USDA consider regarding coexistence among
    diverse agricultural systems in a dynamic, evolving, and complex
    marketplace?" and develop a plan for finalizing the paper and
    presenting it to the Office of the Secretary, USDA;

-   To discuss the new Biotechnology Quality Management System proposed
    by USDA's Animal and Plant Health Inspection Service and offer views
    on a series of questions relating to its implementation; and

-   To consider initial presentations to the committee on transgenic
    animals.

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. Fuller Bazer,
Ms. Nancy Bryson, Dr. Daryl Buss, Dr. Guy Cardineau, Mr. Leon Corzine,
Dr. Michael Dykes, Dr. Michael Engler, Mr. Bowen Flowers, Ms. Carol
Tucker-Foreman, Dr. Randal Giroux, Dr. Gregory Jaffe, Mr. Russell
Kremer, Dr. Margaret Mellon, Dr. Steven Pueppke, Dr. James Robl, Mr.
Jerome Slocum, Dr. Alison Van Eenennaam, and Ms. Stephanie Whalen. *Ex
officio* members Marcia Holden, National Institute for Standards and
Technology, Dr. Elizabeth Milewski, U.S. Environmental Protection
Agency, Mr. Adrian Polansky, Secretary of Agriculture for the State of
Kansas, and Mr. Paul Saxton, U.S. Department of State, also attended.
Dr. Michael Schechtman attended as Executive Secretary and Designated
Federal Official for the AC21. Ms. Cynthia Sulton of HW&W and Ms. Abby
Dilly and Ms. Kathy Grant of RESOLVE facilitated the meeting.

A full transcript of the proceedings was prepared and will be available
on the USDA website [www.usda.gov](http://www.usda.gov/) by clicking
"Agriculture" on the option bar at the left, then "Biotechnology" on the
option bar at the right, then on the committee name and this particular
meeting.

Below is a summary of the proceedings.

**I. Welcome, Committee updates, and meeting objectives**

Dr. Michael Schechtman opened the proceedings at 8:30 a.m. by welcoming
all the members and the public in attendance to the seventeenth meeting
of the AC21. He briefly introduced Dr. Patricia Layton, AC21 Chair and
facilitators Ms. Cynthia Sulton of the consulting firm HW&W and Ms. Abby
Dilley and Ms. Debbie Lee of the consulting firm RESOLVE.

Dr. Schechtman informed the Committee that USDA Chief of Staff, Mr. Dale
Moore, would be addressing the Committee to underscore the importance of
its work and to express the Department's appreciation. He also reminded
the Committee that Ms. Rebecca Bech, the Deputy Administrator for
Biotechnology Regulatory Services from USDA's Animal and Plant Health
Inspection Service (APHIS) would be soliciting the Committee's input on
a new voluntary program under development at APHIS, the Biotechnology
Quality Management System (BQMS).

Dr. Schechtman indicated that the Committee would work to complete its
paper addressing the impact of coexistence considerations for
agriculture. He also noted that the Committee would hear a series of
presentations that would provide background information relating to
transgenic animals in preparation for the Committee receiving its
initial charge on this topic.

Dr. Schechtman pointed out that several background documents were
available to the public, including:

-   The Official AC21 Committee Charter.

-   The AC21 Bylaws and Operating Procedures

-   A package of biographical sketches of all of the current AC21
    members, old and new.

-   The draft meeting summary prepared from the sixteenth AC21 meeting,
    held on August 1-2, 2007.

-   A draft workgroup summary prepared from the discussions of a small
    group which met on September 17, 2007.

-   Two packages of USDA press releases and statements: one relating to
    the announcement by APHIS, of its general plans for the BQMS, and a
    second relating to the conclusion of its investigations of the
    unintended low-level presence of LL rice in the US long-grain rice
    supply and the lessons learned as a result of that investigation.

-   The earlier three reports that were developed by consensus in 2005
    and 2006.

Documents specific to this meeting include:

-   The provisional agenda for this meeting.

-   A document from APHIS describing in more detail some of their
    current thinking on the Biotechnology Quality Management System that
    they are developing.

-   The most recent compilation of comments on the coexistence paper
    under development.

-   A draft of the paper prepared by staff and facilitators, which
    attempts to capture comments intended to clarify the text and
    suggests some possible language in places where there are still
    different points of view among committee members.

Dr. Layton welcomed the Committee and acknowledged the challenge of
completing the coexistence paper. She encouraged the Committee to
continue offering honest feedback and constructive alternatives to
sections of concern.

**II. Review of August Meeting Minutes and Agenda Outline**

Ms. Sulton reviewed the draft meeting summary for the sixteenth AC21
meeting held August 1-2, 2007. She asked the Committee to provide
comments within two weeks in order to finalize the summary, which will
be posted on the USDA AC21 website.

Ms. Dilley reviewed the agenda and noted that the primary focus of the
meeting would be completion of the paper on coexistence.

**III. Remarks from the Office of the Secretary and discussion**

Dr. Layton introduced Mr. Dale Moore, Chief of Staff, and Mr. Jeremy
Stump, Senior Advisor on Biotechnology. Mr. Moore emphasized the
importance of biotechnology to USDA and the excitement about the
direction the technology is taking, including the new frontier of
transgenic animals. He noted that in order to move forward on policy
related to transgenic animals, it will be important to assure the public
of the efficacy and safety of this technology.

Mr. Moore explained that a USDA Advanced Notice of Proposed Rulemaking
(ANPR) on transgenic animals is currently making its way through the
process required by the Federal Administrative Procedures Act. Once the
process is completed and related interagency discussions are concluded,
the Department will be seeking the Committee's comments, to help address
such issues as how regulatory authority should be apportioned among
various federal and state agencies and the implications of having
transgenic livestock animals for non-food use. He noted the challenge of
working under current legislative authorities, none of which were
designed specifically to handle biotechnology.

In the discussion that followed, two Committee members urged USDA to
seek input on its policy from a broad range of stakeholders. One member
suggested that the Department hold public hearings before the agency
takes a position on transgenic animals.

A member suggested that USDA consider asking Congress to enact new
legislation that would address current and anticipated advances in
biotechnology.

During the discussion, Mr. Moore made the following additional points:

-   USDA will reach out to a broad range of interested stakeholders for
    input on its proposed policy.

-   In formulating its policy, USDA will look at recommendations related
    to transgenic animals from previous USDA committees.

-   The government's role in regulating biotechnology is to ensure the
    public safety and environmental safety of the products of the
    technology. It is not the government's role to regulate issues
    related to the efficacy of the products or consumer preferences.

-   The Administration has taken a cautious approach on animal cloning
    and the topic is a sensitive one.

-   The ANPR on transgenic animals would be specific to USDA and would
    not include rulemaking for other federal agencies.

-   The Administration's proposed Farm Bill includes funding for
    technical assistance and resources to gather data to help address
    trade barriers for small market crops.

**IV. Review of Draft Paper on Coexistence**

Dr. Schechtman introduced the discussion of the coexistence paper by
reviewing the work done on the paper since the last plenary session.
After the August plenary, a small work group of interested AC21 members
participated on a conference call convened to work on the "Potential
Factors Inhibiting Coexistence" section of the paper. After the call,
Dr. Schechtman and the facilitators prepared a new draft of the paper,
which included both the outcomes of the August plenary and the
suggestions of the work group. This draft was sent first to the work
group and then to the whole Committee for comment. After receiving the
Committee's comments, Dr. Schechtman and the facilitators created two
new documents: one a compilation of comments from several previous
versions of the paper; and one a document that incorporates recommended
changes and offers potential options for bridging different points of
views. He noted the concessions made by different members to achieve a
more concise and focused version of the paper.

Dr. Schechtman stated that from his perspective the Committee was in
general agreement that, for the most part, farmers are currently able to
provide for their customers and for U.S. consumers. Consequently, U.S.
agriculture continues to enjoy substantial success in each of the three
production systems under discussion. He also acknowledged that there is
not absolute unison about how easy it is at present for various segments
in the food chain to achieve success, how fairly burdens are
distributed, and what challenges the future holds. Dr. Schechtman
emphasized the value to USDA of a paper that works through these points,
including the divergent points of view of different stakeholders. He
also conveyed his view that consensus would not be reached if the paper
suggests that there will be no tensions related to coexistence as U.S.
agriculture moves forward. He encouraged the Committee to work with a
spirit of compromise and cooperation to finish the paper.

The Committee then directed their discussion of the draft paper on
coexistence. They worked on the version of the document that
incorporated recommended changes and discussed each section of the draft
paper: Introduction, Overview, Factors Enabling Coexistence, Factors
Enabling Coexistence, Factors Inhibiting Coexistence, and Issues for
USDA to Consider. During the discussion, Committee members agreed on
additions and deletions to the document, rearrangement of bullets and
other text, and revisions to the existing language.

The Committee also requested that Dr. Schechtman and the facilitators
make the following additional changes to the text after conclusion of
the meeting and before the paper is sent to the Committee for final
approval:

1)  Add definitions for "customer" and "consumer."

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1)  Search the document for uses of "conventional" and "commodity" in
    connection with the words "production systems."  Where appropriate,
    change references to "production systems" to "crops."

2)  Update the sentence describing the content of the paper.

3)  Review the finished paper to see if the balance between the factors
    enabling coexistence and the factors potentially inhibiting
    coexistence is appropriate.

4)  Make minor edits as needed.

5)  Add an Appendix relating to the members on the AC21.

The provisional final draft of the coexistence paper, which incorporates
all of the changes made by the Committee during the meeting can be found
in Attachment A.

Dr. Schechtman noted that he will contact the four members who are
absent from the meeting and offer to set up a conference call to review
changes to the paper.

**V. USDA's Animal and Plant Health Inspection Service Biotechnology
Quality Management System**

Dr. Schechtman introduced Ms. Rebecca Bech, Deputy Administrator for
Biotechnology Regulatory Services at the Animal and Plant Health
Inspection Service (APHIS), and reminded the Committee of the three
questions APHIS she posed to the Committee at its previous plenary
session:

-   What incentives could be developed to increase participation by
    industry and academia?

-   What information about the program should be developed and included
    in an outreach strategy?

-   How might such a system be utilized internationally?

    -   to assist trading partners understand the US regulatory system?

    -   to increase confidence of trading partners in US agricultural
        products?

    -   to increase biotechnology regulatory capacity in other
        countries?

Ms. Bech introduced Mr. Tom Sim, Director for Biotechnology Regulatory
Services, Regulatory Operations Division, APHIS, who gave an overview of
the Biotechnology Quality Management System (BQMS). Mr. Sim explained
that BQMS is a voluntary, compliance assistance and outreach program
intended to help industry improve compliance, increase transparency, and
emphasize proactive measures for preventing compliance infractions. The
goal of the program is to implement continuous improvement of best
management practices for the controlled importation, movement, research
and field testing of regulated articles. The program will apply only to
specific activities covered by USDA-APHIS regulations and will involve a
continuous system of monitoring and verification.

Mr. Sim then described the two-level approach the program will take:
Level A will be based on principles and guidelines of the
internationally recognized Codex Alimentarius Commission *Guidelines for
the Application of the Hazards Analysis and Critical Control Point
System.* This level most likely will be used by academics and small
businesses. Level B will be based on the principles and guidelines of
the internationally recognized International Organization for
Standardization (ISO). This level most likely will be used by large
corporations that have the resources needed to achieve ISO
certification. He noted that the BQMS will be similar to the Grain
Inspection, Packers and Stockyards Administration's Process Verified
Program and Agricultural Marketing Service (AMS) National Organic
Program's Audit Program. He also stated that the APHIS BQMS will not be
a substitute for complying with APHIS biotechnology regulations nor
would it be linked to a specific APHIS-issued permit.

Mr. Sims explained the status of the implementation of BQMS program.
APHIS has had discussions with the Biotechnology Industry Organization,
the American Seed Trade Association, the Association of Seed Certifying
Agencies, and the National Plant Board. Draft guidance is being
developed for review in January, 2008 by interested parties. APHIS is
considering a pilot developmental project for 2008 and will include a
small number of potential participants to assist with the development of
the system.

In response to questions from the Committee, Ms. Bech and Mr. Sim made
the following additional points:

-   Level A of the program would include the basic process control
    activities that all of industry and academia should be implementing;
    Level B would involve additional management processes for those with
    the resources to implement them.

-   Most importantly, the BQMS will focus on proactive measures for
    preventing, for example, inadvertent spills and unauthorized
    releases.

-   There will also be value to the outreach efforts associated with the
    BQMS. Given the prospective changes in the regulatory system and the
    fact that the new start-up companies and universities are entering
    the field, there will be a real need to help everyone understand the
    new regulatory framework.

-   Although the compliance rate is currently over ninety percent, APHIS
    still sees room for improvement. However, APHIS cannot rely just on
    inspections to improve compliance. With the increasing number of
    field trials, sites, and states involved and without the resources
    to increase the number of inspectors, APHIS has to build in multiple
    layers of safeguards, including the BQMS.

-   APHIS intends to post the draft guidance on its website and seek
    feedback from a broad group of people. They also plan to schedule
    feedback sessions in different parts of the country.

-   APHIS is considering suggesting that universities set up safety
    committees to interface with the companies with whom they contract.

-   APHIS is looking at several options for conducting audits, including
    (with?) the Agricultural Marketing Service, the American Seed Trade
    Association, and BIO.

-   APHIS has had conversations with Canada and Mexico about the BQMS
    and received inquiries from Japan and the Philippines.

Committee members offered the following suggestions for adjusting the
BQMS program:

-   Consider having only one level with basic standards that, if met,
    will achieve the intended outcome.

-   Consider whether participation in BQMS should have some effect on
    permit applications under the National Environmental Policy Act.

-   Provide more information to the public about the number of
    compliance infractions as a way to build support for the use of
    taxpayer money for BQMS.

-   To build credibility in the international marketplace, consider
    having the standards for BQMS developed by an independent
    standards-writing organization.

-   Take into consideration the increased cost to universities of the
    added layer of compliance and recordkeeping.

-   Consider possible value propositions to provide universities
    incentives for participation; e.g., allow universities to highlight
    their participation on stationery, link participation in the BQMS to
    the awarding of grants, allow money spent for the additional
    laboratory personnel needed to meet the standard to be considered as
    direct costs.

-   Ensure that the BQMS procedures are not duplicative of other USDA or
    other federal processes.

-   Because of the great risk to U.S. agriculture from compliance
    failures, consider making the program mandatory.

Ms. Bech invited Committee members to send any additional comments and
suggestions to APHIS.

**VI. Presentations on Transgenic Animals**

Dr. Schechtman explained that USDA has modified its plan to present
initial charges to the Committee on transgenic animals for several
reasons, including the ongoing internal discussions on the topic among
various government agencies and the pending confirmation of a new
Secretary. To prepare for working on this topic, the Committee will hear
a series of presentations, two by Committee members and three by outside
speakers, on background information and perspectives related to
transgenic animals.

(NOTE: All of the PowerPoint presentations will be available on the USDA
website [www.usda.gov](http://www.usda.gov/) by clicking on
"Agriculture" on the option bar at the left, then "Biotechnology" on the
option bar on the right, then on the Committee name and this particular
meeting.)

**A.** [Dr. Fuller Bazer and Dr. James Robl, AC21: "Science and
developments in transgenic animal engineering and assisted reproduction
technologies"]{.underline}

Dr. Schechtman introduced Dr. Fuller Bazer and Dr. James Robl, both AC21
members. Dr. Bazer is a distinguished professor and O.D. Butler Chair of
the Department of Animal Science, a Regents Fellow and Associate
Vice-President for Research at Texas A&M University. Dr. Robl is
President and Chief Scientific Officer for the animal biotechnology
company Hematech, based in Sioux Falls, South Dakota.

Dr. Bazer began the presentation by giving an overview of the history of
animal biotechnology and a summary of emerging technologies. He noted
established practices and emerging technologies related to: breeding and
genetics; reproductive management; and gamete and embryo manipulations.
He particularly highlighted several emerging technologies, including
sperm-mediated gene transfer, ectopic DNA constructs, marker-assisted
selection, and genome signal processing. Dr. Bazer closed his portion of
the presentation with a brief summary of the research- and farm-level
applications of animal cloning.

Dr. Robl focused his presentation on primary cell-mediated gene
transfer, or gene transfer by embryonic cloning. He noted that Hematech
uses embryonic cloning to select out transgenic cells from cell
populations and to rejuvenate those cells so that successive
modifications are possible within one cell line. Dr. Robl highlighted
two examples of how embryonic cloning is being used: gene targeting to
stop and inactivate genes and microchromosome transfer. Dr. Robl
explained that these complex modifications are being used to develop
human therapeutics in animals and for agricultural applications. He
noted however, that after many years of activity in this area, it was
not until last year that the first product was approved for a
therapeutic application in Europe. The product is awaiting approval in
the U.S.

In answer to questions from the Committee, Dr. Bazer and Dr. Robl made
the following points:

-   In the pups of female mice or rats injected with ectopic DNA, there
    is an increase in the cells in the pituitary that produces growth
    hormone in prolactin. Dr. Bazer was unsure if this was a genetic or
    environmental effect. He noted that there was no genetic transfer in
    the procedure, just a hormonal change.

-   Pre-implantation genetic diagnosis is performed when approximately
    120 to 200 cells have developed. There is no harm to embryos from
    this procedure.

-   Several agricultural applications of the technology, such as
    engineering animals to produce spider silk, were pursued by industry
    but seem to have been dropped: at this point, industry is not
    actively seeking to commercially market them. Commercial effort is
    focused on therapeutic applications.

-   The barrier to commercialization of agricultural applications seems
    to be the regulatory pathway and the potential consumer response,
    rather than the technology.

-   The types of modifications that would be required to produce a
    consumer benefit, such as lower cost or better taste, are very
    costly. There are few that could be done without harm to the animal.

-   To the best of Dr. Bazar's knowledge, the only commercial species
    that can undergo homologous recombination successfully is salmon.
    Dr. Robl noted that the efficiency for homologous recombination is
    somewhere from a fraction of a percent to 50%, depending on the
    specific genes and whether you are turning one allele or second
    alleles. In order to reach that level of target and efficiency, the
    length of the homology sequence is about 10,000 with the short arm
    and the long arm.

An AC21 member noted one industrial application of the technology: the
biodefense company PharmAthene is producing, under a Defense Department
contract, a broad spectrum chemical, Protexia®, from the milk of
transgenic goats for prophylactic human treatment against nerve agents.
She also mentioned an aquacultural application involving salmon that is
going through the regulatory process.

**B.** [Fred Degnan, J.D., King and Spalding: "Current status of
regulations for transgenic animals and foods derived from
them"]{.underline}

Dr. Schechtman introduced Mr. Fred Degnan, a partner at the law firm
King & Spaulding. Prior to joining King & Spaulding, Mr. Degnan served
for 11 years as the FDA's Associate Chief Counsel for Food in the FDA
Office of Counsel. He also is the General Counsel for the Food and Drug
Law Institute. Mr. Degnan's presentation covered three main topics:
background on the Coordinated Framework for the Regulation of the
Products of Biotechnology; a brief overview of USDA authorities over
transgenic animals; and a detailed description of FDA\'s regulatory
authorities under the so-called "new animal drug" rubric for transgenic
animals.

Mr. Degnan stated that the fundamental theme of the Coordinated
Framework is that federal agencies can use existing statutory
authorities to regulate products of biotechnology. He also noted that
the Council on Environmental Quality concluded in 2001 that the new
animal drug rubric was the logical primary mechanism for control and
entry into other possible regulatory control systems.

Mr. Degnan then summarized USDA's pre- and post-market authorities under
the Animal Health Protection Act (APHA), the Animal Damage Control Act
(ADCA), the Animal Welfare Act (AWA), and the Meat, Poultry and Egg
Inspection Act. He stated that APHA could apply to transgenic animals
containing a "pest," such as a virus. APHA could also provide a basis
for a "permit" system for field trials, as well as for the development
of a tracking and identification system for GE livestock. The ADCA
provides authority to control animals derived through biotechnology
should they prove injurious to agriculture, the environment, or public
health or safety. USDA's Food Safety and Inspection Service has
authority over the products of transgenic animals through the
adulteration provisions of the Meat, Poultry and Egg Inspection Acts.

Mr. Degnan summarized key elements, definitions, and exceptions included
in FDA's new animal drug rubric, which focuses on the safety of the
animal, the safety of any food produced by the animal, and the
effectiveness of the drug. He noted that the New Animal Drug Act (NADA)
goes into effect at the point clinical research begins on a new animal
drug unless the drug is generally recognized by qualified experts as
safe and effective for its intended use.

In answer to questions from the Committee, Mr. Degnan made the following
points:

-   The courts give great deference to FDA's expertise; challenges of
    the agency's decisions have so far been unsuccessful.

-   It would be helpful if there was transparency about the criteria and
    guidance FDA uses to evaluate new animal drugs.

-   In the new animal drug rubric, "intended use" is broadly
    interpreted. It is likely that FDA would want assurances that
    food-producing animals used only for the production of drugs will be
    destroyed and will not enter the human food supply chain.

AC21 members noted that the approval process for a new animal drug is
not, by law, open to the public review or input, unless the drug sponsor
chooses to make the application public. At the point of approval, FDA
provides a summary of the data used to support that approval. However,
there is no opportunity for the public to review the scientific data and
provide input into FDA's decision. They also noted that animals exposed
to drugs during the investigative phase can be authorized for food use.

**C.** [Dr. Michael Engler, AC21: "New animal technologies and animal
producers"]{.underline}

Dr. Schechtman introduced Dr. Michael Engler, an AC21 member and
President and Chief Executive Officer of Cactus Feeders, the largest
cattle feeding operation worldwide. Previously, he was on the faculty of
the Department of Biochemistry and Molecular Biology at the University
of Texas, Houston.

Dr. Engler began his presentation by stating that he does not expect
livestock and poultry producers to embrace genetically engineered
animals for food production without consumer acceptance of the
technology. Consumers will base their acceptance on perceived benefits
to them, i.e. the food is safer, more wholesome, or better tasting. Dr.
Engler stated his belief that it will be most difficult to make the case
that food from transgenic animals is more wholesome, because consumers
equate wholesomeness with terms such as unaltered, natural, or organic.
He noted that genetic engineering could improve the safety of food by
increasing animals' resistance to disease or reducing their reservoirs
of foodborne pathogens. There are more limited possibilities for
improving nutrition and consistency in taste with this technology.

Dr. Engler then offered his opinion that poultry producers are most
likely to be first to use genetic engineering for food production,
particularly to produce poultry that are resistant to avian flu. He
expects hog producers to follow, noting work on the Enviro-Pig (which
allows for more efficient animal uptake of phosphorus in feed), and
cattle producers to be last to use the technology.

In answer to questions from the AC21, Dr. Engler made the following
points:

-   It is not known at this point whether reducing the fatty acid
    content of meat (to improve human health) would affect the taste of
    the meat.

-   The reduction of reservoirs of pathogenic *E. coli* in cattle could
    also be accomplished with a vaccine. However, the vaccine is not
    approved yet in the United States. It also is very expensive and
    only marginally effective.

-   There are several reasons why the cattle industry will lag behind
    others in adopting genetic engineering, including: less vertical
    integration; lower birth rates; smaller herd sizes; and longer
    intervals between generations. The dairy industry, which generally
    adopts technology more readily, may be an exception.

One Committee member questioned the need to devote resources to
transgenic animals given the huge accomplishments that have been and can
be made through traditional breeding. This member suggested that perhaps
the better course would be to develop the technology primarily for
research purposes.

A Committee member suggested that a barrier to the adoption of animal
transgenics is the ability to substitute other, often less expensive,
technologies to get the same results. The one exception may be in the
production of pharmaceuticals where the profit margins could be greater.
In addition to pharmaceutical applications, another member pointed to
the value of using genetically engineered animals to improve the
efficiency of animal production systems.

**D.** [Dr. Michael Fernandez (formerly Executive Director, Pew
Initiative on Food and Biotechnology): "Consumer reactions to products
of new animal technologies"]{.underline}

Dr. Schechtman introduced Dr. Michael Fernandez, the former Executive
Director of the Pew Initiative on Food and Biotechnology, which ended in
March 2007. Previously, Dr. Fernandez was the Associate Administrator of
USDA's Agricultural Marketing Service. Dr. Fernandez provided a summary
of Pew polling data from 2001 to 2006 about consumer reaction to
genetically modified food, transgenic animals, and animal cloning. The
following are highlights from the surveys:

-   There is not a lot of awareness about genetically engineered (GE)
    foods or transgenic animals; there is more awareness about cloning;

-   Women are particularly wary of eating GE foods and significantly
    more uncomfortable than men with animal cloning;

-   The more people know about transgenic animals the less they oppose
    them;

-   Most of those uncomfortable with cloning cite religious, ethical, or
    safety concerns; those who favor cloning gave "support scientific
    advancement" and "lower the price of food" as their top reasons for
    doing so;

-   People think improving the health of animals is the best reason to
    genetically modify animals;

-   People strongly favor government regulation of food products from
    transgenic animals, but not an outright ban; there is no gender
    difference on this point; and

-   A strong majority of people (63%) think moral and ethical
    considerations should be part of regulatory decisions about cloning.

In answer to questions from the AC21, Dr. Fernandez made the following
points:

-   In the Pew polling, it is customary for questions to be phrased
    differently in different surveys; however it is not routine to
    rephrase the same question within a single survey.

-   The polling data was not able to determine:

    -   Regional differences in opinion

    -   The nature of people's concern about safety

-   The telephone polling was done with roughly one thousand people, so
    there is a fair degree of confidence, i.e., a three percent margin
    of error.

-   The survey did show differences in opinion across income levels and
    education levels.

Dr. Fernandez told the AC21 that all the polling data, as well as papers
and presentations at workshops sponsored by the Pew Initiative, is
available online at
<http://www.pewtrusts.org/our_work_detail.aspx?id=442>. In the future,
the information will be housed at the Pew Charitable Trust website.

**E.** [Dr. Paul Thompson, W.K. Kellogg Chair, Department of Philosophy,
Michigan State University: "Social and ethical issues around animals
produced using modern reproductive technologies"]{.underline}

Dr. Schechtman introduced Dr. Paul Thompson, Professor and W.K. Kellogg
Chair in Agricultural, Food and Community Ethics in the Department of
Philosophy, with partial appointments in the Agricultural Economics and
Resource Development Departments at Michigan State University. Dr.
Thompson began by noting that his presentation is not based on formal
public opinion polls but rather on the work of philosophers,
theologians, and others who have written or spoken about the ethically
compelling or problematic issues arising from the use of technology,
including animal biotechnology.

Of several possible topics, Dr. Thompson focused particularly on two of
the most difficult ethical issues, animal welfare and "unnatural"
animals. He stated that even though there could be ethical reasons to
use technology (for example, to reduce stress or increase resistance to
disease), for some people, the issue of animal welfare or changing an
animal's nature provides a more compelling ethical argument against the
technology. A third angle on the ethical issues related to the use of
technology with animals is the view by some that animal scientists and
the livestock industry will do anything to protect profits.

In answer to questions from the AC21, Dr. Thompson made the following
points:

-   The European regulatory system does involve ethical advisory
    committees, but it is unclear the extent to which ethical
    considerations play into regulatory decisions.

-   Sheila Jasanoff, a scholar at Harvard University, and colleagues
    produced a paper for the Pew Initiative on Food and Biotechnology,
    "Engineering Animals: Ethical Issues and Deliberative Institutions,"
    about the relationship between government and ethics of animal
    genetic engineering. (Note: The paper is available online at
    <http://www.pewtrusts.org/uploadedFiles/wwwpewtrustsorg/News/Press_Releases/Food_and_Biotechnology/PIFB_Ethics_and_Biotech.pdf>)

-   There is value in using a European style ethical advisory committee
    or the President's Council on Bioethics to summarize for the public
    the range of ethical views on issues related to animal
    biotechnology.

-   The ethical arguments against animal cloning are weaker than those
    against animal transgenics. However, some people believe life begins
    at conception and cloning is therefore unnatural.

**VII. Public Comment**

There were no comments from the public at the meeting.

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

The AC21 discussed and agreed to the following steps for finalizing the
paper on coexistence:

1)  [December 12^th^]{.underline}: Michael Schechtman and facilitators
    will distribute for review a revised draft coexistence paper with
    the integration of the comments and conclusions reached. Members
    will review document for errors of fact or points that prevent
    "sign-on" -

2)  [December 21^st^]{.underline}: All comments are due on the draft
    coexistence paper. Any member who does not respond will be presumed
    to be comfortable with the report as drafted and will be included in
    the roster of members who have "signed-on."

3)  [January]{.underline}: Upon review of all comments, a schedule will
    be proposed for addressing any remaining issues that need to be
    addressed. A draft cover letter will be circulated for review and
    comment.

4)  [February -- March]{.underline}: The coexistence paper will be
    finalized and delivered to the Secretary in conjunction with the
    next full Committee meeting (if schedules permit).

**VIII. Conclusion**

Dr. Layton thanked Committee members for their work during the meeting
and adjourned the meeting at 4:00 p.m.

Attachment A: Draft Coexistence report after November 28-29, 2007

AC21 plenary session